The 2010 Nagoya Protocol on Access and Benefit-Sharing in Perspective : Implications for International Law and Implementation Challenges [1 ed.] 9789004217201, 9789004217195

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The 2010 Nagoya Protocol on Access and Benefit-sharing in Perspective

Legal Studies on Access and Benefit-sharing Series Editors

Elisa Morgera Matthias Buck Elsa Tsioumani

VOLUME 1

The titles published in this series are listed at brill.com/labs

The 2010 Nagoya Protocol on Access and Benefit-sharing in Perspective Implications for International Law and Implementation Challenges Edited by

Elisa Morgera Matthias Buck Elsa Tsioumani

Leiden  • boston 2013

Library of Congress Cataloging-in-Publication Data The 2010 Nagoya Protocol on Access and Benefit-sharing in perspective : implications for international law and implementation challenges / Edited by Elisa Morgera, Matthias Buck, Elsa Tsioumani.    p. cm. — (Legal studies on access and benefit-sharing ; v. 1)  Includes bibliographical references and index.  ISBN 978-90-04-21719-5 (hardback : alk. paper) — ISBN 978-90-04-21720-1 (e-book) 1. Biodiversity conservation—Law and legislation. 2. Nature conservation—Law and legislation. 3. Renewable natural resources—Law and legislation. 4. Sustainable development—Law and legislation. 5. Convention on Biological Diversity (1992). Protocols, etc., 2010 Oct. 29. I. Morgera, Elisa. II. Buck, Matthias. III. Tsioumani, Elsa.   K3488.N34 2012   344.04’6—dc23

2012033842

ISSN 2213-493X ISBN 978-90-04-21719-5 (hardback) ISBN 978-90-04-21720-1 (e-book) Copyright 2013 by Koninklijke Brill NV, Leiden, The Netherlands. Koninklijke Brill NV incorporates the imprints Brill, Global Oriental, Hotei Publishing, IDC Publishers and Martinus Nijhoff Publishers. All rights reserved. No part of this publication may be reproduced, translated, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior written permission from the publisher. Authorization to photocopy items for internal or personal use is granted by Koninklijke Brill NV provided that the appropriate fees are paid directly to The Copyright Clearance Center, 222 Rosewood Drive, Suite 910, Danvers, MA 01923, USA. Fees are subject to change. This book is printed on acid-free paper.

Contents List of Contributors  . .................................................................................. ix List of Figures and Tables  ......................................................................... xix List of Abbreviations  . ................................................................................ xxi Table of Legal Materials  ............................................................................ xxiii Table of Cases  ............................................................................................. xxxv Preface  .......................................................................................................... xxxix   Braulio Dias, Executive Secretary of the Convention on Biological Diversity Acknowledgements  .................................................................................... xli Introduction  ................................................................................................ Elisa Morgera, Matthias Buck and Elsa Tsioumani

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PART I – IMPLICATIONS FOR INTERNATIONAL LAW Chapter 1.  The Nagoya Protocol on Access and Benefit-sharing: Innovations in International Environmental Law  . .......................... Lyle Glowka and Valérie Normand

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Chapter 2.  The International Human Rights Law Implications of the Nagoya Protocol  .............................................................................. Annalisa Savaresi

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Chapter 3.  An Analysis of the Relationship between the Nagoya Protocol and Instruments related to Genetic Resources for Food and Agriculture and Farmers’ Rights  ................................................. Claudio Chiarolla, Sélim Louafi and Marie Schloen Chapter 4.  A Healthy Look at the Nagoya Protocol—Implications for Global Health Governance  . ........................................................... Marie Wilke

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vi   Contents Chapter 5.  The Law of the Sea: A before and an after Nagoya?  .......... 149 Charlotte Salpin Chapter 6.  The Nagoya Protocol and WTO Law  . .................................. 185 Riccardo Pavoni

PART II – REGIONAL PERSPECTIVES ON IMPLEMENTATION CHALLENGES Chapter 7. Implementing the Nagoya Protocol in Africa: Opportunities and Challenges for African Indigenous Peoples and Local Communities  ........................................................................... 217 Peter Munyi and Harry Jonas Chapter 8.  An Asian Developing Country’s View on the Implementation Challenges of the Nagoya Protocol  .......................... 247 Gurdial Singh Nijar Chapter 9.  Challenges in the Implementation of the Nagoya Protocol from the Perspective of a Member State of the European Union: The Case of Spain  ........................................................................ 269 Alejandro Lago Candeira and Luciana Silvestri Chapter 10. Implementation of the Nagoya Protocol in JUSCANZ Countries: The Unlikely Lot  .................................................................... 295 Geoff Burton Chapter 11.  The Implementation of the Nagoya Protocol in Latin America and the Caribbean: Challenges and Opportunities  ............................................................................................. 331 Jorge Cabrera Medaglia

PART III – CROSS-CUTTING IMPLEMENTATION CHALLENGES Chapter 12.  The Implications of the Nagoya Protocol for the Ethical Sourcing of Biodiversity  . ......................................................................... 371 María Julia Oliva

Contents   vii

Chapter 13.  Governing Global Scientific Research Commons under the Nagoya Protocol  ................................................................................. 389 Tom Dedeurwaerdere, Arianna Broggiato, Selim Louafi, Eric W. Welch and Fulya Batur Chapter 14.  The Role of Private International Law under the Nagoya Protocol  ........................................................................................ 423 Claudio Chiarolla Chapter 15.  An International Cooperation Perspective on the Implementation of the Nagoya Protocol  .............................................. 451 Tomme Rosanne Young Conclusions  .................................................................................................... 507 Elisa Morgera, Matthias Buck and Elsa Tsioumani Bibliography  ................................................................................................... 517 Index  ................................................................................................................ 535

List of Contributors Fulya Batur holds an LLB in Law from the Université Catholique de Louvain, and an LLM in Public International Law from University College London. She is currently a PhD fellow at the Governance of Biodiversity Unit of Université Catholique de Louvain undertaking research on the institutional needs of agricultural biodiversity-related innovation chains, linking intellectual property schemes and other enclosure-oriented regulatory tools with concrete fields of application, ranging from molecular plant breeding to mass selection. Arianna Broggiato is a post-doctoral researcher in the Governance of Biodiversity Unit of the Université Catholique de Louvain, in Belgium, and a member of the International Council of Environmental Law. She holds an LLM in Environmental Law (Nottingham University) and PhD in International Law (Universita’ degli Studi di Milano). Her PhD dissertation focused on the legal regime on marine genetic resources beyond national jurisdiction. She had worked at the European Academy of Bolzano, the European Commission (DG MARE), and the European Bureau for Conservation and Development. She attended several intergovernmental meetings focusing on genetic resources, such as the United Nations Ad Hoc Open-ended Informal Working Group to study issues relating to the conservation and sustainable use of marine biological diversity beyond areas of national jurisdiction and the Commission on Genetic Resources for Food and Agriculture of the Food and Agriculture Organisation of the United Nations (FAO). Matthias Buck works with the European Commission, DG Environment. He was the main EU negotiator of the Nagoya Protocol from 2007 to its adoption in October 2010. He is one of the founders and editors of the Journal for European Environmental and Planning Law (Brill ). Recent publications include: with Clare Hamilton. “The Nagoya Protocol on Access and Benefitsharing.” Review of European Community and International Environmental Law 20 (2011): 47; “The Main Results of the Ninth Conference of the Parties to the Convention on Biological Diversity.” Journal for European Environmental and Planning Law 5 (2008): 249; “Making EU International

x   List of Contributors Environmental Policy,” In The New Economic Diplomacy, edited by Nicholas Bayne, and Stephen Woolcock. Surrey: Ashgate, 2007; and “The EU’s Representation in Multilateral Environmental Negotiations After Lisbon.” In The External Environmental Policy of the European Union: EU and International Law Perspectives, edited by Elisa Morgera. Cambridge: Cambridge University Press, 2012. Geoff Burton is an adjunct senior fellow of the United Nations University, Institute of Advanced Studies (UNU IAS). In 2010, on behalf of the UNU, he coordinated and represented the interests of public research institutions in the negotiations for the Nagoya Protocol. In late 2009, he chaired the inaugural UNU IAS ABS Business and Science Dialogue in Jakarta. He was formerly Australia’s competent national authority on access and benefitsharing (ABS) under the Convention on Biological Diversity (CBD) and lead negotiator on ABS issues from 1999 to 2006. He played a significant role in the negotiations of the Bonn Guidelines and co-chaired the first round of CBD negotiations on an international regime on genetic resources. Within Australia, Mr Burton developed national ABS policy and law, and oversaw the establishment of Australia’s national ABS system. Jorge Cabrera Medaglia is professor of environmental law at the University of Costa Rica. He is also legal adviser to the National Biodiversity Institute of Costa Rica, and lead counsel on international sustainable biodiversity law to the Centre for International Sustainable Development Law based in Canada. He acted as Co-chairman of the Expert Panel on Access and Benefit-sharing of the CBD (1999 to 2001) and Chairman of the Sub-working Group on intellectual property rights and capacity building during the first meeting of the CBD Working Group on Access and Benefit-sharing (Bonn, 2001). He represented Costa Rica in several stages of the Protocol negotiations meetings, including at the tenth meeting of the Conference of the CBD Parties (Nagoya, 2010), and at the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore of the World Intellectual Property Organisation. He contributed to the drafting of several biodiversity or ABS laws and ABS contracts in Costa Rica, Nicaragua, Panama, El Salvador, Chile, Dominica, Bhutan, Seychelles, Honduras, Paraguay, etc. He was one of the experts contributing to the Explanatory Guide to the Nagoya Protocol of the International Union for Conservation of Nature (IUCN). Claudio Chiarolla is research fellow on international governance of biodiversity at the Institute for Sustainable Development and International Relations, Paris. Since February 2011, Claudio is also Maîtres de conferences in

List of Contributors   xi

public international law at the Paris School of International Affairs, Sciences Po. Since October 2007, he has worked for the International Institute for Sustainable Development (IISD) as a writer and editor of the Earth Negotiations Bulletin. His publications include: Intellectual Property, Agriculture and the Global Food Security: The Privatisation of Crop Diversity. Cheltenham: Edward Elgar, 2011; with Mireille Jardin, “Implications of the Nagoya Protocol.” Environmental Policy and Law 41 (2011): 70; “Plant Patenting, Benefit Sharing and the Law Applicable to the FAO Standard Material Transfer Agreement”. The Journal of World Intellectual Property 11 (2008): 1; “The Question of Minimum Standards of Access and Benefit-sharing under the CBD International Regime: Lessons from the International Treaty on Plant Genetic Resources for Food and Agriculture”. Asian Biotechnology and Development Review 10 (2008): 3; and “Commodifying Agricultural Biodiversity and Development-related Issues”. The Journal of World Intellectual Property 9 (2006): 25. Tom Dedeurwaerdere is professor and director of the Biodiversity Governance Unit of the Centre for the Philosophy of Law (http://biogov.cpdr.ucl. ac.be/) at the Université Catholique de Louvain, and research associate of the National Research Foundation, Belgium. He holds a degree in engineering and philosophy, with a PhD in the philosophy of science. He coordinated a number of research programmes, both national and international, in the field of access and benefit-sharing for genetic resources, innovative intellectual property arrangements and governance of global public goods. Recent publications include a special issue on the microbial research commons in Research in Microbiology 161(6), a special issue on international regulation of the global microbial commons in International Journal of the Commons 4(1), and two edited volumes, at Oxford University Press and MIT Press respectively, on the governance of global environmental commons. Lyle Glowka is the senior legal advisor to the Convention on Biological Diversity, serving as a senior member of the Secretariat’s team that supported the Nagoya Protocol’s negotiation and is now supporting its early entry into force and implementation. A biologist and international lawyer, Glowka has been providing legal and policy advice on biodiversityrelated issues to governments, intergovernmental organisations and NGOs for nearly 20 years. He was introduced to ABS issues at United Nations Environment Programme (UNEP) while supporting the CBD’s negotiating process from 1991–92. He was the lead author of the IUCN’s Explanatory Guide to the Convention (1993), and has published widely on ABS issues including a 1998 guide for IUCN on developing access legislation. His 1995 seminal paper, (“Genetic Resources, Marine Scientific Research

xii   List of Contributors and the International Seabed Area.” Review of European Community and International Environmental Law 8 (1999): 56) and advocacy on the genetic resources of the international seabed and marine scientific research placed the issue on the international agenda. Alejandro Lago Candeira is director of the UNESCO Chair for Spatial Planning and Environment at the Rey Juan Carlos University in Madrid. He has served as the legal and technical adviser to the General Direction for Natural Environment and Forestry Policy of the Spanish Ministry of Environment, Rural and Marine Affairs for CBD issues (since 2002), and in particular for the negotiations of the Nagoya Protocol (since 2008). He co-chaired the drafting group on compliance during the final stage of the negotiations of the Protocol in Nagoya. His publications (in Spanish) address the use of marine genetic resources and international environmental commitments, and include “The Nagoya Protocol: The Success of a Hard and Complex Negotiation”. Revista Ambienta 94 (2011). Harry Jonas is founder of ‘Natural Justice: Lawyers for Communities and the Environment.’ Post-Nagoya, Natural Justice’s work on ABS aims to ensure that national laws on ABS are developed in ways that support the concerns of indigenous peoples and local communities, and that the implementation of ABS is undertaken in ways that support the integrity of local biocultural systems. Natural Justice also provides direct support to communities to help them engage with a variety of stakeholders according to their rights and selfdefined responsibilities. Having lived in the Kalahari, Harry has first-hand insights into the reality of the Hoodia-related benefit-sharing agreements. Drawing from that experience, among others, he is – as a part of Natural Justice – working to develop community-based and integrated approaches to a range of relevant laws, including ABS, and to develop community protocols as a local means to achieve that end. He is currently based in Sabah, Malaysia and is an Ashoka Fellow. Sélim Louafi is a senior research fellow at the Centre International de Recherche Agronomique pour le Développement (CIRAD, Montpellier), where since 2010 he is part of a team of agronomists and geneticists working on the governance of genetic resources for food and agriculture. He previously worked at the Centre for Philosophy of Law in Louvain la Neuve in Belgium on Global Governance of Genetic Resources; the Institute for Sustainable Development and International Relations (IDDRI) in Paris; and the Secretariat of the International Treaty on Plant Genetic Resources for Food and Agriculture (FAO). Recent publications include: with Schloen et al. Access and

List of Contributors   xiii

benefit-sharing for genetic resources for food and agriculture. Current use and exchange practices, commonalities, differences and user community needs. Report from a multi-stakeholder expert dialogue. Rome: CGRFA Background Study Paper no. 59, July 2011 and co-edited with Michael Halewood and Isabel Lopez Noriega, Crop Genetic Resources as a Global Commons, Challenges in International Law and Governance. London: Earthscan, 2012. Elisa Morgera is lecturer in European environmental law at the University of Edinburgh School of Law, and director of the Master Programme in Global Environment and Climate Change Law. In Corporate Accountability in International Environmental Law. Oxford: Oxford University Press, 2009 she explored the role of the CBD in setting standards for private companies’ conduct. Recent publications with Elsa Tsioumani include: “The Evolution of Benefit-sharing: Linking Biodiversity and Community Livelihoods.” Review of European Community and International Environmental Law 19 (2010): 150; and “Yesterday, Today and Tomorrow: Looking Afresh at the Convention on Biological Diversity.” Yearbook of International Environmental Law 21 (2011): 3. She has attended CBD meetings, including several negotiating sessions of the Nagoya Protocol, since 2005, as team leader/reporter of the Earth Negotiations Bulletin. Peter Munyi is an advocate of the High Court of Kenya and a researcher with the Law and Governance Group, Wageningen University & Research Centre. His research focuses on the relationship between intellectual property rights and biodiversity. He was an advisor to the African Group during the negotiations leading to the adoption of the Nagoya Protocol. He is based in Nairobi, Kenya and Wageningen, the Netherlands. Valérie Normand is senior programme officer at the Secretariat of the Convention on Biological Diversity and heads the Nagoya Protocol Unit. Since joining the Secretariat in 2000, she has been responsible for the work programme on access and benefit-sharing which supported the negotiations of the Bonn Guidelines adopted in 2002 and of the Nagoya Protocol adopted in 2010. She is currently leading efforts at the Secretariat in preparation for the entry into force of the Nagoya Protocol. Previously, she worked on trade and environment issues for the Organisation for Economic Cooperation and Development (OECD) in Paris from 1994 to 1997 and then on the development aspects of trade and environment issues with the United Nations Conference on Trade and Development (UNCTAD) in Geneva, from 1997 to 2000.

xiv   List of Contributors María Julia Oliva (LLM) is senior adviser on access and benefit-sharing at the Union for Ethical BioTrade (UEBT) providing technical support and legal and policy guidance on benefit-sharing-related issues to UEBT trading and affiliate members since January 2009. Previously, she served as senior programme officer for Trade, Natural Resources, and Environment at the International Centre for Trade and Sustainable Development (ICTSD), legal consultant for the UNCTAD BioTrade Facilitation Programme, and director of the Intellectual Property and Sustainable Development Project at the Center for International Environmental Law (CIEL). She is also a member of the IUCN Commission on Environmental Law and sits on the Board of Directors of IP-Watch, an independent reporting service on intellectual property issues. She was one of the experts contributing to the IUCN Explanatory Guide to the Nagoya Protocol. Riccardo Pavoni is associate professor of International Law, University of Siena, Faculty of Law. He is the associate editor of the Italian Yearbook of International Law, and a member of the editorial board of the Oxford Reports on International Law in Domestic Courts. His publications include: a monograph on the international and European law of biodiversity and biotechnology (Biodiversità e biotecnologie nel diritto internazionale e comunitario. Milano: Giuffrè, 2004); “Mutual Supportiveness as a Principle of Interpretation and Law-Making: A Watershed for the ‘WTO-and-Competing-Regimes’ Debate?” European Journal of International Law 21 (2010): 649; “Biodiversity and Biotechnology: Consolidation and Strains in the Emerging International Legal Regimes.” In Biotechnology and International Law, edited by Francesco Francioni, and Tullio Scovazzi. Oxford: Hart Publishing, 2006; “Biosafety and Intellectual Property Rights: Balancing Trade and Environmental Security.” In Environment, Human Rights and International Trade, edited by Francesco Francioni. Oxford: Hart Publishing, 2001. Charlotte Salpin (DEA and LLM) is legal officer at the Division for Ocean Affairs and the Law of the Sea, Office of Legal Affairs of the United Nations, where she has been working since 2006. She is a former staff member of the Division of Environmental Conventions of the UNEP. In the context of her work on the legal aspects of marine genetic resources, she has followed closely the developments leading to the adoption of the Nagoya Protocol. Her related publications include: with Salvatore Arico, Bioprospecting of Genetic Resources in the Deep Seabed: Scientific, Legal and Policy Aspects. Yokohama: UNU, 2005; and with Valentina Germani. “Patenting of Research Results Related to Genetic Resources from Areas beyond National Jurisdiction: The Crossroads of the Law of the Sea and Intellectual Property Law.” Review of European Community and International Environmental Law 16 (2007): 12.

List of Contributors   xv

Annalisa Savaresi is a research and teaching fellow, University of Edinburgh School of Law, UK. She is member of the IUCN Commission on Environmental Law and recently joined the team of writers of the Earth Negotiation Bulletin at the International Institute for Sustainable Development. Her recent publications include: “Reducing Emissions from Deforestation in Developing Countries under the UNFCCC. Caveats and Opportunities for Biodiversity.” Yearbook of International Environmental Law 21 (2011): 81 and “The Human Rights Dimension of REDD.” Review of European Community and International Environmental Law 21 (2012): 102. Marie Schloen is research fellow on the global governance of genetic resources for food and agriculture at CIRAD in Montpellier, France, and at the Research Centre for European Environmental Law of the University of Bremen, Germany. In 2010/11 she coordinated an international Multi-stakeholder Expert Dialogue on Access and Benefit-Sharing for Genetic Resources for Food and Agriculture which reported its findings to the FAO Commission on Genetic Resources for Food and Agriculture (Schloen et al. Access and benefit-sharing for genetic resources for food and agriculture – current use and exchange practices, commonalities, differences and user community needs. Rome: CGRFA Background Study Paper No. 59, 2011). An agronomist and plant breeder by training, she previously served as professional officer at the Secretariat of the International Treaty on Plant Genetic Resources for Food and Agriculture and at the FAO Seed and Plant Genetic Resources Service in Rome, Italy. Luciana Silvestri is an environmental law researcher and a PhD fellow at the University Rey Juan Carlos in Spain. She holds a MSc in Environmental Sciences, Policy and Management from Lund University and the University of Manchester. She specialised in international environmental law at the University of Florida. Previously she coordinated the Global Leadership for Climate Action Initiative at the Club of Madrid, the largest forum of former Heads of State and Government dedicated to advancing sustainable democratic development. In the past, she served as a legal advisor to the Ministry of Environment in Mendoza, Argentina. Her areas of expertise include environmental law with a special focus on biodiversity, in particular ABS, climate change and energy. Gurdial Singh Nijar is the director of the Centre of Excellence for Biodiversity Law, Malaysia and professor of law at the University of Malaysia. He was involved in the establishment of the mandate for an International Regime on ABS of Genetic Resources, as well as throughout the negotiations of the Nagoya Protocol as lead negotiator for the Malaysian delegation and at various times as the spokesperson for the Like-Minded Megadiverse Coun-

xvi   List of Contributors tries and the Like-Minded Asia Pacific Countries. He has written widely on ABS issues, including: “Biodiversity and Patenting of Life: Problems and Prospects.” Asia Pacific Journal of Environmental Law 12 (2010); “Incorporating Traditional Knowledge in an International Regime on Access to Genetic Resources and Benefit Sharing: Problems and Prospects.” European Journal of International Law 21 (2010): 457; “Food Security and Access and Benefit Sharing Laws Relating to Genetic Resources: Promoting Synergies in National and International Governance.” International Environmental Agreements: Politics, Law and Economics. Published online on 10 August 2010. Elsa Tsioumani (LLM) is a lawyer and consultant in international and European environmental law and policy, based in Thessaloniki, Greece, with a decade-long experience in biodiversity and biosafety-related issues. She has attended meetings of the CBD bodies as team leader and reporter of the Earth Negotiations Bulletin since 1999. She has published periodic analyses of the Nagoya Protocol negotiations on Environmental Policy and Law, and authored: “International Treaty on Plant Genetic Resources for Food and Agriculture: Legal and Policy Questions from Adoption to Implementation.” Yearbook of International Environmental Law 14 (2004): 121; and with Morgera, Elisa. “The Evolution of Benefit-sharing: Linking Biodiversity and Community Livelihoods.” Review of European Community and International Environmental Law 19 (2010): 150 and “Yesterday, Today and Tomorrow: Looking Afresh at the Convention on Biological Diversity.” Yearbook of International Environmental Law 21 (2011): 3. Eric W. Welch is an associate professor of public administration at the University of Illinois at Chicago (UIC). He earned his PhD in public administration in 1997 at Syracuse University’s Maxwell School of Citizenship and Public Affairs. Since 2008 he has directed the Science, Technology and Environment Policy Lab and the PhD programme in Science and Technology Policy at UIC. He is the primary investigator on a USDA-funded project that examines the current patterns of exchange and use of agricultural genetic resources in the US. Welch teaches courses on technology and innovation theory, science and technology policy, decision analysis, and environmental policy. He has authored over 50 articles and book chapters on topics related to science and environment policy in such journals as Ecological Economics, Science and Public Policy, Research Policy, Policy Sciences, and Journal of Policy Analysis and Management. Marie Wilke (LLM) is international trade law programme officer at the International Centre for Trade and Sustainable Development, where she heads the Centre’s research activities on trade law and WTO dispute settlement

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and was responsible for the Centre’s representation during the negotiations of the Nagoya Protocol. Previously, as a fellow of the Robert Bosch Young Expert Programme in International Affairs, she worked for the United Nations Conference on Trade and Development, Trade Negotiation and Commercial Diplomacy Branch and for the German Federal Ministry of Economics and Technology, Trade Policy Branch. Her recent publications include: “The WHO’s Pandemic Influenza Preparedness Framework as a Common Pool in Public Health”. In Common Resources Pools in Access and Benefit Sharing, edited by Evanson Chege-Kamau and Gerd Winter. London: Earthscan, forthcoming 2013; and “The Role of Fair and Equitable BenefitSharing in Global Pandemic Preparedness and Response.” Law, Environment and Development Journal (forthcoming 2013). Tomme Rosanne Young (JD) is consultant on domestic and international environmental law. As the designer and manager of ‘The ABS Project’ (IUCN – Environmental Law Center, with funding from BMU and numerous other contributors), she was series editor to seven books on ABS. Her publications include: for the CBD Ad Hoc Open-Ended Working Group on ABS, “Balancing Building Blocks of a Functional ABS System,” (2 September 2009) UN Doc UNEP/CBD/WG-ABS/8/INF/2; “Administrative and Judicial Remedies Available in Countries with Users under their Jurisdiction and in International Agreements,” (20 July 2007) UN Doc UNEP/CBD/WG-ABS/5/ INF/3; “Analysis of Claims of ‘Unauthorised Access and Misappropriation of Genetic Resources and Associated Traditional Knowledge,” (22 December 2005) UN Doc UNEP/CBD/WG-ABS/4/INF/6; “Summary Analysis: Legal Certainty for Users of Genetic Resources under Existing Access and Benefitsharing (ABS) Legislation and Policy,” (2 February 2005) UN Doc UNEP/ CBD/ABS/3/INF/10; and “Incentive and Effective Operation: Re-linking the Components of International Law on Genetic Resources.” Yearbook of International Environmental Law 15 (2004): 3.

List of Figures and Tables Figure 1.  Schematic representation of the ABS process in light of Nagoya Protocol mechanisms  .....................................................................

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Figure 2.  Percentage of respondents who send/received GRFA  .......... 396 Figure 3.  Exchange patterns amongst microbial collections  . ............... 400 Figure 4.  Global seed exchange network  .................................................. 412 Table 1.  Restrictions on access and use, and expected reciprocity  . .... 397

List of Abbreviations ABS Access and Benefit-Sharing CBD Convention on Biological Diversity CGIAR Consultative Group on International Agricultural Research CGRFA Commission on Genetic Resources for Food and Agriculture CITES Convention on International Trade in Endangered Species COP Conference of the Parties DNA Deoxyribonucleic Acid EEZ Exclusive Economic Zone EU European Union FAO Food and Agriculture Organisation of the United Nations FPIC Free Prior Informed Consent GISN Global Influenza Surveillance Network GISRS Global Influenza Surveillance and Response System GMO Genetically Modified Organism GRFA Genetic Resources for Food and Agriculture GRULAC Group of Latin American and Caribbean countries GURT Genetic Use Restriction Technologies IARC International Agricultural Research Centres IGC Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore of the World Intellectual Property Organisation IIFB International Indigenous Forum on Biodiversity ILO International Labour Organisation ING Interregional Negotiating Group of the Nagoya Protocol IPRs Intellectual Property Rights ITPGRFA International Treaty on Plant Genetic Resources for Food and Agriculture IUCN International Union for Conservation of Nature JUSCANZ Japan, the United States, Canada, Australia and New Zealand LMMC Like-minded Mega-diverse Countries MAT Mutually Agreed Terms MEA Multilateral Environmental Agreement MLS Multilateral System

xxii   List of Abbreviations MOP MSR NGO OECD PGRFA PIC PIPF

Meeting of the Parties Marine Scientific Research Non-Governmental Organisation Organisation for Economic Co-operation and Development Plant Genetic Resources for Food and Agriculture Prior Informed Consent World Health Organisation Pandemic Influenza Preparedness Framework PVP Plant Variety Protection RNA Ribonucleic Acid SBSTTA Subsidiary Body for Scientific, Technical and Technological Advice SMTA Standard Material Transfer Agreement TBT Technical Barriers to Trade TEU Treaty on the European Union TFEU Treaty on the Functioning of the European Union TRIPS Trade-Related Aspects of Intellectual Property Rights UEBT Union for Ethical Biotrade UN United Nations UNCLOS United Nations Convention on the Law of the Sea UNCTAD United Nations Conference on Trade and Development UNDRIP United Nations Declaration on the Rights of Indigenous Peoples UNEP United Nations Environment Programme UNESCO United Nations Educational, Scientific, and Cultural Organisation UNGA United Nations General Assembly UPOV International Union for the Protection of New Varieties of Plants WIPO World Intellectual Property Organisation WTO World Trade Organisation

Table of Legal Materials International Treaties Agreement for the Implementation of the Provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 relating to the Conservation and Management of Straddling Fish Stocks and Highly Migratory Fish Stocks (New York, 4 August 1995, in force 11 December 2001) 2167 UNTS 3 Cartagena Protocol on Biosafety (Montreal, 29 January 2000, in force 11 September 2003) 2226 UNTS 208 Convention Concerning the Protection of the World Cultural and Natural Heritage (Paris, 16 November 1972, in force 17 December 1975) 1037 UNTS 151 Convention for the Protection of the Marine Environment of the North-East Atlantic (Paris, 22 September 1992, in force 25 March 1998) 2354 UNTS 67 Convention on Access to Information, Public Participation in Decisionmaking and Access to Justice in Environmental Matters (Aarhus, 25 June 1998, in force 30 October 2001) 2161 UNTS 447 Convention on Biological Diversity (Rio de Janeiro, 5 June 1992, in force 29 December 1993) 1760 UNTS 79 Convention on Civil Liability for Damage Resulting from Activities Dangerous to the Environment (Lugano, 21 June 1993, not yet in force) 32 ILM (1993) 1228 Convention on Environmental Impact Assessment in a Transboundary Context (Espoo, 25 February 1991, in force 10 September 1997) 1989 UNTS 309 Convention on International Trade in Endangered Species of Wild Fauna and Flora (Washington, 3 March 1973, in force 1 July 1975) 993 UNTS 243

xxiv   Table of Legal Materials Convention on Recognition and Enforcement of Foreign Arbitral Awards (New York, 10 June 1958, in force 7 June 1959) 330 UNTS 3 Convention on the Protection and Use of Transboundary Watercourses and International Lakes (Helsinki, 17 March 1992, in force 6 October 1996) 1936 UNTS 269 Convention on the Transboundary Effects of Industrial Accidents (Helsinki, 17 March 1992, in force 19 April 2000) 2105 UNTS 457 International Convention for the Protection of New Varieties of Plants (as amended) (Paris, 2 December 1961, in force 10 August 1968) 815 UNTS 89 International Convention on the Elimination of All Forms of Racial Discrimination (New York, 7 March 1966, in force 4 January 1969) 660 UNTS 195 International Covenant on Civil and Political Rights (New York, 16 December 1966, in force 23 March 1976) 999 UNTS 171 International Covenant on Economic, Social and Cultural Rights (New York, 16 December 1966, 3 January 1976) 993 UNTS 3 International Labour Organisation Convention 169 Concerning Indigenous and Tribal Peoples in Independent Countries (Geneva, 27 June 1989, in force 5 September 1991) ILO/C169 International Treaty on Plant Genetic Resources for Food and Agriculture (Rome, 3 November 2001, in force 29 June 2004) 2400 UNTS 303 Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety (Nagoya, 15 October 2010, not yet in force) UN Doc UNEP/CBD/BS/COP-MOP/5/17 Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilisation to the Convention on Biological Diversity (Nagoya, 29 October 2010, not yet in force), CBD Decision 10/1, (20 January 2011) UN Doc UNEP/CBD/COP/10/27 Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (Rotterdam, 10 September 1998, in force 24 February 2004) 2244 UNTS 337

Table of Legal Materials   xxv

UN Convention on the Law of the Sea (10 December 1982, in force 16 November 1994) 1833 UNTS 3 UN Convention to Combat Desertification in Countries Experiencing Serious Drought and/or Desertification, Particularly in Africa (Paris, 14 October 1994, in force 26 December 1996) 1954 UNTS 3 UN Framework Convention on Climate Change (Rio de Janeiro, 9 May 1992, in force 21 March 1994) 1771 UNTS 107 Vienna Convention on the Law of Treaties (Vienna, 23 May 1969, in force 27 January 1980) 115 UNTS 331 WTO Agreements (Marrakesh, 15 April 1994, in force 1 January 1995) in WTO Secretariat, The Legal Texts: The Results of the Uruguay Round of Multilateral Trade Negotiations (Cambridge, Cambridge University Press, 1999) EU Treaties Treaty Establishing the European Community [2006] OJ C321E/1 Treaty of Lisbon see Treaty on European Union and Treaty on the Functioning of the European Union Treaty on European Union (TEU) [2010] OJ C83/13 Treaty on the Functioning of the European Union (TFEU) [2010] OJ C83/47 Regional Agreements Additional Protocol to the American Convention on Human Rights in the area of Economic, Social and Cultural Rights (San Salvador, 17 November 1988, in force 16 November 1999) OASTS 69 African Charter on Human and Peoples’ Rights (Nairobi, 27 June 1981, in force 21 October 1986) 1520 UNTS 217 African Convention on the Conservation of Nature and Natural Resources (Algiers, 15 September 1968, in force 16 June 1969) 1001 UNTS 3

xxvi   Table of Legal Materials American Convention on Human Rights (San Jose, 22 November 1969, in force 18 July 1978) 1144 UNTS 123 Andean Community, Common Regime on Access to Genetic Resources (Decision 391, 2 July 1996, in force 17 July 1996) Australia New Zealand Closer Economic Relations Trade Agreement (Canberra, 28 March 1983, in force 1 January 1983) Convention on Jurisdiction and the Enforcement of Judgments in Civil and Commercial Matters (Brussels, 27 September 1968, repealed) Convention on Jurisdiction and the Enforcement of Judgments in Civil and Commercial Matters (Lugano, 16 September 1988, repealed) Convention on Jurisdiction and the Enforcement of Judgments in Civil and Commercial Matters (Lugano, 30 October 2007, in force 1 January 2010) European Convention for the Protection of Human Rights and Fundamental Freedoms (Strasbourg, 4 November 1950, in force 3 September 1953) 213 UNTS 222 European Social Charter (Turin, 18 October 1961, in force 26 February 1965) 529 UNTS 89 North American Agreement on Environmental Cooperation (14 September 1993, in force 1 January 1994) 32 ILM 1480 (1993) Partnership Agreement between the members of the African, Caribbean and Pacific Group of States of the one part, and the European Community and its Member States, of the other part (Cotonou, 23 June 2000, in force April 2003) [2000] OJ L 317 Protocol on Environmental Protection to the Antarctic Treaty (Madrid, 4 October 1991, in force 14 January 1998) 30 ILM (1991) 1461 Protocol to the African Charter on Human and Peoples’ Rights on the Establishment of an African Court on Human and Peoples’ Rights (Ouagadougou, 9 June 1998, in force 25 January 2004) OAU Doc. OAU/LEG/EXP/AFCHPR/ PROT (III) US-Morocco Free Trade Agreement (Washington DC, 15 June 2004, in force 1 January 2006)

Table of Legal Materials   xxvii

Other International Legal Materials CBD Decisions CBD Decision 4/10, “Measures for Implementing the Convention on Biological Diversity” (15 June 1998) UN Doc UNEP/CBD/COP/4/27 CBD Decision 5/26, “Access to Genetic Resources” (22 June 2000) UN Doc UNEP/CBD/COP/5/23 CBD Decision 6/23, “Alien Species that Threaten Ecosystems, Habitats or Species” (27 May 2002) UN Doc UNEP/CBD/COP/6/20 CBD Decision 6/24, “Access and Benefit-Sharing as Related to Genetic Resources” (27 May 2002) UN Doc UNEP/CBD/COP/6/20. ‘Bonn Guidelines on Access to Genetic Resources and the Fair and Equitable Sharing of the Benefits Arising out of Their Utilisation’ CBD Decision 7/12, “Sustainable Use (Article 10)” (13 April 2004) UN Doc UNEP/CBD/COP/7/21 CBD Decision 7/16, “Article 8(j) and Related Provisions” (13 April 2004) UN Doc UNEP/CBD/COP/7/21 CBD Decision 7/19, “Access and Benefit-Sharing as Related to Genetic Resources (Article 15)” (13 April 2004) UN Doc UNEP/CBD/COP/7/21 CBD Decision 8/4 “Access and Benefit-sharing” (15 June 2006) UNEP/CBD/ COP/8/31 CBD Decision 8/17, “Private-Sector Engagement” (15 June 2006) UN Doc UNEP/CBD/COP/ 8/31 CBD Decision 9/6, “Incentive Measures” (9 October 2008) UN Doc UNEP/ CBD/COP/9/29 CBD Decision 9/14, “Technology Transfer and Cooperation” (9 October 2008) UN Doc UNEP/CBD/COP/9/29 CBD Decision 10/1, “Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation” (20 January 2011) UN Doc UNEP/CBD/COP/10/27

xxviii   Table of Legal Materials CBD Decision 10/2 “The Strategic Plan for Biodiversity 2011–2020 and the Aichi Biodiversity Targets” (20 January 2011) UN Doc UNEP/CBD/ COP/10/27 CBD Decision 10/3 “Strategy for resource mobilization in support of the achievement of the Convention’s three objectives” (20 January 2011) UN Doc UNEP/CBD/COP/10/27 CBD Decision 10/42, “The Tkarihwaié:ri Code of Ethical Conduct to Ensure Respect for the Cultural and Intellectual Heritage of Indigenous and Local Communities” (20 January 2011) UN Doc UNEP/CBD/COP/10/27 CBD Decision 10/43, “Multi-Year Programme of Work on the Implementation of Article 8(j) and Related Provisions of the Convention on Biological Diversity” (20 January 2011) UN Doc UNEP/CBD/COP/10/27 General Assembly Resolutions United Nations General Assembly Resolution 1803 (XVII), “Permanent Sovereignty over Natural Resources” (14 December 1962) United Nations General Assembly, “Oceans and the Law of the Sea” (16 March 2007) UN Doc A/RES/61/222 United Nations General Assembly, “United Nations Declaration on the Rights of Indigenous Peoples” (13 September 2007) UN Doc A/RES/61/295 United Nations General Assembly, “Oceans and the Law of the Sea” (14 March 2008) UN Doc A/RES/62/215 United Nations General Assembly, “Optional Protocol to the International Covenant on Economic, Social and Cultural Rights” (10 December 2008) UN Doc A/RES/63/117 United Nations General Assembly, “Oceans and the Law of the Sea” (12 February 2009) UN Doc A/RES/63/111 United Nations General Assembly, “Implementation of Agenda 21, the Programme for Further Implementation of Agenda 21 and the Outcomes of the World Summit on Sustainable Development” (31 March 2010) UN Doc A/ RES/64/236

Table of Legal Materials   xxix

United Nations General Assembly, “Oceans and the Law of the Sea” (12 March 2010) UN Doc A/RES/64/71 United Nations General Assembly, “Oceans and the Law of the Sea” (17 March 2011) UN Doc A/RES/65/37A United Nations General Assembly, “Oceans and the Law of the Sea” (5 April 2012) UN Doc A/RES/66/231 WHO Documents WHO, “Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access to vaccines and other benefits” (effective 24 May 2011) WHA64.5 WHO, “Global Pandemic Influenza Action Plan to Increase Vaccine Supply” (September 2006) WHO/IVB/06.13; WHO/CDS/EPR/GIP/2006.1 Revision of the WHO International Health Regulations (Geneva, 23 May 2005, in force 15 June 2007) WTO Documents WTO, “Doha Ministerial Declaration” (20 November 2001) WTO Doc WT/ MIN(01)/DEC/1 FAO Documents FAO, Global Plan of Action for the Conservation and Sustainable Utilisation of Plant Genetic Resources for Food and Agriculture and the Leipzig Declaration, 1996 FAO Commission on Genetic Resources for Food and Agriculture, Global Plan of Action for Animal Genetic Resources and the Interlaken Declaration, 2007 FAO Resolution 5/89, adopted on 29 November 1989. Accessed 10 June 2012. http://www.fao.org/docrep/x5588E/x5588e06.htm#e.%20commission%20

xxx   Table of Legal Materials on%20plant%20genetic%20resources%20and%20the%20international%20 undertaking:%20prog FAO Resolution 3/91 (adopted at the 26th session of the FAO Conference, (Rome, 9–27 November 1991). Accessed 10 June 2012. http://www.fao .org/docrep/x5587E/x5587e06.htm#e.%20commission%20on%20plant%20 genetic%20resources%20and%20international%20undertaking:%20progress African Union Documents African Union Assembly, “Decision on the Report on Africa’s Participation in the Nagoya Conference on Biodiversity” (30–31 January 2011) Assembly/ AU/Dec.352(16) EU Legislation Council Regulation (EC) No. 44/2001 of 22 December 2000 on Jurisdiction and the Recognition and Enforcement of Judgments in Civil and Commercial Matters [2001] OJ L12/1 Council Decision 2004/579/EC of 29 April 2004 on the Conclusion, on behalf of the European Community, of the United Nations Convention Against Transnational Organized Crime [2004] OJ L261/69 Council Decision 2006/515/EC of 18 May 2006 on the Conclusion of the Convention on the Protection and Promotion of the Diversity of Cultural Expressions [2006] OJ L201/15 Regulation (EC) No. 864/2007 of the European Parliament and of the Council of 11 July 2007 on the Law Applicable to Non-Contractual Obligations (Rome II) [2007] OJ L199/40 National Legal Materials Australia, Environment Protection and Biodiversity Conservation Act, No. 91, 1999

Table of Legal Materials   xxxi

Australia, Environment Protection and Biodiversity Conservation Regulations, No. 181, 2000 Brazil, Access to Genetic Resources, Bill No. 306/95, 1995 Brazil, Access to Genetic Resources, Bill No. 4579/98, 1998 Brazil, Industrial Property Law, No. 9.279, 1996 Brazil, Medida provisoria No. 2186–16, 2001 Brazil, Presidential Decree, No. 6159/2007, 2007 Canada, Court Jurisdiction and Proceedings Transfer Act, 2003 Colombia, Decree No. 309, 2000 Colombia Ministry of Environment, Resolution No. 620, 1997 Colombia, Resolution of the National Council for Economic and Social Policy No. 3533, 2008 Colombia, Resolution No. 1393, 2007 Costa Rica, Decreto No. 31 514, 2003 (ABS Regulations) Costa Rica, Biodiversity Law, No. 7788, 1998 Costa Rica, Regulation of Clause 6 of Article 78 of the Law on Biodiversity, Decree No. 34958-COMEX-MINAET, 2008 Ecuador, National Regulation on the Common Regime on Access to Genetic Resources implementing Anean Community Decision 391, No. 905, 2011 India, The Protection of Plant Varieties and Farmers’ Rights Act, No. 53, 2001 Kenya, Constitution, 1963 Kenya, Constitution, 2010 Malaysia, Constitution, 1957

xxxii   Table of Legal Materials Malaysia, International Trade in Endangered Species Act, No. 686, 2008 Malaysia, Sabah, Biodiversity Enactment, No. 7, 2000 Malaysia, Sarawak, Biodiversity Centre Ordinance, 1997 Mexico, General Law on Ecological Equilibrium and Environmental Protection, 1988 Mexico, General Wildlife Act, 2000 Mexico, Official Mexican Standard, No. 126, 2000 Norway, Act Relating to the Management of Biological, Geological and Landscape Diversity (Nature Diversity Act), No. 100, 2009 Panama, Criminal Code, No. 14, 2007 Panama, Decree No. 12, 2001 Panama, Decree No. 257, 2006 Panama, Decree No. 25, 2009 Panama, General Law on Environment, No. 41, 1998 Panama, Special Intellectual Property Regime with Respect to the Collective Rights of Indigenous Peoples to the Protection and Defence of their Cultural Identity and Traditional Knowledge, No. 20, 2000 Peru, Introducing a Protection Regime for the Collective Knowledge of Indigenous Peoples Derived from Biological Resources, No. 27811, 2002 Peru, Law amending incorporating and regulating miscellaneous provisions on the implementation of the Trade Promotion Agreement signed between Peru and United States, No. 29316, 2009 Peru, Decree No. 003–2009-MINAM, 2009 Peru, Law Declaring Crops, Native Breeds and Usufruct Wildlife Species part of the Nation’s Natural Heritage, No. 28477, 2005

Table of Legal Materials   xxxiii

Peru, Ordinance on Biopiracy, No. 048–2008-CR/GRC.CUSCO, 2008 Peru, Regulation on Access to Genetic Resources, No. 087–2008-MINAM, 2008 Portugal, Law Establishing a Legal Regime for the Registration, Conservation, Legal Safeguarding and Transfer of Autochthonous Plant Material as well as Associated Knowledge, No. 118, 2002 South Africa, National Environment Laws Amendment Act, No. 14, 2009 South Africa, Regulations on Bio-prospecting, Access and Benefit Sharing, No. R. 138, 2008 Spain, Andalusia, Decree, Regulates the Conservation and Sustainable Use of Wild Fauna and Flora and their Habitats, No. 23, 2012 Spain, Natural Heritage and Biodiversity Act, No. 42, 2007 Spain, Royal Decree, No. 1274, 2011 Spain, Constitution, 1978 Spain, Water Law, No. 29, 1985 Switzerland, Federal Law on Patents, No. 232.14, 1954 Venezuela, Biological Diversity Law, 2000 Venezuela, Law on the Cultural Heritage of Indigenous Peoples, No. 39.115, 2009

Table of Cases Australia Mabo v Queensland (No 2) (1992) 175 CLR 1 Minister of Immigration & Ethnic Affairs v Teoh (1995) 183 CLR 273 Colombia Sentence of the Constitutional Court C–137 of 1996, and Concept 8 August 8 1977 by the High Administrative Council Germany Bayerisches Oberstes Landesgericht, 23 September 2004 4Z Sch 5/04 Bundesgerichtshof (BGH) 23 February 2006, III ZB 50/05 Case 876: MAL 16(3) Oberlandesgericht Köln, 15 February 2000, 9 Sch 13/99 New Zealand Waitangi Tribunal Report 2011. “Ko Aotearoa Tēnei: A Report into Claims Concerning New Zealand Law and Policy Affecting Māori Culture and Identity.” Accessed 5 June 2011. http://www.waitangitribunal.govt.nz/scripts/ reports/reports/262/05AC7023-0EEA-4ECC-8B6E-AB136A2EA7F8.pdf United States of America Amgen, Inc. v Chugai Pharm. Co., 927 F.2d 1200 (Fed. Cir. 1991) Diamond v Chakrabarty, (1980) 447 U.S. 303, 310, 206 USPQ 193 European Court of Human Rights Fadeyeva v The Russian Federation, Application No. 55723/00 Guerra and others v Italy, Application No. 14967/89 López Ostra v. Spain, Application No. 16798/90 Moreno Gomez v Spain, Application No. 4143/02 Öçkan and others v Turkey, Application No. 46771/99 Okyay and others v. Turkey, Application No. 36220/97 Öneryıldız v. Turkey, Application No. 48939/99 Taskin and others v Turkey, Application No. 46117/99

xxxvi   Table of Cases European Court of Justice Case 6/641 Costa v ENEL [1964] ERC 585 Case 7–68 Commission of the European Communities v Italian Republic [1968] ECR 423 European Patent Office Transgenic Plant/NOVARTIS (Case G 1/98) [2000] OJ EPO 111 Inter-American Commission on Human Rights Maya Indigenous Community of the Toledo District v. Belize, Case No. 12.053 Yanomani Indians v. Brazil, Case No. 7615 Inter-American Court of Human Rights Case of the Mayagna (Sumo) Awas Tingni Community v Nicaragua, Judgment of 31 August 2001, Series C No. 79 Case of the Moiwana Community v Suriname, Judgment of 15 June 2005, Series C No. 124 Case of the Saramaka People v Suriname, Judgment of 28 November 2007, Series C No. 172 Case of the Sawhoyamaxa Indigenous Community v Paraguay, Judgment of 29 March 2006, Series C No. 146 Case of the Xákmok Kásek Indigenous Community v Paraguay, Judgment of 24 August 2010, Series C No. 214 Case of the Yakye Axa Indigenous Community v Paraguay, Judgment of 17 June 2005, Series C No. 125 African Commission on Human & Peoples’ Rights Centre for Minority Rights Development (CEMIRIDE) and Minority Rights Group International (MRG) (on behalf of the Endorois) v Kenya, Communication No. 276/2003 Media Rights Agenda and Constitutional Rights Project v Nigeria, Communication Nos. 105/93, 128/94, 130/94, 152/96 Social and Economic Rights Action Centre and Centre for Economic and Social v Nigeria, Communication No. 155/96 International Court of Justice Legal Consequences for States of the Continued Presence of South Africa in Namibia (Advisory Opinion) 1971 Pulp Mills on the River Uruguay (Argentina v Uruguay) Judgment of 20 April 2010

Table of Cases   xxxvii

ICSID Mondev International Ltd. v. USA (Award of 11 October 2002) ARB/(AF)/ 99/2 Arbitration Institute of the Stockholm Chamber of Commerce Limited Liability Company AMTO v Ukraine (Award 26 March 2008) 080/2005 WTO Cases Brazil-Measures Affecting Imports of Retreaded Tyres, Appellate Body Report (adopted 17 December 2007) WT/DS332/AB/R Canada-Patent Protection of Pharmaceutical Products, Panel Report (adopted 7 April 2000) WT/DS114/R China-Measures Related to the Exportation of Rare Earths, Tungsten and Molybdenum, (15 March 2012) WT/DS/431–433 China-Measures Related to the Exportation of Various Raw Materials, Appellate Body Report (adopted 22 February 2012) WT/DS394/AB/R, WT/ DS395/AB/R and WT/DS398/AB/R China-Measures Related to the Exportation of Various Raw Materials, Panel Reports, WT/DS394/R, WT/DS395/R and WT/DS398/R European Communities-Measures Affecting Asbestos and Asbestos-Containing Products, Appellate Body Report (adopted 5 April 2001) WT/DS135/ AB/R European Communities-Measures Affecting the Approval and Marketing of Biotech Products, Panel Report (adopted 21 November 2006) WT/DS291/R, WT/DS292/R, WT/DS293/R Thailand-Restrictions on Importation of and Internal Taxes on Cigarettes, Panel Report (adopted 7 November 1990) DS10/R United States-Restrictions on Imports of Tuna, (3 September 1991) DS21/R United States-Restrictions on Imports of Tuna, (16 January 1994) DS29/R United States-Measures Concerning the Importation, Marketing and Sale of Tuna and Tuna Products, Panel Report (15 September 2011) WT/ DS381/R United States-Measures Concerning the Importation, Marketing and Sale of Tuna and Tuna Products, Appellate Body Report (16 May 2012) WT/ DS381/AB/R United States-Standards for Reformulated and Conventional Gasoline, Appellate Body Report (adopted 20 May 1996) WT/DS2/AB/R United States-Import Prohibition on Certain Shrimp and Shrimp Products, Appellate Body Report (adopted 6 November 1998) WT/DS58/AB/R

xxxviii   Table of Cases United States-Import Prohibition of Certain Shrimp and Shrimp Products, Recourse to Article 21.5 of the DSU by Malaysia, Appellate Body Report (adopted 21 November 2001) WT/DS58/AB/RW

Preface Twenty years ago, the countries convened by the United Nations Environment Programme in Nairobi in May 1992 adopted the text of the Convention on Biological Diversity (CBD), and at the UN Conference on Environment and Development held in Rio de Janeiro in June 1992 the Convention was opened for signature. In December 1993, just a year and a half later, the Convention entered into force – a clear demonstration of the broad international support for the fundamental principles it embodied. The principle of benefit-sharing was certainly the most innovative aspect of the Convention, in a clear recognition of the role of developing countries and their indigenous and local communities as the custodians of the bulk of the world’s biodiversity and in recognition of the need to reduce the enormous global asymmetries between the haves and the haves-not. It was agreed that in order to promote the conservation of the world’s wealth of biodiversity it was necessary to create a world with more equity, where the custodians of genetic resources and associated traditional knowledge would also benefit from the commercial and non-commercial uses of such resources and knowledge. The implementation of the benefit-sharing provisions of the CBD proved to be difficult due to the complexities of the issues involved, the uncertainties, the unrealistic expectations, the misunderstandings and, above all, the high level of mistrust amongst the different stakeholder groups and amongst the Parties to the Convention. Few countries up to now have managed to establish national laws and governance structures to deal with this issue. Many of the pioneering laws have proven to be too bureaucratic, overly focused on preventing ‘biopiracy’ and too little concerned with facilitating access to genetic resources and associated traditional knowledge in promoting benefitsharing from the uses of such resources and knowledge. The result has been a disincentive to investments in research and development to fully utilize the potential of the world’s vast biodiversity assets. The adoption of the Nagoya Protocol on Access and Benefit-sharing in October 2010 at the tenth meeting of the CBD Conference of the Parties held in Nagoya, Japan, has been recognized as a breakthrough. It has inaugurated a new phase in the implementation of the Convention and in particular in

xl   Preface the implementation of its access and benefit-sharing provisions – a phase with renewed hope and interest that can help build the trust, understanding and legal certainty needed to fully realize the potential of the original vision for access and benefit-sharing at the heart of the Convention. This publication contributes to this agenda by providing a series of perspectives on the Nagoya Protocol, which will undoubtedly contribute to greater understanding of the Protocol’s numerous innovations. It sheds new light on the influence of the access and benefit-sharing concept and the Nagoya Protocol on other areas of international law, such as intellectual property, human rights, food and agriculture, health, and the law of the sea. It also provides insights regarding the opportunities and challenges faced by countries in various regions of the world in the implementation of this new international instrument. It underscores the need for collaboration and trust to ensure its coherent implementation. Finally, this publication will hopefully not only contribute to a better understanding of the Nagoya Protocol but also open the door to further reflection and action to ensure that the Protocol can assist countries in moving a step further towards sustainable development. Braulio Dias Executive Secretary of the Convention on Biological Diversity

Acknowledgements This book is the result of an international workshop organized on 2–3 December 2011 by the University of Edinburgh School of Law, its Centre for Studies in Intellectual Property and Technology Law, the Scottish Centre for International Law and the Jean Monnet Centre for Excellence of the Europa Institute of the University of Edinburgh. The workshop aimed to create a synergetic dialogue between academics specialised in international law, legal officers in relevant bodies of the United Nations System, a regionally balanced selection of the negotiators of the 2010 Nagoya Protocol on Access and Benefit-sharing, and stakeholders that participated in the Protocol negotiations and are pioneering its implementation. The editors are extremely thankful to the contributors that engaged in this project with commitment and enthusiasm, and greatly contributed to our collective understanding of the implications and challenges of the Protocol. We are also very grateful to the colleagues that accepted to contribute to the edited collection subsequently to the workshop. In addition, we would like to express our gratitude to Prof. Alan Boyle, Prof. Graeme Laurie and Dr. James Harrison from the University of Edinburgh, Ruth McKenzie (University of Westminster), Prof. Alessandro Fodella (University of Trento), Krystyna Swiderska (International Institute for Environment and Development), Dr. Paul Oldham (Lancaster University), Marco d’Alessandro (Federal Office for the Environment, Switzerland), Dr. Alphonse Kambu (UN Environment Programme), Prof. Philippe Cullet (School of Oriental and African Studies), Dr. Abbe Brown (University of Aberdeen), Vassilis Koutsiouris (European Commission), Dr. Francesco Sindico (University of Strathclyde) and Dr. Stefan Jungcurt (Council of Canadian Academies) for their active and stimulating participation in the workshop. Elisa Morgera has a special debt of gratitude towards Prof. Douglas Brodie, Prof. Lesley McAra, Prof. Graeme Laurie and Prof. Niamh Nic Shuibhne, who provided invaluable advice and unfailing encouragement throughout the life of the project. Matthias Buck is greatly indebted to the EU negotiating team for the Nagoya Protocol from 2007 to 2010, in particular Prof. Alejandro Lago, Anca Leroy, Clare Hamilton, Cosima Hufler, Dries van Eeckhoutte, Dr. Hugo Schally, Isabelle Clement-Nissou, Julian Jackson, Carsten Lund,

xlii   Acknowledgements Dr. Ralf Bodle, and Prof. Rene Lefeber. We started as colleagues and parted as friends, and helped giving birth to the Nagoya Protocol: thank you! Elsa Tsioumani wishes to express her gratitude to the members of the Earth Negotiations Bulletin team covering the Nagoya Protocol negotiations, for their invaluable insights, commitment and true friendship. Our heartfelt thanks also go to Dr. James Harrison, Prof. Gerry Maher, Prof. Graeme Laurie and Dr. Gracia Marín Durán for peer-reviewing certain chapters of this book, to Lorna Gallacher for her excellent support in preparing the workshop, and to Stephen Bailey for his outstanding editorial assistance. We are, in addition, very grateful to Marie Sheldon, Alexandra Mitton and Lisa Hanson and their team at Brill for their continued support for this project. On a personal note, Elisa is ever so thankful to Riccardo and her family for their usual (but never taken for granted) understanding and encouragement. Matthias wishes to thank Sibylle, Bruno, Valentin and Johann for helping him every day to see the joys of life beyond work. Elsa wishes to thank Anastasia, Elisa, and her friends in Thessaloniki, for pointing to the light at the end of the tunnel during a very difficult year. Elisa Morgera Matthias Buck Elsa Tsioumani

Introduction Elisa Morgera, Matthias Buck and Elsa Tsioumani The Nagoya Protocol on Access and Benefit-Sharing1 is an innovative multilateral environmental agreement that has significantly developed the international biodiversity regime. In addition, it has considerable implications for the rights of indigenous peoples and local communities, for research and commercial development activities in various sectors, as well as for food security, trade, and development cooperation. The Nagoya Protocol was adopted under the Convention on Biological Diversity (CBD),2 and similarly to its mother instrument it is placed at the crossroads of environmental protection and development.3 Following the steps of the CBD, the Nagoya Protocol provides a flexible framework for accommodating developed and developing countries’ concerns and capacities4 and for encouraging partnerships between national and local authorities, local and indigenous communities, and the private sector.5 The Protocol, however, significantly expands upon the text of the Convention by detailing obligations in relation to genetic resources6 and traditional knowledge  Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilisation to the Convention on Biological Diversity (Nagoya, 29 October 2010, not yet in force), CBD Decision 10/1, (20 January 2011) UN Doc UNEP/ CBD/COP/10/27 [throughout the volume, Nagoya Protocol on Access and Benefit-Sharing]. 2  Convention on Biological Diversity (Rio de Janeiro, 5 June 1992, in force 29 December 1993) 1760 UNTS 79 [throughout the volume, ‘Convention’ or CBD]. 3  For a discussion of the evolution of the CBD, see Elisa Morgera and Elsa Tsioumani, “Yesterday, Today and Tomorrow: Looking Afresh at the Convention on Biological Diversity”, Yearbook of International Environmental Law 21 (2011): 3. 4   Désirée McGraw, “The CBD: Key Characteristics and Implications for Implementation”, Review of European Community and International Environmental Law 11 (2002): 17. 5  Lee Kimball, “Institutional Linkages between the Convention on Biological Diversity and Other International Conventions”, Review of European Community and International Environmental Law 6 (1997): 239. 6  The literature on the CBD provisions on genetic resources is extensive: Daniel Robinson, Confronting Biopiracy: Challenges, Cases and International Debates (London: Earthscan 2010); Suneetha M. Subramanian and Balakrishna Pisupati, Learning from the Practitioners: Benefit Sharing Perspectives from Enterprising Communities (Nairobi: UNEP/UNU, 2009); 1

2   Elisa Morgera, Matthias Buck and Elsa Tsioumani associated with such resources,7 thus leading to a significant development of the concept of benefit-sharing8 under the international biodiversity regime. In addition, the Protocol seeks to strike an innovative balance between the economic and non-economic values of biodiversity, tightly linking access and benefit-sharing with the first and second objectives of the CBD – conservation and sustainable use.9 At the same time, the Nagoya Protocol poses significant implementation challenges at the regional, national and local levels, as well as several questions for the legal interpreter. Investigating ways to respond to these interpretation and implementation challenges, contributors to this collection embark on a systematic exploration of the legal implications of the Nagoya Protocol for other areas of international law and for domestic implementation. Obviously, this collection cannot resolve all these questions, but rather aims to structure a systematic debate on the Protocol. And indeed the different contributions clearly articulate questions that arise and that still await further academic research and coordinated action at international level. By way of introduction, the following sections will briefly illustrate the evolution of the international debate on ABS, point to some of the most innovative

Charles McManis, Biodiversity and the Law (London: Earthscan, 2007); Morten Walløe Tvedt and Tomme Young, Beyond Access: Exploring Implementation of the Fair and Equitable Sharing Commitment in the CBD (Bonn: IUCN, 2007); Natalie Stoianoff, ed., Accessing Biological Resources: Complying with the Convention on Biological Diversity (The Hague: Kluwer Law International, 2004); Walter Reid et al., Biodiversity Prospecting: Using Genetic Resources for Sustainable Development (Washington DC: World Resources Institute, 1993). 7  Anja Meyer, “International Environmental Law and Human Rights: Towards the Explicit Recognition of Traditional Knowledge”, Review of European Community and International Environmental Law 10 (2001): 37, Evanson C. Kamau and Gerd Winter, eds., Genetic Resources, Traditional Knowledge and the Law: Solutions for Access and Benefit Sharing (London: Earthscan 2009); Rachel Wynberg, Doris Schroeder and Roger Chennells, eds., Indigenous Peoples, Consent and Benefit-Sharing: Lessons from the San-Hoodia Case (New York: Springer, 2009); Sarah Laird, ed., Biodiversity and Traditional Knowledge: Equitable Partnerships in Practice (London: Earthscan, 2002); Suneetha M. Subramanian and Balakrishna Pisupati, eds., Traditional Knowledge in Policy and Practice: Approaches to Development and Human Well-being (Tokyo: UNU, 2010); Manuel Ruiz and Ronnie Vernooy, eds., The Custodians of Biodiversity: Sharing Access and Benefits to Genetic Resources (London: Earthscan 2012). 8  This concept has indeed been subject to evolving interpretation by the CBD Parties as a tool for inter-state cooperation as well as for partnership between States, local communities, and the private sector: Elisa Morgera and Elsa Tsioumani, “The Evolution of Benefit-sharing: Linking Biodiversity and Community Livelihoods”, Review of European Community and International Environmental Law 15 (2010): 150. 9  The Nagoya Protocol (Articles 1 and 9–10) promotes an integrative interpretation and coherent implementation of the CBD.

Introduction   3

traits of the Nagoya Protocol and illustrate the objectives and structure of the present collection.

I.  Access and Benefit-sharing: Relevance, Origins and Evolution Modern bio-sciences have led to rapid growth of scientific research on the genetic base of life, on the relevance of genes for the biological and chemical make-up of cells and organisms, and on interactions between the genetic and bio-chemical make-up of organisms and their natural environment. Genes and naturally occurring bio-chemicals play significant and growing roles in different economic sectors and are considered as the basis for meeting important societal challenges in diverse areas such as food security, the development of drugs against cancer and other diseases, the development of bio-based sources of renewable energy, or adaptation to climate change, to name but a few.10 Traditional knowledge associated with genetic resources has on several occasions attracted the interest of bioprospectors as it sparks the utilization process or provides the lead to the potentially useful properties of a genetic resource.11 The CBD was pioneering in introducing the concepts of ABS for genetic resources and traditional knowledge in international environmental law in early recognition of the above-described developments. Until its negotiation and entry into force, an arguable application of the concept of common heritage of mankind12 over biological resources had resulted in an almost

 TEEB, The Economics of Ecosystems and Biodiversity: Mainstreaming the Economics of Nature: A synthesis of the approach, conclusions and recommendations of TEEB (UNEP, 2010). The TEEB website includes a wealth of information on the economics of biodiversity, http://www.teebweb.org/, accessed 15 June 2012. 11  “Report of the sixth meeting of the Ad Hoc Open-ended Inter-sessional Working Group on Article 8(j) and related provisions of the Convention on Biological Diversity” (21 November 2009) UN Doc UNEP/CBD/COP/10/2, 36. 12  This understanding should be compared with the common heritage regime, as provided for in Article 140(2) of the UN Convention on the Law of the Sea (10 December 1982, in force 16 November 1994) 1833 (UNTS 3), which has been described as encompassing four basic elements: resources that cannot be appropriated to the exclusive sovereignty of States; resources that must be conserved and exploited for the benefit of mankind, without discrimination; an international institution to manage and regulate these activities; and the peaceful purposes of these activities. The second element basically provides for all States to share rewards, even if they are unable to participate in the actual process of extraction, in the framework of international regulation of access and benefit-sharing. See Patricia Birnie, Alan Boyle and Catherine Redgwell, International Law and the Environment (Oxford: Oxford University Press, 2009), 128–130 and 197. 10

4   Elisa Morgera, Matthias Buck and Elsa Tsioumani free flow of genetic resources across boundaries:13 access to in situ resources was considered free and unconditional, and the results of research on such resources were expected to benefit future generations. The CBD instead clearly recognized national sovereignty over genetic resources, meaning, in the case of ABS, that access is subject to prior informed consent (PIC) of the Party providing the resource.14 Furthermore, the CBD aimed at the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding.15

This shift in principles can be explained in the light of the growing expectations of the commercial value of biodiversity, as well as the asymmetry caused by the application of intellectual property rights on improved germplasm, developed on the basis of freely acquired wild or traditional one.16 In this connection, benefit-sharing, as enshrined in the CBD, embodies an interState approach to achieve sustainable development and equity.17 On the other hand, another key provision of the CBD establishes a qualitatively different concept of benefit-sharing as a State-to-community contribution to sustainable development and equity: CBD Article 8(j) envisages the establishment of a relationship between the State and the local or indigenous community whose traditional knowledge is utilised for the conservation and sustainable use of biodiversity.18 While very innovative at the conceptual level, the CBD provided only scant detail on how access to and use of genetic resources are to take place to be consistent with benefit-sharing requirements. It also did not expressly link the concepts of ABS and traditional knowledge.19 Few CBD Parties have had the legal capacity to translate the CBD provisions into national ABS legislation.20 In addition, most industrialized country Parties with advanced biotechnology and pharmaceutical industry (and therefore major interest in continued access to and use of genetic resources),  Tvedt and Young, Beyond Access, 1.  CBD Article 15.5. As an expression of national sovereignty, the providing country can also decide not to exercise its right to require PIC. 15  CBD Article 1. 16  Michel Petit et al., Why Governments Can’t Make Policy: The Case of Plant Genetic Resources in the International Arena (2001), accessed 10 June 2012, http://www.iphandbook.org/ handbook/globallearning/videos/Biopiracy/WhyGovernmentCantMakePolicy.pdf 10 and 19. 17  Morgera and Tsioumani, “The Evolution of Benefit-sharing”, 151–159. 18  Ibid., 159–168. 19  Ibid., 155–156. 20  CBD Secretariat, Overview of Recent Developments at National and Regional Levels Relating to Access and Benefit-sharing (30 August 2007) Doc. UNEP/CBD/WGABS/5/4. 13 14

Introduction   5

have been very hesitant to adopt measures supporting effective benefitsharing by their researchers and companies. As a reaction, conditions for access to genetic resources in some megadiverse countries have become very restrictive. At the same time, researchers and companies have repeatedly been exposed to damaging allegations of ‘biopiracy’: such allegations cover a diversity of circumstances, ranging from the granting of patents on inventions developed on the basis of genetic resources accessed in violation of provider countries’ sovereign rights, to inventions that are neither novel nor inventive having regard to traditional knowledge already in the public domain.21 The visible lack of implementation of the CBD’s third objective has arguably held back progress in global, coordinated action to conserve and sustainably use biodiversity: the potential benefits of a functioning ABS framework could have been used to improve biodiversity management and livelihoods of communities that act as stewards of biodiversity in countries providing genetic resources. To provide a paradigmatic scenario of an ABS arrangement, we can imagine a European research team working for the food industry, wishing to conduct research on a wild African plant with highly nutritional value to further advance the development of a functional food. In this ideal case, both the African (provider country) and the European country in question (user country) have national legislation in place clearly setting out, among others, conditions for access including the authority to grant prior informed consent, modalities for the negotiation of a benefit-sharing agreement, and a framework that supports the reporting and tracking of ABS-related obligations. The European research team contacts the provider country’s national authority in order to request a research permit (embodying the prior informed consent). Following negotiations, where both sides are equally aware of their rights and obligations, mutually agreed terms for fair and equitable benefit-sharing are established, including for instance the participation of African researchers in the research team (non-monetary benefit-sharing) and a percentage of royalties in case of commercialization of a product based on the use of the plant provided (monetary benefit-sharing). The European team conducts its research, develops a highly successful functional food with immune system-boosting properties and acts in full compliance with the agreement signed. Benefits flow back to the African country and are consistently used for the conservation and sustainable use of the plant in question, as well as  Tomme Young, An Analysis of Claims of Unauthorized Access and Misappropriation of Genetic Resources and Associated Traditional Knowledge, (22 December 2005), Doc UNEP/ CBD/WG-ABS/4/INF/6); Commission on Intellectual Property Rights, Integrating Intellectual Property Rights and Development Policy (2002), accessed 18 June 2012, http://www .iprcommission.org/papers/pdfs/final_report/ciprfullfinal.pdf, 74.

21

6   Elisa Morgera, Matthias Buck and Elsa Tsioumani to improve the livelihoods of local communities that have for many centuries used the said plant for its recovery properties. Very rarely, however, are real ABS cases that straightforward. In the example above, it could well be that none of the countries involved had national legislation in place; or that the provider country had not established the authority competent to grant prior informed consent. Or that the users decided to proceed without requesting prior informed consent or entering into mutually agreed terms for benefit-sharing. Or that the access proceeded as required by the national legislation of the African country, but later, one member of the research team breached the contract and continued doing research on the plant in another company without sharing benefits. To complicate matters further, we can picture a university researcher who requests prior informed consent and enters into mutually agreed terms for academic, non-commercial research on the African plant. He publishes the results of his research in a scientific journal without mentioning the country of origin of the samples, the limitations on the use, or the existence of a benefitsharing agreement. Two years later, another scientist undertaking applied research in the food industry reads the article and acquires a sample of the African plant from a botanical garden in his country: the research on the plant sample leads to a highly successful (and maybe patented) product. Yet another complexity would arise if the researchers were only interested in the resin produced by a certain plant (a ‘derivative’) rather than its genetic or biochemical makeup. A whole additional level of complication arises then if the plant in question could be found in situ only in indigenous territories in a provider country, and had been traditionally used by an indigenous group that enjoy a high degree of autonomy from the State. The situation could, once again, be complicated by the fact that the same genetic resource could be found in various indigenous territories located in different countries, or the relevant traditional knowledge was shared by various indigenous communities located in different countries. Although the CBD provides for a set of basic principles on ABS, it gives very little guidance on how to address ‘non-ideal’ ABS situations such as those described above. The first effort by the international community to provide more detailed guidance on ABS led to the conclusion of the nonlegally binding Bonn Guidelines. The Bonn Guidelines22 were adopted in April 2002 in order to guide governments in establishing legislative, administrative or policy measures on  Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization (Bonn Guidelines), CBD Decision 6/24, “Access and Benefit-Sharing as Related to Genetic Resources” (27 May 2002) UN Doc UNEP/CBD/ COP/6/20 [throughout the volume, Bonn Guidelines on Access and Benefit-Sharing].

22

Introduction   7

ABS. Following the generally accepted understanding that all countries are both users and providers of genetic resources,23 all countries were expected to adopt both source-country measures, including provisions clarifying each country’s sovereign rights over genetic resources, and the identification of access procedures and requirements; and user-country measures, by which each country addresses the responsibility of users under its jurisdiction who are utilizing genetic resources from other countries.24 Only a few countries developed domestic ABS legislation after adoption of the Bonn Guidelines. This could indicate the limits of a non-binding approach to effective national implementation of ABS. However, it also reflects that only four months later, in August 2002, heads of State and government attending the World Summit on Sustainable Development (WSSD) agreed to launch negotiations on an international regime on benefit-sharing,25 which clearly aimed at a higher level of ambition than the Bonn Guidelines. The WSSD mandate triggered the negotiations that eventually led to the adoption of the Nagoya Protocol. Despite being assessed by many regional groups as ‘far from perfect,’26 the Nagoya Protocol is a legally binding instrument that aims to operationalize the third objective of the CBD by setting out rules and procedures on access, benefit-sharing, and compliance. The Nagoya Protocol defines key concepts related to ABS, such as what constitutes ‘utilisation of genetic resources’ and ‘derivatives.’ It also spells out the basic conditions for ABS, including key elements of national measures in provider and user countries related to access, benefit-sharing, institutional responsibilities, and compliance. The Protocol breaks new ground as regards the rights of indigenous and local communities: it establishes a clear link between ABS and traditional knowledge; affirms in legally binding language the need to ensure the protection of traditional knowledge and to support communities’ customary laws and procedures; provides for situations in which indigenous and local communities hold rights over genetic resources; and specifically provides for supporting the capacity of indigenous and local communities to engage in ABS activities. Critically, the Protocol also creates a complex system for ensuring  CBD Decision 7/19, “Access and Benefit-Sharing as Related to Genetic Resources (Article 15)” (13 April 2004) UN Doc UNEP/CBD/COP/7/21, recital 16. 24   Ibid., at 3. 25  United Nations, “Report of the World Summit on Sustainable Development” (2002) UN Doc A/CONF.199/20, Resolution 2: Johannesburg Plan of Implementation, paragraph 44.o. 26  During the closing plenary, a number of delegations including the African Group, the Central and Eastern European Group, Venezuela, and Bolivia made statements for the record to underscore their doubts about the new instrument’s quality: “Report of the Tenth Meeting of the Conference of the Parties to the Convention on Biological Diversity” (20 January 2011) UN Doc UNEP/CBD/COP/10/27, paragraphs 98–102. 23

8   Elisa Morgera, Matthias Buck and Elsa Tsioumani compliance with ABS laws and concrete benefit-sharing arrangements. This system is based on a mix of international and domestic measures, including: basic obligations on users to respect national access laws, supportive monitoring measures, including through designated ‘checkpoints’, the issuing of internationally recognized certificates of compliance as evidence of legal acquisition in provider countries, and the future establishment of an international mechanism to address the compliance of Parties with their Protocol obligations in a cooperative and non-adversarial manner.27 Once operational, the Nagoya Protocol is expected to generate significant benefits for biodiversity conservation in States that make available the genetic diversity over which they hold sovereign rights. In parallel, it seeks to enhance access of researchers and companies to quality samples of genetic resources, based on reliable access decisions at low transaction costs. This is expected to create new opportunities for nature-based research and development and the creation of innovative goods and services that help to meet important societal challenges. More broadly, the Protocol is expected to strengthen the political and economic interest in, and public awareness of the importance of, preserving genetic diversity in nature (in situ), particularly by communities, and in collections (ex situ). As is recognized in its Preamble: public awareness about the economic value of ecosystems and biodiversity and the fair and equitable sharing of this economic value with the custodians of biodiversity are key incentives for the conservation of biological diversity and the sustainable use of its components.28

II.  The Innovations of the Nagoya Protocol: Global Environmental Law and Multi-level Governance The Nagoya Protocol is the result of six years of intergovernmental negotiations. It was adopted by consensus by the 193 CBD Parties at the tenth meeting of the Conference of the Parties (COP) to the CBD in October 2010 as part of a political package that also included adoption of a global strategic plan for biodiversity policy until 2020 and of a decision on the implementation of the global strategy for resource mobilization.29

 Nagoya Protocol Articles 15–18 and 30.  Nagoya Protocol, preambular paragraph 5. 29  CBD decisions 10/2 “The Strategic Plan for Biodiversity 2011–2020 and the Aichi Biodiversity Targets” and 10/3 “Strategy for resource mobilization in support of the achievement of the Convention’s three objectives”, (20 January 2011) UN Doc UNEP/CBD/COP/10/27. 27 28

Introduction   9

Adoption by consensus, according to Boyle and Chinkin, has a ‘powerful law-making effect, even before the treaty enters into force’30 thus legitimising and promoting consistent State practice. Nonetheless, on the surface, the actual extent of law-making within the Protocol may not be immediately visible. The text of the Protocol leaves significant flexibility to countries in domestic implementation. Furthermore, some of its innovative provisions, such as Article 10 on a Global Multilateral Benefit-sharing Mechanism, did not emerge from formal negotiations amongst the CBD Parties. To break through the deadlock in the final negotiations, and with time running out to comply with the deadline established for the negotiations,31 the Japanese environment minister, as president of the COP and with political responsibility for the overall success of the Conference, took the initiative to table a comprehensive compromise proposal on a take-it-or-leave-it basis, after a series of informal consultations with regional groups. The compromise text proposed solutions on all words or paragraphs that were still pending in the negotiating text – partially by simply deleting controversial provisions (for instance, on the Protocol’s temporal application). As is the case with all compromises, the Japanese text apparently left all Parties equally (un)happy and was eventually adopted by consensus in the final hours of the COP. This politically very successful strategy has its apparent downside from a legal perspective: it did not leave time for the rigorous language and legal consistency checks that normally take place at the end of a treaty negotiation. This inevitably created some interpretative questions. Upon closer inspection, the Protocol creates innovative international obligations that link the performance of countries that provide access to and countries in which use is made of genetic resources. Implementation is thus expected to entail a dynamic web of legal relationships: administrative decisions on access are set out in domestic permits, linking to contractual benefit-sharing agreements between private parties and backed by the establishment and enforcement of benefit-sharing arrangements to be supported by an enabling framework of national laws in provider and user countries. These domestic and transnational relations are supported by some genuinely international tools and mechanisms.32 At all governance levels, the rights of indigenous and local communities and their customary laws must

 Alan Boyle and Christine Chinkin, The Making of International Law (Oxford: Oxford University Press, 2007) 160. 31  CBD Decision 8/4 “Access and Benefit-sharing” (15 June 2006) UNEP/CBD/COP/8/31, paragraph 6. 32  Such as the international ABS clearing-house (Nagoya Protocol Article 14) and a compliance mechanism (Nagoya Protocol Article 30). 30

10   Elisa Morgera, Matthias Buck and Elsa Tsioumani be respected.33 The effective implementation of the Nagoya Protocol thus relies on a plurality of legal orders, based on the compatibility of national measures of different countries with one another. Notably, user countries are to adopt appropriate national measures to prevent biopiracy and to support compliance of individual users of genetic resources or associated traditional knowledge with applicable benefit-sharing requirements, while provider countries are to establish clear and transparent access frameworks that also ensure the appropriate engagement of indigenous and local communities. These inter-dependent domestic legal systems will then operate through fair and equitable private benefit-sharing contracts and inter-State collaborative enforcement actions, and be influenced by future guidance elaborated at the international level by the Protocol governing body. The functioning of this complex structure relies on different levels of government and a plurality of different State and non-State actors for its implementation. In that regard, the Nagoya Protocol provides a glaring example of global environmental law34 – a ‘field of law that is international, national and transnational in character all at once.’35 It goes beyond traditional public international law by coupling the role of States in addressing a matter of international common concern, with the law-making and implementation contributions of key non-State actors such as indigenous and local communities, the research community, the private sector, and NGOs. Equally, the Protocol not only regulates relations between States, but also relations between States and private individuals, groups or entities (‘users’, ‘providers’ and ‘communities’). By promoting such multi-level governance, the Protocol has the potential to go beyond hierarchical relationships. This is clearly provided by wording that allows for flexibility of implementation at the domestic level, and therefore legal experimentation. But it is also actively promoted in a number of provisions, including on model contractual clauses,36 codes of conduct,37 and community protocols,38 where the research community, the private sector, communities and NGOs supporting any of these actors will contribute to the further definition or implementation of the open-ended provisions of the Protocol. This broad approach to implementation is also

 Ibid., Art. 12(1).  Elisa Morgera, “Bilateralism at the Service of Community Interests? Non-judicial Enforcement of Global Public Goods in the Context of Global Environmental Law”, European Journal of International Law 23 (2012): 743. 35  Tseming Yang and Robert Percival, “The Emergence of Global Environmental Law”, Ecology Law Quarterly 36 (2009): 615. 36  Nagoya Protocol Article 19. 37  Nagoya Protocol Article 20. 38  Nagoya Protocol Article 12.3.a. 33 34

Introduction   11

reflected in the Protocol provisions on capacity-building39 that explicitly address a very broad range of non-State actors. Considered in its totality, the Protocol could arguably fuel novel and collaborative processes through which networks of public and private actors at international, regional, national and local levels would gradually work out the details of ABS systems influenced by measures and tools developed from the bottom up and from the top down in mutually reinforcing ways. As a by-product of the flexibility and opportunities for legal experimentation arising from its text, the Protocol will also pose significant implementation challenges to all Parties, both those that predominantly provide genetic resources and those with users within their jurisdiction. There is some experience with domestic access systems, but there is practically no experience with systems to ensure compliance by individual users; and consequently no experience on the legal and practical interactions between access and user-compliance systems – i.e. the two sides of the ABS relationship. Implementation efforts will thus inevitably raise a host of questions. For example, the status of genetic resources may not be defined in domestic law and the authority to grant prior informed consent may depend on whether ownership rights lie at different levels of government or partially in the hands of private actors. The recognition and protection of the rights of indigenous peoples and local communities not only to their traditional knowledge, but also to (biological resources taken from) the environment in which these communities live or which these communities traditionally occupy may vary greatly from one country to another. The impacts of international human rights law may also vary significantly from one country to another or from one region to another depending on the specific instruments and monitoring bodies in place. In addition, the issue of compliance with regard to access to, and use of traditional knowledge is an unchartered field in international law and policy. Other questions surround the capacity of indigenous and local communities to engage in negotiations on access to their traditional knowledge, the support of the State (and likely also of non-State actors) in this regard and the contribution of community protocols – an innovative, endogenous and participatory process for articulating in written form communities’ values and rules related to their knowledge and resources, before entering into ABS negotiations.40 Finally, the role of public or private ex situ collections of

 Nagoya Protocol Article 22.  United Nations Environment Programme (UNEP), Community Protocols for ABS (UNEP, undated), accessed 12 June 2012, www.unep.org/communityprotocols/index.asp; Harry Jonas, Kabir Bavikatte, and Holly Shrumm, “Community Protocols and Access and BenefitSharing”, Asian Biotechnology and Development Review 12 (2010): 49.

39 40

12   Elisa Morgera, Matthias Buck and Elsa Tsioumani genetic resources (e.g., botanical gardens, gene banks, culture collections) in the effective implementation of the Protocol remains to be clarified. The early discussions preparing the entry into force of the Nagoya Protocol have clearly shown that CBD Parties still need to find common understanding on some of the unprecedented or ambiguous provisions of the Protocol, including the Protocol’s interaction with other international legal instruments and processes.41

III.  The Interpretative and Implementation Challenges of the Nagoya Protocol Against this background, the present collection has a two-fold aim: first, to analyse the implications of the Nagoya Protocol for different areas of international law (namely, environmental protection, human rights, food and agriculture, health, oceans, and trade) and second, to explore the implementation challenges arising in different regions, as well as from the perspectives of various stakeholders that will be prominent players in the application of the Protocol (the research community, the private sector, legal advisors, etc). The overall objective is to promote greater understanding of the Nagoya Protocol’s requirements and implications within a wide range of scholars and practitioners working on different but interconnected areas of law, in different parts of the world, or across different sectors. The collection is divided in three parts: Part I is devoted to the implications of the Nagoya Protocol for different areas of international law; Part II offers regional perspectives on the implementation challenges arising from the Protocol; and Part III explores cross-cutting implementation challenges. 1.  Implications for International Law The implications of the Nagoya Protocol are first analysed from the viewpoint of international environmental law. Chapter 1 by Lyle Glowka and Valérie Normand introduces the reader to the negotiation and the main provisions of the Nagoya Protocol, highlighting its innovations vis-à-vis the Convention on Biological Diversity. The authors discuss how the achievement of the Convention’s third objective ultimately contributes to its other two objectives – the conservation and sustainable use of biodiversity, and

 Elisa Morgera, “First meeting of the Intergovernmental Committee for the Nagoya Protocol: All about Compliance”, Environmental Policy and Law 41 (2011): 189.

41

Introduction   13

foreshadow its implications in other areas of international law that are addressed in more detail in the remainder of Part I. In the light of the innovative provisions of the Nagoya Protocol on the role of indigenous peoples and local communities, its implications for international human rights law are explored next. Chapter 2 by Annalisa Savaresi scrutinises the human rights implications of the Nagoya Protocol, including potential avenues for achieving mutual supportiveness with human rights instruments but also human rights concerns raised by the Protocol. The chapter identifies human rights that appear relevant to ABS, including access to information, participation in decision-making and access to justice. The author places particular attention on the way the Protocol articulates the rights of indigenous peoples and local communities over their knowledge and resources, underlining that one key question is the identification of these two categories of rights holders. Chapter 3 by Claudio Chiarolla, Selim Louafi and Marie Schloen assesses the extent to which the Nagoya Protocol applies to genetic resources for food and agriculture that have distinctive characteristics and particular importance for food security. It explores the legal implications of different regulatory options for the food and agriculture sectors. The authors focus on the relationship between the Nagoya Protocol and the International Treaty on Plant Genetic Resources for Food and Agriculture as well as on-going work by the FAO Commission on Genetic Resources for Food and Agriculture. They identify available regulatory options under these instruments and the potential for their harmonious development and implementation. They also address the relationship between farmers’ rights, which are recognised by the International Treaty, and the provisions of the Nagoya Protocol on indigenous and local communities and their traditional knowledge. Chapter 4 by Marie Wilke focuses on the implications of the Nagoya Protocol for global health governance. The author analyses in particular Article 8.b of the Nagoya Protocol, which establishes special circumstances and specifically addresses cases in which genetic resources pose health emergencies. The chapter discusses this provision as a general recognition that ABS is inextricably linked to certain public health efforts and that global policy objectives related to health and biodiversity need to work in a mutually supportive manner. The chapter then illustrates the Protocol’s specific relationship with the World Health Organisation’s Pandemic Influenza Preparedness Framework as a specialised ABS system, arguing that while the main authority on public health rests with the World Health Organisation, the Nagoya Protocol will still play an important role in global health governance. Chapter 5 by Charlotte Salpin focuses on the relationship between the Nagoya Protocol and the law of the sea, as reflected in the 1982 United

14   Elisa Morgera, Matthias Buck and Elsa Tsioumani Nations Convention on the Law of the Sea (UNCLOS). Her analysis contrasts the core provisions of the Protocol with those of UNCLOS on marine scientific research, emphasising that Parties to both instruments may be faced with the challenge of implementing their obligations under the Protocol in a manner that does not call into question the difficult compromise reflected in UNCLOS between the interests of coastal States and researching States. The chapter also explores opportunities for greater interactions between the two regimes, particularly where both fora must address the same or very similar issues, for example, genetic resources for which it is not possible to grant or obtain prior informed consent, that may include marine genetic resources found in areas beyond national jurisdiction. Chapter 6 by Riccardo Pavoni turns to the relationship between the Nagoya Protocol and the law of the World Trade Organisation (WTO). He explains that the Protocol is largely silent and in part ambiguous on this relationship. The author then explores potential instances of conflict or tension with WTO disciplines that may surface in the future, such as in relation to the WTO agreements on trade in goods or WTO obligations in the field of intellectual property rights (IPRs). He focuses on questions related to whether the Protocol allows Parties to restrict access to, and thus export of, ‘derivatives’ found within their jurisdiction; whether the internationally recognised certificate of compliance may be regarded as an export or import licence or a technical regulation with a possible significant impact on imports of genetic resources; and whether the Protocol legitimates forms of benefit-sharing associated with the enjoyment of IPRs granted in respect of commercial products developed from genetic resources. The chapter also explores the implications of the Protocol for the broader and ongoing policy and academic debate on trade and biodiversity. 2.  Regional Perspectives on Implementation Challenges Part II aims to provide, as a whole, a regionally balanced perspective on the various implementation challenges raised by the Nagoya Protocol, ranging from Africa and Asia to Europe, the developed countries known as JUSCANZ,42 and Latin America and the Caribbean. Each contribution has a different focus, depending on whether countries are predominantly (or equally) providers or users of genetic resources, and on the presence, status and protection of indigenous and local communities. Each contributor was involved in different capacities in the negotiation of the Protocol, and reflects on the different regional priorities that emerged in the negotiations

 Japan, the US, Canada, Australia and New Zealand.

42

Introduction   15

of the Protocol and their bearing on the interpretation and implementation of the Protocol. Chapter 7 by Peter Munyi and Harry Jonas focuses on the African region, starting from an analysis of regional instruments relating to biodiversity and traditional knowledge, as well as various ABS experiences that predated the conclusion of the Protocol negotiations. As the African Group was vociferous in its calls for strong provisions in the Nagoya Protocol to support indigenous peoples and local communities’ rights over their genetic resources and associated traditional knowledge, the chapter explores in particular the linkages between ABS and the protection of communities’ ‘biocultural rights.’ In doing so, the chapter draws attention to ‘community protocols’ – a novel methodology enshrined in the Nagoya Protocol – that can contribute to participatory legal empowerment of indigenous peoples and local communities not only in their relationships with governments, but also with the private sector. Chapter 8 by Gurdial Singh Nijar identifies the key implementation challenges arising from the Nagoya Protocol from the viewpoint of Malaysia and other developing countries located in the Asian region, which participated in the negotiations of the Protocol as a group (the Like-Minded Asia Pacific countries). This chapter focuses in particular on challenges related to the scope of the Protocol (derivatives), access and user-compliance, as well as several issues related to traditional knowledge (the specific challenges of obtaining the prior informed consent of indigenous and local communities, as well as unresolved questions related to publicly available and diffuse traditional knowledge and to traditional knowledge accessed from various sources). It also examines specific challenges related to the implementation of the Protocol in federal systems. Chapter 9 by Alejandro Lago and Luciana Silvestri discusses implementation challenges within the European Union (EU) from the viewpoint of one of its Member States – Spain. The chapter considers the implementation challenges arising for European countries that are both providers and users of genetic resources and that host local communities in their territories. The chapter then explores the additional challenges resulting from Spain’s membership of the EU and Spain’s internal division of competences between the central government and the autonomous regions. Attention is also drawn to certain substantive challenges, such as ownership of genetic resources, the traditional knowledge of local communities, channelling benefits towards biodiversity conservation, and compliance measures. Chapter 10 by Geoff Burton explores the role of the group of countries known as JUSCANZ in the development of the Nagoya Protocol, based on lessons learnt in the implementation of the Bonn Guidelines. The chapter then discusses how these countries are likely to address a selected set of

16   Elisa Morgera, Matthias Buck and Elsa Tsioumani implementation challenges, namely non-commercial research, the scope of the Protocol with regard to ‘derivatives’ and the creation of internationally recognized certificates of compliance. It then focuses on the significant legal and political questions arising from the Protocol provisions on the use of indigenous peoples’ and local communities’ traditional knowledge associated with genetic resources in JUSCANZ countries. Chapter 11 by Jorge Cabrera identifies the main challenges and opportunities for the implementation of the Nagoya Protocol in Latin American and Caribbean countries. The chapter illustrates how the region can build on the implementation of regional and domestic ABS measures that had been enacted prior to the adoption of the Nagoya Protocol. It then assesses whether the current domestic legal frameworks on ABS in selected countries (Brazil, Colombia, Costa Rica, Peru, Panama, Mexico and Venezuela) are consistent with the Nagoya Protocol. He also shows that the region offers significant insights into the regulation of traditional knowledge that may potentially prove relevant to other areas of the world. 3.  Cross-cutting Implementation Challenges Part III complements the regional overview of implementation challenges with the views and insights on a number of cross-cutting issues affecting implementation. Chapter 12 by Julia Oliva offers the perspective of private companies working with biodiversity – and particularly those committed to ethical sourcing of biodiversity – in the operationalisation of access and benefit-sharing under the Nagoya Protocol. The chapter illustrates the challenges and opportunities faced by private companies in respecting legal ABS requirements in relation to the use of genetic resources and traditional knowledge falling under the scope of the Nagoya Protocol, as well as ethical ABS requirements related to the use of biological resources more broadly. The author assesses the extent to which the Nagoya Protocol has established clear and practical approaches on critical issues such as the scope of international ABS provisions, access and benefit-sharing related to traditional knowledge, a possible multilateral benefit-sharing approach, monitoring, the role of voluntary standards, and technology transfer. Chapter 13 by Tom Dedeurwaerdere, Arianna Broggiato, Selim Louafi, Eric Welch and Fulya Batur provides, in turn, the perspective of the research community. The authors begin by explaining the social motivations that play a role in the complex non-monetary incentive mechanisms that drive science and innovation in the field of biodiversity research (such as reputational benefits, intrinsic values and reciprocity relationships). They then analyse under what conditions these basic drivers can be harnessed in favour of an effective implementation of the Nagoya Protocol. On the basis of surveyed

Introduction   17

patterns of access and use of genetic resources, the authors evaluate possible scenarios for the implementation of key articles of the Nagoya Protocol that will have an impact on future regulation and governance of international scientific research networks (‘scientific research commons’), focusing on simplified access measures for non-commercial research, a possible multilateral benefit-sharing mechanism, transboundary cooperation, standardisation and guidelines. Chapter 14 by Claudio Chiarolla focuses on the possible roles of private international law under the Nagoya Protocol, both in the context of contractual relations (in the case of a violation of mutually agreed terms – ‘misuse’ of genetic resources or traditional knowledge) and in the context of noncontractual relationships (in the case of a violation of applicable domestic ABS requirements in the absence of mutually agreed terms – ‘misappropriation’ of genetic resources or traditional knowledge). It thus explores the role of private international law in relation to the Nagoya Protocol’s provisions on jurisdictional issues, the law applicable to ABS obligations of contractual as well as non-contractual nature, and the recognition and enforcement of foreign judgments and arbitral awards in the context of ABS disputes. By comparing a narrow and an extensive interpretation of the Protocol’s provisions that appear relevant from a private international law perspective, the chapter aims to clarify the institutional capacities that may be required for implementing the Protocol’s obligations. Chapter 15 by Tomme Young identifies a range of global and other international mechanisms that will or should enable the successful implementation of the Protocol by its Parties. This builds on a thorough analysis of the evolution of the legal discourse on ABS, as well as on a pragmatic assessment of the options for ‘borrowing’ from other areas of international law in building the international institutional framework for the Protocol. Young considers the roles of the international ABS clearing-house and other aspects of the Protocol’s monitoring and compliance provisions, and its call for regular evaluation of regime effectiveness, as well as less formal implementation tools, such as model contractual clauses, model legislation and guidelines. She concludes with a brief consideration of other possible instruments and tools, including the role of bilateral cooperation, for the implementation of the Nagoya Protocol. The overall conclusions (Morgera, Buck, and Tsioumani) will analyse the main findings of each part of the collection, identifying common threads and areas for further research in international, comparative and transnational law.43  As chapters in the collection address tightly connected issues, the editors have highlighted these interlinkages in footnote (in brackets) where appropriate. The law and policy developments throughout this book are reflected as they were on 30 June 2012.

43

Part I – Implications for International Law

Chapter 1.  The Nagoya Protocol on Access and Benefit-sharing: Innovations in International Environmental Law Lyle Glowka and Valérie Normand* With its adoption in 1992, the Convention on Biological Diversity (CBD) represented a fundamental shift in the international community’s treatment of genetic resources. For the first time a new relationship based on equity was established between the providers and users of genetic resources: access to genetic resources in exchange for fair and equitable benefits derived from their use. The concept aimed at re-directing benefit flows back to the countries providing genetic resources, while creating incentives for the conservation and sustainable use of biological diversity. At the time, capturing benefits from the use of genetic resources was in its infancy and there was little or no experience in what has since come to be known as access and benefit-sharing (ABS). With its adoption in October 2010, the Nagoya Protocol and its many innovative provisions significantly deepen and expand upon the Convention’s ABS provisions. They are foreseen to significantly advance the achievement of the Convention’s third objective, while ultimately contributing to its other two objectives – the conservation and sustainable use of biological diversity. Against this background, this chapter examines the Protocol’s innovations over the Convention and some of the contributions it makes to advancing international environmental law. The ABS concept, although initially developed in the context of a multilateral environmental agreement, has since had implications that have gone

* Respectively, Senior Legal Advisor and Senior Programme Officer to the Secretariat of the Convention on Biological Diversity. The views expressed are personal to the authors and should not be attributed to the CBD Secretariat. The authors are grateful to Ms. Mi-Jin Lee for her helpful research assistance and to Ms. Sonia Gautreau for her helpful technical assistance.

22   Lyle Glowka and Valérie Normand beyond international environmental law, influencing other areas of international law addressing such diverse areas as agriculture, intellectual property rights, health, and human rights. The Protocol’s relationship with other international instruments and inter-governmental processes influenced by the ABS concept is, therefore, important and this chapter introduces relevant issues, which will be addressed in more detail in other chapters. Section I provides a short primer on ABS and the CBD including the process leading to the adoption of the Protocol. Section II reviews the Protocol’s innovative provisions in relation to those of the CBD, highlighting how they respond to outstanding implementation challenges, and thereby advance international environmental law addressing ABS. Section III briefly examines some of the other international instruments and intergovernmental processes influenced by the ABS concept and their relationship with the Protocol. Section IV provides some thoughts on the way forward for the implementation of the Protocol.

I.  The CBD and ABS For many developing countries in the intergovernmental negotiations that led to the Convention, a major aim was to redefine benefit flows from the use of genetic resources – to rectify what was viewed as an inequitable situation whereby genetic material was usable by anyone for any purpose, with no requirements to direct benefits back to the original provider once the material was physically obtained. Equity, therefore, was the central principle driving the negotiation of the CBD provisions on ABS. It was complemented by the attractive premise that benefit-sharing could create economic incentives to conserve and sustainably use biological diversity. In effect, genetic resources were innovatively viewed as a means to assign a value to biodiversity and to direct a stream of benefits – at the time viewed primarily in monetary terms – to create an economic basis for its conservation. Both concepts were initially driven by expectations of financial windfalls from use of genetic resources in biotechnological applications (biotechnology at the time was still in its infancy). But whereas the equity thrust ended up being quite prominent in the Convention, the link between benefit-sharing and conservation was only implied by the juxtaposition of the third objective with the Convention’s first and second objectives on conservation and sustainable use.

Innovations in International Environmental Law   23

1.  The CBD Provisions on ABS The Convention provisions on ABS span four articles: 15, 16, 19 and 8(j). Article 15 is the source of the Convention’s access-related principles. The cornerstone is the Convention’s affirmation that States have sovereign rights over their natural resources1 and, by extension, their genetic resources. Until the Convention entered into force, genetic resources were accessible by anyone for any purpose without an explicit obligation to share benefits with the provider country. Sovereign control of the access-determination process was foreseen to ensure fair and equitable benefit-sharing. It would be manifested by the requirements of informed consent prior to access2 and the negotiation of mutually agreed terms (MAT).3 Article 15 is also the source of the primary benefit-sharing provision in the Convention. Accordingly, each Party is to take measures to ensure the sharing of benefits (sharing the results of research and development and those arising from the commercial and other utilisation of genetic resources).4 The CBD does not elaborate in great detail on the types of benefits that can be shared. But a distinction between monetary and non-monetary benefits is evident in its text,5 with the importance of the latter becoming more recognised as CBD implementation progressed and the Bonn Guidelines on ABS (2002)6 were adopted. Supplementary benefit-sharing provisions important to countries providing genetic resources include those with the aim of: ensuring participation in general and biotechnological research;7 access to and transfer of technology;8 and priority access to the results and benefits from biotechnologies based upon genetic resources provided.9 The Convention’s other significant ABS provision – article 8(j) – provides the basis for sharing benefits with indigenous and local communities for the use of the traditional knowledge associated with genetic resources with their approval and involvement.

 CBD Article 15.1.  CBD Article 15.5. 3  CBD Article 15.4. 4  CBD Article 15.7. 5  CBD Article 15.7 and other supplementary benefit-sharing articles CBD Articles 15.6, 19.1 and 19.2. 6  Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilisation, CBD Decision 6/24, “Access and benefit-sharing as related to genetic resources” (27 May 2002) UN Doc UNEP/CBD/COP/6/20 (Bonn Guidelines). 7  CBD Articles 15.6 and 19.1. 8  CBD Article 16.3. 9  CBD Article 19.2. 1 2

24   Lyle Glowka and Valérie Normand 2.  Towards an ABS Protocol: The Need for Legal Certainty As with other provisions in the Convention, the ABS provisions in the CBD are general in nature. The details of implementation are left to Parties to the Convention to decide, taking into consideration their own national circumstances. The apparent simplicity of the ABS concept – premised on a bilateral transaction between a provider and a user of genetic resources – belies the complexity of implementation. The bioprospector’s target invariably focuses on small amounts of biological material or environmental samples. Biodiversity-rich countries – the most desirable for bioprospecting – may be developing countries with limited capacity to regulate access to genetic resources and ensure benefits are shared when genetic resources collected leave the country. In the view of many developing countries, the potential for misappropriation and/or misuse of genetic resources was one of the challenges left inadequately addressed by the Convention, thereby creating an atmosphere of mistrust between developing and developed countries. Developing countries asserted that developed countries, hosts to the primary users of genetic resources, had an obligation pursuant to the Convention10 to take measures to prevent misappropriation and/or misuse, and to assist in ensuring the sharing of benefits. In the view of developed countries, and those entities and individuals seeking to gain access to genetic resources, in some cases well-intentioned first-generation laws developed to implement the Convention proved difficult to navigate, while the lack of a regulatory framework and the absence of competent authorities on ABS in the vast majority of countries caused legal uncertainty. This dissuaded potential bioprospectors, and impeded legitimate domestic and international scientific research, resulting in fewer opportunities to develop the very benefit streams that developing countries had hoped for and were entitled to capture. 3.  Bonn Guidelines Overcoming the implementation challenges left unaddressed by the Convention did not begin in earnest until 1999. The Bonn Guidelines were the first significant output in the Convention process targeted to operationalising its ABS provisions. They provided voluntary guidance to assist governments and stakeholders when developing legislative, administrative or policy measures on access and benefit-sharing and/ or when negotiating access and benefit-sharing arrangements. Key features  CBD article 15.7.

10

Innovations in International Environmental Law   25

of the Guidelines included: (1) the identification of steps in the ABS process, such as national entities granting prior informed consent (PIC) and the procedures for obtaining PIC;11 (2) the identification of basic requirements for MAT, such as legal certainty and clarity and the minimisation of transaction costs;12 (3) the definition of the roles and responsibilities of national authorities and of users and providers of genetic resources in the implementation of ABS arrangements;13 and (4) the participation of stakeholders in the development and implementation of ABS arrangements.14 They also explicitly suggested for the first time that the types of benefits shared could be both monetary and non-monetary, providing examples in an appendix.15 Importantly, during the final negotiations of the Bonn Guidelines,16 developing countries expressed concern that the Guidelines focussed too heavily on the responsibilities of Parties as providers of genetic resources and did not sufficiently address the responsibilities of Parties, as users of genetic resources, to take appropriate measures to ensure that users respected the ABS requirements of provider countries. In response to this concern, the section on responsibilities was expanded to address the responsibilities of Parties as users of genetic resources.17 The Guidelines clarify that ‘[CBD] Parties with users of genetic resources under their jurisdiction should take appropriate legal, administrative, or policy measures, as appropriate, to support compliance with PIC of the Contracting Party providing such resources and MAT on which access was granted.’18 Possible measures for consideration to this end include: (1) mechanisms to provide information to potential users on their obligations regarding access to genetic resources; (2) measures to encourage the disclosure of the country of origin of the genetic resources and of the origin of traditional knowledge of indigenous and local communities in applications for intellectual property rights; (3) measures aimed at preventing the use of genetic resources obtained without the PIC of the Party providing such resources; and, (4) cooperation between Parties to address alleged infringements of access and benefit-sharing agreements.19  Bonn Guidelines section IV.  Bonn Guidelines section IV, paragraph 42. 13  Bonn Guidelines section II. 14  Bonn Guidelines section III. 15  Bonn Guidelines section IV, paragraph 46 and appendix I. 16  At the sixth meeting of the Convention’s Conference of the Parties (COP) in The Hague, the Netherlands, 7–19 April 2002. 17  Bonn Guidelines section II, paragraph 16.d. 18  Bonn Guidelines section II, paragraph 16.d. 19  Bonn Guidelines section II. 11 12

26   Lyle Glowka and Valérie Normand In addition, the Bonn Guidelines include a number of measures to support compliance with PIC and MAT addressing: accountability in implementing access and benefit-sharing arrangements; national monitoring and reporting; means of verification including certification; settlement of disputes with respect to MAT; and remedies for violations of national legislative, administrative or policy measures.20 Both sets of measures helped to address, at least in part, the challenges perceived by developing countries left outstanding by the Convention,21 some of which were later further developed in the Nagoya Protocol. 4.  World Summit on Sustainable Development (2002) and the Process Leading to the Nagoya Protocol In response to the concerns of developing countries, at the World Summit on Sustainable Development (WSSD) in September 2002 – just a few months after the adoption of the Bonn Guidelines – governments went a step further calling for action to ‘negotiate within the framework of the CBD, bearing in mind the Bonn Guidelines, an international regime to promote and safeguard the fair and equitable sharing of benefits arising out of the utilisation of genetic resources’.22 In 2004, the CBD Conference of the Parties (COP) responded to the WSSD’s call for action by mandating the Ad Hoc Open-ended Working Group on Access and Benefit-sharing (created in 2000 to develop the Bonn Guidelines and other approaches) to elaborate and negotiate an international regime on access to genetic resources and benefit-sharing with the aim of adopting an instrument or instruments to effectively implement Articles 15 and 8(j), and the three objectives of the Convention.23 The COP also agreed on the Working Group’s terms of reference, including the process, nature, scope and possible elements of an international regime. Notably, it was decided that the regime would cover both access to genetic resources and benefit-sharing, in response to the needs of developed countries. The two concepts were seen as inextricably linked.

 Bonn Guidelines section V.  Notably by CBD Article 15.7. 22  United Nations, “Report of the World Summit on Sustainable Development” (2002) UN Doc A/CONF.199/20, Resolution 2: Johannesburgh Plan of Implementation, paragraph 44.o. 23  CBD Decision 7/19, “Access and benefit-sharing as related to genetic resources (Article 15)”, (13 April 2004) UN Doc UNEP/CBD/COP/7/21. 20 21

Innovations in International Environmental Law   27

The Nagoya Protocol took six years to negotiate over the course of nine working group meetings.24 Four expert group meetings fed into the process.25 Negotiations spanned four meetings of the Conferences of the Parties with adoption by its tenth meeting in the early hours of 30 October 2010. The same decision adopting the Protocol recognised it as one component of the ‘international regime on access and benefit-sharing’, which also includes the Convention, as well as complementary instruments such as the International Treaty on Plant Genetic Resources for Food and Agriculture and the Bonn Guidelines.26 The Protocol operationalises the Convention’s third objective, CBD Article 15 and the Convention’s various benefit-sharing provisions. Its concise objective is to ensure benefits arising from utilisation of genetic resources are shared fairly and equitably as a contribution to the conservation and sustainable use of biodiversity.27

 The Third Meeting of the Working Group (14–18 February 2005, Bangkok), accessed 31 March 2012 http://www.cbd.int/doc/?mtg=ABSwg-03; the Fourth Meeting of the Working Group (30 January–3 February 2006, Granada), accessed 31 March 2012 http://www .cbd.int/doc/?mtg=ABSwg-04; the Fifth Meeting of the Working Group (8–12 October 2007, Montreal ), accessed 31 March 2012 http://www.cbd.int/wgabs5/; the Sixth Meeting of the Working Group (21–25 January 2008, Geneva), accessed 31 March 2012 http://www.cbd .int/wgabs6/; the Seventh Meeting of the Working Group (1–9 April 2009, Paris), accessed 31 March 2012 http://www.cbd.int/wgabs7/; the Eighth Meeting of the Working Group (9–15 November 2009, Montreal ), accessed 31 March 2012 http://www.cbd.int/wgabs8/; the Ninth Meeting of the Working Group (22–28 March 2010, Cali), accessed 31 March 2012 http://www.cbd.int/wgabs9/; the Resumed Ninth Meeting of the Working Group (10 to 16 July 2010, Montreal ), accessed 31 March 2012 http://www.cbd.int/wgabs9-resumed/; the Resumed Ninth Meeting of the Working Group (16 October 2010, Nagoya), accessed 31 March 2012 http://www.cbd.int/doc/?meeting=ABSWG-09-3RD. 25  Meeting of the Group of Technical Experts on an Internationally Recognised Certificate of Origin/Source/Legal Provenance (22–25 January 2007, Lima) accessed 31 March 2012 http://www.cbd.int/doc/?meeting=ABSGTE-01; Group of Legal and Technical Experts on Concepts, Terms, Working Definitions and Sectoral Approaches (2–5 December 2008, Windhoek), accessed 31 March 2012 http://www.cbd.int/doc/?meeting=ABSGTLE-01; Group of Technical and Legal Experts on Compliance in the Context of the International Regime on Access and Benefit-Sharing (27–30 January 2009, Tokyo), accessed 31 March 2012 http://www.cbd.int/doc/?meeting=ABSGTLE-02; Group of Technical and Legal Experts on Traditional Knowledge Associated with Genetic Resources (16–19 June 2009, Hyderabad), accessed 31 March 2012 http://www.cbd.int/doc/?meeting=ABSGTLE-03. 26  CBD Decision 10/1, “Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation” (20 January 2011) UN Doc UNEP/CBD/ COP/10/27. 27  Nagoya Protocol Article 1. 24

28   Lyle Glowka and Valérie Normand

II.  Nagoya Protocol: Key Innovations in Relation to the CBD Many provisions of the Protocol expand significantly upon and, in some cases, go beyond the Convention provisions on ABS. Notable innovations include: (1) expanded application to biochemicals even where they are not associated with genetic material; (2)  details regarding access-related measures in countries requiring PIC; (3) utilisation of genetic resources as a central concept with implications on the scope and application of the Protocol; (4) activities triggering benefit-sharing, the recognition of non-monetary benefits and the clear link between benefit-sharing and the conservation of biodiversity; (5) a suite of articles designed to support compliance with domestic ABS requirements and MAT with a view to ensuring PIC and benefit-sharing; (6) monitoring of the utilisation of genetic resources with a view to supporting compliance through the establishment of an internationally recog­ nised certificate of compliance; and (7) significant advances for indigenous and local communities in relation to access to traditional knowledge associated with genetic resources and access to genetic resources where indigenous and local communities have established rights to grant access to them, and the need to share benefits arising from their utilisation. These innovations will be discussed in turn below. 1.  Scope The Protocol applies to genetic resources within the scope of CBD Article 15 and the benefits arising from their utilisation.28 The Protocol’s primary innovation over the Convention is the expanded interpretation of ‘genetic resources’ to include their genetic and biochemical composition. This manifests itself in a new definition for ‘utilisation of genetic resources’.29 In addition, the reference to ‘utilisation of genetic resources’ indicates that the Protocol only applies to genetic resources when these are accessed with the intention ‘to conduct research and development on the genetic and/

 Nagoya Protocol Article 3.  Nagoya Protocol Article 2.c.

28 29

Innovations in International Environmental Law   29

or biochemical composition of genetic resources . . .’.30 The term should contribute to greater legal certainty regarding the Protocol’s application, while alleviating concern that the Protocol could apply to biological resources traded as commodities. For example, a plant accessed for the ornamental cut flower trade, and not for research and development on its genetic or biochemical composition, would not trigger the Protocol’s PIC or benefitsharing provisions since its use would not be within the scope of the definition of ‘utilisation of genetic resources’. This important distinction is critical to the Protocol’s focused and efficient application and represents a significant improvement over the Convention. 2.  The Protocol’s Core Elements a.  Access Provisions The Protocol’s access provisions rely on the same foundational principles upon which the Convention is premised – sovereign rights over genetic resources providing the basis for PIC and reaching MAT – while moving significantly beyond CBD Article 15 by responding to the need for greater legal certainty for both users and providers of genetic resources.31 The need for greater legal certainty was a key issue for developed countries in the negotiations. It stemmed in part from the procedural and other difficulties potential users had in trying to obtain PIC in order to access genetic resources and the need to ensure the providers of genetic resources were entitled legally to provide them. Developed countries also emphasised that a more standardised approach to access measures would help, or even be necessary, to ensure compliance. The Nagoya Protocol provides the basis for greater legal certainty for potential users of genetic resources seeking access by obliging each Party requiring PIC to take specific measures with respect to the legal and institutional framework created to regulate access.32 Measures are to provide for: (1)  legal certainty, clarity, transparency and timeliness;33 (2)  fair and non-arbitrary access rules and procedures;34 (3)  information on how to apply for PIC;35  Nagoya Protocol Article 2.c.  Nagoya Protocol Article 6. 32  Nagoya Protocol Article 6. 33  Nagoya Protocol Article 6.3.a. 34  Nagoya Protocol Article 6.3.b. 35  Nagoya Protocol Article 6.3.c. 30 31

30   Lyle Glowka and Valérie Normand (4) a clear and transparent written decision by a competent national authority, in a cost effective manner and within a reasonable period of time;36 and (5) a permit or its equivalent to be issued at the time of access as evidence of a decision to grant PIC and that MAT have been established.37 The issuance of documentary evidence of the decision to grant PIC, and the added requirement to provide this to the international ABS clearinghouse established by the Protocol, should contribute to creating greater confidence in the legal status of genetic resources obtained by a user, and constitutes a key link between the Protocol’s ABS obligations and its obligations to ensure compliance with domestic ABS measures taken by countries providing genetic resources that require PIC. On the other hand, Parties providing genetic resources will benefit from the more robust legal and institutional frameworks resulting from these obligations in support of PIC, and the links created to the compliance provisions of the Protocol. Their interests in benefit-sharing will also be strengthened as a result of the obligation for Parties providing genetic resources to take measures to establish clear rules and procedures for requiring and establishing MAT. MAT are to be in writing.38 Suggested clauses that could be negotiated as part of MAT include: dispute settlement clauses; terms on benefit-sharing; terms on subsequent third party use; and terms on change of intent. These provisions would help to protect the interests of the provider of genetic resources, while providing greater legal certainty to both providers and users of genetic resources. In effect, the Protocol promotes best practice in contractual drafting with the aim of protecting the provider of genetic resources. By promoting the inclusion of a dispute settlement clause in MAT, the Protocol establishes a link with relevant compliance obligations,39 helping to provide the basis to settle disputes between a provider and user in cases of non-compliance with the terms of the contract. In addition, the reference to terms on benefit-sharing is meant to recall that the sharing of benefits is to be negotiated and then reflected in MAT, including benefits arising from intellectual property rights.40 Recognising that access and benefit-sharing rarely take place between one provider and one user, but that more often it applies to a chain of providers  Nagoya Protocol Article 6.3.d.  Nagoya Protocol Article 63.e. 38  Nagoya Protocol Article 6.3.g. 39  Nagoya Protocol Articles 6.3.g.i and 18. 40  Nagoya Protocol Article 6.3.g.ii. 36 37

Innovations in International Environmental Law   31

and users, terms on subsequent third party use are suggested.41 These would ensure that particular conditions apply to subsequent users in the chain of utilisation of genetic resources. For example, to address situations where a genetic resource, initially accessed for basic research purposes, is transmitted to a third party interested in commercialising the results of the research or to carry out further research, the MAT could include a requirement either for the initial user or for the third party user to first seek the PIC of the initial provider. Similarly, a clause addressing changes of intent42 would apply to a situation where a genetic resource was initially accessed for purely non-commercial research purposes and the user, on the basis of the research carried out on the genetic resource accessed, wished, at a later stage, to commercialise a product based on this genetic resource. MAT could provide a requirement to seek PIC from the provider to use the genetic resource for this new purpose. b.  Benefit-sharing Provisions Like the Convention, the Protocol’s benefit-sharing provisions are premised on the establishment of MAT.43 They refer back to CBD provisions establishing who the legitimate provider of genetic resources is for purposes of benefit-sharing under the Protocol and the basic obligation to share benefits fairly and equitably.44 The Protocol goes a step further in three innovative ways by: first, clarifying the activities triggering benefit-sharing; second, suggesting that benefits can be both monetary and non-monetary; and third, clearly linking benefit-sharing to biodiversity conservation and sustainable use. First, with regard to activities that trigger benefit-sharing, the reference in Protocol Article 5.1 to ‘utilisation of genetic resources, as well as subsequent applications and commercialisation,’ clarifies that benefits are to be shared in a fair and equitable way when they arise in relation to the genetic and/ or biochemical composition of genetic resources anywhere along the valueadded chain. This responds to the desire of developing countries to ensure that benefits would be captured by provider countries from the full range of potential subsequent uses for genetic material and biochemical – research and development (through the reference to and definition of ‘utilisation of genetic resources’), as well as subsequent applications and commercialisation. By addressing one of the key concerns of developing countries during the negotiations – ensuring that the Protocol secures benefits arising from  Nagoya Protocol Article 6.3.g.iii.  Nagoya Protocol Article 6.g.iv. 43  Nagoya Protocol Article 5. 44  CBD Articles 15.3 and 15.7. 41 42

32   Lyle Glowka and Valérie Normand subsequent uses of genetic resources – it also helped to clarify confusion surrounding the use of the term ‘derivatives’. Although the use of ‘derivatives’ in relation to subsequent uses was referenced throughout the negotiation process, the absence of a common understanding eventually led to using the phrase ‘subsequent applications and commercialisation’ as a means to more clearly describe the entire value chain that could be potentially subject to benefit-sharing. Second, the Protocol suggests that benefits to be shared can be both monetary and non-monetary.45 An indicative list, initially identified in the Bonn Guidelines, and reproduced in an annex to the Protocol, includes: access fees; milestone payments, license fees, royalties; technology transfer; sharing research results; and effective research participation. The Protocol’s specific reference to non-monetary benefits provides added legitimacy to the desirability and significance of capturing them, first acknowledged in the Bonn Guidelines. While there is often no guarantee of monetary benefits arising from the utilisation of genetic resources, in many cases non-monetary benefits are more immediately identifiable and can contribute to sustainable development, for example through the training of local scientists, the transfer of the results of research, and the transfer of technology. Over the long term, non-monetary benefits may contribute to building the capacity of provider countries in sustainably using/exploiting their own genetic resources rather than having to rely on the capacities of foreign research and business entities. A third innovation related to benefit-sharing is the Protocol’s recognition that benefit-sharing can contribute to biodiversity conservation and sustainable use. As noted earlier, the central principle of the Convention provisions on ABS was equity. It was complemented by the premise that bioprospecting could create economic incentives to conserve and sustainably use biodiversity. However benefit-sharing’s contribution to, and its function of an incentive for, conservation was not explicitly reflected in the Convention. This is also reflected in the results of a simple survey of the CBD thematic work programmes, the most relevant non-ABS cross-cutting CBD work programmes, as well as related COP decisions, which indicate that references to genetic resources and fair and equitable benefit-sharing seem to be well-reflected throughout the work undertaken under the Convention. The survey, however, also indicates that there does not appear to be any explicit reference made to benefit-sharing as an incentive for or as contribution to biodiversity conservation. One notable exception, and it is through an indirect reference, is in the CBD work programme on economics, trade and incentives, where governments and relevant organisations are encouraged  Nagoya Protocol Article 15.4.

45

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‘[t]o undertake value addition and enhancement of naturally occurring genetic resources . . . to work as incentives for their conservation and sustainable use’.46 In addition, the CBD revised strategic plan makes a very limited reference to the linkage, noting that achieving the plan’s mission to take urgent action to halt the loss of biodiversity in order to ensure that by 2020 ecosystems are resilient and continue to provide essential services will, among other things, require benefits arising out of utilisation of genetic resources to be shared in a fair and equitable manner.47 Even within the set of ABS-related COP decisions surveyed, the linkage was not evident or, where it was, it was not strongly made.48 The linkage is instead recognised to some extent in the Bonn Guidelines49 and squarely addressed in the Nagoya Protocol. The Protocol’s preamble sets the initial context. It first recognises that the fair and equitable sharing of the economic value of ecosystems and biodiversity with the custodians of biodiversity are ‘key incentives’ for biodiversity conservation and sustainable use.50 As a component of biodiversity, genetic resources provide ecosystem goods and services. The Protocol then acknowledges the potential role of ABS to contribute to biodiversity conservation and sustainable use and other Millennium Development Goals.51 Four provisions and the Protocol’s annex develop this further. First, the Protocol’s objective clearly recognises fair and equitable benefitsharing as a means of ‘contributing to the conservation of biological diversity  CBD Decision 4/10, “Measures for Implementing the Convention on Biological Diversity” (15 June 1998) UN Doc UNEP/CBD/COP/4/27, paragraph 1.h. Parties were only urged “to ensure that . . . national legislative, administrative or policy measures on access and benefitsharing contribute to conservation and sustainable-use objectives.” 47  CBD Decision 10/2, “The Strategic Plan for Biodiversity 2011–2020 and the Aichi Biodiversity Targets” (20 January 2011) UN Doc UNEP/CBD/COP/10/27, paragraph 12. 48  CBD Decision 5/26, “Access to Genetic Resources” (22 June 2000) UN Doc UNEP/CBD/ COP/5/23, paragraph 3. 49  Paragraph 22 suggests the development of an access and benefit-sharing strategy that ‘should aim at the conservation and sustainable use of biological diversity, and may be part of a national biodiversity strategy and action plan . . .’. Paragraph 48 notes that ‘Benefits should be directed in such a way as to promote conservation and sustainable use of biological diversity.’ In addition, appendix II (Monetary and Non-monetary Benefits) suggests that fees paid into trust funds could support biodiversity conservation (paragraph 1.f). It also suggests that knowledge and technology could be transferred that are relevant to the conservation and sustainable utilisation of biological diversity (paragraph 2.f), and access to scientific information relevant to conservation and sustainable use of biological diversity, including biological inventories and taxonomic studies, could also be sought (paragraph 2.k). 50  Nagoya Protocol preambular paragraph 6. 51  Nagoya Protocol preambular paragraph 7. 46

34   Lyle Glowka and Valérie Normand and the sustainable use of its components.’52 Second, the Protocol obliges Parties to ‘encourage users and providers of genetic resources to direct benefits arising from the utilisation of genetic resources towards’ biodiversity conservation and sustainable use.53 Third, if a global multilateral benefitsharing mechanism is created,54 benefits shared by users of genetic resources and associated traditional knowledge are to be used to support biodiversity conservation and sustainable use globally. Fourth, the Protocol suggests that capacity building measures may include ‘enhancement of the contribution of [ABS] activities’ to biodiversity conservation and sustainable use.55 Finally, the Protocol’s annex on monetary and non-monetary benefits mirrors the Bonn Guidelines,56 suggesting how benefits could contribute to biodiversity conservation.57 c.  Compliance Measures Perhaps the most far-reaching innovation of the Protocol is its suite of provisions designed to support compliance with domestic ABS requirements and MAT with a view to ensuring PIC and benefit-sharing. These articles respond to the long-standing concerns of developing countries highlighted earlier: the difficulty for provider countries to prevent misappropriation and/ or misuse once genetic resources are exported and utilised in another country, compounded by the lack of international measures to address possible infringement of ABS legislation or regulatory requirements of the provider country or the breach of agreements between users and providers. The three cornerstone articles of the Protocol are: (1) Article 15 (compliance with domestic legislation or regulatory requirements on access and benefit-sharing); (2)  Article 18 (compliance with MAT); and (3)  Article 17 (monitoring the utilisation of genetic resources). Along with the Protocol provisions on compliance with domestic legislation or regulatory requirements on access and benefit-sharing for traditional knowledge associated with genetic resources,58 model contractual clauses59  Nagoya Protocol Article 1.  Nagoya Protocol Article 9. 54  Parties are mandated to consider the need for its establishment by Nagoya Protocol Article 10. 55  Nagoya Protocol Article 22.5.h. 56  Bonn Guidelines, Appendix II, paragraphs 1 and 2. 57  Nagoya Protocol Article 6.3.b. 58  Nagoya Protocol Article 16. 59  Nagoya Protocol Article 19. 52 53

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and codes of conduct, guidelines and best practices or standards,60 the provisions in Articles 15, 18 and 17 are unique and their subject matter is not addressed in the Convention. As a whole, these articles are foreseen to make a significant contribution to operationalising CBD Article 15.7, while building upon, and going beyond, the Bonn Guidelines.61 They provide a clear basis for user-related measures to ensure benefit-sharing by addressing the obligations of Parties with users of genetic resource under their jurisdiction as a means to support compliance with PIC and MAT. Article 15 of the Protocol responds to the concerns of developing countries in relation to misappropriation of genetic resources, while providing flexibility to Parties in determining the specific measures to be adopted to meet their obligations. Its thrust is threefold. First, a Party is to take measures which ensure that the genetic resources used within its jurisdiction have been accessed by users in keeping with PIC and the establishment of MAT where these are required by the ABS legislation or regulations of the Party providing genetic resources.62 Second, a Party is also obliged to take measures to address situations of non-compliance with the aforementioned measures.63 Third, an obligation for Parties to cooperate in cases of alleged violation of the domestic ABS legislation or regulatory requirements of the Party providing genetic resources, creates an innovative basis to establish direct lines of communication between a Party providing genetic resources and a Party with users of genetic resources in its jurisdiction that may have violated the former’s ABS requirements.64 Article 18 of the Protocol aims to facilitate the resolution of disputes involving non-compliance with the terms of the agreement between the provider and user of genetic resources and traditional knowledge associated with genetic resources. It responds to the concerns of provider countries in situations where an ABS contract has been concluded between a user and a provider, and the genetic resources or traditional knowledge associated with genetic resources covered by the contract are subsequently misused or other provisions of the agreement are breached. It has no equivalent in the Convention. The provision’s significance lies in the recognition that the establishment of MAT will likely be reflected in a written private contract whose enforcement will be governed by its terms and the applicable law specified in the contract, as well as the principles of private international law governing cross-border  Nagoya Protocol Article 20.  Bonn Guidelines paragraph 16.d. 62  Nagoya Protocol Article 15.1. 63  Nagoya Protocol Article 15.2. 64  Nagoya Protocol Article 15.3. 60 61

36   Lyle Glowka and Valérie Normand enforcement of contracts.65 It aims to acknowledge key mechanisms useful in the cross-border enforcement of contracts, while recognising Parties may need flexibility in providing the basis for their application, as well as in providing effective measures to address situations of non-compliance. As noted earlier, Article 18 complements the Protocol provision calling on Parties requiring PIC to establish clear rules and procedures requiring and establishing MAT and, in particular, suggests the inclusion of a dispute resolution clause as part of MAT.66 Article 18 also complements the provision addressing access to traditional knowledge associated with genetic resources and the establishment of MAT as per domestic law.67 Article 18 has three dimensions. First, as a means to promote best practice and encourage more enforceable contracts, it promotes the use of dispute settlement provisions by those negotiating MAT addressing, for example, the jurisdiction to which a dispute settlement process will be subject, the applicable law and any options for alternative dispute resolution.68 Second, an opportunity to seek recourse in a Party’s legal system must be available in cases of cross-border disputes arising from MAT.69 Third, an obligation is created for Party’s to take measures regarding access to justice and the utilisation of mechanisms regarding mutual recognition and enforcement of foreign judgments and arbitral awards.70 This provision also aims to address the procedural challenges that arise when the provider of genetic resources or traditional knowledge associated with genetic resources and the user are located in different countries, thereby challenging the ability of providers to enforce their contractual rights once the genetic resources or traditional knowledge associated with genetic resources (and in some cases the user) leave the provider country.71 To address these challenges, Parties are obliged to take measures making it procedurally possible for a provider to seek recourse and gain access to justice in a foreign jurisdiction when an ABS contract is breached. Furthermore, in situations, for example, where a judgment is rendered in a provider country for breach of contract, Parties are obliged to take measures providing for the utilisation of mechanisms to enable the judgment to not only be recognised, but also to be enforced in the jurisdiction of the user.

 [See contribution by Chiarolla to this volume (Chapter 14).]  Nagoya Protocol Article 6.3.g.i. 67  Nagoya Protocol Article 7. 68  Nagoya Protocol Article 18.1. 69  Nagoya Protocol Article 18.2. 70  Nagoya Protocol Article 18.3. 71  Nagoya Protocol Articles 18.2 and 3. 65 66

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Articles 15 and 18 establish a number of obligations whose implementation can be tailored to national circumstances. However, the development of a truly coherent international framework to support compliance with PIC and MAT will require more than a collection of individually tailored national responses. Collaboration amongst Parties founded upon a common understanding and shared objective with respect to making the provisions of the Protocol work, will be critical to ensuring coherence globally and instilling mutual trust between users and providers.72 In contrast to Articles 15 and 18 of the Protocol, which do not refer to specific measures to be adopted by Parties, Article 17 of the Protocol provides concrete tools to support compliance. It breaks significant new ground over the Convention in two important ways. First it creates a general obligation for each Party to take measures to monitor and enhance transparency about the utilisation of genetic resources.73 These measures are to include: designating one or more checkpoints; encouraging providers and users to include in MAT provisions on the sharing of information; and encouraging the use of cost-effective communications tools and systems. Second it provides the possibility to elevate a permit or its equivalent issued at the time of access to the status of an ‘internationally recognised certificate of compliance’. The certificate would serve as evidence that the genetic resources it covers have been accessed in accordance with PIC and that MAT have been established.74 To become an internationally recognised certificate of compliance, the permit or its equivalent issued and made available to the ABS clearing-house75 must fulfill minimum information requirements.76 Monitoring the utilisation of genetic resources by designating checkpoints and establishing an internationally recognised certificate of compliance are cornerstones to supporting compliance and ultimately meeting the Protocol’s objective. Checkpoints are to be relevant to the utilisation of genetic resources, or the collection of information, at any stage of research, development, innovation, pre-commercialisation or commercialisation.77 By collecting or receiving information relevant to the utilisation of genetic resources – PIC, MAT, source and/or utilisation78 – incentives will be created for users to

 [The international cooperation challenges are described in Young’s contribution to this volume (Chapter 15).] 73  Nagoya Protocol Article 17.1. 74  Nagoya Protocol Articles 17.2 and 3. 75  Nagoya Protocol Article 6.3.e. 76  Set-out in Nagoya Protocol Article 17.4. 77  Nagoya Protocol Article 17.1.a.iv. 78  Nagoya Protocol Article 17.1.a.i. 72

38   Lyle Glowka and Valérie Normand

USER COUNTRY

PROVIDER COUNTRY PIC • Competent National Authority

MAT • Terms of Use (e.g. Commercial or non-commercial) • Benifit-Sharing (monetary or non-monetary)

Utilization of Genetic Resources Genetic Resources + Cetificate

Benifit-sharing

Checkpoints: • To collect/receive information on PIC, MAT, source of GRs, use of GRs • One or more should be designated • Must be effective • Should be relevant to the utilization of genetic resources or to the collection or relevant information at, inter alia, any stage of reserch, developent, innovation, pre-commercialization or commercialization

Permit

Notified to ABS Clearing-House International Certificate of Compliance

Figure 1:  Schematic representation of the ABS process in light of Nagoya Protocol mechanisms.

respect requirements for obtaining PIC and establishing MAT at the time of access. The establishment of an internationally recognised certificate of compliance providing evidence of PIC and MAT should pave the way to a harmonised approach contributing to legal certainty and offer an easy mechanism for the user to provide information at checkpoints regarding the utilisation of genetic resources. The diagram in figure 1 illustrates, in a simplified manner, the ABS process in light of the mechanisms established by the Nagoya Protocol, including the possible role of the certificate of compliance and checkpoints in relation to genetic resources accessed for their utilisation as defined by the Protocol. Article 17 of the Nagoya Protocol contains a number of caveats providing flexibility for a Party to determine which checkpoints to establish and the information they would receive. The absence of a reference in the article to any specific checkpoints, along with the obligation to establish one or more checkpoints, provides latitude to Parties to best fit their national circumstances. However, the lack of specificity could challenge the efficacy of the emerging system.

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Possible checkpoints were identified and discussed throughout the negotiation process. These included research institutions subject to public funding, entities publishing research results relating to the utilisation of genetic resources, intellectual property examination offices, and authorities providing regulatory or marketing approval of products derived from genetic resources. Particularly sensitive was the proposal to include intellectual property or patent examination offices as potential checkpoints. Some developed countries argued that issues related to intellectual property rights, as they apply to ABS, were being addressed by the World Intellectual Property Organisation (WIPO) and should, therefore, not be covered by the Protocol. Following intense debate in the final hours of the Protocol’s negotiation, and due to great political sensitivity and disagreement over the inclusion of intellectual property examination offices as potential checkpoints, the final compromise text excluded specific reference to any particular checkpoints. This provides flexibility to Parties to determine the most appropriate checkpoints to be established in light of their own national circumstances at the possible expense of clarity and coherence in implementation. Various sectors have different practices in using genetic resources.79 A wide range of sectors undertake research and develop products based on genetic resources, including the medicine, biotechnology, seed, crop protection, horticulture, cosmetics and personal care, botanicals, as well as the food and beverage industries. The Protocol recognises this by encouraging the development of sectoral and cross-sectoral model contractual clauses, and best practices, which may address the particular needs of specific sectors in the implementation of ABS, while encouraging compliance with domestic ABS requirements.80 These provisions implicitly recognise that well-tailored sectoral approaches may strengthen the implementation of the Protocol. 3.  Other Innovations a.  Access to Traditional Knowledge Associated with Genetic Resources and Access to Genetic Resources where Indigenous and Local Communities Have the Established Right to Grant Access to Such Resources Prior to the Protocol, CBD Article 8(j) was the sole Convention provision promoting benefit-sharing for the use of traditional knowledge associated  For further information on ABS practices in different sectors, CBD Secretariat, Access and Benefit-Sharing in Practice: Trends in Partnerships Across Sectors (Montreal: CBD Technical Series No. 38, 2008), accessed 12 March 2012, http://www.cbd.int/doc/publications/ cbd-ts-38-en.pdf. 80  Nagoya Protocol Articles 19–20. 79

40   Lyle Glowka and Valérie Normand with genetic resources. This was, however, only by implication as the term ‘traditional knowledge associated with genetic resources’ was not referred to specifically. Access to genetic resources of indigenous and local communities was not even mentioned. Both aspects were to an extent largely relegated to being a detail of national-level implementation of the other ABS provisions of the Convention with some additional guidance resulting from the adoption of the Bonn Guidelines, which provided the most concrete reference within the CBD processes in relation to PIC and indigenous and local communities.81 The process under the CBD Working Group on Article 8(j), initiated by the seventh meeting of the COP in 2004,82 gradually clarified the link between traditional knowledge and ABS. The Protocol significantly changes this situation. The eight preambular paragraphs and the fourteen articles83 referring to traditional knowledge associated with genetic resources, indigenous and local communities, or the genetic resources held by them, resoundingly demonstrate the profound achievement reflected in the Protocol, particularly for indigenous peoples following the adoption of the United Nations Declaration on the Rights of Indigenous Peoples in September 2007.84 For the first time in a legally binding international treaty, the Protocol concretises many of the aspirations reflected in other processes and soft law instruments, and significantly expands upon the Convention. The Protocol clearly establishes the need for community PIC and/or prior approval and involvement in relation to access to traditional knowledge associated with genetic resources, as well as to genetic resources where indigenous and local communities have the established right to grant access to such resources, while ensuring community-level customary laws and procedures related to traditional knowledge associated with genetic resources are taken into consideration when Parties implement their obligations under

 Bonn Guidelines paragraph 31 provides: ‘Respecting established legal rights of indigenous and local communities associated with the genetic resources being accessed or where traditional knowledge associated with these genetic resources is being accessed, the prior informed consent of indigenous and local communities and the approval and involvement of the holders of traditional knowledge, innovations and practices should be obtained, in accordance with their traditional practices, national access policies and subject to domestic laws.’ 82  CBD Decision 7/16, “Article 8(j) and Related Provisions” (13 April 2004) UN Doc UNEP/ CBD/COP/DEC/VII/16. 83  Nagoya Protocol Articles 3, 5, 6, 7, 10, 11, 12, 13, 14, 16, 18, 21, 22 and 25. 84  United Nations General Assembly “United Nations Declaration on the Rights of Indigenous Peoples,” (13 September 2007) UN Doc A/RES/61/295 (‘UNDRIP’). 81

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the Protocol.85 To facilitate access, the Protocol also obliges each Party to set out criteria and/or processes for obtaining the PIC of indigenous and local communities for access to genetic resources.86 The Protocol clearly obliges each Party to take measures aiming at fair and equitable benefit-sharing in relation to the use of genetic resources held by indigenous and local communities with legal entitlements over the genetic resources87 and the utilisation of traditional knowledge associated with genetic resources.88 In effect, these provisions establish clearly the principle that benefit-sharing is required in relation to the use of genetic resources and traditional knowledge associated with genetic resource held by indigenous and local communities. With the ‘effective participation of indigenous and local communities’, Parties are to establish mechanisms to inform potential users of traditional knowledge associated with genetic resources about their obligations with respect to access and benefit-sharing with respect to use of the knowledge.89 In addition, Parties are also to endeavour to support the development by indigenous and local communities of community protocols,90 minimum requirements for MAT,91 and model contractual clauses for benefit-sharing.92 Building on the Convention provision on customary sustainable use,93 as they implement the Protocol, Parties are not to restrict the customary use and exchange of genetic resources and associated traditional knowledge within and amongst indigenous and local communities.94 In relation to compliance, the Protocol provision on compliance with the provider country’s ABS legislation concerning traditional knowledge,95 which largely parallels in structure and drafting the Protocol provision on compliance with domestic ABS legislation concerning genetic resources,96 sets out requirements for each Party to: (1) take measures which ensure traditional knowledge associated with genetic resources used within its jurisdiction has been accessed by users  Nagoya Protocol Articles 7, 6.2 and 12.1.  Nagoya Protocol Article 6.3.f. 87  Nagoya Protocol Article 5.2. 88  Nagoya Protocol Article 5.3. 89  Nagoya Protocol Article 12.2. 90  Nagoya Protocol Article 12.3.a. 91  Nagoya Protocol Article 12.3.b. 92  Nagoya Protocol Article 12.3.c. 93  CBD Article 10.c. 94  Nagoya Protocol Article 12.4. 95  Nagoya Protocol Article 16. 96  Nagoya Protocol Article 15. 85 86

42   Lyle Glowka and Valérie Normand in keeping with PIC and the establishment of MAT where these are required by the legislation or regulations of the Party in which the communities are located;97 (2) take measures to address situations of non-compliance with the abovementioned measures it has implemented.98 In addition, Parties are to cooperate in cases of alleged violation of the domestic legislation or regulatory requirements of the Party in which the indigenous and local communities affected are located.99 Finally, the Protocol provision addressing compliance with MAT, and previously described above, applies to MAT in relation to traditional knowledge associated with genetic resources.100 b.  Global Multilateral Benefit-sharing Mechanism One of the key issues during the Protocol’s negotiation was its geographical and temporal scope of application – whether it should apply, for example, to marine areas beyond the limits of national jurisdiction, or retroactively to genetic resources collected before the entry into force of the Convention, or after the entry into force of the Convention but before the entry into force of the Protocol. Article 10 of the Nagoya Protocol was not negotiated, but was part of the COP President’s compromise proposal. It drew from earlier concepts developed by the African Group late in the negotiations as a way out of the scoperelated impasse. Although it only creates a procedural obligation for Parties to consider the need for and modalities of a global multilateral benefit-sharing mechanism, it aims to respond to the unresolved scope-related concerns expressed in the negotiations that would have had far-reaching implications for benefit-sharing under the Protocol. It balances the compromise proposal put forth and accepted that the Protocol applies only to genetic resources within the scope of Article 15 of the Convention while leaving ample room for interpretation by future Meetings of the Parties. The article should be read in conjunction with additional compromise text found in the preamble101 pointing to the need for ‘innovative solutions’ to address the fair and equitable sharing of benefits derived from the utilisation of genetic resources and associated traditional knowledge with respect to three situations:  Nagoya Protocol Article 16.1.  Nagoya Protocol Article 16.2.   99  Nagoya Protocol Article 16.3. 100  Nagoya Protocol Article 18. 101  Nagoya Protocol preambular paragraph 12.   97   98

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(1) genetic resources or traditional knowledge associated with genetic resources occur in transboundary situations; (2)  PIC cannot be granted; or (3)  PIC cannot be obtained. In a departure from the bilateral benefit-sharing approach of the Convention and the Protocol, in these situations, benefits shared through the mechanism would be used to support biodiversity conservation and sustainable use globally.

III.  The Protocol’s Relationship with Other Instruments and Processes: Influences on International Law In the 18 years since the Convention’s entry into force its equity-based principles on access and benefit-sharing have influenced a wide-range of other international instruments and intergovernmental fora involved either directly or as a secondary issue with different aspects of genetic resources and traditional knowledge associated with genetic resources. These include the Antarctic Treaty System, the Food and Agriculture Organisation’s Commission on Genetic Resources for Food and Agriculture,102 the International Treaty on Plant Genetic Resources for Food and Agriculture (2001),103 the UN General Assembly’s ongoing process regarding marine biodiversity in areas beyond the limits of national jurisdiction,104 the United Nations Permanent Forum on Indigenous Issues,105 the World Health Organisation (WHO) (pandemic human influenza),106 the WIPO and its Intergovernmental Committee on Intellectual Property, Genetic Resources, Traditional Knowledge and Folklore (IGC), and the World Trade Organisation107 with its work on trade-related aspects of intellectual property rights. With such a wide-variety of different instruments and fora intersecting with different aspects of the ABS spectrum, an important consideration and outstanding contentious issue facing negotiators was the Protocol’s relationship with them. Article 4 emerged after intense negotiations that ended with the COP President’s compromise text. It addresses the relationship of the Protocol with other international instruments and processes.  [See contribution by Chiarolla, Louafi and Schloen to this volume (Chapter 3).]  Nagoya Protocol preambular paragraph 12. 104  [See contribition by Salpin to this volume (Chapter 5).] 105  [See contribution by Savaresi to this volume (Chapter 2).] 106  [See contribution by Wilke to this volume (Chapter 4).] 107  [See contribution by Pavoni to this volume (Chapter 6).] 102 103

44   Lyle Glowka and Valérie Normand Mirroring CBD Article 22(1), it is a savings clause re-stating a general principle of international law: the Protocol does not affect the rights and obligations of a Protocol Party deriving from any existing agreements to which it may already be a party.108 It then obliges Parties to implement the Protocol in a mutually supportive manner with other instruments relevant to it. As they implement the Protocol, Parties also should pay ‘due regard’ to ‘useful and relevant ongoing work or practices’ under these international instruments or within relevant international organisations, ‘provided they are supportive of and do not run counter to the objectives of the Convention and the Protocol’.109 It also allows Parties to the Protocol to develop and implement relevant new specialised international agreements, but clarifies that these must be supportive of and cannot run counter to the objectives of the Convention and the Protocol.110 It then goes a step further by emphasising that the Protocol is the instrument to implement the ABS provisions of the Convention and clarifying that where a specialised instrument is consistent with and does not run counter to the Convention and the Protocol, the Protocol does not apply for the Party or Parties to the specialised instrument with respect to the specific genetic resources covered by a specialised instrument and for its purposes.111 In other words, the Protocol would still apply to the same genetic resources utilised for other purposes not covered by the specialised instrument. Of the instruments or fora working on different aspects of ABS, the following are instructive for the influence they may have had on the Protocol’s negotiation. They also provide examples of the possible relationship the Protocol could have with other instruments or fora contributing to international law addressing ABS. 1.  World Health Organisation One of the most challenging issues faced in the negotiations was the Protocol’s applicability to pathogens. Bracketed text remained unresolvable across three articles (scope,112 relationship113 and special considerations)114 into the final hours of the negotiations, until the compromise proposed by the COP President was finally adopted.

 Nagoya Protocol Article 4.1.  Nagoya Protocol Article 4.3. 110  Nagoya Protocol Article 4.2. 111  Nagoya Protocol Article 4.4. 112  Nagoya Protocol Article 3. 113  Nagoya Protocol Article 4. 114  Nagoya Protocol Article 8. 108 109

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Developed countries were concerned that the Protocol’s implementation, relying as it does on a bilateral approach to ABS, could complicate efforts to quickly respond to emergencies involving human, animal and plant health addressed respectively by the WHO, the World Organisation on Animal Health and the International Plant Protection Convention. Developing countries wanted to avoid such emergencies being used as a pretext to forego protecting their interests with respect to ABS, particularly non-monetary benefits such as access to vaccines developed with pathogens they provided. Influencing the discussions, as well, was the ongoing parallel negotiation in the WHO to create a more equitable system of access to influenza viruses with human pandemic potential and vaccines developed from them. The compromise adopted reflects a balanced approach built upon: (1)  the importance of genetic resources to public health;115 (2)  mindfulness of the WHO International Health Regulations;116 (3) the importance of ensuring access to human pathogens for public health preparedness;117 and (4) concepts of mutually supportive implementation of international instruments.118 In the context of national-level implementation, the compromise included text in Article 8.b obliging each Party to ‘pay due regard’ to human, animal or plant health emergencies as they develop and implement their ABS requirements. The emergencies can be determined by national or international authorities. Parties may consider the need for expeditious access to genetic resources and expeditious fair and equitable benefit-sharing. Article 8.b therefore further deepens the mutual supportiveness principle found in Article 4.3. The adoption of the Protocol may have opened the way for the conclusion in mid-2011 of the WHO Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and other Benefits,119 when the long outstanding uncertainty as to whether there would even be a Protocol was resolved, and the Protocol’s scope was finally settled. An outstanding question remains: Can the WHO Framework be interpreted  Nagoya Protocol preambular paragraph 14.  Nagoya Protocol preambular paragraph 17. 117  Nagoya Protocol preambular paragraph 17. 118  Nagoya Protocol preambular paragraph 20 and Article 4.3. 119  World Health Organisation, “Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access to vaccines and other benefits” (effective 24 May 2011) WHA64.5 (WHO PIPF). 115 116

46   Lyle Glowka and Valérie Normand to be a specialised instrument within the context of Article 4.4 of the Nagoya Protocol? 2.  World Intellectual Property Organisation The ongoing work of the WIPO, particularly the IGC, is another forum whose work influenced the Protocol’s negotiation and may be itself influenced by the Protocol. The IGC’s work relevant to ABS continues to follow two paths: intellectual property and genetic resources and the protection of traditional knowledge including traditional knowledge associated with genetic resources.120 The outcomes of the IGC’s work will include the possible conclusion of at least one new international instrument relevant to ABS. The IGC’s negotiations along the intellectual property and genetic resources path in relation to disclosure of the origin of genetic resources in patent applications influenced the Protocol’s negotiations, particularly in the compliance realm with regard to monitoring the utilisation of genetic resources. A large part of the discussion on checkpoints was the extent to which the designation of specific checkpoints, such as patent examination offices, should be required by the Protocol. Developed countries argued that the issue would be best addressed within the WIPO as the specialised forum already dealing with intellectual property and genetic resources. On the other hand, developing countries sought a specific reference to patent examination offices, particularly considering the negotiations under the WIPO on intellectual property and genetic resources had made limited progress to date. In the end, as indicated earlier, no specific checkpoints were mentioned in the Protocol.121 Instead Protocol Parties were given the flexibility to designate one or more effective checkpoints. In terms of the Protocol’s relationship with the WIPO’s work, the Protocol allows its Parties to work within the WIPO towards developing relevant international agreements supportive of the objectives of the Convention and the Protocol.122 It also ensures that the Protocol would be implemented in a mutually supportive manner.123 Finally, the Protocol also creates the space for its Parties to ‘pay due regard’ to the WIPO’s ongoing work as they implement the Protocol124 to ensure mutual supportiveness.

 World Intellectual Property Organisation, “Intergovernmental Committee,” accessed March 13, 2012, http://www.wipo.int/tk/en/igc/. 121  Nagoya Protocol Article 17. 122  Nagoya Protocol Article 4.2. 123  Nagoya Protocol Article 4.3. 124  Nagoya Protocol Article 4.3. 120

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3.  Food and Agriculture Organisation (FAO) Commission on Genetic Resources for Food and Agriculture Another issue faced by negotiators of the Protocol was balancing the Protocol’s application to genetic resources for food and agriculture, while recognising that the FAO Commission on Genetic Resources for Food and Agriculture actively worked on the issue and would continue to do so after the Protocol entered into force. The need to find this balance was generally well-recognised throughout the negotiations, particularly as the special nature of genetic resources for food and agriculture had been long recognised within the Convention, even as early as 1992.125 Therefore, in some respects, it was far less controversial than, for example, the Protocol’s addressing of human and other pathogens, a relatively new and emerging issue in ABS. The innovative approach taken by negotiators in the Protocol to address genetic resources for food and agriculture, and the work of the FAO Commission, involved a series of references in the Protocol’s preamble to set the context, reliance on the Protocol’s provision on its relationship with other international instruments and processes126 and an obligation targeted to parties regarding national-level implementation.127 The approach specifically built upon: (1)  the importance of genetic resources to food security;128 (2) the special nature of agricultural biodiversity, its distinctive features and the need for distinctive solutions to problems;129 (3) the interdependence of all countries on genetic resources for food and agriculture;130 (4) the special nature and importance of genetic resources for food and agriculture for achieving food security and sustainable development of agriculture particularly with respect to poverty alleviation;131 (5) the fundamental role of the FAO Commission on Genetic Resources for Food and Agriculture;132

 “Nairobi Final Act of the Conference for the Adoption of the Agreed Text of the Convention on Biological Diversity” (22 May 1992). 126  Nagoya Protocol Article 4. 127  Specified in Nagoya Protocol Article 8. 128  Nagoya Protocol preambular paragraph 14. 129  Nagoya Protocol preambular paragraph 15. 130  Nagoya Protocol preambular paragraph 16. 131  Nagoya Protocol preambular paragraph 16. 132  Nagoya Protocol preambular paragraph 16. 125

48   Lyle Glowka and Valérie Normand (6) concepts of mutually supportive implementation of international instruments;133 and (7) the possibility provided in the Protocol for specialised instruments on ABS.134 In the context of national-level implementation, the Protocol obliges each Party to ‘consider the importance of genetic resources for food and agriculture and their special role for food security’.135 This, therefore, further deepens the mutual supportiveness principle found in the Protocol.136 Adoption of the Protocol may have opened the way for the Commission to establish an Ad Hoc Technical Working Group on Access and Benefitsharing to, among other things, identify the distinctive features of animal, aquatic, forest and microbial genetic resources and the sectors using them.137 4.  International Treaty on Plant Genetic Resources for Food and Agriculture The International Treaty exemplified an existing specialised agreement addressing genetic resources that influenced the crafting of the Protocol provision on the relationship with other international instruments.138 Negotiated under the auspices of the FAO Commission on Genetic Resource, the Treaty creates a multilateral ABS system for plant genetic resources for food and agriculture listed in its Annex I that are under the control and management of its Parties and are in the public domain, as well as those held in the ex-situ collections of the Consultative Group on International Agricultural Research. Access to materials in the Multilateral System is facilitated through a standard material transfer agreement. The Protocol preamble recognises the fundamental role of the International Treaty139 and complements the requirement for Parties to implement the Protocol in a mutually supportive way with international agreements such as the International Treaty.140 On the other hand, the Protocol accommodates the Multilateral System and the plant genetic resources that are part of it for the purposes of the International Treaty but only with respect to uses  Nagoya Protocol preambular paragraph 20 and Article 4.3.  Nagoya Protocol Article 4.4. 135  Nagoya Protocol Article 8.c. 136  Nagoya Protocol Article 4.3. 137  Food and Agriculture Organisation of the United Nations, “Report of the Thirteenth Regular Session of the Commission on Genetic Resources for Food and Agriculture” (22 July 2011) UN Doc CGRFA–13/11/Report. 138  Nagoya Protocol Article 4. 139  Nagoya Protocol preambular paragraph 16. 140  Nagoya Protocol Article 4.2. 133 134

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for food and agriculture.141 For other uses of the same genetic resources, the Protocol would apply.

IV.  The Way Forward The ABS principles embodied in the CBD remain one of the most profound developments in international environmental law in the last 20 years. They elevated equity in the use of genetic resources to prominence next to the conservation and sustainable use of biological diversity, while presenting significant challenges to those countries that have sought to capture a fair and equitable share of the benefits from access to their genetic resources. Adopted in October 2010 the Nagoya Protocol is the best chance yet to strengthen the link between access, benefit-sharing, equity and biodiversity conservation, while supporting implementation and, ultimately, advancing the three objectives of the Convention. It significantly deepens and expands upon the Convention’s ABS obligations, while providing the basis for a more systematic approach to ABS both at the national level and internationally. At the national level, the Protocol will expand opportunities to capture benefits from genetic resources (and biochemicals) and associated traditional knowledge, through more robust, efficient and transparent legal and institutional frameworks. Its compliance measures will provide a basis to help level the playing field and build confidence that benefits will be shared even though genetic resources and associated traditional knowledge may have left the country. Countries hosting users of genetic resources will have clearer obligations with respect to compliance, while maintaining flexibility in monitoring utilisation of genetic resources and ensuring transparency. The flexibility embodied in a number of the Protocol’s provisions provides the basis for countries to tailor their implementation to their own national circumstances. The challenge for countries will be to determine the best approaches to implement the Protocol while taking into account their national interests and, at the same time, meeting the common objectives of the Protocol. Internationally, the Protocol can provide the cornerstone for a functional international system on ABS. This will require coherent national-level implementation measures adopted by all Parties, particularly in the area of monitoring the utilisation of genetic resources, to ensure the functionality and coverage of the emerging framework, while avoiding ad hoc approaches that lack complementarity, add to bureaucracy or inefficiency and create  Nagoya Protocol Article 4.4.

141

50   Lyle Glowka and Valérie Normand additional obstacles to the detriment of providers and users and, ultimately, biodiversity conservation. As with any treaty, the threshold step is entry into force triggered, in this case, by what should be a geographically balanced group of 50 Parties. The Protocol’s governing body 142 will thereafter have the central role in ensuring coherence as it keeps the Protocol’s implementation under regular review.143 Good will and collaborative approaches will be needed in the early years of implementation amongst the Parties and key stakeholders, such as the private sector and the research community, to make the Protocol function, combined with a genuine willingness to seek technical solutions to key outstanding issues such as monitoring and the certificate of compliance. A forward-looking collaborative approach will be critical. How will we be able to judge whether the Protocol is having a positive impact? One possible indicator may include a growing number of examples demonstrating best practices and win-win scenarios for both providers and users of genetic resources and associated traditional knowledge. This would be accompanied by an increasing number of ABS agreements/partnerships established on the basis of mutual trust as well as confidence that the international framework provided by the Protocol will provide a safety net should compliance issues arise. Examples of benefits being directed back to biodiversity conservation will demonstrate the promise of one of the conceptual pillars of ABS. Another indicator might include a growing number of developing countries that have built national capacity to exploit genetic resources found within their jurisdictions. The result would contribute to a more balanced and equitable relationship between users and providers of genetic resources, transcending the North-South divide upon which the Convention and the Protocol were premised. The Protocol’s future impact on the body of international law addressing ABS-related issues remains to be seen. The concurrent meetings of the CBD COP and Nagoya Protocol governing body foreseen in the Protocol144 could help to ensure that discussions on ABS within the Protocol process are not disconnected from those on biodiversity conservation and sustainable use within the Convention process, thereby ensuring ABS is well-integrated into the Convention’s work programmes. The relationship between the Protocol and a select group of international instruments and intergovernmental  The Protocol governing body will be the CBD COP serving as the Meeting of the Parties to the Protocol (COP/MOP): Nagoya Protocol Article 26. 143  Nagoya Protocol Article 26.4. 144  Nagoya Protocol Article 26.6. 142

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fora foreshadows the possible influence it could have on other international processes. At a minimum, the Protocol will become the primary additional source of more refined principles on ABS that will act as the standard against which other initiatives will be measured and should not fall below, much as the Convention did before its adoption.

Chapter 2.  The International Human Rights Law Implications of the Nagoya Protocol Annalisa Savaresi*

I.  The Human Rights Dimension of the Nagoya Protocol Although the Nagoya Protocol does not make any textual reference to ‘human rights’,1 several of its provisions include elements that may be traced back to widely ratified human rights instruments. For example, the notion of ‘prior informed consent’ (PIC)2 clearly overlaps with that of ‘free prior informed consent’ (FPIC) engrained in the human rights discourse on access and use of natural resources. Equally, the notions of access to justice,3 participation4 and information5 evoked in the Protocol may (and, as this paper argues, should) be read in light of the vast body of human rights law on the matter. Such considerations are particularly relevant to indigenous peoples and local communities that may act as providers of genetic resources or of the associated traditional knowledge. As argued elsewhere in this collection,6 indigenous and local communities have relied upon the provisions concerning the customary use of biological resources to seek recognition of their interests in relation to biological resources and the related knowledge.7 The Nagoya Protocol has substantially advanced and refined the provisions in *  Research and Teaching Fellow, University of Edinburgh School of Law. The author is grateful to the editors and to Dr Claire Charters, Office of the United Nations High Commissioner for Human Rights, for their comments. 1  For the purposes of the present chapter, the term ‘human rights’ is deployed in connection with the rights of individuals and groups that are recognised as such in international law. See Thomas Buergenthal, “Human Rights,” in Max Planck Encyclopedia of Public International Law, ed. Rudiger Wolfrum (Oxford: Oxford University Press, 2012), 1021. 2  Nagoya Protocol, Articles 6 and 7. 3  Nagoya Protocol, Article 18. 4  Nagoya Protocol, Article 12.2. 5  Nagoya Protocol Articles 6.3, 13.1, 14 and 17. 6  [See contribution by Burton in this volume (Chapter 10).] 7  CBD, Article 8j.

54   Annalisa Savaresi the Convention on Biological Diversity (CBD) by including references to indigenous and local communities’ rights over genetic resources,8 and the fair and equitable sharing of benefits deriving from the utilisation of the associated traditional knowledge.9 The Protocol is thus expected to facilitate the assertion of the rights of indigenous and local communities over genetic resources and the associated traditional knowledge.10 Some caveats do however apply, as the Protocol leaves a wide margin of appreciation to national law-makers, based upon the rationale to accommodate the specificities of domestic legal orders on the issue. This chapter argues that Parties to the Nagoya Protocol are required to read and implement their obligations in light of their extant obligations under human rights instruments. Such interpretation is not only required on grounds of law, but may also turn the Nagoya Protocol in an opportunity to adopt a human rights-based approach to biodiversity conservation.11 To prove this argument, the chapter opens with some general considerations regarding overlaps between international instruments, to then move on to review the relationship between the Nagoya Protocol and human rights. The chapter singles out provisions concerning prior informed consent and mutually agreed terms as those most likely to have human rights implications. As these issues are particularly prominent in connection with indigenous peoples and local communities, the problematic identification of these

 Nagoya Protocol Articles 5–6.  Nagoya Protocol Article 7. 10  CBD Secretariat, “Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity: text and annex”, (Montreal: CBD, 2012), at 1 (Introduction): ‘the Protocol’s provisions on access to traditional knowledge held by indigenous and local communities when it is associated with genetic resources will strengthen the ability of these communities to benefit from the use of their knowledge, innovations and practices.’ See also Kavir Bavikatte and Daniel F. Robinson, “Towards a People’s History of the Law: Biocultural Jurisprudence and the Nagoya Protocol on Access and Benefit Sharing,” Law, Environment and Development Journal 7 (2011): 35, 39. 11  Compare UN Common Understanding on the Human Rights-Based Approach to Development Cooperation, according to which ‘all programmes of development co-operation, policies and technical assistance should further the realisation of human rights as laid down in the Universal Declaration of Human Rights and other international human rights instruments’ (The Human Rights-Based Approach to Development Cooperation: Towards a Common Understanding Among UN Agencies (2003), accessed 4 June 2012, http://www .undg.org/archive_docs/6959-The_Human_Rights_Based_Approach_to_Development_ Cooperation_Towards_a_Common_Understanding_among_UN.pdf). For an analysis, see Thomas Greiber, ed. Conservation with Justice: A Rights-Based Approach (Gland, Switzerland: IUCN, 2009); and Jessica Campese et al., eds., Rights-Based Approaches: Exploring Issues and Opportunities for Conservation (Bogor: CIFOR and IUCN, 2009).  8  9

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two categories of rightholders is analysed in detail.12 The conclusions provide some reflections on potential synergies between international human rights instruments and the Nagoya Protocol. 1.  Overlaps and Mutual Supportiveness Overlaps between international instruments are arguably the result of the fact that international law-making and institution-building ‘tends to take place with relative ignorance of legislative and institutional activities in the adjoining fields and of the general principles and practices of international law’.13 Overlaps may engender deviating institutional practices, but also provide a potential avenue to improve coordination and communication between distinct international legal regimes, and engender synergies.14 Such potential is particularly evident with regard to the protection of biodiversity and human rights.15 Although the right to a healthy environment does not feature in most major human rights instruments,16 over the years

 [Farmers’ rights are instead addressed in the contribution by Chiarolla, Louafi and Schloen to this volume (Chapter 3).] 13  International Law Commission, “Fragmentation of International Law: Difficulties Arising from the Diversification and Expansion of International Law. Report of the Study Group of the International Law Commission,” (2006) UN Doc A/CN.4/L.682, paragraph 8. 14  Cinammon P. Carlarne, “Global Climate Governance: Only a Fragmented System of International Law Away?,” Law and Policy 30 (2008): 452; Jinnah Sikina, “Climate Change Bandwagoning: The Impacts of Strategic Linkages on Regime Design, Maintenance, and Death,” Global Environmental Politics 11 (2011): 1; Harro van Asselt, “Managing the Fragmentation of International Environmental Law: Forests at the Intersection of the Climate and Biodiversity Regimes,” New York University Journal of International Law and Politics (forthcoming, 2012); and Annalisa Savaresi, “The Role of REDD+ in Harmonising Overlapping International Obligations,” in Climate Change and the Law, ed. Erkki Hollo, Kati Kulovesi, and Michael Mehling (Springer, forthcoming, 2012). 15  On the issue, see for example Günther Handl, “Human Rights and Protection of the Environment: A Mildly ‘Revisionist’ View,” in Human Rights, Sustainable Development and the Environment, ed. A. Cançado Trindade (San José: Instituto Interamericano de Derechos Humanos, 1992) 117; Alan Boyle and Michael R. Anderson, eds., Human Rights Approaches to Environmental Protection (Oxford: Oxford University Press, 1998); Romina Piccolotti and Daniel Taillant, eds., Linking Human Rights and the Environment (Tucson: The University of Arizona Press, 2003); Alan Boyle, “Human Rights or Environmental Rights? A Reassessment,” Fordham Environmental Law Review 18 (2007): 471; Francesco Francioni, “International Human Rights in an Environmental Horizon,” European Journal of International Law 21 (2010): 41; and Donald K. Anton and Dinah L. Shelton, Environmental Protection and Human Rights (Cambridge: Cambridge University Press, 2011). 16  The only notable exception being African Charter on Human and People’s Rights (Nairobi, 27 June 1981, in force 21 October 1986) 1520 UNTS 217, 21 ILM 58 (1982) (hereinafter African Charter) Article 24. 12

56   Annalisa Savaresi existing human rights have been increasingly ‘greened’17 and interpreted in a way to encompass environmental matters that were not anticipated when these rights were formulated. Human rights bodies have upheld complaints concerning violations of human rights associated with detrimental environmental conditions,18 and particularly so in connection with the rights of indigenous peoples and other ‘tribal communities’.19 In addition, ‘procedural’ rights on access to justice, information and participation have fostered enhanced transparency in environmental policy and decision-making. Increased awareness of these significant areas of overlap has recently led the Human Rights Council to appoint a Special Rapporteur on the issue of human rights obligations related to the enjoyment of a safe, clean, healthy and sustainable environment,20 thus acknowledging human rights’ potential to ‘inform and strengthen’ international, regional and national policymaking in the area of environmental protection and to promote ‘policy coherence’.21

 For the use of this terminology, see Boyle, “Human Rights or Environmental Rights? A Reassessment,” 472. 18  See for example, European Court of Human Rights: Guerra and others v Italy, Application No. 14967/89, López Ostra v. Spain, Application No. 16798/90, Moreno Gomez v Spain, Application No. 4143/02, Öçkan and others v Turkey, Application No. 46771/99; Okyay and others v. Turkey, Application No. 36220/97; Öneryıldız v. Turkey, Application No. 48939/ 99, Taskin and others v Turkey, Application No. 46117/99; Fadeyeva v The Russian Federation, Application No. 55723/00. 19  See for example Inter-American Commission on Human Rights: Yanomani Indians v. Brazil, Case No. 7615; Maya Indigenous Community of the Toledo District v. Belize, Case No 12.053. Inter-American Court of Human Rights: Case of the Mayagna (Sumo) Awas Tingni Community v Nicaragua, Judgment of 31 August 2001, Series C No. 79; Case of the Moiwana Community v Suriname, Judgment of 15 June 2005, Series C No. 124; Case of the Yakye Axa Indigenous Community v Paraguay, Judgment of 17 June 2005, Series C No. 125; Case of the Sawhoyamaxa Indigenous Community v Paraguay, Judgment of 29 March 2006, Series C No. 146; Case of the Saramaka People v Suriname, Judgment of 28 November 2007, Series C No. 172; Case of the Xákmok Kásek Indigenous Community v Paraguay, Judgment of 24 August 2010, Series C No. 214. African Commission on Human & Peoples’ Rights: Social and Economic Rights Action Centre and Centre for Economic and Social v Nigeria, Communication No. 155/96; Centre for Minority Rights Development (Kenya) and Minority Rights Group (on behalf of Endorois Welfare Council) v Kenya, Communication 276/03. 20  Human Rights Council, “Human Rights and the Environment” (20 March 2012) UN Doc A/HRC/19/L.8/Rev.1. 21  Human Rights Council, “Human Rights and the Environment” (12 April 2011) UN Doc A/HRC/RES/16/11, penultimate preambular paragraph: ‘human rights obligations and commitments have the potential to inform and strengthen international, regional and national policymaking in the area of environmental protection and promoting policy coherence, legitimacy and sustainable outcomes’ (emphasis added). 17

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There are considerable potential overlaps between human rights and environmental law instruments and, when creating new obligations, States are assumed not to derogate from their extant obligations.22 International legal theory has identified three possible means to address these situations of overlap: conflict avoidance; resolution of conflicts through the application of interpretative principles; and institutional cooperation and coordination.23 Conflict avoidance considerations are specifically addressed in the Nagoya Protocol, which includes a sui generis clause concerning its relationship with other international agreements and instruments. Conflict avoidance clauses typically specify that the treaty at issue ‘is subject to,’ or that ‘it is not to be considered as incompatible with, an earlier or later treaty,’ or that ‘the provisions of that other treaty prevail.’24 The Nagoya Protocol, however, rather complicates matters by asserting that: The provisions of this Protocol shall not affect the rights and obligations of any Party deriving from any existing international agreement, except where the exercise of those rights and obligations would cause a serious damage or threat to biological diversity. This paragraph is not intended to create a hier­ archy between this Protocol and other international instruments.25

This anomalous provision builds upon the conflict clause included in the Convention on Biological Diversity (CBD),26 seemingly indicating that priority may be assigned to other agreements, with the effect to counterbalance arguments based upon the principle lex posterior derogat priori.27 The relationship between the Nagoya Protocol and other international instruments is yet more complex. In fact, the Protocol must also be implemented ‘in a mutually supportive manner with other international instruments’ and due regard should be paid to ‘useful and relevant ongoing work or practices under such international instruments and relevant international organisations, provided that they are supportive of and do not run counter to the objectives of the Convention and this Protocol’.28  International Law Commission, “Fragmentation of International Law: Difficulties Arising from the Diversification and Expansion of International Law. Report of the Study Group of the International Law Commission,” (13 April 2006) UN Doc A/CN.4/L.682, 38. 23  Ibid., 13. 24  VCLT, Article 30.2 according to which: ‘When a treaty specifies that it is subject to, or that it is not to be considered as incompatible with, an earlier or later treaty, the provisions of that other treaty prevail.’ 25  Nagoya Protocol Article 4.1. 26  CBD Article 22.1. For a commentary, see Lyle Glowka et al., A Guide to the Convention on Biological Diversity (Gland: IUCN, 1994), 109. 27  [add reference to the commentary] 28  Nagoya Protocol Article 4.3 (emphasis added). 22

58   Annalisa Savaresi This provision seemingly endorses a pragmatic case-by-case approach to mutual supportiveness, requiring that Parties disqualify interpretative solutions to tensions between the Nagoya Protocol and other relevant international instruments involving the subordination of one to the other.29 However, the terminology deployed to convey this crucial interpretative tenet may be regarded as rather unfortunate. Reference to ‘ongoing work’ and ‘practices’ seems inappropriate, as these elements are in a state of constant change and have no legal status under international law.30 The use of the term ‘instrument’ opens the way to further ambiguity. While in fact it may be argued that such term should be interpreted in a way to encompass only treaties, the reference to ‘work’ and ‘practices’ leaves room to speculate that the term may also include, for example, soft law instruments. With respect to human rights law, such opening may lead to significant implications, as discussed in the next section.

II.  Human Rights and the Nagoya Protocol When undertaking activities falling within the scope of the Nagoya Protocol, Parties are expected to comply with their extant international obligations.31 This basic tenet assumes specific colouring in connection with human rights obligations, which have been described by some authors as ‘complementary’ to States’ other obligations and commitments, by reason of their all-encompassing nature.32 States’ obligations on the protection of human rights depend upon their specific commitments under relevant international treaties. The existence of customary international law concerning human rights is instead contentious. It has been argued that the practice of a State in relation to its own citizens is a matter of domestic jurisdiction, which is in principle without significance  Elisa Morgera, Matthias Buck and Elsa Tsioumani, Commentary on the Nagoya Protocol on Access and Benefit-sharing (Leiden/Boston: Martinus Nijhoff Publishers/Brill, 2013). 30  Gurdial S. Nijar, The Nagoya Protocol on Access and Benefit Sharing of Genetic Resources: An Analysis (Kuala Lumpur: CEBLAW, 2011), 25. 31  International Law Commission, “Fragmentation of International Law: Difficulties Arising from the Diversification and Expansion of International Law. Report of the Study Group of the International Law Commission,” 38. 32  Andrew Clapham, ‘The Complementarity Universal Periodic Review in the New Human Rights Council’ (Speaking Notes for Lausanne III, 15 May 2006), at 1, identifies three different notions of complementarity: first, the complementarity between the obligations undertaken by a State under the treaties it has ratified and the State’s other obligations and commitments; second, the complementarity between treaty bodies reporting processes; and third, the complementarity involved in choosing the order in which States should be reviewed. 29

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for the establishment of a customary rule.33 However, the argument has also been made that general opinio iuris as well as consuetudo exist to maintain that at least some human rights ‘are today crystallised in the realm of customary international law’.34 The existence of a customary rule is always difficult to prove and a detailed overview of this question clearly exceeds the scope of this chapter. For present purposes suffice it to recall that most Parties to the CBD have ratified the two ‘foundational’ human rights treaties, the International Covenant on Civil and Political Rights (ICCPR)35 and the International Covenant on Economic, Social and Cultural Rights (ICESCR).36 Several CBD Parties have also ratified regional human rights treaties.37 There is considerable common ground to carry out mutually supportive interpretation and build upon synergies between these instruments and the Nagoya Protocol. Although human rights treaties are agreements between States, they chiefly address States’ relationship with individuals, by conferring upon them a series of entitlements.38 The inherent obligations have been construed to entail a series of common elements. All human rights treaties require States not only to refrain from violating the rights (i.e., to respect the rights), but  E.g., Hugh Thirlway, “The Sources of International Law,” in International Law, ed. M.D. Evans (Oxford: Oxford University Press, 2010), 104. 34  E.g., International Law Association, “The Hague Conference Report, Rights of Indigenous Peoples,” (The Hague: International Law Association, 2010), 43–52; and James Anaya, “The Human Rights of Indigenous Peoples, in Light of the New Declaration, and the Challenge of Making Them Operative: Report of the Special Rapporteur on the Situation of Human Rights and Fundamental Freedoms of Indigenous People,” (5 August 2008) UN Doc A/HRC/9/9, paragraph 41. 35  International Covenant on Civil and Political Rights (New York, 16 December 1966, in force 23 March 1976), 999 UNTS 171, 6 ILM 368 (1967), (hereinafter ICCPR). As of 31 December 2011, the ICCPR had 167 Parties (United Nations Treaty Collection, accessed 4 June 2012, http://treaties.un.org/Pages/Treaties.aspx?id=4&subid=A&lang=en). 36  International Covenant on Economic, Social and Cultural Rights (New York, 16 December 1966, 3 January 1976) 993 UNTS 3, 6 ILM 360 (1967) (hereinafter ICESCR). As of 31 December 2011, the ICESCR had 160 Parties (United Nations Treaty Collection, accessed 4 June 2012, http://treaties.un.org/Pages/Treaties.aspx?id=4&subid=A&lang=en). 37  African Charter; European Convention for the Protection of Human Rights and Fundamental Freedoms (Strasbourg, 4 November 1950, in force 3 September 1953) UNTS 222 (hereinafter ECHR); and European Social Charter (Turin, 18 October 1961, in force 26 February 1965) 529 UNTS 89. The Council of Europe has adopted a more detailed and extensive Revised Social Charter in 1996, opened for signature 3 May 1996; American Convention on Human Rights (San Jose, 22 November 1969, in force 18 July 1978) 1144 UNTS 123, 9 ILM 673 (hereinafter American Convention); and Additional Protocol to the American Convention on Human Rights in the area of Economic, Social and Cultural Rights (San Salvador, 17 November 1988, in force 16 November 1999) OASTS 69, 28 ILM 156 (1989). 38  Human Rights Committee, “General Comment No. 31, Nature of the General Legal Obligation on States Parties to the Covenant,” (26 May 2004) UN Doc CCPR/C/21/Rev.1/Add.13, 9. 33

60   Annalisa Savaresi also to take positive measures, including protecting against infringements of the rights by non-State actors (i.e., to protect the rights) and other appropriate measures towards the full realisation of the right (i.e., to fulfil the rights).39 Another common feature is the establishment of specific bodies to monitor States’ compliance with their obligations,40 which has been in recent years coupled by a quadrennial review of the human rights records of all UN Member States.41 In addition, some conventions have established individual complaint mechanisms with the authority to receive communications from individuals (or groups) claiming that a State Party has failed to comply with its obligations under the relevant treaty.42 Human rights bodies operate according to ‘complementarity’, with a view to avoiding duplication of efforts.43 The decisions rendered by human rights bodies are not always endowed with legally binding force. In some systems, however, the declaration of a breach of human rights has the effect of imposing legal obligations on respondent States to put an end to the breach and, sometimes, even to provide

 For this terminology, Asbjørn Eide, “Realization of Social and Economic Rights and the Minimum Threshold Approach,” Human Rights Law Journal 10 (1989): 35; and Ida E. Koch, “Dichotomies, Trichotomies or Waves of Duties?,” Human Rights Law Review 5 (2005): 81. 40  For example, the ICCPR and the ICESCR have set up treaty bodies to this purpose, the Human Rights Committee (HRC) and the Committee on Economic, Social and Cultural Rights (CESCR), respectively. 41  On the Human Rights Council Universal Periodic Review, UN Human Rights Office of the High Commissioner for Human Rights, accessed 4 June 2012, http://www.ohchr .org/en/hrbodies/upr/pages/uprmain.aspx. The Review assesses the extent to which states respect the human rights obligations set out in the UN Charter; the Universal Declaration of Human Rights; human rights instruments to which the state is Party; voluntary pledges and commitments made by the State; and applicable international humanitarian law. 42  The ICCPR and all regional human rights treaties provide such mechanisms only in connection with civil and political rights. Under the African system, however, it is possible to bring claims also in connection with breaches of economic, social, and cultural rights. Cf. Protocol to the African Charter on Human and Peoples’ Rights on the Establishment of an African Court on Human and Peoples’ Rights (Ouagadougou, 9 June 1998, in force 25 January 2004) Articles 5.3 and 34.6. The same applies under the European Social Charter, although only for groups. Cf. Additional Protocol to the European Social Charter Providing for a System of Collective Complaints CETS No. 158 (Strasbourg, 9 November 1995, in force 1 July 1998). In 2008, however, the UN General Assembly unanimously adopted an Optional Protocol to the ICESCR, which empowers the CESCR to receive and consider individual communications. At the time of writing the Protocol has not entered into force. See UNGA, “Optional Protocol to the International Covenant on Economic, Social and Cultural Rights,” (10 December 2008) UN Doc A/RES/63/117. 43  Andrew Clapham, “The Complementarity Universal Periodic Review in the New Human Rights Council’ ” 1. 39

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just satisfaction.44 States retain considerable freedom in the choice of measures they may take to meet their human rights obligations. Nevertheless, the blame-and-shame effect associated with the declaration of human rights violations exerts some influence on States, which normally go to great lengths not to be regarded as human rights violators.45 International human rights bodies have played a particularly important role in promoting and securing the implementation of human rights obligations, and in substantiate the core content of the inherent rights. Their action has increasingly extended to matters overlapping with those addressed in the framework of international environmental law instruments. For example, some human rights bodies have found that natural resource extraction activities may be associated with the violation of the rights of indigenous peoples and ‘tribal’ communities. Thus, in Mayagna (Sumo) Awas Tingni Community v. Nicaragua, the Inter-American Court of Human Rights found that the right of the members of the community to use and enjoy their property had been violated by the granting of logging concessions in the area where members of the community lived and carried out their activities.46 Inadequate involvement of affected subjects in decision-making processes can also lead to human rights infringements. Provisions on public participation, access to justice and information are an undisputed component of internationally protected human rights.47 Public participation requirements have also become a common feature of environmental law-making, based on the rationale that ‘environmental issues are best handled with the participation of all concerned citizens at the relevant level’.48 The Rio Declaration articulates such participation around the pillars of access to information, the opportunity to participate in decision-making

 E.g., ECHR Article 41.  For an overview on the complex dynamics engendered by naming and shaming, Emilie Hafner Burton, “Sticks and Stones: Naming and Shaming the Human Rights Enforcement Problem,” International Organization 62 (2008): 689. 46  Case of the Mayagna (Sumo) Awas Tingni Community v Nicaragua, Judgment of 31 August 2001, Series C No. 79, 153. 47  For a commentary, see Boyle, “Human Rights or Environmental Rights? A Reassessment”. 48  Rio Declaration on Environment and Development, found in UN, “Report of the UN Conference on Environment and Development,” (1993) UN Doc A/CONF.151/26/Rev.1 (Vol. I), Annex I (Rio Declaration), Principle 10. Agenda 21 asserts that broad public participation is a fundamental prerequisite for sustainable development (UNCED, “Report of the United Nations Conference on Environment and Development,” (1993) UN Doc A/CONF.151/26/Rev.1 (Vol. I); the Regional Convention for the management and conservation of the natural forest ecosystems and the development of forest plantations (Guatemala City, 29 October 1993, in force 15 October 1999) Chapter 23, 2. 44 45

62   Annalisa Savaresi processes, and effective access to judicial and administrative proceedings.49 The Declaration emphasises that indigenous peoples and other local communities have a vital role in environmental management and development because of their knowledge and traditional practices. States are therefore invited to recognise and duly support the identity, culture and interests of indigenous peoples and other local communities, and to enable their effective participation in the achievement of sustainable development.50 While the Rio Declaration does not ex se create obligations under international law, provisions concerning public participation, and access to justice and information have been included in a series of environmental agreements. And, although the Nagoya Protocol may not be considered a ‘human rights instrument,’ it seems plausible to regard it as an environmental agreement with some built-in ‘participation’ requirements. The right to participation has its roots in the human right to participate in public affairs, which encompasses also the right to vote and the right to be elected.51 The protection of human rights, such as the right to life, and the right to respect for privacy, family, and home, have also been interpreted in the sense to require some form of public participation.52 Some environmental treaties have injected additional elements into these entitlements, by requesting that the public, or affected subjects, be given the possibility to participate to certain environmental decision-making processes.53 Equally, access to information may be regarded as an emanation of the human right to freedom of expression, which entails the freedom to seek

 Rio Declaration, Principle 10.  Ibid., Principle 22. 51  See for example ICCPR Article 25 and African Charter Article 13. 52  For example, the European Court of Human Rights has established that ‘the decisionmaking process leading to measures of interference with the right to respect for privacy, family, and home, must be fair and such as to afford due respect to the interests of the individual’ (European Court of Human Rights, Taskin and others v Turkey, Application No. 46117/99,115). 53  E.g., United Nations Economic Commission for Europe Convention on EIA in a Transboundary Context (Espoo, 25 February 1991, in force 10 September 1997), 30 ILM 802 (1991), Article 2.2; Protocol on Environmental Protection to the Antarctic Treaty (Madrid, 4 October 1991, in force 14 January 1998), 30 ILM 1461 (1991), Article 6; Convention on the Transboundary Effects of Industrial Accidents (Helsinki, 18 March 1992, in force 19 April 2000) 2105 UNTS 457, 31 ILM 1333 (1992), Article 9.2; and United Nations Convention to Combat Desertification (Paris, 17 June 1994, in force 26 December 1996) 1954 UNTS 3, Article 3(a); United Nations Economic Commission for Europe Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters (Aarhus, 25 June 1998, in force 30 October 2001) 2161 UNTS 447 (hereinafter Aarhus Convention), Articles 6–8. 49 50

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information, as well as to receive it.54 Also access to information is instrumental to the enjoyment of some human rights.55 In addition, some international environmental law instruments prescribe the right to access to specific kinds of ‘environmental’ information.56 Finally access to justice encompasses entitlements associated with the right to access an effective remedy,57 to take proceedings before a court58 and, when the latter applies, also the right to a fair and public hearing.59 These entitlements apply also to breaches of human rights.60 Some treaties require that States give access to justice in cases of environmental damage, refused access to information, or failure to enforce environmental regulations.61 Others require that members of the concerned public be given access to adequate and effective remedies, including injunctive relief, and be ‘fair, equitable, timely and not prohibitively expensive.’62  E.g., ICCPR Article 19.2.  In this respect, the European Court of Human Rights has found that the protection of some substantive human rights requires ‘informing potentially affected subjects of the risks to which they may be exposed’ (European Court of Human Rights, Guerra and Others v Italy, Application No. 14967/89, 60). 56  E.g., United Nations Educational, Scientific and Cultural Organisation Convention for the Protection of World Cultural and Natural Heritage (Paris, 16 November 1972, in force 17 December 1975), 11 ILM 1358 (1972), Article 27.2; United Nations Framework Convention on Climate Change (New York, 9 May 1992, in force 21 March 1994) 1771 UNTS 107, Article 6.a.ii; Convention on the Transboundary Effects of Industrial Accidents (Helsinki, 18 March 1992, in force 19 April 2000) 2105 UNTS 457, 31 ILM 1333 (1992), Article 9.1; Convention on the Protection and Use of Transboundary Watercourses and International Lakes (Helsinki, 17 March 1992, in force 6 October 1996) 1936 UNTS 269, 31 ILM 1312 (1992), Article 16; Convention for the Protection of the Marine Environments of the North-East Atlantic (Paris, 22 September 1992, in force 25 March 1998), 32 ILM 1072 (1993), Article 9; and Convention on Civil Liability for Damage Resulting from Activities Dangerous to the Environment (Lugano, 21 June 1993, not in force), 32 ILM 1228 (1993), Articles 14–16; Aarhus Convention, Articles 4–5. 57  ICCPR Article 2.3. 58  ICCPR Article 9.4. 59  ICCPR Article 14.1. For a comprehensive commentary, see Francesco Francioni, “The Right to Access to Justice under Customary International Law,” in Access to Justice as a Human Right ed. Francesco Francioni (Oxford: Oxford University Press, 2007), 24–25. 60  In this regard, the European Court of Human Rights has established that ‘the individuals concerned must also be able to appeal to the courts against any decision, act or omission where they consider that their interests or their comments have not been given sufficient weight in the decision-making process’ (European Court of Human Rights, Taskin and others v Turkey, Application No. 46117/99,116). 61  Cf. for example Convention on the Transboundary Effects of Industrial Accidents, Article 9.3; Convention on Civil Liability for Damage Resulting from Activities Dangerous to the Environment, Articles 1, 6–11, 18. 62  As is the case, for example, in Aarhus Convention, Article 9.4. 54 55

64   Annalisa Savaresi Human rights concerning access to justice, information and participation are highly context-specific, as the inherent entitlements greatly depend upon which treaty each State has ratified. Nevertheless, international human rights bodies have developed a sizeable caselaw outlining remarkably similar requirements,63 including full and informed participation by those affected, and judicial recourse for States’ failure to comply with certain obligations.64 These rights apply to different groups discretely. So while some forms of participation or information may need to be made available to the public at large or to non-governmental organisations (NGOs), often only ‘individuals concerned’ benefit from such rights. Indigenous peoples enjoy special protection in this regard, as the next section illustrates. 1.  The Rights of Indigenous Peoples Participation by indigenous peoples in decisions that affect them has been deemed to be necessary to protect their cultures, lands, territories and resources.65 The right of indigenous peoples to participation arguably focuses not only on allowing indigenous peoples to participate in decision-making processes affecting them, but also to actually control the outcome of such processes.66 Such rights are enshrined in a host of hard and a soft law instruments, as well as in the caselaw of human rights bodies. The International Labour Organisation Convention Concerning Indigenous and Tribal Peoples no. 169 (ILO Convention 169)67 requires that indigenous peoples be consulted through appropriate procedures whenever considering legislative or administrative measures that may affect them directly, such as activities carried out on their traditional lands.68 States must furthermore establish means by which indigenous peoples can freely participate, to at least the same extent as other sectors of the population and at all levels of decision-making, in bodies responsible for policies and  Boyle, “Human Rights or Environmental Rights? A Reassessment,” 504.  European Court of Human Rights, Taskin and others v Turkey, Application No. 46117/ 99,119. The Court has found that these requirements apply also to the right to life (European Court of Human Rights, Oneryildiz v. Turkey, Application No. 48939/99, 90). 65  Expert Mechanism Advice No. 2, “Indigenous peoples and the right to participate in decision-making,” (2011), accessed 4 June 2012, http://www.ohchr.org/Documents/Issues/ IPeoples/EMRIP/Advice2_Oct2011.pdf, paragraph 1. 66  Ibid., paragraph 2. 67  International Labour Organisation Convention 169 Concerning Indigenous and Tribal Peoples in Independent Countries (Geneva, 27 June 1989, 5 September 1991) ILO/C169 (hereinafter ILO Convention 169). To date the Convention has been ratified by 22 countries (Convention No. C169, accessed 4 June 2012, http://www.ilo.org/ilolex/cgi-lex/ratifce .pl?C169). 68  ILO Convention 169 Article 6.1(a). 63 64

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programmes that concern them.69 Consultations must be undertaken in good faith and in a form appropriate to the circumstances, with the objective of achieving agreement or consent to the proposed measures.70 ILO Convention 169 provides also indigenous peoples’ right to participate in the use, management and conservation of natural resources and States are required to consult indigenous peoples before undertaking or permitting any exploration or exploitation of such resources in their lands.71 Whenever possible, indigenous peoples must participate in the benefits of such activities and receive compensation for any damage sustained.72 Only few States have ratified ILO Convention 169.73 However, the general ‘normative underpinning’ and specific human rights embodied in the Convention have arguably acted as a ‘powerful catalyst for the consolidation at the international level of the common normative understanding regarding the rights of indigenous peoples.’74 Most Parties to the CBD have instead supported the adoption of the UN Declaration on the Rights of Indigenous Peoples (UNDRIP).75 UNDRIP does not affirm ‘special rights’ which are separate from the fundamental rights in the specific circumstances of indigenous peoples, but rather builds upon existing human rights.76 The Declaration recognises indigenous peoples’ right to determine their own economic, social and cultural development and to manage their natural resources.77 In particular, UNDRIP recognises indigenous peoples’ right to ‘maintain, control, protect and develop their cultural heritage, traditional knowledge and traditional cultural expressions (. . .) including human and genetic

 ILO Convention 169 Article 6.1(b).  ILO Convention 169 Article 6.2. 71  ILO Convention 169 Article 15.1. 72  ILO Convention 169 Article 15.2. 73  To date the Convention has been ratified by 22 countries (Convention No. C169, accessed 4 June 2012, http://www.ilo.org/ilolex/cgi-lex/ratifce.pl?C169). 74  Anaya, “The Human Rights of Indigenous Peoples, in Light of the New Declaration,” paragraph 33. 75  United Nations General Assembly “United Nations Declaration on the Rights of Indigenous Peoples,” (13 September 2007) UN Doc A/RES/61/295 (‘UNDRIP’). The Declaration was adopted by a majority of 144 States in favour, 4 votes against (Australia, Canada, New Zealand and the United States). Since its adoption, Australia, New Zealand, Canada and the United States have all reversed their positions and now endorse the Declaration (http:// social.un.org/index/IndigenousPeoples/DeclarationontheRightsofIndigenousPeoples.aspx, accessed on 11 June 2012). 76  Anaya, “The Human Rights of Indigenous Peoples, in Light of the New Declaration,” paragraph 40. 77  UNDRIP Article 3. 69 70

66   Annalisa Savaresi resources, seeds, medicines, knowledge of the properties of fauna and flora’.78 States must consult and cooperate in good faith with the indigenous peoples concerned through their own representative institutions in order to obtain their FPIC, ‘particularly in connection with the development, utilisation or exploitation of mineral, water or other resources’.79 UNDRIP requires FPIC also with regard to all legislative or administrative measures that may affect indigenous peoples.80 The requirement of consent has been interpreted in the sense to entail that indigenous peoples be empowered to ‘effectively determine the outcome of decision-making that affects them, not merely a right to be involved in such processes.’81 A report by the International Law Association has argued that indigenous peoples’ right to FPIC may be regarded as part of customary international law.82 The latter conclusion seems premature. Some legal consequence may nevertheless be derived from the inclusion of FPIC in UNDRIP. As a UN General Assembly Resolution,83 the Declaration does not impose legally binding obligations on Members of the United Nations.84 However, it no doubt provides an authoritative statement of the rights of indigenous peoples, which has been viewed as an expression of a ‘commitment to its provisions’ by the United Nations and its Member States within the framework of the obligations established by the United Nations Charter to promote and protect human rights on a non-discriminatory basis.85 The Preamble to the Nagoya Protocol expressly refers to UNDRIP.86 The reference to mutually supportive interpretation with ‘other international instruments’ that are relevant to the Protocol’s subject matter may furthermore be interpreted in the sense to include also UNDRIP.87 Thus, in spite of  UNDRIP Article 31.1 (emphasis added).  UNDRIP Article 32.2. 80  UNDRIP Article 19. 81  Expert Mechanism Advice No. 2, http://www.ohchr.org/Documents/Issues/IPeoples/ EMRIP/Advice2_Oct2011.pdf 21. 82  See, for example, International Law Association, “The Hague Conference Report, Rights of Indigenous Peoples,” 51. 83  Expert Mechanism Advice No. 2. 84  On the legal status of the Declaration, see Luis Rodríguez-Piñero Royo, “‘Where Appropriate’: Monitoring/Implementing of Indigenous Peoples’ Rights under the Declaration,” in Making the Declaration Work: The United Nations Declaration on the Rights of Indigenous Peoples, ed. Claire Charters and Rodolfo Stavenhagen (Copenhagen: International Work Group for Indigenous Affairs, 2009), 314, 315–318. 85  Anaya, “The Human Rights of Indigenous Peoples, in Light of the New Declaration,” paragraph 41. 86  Nagoya Protocol Preamble, second last paragraph: “Noting the United Nations Declaration on the Rights of Indigenous Peoples.” 87  Nagoya Protocol Article 4.3. 78 79

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its undefined legal status, Parties to the Nagoya Protocol that have supported UNDRIP may be expected to interpret their obligations in accordance with the Declaration.88 Regardless of such considerations, indigenous peoples’ right to FPIC has found decisive recognition in the case law of human rights bodies. In Maya Indigenous Community of Toledo v. Belize case, for example, the Inter-American Commission of Human Rights found that the granting of logging and oil concessions to third parties in the absence of effective consultations with, and the informed consent of, the Maya people had breached their right to property.89 This requirement has been applied to communities that were not considered to be indigenous peoples. In Saramaka People v. Suriname, the InterAmerican Court of Human Rights held that the State had a duty not only to consult with the Saramaka (that were regarded by the Court as a ‘tribal community’),90 but also to obtain their FPIC for large-scale development or investment projects that could have a major impact within their territory.91 Other international human rights bodies, like the Committee on Economic, Social and Cultural Rights established pursuant to the ICESCR have clarified that FPIC is required in accordance with state obligations under the corresponding treaties.92 Irrespective of considerations concerning the legal status of the UNDRIP, therefore, Parties to these human rights instruments are expected to abide to FPIC requirements, as they have emerged from interpretation of the inherent treaties.93

 For an overview, see Grand Council of the Crees (Eeyou Istchee) et al., “Nagoya Protocol on Access and Benefit Sharing: Substantive and Procedural Injustices relating to Indigenous Peoples’ Human Rights,” Expert Mechanism on the Rights of Indigenous Peoples, 4th session, Geneva (July 2011), accessed 11 June 2012, http://www.ubcic.bc.ca/News_Releases/ UBCICNews06061101.html#axzz1wzzjmEot, 197. 89  Inter-American Commission on Human Rights: Maya Indigenous Community of the Toledo District v. Belize, Case No 12.053, 194. 90  Inter-American Court of Human Rights, Case of the Saramaka People v Suriname, Judgment of 28 November 2007, Series C No. 172, 79–86. 91  Ibid., 134. See also Inter-American Commission on Human Rights, Indigenous and Tribal Peoples’ Rights over their Ancestral Lands and Natural Resources (OEA/Ser.L/V/II. Doc. 50/09, 30 December 2009), at 273 (emphasis added). 92  E.g., Committee on Economic, Social and Cultural Rights, “General Comment No. 21, Right of everyone to take part in cultural life (art. 15.1(a), of the International Covenant on Economic, Social and Cultural Rights),” (21 December 2009) UN Doc E/C.12/GC/21, paragraph 37. 93  Anaya, “The Human Rights of Indigenous Peoples, in Light of the New Declaration,” paragraph 36. 88

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III.  Human Rights in the Nagoya Protocol? As anticipated above, several provisions in the Nagoya Protocol build upon notions and concepts that may be traced back to human rights. The Protocol arguably advances the international protection of the rights of indigenous and local communities in connection with genetic resources.94 In particular, it is here argued that references to PIC and requirements concerning participation and access to justice and information associated with mutually agreed terms (MAT) could and should be read through a human rights lens. The following analysis provides an overview of these two matters in turn. 1.  Prior Informed Consent The notion of PIC embodied in the Nagoya Protocol builds and expands upon the notion of ‘approval and involvement’ used in the CBD. The CBD requires Parties to respect, promote the wider application of the knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity, with the ‘approval and involvement of the holders of such knowledge, innovations and practices.’95 This requirement is qualified by the expression ‘subject to national legislation’. Such qualification has been the matter of much debate. Glowka et al. observe how the unusual proviso of subjecting an international obligation to national legislation was inserted in the Convention to preserve the legal relationships that some States had previously established with indigenous peoples through treaties and national legislation.96 The reference to national law has nevertheless potentially opened the way to a wide margin of appreciation by Parties, which remain the ultimate judges as to whether to provide legislation to grant such forms of approval and involvement. A similar formula is replicated in the 2002 Bonn Guidelines on ABS, which make reference to the fact that the consent of relevant stakeholders should be obtained ‘as appropriate to the circumstances and subject to domestic law’.97 An analogous expression appears in the Akwé: Kon Guidelines on sociocultural and environmental impact assessments, which mention that, where the national legal regime requires the prior informed consent of indigenous  Kabir Bavikatte and Daniel F. Robinson, “Towards a People’s History of the Law: Biocultural Jurisprudence and the Nagoya Protocol on Access and Benefit Sharing,” Law, Environment and Development Journal 7 (2011) 35, 39. 95  CBD Article 8.j. 96  Glowka et al., A Guide to the Convention on Biological Diversity: 48. 97  CBD Decision 6/24, “Access and benefit-sharing as related to genetic resources” (27 May 2002) UN Doc UNEP/CBD/COP/6/20, 26(d). 94

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and local communities, the assessment process should consider whether such prior informed consent has been obtained.98 These formulas have become a common feature of decisions adopted by the CBD Conference of the Parties (COP) and appear also in the Nagoya Protocol. In particular, the Protocol requires Parties to take measures to ensure that access to genetic resources is obtained with indigenous and local communities’ prior informed consent or approval and involvement, ‘where they have the established right to grant access to such resources’.99 This reference to PIC or approval and involvement has raised some doubts, as the text may be read to require both consent and involvement, or only one of the two.100 More crucially, the Protocol does not require that PIC be sought tout court, but only that this is the case where they have the ‘established right’ to grant access to such resources. PIC is thus subjected to the existence of (international or national) rules that somewhat empower the mentioned communities to give access to such resources. A similar expression appears where the Protocol provides that each Party requiring PIC take the necessary legislative, administrative or policy measures, as appropriate, to set out criteria and/or processes for obtaining such consent or approval and involvement ‘where applicable, and subject to domestic legislation.’101 This reference has raised concerns that the claims of indigenous peoples and local communities may be protected only if their rights are already affirmed by domestic law.102

 Akwé: Kon Voluntary Guidelines for the Conduct of Cultural, Environmental and Social Impact Assessment regarding Developments Proposed to Take Place on, or which are Likely to Impact on, Sacred Sites and on Lands and Waters Traditionally Occupied or Used by Indigenous and Local Communities, in Article 8(j) and related provisions in CBD 7/16F, “Article 8(j) and related provisions” (13 April 2004) UN Doc UNEP/CBD/ COP/7/21, 261.   99  Nagoya Protocol Article 6.2 (emphasis added). A similar formulation may also be found in CBD 10/42, “The Tkarihwaié:ri Code of Ethical Conduct to Ensure Respect for the Cultural and Intellectual Heritage of Indigenous and Local Communities,” (20 January 2011) UN Doc UNEP/CBD/COP/10/27, 302. 100  See, Grand Council of the Crees (Eeyou Istchee) et al., “Nagoya Protocol on Access and Benefit Sharing: Substantive and Procedural Injustices relating to Indigenous Peoples’ Human Rights,” 134–136. The authors report that Canada suggested to read ‘prior and informed consent’ and ‘approval and involvement’ as alternatives. The authors argue that indigenous peoples’ mere ‘involvement’ and ‘approval’ would not be consistent with international law. 101  Nagoya Protocol Article 6.3. 102  Grand Council of the Crees (Eeyou Istchee) et al., “Nagoya Protocol on Access and Benefit Sharing: Substantive and Procedural Injustices relating to Indigenous Peoples’ Human Rights,” 68.   98

70   Annalisa Savaresi Even if these provisions were to be interpreted in the sense of leaving such discretion to Parties in determining indigenous peoples and local communities’ rights,103 Parties to the Nagoya Protocol are required to comply with their human rights commitments. Therefore, Parties to international human rights instruments should use human rights standards to interpret PIC requirements under the Nagoya Protocol. As mentioned earlier, numerous international and regional human rights instruments have been interpreted in the sense to require the FPIC of indigenous peoples and tribal communities, in connection with any project affecting their lands or territories and other resources, particularly with regard to the development, utilisation or exploitation of mineral, water or other resources.104 The duties to consult with indigenous peoples and to obtain FPIC has been viewed as crucial elements of the right to self-determination,105 and the inherent body of human rights jurisprudence has arguably exercised an important ‘normative effect’.106 Parties to human rights treaties are expected to abide to FPIC requirements, as they have emerged from the interpretation of these treaties. In addition, ‘procedural’ requirements included in human rights treaties could be used to identify what is expected of a State in order to obtain PIC. The requirement that consent be ‘informed’ should be read in light of human rights standards formulated with regard to the right to access information, as interpreted in the caselaw of human rights bodies. More generally, human rights standards could be applied to assess the quality of information that a State Party may be required to provide. Human rights instruments also supply useful guidance to fill in with content the Protocol’s references to participation and transparency in connection with the legislative, administrative or policy measures to be adopted in relation to PIC.107 Human rights standards may be used as a yardstick to assess whether the affected communities have been properly involved in the relevant processes. Finally, PIC may be viewed as a civil right, which entails access to adequate remedies, in line with

 Ibid., 137–143.  UNDRIP Article 32.2. See also Committee on Economic, Social and Cultural Rights, “General Comment No. 21”, paragraphs 5 and 37; Committee on the Elimination of Racial Discrimination (CERD), “Concluding observations of the Committee on the Elimination of Racial Discrimination: Suriname,” (28 April 2004) UN Doc CERD/C/64/CO/9, paragraph 11. For a commentary, see International Law Association, “The Hague Conference Report, Rights of Indigenous Peoples,” 24. 105  Expert Mechanism Advice No. 2, paragraph 18. 106  For this expression, see Anaya, “The Human Rights of Indigenous Peoples, in Light of the New Declaration,” paragraph 28. 107  Nagoya Protocol Article 6.3.c. 103 104

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the right to a fair hearing concerning the determination of all civil rights and obligations laid out in domestic law.108 2.  Mutually Agreed Terms The Nagoya Protocol requires Parties to take measures to ensure that benefits arising from the utilisation of genetic resources held by indigenous and local communities are shared in a fair and equitable way with the communities concerned, based on MAT and ‘in accordance with domestic legislation regarding the established rights’ of these communities over genetic resources’.109 This reference to domestic law raises the same interpretative dilemmas mentioned in connection with access to genetic resources. If this provision is interpreted in the sense that indigenous peoples or local communities demonstrate that the right is affirmed by existing domestic legislation, it may lead to inequitable and potentially discriminatory outcomes.110 Also here, however, human rights standards and caselaw provide a precious term of reference on how Parties are expected to perform the inherent obligations, depending upon the human rights commitments that they have undertaken under the relevant treaties. In fact, although MAT are likely to take the form of contracts,111 this does not exclude the applicability of human rights. As recalled earlier, human rights obligations do not only require that States abstain from interfering with the enjoyment of human rights. States are also expected to protect subjects within their jurisdictions against violations of human rights by non-State actors. As far as MAT are concerned, this may entail providing adequate access to remedies in connection with breaches of the agreement, and ensuring that certain standards are upheld, particularly with regard to access to information. In some cases, accessibility requirements may even include that remedies are not prohibitively expensive.112 Obligations concerning public participation and access to justice and information in the Nagoya Protocol should be interpreted in the light of States’ extant human rights commitments. The Protocol establishes an obligation on Parties to provide access to justice in case of disputes arising from MAT. The Protocol specifically requests Parties to ensure that in cases of disputes  E.g., ECHR Article 6.1.  Nagoya Protocol Article 5.2 (emphasis added). 110  For this argument, see Grand Council of the Crees (Eeyou Istchee) et al., “Nagoya Protocol on Access and Benefit Sharing: Substantive and Procedural Injustices relating to Indigenous Peoples’ Human Rights,” 68. 111  [See e.g., the contribution by Glowka and Normand to this volume (Chapter 1).] 112  Aarhus Convention Article 9.4. 108 109

72   Annalisa Savaresi arising from MAT an opportunity to seek recourse is available under their legal systems, consistent with applicable jurisdictional requirements.113 Parties are also asked to take effective measures providing access to justice and the utilisation of mechanisms for the mutual recognition and enforcement of foreign judgments and arbitral awards. Procedural human rights may be instrumental in defining what ‘access to justice’ entails. A phenomenon observed in relation to bilateral investment treaties (BIT) is theoretically replicable here. Human rights standards have in fact been used in BIT related arbitrations as a yardstick to assess whether States have fulfilled their obligation to provide adequate access to justice to non-State parties.114 Cases regarding breaches of BIT have also ended up before human rights bodies, on grounds of denied access to justice.115 There is no reason why the same should not apply, mutatis mutandis, to disputes concerning MAT. Therefore, human rights standards could be deployed by domestic courts, as well as international bodies, to assess whether parties to a dispute concerning MAT have been granted adequate access to justice. During negotiations on the Nagoya Protocol, CBD parties considered establishing an international ombudsperson to support developing countries and indigenous and local communities to identify breaches of rights and provide technical and legal support in ensuring effective redress of such breaches.116 While for the time being this proposal has been set aside,117 it is possible to envision that human rights bodies perform a watchdog function over the implementation of the Nagoya Protocol. As mentioned earlier, human rights bodies’ scrutiny encompasses compliance with human rights also when implementing other international instruments. For example, the UN Committee on the Elimination of Racial Discrimination (UNCERD)118  Nagoya Protocol Article 18.2.  International Centre for the Settlement of Investment Disputes, Mondev International Ltd. v. USA (Award of 11 October 2002) ARB/(AF)/99/2, paragraph 144. 115  For example, investors in the Russian oil company, Yukos, have pursued both BIT claims, as well as claims before the European Court of Human Rights. In an instance before the Arbitration Institute of the Stockholm Chamber of Commerce, Limited Liability Company AMTO v Ukraine (Award 26 March 2008, 080/2005), claimants also mounted a case against the Ukraine before the European Court of Human Rights. For an analysis of the role of human rights in connection with BIT, Luke E. Peterson, “Human Rights and Bilateral Investment Treaties. Mapping the Role of Human Rights Law within Investor-State Arbitration,” (Rights & Democracy, 2009). 116  See CBD COP, “Report of the Third Part of the Ninth Meeting of the Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing,” (17 October 2010) UN Doc UNEP/CBD/ COP/10/5/Add.5, Article 14bis. 117  [See options for its creation discussed in Young’s contribution to this volume (Chapter 15).] 118  International Convention on the Elimination of All Forms of Racial Discrimination (New York, 7 March 1966, in force 4 January 1969) 660 UNTS 195. 113 114

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has been quick in underscoring the potentially negative human rights impact of measures adopted to facilitate the reduction of emissions in the forest sector, in pursuit of international initiatives established under objectives set out in the UN Framework Convention on Climate Change.119 Implementation of the Nagoya Protocol will surely benefit from this form of cross-monitoring. Finally, States’ positive obligations to protect the human rights of indigenous and local communities may be interpreted in the sense to require some form of scrutiny on the substance of MAT.120 In this regard, the Nagoya Protocol specifically mentions that Parties ‘endeavor to support’ the development of minimum requirements for MAT to secure the fair and equitable sharing of benefits arising from the utilization of traditional knowledge associated with genetic resources.121 The inherent human rights requirements, however, clearly vary from one human rights instrument to the other and may therefore have different implications for different Parties. Another matter that is likely to benefit from increased cross-fertilisation with human rights instruments is that concerning the identification of rightholders, as further discussed in the next section.

IV.  The Definition of Rightholders Although States are expected to comply with their international human rights obligations, it is up to national authorities to identify the relevant rightholders. This margin of appreciation needs to be exercised in good faith, as States may not interpret the notion of eligible rightholders in a way to de facto deprive their human rights obligations of any scope.122 Relevant human  In particular, CERD has adopted early warning measures against Indonesia, urging it to ‘review its laws, as well as the way they are interpreted and implemented in practice, to ensure that they respect the rights of indigenous peoples to possess, develop, control and use their communal lands’ (CERD, “Communication of the Committee Adopted Pursuant to the Early Warning and Urgent Action Procedures,” (2 September 2011), accessed 5 June 2012, http://www2.ohchr.org/english/bodies/cerd/docs/early_warning/Indonesia02092011. pdf). For a review, see Naomi Johnstone, “Indonesia in the ‘REDD’: Climate Change, Indigenous Peoples and Global Legal Pluralism,” Asian-Pacific Law & Policy Journal 12 (2011): 93; and Annalisa Savaresi, “The Human Rights Dimension of REDD,” RECIEL 2 (fortcoming 2012). 120  A form of public scrutiny is already provided in Australian Law: e.g., Northern Territory of Australia, Biological Resources Act 2006, 29, accessed 11 June 2012, http://www.wipo. int/wipolex/en/text.jsp?file_id=180842. 121  Nagoya Protocol, Article 12.3. 122  For instance, the International Law Association cautioned that a definition may be necessary to prevent that certain States, while supporting UNDRIP in principle, claim that it is not applicable in their territory in light of the assumed absence of indigenous communities 119

74   Annalisa Savaresi rights instruments and the related caselaw may provide useful terms of reference in this connection. With regard to the Nagoya Protocol, the main groups of rightholders are providers and users of genetic resources,123 as well as the wider public. The term ‘users’ is most likely to encompass private individuals and entities, including corporations. Access to genetic resources may be required by different types of users, each with different modi operandi and objectives. Measures to support compliance, therefore, need to be adapted to this diversity and to the intended use of the genetic resources. As mentioned earlier, the most salient human rights considerations in this regard concern regulation and implementation of MAT, in particular with reference to access to information and access to justice.124 There are, in addition, provisions in the Protocol that may apply also to the public at large. This is rarely the case for access to justice and participation, which normally require a qualified interest in the matter at issue. It is, therefore, more likely that the public at large be entitled to access information in connection with the ABS clearing-house125 or as a result of specific entitlements under other international law instruments.126 The providers of genetic resources are potentially the most vulnerable category of rightholders, and particularly so with reference to indigenous peoples and local communities. As mentioned earlier, the CBD has arguably emerged as a prime international forum for indigenous and local communities to express their interests and demands for the protection of their traditional knowledge.127 The CBD Working Group on Article 8(j) has

within their borders. International Law Association, The Hague Conference Report, Rights of Indigenous Peoples,” at 7. 123  For Parties’ submissions regarding the definition of these terms, see CBD COP, “Access and benefit-sharing as related to genetic resources. Compilation of Submissions by Experts on the Use of Terms,” (29 March 2002) UN Doc UNEP/CBD/COP/6/INF/40, paragraphs 77–86; and CBD Ad Hoc Open-Ended Working Group on Access and Benefit Sharing, “Further Consideration of Outstanding Issues Related to Access And Benefit-Sharing: Use of Terms, Other Approaches and Compliance Measures,” (16 September 2003) UN Doc UNEP/CBD/WG-ABS/2/2. 124  International Law Association, The Hague Conference Report, Rights of Indigenous Peoples,” at 7. 125  Nagoya Protocol, Article 14. 126  Such as, for example, access to environmental information under the Aarhus Convention Article 4. 127  Elisa Morgera and Elsa Tsioumani, “Yesterday, Today and Tomorrow. Looking Afresh at the Convention on Biological Diversity” in Yearbook of International Environmental Law, ed. O.K. Fauchald, D. Hunter, and W. Xi (Oxford University Press, 2011), 19.

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also acknowledged some form of participation for representatives of these communities.128 The following section investigates how these categories of rightholders have been dealt with in the framework of the CBD, and possible means for interpreting these elusive terms in the context of the Nagoya Protocol. 1.  Indigenous Peoples and Local Communities The expression ‘indigenous and local communities’ has been deployed as an ‘indivisible whole’ in the framework of the CBD and its related instruments.129 The Convention does not make specific reference to indigenous peoples as the subjects protected by specific international instruments. In fact, the Convention does not even use the term ‘indigenous peoples.’ In this regard, the CBD and related instruments are not consistent with established international law terminology.130 Although indigenous peoples enjoy special protection under international law, presently there is no agreed definition of the term.131 Representatives from indigenous organisations have rejected the adoption of a formal definition,132 and preferred to use self-identification in its stead.133 Nevertheless, the question of a definition has re-emerged in recent years, as a means to limit States’ discretion in determining who indigenous peoples are.134

 On recent developments concerning this practice, see “Summary of the Tenth Conference of the Parties to the Convention on Biological Diversity,” Earth Negotiations Bulletin 9(544) (2010); and Grand Council of the Crees (Eeyou Istchee) et al., “Nagoya Protocol on Access and Benefit Sharing: Substantive and Procedural Injustices relating to Indigenous Peoples’ Human Rights,” 176–9. [See also contribution by Burton to this volume (Chapter 10).] 129  Morgera and Tsioumani, “Yesterday, Today and Tomorrow. Looking Afresh at the Convention on Biological Diversity”, 21. 130  See Grand Council of the Crees (Eeyou Istchee) et al., “Nagoya Protocol on Access and Benefit Sharing: Substantive and Procedural Injustices relating to Indigenous Peoples’ Human Rights,” 120. See also UN Permanent Forum on Indigenous Issues, “Report on the ninth session,” (19–30 April 2010) UN Doc E/2010/43-E/C.19/2010/15. 131  For one authoritative attempt to provide such definition, see UN Special Rapporteur Martinez Cobo of the Subcommission on Prevention of Discrimination and the Protection of Minorities, ‘Study on the Problem of Discrimination against Indigenous Populations’ (11 March 1986) UN. Doc. E/CN.4/Sub.2/1986/7. 132  See UN Commission on Human Rights, “Discrimination Against Indigenous Peoples. Report of the Working Group on Indigenous Populations on its Fourteenth Session,” (16 August 1996) UN Doc E/CN.4/Sub.2/1996/21. 133  International Law Association, “The Hague Conference Report, Rights of Indigenous Peoples,” 6. 134  Ibid. 128

76   Annalisa Savaresi A number of possible criteria have been identified. The Permanent Forum on Indigenous Issues has outlined a ‘modern understanding’ of the notion of indigenous peoples, building upon the following characteristics: selfidentification; historical continuity; special relationship with ancestral lands; distinctiveness; non-dominance; and perpetuation.135 According to the International Law Association, the evaluation of such criteria requires a degree of flexibility, and not all criteria need to be met for a community to be considered indigenous.136 A significant example of such flexibility came with a communication by the African Commission on Human and Peoples’ Rights.137 The Commission recognised the community concerned as ‘indigenous’ in light of the existence of an intimate/sacred relationship with its ancestral lands, and of its self-identification. The latter requirement was interpreted as determination ‘to preserve, develop and transmit to future generations their ancestral territories and their ethnic identity [. . .] [and to influence] their own fate and to living in accordance with their own cultural patterns, social institutions and religious systems’.138 The notion of local communities is yet more elusive than that of indigenous peoples. While the term is deployed in a host of international instruments, there is no internationally agreed definition for it.139 The involvement of local communities has been particularly emphasised in policy discourses on natural resource management and conservation. Guidance adopted in the framework of the Ramsar Convention emphasises that ‘local’ is a relative term, as some stakeholders may live at a distance from a wetland and still have claims to its resources.140 However, groups that lack formal or legal recognition or documentation of their links to a land or resources may be excluded from participation to decision-making processes. In this regard, the Special Rapporteur on the Right to Food has emphasised

 UN Permanent Forum on Indigenous Issues, Fact Sheet, 21 October 2007.  International Law Association, “The Hague Conference Report, Rights of Indigenous Peoples,” 8. 137  See African Commission on Human and Peoples’ Rights, Communication No. 276/2003, Centre for Minority Rights Development (Kenya) and Minority Rights Group International on behalf of Endorois Welfare Council v. Kenya, 4 February 2010. 138  Ibid., paragraph 157. 139  For a comprehensive review, see Estelle Fach, “Legal Empowerment of Local Communities: A Role for International Environmental Law?,” accessed 5 June 2012, http://www.scps .nyu.edu/export/sites/scps/pdf/global-affairs/estelle-fach.pdf, 5–7. 140  Conference of the Contracting Parties Decision 7.8, “Guidelines for establishing and strengthening local communities’ and indigenous peoples’ participation in the management of wetlands” (10–18 May 1999), 6. 135 136

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how States should generally assist local communities in obtaining collective registration of the land they use.141 As mentioned earlier, in the framework of the CBD the term local communities has been systematically paired with ‘indigenous’. The terms appear together in the Bonn Guidelines,142 the Akwé: Kon Guidelines143 and the Addis Ababa Principles and Guidelines on Sustainable Use.144 The parallelism is maintained in the Nagoya Protocol. The symmetry between indigenous and local communities seemingly allows concluding that, for the purposes of the CBD, the two groups should be treated equally. A distinction between these two sets of communities in the framework of the Nagoya Protocol, therefore, may be regarded as unnecessary. Nevertheless, outside the scope of the CBD, there are some differences between the rights enjoyed by these two groups. While, as seen earlier, some rights (like FPIC) have been applied indiscriminately both to local communities and indigenous peoples,145 the latter feature specific characteristics that have motivated their protection under international law. The more institutionalised international presence of indigenous peoples, and their more pervasive protection under international law, theoretically place them in a better position to benefit from the rights and opportunities provided by the Nagoya Protocol. By comparison, the protection of the rights of local communities in connection with genetic resources faces greater challenges, which are at least in part related to uncertainties embedded in the indeterminateness of the concept of local communities. With an unprecedented move, the CBD COP has attempted to remedy this indeterminacy, by convening an ad hoc expert group meeting to identify the common characteristics of local communities, and gather advice on how local communities can more effectively participate in the Convention processes.146 The group adopted a report that includes a list of characteristics  Olivier De Schutter, “Large-Scale Land Acquisitions and Leases: A Set of Core Principles and Measures to Address the Human Rights Challenge,” (28 December 2009) UN Doc A/ HRC/13/33/Add.2, 14. 142  CBD Decision 6/24, “Access and benefit-sharing as related to genetic resources” (27 May 2002) UN Doc UNEP/CBD/COP/6/20. 143  CBD Decision 7/16, “Article 8(j) and related provisions” (13 April 2004) UN Doc UNEP/ CBD/COP/7/21, 261. 144  CBD Decision 7/12, “Sustainable Use (Article 10)” (13 April 2004) UN Doc UNEP/CBD/ COP/7/21. 145  Inter-American Court of Human Rights, Case of the Saramaka People v Suriname, Judgment of 28 November 2007, Series C No. 172, 79–86. 146  CBD Decision 10/43, “Multi-year programme of work on the implementation of Article 8(j) and related provisions of the Convention on Biological Diversity” (20 January 2011) UN Doc UNEP/CBD/COP/10/27, paragraph 21. 141

78   Annalisa Savaresi that may provide ‘useful advice in identifying local communities within the mandate of the convention.’147 The characteristics include self-identification; lifestyles linked to traditions associated with natural cycles; a relationship to territory which is important for the maintenance of social, cultural, and economic aspects of the community; culture, including traditional cultural expressions captured through local languages, highlighting common interest and values; sometimes marginalised from modern geopolitical systems and structures; shared common property over land and natural resources; traditional right holders to natural resources; and vulnerability to outsiders and little concept of intellectual property rights.148 These criteria identify local communities based upon their relationship to territory and behaviour. Some of these characteristics recall those of indigenous peoples and indeed distinguishing between these two groups may be difficult. The ad hoc expert group meeting of local-community representatives has placed great emphasis on self-identification and on the participation of the affected groups to the process of identification.149 However, as discussed also in connection with indigenous peoples, lack of a precise definition of local communities leaves discretion to national governments in choosing the criteria to identify the beneficiaries of the inherent rights. The elaboration of specific definitions may therefore be necessary to assess the scope of application of the relevant legal instruments, and to prevent States from claiming that such communities are absent tout court within their borders.150 Concerns regarding States’ discretion in the identification of such communities may be addressed through the adoption of specific institutional arrangements at the international level. For example, the United Nations Collaborative Programme on Reducing Emissions from Deforestation and Forest Degradation in Developing Countries (UN-REDD) is in the process of developing an international mechanism to address grievances from individuals and communities affected by the implementation of activities to facilitate the reduction of emissions from the forest sector in the framework of the United Nations Framework Convention on Climate Change (UNFCCC),

 CBD Ad Hoc Open-Ended Inter-Sessional Working Group on Article 8(j) and Related Provisions of the Convention on Biological Diversity, “Participatory mechanisms for indigenous and local communities in the work of the convention. Draft recommendation submitted by the Chair,” (3 November 2011) UN Doc UNEP/CBD/WG8J/7/L.3, 19. 148  “Report of the Expert Group Meeting of Local Community Representatives within the Context of Article 8(J) and related Provisions of the Convention on Biological Diversity” (4 September 2011) UN Doc UNEP/CBD/WG8J/7/8/Add.1, Annex, at I. 149  Ibid. 150  For an analysis, see International Law Association, “The Hague Conference Report, Rights of Indigenous Peoples,” 7. 147

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as well as reports of non-compliance with its guidance and policies.151 This mechanism is set to operate in addition to grievance mechanisms that State partners are required to establish at the national level.152 The creation of an international ombudsperson under the Nagoya Protocol to support developing countries and indigenous and local communities in the identification of breaches of rights may systematically address concerns regarding the protection of these communities at the inter-state level.153 The adoption of any such mechanism in the framework of the Nagoya Protocol, however, seems unlikely at present. For the time being, extant human rights monitoring mechanisms provide the only available means to scrutinise States’ compliance with human rights standards as they implement the Nagoya Protocol. In this respect, building some explicit ‘operational links’ could facilitate the monitoring of compliance with interconnected obligations.154

V.  Conclusions The CBD has strived to promote an inclusive approach to natural resource management and conservation.155 This character of the Convention has become more prominent over time, and the Nagoya Protocol may be regarded as the pinnacle of such evolution.156 Lack of political will remains the main hindrance to progress towards improved implementation of this inclusive approach to natural resource management and conservation. While international law has arguably eroded national sovereignty over natural resources from the outside,157 instruments such as the Nagoya Protocol have opened the  UN-REDD Programme, “Guidelines on Free, Prior and Informed Consent Draft for Comment,” (2011), 17, accessed 11 June 2012, http://www.unredd.net/index.php?option=com_ docman&task=cat_view&gid=1333&Itemid=53. 152  Ibid., 18. 153  See CBD COP, “Report of the Third Part of the Ninth Meeting of the Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing,” (17 October 2010) UN Doc UNEP/CBD/ COP/10/5/Add.5, Article 14bis. 154  See Elisa Morgera, “No Need to Reinvent the Wheel for a Human Rights-Based Approach to Tackling Climate Change: The Contribution of International Biodiversity Law,” in Climate Change and the Law, ed. Erkki Hollo, Kati Kulovesi, and M. Mehling (Springer, forthcoming 2012). 155  In this regard, see for example Elisa Morgera and Elsa Tsioumani, “The Evolution of Benefit-Sharing: Linking Biodiversity and Communities’ Livelihoods,” Review of European Community and International Environmental Law 19 (2010): 150. 156  Bavikatte and Robinson, “Towards a People’s History of the Law: Biocultural Jurisprudence and the Nagoya Protocol on Access and Benefit Sharing,” 51. 157  See e.g., Jutta Brunnée, “The Stockholm Declaration and the Structure and Processes of International Environmental Law,” in The Future of Ocean Regime Building: Essays in 151

80   Annalisa Savaresi way to a certain degree of erosion also from the inside, by recognizing the role of indigenous and local communities in relation to genetic resources. The extent to which States may be willing to allow such internal erosion, however, remains to be ascertained. In the meantime, the Nagoya Protocol must be implemented in a ‘mutually supportive manner’ with other international instruments.158 This chapter has argued that as Parties to human rights instruments must comply with their extant obligations, and most Parties to the CBD are also Parties to human rights agreements, these Parties will be expected to interpret their obligations under the Nagoya Protocol in light of their extant human rights commitments. Be this as it may, the Nagoya Protocol may not become an instrument to impose upon States obligations contained in treaties they have not ratified. Parties that have ratified human rights agreements will instead be expected to deploy human rights to interpret and fill in with content their obligations under the Nagoya Protocol. This chapter has shown that such obligations are particularly relevant to PIC and MAT. The inherent requirements do vary from one instrument to the other, although there is some of convergence in the interpretation of the inherent rights in the caselaw of human rights bodies. In this connection, Parties to the Nagoya Protocol may be expected to interpret PIC requirements in line with FPIC, whereas requirements associated with MAT may need to be read in light of applicable human rights standards. In addition, Parties may also be subjected to the scrutiny of human rights bodies in connection with measures adopted to implement the Nagoya Protocol. In the absence of an inter-State body specifically designated for the purpose (such as an ombudsman), however, ensuring ABS arrangements’ consistency with human rights is largely left to States’ initiative. The second part of the chapter addressed the identification of potential rightholders, focussing upon the notions of indigenous peoples and local communities. While the rights of these communities in the framework of the CBD appear to be entirely symmetric, the absence of a clear definition for these terms leaves much discretion to national law-makers. Future developments in international law and practice may lead to the adoption of more Tribute to Douglas M. Johnston, ed. A. Chircop and T. MecDorman (London, UK: Kluwer Law, 2008); Jutta Brunnée, “Common Areas, Common Heritage, Common Concern” in The Oxford Handbook of International Environmental Law, ed. Daniel Bodansky, Jutta Brunnée, and Ellen Hey (Oxford, UK: Oxford University Press, 2007); and Ulrich Beyerlin and Vanessa Holzer, “Conservation of Natural Resources,” in Max Planck Encyclopedia of Public International Law ed. Rüdiger Wolfrum (Heidelberg and Oxford: Heidelberg and Oxford University Press, 2010). 158  Nagoya Protocol, Article 4.3.

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structured criteria to identify these communities. In the meantime, implementation of the Nagoya Protocol needs to be consistent with human rights standards developed to identify such communities. CBD Parties should also abandon outdated terminologies in connection with indigenous peoples. The suggested interpretation of the obligations in the Nagoya Protocol would be in line with the ‘complementarity’ of human rights and facilitate the monitoring of compliance with interconnected international obligations. Time will tell whether Parties to the Nagoya Protocol will be willing to undertake such synergistic approach to the interpretation of their obligations.

Chapter 3.  An Analysis of the Relationship between the Nagoya Protocol and Instruments related to Genetic Resources for Food and Agriculture and Farmers’ Rights Claudio Chiarolla*, Sélim Louafi** and Marie Schloen*** The genetic diversity of crops, farm animals, forest trees, aquatic organisms, micro-organisms and invertebrates provides the biological foundation for the world’s food production. While these different genetic resources for food and agriculture (GRFA) have specific characteristics, they all play a major role for food security. Since the beginning of agriculture more than 10,000 years ago, the early use and exchange of GRFA has been more or less organised and aimed to increase food security by increasing and diversifying production. However, GRFA management became a global challenge requiring international coordination only quite recently, in the 1960s. These efforts deal with various objectives closely related to those of the Convention of Biological Diversity (CBD): the conservation of biodiversity, the sustainable use of its components, and the promotion of GRFA-based innovations and equity in the sharing of the benefits derived from their use. This chapter considers the extent to which the Nagoya Protocol applies to GRFA and the legal implications of different regulatory options for the food and agriculture sectors. Attention is paid in particular to the interaction between the Protocol and one specific legally binding international access and benefit-sharing (ABS) instrument, namely the International Treaty on Plant Genetic Resources for Food and Agriculture (International Treaty) of

  *  Research Fellow on International Governance of Biodiversity at Institut du développement durable et des relations internationales (Iddri) Paris.   **  Senior Research Fellow at the Centre International de Recherche Agronomique pour le Développement (Cirad), UMR AGAP, Montpellier, France. ***  Research Fellow at the Centre International de Recherche Agronomique pour le Développement (Cirad), UMR AGAP, Montpellier, France and Research Centre for European Environmental Law, University of Bremen, Germany.

84   Claudio Chiarolla, Sélim Louafi and Marie Schloen the Food and Agriculture Organisation of the United Nations (FAO). It also considers the relationship between farmers’ rights, which are recognised by the FAO Treaty, and the relevant provisions of the Nagoya Protocol; in particular, those concerning the protection of the rights of indigenous and local communities and their traditional knowledge. The chapter is divided into two parts. Part one provides background information on the distinctive characteristics of GRFA that should be duly taken into account in the development and implementation of ABS legislation and/ or regulatory requirements for GRFA (Part I, section 1), and on the international institutional framework on GRFA and ABS that predates the adoption of the Nagoya Protocol (Part I, section 2). Part two specifically analyses the legal interaction between the Nagoya Protocol and the above described regulatory framework, its related institutions and the on-going processes within those institutions. Particular attention is paid to the international ABS instrument already in force in the plant sector, namely the International Treaty (Part II, sections 2 to 4), and the on-going ABS-related international process concerning GRFA under the aegis of the FAO Commission on Genetic Resources for Food and Agriculture (Part II, section 5). Finally, this chapter concludes that the ABS-implementing instruments for GRFA need to accommodate their distinctive characteristics and, therefore, their approach may differ from the mainstream bilateral ABS approach envisaged under the Nagoya Protocol. To date, the ABS regulatory framework in the food and agriculture sector appears to be in harmony with the objectives of the CBD and its Nagoya Protocol. Besides, the regulatory options that are available under these instruments hold the potential for it to continue being developed and implemented in harmony with such objectives, while increasing equity in the way resources are exchanged and used, and the ensuing benefits shared not only between users and providers, but also between the GRFA sectors and society at large.

I.  Genetic Resources for Food and Agriculture and Access and Benefit-sharing 1.  The Specificities of Genetic Resources for Food and Agriculture1 Crop, animal and microbial genetic resources play an integral part in agricultural and food production systems. The diversity of these GRFA is to a 1

 The information contained in this section is based primarily on: Marie Schloen, Selim Louafi and Tom Dedeurwaerdere, Access and benefit-sharing for genetic resources for food and agriculture. Current use and exchange practices, commonalities, differences and user community

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large extent the result of human activity. GRFA have been widely exchanged across communities, countries and regions, often over long periods of time. As they are inherently linked to human livelihoods and food security, they have historically moved together with people throughout the world. Furthermore, it has been common practice in the food and agriculture sector to exchange genetic material among local communities, farmers and breeders, as part of the normal improvement and production process. Successful production systems and technologies, including the associated genetic diversity, have also frequently been transferred to other countries and regions. This has led to a situation in which a significant part of the genetic diversity used in food and agriculture today is of exotic origin. The fact that an important part of agricultural and food production relies on the use of species of exotic origin also means that countries are usually not self-sufficient with regard to GRFA. Most countries need to access genetic resources from elsewhere for their agricultural production and food security, and can consequently be regarded as interdependent. This makes it very difficult to draw a clear line between provider and recipient countries, as most countries may, at least potentially, be providers of some types of genetic diversity and recipients of others. The same observation is also true at the stakeholders’ level: no single set of actors in any subsector is entirely self-sufficient with regard to their need for GRFA. Even in cases where a substantial part of the exchange of genetic resources takes place within a particular group or category of stakeholders, interdependence between different stakeholder groups still exists. This interdependence is a consequence of the diversity of activities undertaken and objectives pursued by the range of actors using and managing genetic diversity at local, national, regional and international levels. Both interdependency and exotic origin of most genetic resources used and exchanged in the food and agriculture sectors are key features that classically characterise GRFA. In particular, they were key arguments for the establishment of the International Treaty on Plant Genetic Resources for Food and Agriculture. The degree to which these features apply to all GRFA varies between the subsectors of food and agriculture and from one species to another.2 While animal genetic resources and plant genetic resources have been extensively exchanged over the last 10,000 years, and livestock and crop production in most regions of the world today utilises genetic resources that originated or were developed elsewhere, the situation in the forestry needs. Report from a multi-stakeholder expert dialogue (Rome: CGRFA Background Study Paper no. 59, July 2011). 2  Schloen, Louafi and Dedeurwaerdere, Access and benefit-sharing for genetic resources for food and agriculture, 19.

86   Claudio Chiarolla, Sélim Louafi and Marie Schloen and aquaculture sectors, which are in much earlier stages of development, is mixed.3 On the one hand, some of the commercially most relevant species (e.g., farmed aquatic species and fast-growing forest plantation species) have been moved extensively throughout the world and are now cultivated far beyond their natural distribution ranges. On the other hand, there are several species that are just starting to be farmed in aquaculture, that are only used within their natural habitat in native forests, or that are only being produced on a rather local scale for limited markets. For such species, exchange of genetic resources has been limited and their production still relies mainly on native genetic diversity. However, to the extent that new species are taken into production and related commercial activities grow, it can in general be expected that they will come to be exchanged more widely, both on a regional and a global scale. A recent study on the differences and commonalities amongst the different sectors of GRFA has identified a series of additional distinctive features that had, have or might have significant impacts on the way ABS measures are designed and implemented at the international, national or practical level.4 In particular, three important features deserve attention. The first one is linked to the fact that many GRFA are human-modified forms of biodiversity and their existence is closely linked to human activity. Humans have shaped the evolutionary processes by which they were developed in two ways: whether through modification of living conditions in ecosystems and agricultural production environments; or through often long and complex processes of domestication and selective breeding, which considerably altered the genotypic and phenotypic characteristics of the originally wild species and populations. In this latter case, the process of genetic improvement is usually incremental: genetic material is being continuously improved over many successive generations and one innovative step is added on to another. A product is not the end point of a development process, but an intermediate step in an on-going chain of improvement. This leads us to the second important feature, which is the fact that most products derived from the use of GRFA can themselves be used as genetic resources. They mostly constitute genetic material containing functional units of heredity and are, at least theoretically, ready to be reproduced and used for further research and development based on their genetic set-up.  David Bartley et al., The use and exchange of aquatic genetic resources for food and agriculture (Rome: CGRFA Background Study Paper no. 45, September 2009); and Jarkko Koskela et al., The use and exchange of forest genetic resources for food and agriculture (Rome: CGRFA Background Study Paper no. 44, January 2010). 4  Schloen, Louafi and Dedeurwaerdere, Access and benefit-sharing for genetic resources for food and agriculture. 3

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This feature contributes to blur the line between providers and recipients of GRFA, since every recipient of genetic material can, at least potentially, also become a provider of genetic resources. This feature also blurs the line between genetic resources and biological resources since many agricultural products reach the market place in a form in which they may be used both as biological resources (i.e., for production) or as genetic resources (i.e., for reproduction and further development). In addition, the purpose for which they will ultimately be used will often be unclear and unpredictable at the time of the first accession. The third important feature relates to the risks associated with genetic erosion in the food and agriculture sectors and the response to it. Even if the intensity of loss of diversity and the underlying driving factors vary between sectors and species, the erosion of genetic diversity poses a threat to future research and development options in all the food and agriculture sectors. Since the maintenance and evolution of GRFA depend on continued human intervention, their sustainable utilisation in research, development and production is an important means to ensure their conservation. In other words, and unlike most ‘wild’ genetic resources, the erosion of GRFA does not primarily derive from their over-exploitation, but from their under-utilisation, which is a consequence of the specialisation and homogenisation of modern farming systems.5 The following section examines the international institutional framework concerning GRFA with the objective of assessing the extent to which existing instruments, agreements and institutions address the specific features of GRFA. 2.  Existing International Instruments, Agreements and Institutions Concerning GRFA The international institutional landscape concerning GRFA is the product of a long history that started in the 1960s. We present in this section the four main international instruments and/or organisations that are involved in GRFA conservation, use and exchange regulation, namely, the International Agricultural Research Centres of the Consultative Group on International Agricultural Research; the FAO Commission on Genetic Resources for Food and Agriculture; the Union for the Protection of New Varieties of Plants; and the International Treaty.

 Stewart Lockie and David Carpenter, eds., Agriculture, Biodiversity and Markets, Livelihoods and Agroecology in Comparative Perspective (London: Earthscan, 2009).

5

88   Claudio Chiarolla, Sélim Louafi and Marie Schloen a.  The Consultative Group on International Agricultural Research GRFA appeared for the first time on the international agenda in a conference organised by the FAO and the International Biological Program (IBP)6 in 1967. This conference was intended to recognise the importance of the erosion of plant genetic resources for food and agriculture (PGRFA) and the need to initiate some coordinated actions at the international level to respond to it. Following this conference, the FAO established in 1968 the Genetic Resources and Plant Ecology Unit, responsible for coordinating the collection, storage and referencing of plant genetic resources for food and agriculture (PGRFA). But it was the network of International Agricultural Research Centres (IARC) of the Consultative Group of International Agricultural Research (CGIAR),7 established in 1971, which actually took the lead in the international collection of plant genetic resources and the building up of an international system of genebanks for the most important crops. In September 1973, a subcommittee of the CGIAR on genetic resources took place and decided to establish the International Board for Plant Genetic Resources. Although under the aegis of the FAO, this new organisation had an auto-nomous status and focused its mission on the conservation of the main crops, motivated by the needs of the IARC in charge for prompting a green revolution.8 Through its establishment, the CGIAR thus hallowed the importance of plant genetic resources for food and agriculture (PGRFA) for food security  The International Board is an initiative established in 1964 by the International Council of Scientific Union (ICSU) to coordinate large-scale ecological and environmental studies (see The National Academies, accessed 1 June 2012, http://www7.nationalacademies.org/ archives/International_Biological_Program.html ). 7  The CGIAR is a global partnership that unites organisations originally engaged in research for agricultural development with the funders of this work. The funders include developing and industrialised country governments, foundations, and international and regional organisations. The group sponsors 15 agricultural and natural resource centres that cover a wide range of research activities in and for developing countries. The CGIAR, originally hosted at the World Bank, was responsible for coordinating donor support for programs or specific International Agricultural Research Centres. Since 2008, the CGIAR is engaged in an important reform process and in 2010, the Consultative Group has been replaced by a legal entity – the Consortium – to provide leadership and better coordination among the Centres (see CGIAR, accessed 1 June 2012, http://www.cgiar.org). 8  The term ‘green revolution’ refers to the renovation of agricultural practices thanks to use of high-yield varieties combined with new mechanised agricultural technologies. Plants were bred specifically to respond to fertilisers and produce an increased amount of grain per acre planted (for more details about the role of the IARC in the Green Revolution, see: Robert Evenson and David Gollin, eds., Crop Variety Improvement and Its Effect on Productivity: The Impact of International Agricultural Research (Wallingford: CAB International, 2003). 6

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objectives. It also addressed PGRFA conservation through the specific choice of maintaining ex situ collections of selected major crops and by favouring and facilitating their worldwide exchange and use to a wide range of stakeholders. However, by opting for this network model of genebanks mainly under the aegis of donor countries and focused on the agro-economic value of plant genetic resources, the CGIAR opened the way for political criticism – by NGOs at first, then by some developing countries. As host (in aggregate) of the world’s largest collection of crop germplasm, mainly collected between the 1960s and 1980s, the IARC were placed at the forefront of what will later become the ABS debate. Alerted by the case of Diamond vs. Chakrabarty in the United States in the late 1970’s that opened the way to the patenting of living organisms,9 some NGOs started to lobby developing countries’ delegates to the FAO about the risk of ‘commodification’ of plant genetic resources.10 During the FAO Council in November 1979, Mexico, supported by other developing countries, raised the issue of the legal status of germplasm collections collected by the International Board for Plant Genetic Resources and other IARC. This issue marked the start of a negotiation process for the establishment of a framework for PGRFA conservation, use and exchange. This process resulted, at the 22nd FAO Council in November 1983, in the proposal of an International Undertaking, which provided for the creation of an intergovernmental commission on plant genetic resources to monitor its implementation. b.  The Commission on Genetic Resources for Food and Agriculture The International Undertaking addressed the issue of countries’ interdependence by reaffirming the concept of common heritage of mankind for PGRFA as access without restrictions,11 which was considered by the agricultural community as the most efficient way to promote the use of genetic diversity12 and ensure its conservation. This concept also provided an answer

 For the first time the US Supreme Court recognises in 1980 the right to patent an oil-eating microbe in Diamond v Chakrabarty, (1980) 447 U.S. 303, 310, 206 USPQ 193, 197. 10  Cary Fowler, The Graham Centre Seed Directory (Wadesboro; United States of America: National Sharecroppers Fund, 1979); Pat Mooney, Seeds of the Earth: A Private or Public Resource? (San Francisco: Institute for Food and Development Policy, 1979). 11  The International Undertaking Article 1 states that it is based on the ‘universally accepted principle that plant genetic resources are a heritage of mankind and consequently should be available without restriction’ (FAO International Undertaking on Plant Genetic Resources for Food and Agriculture, 1983). 12  Marie-Angele Hermitte, Les ressources génétiques végétales et le droit dans les rapports Nord-Sud (Bruxelles: Bruylant, 2004).  9

90   Claudio Chiarolla, Sélim Louafi and Marie Schloen to the status of the CGIAR’s ex situ collections. The International Undertaking supported the creation of an internationally coordinated network of national, regional and international centres . . . under the auspices of the jurisdiction of FAO, that have assumed the responsibility to hold, for the benefit of the international community and on the principle of unrestricted exchange, base or active collections of plant genetic resources.13

But this situation rapidly evolved in the late 1980s with a twofold development.14 First, the double extension of intellectual property rights (IPR) (both on subject matter – living organisms – and geographic coverage) eventually established by the Marrakech agreements under the General Agreement on Tariffs and Trade in 1994. Second, the starting, in 1988, of the negotiation process of the CBD that formally acknowledged sovereign rights of individual States over their genetic resources. In response to these developments, the FAO Conference in 1991 recognised national sovereignty over plant genetic resources.15 Interestingly, as noted by Halewood, the paradigm shift from ‘PGRFA as heritage of mankind’ to ‘PGRFA as subject to national sovereignty and intellectual property rights’ did not deter efforts within the [Commission on Genetic Resources for Food and Agriculture] to collectively pool and manage genetic resources on an international scale.16

In its continuous effort to address the specific need of the agricultural sector in term of biodiversity, the CGRFA followed two major parallel tracks in the mid-1990s. The first one related to the CGRFA Members’ decision in 1994 to initiate a process of alignment of the International Undertaking on plant genetic resources with the CBD. In 1996, the Global Plan of Action for the Conservation and Sustainable Utilisation of Plant Genetic Resources for Food and Agriculture (i.e., the two first objectives of the CBD) was adopted;17 and in November 2001, after seven years of negotiations, a legally binding international treaty, the International Treaty, was adopted by the FAO Conference.18  International Undertaking Article 7a.  Nicolas Brahy and Selim Louafi, “La convention sur la diversité biologique à la croisée de quatre discours,” Les rapports de l’Iddri 4 (2004). 15  See FAO Resolution 3/91. 16  Michael Halewood, “Securing the global crop commons in support of agricultural innovation,” in Intellectual Property Rights: Legal and Economic Challenges for Development, ed. Mario Cimoli et al. (Oxford: Oxford University Press, forthcoming). 17  “Global Plan of Action for the Conservation and Sustainable Utilisation of Plant Genetic Resources for Food and Agriculture” (Leipzig, Germany, 23 June 1996). 18  International Treaty on Plant Genetic Resources for Food and Agriculture (Rome, 3 November 2001, in force 29 June 2004). As of January 2011, there are 127 contracting 13 14

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Its provisions fully reflect the compromise that was needed to address the specificities of PGRFA by preserving some elements of an open access regime through its multilateral mechanism of ABS. The second important evolution related to the decision of the CGRFA in 1995 to broaden its mandate to encompass all other components of genetic diversity for food and agriculture – animal, aquatic, forest tree, invertebrate and micro-organism genetic resources. It established, in 1997, two technical working groups, one on PGRFA and the other on Animal GRFA. In 2007, the first State of the World’s Animal Genetic Resources for Food and Agriculture was launched and a Global Plan of Action on Animal Genetic Resources was adopted.19 And in June 2007, through its Multi-Year Programme of Work,20 the CGRFA decided to expand its scope to ABS in relation to all components for food and agriculture, whereas in October 2009 it considered arrangements and policies for ABS for GRFA. This work is still on-going and further details are provided in the last section of this chapter. c.  The Union for the Protection of New Varieties of Plants and the World Trade Organisation Agreement on Trade-related Aspects of Intellectual Property Rights The emergence of breeders as a new profession, separated from farmers in the plant sector, goes back to the early twentieth century. Selection and breeding became specific activities initially assumed by the public sector and, increasingly, by the private sector which started to look for ways to recoup the amount invested in research and development. Biological and legal protection mechanisms were sought: the former consisted of sterile hybrid varieties that oblige farmers to buy seeds every year. However, the selfreplicating nature of plant material, which renders it easy to freely use a breeder’s innovation, made it difficult to protect plants in the same way as industrial products. Breeders felt, accordingly, the necessity to lobby their government to establish a specific instrument to provide intellectual protection for their innovations. This was done in 1961 with the creation of the Union for the Protection of New Varieties of Plants (UPOV). Its mission was ‘to provide and promote an effective system of plant variety protection, with the aim of encouraging the development of new varieties of plants, for the benefit of society.’21 The UPOV Convention created a new sui generis form of IPR (i.e., different from patent, copyright or trademark) called plant Parties. See Claudio Chiarolla, Intellectual Property, Agriculture and Global Food Security: The Privatisation of Crop Diversity (Cheltenham: Edward Elgar, 2011). 19  “Global Plan of Action on Animal Genetic Resources” (Interlaken, Switzerland, 7 September 2007). 20  “Multi-Year Programme of Work” (15 June 2007), CGRFA-11/07/Report. 21  See UPOV, accessed 1 June 2012, http://www.upov.int/about/en/.

92   Claudio Chiarolla, Sélim Louafi and Marie Schloen variety protection (PVP), which provides breeders with exclusive rights on the propagating material (such as seeds) of new plant varieties. Protected plant varieties must be ‘distinct’ or clearly distinguishable from previously known varieties and ‘uniform’ in the sense that they cannot lead to excessive differences between individuals; finally, their characteristics must be ‘stable’ over generations. Notably, remarkable differences exist between the requirement for repeatability under patent law and the lower thresholds required by the uniformity and stability requirements under sui generis PVP.22 Besides, unlike the patent system, a breeder’s exemption allows access to PVPprotected material for research, for further breeding, and for non-commercial use by farmers without any authorisation or payment of royalties.23 Finally, the farmers’ privilege allows farmers to retain seeds for their own use and for noncommercial exchange. The 1991 revision Act of the UPOV Convention, however, introduced some changes in both exemptions in a way that strengthened breeders’ rights and brought it more in line with patent protection. First, the scope of protection was extended beyond the propagating material of protected varieties to include also ‘essentially derived varieties.’24 The exploitation of an essentially derived variety requires the authorisation of the title-holder, who owns the variety from which the former is derived. The essential derivation criterion is met when the essential characteristics of the first plant are replicated in the second one.25 The concept of essential derivation was introduced in the UPOV Convention as a safeguard against use of the breeders’ exemption for ‘cosmetic modifications’ and plagiarism.26 Second, the 1991 revision of UPOV imposed restrictions on the ability of its Member States to introduce the farmers’ privilege in their national legislation. In particular, the amount of farmsaved seeds was limited and their sale or exchange was made more difficult. Therefore, UPOV is a specific or sui generis system for PVP that seeks to establish an adequate balance between rewarding innovation and not restricting access to genetic resources. Such balance is considered a major challenge for achieving food security in the food and agriculture sector. While UPOV is not explicitly mentioned in the WTO Agreement on Trade-related Aspects  Claudio Chiarolla, “Commodifying Agricultural Biodiversity and Development-related Issues,” The Journal of World Intellectual Property 9 (2006): 28–31. 23  Graham Dutfield, “Food, Biological Diversity and Intellectual Property: The Role of the International Union for the Protection of New Varieties of Plants (UPOV),” QUNO Intellectual Property Issues Paper 9 (2011): 1–20. 24  International Convention for the Protection of New Varieties of Plants (2 December 1961, as revised at Geneva on November 1972, on 23 October 1978 and 19 March 1991) Article 14.5. 25  Jayashree Watal, Intellectual Property Rights in the WTO and Developing Countries (The Hague: Kluwer Law International, 2001). 26  Chiarolla, “Commodifying Agricultural Biodiversity,” 28–31. 22

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of Intellectual Property Rights (TRIPS) that was concluded as part of the Uruguay Round in 1994 to set minimum requirements for intellectual property protection, WTO Members may extend patent protection to cover plant varieties and/or may choose to use an effective sui generis PVP system.27 At present, the UPOV Convention provides the only ready-made model for sui generis PVP that certainly meets the requirement of the TRIPS Agreement. However, various developing countries have enacted national PVP laws, which depart from the UPOV model (e.g., India).28 d.  The International Treaty and Farmers’ Rights The International Treaty provides an internationally agreed framework for the conservation and sustainable use of crop diversity and the fair and equitable sharing of benefits, in harmony with the CBD.29 Within biodiversity, the Treaty defines a subset of genetic resources of particular importance for agriculture and food security – i.e., PGRFA – and it limits the scope of application of its norms to them. In this respect, the Treaty could be considered as a lex specialis for this particular agriculture sector, whereas the CBD provides the general framework for the protection of biodiversity. The International Treaty was specifically created to suit the needs of agriculture and plant breeding, and address the specific nature of PGRFA.

 WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (Marrakech, 15 April 1994, in force 1 January 1995) Article 27.3.b. 28  India has adopted a sui generis system not fully compliant with UPOV standards. On the 2001 Protection of Plant Varieties and Farmers’ Rights Act of India (India, The Protection of Plant Varieties and Farmers’ Rights Act, No. 53, 2001), see: Philippe Cullet, Intellectual Property Protection and Sustainable Development (New Delhi: LexisNexis Butterworths, 2005), 270–84. Cullet explains that the inclusion of provisions concerning the protection of farmers’ rights and their extant varieties ‘goes beyond what a ‘normal’ plant breeders’ rights regime would do . . .’. Besides, Rangnekar argues that ‘this law is . . . significant for charting a relatively unique path in differing from the UPOV template that has dominated the regulatory landscape of plant variety protection. While retaining the UPOV template of distinctiveness, uniformity and stability requirements, the Indian law differs in requiring varieties to distinguish themselves in at least one essential characteristic [from any other known variety. Besides,] the exemption to use a protected variety as a source of initial variation . . . is set out as a researchers’ right rather than an exception to the rights conferred on breeders’ (Dwijen Rangnekar, “Assessing the Economic Implications of Different Models for Implementing the Requirement to Protect Plant Varieties: A Case Study of India,” in Impacts of the IPR Rules on Sustainable Development, European Commission project (2006), 50–51. 29  Gerald Moore and Witold Tymowski, Explanatory Guide to the International Treaty on Plant Genetic Resources for Food and Agriculture (Switzerland: IUCN Environmental Policy and Law Paper No. 57, 2005). 27

94   Claudio Chiarolla, Sélim Louafi and Marie Schloen In particular, the preamble of the Treaty insists on countries’ interdependence30 for PGRFA to justify that in the exercise of their sovereign rights over their plant genetic resources for food and agriculture, States may mutually benefit from the creation of an effective multilateral system for facilitated access to a negotiated selection of these resources and for the fair and equitable sharing of the benefits arising from their use.31

The Treaty establishes a Multilateral System of ABS (MLS) that consists in pooling selected crop genetic resources coming from various countries.32 These pooled resources are available under the facilitated access mechanism of the MLS only if access is requested for the purpose of utilisation and conservation for research, breeding and training for food and agriculture. This means that national ABS laws that are consonant with the CBD may apply if recipients intend to make use of PGRFA for other purposes, ‘such as chemical, pharmaceutical and/or other non-food/feed uses’.33 The material pooled in the MLS is governed by a set of common rules of ABS that States agreed upon and were formalised in a standard contract, the Standard Material Transfer Agreement (SMTA). While the CBD promotes the development of a regime of contractual rules for the exchange of genetic resources that is based on bilateral contracts, access to PGRFA included into the FAO MLS is done on the basis of the SMTA and hence does not require ad hoc negotiations between providers and recipients of PGRFA. This reduces transaction costs as ‘access shall be accorded expeditiously, without the need to track individual accessions and free of charge, or, when a fee is charged, it shall not exceed the minimal cost involved’.34 The International Treaty does not require a burdensome mechanism to track individual accessions, as providers of PGRFA do not have the obligation to keep track of all subsequent transfers of the material. However, reporting

 ‘The Contracting Parties, Cognizant that plant genetic resources for food and agriculture are a common concern of all countries, in that all countries depend very largely on plant genetic resources for food and agriculture that originated elsewhere’ (FAO Treaty Preamble). 31  International Treaty Preamble. 32  International Treaty Annex I lists the 64 important crops and forages to ensure worldwide food security that are part of the MLS. Besides, Article 10.2 of the International Treaty states that ‘in the exercise of their sovereign rights, the Contracting Parties agree to establish a multilateral system, which is efficient, effective, and transparent, both to facilitate access to plant genetic resources for food and agriculture, and to share, in a fair and equitable way, the benefits arising from the utilisation of these resources, on a complementary and mutually reinforcing basis.’ 33  International Treaty Article 12.3.a. 34  In accordance with the International Treaty Article 12.3.b. 30

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obligations for both providers and recipient are included in the SMTA in order to ensure that some benefits flow back to the MLS when a product based on MLS materials is commercialised on the market; and to enable the functioning of dispute settlement procedures.35 With regard to the latter, the SMTA contains procedures for the settlement of any dispute that may arise between a provider and a recipient. However, the obligation to share benefits is not in favour of the provider, but of the MLS. A provider, therefore, has no financial interest in initiating dispute resolution, should a recipient not fulfil his obligations, and to do so could also mean incurring potentially substantial costs. Instead, the SMTA provides for a ‘Third Party Beneficiary’ to be able to initiate dispute settlement, should this become necessary, in order to enforce the beneficial interest of the MLS.36 Through reporting obligations, and in conjunction with the obligation to use the SMTA for any subsequent transfer, the SMTA enables following of the chain of transfers between individual providers and recipients of PGRFA at reduced costs for providers and recipient (i.e., without the need for them to track individual accessions or monitor their utilisation). While the International Treaty encourages facilitating access to all PGRFA,37 only PGRFA that are under ‘the management and control of the Contracting Parties and in the public domain’ will be automatically included into the MLS.38 But the Treaty accounts for the diversity of actors that hold material under different types of ownership by encouraging them to also include the material they hold in the MLS. More precisely, it requests Parties to encourage all other holders of PGRFA listed in Annex 1 to include these into the MLS ‘with a view to achieving the fullest possible coverage of the Multilateral

 In accordance with SMTA Article 8.  FAO, “Review of the implementation and operation of the standard material agreement” (1–5 June 2009) UN Doc IT/GB-3/09/14, paragraph 12. 37  International Treaty Articles 11.2 second sentence and Article 11.3. 38  International Treaty Article 11.2. In other words, not all the PGRFA listed in Annex I are automatically included in the MLS. A Report of the World Intellectual Property Organisation (WIPO) stresses the difference between ‘material which is covered in the MLS’, namely Annex I listed material, and ‘material which in included in the Multilateral System at a given time’ (see WIPO, “Preliminary Report on Work towards the Assessment of Patent Data Relevant to Availability and Use of Material from the International Network of Ex-Situ Collections under the Auspices of FAO and the International Treaty on Plant Genetic for Food and Agriculture,” (15–19 November 2004) UN Doc CGRFA/MIC-2/04/ Inf.5, 3–4), ftp://ftp.fao.org/docrep/fao/meeting/014/j3683e.pdf, accessed 10 June 2012. For example, materials in private collections, if not voluntarily included, are outside of the purview of the MLS. 35 36

96   Claudio Chiarolla, Sélim Louafi and Marie Schloen System’.39 Then, parties undertake to take appropriate measures to encourage such persons to do so.40 The benefit-sharing mechanism of the International Treaty differs from the bilateral, contract-based approach of the CBD, inter alia, because the benefits are shared on a multilateral basis in the MLS.41 Importantly, the Treaty also establishes that facilitated access to the PGRFA that are included in the MLS constitutes itself a major benefit of the MLS.42 The Treaty also envisages four different tools through which benefits can be shared, namely: the exchange of information; access to and transfer of technology; capacity building; and the sharing of monetary and other benefits from commercialisation. Although much attention is paid to the monetary aspects, it is important to acknowledge that non-monetary benefits are taking on full meaning in the context of MLS implementation. As Schloen et al. put it: product development and release involving the use of GRFA frequently leads to external effects that go far beyond the individual provider and recipient of the respective genetic material. These external effects may, for example, contribute to the creation of important public goods such as rural development and poverty alleviation, environmental protection, food security and cultural diversity. In some cases the external effects of product development and release are much more important than the profit that can be made.43

Since most crops and associated genetic materials are used across a wide range of countries, there are mutual benefits in increasing the exchange of information about PGRFA, expanding capacity and improving access to the technologies to use them. Besides, the Benefit-sharing Fund of the Treaty provides funding for the operationalisation of the above tools to implement activities, ‘plans and programmes for farmers in developing countries, especially in least developed

 International Treaty Article 11.2.  International Treaty Article 11.3. To date, three natural or legal persons have referred to Article 11.3 to voluntarily include PGRFA material they hold under the MLS: two French public-private organisations (see: http://www.planttreaty.org/sites/default/files/gb4w13e .pdf, 8, footnote 5, accessed 10 June 2012) and INRA, accessed 7 June 2012, http://www .planttreaty.org/sites/default/files/inclu_afsa_inra.pdf ) and, an Association of Communities in the Potato Park of Cusco, Peru (see ANDES, accessed 1 June 2012, http://www.planttreaty.org/sites/default/files/IT%20Application%20letter.Potato%20Park.pdf ). 41  However, a multilateral approach to benefit-sharing is also envisaged under Nagoya Protocol Article 10. [See contributions by Salpin and by Young to this volume (Chapters 5 and 15)]. See also M.W. Tvedt, “A Report from the First Reflection Meeting on the Global Multilateral Benefit-Sharing Mechanism,” FNI Report 10 (2011): 1. 42  International Treaty Article 13.1. 43  Schloen, Louafi and Dedeurwaerdere, Access and benefit-sharing for genetic resources for food and agriculture, 17. 39 40

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countries and in countries with economies in transitions, who conserve and sustainably utilise PGRFA’.44 In June 2006, with the adoption of the SMTA, the Treaty’s Governing Body established the level, form and manner of mandatory payments to be made by users of PGRFA to the Benefit-sharing Fund of the Treaty. Under the SMTA, recipients are free to transfer received materials to third parties without the need to seek the providers’ prior informed consent (PIC). However, they must ensure that subsequent recipients are bound by the same benefit-sharing conditions. Thus, a chain of SMTAs ensures that benefitsharing obligations are passed onto any ‘other person or entity’ that receives materials (e.g., seeds) derived from the MLS. If certain legal requirements are met, compulsory benefit-sharing of 1.1 per cent of income from the sale of seeds must be paid by recipients to the MLS.45 The first requirement is that the commercialised ‘product’ must incorporate ‘the material’ received from the MLS.46 The second requirement is that payments are due only if the ‘product’ (i.e., seeds) is not freely available for further research and breeding. In essence, this requirement entails the existence of a patented product (legal restrictions) or restrictions deriving from particular technologies, such as Genetic Use Restriction Technologies (GURT), or certain restrictive licensing practices.47 Thus, under the International Treaty the existence of IPR, which restrict access to a product based on genetic resources/PGRFA,  International Treaty Article 18.5. Emphasis added.  Standard Material Transfer Agreement (Rome, 16 June 2006), accessed 1 June 2012, ftp:// ftp.fao.org/ag/agp/planttreaty/agreements/smta/SMTAe.pdf ), Article 6.7 and Claudio Chiarolla, “Plant Patenting, Benefit-Sharing and the Law Applicable to the FAO Standard Material Transfer Agreement,” The Journal of World Intellectual Property 11 (2008): 1–28. 46  The definition of ‘product’ which is given in Article 2 of the SMTA excludes products other than PGRFA and other products used for food, feed and processing. Hence, the commercialisation of bulk goods that are ‘sold or traded as commodities’ shall not be considered. 47  SMTA Article 6.7 not only seems to legitimise, inter alia, the patenting of seeds that incorporate materials accessed from the MLS, but also creates a strong link between monetary benefit sharing and the patenting of biotechnological products and processes. Besides, SMTA Article 5.d provides that intellectual and other property rights must be respected. However, interpretative problems may arise because the SMTA prohibits recipients to claim ‘any intellectual or other property rights that limit the facilitated access to the Material . . . or its genetic parts or components, in the form received from the Multilateral System’. Thus, it is questionable whether patent claims to the ‘material’, its ‘progeny’ and ‘unmodified derivatives’ should be allowed. This is because such claims can restrict access to germplasm, genome sequences and their functional characterisations, which ‘may be deemed to be international public goods.’ Robin Fears, Genomics and Genetic Resources for Food and Agriculture (Rome: CGRFA Background Study Paper no. 34, June 2007). On this particular issue see also Claudio Chiarolla and Stefan Jungcurt, “Outstanding Issues on Access and Benefit Sharing under the Multilateral System of the International Treaty on Plant Genetic Resources for Food and Agriculture” (Zurich: The Berne Declaration and 44 45

98   Claudio Chiarolla, Sélim Louafi and Marie Schloen is a precondition for the sharing of monetary benefits arising from the commercialisation of such a product.48 In the PGRFA sector, the development of a new plant variety may take more than ten years. During this period recipients are not normally required to make payments to the MLS. Therefore, the SMTA also envisages an alternative payment scheme, which may provide an immediate flow of financial resources to the Benefit-sharing Fund of the Treaty. This is because it derogates from both requirements of the SMTA.49 In sum, the alternative payment scheme provides that recipients may voluntarily choose to make crop-based payments at the discounted rate of 0.5 per cent of the overall sales of seeds pertaining to the same crop species obtained from the MLS by the recipient.50 The other emblematic element of the International Treaty is its provision on farmers’ rights.51 In the 1980s, the implementation of plant patents and breeders’ rights in industrialised countries was perceived as a matter of importance for the private seed industry and the infant biotechnology sector. The pressure to adopt higher international intellectual property standards was also mounting on developing countries, including through UPOV and the inclusion of intellectual property rights in the Uruguay Round negotiations of the General Agreement on Tariffs and Trade; the latter concluded with the establishment of the World Trade Organisation (WTO) and the adoption of a new WTO Agreement on TRIPS.52 In the FAO Conference of 1989, the concept of farmers’ rights was conceived by developing countries as a counterbalance to plant breeders’ rights under the 1978 Act of the UPOV Convention. FAO Resolution 5/89 endorsed the concept of farmers’ rights defined as rights

the Development Fund Background Study Paper, March 2011), accessed 12 February 2012, http://www.evb.ch/en/p25019093.html. 48  However, while a strong link between patenting and (potential) benefit-sharing appears to exist for many biotechnology sectors (e.g., pharmaceutical), it is also true that in other areas potentially covered by the Nagoya Protocol, such as cosmetics, the food and beverage industry and in other GRFA sectors, the industry can be less dependent from patent protection as a mean to secure its investment in innovation. In such cases, relevant information is often kept secret from competitors rather than disclosed in the patent. Nevertheless, monetary benefits may be shared on the basis of the MAT. 49  SMTA Article 6.7. 50  SMTA, Article 6.11. 51  International Treaty Article 9. 52  [See contribution by Pavoni to this volume (Chapter 6).]

Relationship with Instruments on Food and Agriculture   99 arising from the past, present and future contributions of farmers in conserving, improving, and making available plant genetic resources, particularly those in the centres of origin/diversity.53

While there is no agreed definition for farmers’ rights in international law, the FAO Treaty recognises: . . . the enormous contribution that the local and indigenous communities and farmers of all regions of the world, particularly those in the centres of origin and crop diversity, have made and will continue to make for the conservation and development of plant genetic resources which constitute the basis of food and agriculture production throughout the world.54

The provision further states that ‘the responsibility for realising Farmers’ Rights, as they relate to PGRFA, rests with national governments’ and specifies three possible elements of these rights, namely: the protection of traditional knowledge relevant to PGRFA; the right to equitably participate in sharing benefits arising from the utilisation of PGRFA; and the right to participate in making decisions on matters related to the conservation and sustainable use of PGRFA. Finally, it states that ‘nothing in this Article shall be interpreted to limit any rights that farmers have to save, use, exchange and sell farm-saved seed/propagating material.’ This is now consistent with the Nagoya Protocol, which provides that Parties shall, as far as possible, not restrict the customary use and exchange of genetic resources and associated traditional knowledge within and amongst indigenous and local communities.55 All the above elements constitute a bundle of rights, which states may confer upon the farmers to preserve and promote their traditional practices, knowledge and innovations that help conserving and developing crop diversity. Importantly, this bundle of rights relates to all PGRFA activities and is

 FAO Resolution 5/89, adopted on 29 November 1989, http://www.fao.org/docrep/x5588E/ x5588e06.htm#e.%20commission%20on%20plant%20genetic%20resources%20and%20 the%20international%20undertaking:%20prog (third paragraph), accessed 7 June 2012. Two years later, in FAO Resolution 3/91 (adopted at the 26th session of the FAO Conference, (Rome, 9–27 November 1991), http://www.fao.org/docrep/x5587E/x5587e06.htm#e.%20 commission%20on%20plant%20genetic%20resources%20and%20international%20undertaking:%20progress, accessed 7 June 2012) countries expressed their moral and political commitment to implement farmers’ rights through the establishment of the International Fund for Plant Genetic Resources. However, this Fund did not receive much support as voluntary contributions fell short of expectations and it was never implemented. Regine Andersen, “The Farmers’ Rights Project – Background Study 1: The History of Farmers’ Rights – A Guide to Central Documents and Literature,” FNI Reports 8 (2005). 54  International Treaty Article 9. 55  Nagoya Protocol Article 12.4. 53

100   Claudio Chiarolla, Sélim Louafi and Marie Schloen relevant beyond the mere scope of the MLS. It can further be argued that farmers’ rights – or at least the component of farmers’ rights that concerns the protection of traditional agricultural knowledge – may directly affect resources in other GFRA sectors. This is because in most traditional agricultural systems traditional knowledge has a holistic nature and it is intimately linked with them through a complex of traditional practices and cultural and spiritual values. As explained below,56 the implementation of the Nagoya Protocol, and in particular its provisions that concern the protection of traditional knowledge and the rights of indigenous and local communities, hold potential for creating synergies with the Treaty in protecting farmers’ rights,57 as well as tensions between the stewardship approach (that is prevalent in the Treaty) and the ownership approach (that is prevalent in the Nagoya Protocol).

II.  The Treatment of GRFA under the Nagoya Protocol and Its Relationship with Existing International Instruments, Agreements and On-going Work and Practices in the GRFA Sectors 1.  Special Considerations: Food Security and GRFA The Preamble of the Nagoya Protocol recognises, inter alia: the special nature of agricultural biodiversity and its distinctive features and problems; the importance of genetic resources to food security and the interdependence of all countries; and acknowledges ‘the fundamental role’ of the `international Treaty and the CGRFA in this regard.58 The Preamble specifically recognises ‘the importance of genetic resources to food security [. . .]’,59 which parallels the operative provisions of the Protocol on special considerations.60 In particular, on the basis of Article 8.c,61 it is clear, on the one hand, that the Parties to the Protocol are free to afford a special treatment to GRFA on the basis of the above considerations. On the other hand, the Protocol does not spell out in any detail the kind of measures  See Part II, section 4 below.  [On the human rights dimensions of the Nagoya Protocol, see contribution by Savaresi to this volume Chapter 2).] 58  Nagoya Protocol preambular paragraph 16. 59  Nagoya Protocol preambular paragraph 14. 60  Nagoya Protocol Article 8. See, also, Thomas Greiber and Sonia Peña Moreno (eds.). IUCN Explanatory Guide to the Nagoya Protocol on Access and Benefit-sharing (Bonn: IUCN, 2012). 61  Nagoya Protocol Article 8.c states that: ‘In the development and implementation of its [ABS] legislation or regulatory requirements, each Party shall [. . .] consider the importance of genetic resources for food and agriculture and their special role for food security.’ 56 57

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that would be most appropriate for the food and agriculture sectors. Besides, while the Protocol does exclude explicitly from its scope the specific genetic resources that are ‘covered by and for the purpose of ’ a specialised international ABS instrument,62 the face value of this provision is that the Parties are equally free not to exclude GRFA from the purview of their ordinary ABS requirements in all other cases. For instance, all GRFA that are currently outside the scope of application of a specialised international ABS instrument are covered by the Protocol and its implementing legislation. However, Article 8.c together with the preambular paragraphs on GRFA would not support treating GRFA and non-GRFA in the same way. Therefore, the real issue is not one of inclusion versus exclusion from the scope of the Protocol, but rather how to give special consideration to GRFA in domestic ABS legislation or regulatory measures. In essence, the balance to be struck in developing and implementing domestic ABS measures under Article 8.c is between fostering and preserving patterns of use, exchange and benefit-sharing adapted for the food and agriculture sectors, on the one hand, and preventing such specialised ABS measures being abused to circumvent users’ benefit-sharing obligations, on the other hand. 2.  Relationship with the International Treaty as a Specialised International ABS Instrument Concerning Food and Agriculture During the final stage of its negotiations, the draft protocol on ABS provided two alternative options to exclude from its scope:63 (1) genetic resources contained in Annex I of the International Treaty provided they are used for the purposes of the Treaty; or (2) genetic resources under the MLS of the International Treaty, both current and as may be amended by the Treaty’s Governing Body.64 However, in Nagoya a common understanding emerged  Nagoya Protocol Article 4.4, which is discussed in the following section.  See CBD Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing, “Meeting of the Interregional Negotiating Group,” (21 September 2010) UN Doc UNEP/CBD/WGABS/9/ING/1 Article 3.c. The Interregional Negotiating Group (ING) was established by the Ad Hoc Open-ended Working Group on ABS at its resumed ninth meeting (Montreal, 10–16 July 2010). The text developed by the ING was considered by the ABS Working Group, when it resumed its ninth meeting in Nagoya on 16 October 2010. Then, the tenth meeting of the Conference of the Parties (COP) to the CBD finalised negotiations and adopted the Nagoya Protocol. 64  Emphasis added. The exclusion under the first option is narrower than the second one, since the latter makes no reference to purpose-of-use-related requirements for the inclusion of PGRFA into the MLS. Relevant purpose-of-use-related requirements are set forth in SMTA Article 6.2 under the ITPGR, which provides that ‘the Material shall be used or conserved only for the purposes of research, breeding and training for food and agriculture. 62 63

102   Claudio Chiarolla, Sélim Louafi and Marie Schloen that the finalisation of the Protocol would entail the deletion of both options concerning the express exclusion of PGRFA from the Protocol’s scope. When the Nagoya Protocol was adopted, the solution to delete all the express exclusions from its scope prevailed. On the other hand, a fundamental provision on the ‘relationship with other instruments’65 addresses the issue of genetic resources covered by more specialised ABS instruments. Article 4.4 of the Protocol currently states that . . . where a specialised international [ABS] instrument applies that is consistent with, and does not run counter to the objectives of the Convention and this Protocol, this Protocol does not apply for the Party or Parties to the specialised instrument in respect of the specific genetic resource covered by and for the purpose of the specialised instrument.

Prima facie this provision requires a Party to a specialised ABS instrument not to apply the Nagoya Protocol in respect of genetic resources that are within the purview of such a specialised instrument. Besides, a safeguard clause also allows the Parties to the Protocol not to apply the above exclusion if the specialised international instrument (to which they are also a Party) is deemed to be inconsistent with, and to run counter to, the objectives of the Convention and the Protocol. While the safeguard clause may be said to have very limited practical implications, because no Party would ratify a specialised ABS instrument that is believed to run counter to the Protocol, certainly it does not apply to the ITPGRA. This is because the Preamble of the Nagoya Protocol expressly recalls that ‘the Multilateral System of [ABS] established under the International Treaty on Plant Genetic Resources for Food and Agriculture [was] developed in harmony with the Convention.’66 In turn, the International Treaty also states that the objectives of this Treaty are the conservation and sustainable use of [PGRFA] and the fair and equitable sharing of the benefits arising out of their use, in harmony with the Convention on Biological Diversity, for sustainable agriculture Such purposes shall not include chemical, pharmaceutical and/or other non-food/feed industrial uses.’ Besides, the second option envisages the potential expansion of the MLS’ coverage to other crops and forages not currently listed in Annex I. 65  Nagoya Protocol Article 4. Compare with CBD Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing, “Meeting of the Interregional Negotiating Group,” (21 September 2010) UN Doc UNEP/CBD/WG-ABS/9/ING/1 Article 3bis.4 which stated that: ‘This Protocol is the instrument for the implementation of the [ABS] provisions of the Convention. Where a specialised international [ABS] instrument applies that is consistent with, and does not run counter to the objectives of the Convention and this Protocol, this Protocol does not apply for the Party or Parties to the specialised instrument in respect of the specific genetic resource covered by and for the purpose of the specialised instrument.’ 66  Nagoya Protocol preambular paragraph 19.

Relationship with Instruments on Food and Agriculture   103 and food security. These objectives will be attained by closely linking this Treaty to . . . the Convention on Biological Diversity.67

Therefore, in light of the above provisions of the Treaty and the Preamble of the Protocol, Protocol Article 4.4 establishes a legal presumption of compatibility between the FAO Treaty, the CBD and the Nagoya Protocol, which may not be countered. Finally, the Nagoya Protocol sets out a specific obligation to implement the Protocol ‘in a mutually supportive manner with other international instruments relevant to this Protocol.’68 This must be read jointly with another provision stating that the Protocol is not intended to create a hierarchy between the Protocol and other international instruments.69 From the viewpoint of the International Treaty, the purpose of the above provisions is to avoid the subordination that would otherwise derive from the application of the 1969 Vienna Convention on the Law of Treaties (VCLT).70 In particular, the latter normally requires the Parties to an earlier treaty (e.g., the International Treaty), which are also Parties to a later treaty (e.g., the Nagoya Protocol ) relating to the same subject matter (e.g., genetic resources), to apply the earlier treaty only to the extent that its provisions are compatible with those of the later treaty. However, when a treaty (e.g., the Nagoya Protocol ) specifies that is not to be considered as incompatible with an earlier or later treaty, the provisions of that other treaty can prevail (e.g., the International Treaty).71 Therefore, the provisions of the International Treaty will prevail over those of the Nagoya Protocol in respect of plant genetic resources for food and agriculture that are covered by the MLS (i.e., those listed in Annex 1) and that are accessed for the purpose of research, breeding and training for food and agriculture. From a practical standpoint, it has also been suggested that the Parties that endeavour to implement the FAO International Treaty and the Nagoya Protocol in a mutually supportive manner may envisage using the SMTA as an internationally recognised certificate of compliance to be presented by resource users at all relevant checkpoints.72

In other words, in relation to plant genetic resources that are made available under the terms of the SMTA, the latter may be considered as the ‘permit or its equivalent’ that the Parties to the Nagoya Protocol are to provide ‘at the  International Treaty Article 1, emphasis added.  Nagoya Protocol Article 4.3 first sentence. 69  Nagoya Protocol Article 4. 70  VCLT Article 30.3. 71  VCLT Article 30.2. 72  Chiarolla, The Privatisation of Crop Diversity, 200. 67 68

104   Claudio Chiarolla, Sélim Louafi and Marie Schloen time of access . . . as evidence of the decision to grant prior informed consent and of the establishment of mutually agreed terms.’73 In addition to making available the internationally recognised certificate of compliance – namely, the SMTA – to the ABS clearing-house,74 a possible way to enhance transparency and the mutual supportiveness between the Nagoya Protocol and the [International] Treaty would be to amend the SMTA in order to request recipients to disclose, at plant variety protection and patent offices, that the materials for which protection is sought have been obtained from the Multilateral System, and to inform the Governing Body [of the International Treaty] accordingly. The disclosure of legal access from the Multilateral System and the related notifications should [also] include a quote of the accessions’ unique identifier numbers.75

The above proposal appears to be in consonance with the obligation to disclose information under the Protocol76 and the minimum information requirements.77 Besides, in the context of the options for disclosure that are discussed at the WIPO Intergovernmental Committee on Intellectual Property, Genetic Resources, Traditional Knowledge and Folklore, some countries have supported including a provision, which states that if access to genetic resources has been provided in pursuance of Article 12.2 and Article 12.3 of the [International] Treaty, a copy of the [SMTA] shall be enclosed with the patent application [. . .].78

Therefore, the idea that underpins this proposal is that recipients of PGRFA from the MLS of the International Treaty, would be required to demonstrate that they have complied with the applicable ABS requirements of the Treaty by showing that they have acquired the material under the SMTA. The most important implication would be that the Treaty’s Governing Body could possibly collect or receive this information from a checkpoint (e.g., the patent office) as a means to verify that the information that is provided by users, in accordance with their reporting obligations under the SMTA, is complete and correct as required by the law.

 See, in particular, Nagoya Protocol Articles 6.3.e, 17.1.a.iii, 17.2, 17.3 and 17.4.  Nagoya Protocol Article 14. 75  Nagoya Protocol Article 14. 76  Nagoya Protocol Article 17.1.a.iii. 77  Nagoya Protocol Article 17.4. 78  WIPO-IGC, Consolidated Document Relating to Intellectual Property and Genetic Resources (22 February 2012), Sub-option 6, paragraph 3.24. 73 74

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3.  The International Treaty and the Exclusion of Certain Plant Genetic Resources for Food and Agriculture Although the FAO Treaty and its MLS are not explicitly referred to in Article 4.4 of the Protocol, there is no doubt that the former is the only existing specialised international ABS instrument that has the same legal status of, and is consistent with, the CBD and its Nagoya Protocol. As the above section explains, the legal presumption of their mutual supportiveness is confirmed by the express recognition of their consistency that is contained, inter alia, in the Preamble of the Protocol. However, from the point of view of the subject-matter exclusions for PGRFA under Article 4.4 of the Protocol, since the scope of the MLS is narrower than the scope of the International Treaty,79 three different practical cases may be envisaged: i) PGRFA listed in Annex I of the International Treaty that are included into the Multilateral System; ii) non-Annex I PGRFA that are made available under the same conditions of the Standard Material Transfer Agreement; and iii) transfer of PGRFA to non-Parties to the specialised international ABS instrument (i.e., the International Treaty). A fourth hypothetical case may be envisaged in relation to the possibility that some parties may consider making available GRFA (other than PGRFA) under the same conditions of the SMTA. However, such a hypothetical case is not considered in this chapter as a feasible regulatory option, because the SMTA is the specific instrument for the implementation of the MLS and it is intimately connected to the institutional framework of the FAO Treaty, including its Third Party Beneficiary (i.e., the FAO). The fundamental difference between this hypothetical case and the case presented under ii) is the following. On the one hand, crops and forages (i.e., PGRFA) not listed in Annex I can be exchanged under the same conditions that apply to the species included into the MLS without requiring substantive amendments to the SMTA. On the other hand, the SMTA would need to be completely delinked from the International Treaty if it had to be used for the transfer of GRFA which are outside the plant kingdom, because the Treaty only applies to PGRFA. Therefore, the SMTA of the Treaty, in its current form, may not be used for the exchange of animal, aquatic and microbial GRFA, and biological control agents.  The latter applies to all PGRFA, while the former covers only PGRFA listed in Annex I that are under the managements and control of the contracting Parties and in the public domain. See International Treaty Article 11.2.

79

106   Claudio Chiarolla, Sélim Louafi and Marie Schloen The following subsections will provide a legal analysis of how the Protocol relates to PGRFA in the three cases enumerated above. a.  PGRFA Listed in Annex I of the International Treaty That Are Included in the Multilateral System As anticipated,80 all PGRFA listed in Annex I of the Treaty that are included into the MLS are by default excluded from the scope of application of the Nagoya Protocol.81 Thus, there is no doubt that such PGRFA shall be made available under the jurisdiction of the Parties by using the SMTA, which will bound providers and recipients of PGRFA to the terms and conditions that are established by the Treaty. Therefore, all the exchanges of PGRFA that occur within the MLS are solely regulated by the provisions of the Treaty, which must be understood as a ‘specialised international ABS instrument’ under the Protocol.82 b.  Non-Annex I PGRFA That Are Made Available under the Same Conditions of the SMTA As regards Non-Annex I PGRFA, a distinction may be drawn between: (a) materials covered by the Agreements between the IARC of the CGIAR and the Treaty’s Governing Body and (b) materials voluntarily made available by the parties under the same conditions of the SMTA. As regards the first category, it is worth emphasising that the MLS also includes the ex-situ collections of the IARC of the CGIAR, which are supporting components of the Treaty.83 In particular, thirteen CGIAR Centres, the Tropical Agricultural Research and Higher Educational Centre and the joint division of the FAO and the International Atomic Energy Agency have signed agreements with the Treaty’s Governing Body, whereby they have placed their collections within the MLS.84 In concluding these Agreements, the Centres have also recognised the authority of the Treaty Governing Body

 See Part II, section 2.  In accordance with Nagoya Protocol Article 4.4. 82  Nagoya Protocol Article 4.4. 83  This subsection is based on Chiarolla, The Privatisation of Crop Diversity, 127–128. The other supporting components of the International Treaty are described in Part V of the Treaty. They are: the Global Plan of Action for the Conservation and Sustainable Use of PGRFA (Article 14); International Plant Genetic Resource Networks (Article 16); and the Global Information System (Article 17). 84  The Agreements between FAO, acting on behalf of the Treaty’s Governing Body, and the Centres of the CGIAR, are available at FAO Legal Office, accessed 1 June 2012, http://www .fao.org/legal/treaties/list_pgr-e.htm. 80 81

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to provide policy guidance relating to their collections.85 As a consequence of these Agreements, the legal status of materials in the International Network collected before the entry into force of the Treaty is now regulated by the provisions of the Treaty and its SMTA.86 Besides, the issue of whether the SMTA needs to be modified for its use with non-Annex I crops has been discussed by the Treaty’s Governing Body in June 2009. No substantial changes have been made to the SMTA and the latter is currently also being used for the transfer of non-Annex I crops with a series of interpretative footnotes.87 In particular, it is worth noting the footnote, which states that while Non-Annex I material distributed with the . . . SMTA does not become part of the Multilateral System, it will however be available under the same conditions.88

Therefore, the question arises regarding whether the provision on relationships in the Protocol89 provides scope for using the SMTA for the transfer of non-Annex I PGRFA held in the ex-situ collections of the CGIAR, in accordance with the relevant decision of the Treaty’s Governing Body and the Agreements with the IARC.90 On the one hand, it could be argued that the subject-matter exclusion91 is prima facie inapplicable because the above footnote clarifies that in the event that the SMTA is used for the transfer of PGRFA, other than those listed in Annex I of the Treaty, they do not become part of the MLS. Therefore, such Non-Annex I PGRFA may not be said per se to be ‘covered by’ a specialised international ABS instrument. On the other hand, the Agreements between the IARC of the CGIAR and the Governing Body can be legitimately recognised under the Protocol,92 which requires that  International Treaty Article 15. CBD Group of Technical Experts on an Internationally Recognised Certificate of Origin/Source/Legal Provenance, “Submission by the International Agriculture Research Centres of the Consultative Group on International Agriculture Research (CGIAR),” (13 December 2006) UN Doc UNEP/CBD/GTE-ABS/1/3/ADD2. 86  FAO, “Consideration of the Material Transfer Agreement to Be Used by the International Agricultural Research Centers of the CGIAR and other Relevant International Institutions, for Plant Genetic Resources for Food and Agriculture not Included in Annex 1 of the Treaty” (29 October 2007–2 November 2007) UN Doc IT/GB-2/07/13 Rev 1. 87  FAO, “Report of the Third Session of the Governing Body of the International Treaty on Plant Genetic Resources for Food and Agriculture” (1 June 2009–5 June 2009) UN Doc IT/ GB-3/09/Report, paragraphs 38 and 39. 88  Ibid. 89  Nagoya Protocol Article 4. 90  FAO, “Report of the Second Session of the Governing Body of the International Treaty on Plant Genetic Resources for Food and Agriculture” (29 October 2007–2 November 2007) UN Doc IT/GB-2/07/Report, paragraph 68. 91  Nagoya Protocol Article 4.4. 92  Nagoya Protocol Article 4.3. 85

108   Claudio Chiarolla, Sélim Louafi and Marie Schloen the Protocol is implemented in a mutually supportive manner with other relevant international instruments. Therefore, the application of the Protocol shall not preclude that ‘[PGRFA] other than those listed in Annex I of the Treaty and collected before its entry into force . . . be made available in accordance with’ the amended SMTA.93 As regards the second category of Non-Annex I PGRFA, it was noted above that such materials may also be made voluntarily available by Parties under the same conditions of the SMTA. Also in this case, the subject-matter exclusion under the Protocol94 would not apply since such PGRFA do not legally become part of the MLS (even though they are exchanged under the same conditions). However, under the Protocol, Parties are free to decide not to subject access to their genetic resources to a compulsory requirement concerning the grant of PIC.95 By inference, this means that Parties are also free to make a specific subset of genetic resources available under any conditions that they deem appropriate, including those provided for under the MLS of the Treaty. This interpretation appears also to be supported by the Protocol provision stating that in the development and implementation of ABS legislation or regulatory requirements, Parties shall consider the importance of GRFA and their special importance of food security.96 Such special considerations may indeed include consideration of the facilitated access conditions of the MLS. Therefore, even though this particular category of PGRFA may not be directly concerned by the application of Article 4, which regulates stricto sensu the ‘relationship with international agreements  See the Agreements between the International Agricultural Research Centers of the CGIAR and the Governing Body Article 2.b. Besides, under Article 3 of such Agreements, ‘Centres wishing to transfer Non-Annex I PGRFA received after the entry into force of the Treaty are required to make the material available for access on terms consistent with those mutually agreed between the Centres concerned and the country of origin of the [PGRFA] or the country that has acquired them in accordance with the Convention on Biological Diversity or other applicable law.’ See also System-Wide Genetic Resources Programme (SGRP), Guide for the CGIAR Centres’ Use of the Standard Material Transfer Agreement (Rome; Italy: Bioversity International, 2009), 25. This is because only materials collected before the entry into force of the Treaty are covered by the Agreements with the Governing body, namely PGRFA that were previously held ‘in trust for the benefit of the international community, in particular the developing countries.’ Such materials were collected with the understanding that they would ‘be made available directly to users or through FAO, for the purpose of scientific research, plant breeding or genetic resources conservation, without restrictions.’ See, in particular, he Agreement Between the Centres of the CGIAR and the FAO Placing Collections of Plant Germplasm under the Auspices of FAO (26 October 1994), Articles 3 and 9, reproduced in SGRP (2009), ibid. 94  Nagoya Protocol Article 4.4. 95  Nagoya Protocol Article 6. 96  Nagoya Protocol Article 8.c. 93

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and instruments’, nothing in the Protocol prevents the Parties from providing facilitated access to their plant genetic resources, with the caveat that no other legal requirement should prevent them from doing so.97 A first example of legal requirements, which may prevent them from doing so, may concern PGRFA acquired after the entry into force of the CBD in violation of the applicable ABS legislation or regulatory requirements of the country of origin. A second example may concern PGRFA covered by third parties’ intellectual property claims. It shall also be emphasised that when the parties decide to use the terms and conditions of the SMTA for the transfer of non-Annex I crops, no obligation can automatically be placed on the Third Party Beneficiary or on the Treaty’s Governing Body to record, monitor or enforce the SMTA in respect of transfers of such crops.98 This is primarily because any such obligations could have important implications, including in terms of budget, which would require appropriate funding and prior approval by the Governing Body and the FAO. In conclusion, the question of whether the Protocol provides legal scope for using the SMTA for the transfer of non-Annex I PGRFA shall be answered in the positive in both cases. The relevant provisions of the Protocol99 are drafted in broad terms that allow both the IARC of the CGIAR and the parties to the Protocol to also make crops and forages, other than those already included into the MLS, available under the terms of the SMTA. However, it should be excluded that the SMTA can be used for purposes other than research, breeding and training for food and agriculture, such as chemical, pharmaceutical and/or other non-food/feed uses100 (e.g., ornamentals) as well as for the transfer of GRFA other than PGRFA. c.  Transfer of PGRFA to Non-Parties to a Specialised International ABS Instrument The Protocol also allows for the transfer of PGRFA from providers, under the jurisdiction of a Party to the International Treaty, to recipients under the jurisdiction of non-Parties. This interpretation appears to be supported by a provision of the Protocol, which states that: ‘[. . .] this Protocol does not apply for the Party or Parties to the specialised instrument [. . .].’101 It must  For instance, Memorandum of Understanding for the establishment of a European Genebank Integrated System (AEGIS) Article 8.a.iii entails that ‘only accessions that are free from any third party obligations or restrictions’ will be transferred with the SMTA.   98  AEGIS Article 8.v footnote 2.   99  Nagoya Protocol Articles 4, 6 and 8. 100  SMTA Article 6.1. 101  Nagoya Protocol Article 4.4.   97

110   Claudio Chiarolla, Sélim Louafi and Marie Schloen therefore be emphasised that the above provision specifically refers to either ‘the Party or Parties’, while it could have simply referred to ‘the Parties’ in the plural. In other words, if the Protocol had referred only to ‘the Parties’ in the plural, this provision could have been interpreted as requiring that both the provider and the recipient be established under the jurisdiction of two different Parties to the concerned specialised ABS instrument. However, this is not the case, since it suffices that at least the provider is under the jurisdiction of a Party to a specialised ABS instrument for the latter to prevail over the application of the Nagoya Protocol in respect of the concerned genetic resources. Therefore, the transfer of genetic resources covered by a specialised international ABS instrument to non-Parties does not appear to conflict with the provisions of the Protocol. 4.  Farmers’ Rights vis-à-vis the Rights of Indigenous and Local Communities under the Nagoya Protocol As explained above,102 the International Treaty recognises farmers’ rights in light of [. . .] the enormous contribution that the local and indigenous communities and farmers [. . .] have made and will continue to make for the conservation and development of plant genetic resources [. . .].103

The comparative analysis between the relevant norms of the International Treaty and those of the Nagoya Protocol shows that both legal instruments identify indigenous and local communities as legitimate right-holders, which are granted certain prerogatives vis-à-vis their genetic resources and traditional knowledge, which may have implications for the food and agriculture sector. In the International Treaty context, farmers’ rights are mostly framed in the negative – that is to say that provisions concerning farmers’ rights shall not limit any rights that farmers have to save, use, exchange and sell farmsaved seeds and other propagating materials. This highlights the Treaty’s concern not to prejudice (and possibly to help preserving) traditional agricultural farming practices. A similar concern certainly underpins the Nagoya Protocol, which provides that Parties shall, as far as possible, not restrict the customary use and exchange of genetic resources and associated traditional knowledge within and amongst indigenous and local communities.104 However, the practical mechanisms through which indigenous and local communities and farmers may attain the protection of their traditional  See Part I, section 2d.  International Treaty Article 9. 104  Nagoya Protocol Article 12.4. 102 103

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knowledge relevant to PGRFA as well their rights to equitably participate in sharing benefits and in decision-making are not spelt out by the International Treaty. Farmers’ rights have been understood primarily as collective rights.105 The Farmers’ Rights Project has compared two potentially conflicting approaches for implementing these rights, which are based respectively on the concepts of ownership and stewardship of PGRFA.106 On the one hand, the ownership approach emphasises the right of farmers to be rewarded for genetic material obtained from their fields which is used in commercial varieties and/or protected with intellectual property rights.107

This approach privileges direct benefit-sharing between the purported ‘owners’ and ‘buyers’ of PGRFA and relies on the existence of measures to restrict access to such resources through IPR and/or ABS mechanisms. On the other hand, the stewardship approach upholds the idea that legal space needs to be created and maintained for farmers to continue their role as stewards of agrobiodiversity and that they should collectively be rewarded and supported for their contributions. In the latter case, benefit-sharing would only indirectly occur between farmers involved in the maintenance of agrobiodiversity and the society at large.108 The Farmers’ Rights Project eventually concludes that while the two approaches may to some extent coexist, in the case of conflict, the stewardship approach should prevail over the ownership approach, in consonance with the overarching objectives of the Treaty. At the international level, the only mechanism to facilitate implementing farmers’ rights is the Benefit-sharing Fund of the International Treaty, which operates by allocating grants for capacity-building projects and programmes in developing countries.109 An independent background study notes that  For instance, The Farmers’ Rights Project by the Fridtjof Nansen Institute defines farmers’ rights as ‘customary rights that farmers have had as stewards of agrobiodiversity since the dawn of agriculture to save, grow, share, develop and maintain plant varieties, of their legitimate right to be rewarded an supported for their contribution to the global pool of genetic resources as well as to the development of commercial varieties of plants, and to participate in decision making on issues that affect these rights’ (Farmers’ Rights, accessed 1 June 2012, http://www.farmersrights.org/). 106  Regine Andersen, “Realising Farmers’ Rights Under the International Treaty on Plant Genetic Resources for Food and Agriculture: Summary of Findings from Phase 1”, FNI Report 11 (2006). 107  Ibid., 4. 108  Ibid., 4–7. 109  Chiarolla and Jungcurt, “Outstanding Issues,” 44–45. See, also, Michael Halewood et al., “Participatory Plant Breeding to Promote Farmers’ Rights” (Rome: Bioversity International, October 2007), accessed 1 June 2012, http://www.bioversityinternational.org/fileadmin/ bioversity/publications/pdfs/1254.pdf; and Geoffrey Hawtin et al., “Expert Advice on the 105

112   Claudio Chiarolla, Sélim Louafi and Marie Schloen one of the most effective ways to provide benefits to communities through participation in the Multilateral System is the establishment of programs of participatory plant breeding and participatory variety selection. . . . The involvement of farmers in plant breeding can take many forms, ranging from the selection of materials for breeding, to full collaboration with scientists in the selection of source germplasm, trait development, cultivar development, and varietal evaluation. Next to access to improved varieties and targeted breeding, participatory plant breeding offers a number of additional benefits, and has been advocated as a means to promote farmers’ rights, gender equality and capacity building. Participatory plant breeding is one way to achieve the Treaty’s multiple objectives with regard to benefit-sharing, and it has been proposed as one of the main activities to be supported through the Benefit Sharing Fund, together with on-farm conservation and management, and dissemination of seed and planting materials.110

However, the extent to which the resources that are made available through this Fund may actually trickle down to indigenous and local communities and farmers (in a measure barely sufficient to meet the needs) is challenged by some developing countries and civil society organisations.111 Besides, under the International Treaty, there appears to be no international legal obligation to grant exclusive entitlements to farmers’ communities or individuals over their PGRFA in the sense envisaged by the ownership approach. This is because the implementation of farmers’ rights under the Treaty ‘rests with national governments’ and is ‘subject to national legislation.’112 The only exception to national governments’ broad discretion in implementing farmers’ rights concerns the right to deny access to materials under development in accordance with the Treaty, which states:

Second Call for Proposals, Including a Strategy and Programme for the Benefit-Sharing Fund” (Rome: FAO, April 2010), accessed 1 June 2012, ftp://ftp.fao.org/ag/agp/planttreaty/ funding/experts/bsf_exp_p01_en.pdf. 110  Chiarolla and Jungcurt, “Outstanding issues.” 111  See, for instance, the statement presented by a coalition of civil society organisations at the fourth meeting of the Treaty’s Governing Body in Bali, Indonesia (14–18 March 2011), accessed 1 June 2012, http://www.farmersrights.org/pdf/GB4_Farmers_Rights_CSO_ EN.pdf. 112  International Treaty Article 9.2. Historically, in the FAO Conference of 1989, farmers’ rights were conceived by developing countries as a counterbalance to plant breeders’ rights under the 1978 Act of the UPOV. In particular, FAO, Farmers’ Rights, Resolution 5/89 (see above footnote 52 and accompanying text) which endorsed for the first time the concept of Farmers’ Rights at the international level, defined them as rights ‘arising from the past, present and future contributions of farmers in conserving, improving, and making available plant genetic resources, particularly those in the centres of origin/diversity.’ See Chiarolla, The privatisation of Crop Diversity, 10; Andersen, “The History of Farmers’ Rights”.

Relationship with Instruments on Food and Agriculture   113 Access to [PGRFA] under development, including material being developed by farmers, shall be at the discretion of its developer, during the period of its development.113

Thus, this provision is primarily relevant in the context of efforts to collect new acquisitions of PGRFA from in situ conditions. At the domestic level, several countries in the Southern Hemisphere have adopted ABS laws that privilege the ownership approach for providing direct benefits to farmers. However, in practice successful examples of benefit-sharing with farmers and their communities are still hard to find.114 In accordance with the ownership approach, the Nagoya Protocol expressly requires Parties to take measures with the aim of ensuring that indigenous and local communities will participate in sharing: • the benefits arising from the utilisation of genetic resources that are held by indigenous and local communities, in accordance with domestic legislation regarding their established rights over these resources, based on mutually agreed terms;115 and • the benefits arising from the utilisation of traditional knowledge held by them upon mutually agreed terms.116 Therefore, the Protocol requires subjecting access to genetic resources that are held by indigenous and local communities (where they have the established right over them) as well as access to traditional knowledge associated with such resources to the granting of PIC or the approval and involvement of relevant indigenous and local communities.117 Thus, national measures that implement the above provisions of the Protocol may affect the legal status of PGRFA (and traditional knowledge related to PGRFA), which are covered by the MLS of the International Treaty. On the one hand, such measures could provide for and/or strengthen the rights of farmers in accordance with the Treaty118 and in line with the ownership approach. On the other hand, PGRFA that are covered by the rights of indigenous and local  International Treaty Article 12.3.e. For a legal analysis of the definition of ‘PGRFA under development’ and their treatment under the SMTA, see Chiarolla, “Plant Patenting, Benefit Sharing and the Law Applicable to the FAO Standard Material Transfer Agreement,” 16–17. 114  See, for instance, Christine Frison, Francisco López and José Esquinas-Alcázar. eds., Plant Genetic Resources and Food Security. Stakeholder Perspectives on the International Treaty on Plant Genetic Resources for Food and Agriculture (London: Earthscan, 2012). 115  Nagoya Protocol Article 5.2. 116  Nagoya Protocol Article 5.4. 117  Nagoya Protocol Articles 6.2 and 7. 118  International Treaty Article 9. 113

114   Claudio Chiarolla, Sélim Louafi and Marie Schloen communities and farmers could not (automatically) be included into the MLS, even if they are listed in Annex I of the Treaty. This is because these PGRFA would not be in the public domain. Therefore, in this case, an express decision of the right holders may be necessary to provide facilitated access to their PGRFA under the MLS.119 In conclusion, in light of the above norms, where domestic ABS legislation or regulatory requirements afford indigenous and local communities with the right to grant access to their genetic resources and traditional knowledge, in accordance with the Protocol, the potential inclusion (and the subsequent exchange) of such resources and traditional knowledge under sectoral instruments and mechanisms will require the indigenous and local communities’ PIC or their approval and involvement. These norms may also apply to PGRFA in Annex I of the Treaty that are held by indigenous and local communities and farmers and will affect their possible (automatic) inclusion into the FAO MLS. This is not only consistent with Treaty’s requirement that included materials be in public domain, but also with the legal entitlement to provide discretional access to PGRFA under development, which also applies to PGRFA developed by farmers in in-situ conditions through traditional agricultural practices.120 5.  ABS-Related International Processes Concerning GRFA Besides regulating its relationship with other relevant international instruments, the Nagoya Protocol also includes provisions that concern the development of ABS norms within the auspices of other international organisations and related processes. In particular, the Preamble acknowledges the ‘ongoing work in other international forums relating to access and benefit-sharing.’121 Then, the operative text of the Protocol calls upon – but does not impose on – Parties in implementing the Protocol to pay due regard [. . .] to useful and relevant on-going work or practices under such international instruments and relevant international organisations, provided that they are supportive of and do not run counter to the objectives of the Convention and this Protocol.122

 See, for instance, the inclusion of materials by the Association of Communities in the Potato Park of Cusco, Peru, above footnote 39. 120  International Treaty Article 12.3.e. 121  Nagoya Protocol preambular paragraph 18. 122  Nagoya Protocol Article 4.3 second sentence. 119

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For instance, the on-going work that is undertaken within the CGRFA123 or relevant ABS practices, such as those which are endorsed through the Global Plan of Action on Animal Genetic Resources,124 would deserve ‘due regard’ when implementing domestic ABS legislation. Finally, the Protocol contains a safeguard clause specifically protecting the prerogative of the Parties to further develop and implement other relevant international agreements, including other specialised [ABS] agreements, provided that they are supportive of and do not run counter to the objectives of the Convention and this Protocol.125

Therefore, the above provision is consistent with and further elaborates a normative principle that is already enshrined in the Preamble to the Decision accompanying the final text of the Protocol,126 notably where it reminds us of the prominence that should be given to complementary instruments that constitute the ‘international regime on ABS’ alongside the CBD and its Nagoya Protocol.127  See further below, in particular, the Commission’s decision to establish an Ad Hoc Technical Working Group on Access and Benefit-sharing for Genetic Resources for Food and Agriculture. Food and Agriculture Organisation of the United Nations, “Report of the Thirteenth Regular Session of the Commission on Genetic Resources for Food and Agriculture” (22 July 2011) UN Doc CGRFA-13/11/Report, paragraph 60 and Appendix D.1. 124  FAO, “Implementing the Global Plan of Action for Animal Genetic Resources”, accessed 21 February 2011, http://www.fao.org/ag/againfo/programmes/en/A5.html; FAO, “Report of the International Technical Expert Workshop on Exploring the need for specific measures for access and benefit-sharing of animal genetic resources for food and agriculture” (18–22 May 2011) UN Doc CGRFA-13/11/Circ.1. In particular, workshop participants emphasised that negotiating a legally binding instrument for animal GRFA is not a first choice. ‘Some participants considered that in order to avoid possible negative effects of the implementation of the Nagoya Protocol for animal genetic resources exchange, conservation and sustainable use, some countries may promote the development of specific international legally binding ABS measures for the exchange of animal genetic resources for food and agriculture, comparable to the International Treaty. However, the participants felt strongly that it might be better to promote conservation and sustainable use within the framework of the Global Plan of Action, and to develop specific voluntary instruments for animal genetic resources for food and agriculture where felt necessary’ (Ibid., 6, paragraph 3). See also FAO, The use and exchange of animal genetic resources for food and agriculture (Rome: CGRFA Background Study Paper no. 43, July 2009). 125  Nagoya Protocol Article 4.2. 126  CBD Decision 10/1, “Access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation” (20 January 2011) UN Doc UNEP/CBD/COP/10/27. 127  The Preamble to CBD Decision 10/1 recognises ‘that the international regime is constituted of the Convention on Biological Diversity, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation to the Convention on Biological Diversity, as well as complementary instruments, including the International Treaty on Plant Genetic Resources for Food and Agriculture and the 123

116   Claudio Chiarolla, Sélim Louafi and Marie Schloen The FAO CGRFA started work in this field as an early task within its Multi-Year Programme of Work.128 After having decided in 2007 to consider ABS in relation to extend its scope on all GRFA, it reviewed arrangements and policies for ABS for GRFA in October 2009. To facilitate discussions and debate on ABS for GRFA, several background study papers on use and exchange patterns of genetic resources in the different subsectors of food and agriculture were commissioned.129 These studies provide an overview of past, current and possible future use and exchange patterns, as well as a description of terms and modalities for the use and exchange of GRFA, in the subsectors dealing with animal, aquatic, forest, invertebrate, microbial and plant genetic resources. Additionally, cross-sectoral studies were prepared on the role of GRFA in existing ABS policies and arrangements,130 on trends in IPR relating to GRFA,131 and on the impact of climate change on countries’ interdependence in the use of GRFA.132 In July 2011, the Commission took note of the adoption of the Nagoya Protocol and invited countries to consider in the development and implementation of legislative, administrative or policy measures on access and benefit-sharing, the importance of genetic resources for food and agriculture and their special role for food security.133

Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization.’ 128  FAO, “Report of the Eleventh Regular Session of the Commission on Genetic Resources for Food and Agriculture” (15 June 2007) UN Doc CGRFA-11/07/Report, Appendix E and FAO, “Report of the Twelfth Regular Session of the Commission on Genetic Resources for Food and Agriculture” (23 October 2009) UN Doc CGRFA-12/09/Report, Appendix G. 129  FAO, The use and exchange of animal genetic resources for food and agriculture; Bartley et al., The use and exchange of aquatic genetic resources for food and agriculture; Koskela et al., The use and exchange of forest genetic resources for food and agriculture; Tom Dedeurwaerdere et al., The use and exchange of microbial genetic resources for food and agriculture (Rome: CGRFA Background Study Paper no. 46, October 2009). 130  See Gurdial Nijar et al., Framework study on food security and access and benefit-sharing for genetic resources for food and agriculture (Rome: CGRFA Background Study Paper no. 42, September 2009). 131  Carlos Correa, Trends in Intellectual Property Rights relating to Genetic Resources for Food and Agriculture (Rome: CGRFA Background Study Paper no. 49, October 2009). 132  Sam Fujisaka, David Williams and Michael Halewood, The Impact of Climate Change on Countries’ Interdependence on Genetic Resources for Food and Agriculture (Rome: CGRFA Background Study Paper no. 48, April 2011). The findings of the studies were discussed in a Special Event immediately preceding the Twelfth Regular Session of the Commission. 133  CGRFA-13/11/Report, paragraph 58.

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It further invited countries to explore and assess in the development of legislative, administrative or policy measures on access and benefit-sharing, sectoral approaches that allow for differential treatment of different sectors or sub-sectors of genetic resources for food and agriculture, and different genetic resources or different activities or purposes for which activities are carried out.134

As an analysis commissioned by the FAO has indeed identified, very few of the existing laws and instruments seem to distinguish between GRFA and other uses of genetic resources.135 Besides, it is sometimes the case that laws include in their scope even biological resources.136 This would mean that, unless they are explicitly exempted, agricultural commodities are potentially covered under ABS legislation. Not paying due attention to the specific characteristics and requirements of GRFA consequently implies a risk of overregulation or inefficient regulation that could hamper exchange and reduce the flow of genetic resources in the food and agriculture sector. The adoption of the Nagoya Protocol both increases the need and opens new opportunities to identify the specific characteristics of GRFA, assess the potential impact of different ABS measures on their use and exchange, and explore existing and develop new options for implementing ABS in the food and agriculture sector. For this reason, the Commission decided to establish137 an Ad Hoc Technical Working Group on Access and Benefit-sharing for Genetic Resources for Food and Agriculture with the following tasks:138 • identify relevant distinctive features of the different sectors and sub-sectors of GRFA requiring distinctive solutions; • taking into account the relevant distinctive features identified, develop options to guide and assist countries, upon their request, in developing legislative, administrative and policy measures that accommodate these features; and • analyse, as appropriate, possible modalities for addressing access and benefit-sharing for GRFA, taking into account the full range of options, including those presented in the Nagoya Protocol.139  CGRFA-13/11/Report, paragraph 59.  Nijar, Framework study on food security. 136  Ibid. 137  In accordance with Article 5 of the Statutes of the Commission on Genetic Resources for Food and Agriculture, as adopted by the FAO Council, at its 110th Session (Rome, 20–31 October 1995), http://www.fao.org/nr/cgrfa/cgrfa-about/cgrfa-statu/en/, accessed 7 June 2012. 138  CGRFA-13/11/Report, paragraph 60 and Appendix D.1. 139  Ibid. 134 135

118   Claudio Chiarolla, Sélim Louafi and Marie Schloen The outcomes of its meeting will be discussed at the next session of the CGRFA in April 2013 to ‘consider the need for, and modalities of, access and benefit-sharing arrangements for genetic resources for food and agriculture.’140 It is difficult to predict at the time of writing what could be the outcomes of such process. Several options, all fully in line with the windows of opportunities opened by the Nagoya Protocol, and not necessarily mutually exclusive, are possible. At the practical level, including stakeholder and institutional initiatives,141 voluntary codes of conduct, guidelines and best practices and/ or standards could be developed and used in relation to ABS in the food and agricultural sector; or sectoral and cross-sectoral model contractual clauses for MAT could be developed. At the national level,142 principles and guidelines for the design of dedicated ABS provisions could be developed to specifically take into account the distinctive features of genetic resources for food and agriculture. And at the international level,143 the need for and possible modalities of specialised ABS agreements for certain sectors, types of genetic resources or types of uses, could be explored. 6.  Model Contractual Closes and Soft Law Approaches The Nagoya Protocol also envisages that sectoral specificities in term of access and use of genetic resource be taken into account through the development, update and use of sectoral and cross-sectoral model contractual clauses.144 In particular, a bottom-up or users-led approach for the development of new model contractual clauses (as well as for the recognition of existing ones within domestic and international ABS frameworks) may, inter alia: help promote best practices; reduce transaction costs associated with the negotiation of MAT; and build capacities of the concerned sectors in counties where they are less developed.145 The integration of benefit-sharing obligations into existing contractual practices, which could require only relatively minor adjustments, as well as their standardisation with the involvement of relevant users’ communities, appears to be preferable to imposing radical departures from such practices. This is because the more the users’ communities will feel ownership of ABS tools and will perceive them as useful, the more they are likely to use them for generating and sharing benefits from the use of biodiversity, and to promote compliance with ABS legislation.  Ibid., paragraph 62.  Nagoya Protocol Articles 19 and 20. 142  Nagoya Protocol Article 8. 143  Nagoya Protocol Article 4.3. [See contribution by Young to this volume (Chapter 15).] 144  Nagoya Protocol Article 19.1. 145  For further explanation of Article 19 of the Nagoya Protocol see: Greiber and Peña Moreno (eds.). IUCN Explanatory Guide. 140 141

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In the same spirit, the Nagoya Protocol also recognises the usefulness of soft law approaches and demands Parties to promote users-led initiatives for the development, update and use of ABS voluntary codes of conduct, guidelines and best practices and/or standards.146 Relevant examples include the Ethical BioTrade standard developed by the Union for Ethical BioTrade,147 the Standards and Guidelines adopted by the Barcode of Life Initiative148 and many others.149 All the above tools can play an important role for taking into account GRFA specificities when developing and implementing domestic ABS legislation or regulatory requirements as well as for promoting compliance with them by relevant users’ communities.

III.  Conclusions As shown in this chapter, many GRFA are human-modified forms of biodiversity, whose existence is closely linked to human activity. The process of genetic improvement is incremental in nature: genetic material is continuously improved over many successive generations and one innovative step is added on to another. Therefore, most GRFA products may not be understood merely as the end point of a development process, but as an intermediate step in an on-going chain of improvements. This is because most GRFA products can themselves be used as genetic resources. This particular feature of GRFA contributes to blur the line, on the one hand, between providers and recipients of GRFA, since every recipient of genetic material can, at least potentially, also become a provider of genetic resources; and, on the other, between genetic resources and biological resources, since many agricultural products reach the market place in a form in which they may be used both  Nagoya Protocol Article 20.1 See Greiber and Peña Moreno (eds.). IUCN Explanatory Guide. 147  The Ethical BioTrade Standard, accessed 1 June 2012, http://www.ethicalbiotrade.org/ verification/standard.html In particular, it contains a section that specifically concerns the ‘Fair and equitable sharing of benefits derived from the use of biodiversity.’ [See contribution by Oliva to this volume (Chapter 12).] Voluntary compliance mechanisms such as this one may also provide for a certification-like system at the institutional level. In such cases, experts have noted that the certification needs to go beyond what is required by the law in order to promote a bio-piracy-free zone among certified user-provider groups. See, IDDRI, Report of the First Steering Committee Meeting on Outstanding ABS Issues (Paris: 4 February 2011), 8, accessed 21 February 2011, http://www.iddri.org/Activites/ Conferences-internationales/Report_SC_Meeting_on_ABS[01%2006%202011].pdf. 148  Barcode of Life, “Standards and Guidelines”, accessed 1 June 2012, http://.barcodeoflife .org/content/resources/standards-and-guidelines 149  See CBD, “Existing instruments, guidelines, codes of conduct and tools addressing ABS”, accessed 7 June 2012, http://www.cbd.int/abs/instruments/. 146

120   Claudio Chiarolla, Sélim Louafi and Marie Schloen as biological resources (i.e., for production) or as genetic resources (i.e., for reproduction and further development). Besides, unlike most ‘wild’ genetic resources, the erosion of GRFA does not primarily derive from their overexploitation, but from their under-utilisation, which is a consequence of the specialisation and homogenisation of modern farming systems. Therefore, GRFA poses specific challenges from the standpoint of ABS regulation and the protection of associated agricultural traditional knowledge. In the PGRFA sector, lengthy negotiations have eventually produced an innovative solution – the International Treaty on PGRFA – that is characterised by a multilateral common-pool approach to ABS that differentiates itself from the bilateral case-by-case approach promoted under the CBD. The outcomes of the on-going work under the CGRFA are still uncertain but, in all cases, these efforts are geared towards finding appropriate ways to address the specific challenges of ABS for all GRFA not covered by the Treaty’s MLS. In particular, this study emphasises the importance of fostering and preserving patterns of use, exchange and benefit sharing, which are adapted for the food and agriculture sectors, while preventing that specialised ABS measures be abused with the view to circumventing the minimum standards concerning the benefit sharing obligations of the Nagoya Protocol. The solution that was eventually adopted in the Nagoya Protocol with regard to its relationship with other international instruments and processes appears neither to affect the rights and obligations of any Party deriving from existing international agreements150 – in particular, concerning PGRFA – nor to prevent Parties from developing new specialised ABS agreements for GRFA.151 This study emphasises that all PGRFA within the MLS are solely regulated by the provisions of the Treaty, which must be understood as a ‘specialised international ABS instrument’.152 It also argues that the Protocol does not preclude that PGRFA other than those listed in Annex I of the Treaty and collected before its entry into force, which are covered by the Agreements between the IARC of the CGIAR and the Treaty’s Governing Body, be made available under the same terms and conditions of the SMTA.153 Besides, the Protocol also allows its Parties to provide facilitated access, on a voluntary basis, to crops and forages, other than those already included into the MLS, under the same conditions of the SMTA. However, the SMTA may neither be used for purposes other than research, breeding and training for food and agriculture nor for the transfer of GRFA other than PGRFA. Finally, the transfer of GRFA that are covered by a specialised international  Nagoya Protocol Article 4.1.  Nagoya Protocol Article 4.2. 152  Nagoya Protocol Article 4.4. 153  FAO Treaty Article 15. 150 151

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ABS instrument to non-Parties does not appear to conflict with the provisions of the Protocol. As regards the relationship between farmers’ rights and the Nagoya Protocol, this study highlights that the latter requires subjecting access to genetic resources that are held by indigenous and local communities (where they have the established right over them), as well as access to traditional knowledge, to the granting of the PIC or the approval and involvement of relevant communities. Thus, implementing measures can provide for and/or strengthen the rights of farmers within such communities, in particular, in accordance with the ownership approach under the International Treaty.154 However, such measures may also affect PGRFA in Annex I of the Treaty, namely those held by indigenous and local communities and farmers, and may have implications regarding their possible (automatic) inclusion into the FAO MLS. Therefore, the consideration of the rights of indigenous and local communities and farmers is particularly important in relation to new acquisitions of PGRFA from in situ conditions, as well as for PGRFA under development within traditional agricultural systems. Finally, a fundamental principle that is common to both the International Treaty and the Nagoya Protocol is that the customary use and exchange of genetic resources and associated traditional knowledge within and amongst indigenous and local communities and farmers shall not be restricted. In particular, farmers should not be deprived of their traditional rights to save, use, exchange and sell farm-saved seeds and propagating materials. As regards the relationship between the Nagoya Protocol and other international processes concerning GRFA, this study emphasises that due prominence should be given to the further development of the complementary instruments and ABS approaches for GRFA, which may become part of the ‘international regime on ABS’ alongside the CBD and its Nagoya Protocol.155 This is important for reasons of efficient implementation of ABS objectives while ensuring at the same time that food security is properly taken into account. As a matter of fact, this chapter shows that while the food and agriculture sector share the same objectives of the CBD and its Nagoya Protocol, GRFA specificities and their particular role for food security call for distinctive solutions to reach these objectives. Several characteristics of GRFA should be duly taken into account in the development and implementation of ABS legislation and/or global regulatory requirements for GRFA. To conclude, instruments on ABS for GRFA need to accommodate their distinctive characteristics and, therefore, their approach may differ from the mainstream bilateral ABS approach envisaged under the Nagoya Protocol.  FAO Treaty Article 9.  CBD Decision 10/1, Preamble.

154 155

122   Claudio Chiarolla, Sélim Louafi and Marie Schloen To date, the ABS regulatory framework in the food and agriculture sector appears to be in harmony with the objectives of the CBD and its Nagoya Protocol. Besides, the regulatory options that are available under these instruments hold the potential for it to continue being developed and implemented in harmony with such objectives, while increasing equity in the way resources are exchanged and used, and the ensuing benefits shared not only between users and providers, but also between the GRFA sectors and the society at large.

Chapter 4.  A Healthy Look at the Nagoya Protocol—Implications for Global Health Governance Marie Wilke* Though a multilateral environmental agreement by nature, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilisation (Nagoya Protocol ) may have critical implications for global health. By regulating access to genetic resources and the related benefit-sharing (ABS), the agreement is set to impact all those industries that are dependent on or make use of research and development on genetic resources.1 This includes the pharmaceutical and health sectors. First, genetic resources are often utilised to develop new drugs. This can include, but is not limited to, the screening of compounds for biological activity, analysis of chemical structures and reactions, analysis of genetic sequences and the recombination of genetic materials.2 Moreover, the use of genetic resources and associated traditional knowledge in the health sector has increased with the greater popularity of traditional medicine and naturebased cosmetic or food supplement products with therapeutic effect.3 Finally, access to genetic resources is of great importance for the development of vaccines as these are based upon the original pathogenic material. The process of vaccine development depends upon isolating or creating antigens that initiate effective immune response.4 The importance of genetic resources utilisation *  International Trade Law Programme Officer, International Centre for Trade and Sustainale Development (ICTSD). 1  [See contribution by Oliva to this volume (Chapter 12).] 2  Padmashree Gehl Sampath, Regulating Bioprospecting: Institutions for Drug Research, Access, and Benefit-Sharing (Tokyo: UNU Press, 2005), 12–3. 3  See Union for Ethical BioTrade, “A review of patent activity in the cosmetics sector in the context of the ethical sourcing of biodiversity: information note 1 of 4,” accessed February 2012,  http://www.ethicalbiotrade.org/news/wp-content/uploads/UEBT_Trends_Patents_ Activity1_22-09-101.pdf. 4  WHO Department of Immunisation, Vaccines and Biologicals and Department of Epidemic and Pandemic Alert and Response, “Global pandemic influenza action plan to increase

124   Marie Wilke and related benefit-sharing for the development of vaccines became apparent during the H5N1, or avian flu crisis that began in 2006.5 Indonesia, the country that reported the first human infections with this particular virus strain, had shared relevant virus samples with the World Health Organisation (WHO) for surveillance and research purposes. However, after learning about an Australian company applying for a vaccine patent developed on the basis of its sample, Indonesia refused to submit further samples to the WHO.6 Indonesia argued that it had never consented to the sharing of samples with private companies or to the commercial application of the samples or the derivatives and that the process, now limiting Indonesia’s access to said vaccines, was in violation of the principle of sovereignty over genetic resources as enshrined in the Convention on Biological Diversity (CBD) as well as internal WHO procedures.7 Indonesia was particularly concerned as it could not access the vaccines on the global market due to insufficient global production capacities and advance purchase agreements placed by developed countries.8 In 2005, global production capacities for influenza vaccines were estimated to be 350 million doses which stood in stark contrast to the approximately 13.4 billion doses needed in times of pandemic to immunise the entire world population.9 This case exemplifies developing countries’ dilemma in relation to genetic resource-based medication. As their research and development capacities remain limited, most utilisation of genetic resources in the health sector takes place in developed countries. At the same time it is developing countries that are most dependent on new medication and access to vaccines, since pathogens often emerge within their jurisdiction and their poor populations are among the most vulnerable.

vaccine supply,” (September 2006) WHO/IVB/06.13; WHO/CDS/EPR/GIP/2006.1 (WHO ‘Global Action Plan’), 4, 8. 5  In the following, H5N1 is used to refer to the Asian lineage subclade 2 of the highly pathogenic avian influenza (HPAI) strain H5N1 that was first discovered among Indonesian poultry in 2003; see World Health Organisation, “Avian influenza,” accessed 10 February 2012, http://www.who.int/mediacentre/factsheets/avian_influenza/en/. 6  See Endang R Sedyaningsih et al., “Towards Mutual Trust, Transparency and Equity in Virus Sharing Mechanism: The Avian Influenza Case of Indonesia,” Annals of the Academy of Medicine Singapore 37 (2008): 486. 7  Ibid.; Intellectual Property Watch, “Indonesia Avian Flu Stance Reveals Potential Weakness in Global System,” Intellectual Property Watch, 8 March 2007, accessed 10 February 2012, http://www.ip-watch.org/2007/03/08/indonesian-avian-flu-stance-reveals-potential-weaknessin-global-system/. 8  Sedyaningsih, “Towards Mutual Trust.” 9  Martin Friede et al., “WHO initiative to increase global and equitable access to influenza vaccine in the event of a pandemic: Supporting developing country production capacity through technology transfer”, Vaccine 29S (2011): A2–A7.

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The Nagoya Protocol is likely to impact these dynamics in both an upstream and a downstream manner. Clear access rules can facilitate research and development while the benefit-sharing obligations can help ensure access to the needed pharmaceuticals. Moreover, benefit-sharing can contribute to building production capacities in developing countries through, for instance, joint ownership of relevant intellectual property rights, revenue generation, technology transfer and collaboration on research. Most importantly, the Protocol also recognised the need for specialised processes in times of health emergency: its Article 8.b calls upon States to consider special rules on access and benefit-sharing, including access to pharmaceuticals for those in need, during health emergencies. As a ‘specialised consideration’ clause, Article 8.b forms the centrepiece of health-relevant ABS clauses in the Nagoya Protocol, making it the necessary starting point of any legal assessment. At the same time, the two issues – access to health-relevant resources and access to pharmaceuticals – are also subject to other international agreements concluded outside the CBD framework. This chapter seeks to analyse Article 8.b and its impact on public health efforts. A particular focus will rest on the relationship between the Nagoya Protocol and the WHO Pandemic Influenza Preparedness Framework (PIP Framework). The latter is an ABS instrument addressing the interrelationship of access to influenza viruses and pandemic preparedness and response, adopted only months after the Nagoya Protocol.10 The negotiation dynamics of these two instruments were highly interlinked, with each process impacting the outcome in the other fora. In fact, Article 8.b and the PIP Framework are responses to the same international event: the H5N1 crisis. The Framework is the consequence of Indonesia’s insistence on establishing a new system that would ensure fair and equitable benefit-sharing, while Nagoya Protocol Article 8.b came into being as a response to these WHO negotiations. The chapter will first discuss the scope of Nagoya Protocol Article 8.b and its relationship with other provisions in the Nagoya Protocol. Section II will then address the PIP Framework and its status as a specialised ABS instrument within the meaning of the Nagoya Protocol. Finally, section III provides some lessons and conclusions on positive linkages between ABS and public health efforts. The main argument that this chapter puts forward is that Nagoya Protocol Article 8.b calls upon States to ensure that normal ABS rules and procedures do not interfere with public health efforts. This concerns the development of needed pharmaceuticals as well as access to the same. While the  World Health Organisation, “Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access to vaccines and other benefits” (effective 24 May 2011) WHA64.5 (PIP Framework).

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126   Marie Wilke provision does not require States to take particular measures, all Parties are obligated to ensure that public health objectives can be met and are indeed supported by access as well as benefit-sharing rules. Furthermore, the chapter argues that the WHO PIP Framework is an important and interesting ABS instrument that has the potential to achieve ABS in the area of influenza pandemics while supporting global response efforts. However, for the sake of the Nagoya Protocol, the Framework may only partially be considered a specialised ABS instrument within the meaning of the Protocol,11 thereby excluding the genetic resources in question from the Protocol’s scope. First, the Framework’s scope is rather limited in substance as it only applies to influenza viruses with pandemic potential. All other pathogens thus remain within the purview of the Nagoya Protocol. Moreover, this paper argues that the Framework only functions as a specialised ABS instrument for influenza viruses where transfers are covered by the Framework’s binding contract clauses, which are stipulated in standard material transfer agreements (SMTAs) included in the annex to the Framework. That is because the Framework itself, which was adopted as a resolution by the World Health assembly, is not binding. The chapter further finds that the PIP Framework’s approach, namely the use of binding standard material transfer agreements, can be an important model for future ABS instruments in the area of public health. However, the chapter also reveals that it could be difficult to replicate this standing or permanent exchange system that is made conditional upon benefit-sharing. The chapter concludes that it is of vital importance for the global public health governance system that the Nagoya Protocol generally captures genetic resources with pathogenic and anti-pathogenic properties, thus remaining applicable as a fallback option.

I.  Special Considerations for Health Emergencies Article 8.b of the Nagoya Protocol, through its chapeau, clearly requires countries to design their domestic ABS legislation in a manner that pays due regard to health emergencies. The extent or form of such consideration, however, is not further specified. Rather, the provision allows for a considerable degree of flexibility. It does not obligate countries to provide for accelerated or additional ABS rights and obligations in situations that amount to health emergencies.12 Instead such expedited processes are only suggested as one option. As a consequence of this phrasing, the Nagoya Protocol may  Nagoya Protocol Article 4.  The chapeau of Nagoya Protocol Article 8 and the first sentence of its paragraph b call upon countries to pay ‘due regard’ to health emergencies when designing national ABS

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well be understood as refraining from imposing any concrete additional ABS obligations in cases of emergency, while requiring countries to ensure that its general ABS obligations do not interfere with public health objectives in times of emergency. The outcome notably differs from some other approaches that had been suggested during the course of the negotiations, first and foremost suggestions on addressing the issue through explicit exclusions, particularly of ‘human pathogens,’ from the Protocol’s scope.13 In that context it is noteworthy that the provision does not mention either pathogens, genetic resources with pathogenic potential or materials related with health emergencies. Rather than addressing the type of material, the Nagoya Protocol now makes reference to a situation, namely emergencies that threaten health. Against this background, the provision’s scope deserves further analysis. 1.  The Definition of Health Emergencies The special ABS procedures suggested in Article 8.b are conditional upon the existence of ‘present or imminent emergencies that threaten or damage human, animal or plant health, as determined nationally or internationally’. Three elements form this scope, namely the subjects threatened by the emergency, the cause of the emergency, and the regulatory status of the emergency. Regarding the first element – the subject threatened by the emergency – it should be noted that the definition used in Article 8.b refers to threats to ‘human, animal or plant health’ rather than only human health. This broad scope is welcome for at least two reasons. First, infectious diseases are often characterised by zoonotic properties, which is the ability to be transmitted from humans to animals or animals to humans.14 In particular viruses, first

legislation. The second sentence in paragraph b further suggests that countries can consider expedited processes. Such speedy procedures are thus not made mandatory. 13  The issue was first addressed in 2009, during the seventh meeting of the CBD Ad Hoc Open-Ended Working Group on Access and Benefit Sharing by the European Union when it proposed to exclude ‘human pathogens’ from the Protocol’s scope; see CBD, “Report of the Seventh Meeting of the Ad Hoc Open-Ended Working Group on Access and BenefitSharing,” (5 May 2009) UN Doc UNEP/CBD/WG-ABS/7/8, paragraph 58. This proposal was later taken up during the third part of the ninth meeting of the Working Group with Parties proposing to exclude ‘a genetic resource when it constitutes a serious and direct danger to the health of humans’, see CBD COP, “Report of the Third Part of the Ninth Meeting of the Ad Hoc Open Ended Working Group on Access and Benefit-Sharing,” (17 October 2010) UN Doc UNEP/CBD/COP/10/5/Add.5. 14  Nigel J. Dimmock, Andrew J. Easton and Keith N. Leppard, Introduction to Modern Virology (Malden, MA: Blackwell, 2007), 268.

128   Marie Wilke and foremost influenza viruses, tend to cross the inter-species barrier.15 In many cases this occurs through mutations while the virus circulates among animals. A health emergency that threatens animals or plants can thus easily develop into a human health emergency. In such instances, emergency response is most effective if the research already responds to animal or plant infections.16 Second, even though the negotiations that resulted in Article 8.b were triggered by the H5N1 crisis and the WHO PIP negotiation process, given the CBD framework, it would have been implausible to limit the special considerations on health emergencies to instances that threaten human health and to exclude emergencies that threaten biodiversity. To recognise the importance of ABS in preventing health threats and thereby conserving biodiversity appears as important as recognising the value of expedited access to material and benefits in times of human health emergencies. Article 8.b, however, remains silent as to the second element – the cause of the emergency. This is striking as the negotiations were triggered by the avian flu epidemic, with most proposals, as a consequence, focusing on emergencies caused by ‘human pathogens’17 or by ‘genetic resources when they constitutes a serious and direct danger to the health of humans.’18 Such an approach would have limited the scope mainly to emergencies caused by infectious or communicable diseases.19 The final provision instead broadly refers to any type of ‘present or imminent emergency that threatens [. . .]

 Ibid.  The WHO clearly recognises the threat of influenza viruses that circulate among animals and the need to coordinate public action already at this level of circulation, as is reflected in the WHO’s definition of an influenza pandemic. This definition of a pandemic distinguishes among six phases plus post-peak periods. Phase 1 refers to a situation where influenza viruses circulate among animals with the potential to develop into pandemic viruses, but are not yet known to have caused human infections. Phase 2, on the other hand, refers to situations where sporadic infections have been observed; World Health Organisation Global Influenza Programme, Pandemic Influenza Preparedness and Response: A WHO Guidance Document (WHO Geneva, 2009), 25. On the importance of research on influenza types circulating among domesticated or wild birds, see also Robert G. Webster and Elizabeth Jane Walker, “Influenza: The world is teetering on the edge of a pandemic that could kill a large fraction of the human population,” American Scientist 9 (2003): 122. 17  CBD, “Report of the Second Part of the Ninth Meeting of the Ad Hoc Open Ended Working Group on Access and Benefit-Sharing,” (28 July 2010) UN Doc UNEP/CBD/COP/10/5/ Add.4, Article 3. 18  CBD, “Report of the Third Part of the Ninth Meeting of the Ad Hoc Open Ended Working Group on Access and Benefit-Sharing,” (17 October 2010) UN Doc UNEP/CBD/COP/10/5/ Add.5, Article 3. 19  Fredrick Abbot, “Exception #2: Sharing pathogens,” Bridges Trade BioRes Trade & Environment Review 4 (October 2010): 7. 15 16

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health’. In fact, it does not even refer to emergencies caused by genetic resources. Instead it broadly refers to health threats. According to the ordinary meaning given to these terms, this wording may well include emergencies caused by non-natural pathogens or other instances. This can include, for instance, nuclear power plant accidents, natural disasters, chemical or other polluting spills or contaminated food. This textual reading is endorsed by the Protocol’s reference to the WHO International Health Regulations from 2005. While the Nagoya Protocol itself does not include a definition of ‘public health emergency’, the preambular text refers to the WHO’s International Health Regulations (2005).20 Interestingly, the revised International Health Regulations from 2005 apply to ‘public health emergenc[ies] of international concern’.21 The language used in these regulations closely resembles that of the Nagoya Protocol and the Protocol’s negotiation history shows that this is by no means incidental.22 Definitions provided by the WHO Regulations may thus be useful in further defining the scope of Article 8.b of the Nagoya Protocol as to the cause, and thus

 The preamble of the Nagoya Protocol states that ‘The Parties to the protocol [. . .] Mindful of the International Health Regulations (2005) of the World Health Organisation and the importance of ensuring access to human pathogens for public health preparedness and response purposes’. At first sight, the reference may be understood to be of relevance only in relation to the ‘human pathogens’. However, upon closer inspection, the language does not refer to the regulations ‘for the purpose of ’ or ‘in relation to’ pathogens, but rather the reference to the International Health Regulations (2005) stands next to the reference to human pathogens. Semantically the two issues are only linked through the word ‘and’. Furthermore, the negotiation history indicates that this specific reference was a compromise between those countries (predominantly developing countries) that wanted to ensure the prevalence of public health efforts and the important guidance provided by the new International Health Regulations, and those countries that wanted to strengthen the legal basis for requiring Parties to provide access to human pathogen, especially in times of emergency, in order to ensure timely and efficient research and development for response purposes. The final outcome addresses the two issues in a joint manner, but neither textually nor conceptually is the scope limited to human pathogens. 21  Revision of the International Health Regulations, (Geneva, 23 May 2005, in force 15 June 2007) Fifty-Eighth World Health Assembly, WHA58.3, (IHR 2005), Article 12. 22  During the ninth meeting of the CBD ABS Working Group two alternative proposals using the language of the IHR 2005, and making specific references to these, were proposed with the most relevant one reading as follows: ‘This protocol does not apply to: A genetic resource when it constitutes a serious and direct danger to the health of humans as described in the International Health Regulations, and it is covered by and for the purpose of a specialised instrument as described in paragraph (b) of Article 6’. See CBD, “Report of the Second Part of the Ninth Meeting of the Ad Hoc Open Ended Working Group on Access and BenefitSharing,” (28 July 2010) UN Doc UNEP/CBD/COP/10/5/Add.4; and CBD, “Report of the Third Part of the Ninth Meeting of the Ad Hoc Open Ended Working Group on Access and Benefit-Sharing,” (17 October 2010) UN Doc UNEP/CBD/COP/10/5/Add.5, Article 3. 20

130   Marie Wilke ‘nature’, of health emergencies. The meaning of ‘public health emergenc[ies] of international concern’ is defined as .

an extraordinary event which is determined to constitute a public health risk to other States through the international spread of disease and to potentially require a coordinated international response.23

The scope is thus further defined by the definitions for ‘event’, ‘disease’ and ‘public health risk’. The term ‘event’ is broadly defined as ‘a manifestation of disease or an occurrence that creates a potential for disease’.24 ‘Disease’ further means ‘an illness or medical condition, irrespective of origin or source, that presents or could present significant harm to humans’.25 Finally, ‘public health risk’ refers to ‘a likelihood of an event that may affect adversely the health of human populations [. . .]’.26 This broad scope, covering diseases caused by non-biological pathogens, industrial accidents or contaminated food products, for instance, has been lauded as one the most important successes of the Regulations’ revision in 2005.27 The use of almost identical language in the Nagoya Protocol, the absence of limitations or restrictions in Article 8.b and the reference to the WHO International Health Regulation (2005) in the preamble support the above reading that the scope of Article 8.b of the Nagoya Protocol equally extends well beyond health emergencies caused by biological pathogens to cover other external instances such as plant accidents. Finally, it is noteworthy that Article 8.b is neither limited to health emergencies of international concern, as are the International Health Regulations (2005), nor is it limited to emergencies that have a particular international status. Rather, it refers to ‘public health emergencies as determined internationally or nationally’. Internationally, the WHO would be the institution to determine the status of a health incident on the basis of the International Health Regulations (2005) and other relevant documents. Thus, this phrasing suggests that where a health emergency is found to fall within the Regulation’s definition of a ‘public health emergency of international concern’, it would also fall within the scope of Article 8.b of the Nagoya Protocol. The determination of instances of national concern, however, lies within the discretion of affected States. While guidance is provided by the International Health Regulations (2005) to the extent that they define health emergencies,  IHR 2005 Article 1 (emphasis added).  IHR 2005 Article 1. 25  IHR 2005 Article 1 (emphasis added). 26  IHR 2005 Article 1 (emphasis added). 27  David P. Fidler and Lawrence O. Gostin, “The New International Health Regulations: An Historic Development for International Law and Public Health,” Journal of Law, Medicine & Ethics 33 (2006) 86–87. 23 24

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there is no internationally binding definition of local or national health emergencies. Countries are thus free to also take account of health emergencies caused by natural pathogens, or as discussed above, by instances such as plant accidents or natural disasters, but there is no requirement to do so. Especially for biodiversity-rich countries that provide resources for utilisation in the pharmaceutical sector, it might, however, be desirable to opt for such a broad scope in order to capture these benefits by expedited benefitsharing procedures in case of health emergencies. 2.  Access to Genetic Resources in Times of Emergency An issue that continues to be mentioned in relation to the Nagoya Protocol’s scope is whether the agreement, as a protocol to the CBD, can capture resources (pathogens) that are meant to be extinct rather than conserved. This discussion is certainly of utmost relevance for the scope of Article 8.b as the provision can only apply to resources that are also covered by the Protocol itself. Strikingly, the issue tends to be raised by non-CBD Parties and non-governmental organisations, rather than States that have subscribed to the objectives of biodiversity conservation.28 The Nagoya Protocol and specifically Article 8.b, supported by the negotiation history, in fact, leave no doubt that pathogens are indeed covered by the Protocol. This is particularly true as almost all pathogens also have benign functions and often the line between pathogenic and benign functions are hard to distinguish. The exclusion of genetic resources on the basis of their type of utilisation, on the other hand, would not be feasible. Nonetheless, it is worth mentioning an example that succinctly makes the point that pathogenic genetic resources in fact must be and are covered by the CBD and the Nagoya Protocol and that this wide scope, by no means, is contradictory to the objective of biodiversity conservation.  E.g., the positions of the International Chamber of Commerce in CBD Ad Hoc OpenEnded Working Group on Access and Benefit-Sharing, “Collation of any other views and information submitted by Parties, governments, international organisations, indigenous and local communities and relevant stakeholders in respect of the main components of the international regime on access and benefit-sharing listed in Decision IX /12, Annex I,” (8 January 2009) UN Doc UNEP/CBD/WG-ABS/7/6; and ICC Task Force on the Convention on Biological Diversity, “Pathogens and the International Regime on Access and Benefitsharing,” ICC Policy Brief 450/1051 (11 September 2009). It is more difficult to obtain written confirmations on informal positions taken by countries not Parties to the Convention, in particular the United States. Nonetheless it should be noted that, in particular, the United States were vocal advocates of a limited scope on pathogens in the Nagoya Protocol as observed by the author and as reported (on the basis of unverified observations) by a former delegate; see Gurdial Singh Nijar, “The Nagoya ABS Protocol and Pathogens,” South Centre 4 (11 March 2011): 1–6.

28

132   Marie Wilke Influenza viruses, primarily threaten animals and plants. In the case of H5N1, for instance, infections with the relevant Asian lineage were responsible for the loss of 250 million domestic poultry between 2005 and 2010. Moreover, several major wild bird mortality events due to H5N1 infections have been reported since 2005. This included an instance in May to June 2005 in Qinghai Lake, China where six thousand migratory wild birds died of the influenza clade29 and the death of approximately 15 to 25 thousand waterbirds in Northern Azerbaijan in 2006 (though it was not confirmed that all mortalities were due to the H5N1 infections).30 But the virus also threatens mammals as a number of wildcat and civet infections in Asia show. For instance, in 2005, researchers reported about three fatal infections of Owston’s civets – a globally threatened viverrid type – in a Vietnamese conservation centre.31 The development of effective treatment is thus pivotal for the conservation of biodiversity – rather than the contrary. For that very reason, and as a consequence of a lack of language that would suggest otherwise, the Nagoya Protocol, as well as Article 8.b, apply to genetic resources with pathogenic potential, including viruses. Another question that arises regarding the type of genetic resources addressed by Article 8.b is whether it applies only to certain types of pathogenic materials. As discussed above, the majority of negotiating proposals brought forward in this regard referred to biological material with human pathogenic potential.32 This proposed scope would have applied to both the access and the benefit-sharing obligations. The final provision, however, is  Ji-Yong Zhou et al., “Characterisation of a highly pathogenic H5N1 influenza virus derived from bar-headed geese in China,” Journal of General Virology 87 (2006). 30  Scott Newman et al., “FAO EMPRES Wildlife Unit Fact Sheet: Wildlife and H5N1 HPAI Virus – Current Knowledge,” Animal Production and Health Division, FAO (2010). 31  S.I. Roberton et al., “Avian influenza H5N1 in viverrids: implications for wildlife health and conservation,” Proceedings of the Royal Society: Biological Sciences 273 (22 July 2006). 32  CBD, “Report of the Second Part of the Ninth Meeting of the Ad Hoc Open Ended Working Group on Access and Benefit-Sharing,” (28 July 2010) UN Doc UNEP/CBD/COP/10/5/ Add.4, Article 3; and CBD COP, “Report of the Third Part of the Ninth Meeting of the Ad Hoc Open Ended Working Group on Access and Benefit-Sharing,” (17 October 2010) UN Doc UNEP/CBD/COP/10/5/Add.5, Article 3. A notable exception was a proposal by the EU submitted during the first and again the second part of the 9th meeting of the CBD ABS Working Group. It read as follows: ‘In developing and implementing domestic ABS laws, policies or measures, provide immediate access to pathogens falling also under the scope of relevant international organisations and conventions, such as the World Health Organisation, International Plant Protection Convention, or the World Organisation for Animal Health, and which are of particular public concern for the health of humans, animals or plants, in ways and for uses provided for in existing and future rules, procedures or practices on the sharing of pathogens and related benefits established under those international organisations and conventions’; CBD, “Report of the Ninth Meeting of the Ad Hoc Open 29

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silent as to the type of genetic resources covered. Instead it simply refers to ‘genetic resources’. The substantive scope is thus only informed by the abovediscussed conditionality, i.e. the existence of a health emergency. However, the provision does not require the genetic resources addressed therein to be the cause of the health emergency. Instead the language suggests that the genetic resources must be relevant, which could also be the case where the genetic resource is relevant for emergency response. This in turn means that unlike what had been originally proposed, Article 8.b does not only apply to material with pathogenic potential but also to material with anti-pathogenic properties. The critical element is that access to a certain resource in times of emergency is relevant for responding effectively to said crisis. A classical example of a genetic resources derived pharmaceutical that is not based on a pathogen is Aspirin. 3.  Benefit-sharing in Times of Health Emergencies As in the case of the material scope of genetic resources, the material scope of benefits covered by Article 8.b is only defined by the relationship of benefits and public health emergencies. Beyond that there is no further specification as to what type or form of benefits is covered by Article 8.b. While it can be fairly assumed that Article 8.b covers all benefits recognised by the Protocol, the relationship of the resources and benefits addressed in Article 8.b is less clear. That is because the provision refers to ‘benefits arising out of the use of such genetic resources’ (emphasis added), which, at first sight, appears to refer to the resources accessed through the fast-track procedures suggested by Article 8.b. This language raises the question whether benefit-sharing obligations that arise on the basis of access that occurred prior to the emergence of a public health threat, are not covered by the requirement to consider expeditious benefit-sharing. This is against the background that the standard ABS framework introduced by the Nagoya Protocol applies to pathogens, i.e., the standard ABS obligations.33 The questions is thus whether the Article 8 special considerations only apply to benefit-sharing obligations that derive from resources made available through expedited access procedures, or whether other benefits could also fall within the scope of Article 8.b. For instance, a pharmaceutical company may have accessed relevant anti-pathogenic material to develop a medicine at a time when no health emergency existed. By the time a relevant health emergency develops, the company already Ended Working Group on Access and Benefit-Sharing,” (26 April 2010) UN Doc UNEP/ CBD/WG-ABS/9/3, paragraph 97, Article 6. 33  Enshrined, among others, in Nagoya Protocol Articles 5–6.

134   Marie Wilke produces the medicine and, due to the specific production procedures, no longer requires physical access to the resource. If it were true that Article 8.b only covered benefit-sharing obligations that arise from expedited access, these benefit-sharing obligations would not need to be executed on a priority or otherwise expedited basis, despite the apparent linkage and importance of the benefits. However, the language used in Article 8.b mirrors that used throughout the Protocol, including in relation to the Protocol’s scope.34 Moreover, nowhere else does the Protocol make access the relevant determination for benefitsharing. On the contrary, the relevant activity is utilisation, which is one of the main concepts of the Nagoya Protocol.35 If Article 8.b were interpreted to make access the relevant activity, it would follow a different logic than the rest of the Protocol. Moreover, the objective of Article 8.b is to ensure that ABS obligations support public health response and prevention efforts.36 To then exclude relevant benefits deriving from continuous utilisation, but where access occurred before the emergency, would run counter to these objectives. Finally, as the negotiation history shows, and as reflected in the suggested benefit-sharing options, Article 8.b refers to providing access to affordable treatments by those in need, especially in developing countries. Thus, Article 8.b is meant to ensure equitable access to benefits on the basis of need rather than entitlement.37 Unlike in most other ABS situations, an entitlement to benefit-sharing does not derive from a bilateral access relationship but from a situation of need. This distributive justice38 dimension would be seriously prejudiced if the benefit-sharing obligations enshrined in Article 8.b were made subject to the requirement that the recipients (prior to the benefit-sharing) granted expedited access. This is particularly true where there is no direct correlation between the provider country, the user and the point of access and ‘those in need’. Article 8.b, however, remains silent on the practical execution of this concept. Especially, the authority that determines ‘those in need’ and that decides on an appropriate allocation of resources is unknown. Instead the Protocol points to the discretion of the relevant user country to determine, in its relevant ABS legislations and regulations, who it considers to be ‘in need’ and thus to regulate the appropriate allocation of resources. As a consequence, in  Nagoya Protocol Article 3.  [See contribution by Lyle Glowka and Valérie Normand to this volume (Chapter 1).] 36  As it is clearly reflected in the last sentence of Nagoya Protocol Article 8.b. 37  Marie Wilke, “A Trace of Distributive Justice in the Nagoya Protocol: Rules for Health Emergencies,” (contribution to workshop on “Fairness and Bio-Knowledge” at University of Warwick, Coventry, United Kingdom, 16–17 June, 2011). 38  Bram de Jonge, “Plants, Genes and Justice: An Inquiry into Fair and Equitable BenefitSharing” (PhD diss., Wageningen University, 2009): 18. 34 35

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practice, this may come down to donations and traditional development aid. In that regard the Protocol notably differs from similar regimes established under the auspices of the World Health Organisation. Likewise, Article 8.b does not further specify the relationship of private rights and obligations and State obligations. As the Nagoya Protocol is an international treaty, Article 8.b may only bind its contracting Parties. These will need to ensure that their ABS legislation is designed in a manner that the realisation of the special considerations for health emergencies is not undermined by private rights that might arise from mutually agreed terms of material transfer agreements. To achieve this in a unilateral manner could prove highly difficult. Thus, to put the principle of distributive justice into practice and to ensure the system’s sustainability, contracting Parties would be well advised to jointly discuss potential solutions and approaches and to develop non-binding guidelines or even a regulatory framework. Experiences from the WHO might be telling and guiding in this regard. Absent such clarifications, however, Article 8.b must be understood to cover, in an abstract manner, all benefit-sharing obligations that are relevant to ensure appropriate public health responses in times of emergency. This may cover pharmaceuticals needed to prevent the spread of a disease, diagnostics and monitoring tools and vaccines as well as knowledge relevant for the production processes of any of the above. Furthermore it should be noted that the ‘type’ of benefit sharing would also be informed by the objective to support emergency response measures. While in certain circumstances, and for certain resources, knowledge or technology transfer could prove helpful to build production capacities over time (in instances where health emergencies are of rather long-term character), in other situations in-kind contributions in the form of the pharmaceutical product in question might be more suitable. This is particularly true for vaccines, where countries depend on direct, quick access to the actual products, as the limited global vaccine production capacity can prevent countries from accessing materials from other sources. In these instances, financial contributions would not be able to provide the same relief. Thus, usually in-kind contributions are required through expedited processes. Alternatively, tiered pricing and delivery guarantees could help mitigate the negative effects that arise from limited global production.

II.  The Relationship with Other International Instruments While the development of genetic resource-based medication is a classical example of utilisation of genetic resources and related benefit-sharing, global coordination of public health responses in times of emergency is largely

136   Marie Wilke addressed by international systems outside the CBD framework. In fact, public health research and development is highly shaped by multilateral cooperation and public incentives aiming to increase research on neglected diseases.39 Various WHO instruments also aim at ensuring the development and improvement of needed vaccines and treatments, increasing global production capacities to mitigate shortages and guaranteeing fair distribution.40 Furthermore, with the recently agreed PIP Framework, WHO Member States adopted the first ABS agreement in the area of public health.41 The Nagoya Protocol is thus set to touch upon a number of issues also addressed by WHO or other relevant public health agreements and efforts. Against this background, the relationship of Article 8.b and other international instruments deserves further attention. The relationship of the ABS regime under the CBD with other international agreements, instruments and works and practices is explicitly addressed in the Nagoya Protocol through Article 4. The provision first addresses the Protocol’s relationship with other, either existing or future, international agreements.42 It further addresses the relationship of the Nagoya Protocol and specialised ABS instruments, stating, ‘where a specialised instrument exists that is consistent with the [P]rotocol’s objectives, the [P]rotocol does not apply between the Parties to the resources in question and for the purpose of the specialised instrument’.43 This is a clear recognition of the need for specialised rules for certain genetic resources, and of the possibility of developing and implementing further specialised ABS regimes in the future. The Nagoya Protocol would inform such negotiations, as the instruments must be supportive of the Protocol’s objectives. The same applies for other relevant international agreements that are non-ABS agreements. In addition, the Protocol encourages ‘mutual supportiveness’ between the protocol and other relevant international instruments.44

 E.g., WHO Consultative Expert Working Group on Research and Development: Financing and Coordination, “Research and Development to Meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination” (Report for WHO, 5 April 2012). 40  WHO Global Action Plan. 41  Marie Wilke, “The WHO’s Pandemic Influenza Preparedness Framework as a Common Pool in Public Health,” in Common Resources Pools in Access and Benefit Sharing, ed. Evanson Chege-Kamau and Gerd Winter (London: Earthscan, forthcoming 2012). 42  Nagoya Protocol Article 4.1–4.2. 43  Nagoya Protocol Article 4.4. 44  Nagoya Protocol Article 4.3. 39

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1.  Mutual Supportiveness The concept of mutually supportive implementation in international law has recently received much attention, as it has become an almost standard clause in conflict rules of international agreements.45 Little is known, however, at this stage as to the exact legal nature and scope of the concept and its role in treaty interpretation and adjudication at the international and national level. Some lawyers understand this concept as a principle that further develops the approaches of harmonious application or systemic integration, by adding an additional law-making dimension.46 However, often the concept is overlooked, labelled as merely a diplomatic platitude that reflects the understanding that countries shall not sign onto conflicting agreements. It is beyond the scope of this chapter to explore this discussion in detail or to even discuss a possible approach in the context of Article 8.b of the Nagoya Protocol as the applicability is very case-specific. Nonetheless, it can be said that in abstract terms, the concept requires ABS obligations to be interpreted in a manner that does not frustrate international, regional or national public health efforts while these efforts in turn may not go against the object and purpose of the Nagoya Protocol. This is an affirmation of the objective enshrined in Article 8.b itself; that ABS systems must not stand in the way of global health and that the two systems can function in a mutually reinforcing manner. Access to genetic resources and benefit-sharing promote research in and access to needed pharmaceuticals, while public health supports biodiversity conservation and potentially ABS. 2.  The WHO PIP Framework As a Specialised Instrument As mentioned above, the WHO PIP Framework is the first ABS mechanism in the area of public health. Moreover, its coming into being was closely linked to the ABS negotiations under the CBD with one process impacting the other. The following discussion will thus focus on these two instruments with the aim of assessing their legal and regulatory interrelation, including  See generally Laurence Boisson de Chazournes and Makane Moïse Mbengue, “A propos du principe soutien mutuel: Les relations entre le Protocol de Cartagena et les Accords de l’OMC,” Revue Générale de Droit International Public 4 (2007); see also Laurence Boisson de Chazournes and Makane Moïse Mbengue, “A ‘Footnote as a Principle.’ Mutual Supportiveness and its Relevance in an Era of Fragmentation,” in Coexistence, Cooperation and Solidarity: Liber Amicorum Rüdiger Wolfrum, ed. Holger P. Hestermeyer et al. (Leiden, The Netherland; Boston: Martinus Nijhoff Publishers/Brill, 2012): 1615; see also Riccardo Pavoni, “Mutual Supportiveness as a Principle of Interpretation and Law-Making: A Watershed for the ‘WTO-and-Competing-Regimes’ Debate?” European Journal of International Law 21 (2012): 649. 46  See generally de Chazournes and Moïse Mbengue, “Mutual Supportiveness.”

45

138   Marie Wilke their potential to be mutually supportive. The discussion sheds light on ABS in the area of influenza pandemic preparedness, as well as the possible interrelation of the Nagoya Protocol and future ABS health instruments. a.  An Introduction to the WHO PIP Framework The final PIP Framework largely builds upon existing WHO structures, first and foremost the WHO’s Global Influenza Surveillance and Response System (GISRS).47 The system links national laboratories, so called National Influenza Centres, with WHO laboratories, consisting of six recognised WHO Collaborating Centres, situated in Australia, China, Japan, the United Kingdom and the United States, three H5N1 Reference Laboratories and nine Essentially Regulatory Laboratories.48 On a basic level, National Influenza Centres submit national viral samples to the WHO laboratories, which use them for genetic and antigenic analysis and that develop relevant testing kits and candidate vaccine viruses on the basis of the samples.49 These samples and testing kits are returned to the National Influenza Centres on a regular basis. Epidemiological information, such as the emergence and spread of certain virus strains is further stored in a WHO administered database, the FluNet.50 For the past sixty years, the Global Influenza Surveillance and Response System has been at the core of global seasonal influenza epidemic response, including vaccine development. The H5N1 crisis, however, substantially weakened the system as the scandal surrounding the vaccine development questioned the legitimacy of the system, which had been used for the transfer of the samples in question.51 Against that background, the PIP Framework negotiations were concerned with clarifying the terms and conditions of the system,

 The Global Influenza Surveillance and Response System was formerly known as Global Influenza Surveillance Network (GISN) and has been in place since 1952. One of the declared goals of the PIP negotiations was to strengthen the system by clarifying rules and procedures and by adding obligations that would balance actors’ rights and obligations. See Sixtieth World Health Assembly, “Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits,” (23 May 2007 WHA60.28 (PIP Mandate), paragraphs 1.1, 2.1–2.5. 48  WHO, “Global Influenza Surveillance and Response System (GISRS)”, accessed 10 February 2012, http://www.who.int/influenza/gisrs_laboratory/en/. 49  WHO, “National Influenza Centres”, accessed 10 February 2012, http://www.who.int/ influenza/gisrs_laboratory/national_influenza_centres/en/. 50  WHO, “FluNet”, accessed February 2012, http://www.who.int/influenza/gisrs_laboratory/ flunet/en/. 51  Adam Kamradt-Scott and Kelley Lee, “The 2011 Pandemic Influenza Preparedness Framework: Global Health Secured or a Missed Opportunity?” Political Studies 59 (December 2011): 832. 47

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strengthening its application and use and adding benefit-sharing obligations to the Global Influenza Surveillance and Response System.52 The PIP Framework strengthens this system in various ways, amongst others through the introduction of new reporting obligations for all involved GISRS laboratories, links with other relevant activities at the WHO, first and foremost activities on increasing vaccine production capacities, and newly agreed goals in the areas of technology transfer, research collaboration and emergency stockpiles.53 However, as the Framework itself was adopted in the form of a non-binding resolution by the World Health Assembly,54 the most important addition are binding standard material transfer agreements (SMTAs) that regulate the exchange of samples and introduce binding benefit-sharing obligations. These agreements automatically apply to any actor that makes use of the system, whether it is a submitting National Influenza Centre, a WHO laboratory or an outside institution that seeks to receive processed material for commercial or non-commercial utilisation.55 Thus, while the Framework agreement is non-binding for Member States, it comes with binding agreements that govern the use of the system in the form of ‘contract clauses’. There exist two models: SMTA1 applies to institutions within the Global Influenza Surveillance and Response System, SMTA2 applies to material recipients56 outside the system.57 According to the framework agreement, when providing biological material, a country consents to its onward transfer and use.58 SMTA1 accordingly applies automatically between the providing and the receiving party, that is the National Influenza Centres and the WHO laboratories. Their obligations are further detailed in standard terms of references attached to the Framework.59 SMTA2, on the other hand, needs to be negotiated prior to the transfer of resources.60 Parties to the Agreement are the WHO and the receiving  PIP Mandate paragraphs 1.1, 2.1–2.5.  PIP Framework Annex 4 and Articles 6.2, 6.9 and 6.13. 54  Sixty-fourth World Health Assembly, “Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits,” (24 May 2011) WHA64.5. 55  PIP Framework Articles 5.4.1–2. 56  The PIP framework refers to ‘recipients’ rather than ‘user’. The term refers to the person receiving a sample from the Global Influenza Surveillance and Response System. As this form of resource-sharing is embedded in an institutionalised system and based on contracts, it does not follow the terminology of the CBD (provider, holder and user) but identifies actors according to their relationship with the Global Influenza Surveillance and Response System system (provider is the institution lawfully providing a sample, recipient is the person lawfully receiving a sample from the system). 57  Ibid. 58  PIP Framework Article 5.1.1–2. 59  PIP Framework Annex 4–8. 60  PIP Framework Annex 2, Article 4.4. 52 53

140   Marie Wilke institution that is outside the Global Influenza Surveillance and Response System.61 Thus, the WHO is responsible for negotiating the SMTA2 with outside institutions prior to the transfer.62 The originally submitting country no longer participates in this process, but instead the relationship is ‘multilateralised’ through the role of the WHO. While SMTA1 comes without any benefit-sharing obligations and a clear statement on intellectual property rights providing that ‘neither the provider nor the recipient should seek to obtain any intellectual property rights on the material’,63 SMTA2 allows for intellectual property rights, but obliges the recipient to engage in at least two different benefits-sharing activities.64 The distinction reflects the nature of the Framework. While the sharing of viruses with the WHO and its Collaborating Centres takes place for research purposes, and with the aim to facilitate global responses, private actors usually aim at the utilisation of the resources for commercial purposes. According to SMTA2,65 as a benefit-sharing contribution, the recipient must, as applicable, commit to either make available vaccines/antiviral medicine or grant licenses to manufacturers in developing countries or the WHO.66 However, contrary to the requests from most developing countries, neither option must be free of costs.67 Rather, each option can be either a donation (at no cost) or at affordable prices – this remains subject to negotiations in each case.68 Consequentially, the case-specific negotiation of applicable material  PIP Framework Article 5.4.2.  PIP Framework Annex 2, Article 4.1.1. 63  PIP Framework Annex 1, Article 6.1. 64  PIP Framework Annex 2, Article 4.1.1(A). 65  SMTA2 Article 4. 66  SMTA2 Article 4. 67  Brazil, Indonesia, India and others had insisted on these options in earlier negotiation proposals. See “SMTA 1 and 2 Proposals from Brazil, Indonesia and India to the WHO Open-Ended Working Group on Pandemic Influenza Preparedness: sharing of influenza viruses and access to vaccines and other benefits, White Paper 1 and 2” included in the Report by the Director General, “Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits: Outcome of the Open-ended Working Group on Pandemic Influenza Preparedness: sharing of influenza viruses and access to vaccines and other benefits” (14 May 2010) A63/48, Annex I, Appendix I “EB/PIP/OEWG/ White Paper 2 and 3”, pp. 14–20. 68  The full text of SMTA2 Article 4.1.1(A) provides that: For manufacturers of vaccines and/or antivirals, the recipient shall commit to at least two of the following options: A1. Donate at least 10%* of real time pandemic vaccine production to WHO. A2. Reserve at least 10%* of real time pandemic vaccine production at affordable prices to WHO. A3. Donate at least X treatment courses of needed antiviral medicine for the pandemic to WHO. 61 62

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transfer agreements continues to be critical for the process of virus-sharing under the PIP Framework. Yet, in emergency situations where all actors are dependent on the timely development of vaccines, STMAs subject to negotiations can nonetheless be helpful as they provide for a framework within which the actors can manoeuvre. Also, in the PIP Framework it is the WHO that negotiates the final SMTAs and not isolated developing countries. This introduces further checks and balances. b.  Ambiguity As to the Relationship of the PIP Framework and the Nagoya Protocol During the negotiations of the Nagoya Protocol, as well as of the WHO PIP Framework, the relationship of the two instruments was discussed controversially. The Nagoya Protocol was adopted at a time where WHO negotiations had not proceeded far, with the legal nature of the final WHO system still being disputed (with some countries refusing to agree to obligatory benefit-sharing obligations).69 It was clear to Members that any agreement in Nagoya would influence the WHO outcome. Recognising the WHO system as a specialised regime would have excluded the relevant materials from the scope of the Nagoya Protocol and, arguably, also confirmed their exclusion from the CBD. This would have severely diminished the negotiation power of the WHO demandeur countries as the potentially far reaching ABS obligations on a bilateral basis deriving from the CBD system, and corresponding legal insecurity, were among the main incentives for industry and developed country representatives to actively engage in the PIP negotiations.70 Also, A4. Reserve at least X treatment courses of needed antiviral medicine for the pandemic at affordable prices. A5. Grant to manufacturers in developing countries licenses on mutually agreed terms that should be fair and reasonable including in respect of affordable royalties, taking into account development levels in the country of end use of the products, on technology, know-how, products and processes for which it holds intellectual property rights for the production of (i) influenza vaccines, (ii) adjuvants, (iii) antivirals and/or (iv) diagnostics. A6. Grant royalty free licenses to manufacturers in developing countries or grant to WHO royalty-free, non-exclusive licenses on intellectual property rights, which can be sublicensed, for the production of pandemic influenza vaccines, adjuvants, antivirals products and diagnostics needed in a pandemic. WHO may sublicense these licenses to manufacturers in developing countries on appropriate terms and conditions and in accordance with sound public health principles. 69  Report by the Director General, “Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits: Outcome of the resumed Intergovernmental Meeting,” (18 May 2009) A62/5 Add.1, paragraph 5.4. 70  These dynamics were apparent during the final negotiation round as reflected in informal comments from industry and governments. E.g., Roy Zwahlen, “Pathogens and the Nagoya Protocol of the Convention on Biological Diversity,” Patently Biotech, 7 December 2010,

142   Marie Wilke the legally binding ABS obligations as included in the CBD, were one of the international legal bases for the WHO negotiations.71 Thus, excluding pathogens or viruses or health emergencies from the scope of the Nagoya Protocol would have severely diminished the chances for a strong benefitsharing accord at the WHO. This was particularly true as by the time of the adoption of the Nagoya Protocol, it was still disputed whether the WHO instrument could take the form of a legally binding instrument and whether benefit-sharing obligations should be obligatory or simply governed through a voluntary ‘donation’ system.72 At the same time, for obvious reasons, it was critical to ensure that the Nagoya Protocol would not interfere with the present and future WHO system. The history of the negotiations under the WHO indicates that the conclusion of the negotiations of the Nagoya Protocol indeed proved a critical facilitator for the WHO negotiations. Once countries knew what to expect from the CBD, they were willing to negotiate the core parts of the PIP Framework. As of that point the Nagoya Protocol served as a fall-back regime which recognised the sovereign right to pathogens, including viruses, and the related right to benefit-sharing even in times of emergency. This ‘minimal threshold’ induced developed countries in December 2010 – only two weeks after the adoption of the Nagoya Protocol – to finally consider binding benefitsharing commitments as a viable option; though it took six more months for countries to find consensus.73 More importantly, the Nagoya Protocol, with its looming ambiguity, induced the private sector to support a strong WHO mechanism that would introduce legal certainty and clarity regarding their rights and obligations.74 Their main fear was that the effective Global Influenza Surveillance and Response System would be substantially weakened through the Nagoya regime. In April 2011, shortly before the agreement was finalised, Member States undertook intense one-week consultations with accessed 10 February 2012, http://www.biotech-now.org/public-policy/patently-biotech/ 2010/12/pathogens-and-the-nagoya-protocol-of-the-convention-on-biological-diversity; and ICTSD, “WHO Virus Sharing Agreement After Four-Year Debate,” Bridges Weekly Trade News Digest 15 (4 May 2011): 6–9. 71  PIP Mandate paragraph 4; the Mandate specifically ‘[re]cognis[ed] the sovereign right of States over their biological resources, and the importance of collective action to mitigate public health risks.’ 72  Report by the Director General, “Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits: Outcome of the resumed Intergovernmental Meeting,” (18 May 2009) A62/5 Add.1. 73  World Health Organisation, “Report of the Open-Ended Working Group of Member States on Pandemic Influenza Preparedness: Sharing of Influenza Viruses and Access to Vaccines and Other Benefits,” (17 December 2010) A/PIP/OEWG/2. 74  Zwahlen, “Pathogens and the Nagoya Protocol of the Convention on Biological Diversity”; ICTSD, “WHO Reaches Virus Sharing Agreement After Four-Year Debate.”

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private sector representatives to discuss viable technical options and solutions in this regard.75 One co-chair later called it the ‘decisive meeting that made the SMTAs possible’.76 Without the private sector’s participation it was unlikely that Members such as the US, that were strictly opposing the idea of binding benefit-sharing commitments, would adopt the resolution or that it would work in practice – for the rapid development of effective vaccines and for timely and affordable access to these. The legal relationship between the Nagoya Protocol and the PIP Framework, however, remained disputed. While the US aimed at introducing a statement in the PIP Framework that would have effectively placed pathogens per se outside the scope of the Nagoya Protocol (by reaffirming the Protocol’s non-applicability), Australia and other countries pushed for recognising the PIP Framework’s prevalence.77 In the last hour a reference to the Nagoya Protocol that would have established the Framework as a specialised ABS instrument within the meaning of Article 4 Nagoya Protocol was deleted from the World Health Assembly resolution adopting the new Framework.78 Instead the Framework and the SMTAs remain silent on the issue. Thus the relationship needs to be evaluated from the perspective of the Nagoya Protocol and its conflict rules.79 c.  The PIP Framework As a Specialised Instrument As mentioned above, the development and implementation of specialised instruments is generally permitted by the Nagoya Protocol,80 provided that these are ‘supportive of and do not run counter to the objectives of the convention’. Accordingly, where such a specialised international ABS instrument exists, the Protocol does not apply for the Parties in respect to the resources covered by the specialised instrument.81 The main question in this regard is whether the PIP Framework runs counter to the objectives of the Protocol. It is the Protocol’s declared objective to achieve ‘fair and equitable sharing of the benefits arising from the utilisation of genetic resources, including by appropriate access to genetic resources  Intellectual Property Watch, “Preparing The World For Influenza Pandemic, Industry Role Key, Says WHO,” 12 April 2011, accessed 10 February 2012, http://www.ip-watch. org/2011/04/12/preparing-the-world-to-influenza-pandemic-industry-key-role-says-who/. 76  Anonymous interview, on file with author. 77  Intellectual Property Watch, “WHO Members on Verge of New Framework for Pandemic Flu Response,” 23 May 2011, accessed 10 February 2012, http://www.ip-watch .org/2011/05/23/who-members-on-verge-of-new-framework-for-pandemic-flu-response/. 78  Ibid. 79  Contained in Nagoya Protocol Article 4. 80  Nagoya Protocol Article 4.2. 81  Nagoya Protocol Article 4.3. 75

144   Marie Wilke and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding, thereby contributing to the conservation of biological diversity and the sustainable use of its components’.82 As established above, the fact that the Framework aims at extinguishing certain resources does not per se indicate that it runs counter to the objectives of the Protocol. To the contrary, these two objectives are mutually supportive as the fight against highly aggressive zoonotic viruses supports the objectives of biodiversity conservation as it supports public health efforts. Consequently, concerning the Nagoya Protocol requirements regarding specialised instruments,83 the focus should rather rest on assessing to what extent the PIP Framework meets the objectives of ensuring access to genetic resources and the fair and equitable sharing of related benefits. The PIP Framework notes that its objective is ‘a fair, transparent, equitable, efficient, effective system for, on an equal footing, i) the sharing of [viruses]; and ii) access to vaccines and sharing of other benefits’.84 As under the Nagoya Protocol, the objective thus follows a dual approach: securing access as well as benefit-sharing. Both objectives are further strengthened through substantive provisions in the Framework as well as the individual SMTAs. For instance, the Framework notes that countries should, through their National Influenza Centres, provide in a rapid, systematic and timely manner, relevant resources and, where they decide to transfer material to non-GISRS institutions or not directly through the system, must provide the same materials on a priority basis to the WHO.85 This transfer may not be subject to conditions other than those already agreed to in the Framework agreement or stipulated in the SMTAs. The objective of unconditional and timely access is thus clearly reflected in the agreement. The same can be said about benefit-sharing obligations. The Framework lists a number of benefits, including those provided directly by the system such as diagnostic kits, epidemiological information and early warning services, and those provided by material recipients and countries.86 Importantly, the benefits provided directly by the WHO, as well as those by material recipients, are required in a legally binding way through the relevant terms of reference and SMTAs. These alternative benefit-sharing options fall within several categories of financial and non-financial benefits listed in the Nagoya Protocol.87  Nagoya Protocol Article 1.  Nagoya Protocol Article 4.4. 84  PIP Framework Article 2. 85  PIP Framework Article 5.1. 86  PIP Framework Article 6. 87  This includes, but is not limited to, those listed in the Nagoya Protocol Annex Articles 1.j and 2.b, c, d, f, m and q. 82 83

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However, while these rules reaffirm and support the objective of the Nagoya Protocol, it is worth noting that the PIP Framework is of nonbinding character.88 This is relevant to the extent that the non-legally binding nature could prejudice benefit-sharing in cases where non-GISRS institutions acquire GISRS material in an unlawful manner. For instance, where a National Influenza Centre transfers material that it previously received through the WHO from another National Influenza Centre to a non-GISRS institution, this intent must be notified to the WHO in advance in order to allow the WHO Director General to enter into the necessary SMTA2 negotiations.89 As non-GISRS institutions are not bound by ToRs or other predefined terms, the SMTA2 are the only applicable legal basis for benefitsharing claims. If the Nagoya Protocol was generally not available to any such transfer among institutions in WHO Member States, submitting countries would be left without any international legal right to benefit-sharing where another national laboratory or a WHO laboratory commits unauthorised onward transfer. For that reason, the Nagoya Protocol must remain applicable in the background. While this position might read as a form of ‘cherry picking’, this can be the only correct reading of Article 4.4 of the Nagoya Protocol. The PIP Framework reaffirms the sovereign right of States over their biological resources,90 but does not mean to replace this right in its entirety. Due to its non-binding character it can only apply to situations that are indeed covered by the agreement. Article 4.4 of the Nagoya Protocol does not preclude non-binding agreements from being recognised as specialised agreements as it clearly refers to ‘instruments’ rather than international agreements.91 Nonetheless, this cannot, in turn, be read as saying that the Nagoya Protocol ceases to be applicable to situations that are only on the face of it, but not effectively, covered by the specialised instrument. This position seems further supported by the negotiation history. The objective of Article 4.4 is to allow for the effective regulation of ABS in defined areas through specialised instruments without prejudicing the legal certainty of actors.92 However, where an actor knowingly escapes the realm of a specialised instrument by engaging in unauthorised transfer/receipt, Nagoya Protocol Article 4.4 may not be interpreted as the country having lost its benefit-sharing rights under the Nagoya Protocol. Against this background, the PIP Framework appears as a specialised instrument within the meaning of the Nagoya Protocol for the purpose of H5N1  As a consequence of the Framework’s adoption as a resolution by the World Health Assembly.  PIP Framework Annex 2, Article 4.4. 90  As noted in PIP Framework Principle 11. 91  As opposed to the reference to international agreements in Nagoya Protocol Article 4.2. 92   Elisa Morgera, Matthias Buck and Elsa Tsioumani, Commentary on the Nagoya Protocol on Access and Benefit-sharing (Boston: Martinus Nijhoff Publishers/Brill, forth. 2013), Article 4. 88 89

146   Marie Wilke and other influenza viruses with human pandemic potential lawfully shared through the Global Influenza Surveillance and Response System. Finally it should be noted that, in line with the PIP Framework, not all materials shared through the Global Influenza Surveillance and Response System could be considered exempt from the Nagoya Protocol’s scope by virtue of Article 4.4. Rather, ‘not included are seasonal influenza viruses or other non-influenza pathogens or biological substances that may be contained in clinical specimens shared through the Framework’.93 Even where accidentally shared, these resources remain outside the Global Influenza Surveillance and Response System’s scope and thus within the scope of the Nagoya Protocol, as relevant. This relationship of Article 8.b of the Nagoya Protocol and the WHO PIP Framework seems carefully designed, taking account of the distinctive characteristics of pandemic response dynamics. This might seem surprising, as the text of Article 8.b was only introduced by the Japanese Presidency in the final hours of the tenth meeting of the CBD COP on a take-it or leave-it basis with the issue being one of the ‘deal-breakers’ that characterised the last days of negotiations in Nagoya. The same goes for the PIP Framework where Members continued to argue over this relationship until the last minute before the adoption of the World Health Assembly resolution. In practice, however, the two instruments seem to be well equipped to form a working symbiosis: the core of the system forms the WHO Global Influenza Surveillance and Response System, which largely builds upon existing structures. This ensures that relevant activities are not disrupted and that actors can continue to work with familiar structures, which reduce burden and support efficiency and effectiveness. The Global Influenza Surveillance and Response System is further administered by the WHO, which reduced the potential for political manoeuvring and (though not fully) reduces power imbalances that characterise pharmaceutical research and development. Moreover, this anchor allows WHO Member States to establish further links between the PIP Framework and other WHO efforts, first and foremost the Global Action Plan. The PIP Framework already builds upon this initiative and further links would be highly desirable. At the same time, however, reliance on the WHO system does not reduce countries’ rights under the Nagoya Protocol as to a fair and equitable share to benefits. The Protocol is now reflected in the PIP Framework, but wherever the Framework is unable to deliver on these promises, the Nagoya Protocol remains applicable in the background. This overall constellation increases the likelihood that in the event of future pandemics,  As noted in Article 3.2 of the PIP Framework.

93

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countries can easily share relevant samples without having to engage in burdensome material transfer negotiations and that they will be supported with access to relevant pharmaceuticals. At the same time, the right to benefits remains a right protected by international law – and not only a principle subscribed to in a non-binding resolution by the World Health Assembly.

III.  Conclusion Article 8.b of the Nagoya Protocol can have great positive ramifications beyond pandemic influenza response. As the discussion in section I has shown, the scope of Article 8.b is fairly broad, covering all different kinds of health emergencies for humans, animals and plants and all related genetic resources – whether they are of pathogenic or anti-pathogenic nature. These two indirect confirmations, that the Protocol applies to pathogens and that ABS rules may not hamper public health efforts are of great importance. They strengthen both global ABS and global health systems. From the perspective of global health, however, stronger rules for health emergencies would have been desirable. The call for ‘special considerations’ and the obligation to ensure that ABS does not interfere with public health actions are rather weak, leaving substantial discretion to countries. This may be particularly critical where bilateral relationships are governed by contract terms, as the relationship of material transfer agreements and Article 8.b is unclear. This will need to be addressed through national ABS legislation. Moreover, against this background of ambiguity, countries might continue to prefer to negotiate material transfer agreements in times of emergency to ensure that their needs are met. As experienced in the case of H5N1, this can result in considerable delays or, given the power asymmetries, in weak benefit-sharing obligations. These negative effects could have been mitigated through more explicit rules for emergency situations. It is now up to States to address these insufficiencies through clever designed national legislation. Standard material transfer agreements, as in the case of the PIP Framework, however, would have been more desirable. Another positive effect of Article 8.b – going beyond the health area – is the affirmation that ABS may work on the basis of distributive justice, to the benefit of those in need. The fact that the Protocol diverts from its traditional bilateral approach in the area of public health is of great value. It may not only be the proper approach to this matter, but also the more effective one for all those situations in which a public good, a common value or an area of multilateral cooperation is concerned. In conclusion, countries may be well advised to turn to this principle and give it precedence when implementing

148   Marie Wilke other parts of the Protocol, be it under Article 8 (special considerations)94 or, for instance, Article 10 (global multilateral benefit-sharing mechanism).95 The value of distributive justice anchored in the Nagoya Protocol could turn out to be of equal value for other areas of ABS, as Article 8.b for the area of public health ABS.

 [This provision is also discussed in the contributions by Chiarolla, Louafi and Scholen and by Dedeurwaerdere et al. to this volume (Chapters 3 and 13).] 95  [This provision is also discussed in the contributions by Salpin, Oliva and by Young to this volume (Chapters 5, 12 and 15).] 94

Chapter 5:  The Law of the Sea: A before and an after Nagoya? Charlotte Salpin* With the completion of the Census of Marine Life in October 2010, a tenyear marine scientific research (MSR) expedition was coming to a close, having confirmed that the ocean biome, which makes up over 70 percent of the Earth, may be the most biodiverse ecosystem. As of January 2011, the Census had catalogued over 30 million species-level records, including 1200 newly discovered species. It also estimated that more than a billion types of microbes might live in the oceans.1 While much is yet to be discovered and described, we know that every component making up this diversity, from microbes to the emblematic blue whale, has critical functions in the marine ecological cycle. It is therefore not surprising that as much as humans have used terrestrial plants and organisms for centuries to cure diseases, they have also increasingly researched the marine environment in the hope of identifying organisms of actual or potential value to a number of sectors such as healthcare, cosmetics, the food processing industry, bioremediation, etc.2 Albeit a relatively recent phenomenon, the number of patent claims associated with genes of marine organisms has steadily grown by twelve percent per year, with 95 percent * Legal Officer, Division for Ocean Affairs and the Law of the Sea, Office of Legal Affairs, United Nations. The views expressed herein are those of the author and do not necessarily reflect the views of the United Nations. The author would like to thank all those that provided comments on earlier drafts of this paper, in particular Mr. Elie Jarmache. 1  Census of Marine Life, Highlights of a decade of discovery of marine life – A summary of the Census of Marine Life for decision makers (2011), 3–4. 2  For a review of discoveries and applications to date, see Salvatore Arico and Charlotte Salpin, Bioprospecting of Genetic Resources in the Deep Seabed: Scientific, Legal and Policy Aspects (Yokohama: United Nations University, 2005); United Nations, “Report of the Secretary General on oceans and the law of the sea” (2007) UN Doc A/62/66; David Leary et al., “Marine genetic resources: A review of scientific and commercial interest,” Marine Policy (2009); Tadeusz F. Molinski et al., “Drug development from marine natural products,” Drug Discovery 8 (2009), accessed 15 November 2011, doi:10.1038/nrd2487.

150   Charlotte Salpin of patent claims having been filed after 2000.3 In recent years, the General Assembly of the United Nations has recognised the value of marine genetic resources in terms of the benefits, goods and services they can provide, and recognised the importance of research on them.4 One would be hard-pressed to find a specific mention of genetic resources or biodiversity in the 1982 United Nations Convention on the Law of the Sea (UNCLOS), which sets out the legal framework for all activities in the oceans, from navigation and exploitation of fisheries, to MSR and the protection and preservation of the marine environment.5 Yet, UNCLOS addresses ‘marine life’,6 ‘natural resources’,7 ‘living resources’8 and ‘living organisms’9 in a number of ways from conservation, protection and preservation, to utilisation and research. These terms are general and can reasonably be understood, in light of the object and purpose of UNCLOS,10 to encompass all biological resources including genetic resources (defined as any material of plant, animal, microbial or other origin containing functional units of  Sophie Arnaud-Haond, Jesús M. Arrieta and Carlos M. Duarte, “Marine Biodiversity and Gene Patents,” Science 331 (2011): 1521, accessed 24 March 2011, doi:10.1126/science .1200783.  4  United Nations General Assembly, “Oceans and the Law of the Sea” (14 March 2008) UN Doc A/RES/63/111; United Nations General Assembly, “Oceans and the Law of the Sea” (12 February 2009) UN Doc A/RES/64/71; United Nations General Assembly, “Oceans and the Law of the Sea” (12 March 2010) UN Doc A/RES/65/37A; United Nations General Assembly, “Oceans and the Law of the Sea” (17 March 2011) UN Doc A/RES/66/231.  5  The 1982 United Nations Convention on the Law of the Sea (UNCLOS) is generally considered to reflect customary international law, either as a result of its codification of preexisting customary law or because its provisions, some of which were novel at the time of its adoption, have acquired such status. This is, for example, the case of its provisions on marine scientific research. See Annick de Marffy, “Les difficultés posées par la mise en application du nouveau regime de la recherche scientifique marine avant l’entrée en vigueur de la Convention des Nations Unies sur le droit de la mer,” Revue québécoise de droit international 5 (1988): 320; Elie Jarmache, “Sur quelques difficultés de la recherche scientifique marine,” in La Mer et son droit, Mélanges offerts à Laurent Lucchini et JeanPierre Quéneudec, ed. Daniel-Heywood Anderson et al. (Paris: Pedone, 2003), 314.  6  UNCLOS Articles 1.1.4 and 194.5.  7  UNCLOS Articles 56.1.a, 77, 79.2, 145, 193, 194.3, 246.5 and 249.2. The concept of natural resources under UNCLOS includes both living and non-living resources, see articles 56.1.a and 246.5.a.  8  UNCLOS Preamble and articles 1.1.4, 21.1, 56.1, 61, 62, 69, 70, 71, 72, 73, Section II of Part VII, 123, 277 and 297.3.  9  UNCLOS Article 77. 10  Article 31.1 of the 1969 Vienna Convention on the Law of Treaties provides that ‘a treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose’. The object and purpose of UNCLOS include the equitable and efficient utilization of oceans resources (Preamble).  3

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heredity of actual or potential value), organisms or parts thereof, populations, or any other biotic component of ecosystems.11 With the adoption and future entry into force of the 2010 Nagoya Protocol, which applies to marine genetic resources by virtue of the scope of the Convention on Biological Diversity (CBD),12 it is useful to consider the relationship between UNCLOS and the Nagoya Protocol, in particular as it is expected that some Parties to UNCLOS will also become Parties to the Nagoya Protocol.13 UNCLOS, which aims at establishing a legal order for the seas and oceans that will promote, inter alia, the equitable and efficient utilisation of their resources and the study of the marine environment,14 reflects a delicate balance between the respective interests, rights and obligations of coastal States and other States in the oceans. In the same manner, the Nagoya Protocol, which goes a step further than the voluntary Bonn Guidelines,15 by providing a legally binding framework, tries to balance the rights and obligations of provider and user countries of genetic resources in implementing the third objective of the CBD, namely the fair and equitable sharing of the benefits arising from the utilisation of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources.16 The Protocol establishes more predictable conditions for access to genetic resources and defines the modalities for prior informed consent (PIC) and fair and equitable sharing of benefits as required under CBD article 15. The balance of interests and rights, which underpins both instruments, is to be borne in mind when considering their relationship and implementation. In addition, article 22 of the CBD, which provides that its Parties shall implement it with respect to the marine environment consistently with the rights and obligations of States under the law of the sea, is also critical. That article provides guidance on the way in which the Nagoya Protocol,  See the definition of genetic resources and genetic material included in article 2 of the Convention on Biological Diversity (CBD). 12  According to Article 2 of the CBD, biological diversity is the variability among living organisms from all sources, including terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part, including diversity within species, between species and of ecosystems. 13  As of 10 June 2012, there were 162 Parties to UNCLOS. The Nagoya Protocol had 92 signatories, of which 81 were Parties to UNCLOS. 14  UNCLOS Preamble. 15  Bonn Guidelines on access to genetic resources and the fair and equitable sharing of the benefits arising from their utilisation, CBD Decision 6/24, “Access and benefit-sharing as related to genetic resources” (27 May 2002) UN Doc UNEP/CBD/COP/6/20. 16  Nagoya Protocol Article 1. 11

152   Charlotte Salpin which pursues the implementation of the objective of the CBD on access and benefit-sharing (ABS), relates to the law of the sea,17 in addition to the specific relationship clause included in the Protocol itself, which provides for mutual supportiveness with other international instruments.18 In essence, the Nagoya Protocol should also be implemented with respect to the marine environment consistently with the rights and obligations of States under the law of the sea.19 This paper will consider the implications that the Nagoya Protocol may have on the law of the sea, as reflected in UNCLOS, and vice-versa. The first section will consider whether tensions might be lying ahead between the Protocol and UNCLOS as far as the core provisions on ABS are concerned. The second section will then focus on the areas where the Protocol and UNCLOS may work in tandem to positively influence the implementation and development of international law, including in relation to marine genetic resources from areas beyond national jurisdiction. In light of the extent and complexity of the subject, this article can only highlight a few of the many issues that may arise from the simultaneous implementation of both instruments.

I.  Access and Benefit-sharing: Walking on Eggshells At the core of the Nagoya Protocol’s ABS provisions lie the requirements to obtain PIC of the State that is the country of origin of the resources20 (the  The 1969 Vienna Convention on the Law of Treaties is silent on the question of the relationship of a protocol to its parent treaty. However, the parent treaty (the CBD in this case) provides the overarching legal framework for the implementation of the protocol. In so far as the protocol does not purport to modify or replace any of the provisions of the parent convention, but rather implement it, its implementation can reasonably and logically be expected to have to be consistent with the parent convention in its entirety, including its relationship clause. 18  Nagoya Protocol Article 4. The relationship clause of UNCLOS is found in Article 311. Although the nature of the Protocol as a purely environmental treaty is questionable, it is also noteworthy that UNCLOS Article 237, which addresses obligations under other conventions on the protection and preservation of the marine environment, requires consistency of their implementation with the general principles and objectives of UNCLOS. 19  The relationship of the Nagoya Protocol to other international instruments, organisations and processes was one of the main issues under discussion up to the last stages of the negotiations of the Protocol. See Matthias Buck and Clare Hamilton, “The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity,” Review of European Community and International Environmental Law 20 (2011): 50, 58. 20  The “country of origin of genetic resources” is the country that possesses those genetic resources in in situ conditions (CBD, article 2). 17

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coastal State in the law of the sea context) or of the Party that has acquired the genetic resources in accordance with the CBD (a researching State in the law of the sea context), and to share in a fair and equitable way the benefits arising from the utilisation of genetic resources as well as subsequent applications and commercialisation.21 The counterparts to these obligations are twofold: the obligation for the State providing genetic resources which requires PIC and mutually agreed terms (MAT) to take the necessary legislative, administrative or policy measures regarding PIC and MAT;22 and the obligation for the State within the jurisdiction of which genetic resources are utilised to take legislative, administrative and policy measures to ensure that PIC and MAT have been established,23 and benefits from the utilisation of genetic resources as well as subsequent applications and commercialisation are shared in a fair and equitable way.24 UNCLOS sets out the rights and obligations of coastal States and other States regarding access to the maritime spaces and the resources found therein. It also embodies some form of benefit sharing, with varying degrees depending on the activities carried out and the zone where they take place. Following some preliminary observations, this section considers how the concomitant application of the provisions of UNCLOS and the Protocol in relation to ABS may affect coastal States and researching States. 1.  Preliminary Observations At the outset, it must be noted that the notion of what constitutes ‘access’ to genetic resources has evolved. Breakthroughs in high-throughput DNA sequencing and bioinformatics have contributed to rendering genetic resources into informational forms such as gene or protein sequence data held in databases. Practices in open science, technological advances and the digitability of genetic and other information have rendered genetic resources and derived information more accessible. Research and development on genetic resources has shifted from being solely a field biologist’s domain to one increasingly dominated by computational biologists and bioinformaticists.25 This means, consequently, that access does not necessarily involve in situ

 Nagoya Protocol Articles 6.1 and 5.1.  Nagoya Protocol Article 6.3. 23  Nagoya Protocol Article 1511. 24  Nagoya Protocol Article 5.3. 25  Lyle Glowka, “Evolving Perspectives on the International Seabed Area’s Genetic Resources: Fifteen Years after the ‘Deepest of Ironies’,” in Law, Technology and Science for Oceans in Globalisation, ed. Davor Vidas (Leiden/Boston: Martinus Nijhoff Publishers/Brill, 2010), 410–413. 21 22

154   Charlotte Salpin access anymore.26 This is particularly interesting as UNCLOS primarily focuses on an in situ approach – an approach that this article consequently follows. It must be noted, however, that the regime for ABS under the Nagoya Protocol does not take into account the complexity of the jurisdictional framework under the law of the sea, where the maritime space is multi-dimensional and divided both horizontally and vertically in a number of zones within which the rights of the coastal State and other States vary. There are thus different sets of regimes under national jurisdiction, depending on where an activity takes place: in the internal waters,27 archipelagic waters28 and the territorial sea;29 or in the exclusive economic zone (EEZ)30 and the continental shelf.31 This distinction is important as the impact of the Protocol may not necessarily be the same depending on where the biological material is taken. As regards physical access, both fishing and MSR, which are covered under UNCLOS, are, arguably, means of accessing biological material for subsequent use.32 However, the Protocol applies to activities undertaken with the intent of conducting research and development33 on the genetic and/or biochemical composition of genetic resources. On the contrary, utilisation  ‘Access’ under the Nagoya Protocol can include: physically collecting biological material in the wild; obtaining samples of genetic resources or biochemicals from collections and gene banks; obtaining samples of DNA sequences or biochemicals from a researcher working at a university or in the laboratory of a company; obtaining physical access to a digital library with information about genetic resources and their biochemical make-up found in in situ conditions; and the electronic transfer of digitalised information about gene sequences and naturally occurring biochemicals. Elisa Morgera, Matthias Buck and Elsa Tsioumani, Commentary on the Nagoya Protocol on Access and Benefit-sharing (Boston: Martinus Nijhoff Publishers/Brill, forth. 2013), Article 2. 27  The internal waters are the waters situated on the landward side of the baselines (UNCLOS Article 8). 28  The archipelagic waters are the waters enclosed by the archipelagic baselines (UNCLOS Article 49). 29  The breadth of the territorial sea extends up to a limit not exceeding 12 nautical miles, measured from the baselines (UNCLOS Article 3). 30  The EEZ lies beyond and adjacent to the territorial sea up to 200 miles from the baselines (UNCLOS Articles 55 and 57). 31  The continental shelf comprises the seabed and subsoil that extend beyond the territorial sea throughout the natural prolongation of its land territory to the outer edge of the continental margin, or to a distance of 200 nautical miles from the baselines where the outer edge of the continental margin does not extend up to that distance (UNCLOS Article 76). 32  Giuseppe Cataldi, “Biotechnology and marine biogenetic resources: the interplay between UNCLOS and the CBD,” in Biotechnology and International Law, ed. Francesco Francioni and Tullio Scovazzi (Oxford and Portland: Hart Publishing, 2006), 104. 33  See the contribution by Glowka and Normand to this volume. Article 2 of the Nagoya Protocol defines ‘utilisation’ of genetic resources as the ‘conduct [of] research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology as defined in Article 2 of the CBD’. It must be noted that 26

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of genetic resources through fishing is, at best, incidental as the conduct of research and development on the genetic composition of the fish is not the primary aim of fishing.34 Interestingly, though, fishing wastes can offer a source of high-value products, one such example arising from the extraction of cold alkaline phosphatase, used for dephosphorylation of DNA and proteins, from thawing shrimp waste.35 The notion of intent, intrinsic in the Nagoya Protocol, and the differences between fishing and utilisation of the genetic resources eliminate, a priori, the need to consider the provisions of UNCLOS related to the utilisation of marine living resources, which were designed with fisheries resources in mind. Those provisions are thus based on an understanding of living resources, which did not go below the individual level of a population or species down to the genetic level and was very much focused on exploitation for the purpose of consumption as food.36 On the other hand, the provisions of UNCLOS on MSR are particularly relevant. During the negotiations of UNCLOS, while the right to conduct scientific research in the oceans was widely accepted, the definition of what constituted such research, in particular whether it was limited to the study of the marine environment and its resources with a view to increasing humankind’s knowledge (so-called ‘pure’ or ‘fundamental’ research), or embraced all types of scientific activity, including research for the purpose of exploitation of resources (so-called ‘applied’ research), remained controversial. The equipment used is the same and it is generally recognised that the only distinction lies in the intent and purpose of the research, as well as the use of the knowledge and results derived thereof. In view of the impossibility research and development do not necessarily lead to commercialisation. As such, the Protocol distinguishes utilisation from subsequent applications and commercialisation. 34  For an analysis of the relation between bioprospecting and fishing, see Tullio Scovazzi, “Bioprospecting on the Deep Seabed: a Legal Gap Requiring to be Filled,” in Biotechnology and International Law, ed. Francesco Francioni and Tullio Scovazzi (Oxford and Portland: Hart Publishing, 2006), 83. For considerations related to bioprospecting, see United Nations, “Report of the Secretary General on oceans and the law of the sea” (12 March 2007) UN Doc A/62/66. 35  Michael J. Allen and Marcel Jaspars, “Realizing the potential of marine biotechnology – Challenges & Opportunities,” Industrial Biotechnology 5 (2009): 79. 36  While early proposals during the negotiations of UNCLOS distinguished between fisheries and other living resources, later drafts did not do so. Much of the language used throughout the negotiations and in the final text of UNCLOS relates to fisheries and fish stocks. A working paper submitted by Canada to Sub-Committee II of the Seabed Committee in 1972 promoted a ‘functional’ approach for the management of the living resources of the sea but fell short of considering anything below the species level. See United Nations, “Official records of the General Assembly, Twenty-seventh session, Supplement No.21” UN Doc A/8721, section 6. See also United Nations, Conservation and Utilization of the Living Resources of the Exclusive Economic Zone – Legislative History of Articles 61 and 62 of the United Nations Convention on the Law of the Sea (1995).

156   Charlotte Salpin at reaching consensus, the term was left undefined in UNCLOS,37 and the understanding has been that MSR encompasses both types of research.38 Attempts at clarifying the relationship between bioprospecting and MSR and highlighting elements of difference have met with resistance.39 The experience of States in implementing the provisions of UNCLOS related to MSR has shown that the assessment by the coastal State of a given MSR project is what, in practice, defines its nature.40 This article therefore focuses on the provisions of UNCLOS related to MSR, as set out in its Part XIII, since they are the necessary point of entry for any research in the marine environment, including research and development on marine genetic resources. However, assuming that a valuable marine compound had been identified and isolated but could not be cultured in laboratory in sufficient quantities for further research and subsequent application,41 one could wonder, in the absence of any explicit provision in the coastal State’s legislation or through its consent for MSR, whether the procurement of additional material in situ in the marine environment would still qualify as MSR, in particular if the quantities of material required were significant.42 Under the MSR regulations in effect in some States, the collection of large  For a brief history of the negotiations on MSR, see United Nations, Marine Scientific Research – A revised guide to the implementation of the relevant provisions of the United Nations Convention on the Law of the Sea (2010), 4–6. 38  See, for example, UNCLOS Article 246 which addresses both types of research, albeit implicitly. As required under UNCLOS Article 251, States have started work, in the context of the Advisory Body of Experts on the Law of the Sea to the Intergovernmental Oceanographic Commission (IOC) of UNESCO, towards the establishment of general criteria and guidelines to assist States in ascertaining the nature and implications of MSR. For a critical view of the exercise, see Jarmache, “Sur quelques difficultés,” 311. 39  Charlotte Salpin and Valentina Germani, “Patenting of Research Results Related to Genetic Resources from Areas beyond National Jurisdiction: The Crossroads of the Law of the Sea and Intellectual Property Law,” Review of European Community and International Environmental Law 16 (2007): 16. It is also noteworthy that Annex III to UNCLOS on ‘basic conditions of prospecting, exploration and exploitation’ differentiates prospecting from exploration and exploitation, at least as far as activities in the Area are concerned. Under that Annex, a prospector may recover a reasonable quantity of minerals to be used for testing but prospecting does not confer on the prospector any rights with respect to resources. For considerations related to MSR and prospecting, see Arico and Salpin, “Bioprospecting,” 16. 40  See United Nations, Marine Scientific Research, 29. 41  For example, Molinski et al. note that sponges and their microbial fauna are largely unculturable. In Molinski et al., “Drug development,” 70, 80. It has also been noted that ‘the vast majority of marine microbes have resisted all efforts at culturing under laboratory conditions. Furthermore, many marine species live in essential symbiotic relationships, and all partners will need to be sequenced to understand the symbiosis and the factors that govern them.’ See Allen and Jaspars, “Realizing the potential,” 80. 42  For example, producing 1 gram of an anti-cancer agent required close to 1 metric ton (wet weight) of Ecteinascidia turbinate. See David Leary, “Marine Genetic Resources: the 37

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amounts of fish would entail the deduction of the catch from the researching State’s annual fishing quota,43 and most of the bioprospecting laws in place usually refer to small quantities of algae, animals and micro-organisms.44 It is beyond the scope of this article to further consider this question but the issue may deserve attention. 2.  Access and PIC: Re-opening Pandora’s Box? The regime for MSR under national jurisdiction, as set out in UNCLOS, is the result of divergence between the interests and concerns of two categories of actors: researching States’ attachment to the long-held principle of unimpeded freedom of scientific inquiry and discovery; and coastal States’ attachment to the sovereign rights over their resources and the consequent wariness regarding scientific activity in their maritime zones.45 The consent regime for MSR under UNCLOS, while not perfect from either perspective, tries to accommodate these two categories of interests. The sovereign rights of States over their natural resources are recognised under both UNCLOS46 and the Nagoya Protocol.47 While both include provisions to encourage the promotion of scientific research or to facilitate such research,48 it is therefore not surprising that both also embody a certain degree of discretion of the coastal State/provider of genetic resources in granting access to the resources found under its sovereignty or jurisdiction. In practice, several States have adopted legislation or regulatory requirements setting out the terms and conditions under which they allow MSR in the maritime spaces under their sovereignty or jurisdiction.49 Some of these measures specifically address collection of marine biological resources, either directly or by reference to their ABS legislation adopted prior to the

patentability of living organisms and biodiversity conservation,” in A Planet for Life – Oceans: The New Frontier, ed. Pierre Jacquet et al. (Delhi: TERI Press, 2011), 191. 43  Ministry of Foreign Affairs of Sweden, Note Verbale to Diplomatic Missions in Sweden dated January 3, 1990, at “National Legislations,” IOC/UNESCO, accessed February 27, 2012, http://ioc-unesco.org/index.php?option=com_content&view=category&layout=blog &id=45&Itemid=100026. 44  See, for example, Australia’s Queensland Biodiversity Act 2004 (Reprint effective 30 June 2010), which refers to ‘minimal quantities’. 45  de Marffy, “Les difficultés,” 15. 46  UNCLOS Article 193. 47  Nagoya Protocol Preamble and Article 6(1). 48  See UNCLOS Articles 239 and 243, and Nagoya Protocol Article 8.a. 49  See United Nations, National Legislation, Regulations and Supplementary Documents on Marine Scientific Research in Areas Under National Jurisdiction (1989). See also “National Legislations”.

158   Charlotte Salpin Protocol.50 Will the Nagoya Protocol be respectful of the balance achieved in UNCLOS or is it likely to re-open Pandora’s box and tilt what was the result of a difficult compromise? The answer is not black or white and there are many shades of grey as shown below. a.  Research in the Internal Waters, Archipelagic Waters, Territorial Sea and Straits In the internal waters, archipelagic waters and territorial sea, a coastal State has sovereignty over the maritime space, including its bed and subsoil.51 In the exercise of their sovereignty, coastal States have the exclusive right to regulate, authorise and conduct MSR in their internal waters and territorial sea, where it can only be conducted with the express consent of, and under the conditions set forth by, the coastal State.52 These requirements are similar to PIC and MAT under the Protocol. However, the Nagoya Protocol requires providers of genetic resources to create conditions to promote and encourage research which contributes to the conservation and sustainable use of biological diversity, including through simplified measures on access for non-commercial research purposes.53 It also puts an obligation on providers of genetic resources requiring PIC to adopt the necessary legislative, administrative and policy measures.54 UNCLOS, which also provides that States and competent international organisations must promote and facilitate the development and conduct of MSR,55 only puts an obligation on the coastal State to adopt reasonable rules, regulations and procedures to promote and facilitate MSR beyond its territorial sea.56 The full discretion that a coastal State enjoys under UNCLOS in its internal waters, archipelagic waters and territorial sea may therefore be slightly constrained, to the benefit of researching States, by the requirements of the Protocol. Depending on the interpretations that coastal States and researching States will make of the compatibility clauses of the two instruments, a first area of tension may therefore exist. In straits used for international navigation and in archipelagic sea lanes, foreign ships, including MSR ships, may not carry out any research activities without the prior authorisation of the States bordering straits.57 The regime  See Australian Government, Department of Foreign Affairs and Trade, Public Vessel Status Guidelines (May 2011). 51  UNCLOS Articles 2 and 49. 52  UNCLOS Article 245. 53  Nagoya Protocol Article 8.a. 54  Nagoya Protocol Article 6.3. 55  UNCLOS Article 239. 56  UNCLOS Article 255. 57  UNCLOS Articles 40 and 54. 50

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of transit passage in straits does not affect the regime applicable to the waters forming the strait or the exercise by the States bordering the straits of their sovereignty or jurisdiction over such waters and their bed and subsoil.58 A State bordering a strait could therefore possibly require PIC and MAT for research in the portions of the strait falling under its sovereignty or jurisdiction. Whether tensions may arise or not in this regard will again largely depend on the reading of the compatibility clauses of the two instruments by researching States and States bordering straits. b.  Research in the EEZ and the Continental Shelf In the EEZ and the continental shelf, UNCLOS tries to balance the freedom of scientific research with the expansion of the sovereign rights of coastal States beyond the territorial sea out to 200 nautical miles, by framing the discretion of the coastal State. While access to the EEZ and the continental shelf for MSR purposes is also subject to the discretion of the coastal State, this discretion is slightly moderated. In those zones, MSR is not regulated on the basis of the sovereignty of the coastal State but on the basis of its jurisdiction.59 The coastal State has the right to regulate, authorise and conduct MSR, which can only be conducted with its consent.60 Such consent is expected to be granted, in normal circumstances,61 for MSR activities, which are to be carried out exclusively for peaceful purposes and in order to increase scientific knowledge of the marine environment for the benefit of all mankind.62 Presumably, research which contributes to the conservation and sustainable use of marine biodiversity, for which the Protocol requires the creation of conditions for its promotion, including through simplified measures on access for non-commercial purposes,63 would qualify as being for peaceful purposes and to increase scientific knowledge for the benefit of all mankind, since the conservation of biodiversity is a common concern of humankind.64  UNCLOS Article 34.  Jurisdiction is constrained by the rights of other States, unlike sovereignty, which encompasses the full extent and exclusivity of the legislative, judicial and executive powers of a State over its territory and resources. For a discussion of the meaning and extent of the concept of sovereignty, Patrick Daillier et al., Droit International Public (Paris: LGDJ, 2009), 527 et seq. 60  UNCLOS Articles 245 and 246. 61  Abnormal circumstances would include a situation of imminent danger of armed conflict or a jurisdictional dispute over the area for which the request for consent is being made. See United Nations, Marine Scientific Research, 41. 62  UNCLOS Article 246.3. 63  Nagoya Protocol Article 8.a. 64  CBD, Preamble. 58 59

160   Charlotte Salpin Notwithstanding this expectation, there are a number of cases in which a coastal State may withhold its consent under UNCLOS. These cases are explicitly listed in UNCLOS65 and, of particular relevance to the Nagoya Protocol, include research of direct significance for the exploration and exploitation of natural resources, whether living or non-living.66 This exception flows logically from the sovereign rights that the coastal State enjoys in the EEZ for the purpose of exploring, exploiting, conserving and managing the natural resources, whether living or non-living,67 and on the continental shelf for the purpose of exploring it and exploiting its natural resources.68 Research of direct significance for the exploration and exploitation of natural resources may generally be considered to be research which can reasonably be expected to produce results that would enable to locate, assess and monitor resources with respect to their status and availability for commercial exploitation.69 Presumably, this would include access for research and development purposes in the sense of the Nagoya Protocol. Conditions can be established through the laws and regulations of the coastal State in the exercise of its discretion to grant or withhold consent in relation to research projects of direct significance for the exploitation of natural resources.70 In that regard, a coastal State may require compliance with its ABS legislation adopted pursuant to the Protocol. As a comparison of the Protocol’s PIC procedure with the UNCLOS consent regime shows, the Nagoya Protocol will not deprive the coastal State of its discretion to grant or withhold consent for MSR in the EEZ or the continental shelf. However, it may impact the exercise of that discretion as the procedural requirements of the Protocol include obligations of result for  UNCLOS Article 246.5.  UNCLOS Article 246(5)(a). 67  UNCLOS Article 56. 68  The natural resources of the continental shelf include the living organisms belonging to sedentary species, that is to say, organisms which, at the harvestable stage, either are immobile on or under the seabed or are unable to move except in constant physical contact with the seabed or the subsoil (UNCLOS Article 77). No one may explore the continental shelf or exploit its resources without the express consent of the coastal State. These rights also apply when the continental shelf extends beyond 200 nautical miles from the baselines from which the breadth of the territorial sea is measured up to 350 nautical miles from those baselines. However, on the continental shelf beyond 200 nautical miles, the coastal State may not exercise its discretion to withhold consent in respect of MSR projects of direct significance for the exploration and exploitation of natural resources outside those specific areas which it may publicly designate as areas in which exploitation or detailed exploratory operations are occurring or will occur within a reasonable period of time (UNCLOS Article 246.6). 69  See United Nations, Marine Scientific Research, 10. 70  UNCLOS Article 249.2. 65 66

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the provider of genetic resources that go beyond the standards of conduct set forth under UNCLOS for coastal States, in some instances. In that regard, the Protocol may promote greater clarity, transparency and certainty in the MSR consent process to the benefit of researching States. For example, where UNCLOS establishes an obligation of means for the coastal State to endeavour to adopt reasonable rules, regulations and procedures to promote and facilitate MSR beyond the territorial sea,71 the Protocol establishes an obligation of result for the provider of genetic resources requiring PIC to take the necessary legislative, administrative or policy measures to achieve a number of things,72 including legal certainty, clarity and transparency of their domestic ABS legislation or regulatory requirements,73 and fair and non-arbitrary rules and procedures on accessing genetic resources.74 The concept of reasonableness found in UNCLOS, which is vague and subject to a great deal of subjectivity, leaves more leeway to coastal States than the concepts of transparency, fairness and non-arbitrariness found in the Protocol. In addition, while UNCLOS requires publication and dissemination through appropriate channels of information on proposed major MSR programmes,75 this obligation does not fall on the coastal State – at least not explicitly. In practice, information on MSR projects is not easily found in the public domain and the voluntary exchange of information by the scientific community has acted as a de facto clearing-house.76 By establishing an international clearinghouse mechanism77 and requiring providers of genetic resources to notify the mechanism of the issuance of access permits,78 the Protocol adds to the obligations of coastal States. It may, however, contribute to easier access to information on MSR projects related to biological resources to the benefit of both coastal States and researching States. On the other hand, in areas where UNCLOS sought to frame the discretion of the coastal State in the interest of scientific research, the Protocol leaves considerable leeway to the provider of genetic resources or adds administrative layers to the detriment of researching States. For example,  UNCLOS Article 255.  Nagoya Protocol Article 6.3. 73  Nagoya Protocol Article 6.3.a. 74  Nagoya Protocol Article 6.3.b. 75  UNCLOS Article 244. 76  See, for example, the InterRidge Cruise Database at http://www.interridge.org/IRcruise, accessed 27 February 2012; the Research Ship Schedules database of the University of Delaware at http://www.researchvessels.org/ship_gen.asp, accessed 27 February 2012; the Woods Hole Oceanographic Institution Cruise Database at http://dla.whoi.edu/cruises/, accessed 27 February 2012. 77  Nagoya Protocol Article 14. 78  Nagoya Protocol Article 6.3.e. 71 72

162   Charlotte Salpin where UNCLOS requires the coastal State to establish rules and procedures ensuring that the consent will not be delayed or denied unreasonably,79 and also provides that an MSR project may proceed six months after the date upon which the request was made unless within four months of the receipt of the request the coastal State has communicated, inter alia, that it withheld its consent or required more information,80 the Protocol only requires a decision ‘within a reasonable period of time’.81 In addition, while in practice, in general, the consent for MSR is given expressly, in order to overcome ‘bureaucratic heaviness’ of the overall consent regime and allow MSR to proceed smoothly,82 UNCLOS foresees the possibility for the consent to be tacit.83 Unlike UNCLOS, the Protocol specifically requires a written decision84 and the issuance of a permit or its equivalent as evidence of the decision to grant PIC and of the establishment of MAT.85 Where the Protocol requires PIC or approval and involvement of indigenous and local communities,86 where applicable, UNCLOS does not include such requirements, let alone addresses indigenous and local communities.87 Finally, the nature of the PIC and MAT process under the Protocol accentuates a discrete trait of the MSR consent process, namely negotiation, including by requiring the establishment of MAT at the time of access.88 The conditions that a coastal State can establish pursuant to UNCLOS Article 249(2) in its discretion to grant or withhold consent could foresee requirements relating to MAT, including those listed in the Protocol.89 However, for research that does not fall within the scope of UNCLOS Article 249.2, i.e., which is not of direct significance for the exploration or exploitation of natural resources, the process under the Protocol is likely to lead to additional negotiations prior to the undertaking of the MSR project. This may act as an obstacle to scientific enquiry as this will add up to the degree of negotiation already inherent in the implementation of the conditions set out in UNCLOS Article 249.1, such as in relation to the modalities of participation  UNCLOS Article 246.  UNCLOS Article 252. 81  UNCLOS Article 6.3.d. 82  de Marffy, “Les difficultés,” 13. 83  UNCLOS Articles 247 and 252. 84  Nagoya Protocol Article 6.3.d. 85  Nagoya Protocol Article 6.3.e. For the purposes of facilitating the process, a draft standard form for granting consent was developed by a Group of Experts on MSR. See United Nations, Marine Scientific Research, 29 and Annex I. 86  Nagoya Protocol Articles 6.2 and 6.3.f. 87  See infra, section II.1.a. 88  Combined reading of Nagoya Protocol Articles 5 and 6.3.e. 89  Nagoya Protocol Article 6.3.g. 79 80

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of the coastal State in the MSR project.90 In addition, a number of aspects left to the negotiation of MAT under the Protocol are specifically set out in UNCLOS, the latter leaving little margin for negotiation. For example, with regard to change of intent, UNCLOS specifically requires researching States to inform the coastal State immediately of any major change in the research programme91 and the coastal State has the right to require the cessation of the research activities in case of major changes.92 With regard to dispute settlement, disputes concerning MSR are to be settled through compulsory dispute settlement procedures entailing binding decisions. However, the coastal State is not obliged to accept the submission to such settlement of any dispute arising out of, inter alia, the exercise of its right or discretion to grant or withhold its consent. Such disputes can be submitted to conciliation provided that the conciliation commission does not call in question the exercise by the coastal State of its discretion to withhold consent in relation to research of direct significance for the exploration or exploitation of natural resources.93 It is only in the circumstances in which the coastal State has withheld its consent that the researching State and the coastal State have been encouraged to consult among themselves.94 There may therefore be areas of tensions in the simultaneous implementation of UNCLOS and the Protocol. The interpretation by each State of the compatibility clauses of the two instruments and the extent to which they maintain cooperative relations will be crucial, in practice, to avoid conflicts and ensure that the balance established under UNCLOS between the rights and obligations of coastal States and researching States is not upset. 3.  Benefit-sharing under the Protocol: A Deterrent to MSR? The scope of benefit-sharing obligations under the Protocol is broad as it not only includes benefits arising from the utilisation of genetic resources but also from subsequent applications and commercialisation.95 Benefits may include monetary and non-monetary benefits, including those listed in the Annex to the Protocol.96 Monetary benefits include access fees/fee per sample collected or otherwise acquired, licence fees in case of commercialisation, and joint ventures. Non-monetary benefits include: sharing of research and development results; participation in product development; transfer of  Jarmache, “Sur quelques difficultés,” 307.  UNCLOS Article 249. 92  UNCLOS Article 253. 93  UNCLOS Article 297.2. 94  See United Nations, Marine Scientific Research, 42. 95  Nagoya Protocol Article 5.1. 96  Nagoya Protocol Article 5.4. 90 91

164   Charlotte Salpin knowledge and technology under fair and most favourable terms, including on concessional and preferential terms; and strengthening capacities for technology transfer.97 While this is not explicitly stated in UNCLOS, nothing prevents a coastal State, in the exercise of its sovereign rights, to require some form of sharing of benefits of a monetary or non-monetary nature, as foreseen in the Protocol, for the MSR activities that it allows in its internal waters, territorial sea or archipelagic waters. UNCLOS, however, does not explicitly include, ab initio, obligations of benefit-sharing for researching States. In that regard, by putting an obligation on user countries to take legislation, administrative or policy measures to implement fair and equitable benefit-sharing98 as well as compliance measures to provide that genetic resources utilised within their jurisdiction have been accessed in accordance with PIC and MAT,99 the Protocol goes beyond UNCLOS as far as the obligations of researching States are concerned. As regards MSR in the EEZ and the continental shelf, UNCLOS provides for a number of rights (for the coastal State) and obligations (for the researching State), which constitute a form of benefit sharing in the sense of the Protocol. However, while the non-monetary benefits of the Protocol mirror those that can be found in UNCLOS, which explicitly addresses sharing of information, data and research samples100 as well as participation in the research project101 and training, monetary benefits are not foreseen in UNCLOS. The difference in the two instruments regarding non-monetary and monetary benefits points to an interesting question deserving further attention, namely the relation between MSR and subsequent commercial exploitation.102 As mentioned above, conditions can be established by the coastal State in the exercise of its discretion to grant or withhold consent for an MSR project of direct significance for the exploration and exploitation of natural resources.103 UNCLOS only mentions as an example of such conditions the requirement that prior agreement be given for making internationally available the research results. One could assume, however, that sharing of monetary benefits may also be  Nagoya Protocol, Annex.  Nagoya Protocol Article 5.3.   99  Nagoya Protocol Article 15. 100  UNCLOS Article 249.1.b and c. 101  UNCLOS Article 249.1.a. 102  Similarly, the need to further study the relation and arrangements between scientific research institutions undertaking MSR and R&D and private companies undertaking commercial exploitation has been highlighted at all the meetings of the General Assembly Ad Hoc Open-ended Informal Working Group to study issues relating to the conservation and sustainable use of marine biological diversity beyond areas of national jurisdiction. 103  UNCLOS Article 249.2.   97   98

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part of the requirements. Where research is undertaken without a commercial purpose, requirements for sharing of monetary benefits in the form of access fees or fee per sample collected may nevertheless act as deterrent to MSR, depending on the amount of those fees. Besides Part XI of UNCLOS which aims at implementing the concept of common heritage of mankind, the idea of equitable benefit-sharing is perhaps most evident in UNCLOS through its provisions on transfer of marine technology, included in its Part XIV.104 Interestingly, though, while marine technology is an essential underpinning of MSR and the exploitation of natural resources, transfer of marine technology is not among the duties for researching States, as listed in Article 249. Under Part XIV, States are required to cooperate to promote the development and transfer of marine science and marine technology on fair and reasonable terms and conditions.105 They must also endeavour to foster favourable economic and legal conditions for the transfer of marine technology for the benefit of all parties concerned on an equitable basis. In doing so, they must have due regard for all legitimate interests, including the rights and duties of holders, suppliers and recipients of marine technology.106 While Part XIV is generally considered to have suffered from an implementation gap,107 partnerships and joint ventures seem to be the preferred form of transfer of marine technology for both suppliers and recipients.108 Transfer of technology as a benefit-sharing modality under the Nagoya Protocol, where established by coastal States as a condition when granting its consent for MSR of direct significant to the exploration and exploitation of resources, may support implementation of UNCLOS in that regard. A number of so-called ‘megadiverse’ countries, which are also coastal States, have developed a robust MSR capacity and have a strong marine biotechnology sector. However, that capacity is still lagging behind in some coastal States which are equally rich in marine biodiversity.109 In the latter context, the ABS arrangements which a coastal State can require pursuant to the Nagoya Protocol may be significant in developing that capacity.

 See also Annex VI to the Final Act, Resolution on the Development of National marine Science, Technology and Ocean Service Infrastructure. 105  UNCLOS Article 266. 106  UNCLOS Article 267. 107  With a view to assisting implementation of Part XIV, IOC/UNESCO adopted “Criteria and Guidelines on Transfer of Marine Technology” in 2003. See IOC/UNESCO Assembly, “Criteria and Guidelines on Transfer of Marine Technology” (24 April 2003) UN Doc IOC-XXII/2. 108  See United Nations, Marine Scientific Research, 35. 109  United Nations, “Oceans and the Law of the Sea, Report of the Secretary-General” (10 September 2007), UN Doc A/62/66/Add.2. 104

166   Charlotte Salpin Under the Protocol, coastal States therefore have at their disposal a wider array of benefit-sharing modalities than they have under UNCLOS. MSR projects usually require significant investments ranging from tens to hundreds of thousands of dollars accounting for cruise time, manning, scientific expertise, administrative fees where applicable, etc. Sharing of benefits in the form of monetary benefits as foreseen under the Protocol is likely to increase the costs of carrying out MSR. However, whether this will negatively impact on the undertaking of MSR will greatly depend on the way in which coastal States avail of their right under the Protocol. As seen throughout this section, great care will need to be exercised, in order not to tip the balance achieved in UNCLOS between the rights of coastal States and those of researching States, since there are a number of areas of potential difficulties arising from the implementation of the Protocol’s ABS core provisions. In light of the benefits of MSR for both coastal States and researching States, one can reasonably expect, though, that a Party to both instruments will avail of its rights and comply with its obligations under both instruments in good faith and in a manner that is mutually beneficial. In that regard, a particular group of States, namely those which are both coastal and researching States and Parties to UNCLOS and the Protocol,110 will provide interesting case studies of the manner in which mutual supportiveness between the two instruments can be achieved.

II.  The Law of the Sea and the Nagoya Protocol: Working in Tandem? Beyond the core ABS provisions, the Protocol may work in tandem with the law of the sea to influence the development and implementation of international law. Two aspects are particularly noteworthy in that regard: coordination and cooperation at the national and international levels; and marine genetic resources beyond areas of national jurisdiction. 1.  National Coordination and International Cooperation To realise the potential that the oceans offer in terms of new products and processes requires the concerted effort of many actors.111 Yet, up to recently, there has been a clear disconnect between the law of the sea and the ABS communities of government officials and academics, as evidenced by the limited participation of experts on ABS in the intergovernmental meetings  For example, Argentina, Australia, Brazil, France, Japan, India, Mexico, South Africa and Spain, which had all signed the Protocol as of 1 March 2012. 111  Allen and Jaspars, “Realizing the potential,” 82. 110

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dealing with ocean affairs and the limited consideration given to marine genetic resources in the ABS negotiations. Cooperation being an essential underpinning of the provisions of UNCLOS on MSR, and also critical in the implementation of the Protocol,112 it is hoped that the implementation of both instruments will foster increased coordination at the national level and promote cooperation at the international level. a.  At the Domestic Level The tasks that coastal States have to exercise in the implementation of their rights and duties related to MSR under UNCLOS require the establishment of the necessary infrastructure and administrative networks to, inter alia, assess the information contained in the request, identify the nature and objectives of the project, and control the fulfillment of the conditions established with the consent.113 The challenge is real for both developed and developing countries. To the dispersal of responsibilities, in some cases, in the field of oceanography and the limited coordination between various relevant actors such as diplomats and scientists,114 will be added another layer of difficulty with the Nagoya Protocol, which sets up its own architecture of approvals and checkpoints. Under UNCLOS, communications concerning MSR projects must be made through appropriate official channels, unless otherwise agreed.115 Unless the coastal State has designated other channels and unless the States concerned otherwise agree, the request for consent is submitted through diplomatic channels.116 The consent process for MSR remains in the domain of interStates relations as scientists seeking to undertake MSR need to seek the necessary approvals through the appropriate official channels in their country, which will then transmit the request to the appropriate official channels in the coastal State. That counterpart will then coordinate among various relevant agencies and ministries.117 While not specifically speaking of ‘sponsorship’ – a term which is used in the context of activities in the Area118 – Part XIII  Glowka and Normand (Chapter 1).  de Marffy, “Les difficultés,” 9. 114  Jarmache, “Sur quelques difficultés,” 308. 115  UNCLOS Article 250. 116  See United Nations, Marine Scientific Research, 39. 117  The desirability for the coastal State to consider centralizing and simplifying the processing of applications for consent, for example by identifying a specific focal point for such process, has been suggested. See United Nations, Marine Scientific Research, 41. 118  For an analysis of the implications of the sponsorship provisions of UNCLOS, see International Tribunal for the Law of the Sea, Responsibilities and Obligations of States Sponsoring Persons and Entities with Respect to Activities in the Area (Advisory Opinion) 2011 http:// www.itlos.org/index.php?id=109#c587 accessed 6 April 2012. 112 113

168   Charlotte Salpin of UNCLOS nevertheless embodies such a notion. The process established under Part XIII aims at implementing the basic principle of international law that a State Party to a treaty has the responsibility to ensure that natural and juridical persons which have its nationality, or are effectively controlled by it or its nationals, comply with the obligations of the State under that treaty. However, the process is very different from the ABS process whereby scientists or companies may directly submit applications for PIC to the designated national entity, which could be for instance a university or governmental research institute.119 There is no requirement under the Nagoya Protocol for the procedure to take place through diplomatic channels. The Protocol only requires the designation of one or more competent national authorities responsible for granting access or issuing written evidence that access requirements have been met.120 The link between the researching entities and their State of origin seems therefore looser under the Protocol than is the case under UNCLOS. In the latter case, the State may have greater control to ensure that the researching activities carried out under its jurisdiction or control comply with the provisions of UNCLOS. Overlaps between the process under UNCLOS and that under the Protocol are bound to occur and will provide a test case of existing coordination mechanisms at the national level, where they exist. Government offices processing clearance requests for MSR are likely to be increasingly confronted with issues arising out of the Nagoya Protocol and the articulation of its provisions with UNCLOS. This will require close coordination among all relevant offices and ministries and the consequent necessary administrative infrastructure to that end. Where that infrastructure does not exist, it will be in the interest of a Party to both UNCLOS and the Protocol to establish appropriate mechanisms of coordination between the authorities competent under each instrument.121 Among others, improved coordination would work to the benefit of compliance with both instruments by researching entities. A review of clearance procedures for MSR showed that there was limited information on how States had integrated the provisions of the CBD on ABS in clearance procedures for MSR.122 More practice and information may become available with the implementation of the Protocol.

 Morgera, Buck and Tsioumani, Commentary on the Nagoya Protocol, Article 13.  Nagoya Protocol Article 13.2. 121  For an interesting example of the consequences of limited national coordination prior to granting consent to proceed with an MSR project with a biomedical component, see Montserrat Gorina-Ysern, An International Regime for Marine Scientific Research (New York: Transnational Publishers, 2003), 376–387. 122  Gorina-Ysern, An International Regime. 119 120

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Another area, which may result in greater coordination at the national level, pertains to the role attributed to indigenous and local communities under the Protocol.123 As noted by some commentators, the Nagoya Protocol very significantly enhances the protection of the holders of traditional knowledge in public international law.124 In particular, PIC suggests a more formal statement of knowledge holders to document their agreement, and ‘approval and involvement’ also includes the direct participation of knowledge holders in government decision-making on access. There is no mention of indigenous and local communities in UNCLOS. References are made to fishing communities and traditional fishing rights four times throughout UNCLOS,125 and only as far as considering the detrimental effects of foreign fisheries on them. There is thus no formal link between MSR and indigenous and local communities, and MSR legislation and regulations very seldom refer to those communities. In that regard, the Nagoya Protocol goes much further by providing for the PIC or approval and involvement of indigenous and local communities for access to genetic resources where they have the established right to grant access to such resources.126 It will thus be interesting to see how the involvement or PIC of communities, where required under national legislation, will be integrated in the consent regime for MSR other than by adding another layer of complexity in the assessment of the requests. As much as coherent national level implementation will be key in the implementation of the Protocol alone,127 coordination will therefore also be required between the competent authorities designated pursuant to the Protocol and the diplomatic channels responsible for MSR clearance to address some of those issues. b.  At the International Level International cooperation is a necessary underpinning of MSR as a result, inter alia, of its undertaking in areas under the sovereignty or jurisdiction of another State, and sharing of research results and data.128 This is recognised by UNCLOS, which requires States and competent international organisations, in accordance with the principle of respect for sovereignty and jurisdiction and on the basis of mutual benefit, to promote international cooperation in  No definition is found of ‘indigenous and local communities’ either in the Protocol or in any other international instrument, including the 2007 United Nations Declaration on the Rights of Indigenous Peoples (13 September 2007)) UN Doc A/RES/61/295. 124  Buck and Hamilton, “The Nagoya Protocol,” 54. 125  See UNCLOS Articles 51, 61, 69 and 70. 126  Nagoya Protocol Article 6.2. 127  Glowka and Normand (Chapter 1). 128  Jarmache, “Sur quelques difficultés,” 308. 123

170   Charlotte Salpin MSR for peaceful purposes;129 to create favourable conditions for the conduct of MSR in the marine environment;130 and to actively promote the flow of scientific data and information and the transfer of knowledge resulting from MSR, especially to developing States, as well as the strengthening of the autonomous MSR capabilities of developing States through, inter alia, programmes to provide adequate education and training of their technical and scientific personnel.131 Cooperation is also required to promote actively the development and transfer of marine science and marine technology on fair and reasonable terms and conditions.132 Beyond these general provisions on the promotion of international cooperation, the cooperative aspect of UNCLOS is critical in the consent regime, where good faith and trust between the coastal State and the researching State are key to the undertaking of scientific inquiry to the mutual benefit of both. Also dependent on international cooperation, the ABS system established by the Nagoya Protocol, by offering guarantees to the coastal State that it will benefit, in some form or another, from the utilisation of its resources by researching States, should ensure continued scientific research in the oceans and a continuing flow of scientific information. The provisions of UNCLOS and the Protocol may support each other in that regard. The facilitated access, under UNCLOS, for research aimed at increasing scientific knowledge of the marine environment for the benefit of mankind and, under the Protocol, for non-commercial research purposes,133 should also work together to attenuate the impacts of a bilateral relation between researching State and coastal State – including the discretion to ‘lock up’ valuable scientific knowledge – on research which could otherwise benefit humankind as a whole. The successful concomitant implementation of UNCLOS and the Protocol will, however, require the shared vision and the willingness of Parties to collaborate in order to achieve a harmonious implementation of both instruments.134 Of the complex architecture established by the Protocol, monitoring and compliance will be one of the greatest areas for which international cooperation will be essential and which may benefit implementation of UNCLOS. Under UNCLOS, the researching State has a duty to comply with specific conditions,135 including the type of information to be provided to the coastal  UNCLOS Article 242.  UNCLOS Article 243. 131  UNCLOS Article 244. 132  UNCLOS Article 266. 133  Nagoya Protocol Article 8.a. [For a discussion, see contribution by Dedeurwaerdere et al. in this volume (Chapter 13).] 134  Glowka and Normand (Chapter 1). 135  Listed in UNCLOS Articles 248 and 249. 129 130

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State.136 A coastal State has the right to require the suspension of any MSR activities in progress within its EEZ or on its continental shelf which are not being conducted in accordance with the information communicated137 and upon which the consent of the coastal State was based, or if the research activities fail to comply with the provisions concerning the rights of the coastal State.138 A coastal State also has the right to require the cessation of an MSR activity in case of non-compliance with the provisions on the duty to provide information to the coastal State,139 which would amount to a major change in the research project or activities. It is, however, unclear how, in practice, a coastal State can assess the cases of non-compliance other than by having a representative on-board or, absent such representative, becoming aware, post facto, of a major change in the project (for example through the publication of scientific findings on the biomedical applications of a compound sourced in the course of an oceanographic project). In that regard, the monitoring and compliance system established under the Protocol,140 through its requirement for Parties to take measures to provide that genetic resources utilised within their jurisdiction have been accessed in accordance with PIC and MAT, as required by the domestic access and benefit-sharing legislation or regulatory requirements of the other Party,141 coupled with checkpoints and an internationally recognised certificate of compliance,142 should, incidentally, ensure that the rights and interests of the coastal State have been respected.143 In turn, while undoubtedly putting a burden on the researching States to have the appropriate administrative infrastructure in place, as noted above, this may also encourage greater trust from coastal States in allowing MSR projects under one’s sovereignty or jurisdiction.144 It must be  UNCLOS Article 248.  Pursuant to UNCLOS Article 248. 138  UNCLOS Article 249. 139  UNCLOS Article 248. 140  Nagoya Protocol Articles 15 to 18. 141  Nagoya Protocol Article 15. 142  Nagoya Protocol Article 17. 143  This will depend on the establishment of some mechanism in countries with users in their jurisdiction that would ensure that these users receive information on, and respect, the legislation of the countries that have provided the genetic resources or traditional knowledge. This will also depend on the capacity of authorities to monitor genetic resources at the established checkpoints. See Elisa Morgera and Elsa Tsioumani, “Yesterday, Today, and Tomorrow: Looking Afresh at the Convention on Biological Diversity,” Yearbook of International Environmental Law 21 (2011): 17. 144  By adding an element of certainty to the ABS process, the provisions on monitoring and compliance of the Protocol should help in avoiding future occurrences of cancelled MSR projects. For an example of how a strong reliance on the CBD ABS provisions led to the cancellation of an MSR project, see Jarmache, “Sur quelques difficultés,” 311. 136 137

172   Charlotte Salpin noted, however, that the obligations of Parties under the Protocol’s provisions on compliance with domestic ABS requirements and on monitoring145 only apply to the utilisation of genetic resources, leaving benefit-sharing from subsequent applications and commercialisation without compliance or monitoring measures. International cooperation will also be an essential underpinning in regards of biological material which straddles several maritime zones. Two articles of the Protocol address the need for cooperation in such situations: Article 10 which foresees the establishment of a global multilateral benefit-sharing mechanism for genetic resources occurring in transboundary situations; and Article 11 which provides that in instances where the same genetic resources are found in situ within the territory of more than one Party, those Parties shall endeavour to cooperate. The regime for MSR under UNCLOS is first and foremost determined by the maritime space in which the research is to be undertaken, and then by the resources that may be the object of such research. Thus, where a researching State is seeking access to material found within two or more territorial seas and/or EEZs for MSR purposes, the onus will not be on the coastal States concerned to cooperate but on the researching State to seek the consent of all the coastal States concerned. It is, however, not excluded that the implementation of the Nagoya Protocol in such cases may foster greater cooperation and coordination among coastal States sharing the same resources. The nature of the marine environment as constantly moving and the complexity of the jurisdictional framework in the oceans are such that international cooperation may encounter some challenges in cases where the material is found in areas within and beyond national jurisdiction.146 The regime for ABS is fundamentally based on a bilateral relation between a right-holder over a genetic resource and a user of that resource, whereas no one owns the resources found beyond national jurisdiction, which are res nullius. Such cases will therefore not be covered by the Protocol provision on transboundary cooperation147 as the scope of that article, much as the scope of the Protocol itself,148 is limited to resources within national jurisdiction.

 Nagoya Protocol Articles 15 and 17.  Areas beyond national jurisdiction include the high seas and the Area. The high seas are all areas of the water column that are not included in the EEZ, the territorial sea or the internal waters of a State, or in the archipelagic waters of an archipelagic State (UNCLOS, article 86). The Area is the seabed and ocean floor and subsoil thereof beyond the limits of national jurisdiction (UNCLOS, article 1(1)(1)). 147  Nagoya Protocol Article 11. 148  See infra, sub-section 2. 145 146

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The potential of the global benefit-sharing mechanism149 (see infra) will need to be further explored in that regard. The first of such cases relates to biological material which is found both within the EEZ of one or more coastal States and in the high seas, such as the free-floating microbes of the pelagic zone or the genetic resources hosted by migratory species of fish, cetaceans or mammals. In the case of fisheries resources, the 1995 United Nations Fish Stocks Agreement,150 besides international cooperation, builds on such principles as the ecosystem approach and the compatibility of the management measures taken for the EEZ and the high seas. Those principles are valid for management but it is difficult to see how they could possibly be replicated for issues of ABS from the utilisation of genetic resources. The other complexity originates in organisms or other biotic components which may depend on, or be associated with, sedentary species, such as sponge or corals found on the continental shelf beyond 200 nautical miles,151 but which are not necessarily sedentary in nature.152 Within 200 nautical miles, the coastal State has sovereign rights over resources both on the continental shelf and in the superjacent territorial sea and the EEZ (where an EEZ has been declared). However, when the continental shelf extends beyond 200 nautical miles, while the sovereign rights of the coastal State apply to the shelf, those rights do not apply to the superjacent water column – in other words, the high seas. Under UNCLOS, as reinforced by the Nagoya Protocol, the prior consent of the coastal State is required for research on biological resources on its continental shelf. However, access to the nonsedentary organisms or compounds secreted by the sedentary species or closely associated with them,153 but found in the high seas, would not be  Nagoya Protocol Article 10.  United Nations Agreement for the Implementation of the Provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 relating to the Conservation and Management of Straddling Fish Stocks and Highly Migratory Fish Stocks (New York, 4 August 1995, in force 11 December 2001) 2167 UNTS 3. 151  UNCLOS Article 76 provides the criteria according to which a State may establish the outer edge of the continental margin wherever the margin extends beyond 200 nautical miles. The outer limits of the continental shelf cannot exceed 350 nautical miles from the baselines. 152  For recent discoveries of such symbiosis, see Ed Young, “Yeti crab grows its own food,” Nature, 2 December 2011, doi:10.1038/nature.2011.9537. See also “No sow’s ear – species of crustacean makes silk underwater”, The Economist, 19 November 2011, accessed 25 November 2011, http://www.economist.com/node/21538659. 153  The Nagoya Protocol, which applies to genetic resources as defined by the CBD, also includes within its scope derivatives, which are defined as naturally occurring biochemical compounds resulting from the genetic expression or metabolism of biological or genetic resources, even if they do not contain functional units of heredity (Article 2). 149 150

174   Charlotte Salpin subject to any prior consent requirement. The dichotomy between the legal boundaries established under UNCLOS and the biological and ecosystem characteristics of the marine environment is perplexing and a challenge to both UNCLOS and the Protocol. It will be interesting to see how discussions on marine genetic resources beyond areas of national jurisdiction will evolve in the context of the General Assembly (discussed below), and whether they will help clarify situations such as those. In the meantime, the legal uncertainty concerning the regime applicable may act as a deterrent to researchers and investors.154 2.  Marine Genetic Resources beyond Areas of National Jurisdiction An area where the Protocol may work in tandem with the law of the sea in the development of international law is in regards of marine genetic resources beyond areas of national jurisdiction, namely from the high seas and the Area. Research on the degree to which genetic resources from areas beyond national jurisdiction have contributed to commercial developments has shown that, to date, a very small number of patents have related to inventions based on resources from the seabed beyond national jurisdiction (generally related to bacteria), while a greater number have been based on genetic resources from the high seas (primarily micro-organisms, floating sargassum weed, fish and krill).155 Yet, it is important to recall that an even greater number has been based on resources sampled from areas under national jurisdiction.156 The regime for ABS under the CBD and the Protocol is based on two premises: the sovereign rights of a State over its resources; and a bilateral transaction between the provider and the user of the resources, where each is clearly identified. The scenario for resources in areas beyond national jurisdiction is fundamentally different as no State has any sovereign rights over these resources ab initio, and the actors and stakeholders are many. As res nullius, it is only once captured or sampled that the resources of the high seas  The need for legal clarity for investors was generally highlighted at the eighth meeting of the United Nations General Assembly Informal Consultative Process on Oceans and the Law of the Sea, which focused its discussions on marine genetic resources in 2007. See United Nations, “Report on the work of the United Nations Open-ended Informal Consultative Process on Oceans and the Law of the Sea at its eighth meeting” (30 June 2007) UN Doc. A/62/169. 155  United Nations, “Report of the Secretary-General on oceans and the law of the sea” (22 March 2011) UN Doc. A/66/70. 156  United Nations, “Report of the Secretary-General on oceans and the law of the sea” (19 October 2009) UN Doc. A/64/66/Add.2. 154

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are appropriated and rights over them ensue. Similarly, the resources of the Area157 cannot be appropriated and remain common heritage of mankind. It is only once recovered from the Area that the minerals may be alienated, in accordance with Part XI and the rules, regulations and procedures of the International Seabed Authority (the Authority).158 Following a brief description of the regime for areas beyond national jurisdiction, this section considers how developments related to the Protocol and UNCLOS may work together to promote the advancement of international law in regards of marine genetic resources from areas beyond national jurisdiction. a.  Areas beyond National Jurisdiction under UNCLOS The high seas are open to all States, and freedom of the high seas, which includes the freedom of fishing and of scientific research, must be exercised under the conditions laid down by UNCLOS and by other rules of international law.159 Freedom of scientific research is specifically subject to Parts VI (continental shelf ) and XIII (MSR). Freedom of the high seas must also be exercised by all States with due regard for other States’ interests in their exercise of the freedom of the high seas.160 States have exclusive jurisdiction over ships flying their flag on the high seas.161 The Area and its resources are the common heritage of mankind.162 Activities in the Area, which are ‘all activities of exploration for, and exploitation of, the resources of the Area’,163 must be carried out for the benefit of mankind as a whole, and the Authority, the organisation through which States organise and control all activities in the Area, must provide for the equitable sharing of financial and other economic benefits derived from such activities.164 No State can claim or exercise sovereignty or sovereign rights over any part of the Area or its resources, nor can any State or natural or juridical person appropriate any part thereof. No such claim or exercise of sovereignty or sovereign rights nor such appropriation can be recognised.165 All rights in the resources of the Area166 are vested in mankind as a whole,  The resources of the Area are ‘all solid, liquid and gaseous mineral resources in situ in the Area at or beneath the seabed, including polymetallic nodules’ (UNCLOS Article 133). 158  UNCLOS Article 137.2. 159  UNCLOS Article 87. 160  UNCLOS Article 87. 161  UNCLOS Article 92. 162  UNCLOS Article 136. 163  UNCLOS Article 1.1.3. 164  UNCLOS Article 140. 165  UNCLOS Article 137. 166  As defined in UNCLOS Article 133. 157

176   Charlotte Salpin on whose behalf the Authority must act. The 1994 Agreement relating to the implementation of Part XI of UNCLOS, which addresses the various issues that were identified as problem areas preventing the ratification of UNCLOS by certain States,167 is to be interpreted and applied together with UNCLOS as a single instrument. With specific regard to MSR, all States, irrespective of their geographical location, and competent international organisations have the right to conduct MSR in the Area and in the high seas.168 Of particular relevance to MSR undertaken in the high seas are the requirements related, respectively, to the promotion of international cooperation, the creation of favourable conditions and the publication and dissemination of information and knowledge.169 MSR in the Area is carried out exclusively for peaceful purposes and for the benefit of mankind as a whole.170 The Authority may carry out MSR concerning the Area and its resources, and may enter into contracts for that purpose. It must promote and encourage the conduct of MSR in the Area, and must coordinate and disseminate the results of such research and analysis when available.171 Parties that carry out MSR in the Area must also promote international cooperation, including by ensuring that programmes are developed through the Authority or other international organisations for the benefit of developing States and technologically less developed States with a view to, inter alia, training their personnel and the personnel of the Authority in the techniques and applications of research,172 and by effectively disseminating the results of research and analysis, when available, through the Authority or other international channels when appropriate.173 The Authority and State Parties must cooperate in promoting the transfer of technology and scientific knowledge relating to activities in the Area so that the Enterprise174 and all States Parties may benefit therefrom.175

 The Agreement addresses, inter alia: costs to State Parties and institutional arrangements; the Enterprise; decision-making; transfer of technology; production policy; economic assistance; and financial terms of contracts. 168  UNCLOS Articles 256 and 257. 169  UNCLOS Articles 242, 243 and 244. 170  UNCLOS Article 143. 171  UNCLOS Article 143.2. 172  UNCLOS Article 1433.b. 173  UNCLOS Article 1433.c. 174  The Enterprise is the organ of the Authority that carries out activities in the Area directly, pursuant to UNCLOS Article 153.2.a, as well as the transporting, processing and marketing of minerals recovered from the Area. See UNCLOS Article 170 and 1994 Part XI Agreement, Annex section 2. 175  UNCLOS Article 144. 167

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b.  MGR in Areas beyond National Jurisdiction and the Nagoya Protocol Discussions among States and scholars have been, and continue to be, held on the question of whether marine genetic resources sourced beyond areas of national jurisdiction fall within the scope of the CBD.176 The geographical scope of the Nagoya Protocol itself, i.e. applying to resources obtained from areas under the jurisdiction of its Parties or also to material obtained from areas beyond national jurisdiction or from Antarctica, remained among the main issues under discussion until the last hours of the Protocol’s negotiations.177 The various iterations of the draft text produced by the Ad Hoc Open-ended Working Group on Access and Benefit-sharing, from its sixth meeting onwards, all contain bracketed references to genetic resources from areas beyond the limits of national jurisdiction.178 It has been noted that the explicit reference of the Nagoya Protocol179 to CBD Article 15 (access to genetic resources) rather than to its Article 4 on the scope, which was an option under discussion, indicates that Parties did not wish to link the geographical scope of the Nagoya Protocol to CBD Article 4.b, as this could have raised the question of whether the Nagoya Protocol would apply to bioprospecting beyond the limits of national jurisdiction.180 Ultimately, thus, the Protocol applies to genetic resources sourced in areas under national jurisdiction. Nevertheless, the Protocol includes a fairly enigmatic provision whereby Parties are to consider the need for, and modalities of, a global multilateral benefit-sharing mechanism to address the fair and equitable sharing of benefits derived from the utilisation of genetic resources and traditional knowledge associated with genetic resources that occur in transboundary situations or for which it is not possible to grant or obtain prior informed consent. The benefits shared by users of genetic resources and traditional knowledge associated with genetic resources through this mechanism would be used to support the conservation of biological diversity and the sustainable use of its components globally.181

 See for example Rüdiger Wolfrum and Nele Matz, “The Interplay of the United Nations Convention on the Law of the Sea and the Convention on Biological Diversity,” Max Planck Yearbook of United Nations Law, 4 (2000): 445; Scovazzi, “Bioprospecting”; Alexander Proelss, “Marine Genetic Resources under UNCLOS and the CBD,” German Yearbook of International Law, 51 (2008): 417. 177  Buck and Hamilton, “The Nagoya Protocol,” 50. 178  See reports of the ABS Working Group, documents UNEP/CBD/COP/9/6, UNEP/ CBD/WG-ABS/7/8, UNEP/CBD/WG-ABS/8/8, UNEP/CBD/WG-ABS/9/3, UNEP/CBD/ COP/10/5/Add.4, and UNEP/CBD/COP/10/5/Add.5. 179  Nagoya Protocol Article 3. 180  Buck and Hamilton, “The Nagoya Protocol,” 57. 181  Nagoya Protocol Article 10. 176

178   Charlotte Salpin The idea of a global multilateral benefit-sharing mechanism was informally proposed by some developing countries as an alternative to the application of the Protocol to material accessed before the entry into force of the CBD or to areas beyond national jurisdiction. The current wording of Article 10 was, however, not negotiated but proposed by the Presidency of the tenth meeting of the Conference of the Parties to the CBD as part of its compromise proposal, and was accepted as such by all Parties.182 Ultimately, the Protocol only establishes a procedural obligation to consider the need for, and modalities of, a global mechanism. This provision nevertheless raises a number of interesting questions. First, the mechanism envisioned would be of a multilateral character, thus departing from the bilateral approach to benefit-sharing established by the CBD and the Nagoya Protocol. Second, the expression ‘genetic resources for which it is not possible to grant or obtain prior informed consent’ could eventually lead to broadening the scope of the Protocol to genetic resources from areas beyond national jurisdiction. In a more narrow reading, which would be consistent with the scope of the Protocol as set out in its Article 3, it could simply help resolving situations where genetic resources in user country jurisdiction are of unclear origin or legal status or also help addressing benefit-sharing for material held in exsitu collections, as noted by some commentators.183 The issue of the global mechanism is scheduled for discussion at the second meeting of the Open-ended Ad Hoc Intergovernmental Committee for the Nagoya Protocol on Access and Benefit-sharing in July 2012.184 In those discussions, Paragraph 3 of Article 4 of the Protocol should be borne in mind as it provides that ‘due regard should be paid to useful and relevant ongoing work or practices under such international instruments and relevant international organisations, provided that they are supportive of and do not run counter to the objectives of the Convention and this Protocol’. While not explicitly referred to in the Preamble of the Protocol, unlike work under other international organisations,185 the work of the General Assembly Ad Hoc Open-ended Informal Working Group to study issues relating to the conservation and sustainable use of marine biological diversity beyond areas  Buck and Hamilton, “The Nagoya Protocol,” 59.  Ibid., 60. 184  See CBD Decision 10/1, “Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation” (20 January 2011) UN Doc UNEP/CBD/ COP/10/27. 185  The preamble of the Protocol refers to the FAO Commission on Genetic Resources for Food and Agriculture, the World Health Organisation and the Multilateral System of Access and Benefit-sharing established under the International Treaty on Plant Genetic Resources for Food and Agriculture. [See contributions by Chiarolla, Louafi and Schloen and by Wilke in this volume (Chapters 3 and 4).] 182 183

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of national jurisdiction (hereafter ‘Working Group’) is certainly relevant in that regard. c.  MGRs from Areas beyond National Jurisdiction in the Work of the General Assembly Since 2006, the General Assembly has consistently reaffirmed its role (and, most recently, its ‘central’ role) relating to the conservation and sustainable use of marine biodiversity beyond areas of national jurisdiction, noted the work of States and relevant complementary intergovernmental organisations and bodies on those issues, including the CBD and the Food and Agriculture Organisation of the United Nations, and invited them to contribute to its consideration of these issues within the areas of their respective competence.186 Since the first meeting of the Working Group, in 2006, issues related to marine genetic resources beyond areas of national jurisdiction have been central to the discussions.187 While States recognise that UNCLOS provides the framework for all activities in the oceans and seas, including in relation to marine genetic resources beyond areas of national jurisdiction, divergent views continue to be held on the respective application of Part VII (high seas) and Part XI (the Area) to those resources and activities related thereto. A majority of developing countries holds the view that the common heritage of mankind, as set out under Part XI of UNCLOS, not only applies to mineral resources but also to the biological resources of the Area. Among the arguments advanced is the fact that UNCLOS is a living instrument  UN General Assembly, “Oceans and the Law of the Sea” (16 March 2007) UN Doc A/ RES/61/222 adopted in 2006; UN General Assembly, “Oceans and the Law of the Sea” (14 March 2008) UN Doc A/RES/62/215 adopted in 2007; UN General Assembly, “Oceans and the Law of the Sea” (12 February 2009) UN Doc A/RES/63/111 adopted in 2008; UN General Assembly, “Oceans and the Law of the Sea” (12 March 2010) UN Doc A/RES/64/71 adopted in 2009; UN General Assembly, “Oceans and the Law of the Sea” (17 March 2011) UN Doc A/RES/65/37A adopted in 2010; UN General Assembly, “Oceans and the Law of the Sea” (5 April 2012) UN Doc A/RES/66/231 adopted in 2011. 187  The Working Group was established by resolution 59/24 of the General Assembly to: (a) survey the past and present activities of the United Nations and other relevant international organisations with regard to the conservation and sustainable use of marine biological diversity beyond areas of national jurisdiction; (b) examine the scientific, technical, economic, legal, environmental, socio-economic and other aspects of these issues; (c) identify key issues and questions where more detailed background studies would facilitate consideration by States of these issues; and (d) indicate, where appropriate, possible options and approaches to promote international cooperation and coordination for the conservation and sustainable use of marine biological diversity beyond areas of national jurisdiction. It has met five times to date in 2006, 2008, 2010, 2011 and 2012. The reports on the work of the Working Group are available at: http://www.un.org/depts/los/biodiversity workinggroup/biodiversityworkinggroup.htm. 186

180   Charlotte Salpin which must be interpreted in the light of the focus being placed during a given period – the focus today also including marine biodiversity. It is also pointed out that the applicable provisions are determined by the maritime zones in which the resources are found, not by the nature of these resources. Developed countries, generally, based on a literal interpretation of UNCLOS, are of the opinion that Part XI only encompasses mineral resources, while marine genetic resources fall under the regime of the high seas – the freedom of the high seas would therefore govern their collection and exploitation.188 By and large, those positions reflect the respective capacity of each group of States to access, explore and exploit those resources, taking into account varying degrees of capacities within each group.189 With a view to getting out of the deadlock in the discussions, a number of States, at the 2008 and 2010 meetings of the Working Group, proposed to focus on practical measures to address existing implementation gaps and to enhance the conservation and sustainable use of marine genetic resources. Such measures included: the promotion of MSR and development of codes of conduct; mechanisms for cooperation, sharing of information and knowledge resulting from research on marine genetic resources, including by increasing the participation of researchers from developing countries in relevant research projects; discussion of practical options for benefit-sharing, including options for facilitating access to samples; and consideration of the intellectual property aspects of marine genetic resources beyond areas of national jurisdiction. While open to considering practical measures, other States continue to stress the importance of discussions on the legal regime.190 All issues under consideration by the Working Group, including marine genetic resources, marine protected areas and environmental impact assessments, are now bundled into a package as evidenced by the outcome of the fourth meeting of the Working Group held in 2011. The Working Group recommended, inter alia, that a process be initiated, by the General Assembly, with a view to ensuring that the legal framework for the conservation and sustainable use of marine biodiversity in areas beyond national jurisdiction effectively addresses those issues by identifying gaps and ways forward,  United Nations, “Letter dated 15 May 2008 from the Co-Chairpersons of the Ad Hoc Open-ended Informal Working Group to study issues relating to the conservation and sustainable use of marine biological diversity beyond areas of national jurisdiction addressed to the President of the General Assembly” (16 May 2008) UN Doc A/63/79; and United Nations, “Letter dated 16 March 2010 from the Co-Chairpersons of the Ad Hoc Openended Informal Working Group to the President of the General Assembly” (17 March 2010) UN Doc A/65/68. 189  Valentina Germani and Charlotte Salpin, “The Status of High Seas Biodiversity in International Policy and Law”, in Pierre Jacquet et al. ed., 196. 190  United Nations, “Letter dated 15 May 2008”; United Nations, “Letter dated 16 March 2010”. 188

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including through the implementation of existing instruments and the possible development of a multilateral agreement under UNCLOS. It further recommended that this process would address the conservation and sustainable use of marine biodiversity in areas beyond national jurisdiction, in particular, together and as a whole, marine genetic resources, including questions on the sharing of benefits, measures such as area-based management tools, including marine protected areas, and environmental impact assessments, capacity-building and the transfer of marine technology.191 The General Assembly endorsed these recommendations and initiated the process.192 The fifth meeting of the Working Group was held in May 2012 and marked the first meeting in the process. It recommended that, with a view to improving understanding of the issues and clarifying key questions as an input to the work of the Working Group, the Secretary-General be requested to convene two intersessional workshops and that the Working Group, at its next meeting in 2013, continue to consider, together and as a whole, all issues under its mandate, taking into account the discussions at its 2012 meeting as well as the input of the workshops.193 In light of the debate currently held at the General Assembly, it will be interesting to see how the multilateral benefit-sharing mechanism provided for in the Nagoya Protocol will evolve, if it is eventually established by the meeting of the Parties to the Protocol, and how it could inspire benefitsharing related to marine genetic resources sourced beyond areas of national jurisdiction. At this stage, the Protocol’s major implications will be on governance. First, the experience and lessons learnt gained in the negotiating process leading up to the adoption of the Protocol, including as regards participation of all stakeholders in the discussions, in particular scientists, industry and governments, may be beneficial to the work of the General Assembly. Second, progress under the Protocol in regards of the global mechanism, or lack thereof, could sway the discussions at the General Assembly one way or another. Developments under the Protocol may either stimulate progress at the General Assembly and in the context of UNCLOS, including by providing a source of inspiration, or they may put a halt to the General Assembly’s discussions to the benefit of more focused discussions in other fora. The discussions envisaged on the multilateral benefit-sharing mechanism bring back to light a number of proposals made by various authors in the  United Nations, “Letter dated 30 June 2011 from the Co-Chairs of the Ad Hoc Openended Informal Working Group to the President of the General Assembly” (30 June 2011) UN Doc A/66/119. 192  UN General Assembly, “Oceans and the law of the sea” (5 April 2011) UN Doc A/ RES/66/231. 193  United Nations, “Letter dated 8 June 2012 from the Co-Chairs of the Ad Hoc Openended Working Group to the President of the General Assembly” (13 June 2012) UN Doc A/67/95. 191

182   Charlotte Salpin past, on modalities for sharing of the benefits arising out of the utilisation of marine genetic resources sourced in areas beyond national jurisdiction. In particular, at the 2008 meeting of the Working Group, the multilateral system developed under the International Treaty on Plant Genetic Resources for Food and Agriculture was proposed as a possible reference point for discussions on practical measures.194 Author D. Leary had also proposed the creation of a global commons trust fund, possibly managed by the Global Environment Facility, linked to international and national legal regimes for the grant of patents. In such a system, the grant of a patent would be conditional upon payment of a royalty to the global commons trust fund and the proceeds used to fund measures for the sustainable management of the marine environment and sustainable development.195 As proposals such as those are put forward, one should not forget that the regime established in regards of resources found in the Area196 is based on some of the most visionary and intricate provisions aimed at benefit-sharing yet to be found in any treaty, with an institutional set up and benefit-sharing mechanism, including transfer of technology. The complexity of these provisions is undeniable, and it is yet to be seen whether they will work to their intended effect when exploitation of the Area’s minerals and production eventually get underway. It remains that they provide an example of what can be achieved as the need for, and modalities of, benefit-sharing from the utilisation of marine genetic resources sourced from areas beyond national jurisdiction are being considered. In that regard, they may even provide a source of inspiration for the multilateral benefit-sharing mechanism envisaged in the Protocol.197 Besides national coordination and international cooperation in other areas, marine genetic resources beyond areas of national jurisdiction will thus provide an interesting case to see how UNCLOS and the Protocol may work in tandem to benefit the development of international law.

III.  Conclusion Will there be a ‘before and after’ Nagoya as far as the law of the sea is concerned? It is clear from the analysis of the core provisions of the Nagoya Protocol on ABS – PIC and benefit sharing – in the context of the law of the sea, that for States Parties to both UNCLOS and the Nagoya Protocol,  United Nations, “Letter dated 15 May 2008”.  David K. Leary, International Law and the Genetic Resources of the Deep Sea (Boston: Martinus Nijhoff Publishers/Brill, 2007), 179 et seq. 196  As set out under UNCLOS Part XI (see supra) and the 1994 Agreement. 197  Nagoya Protocol Article 10. 194 195

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implementing the two instruments while maintaining the balance between various interests that both seek to achieve, including with a view to not unduly restricting scientific research undertaken without intent of commercial gain, may prove challenging. However, the two instruments may also work together to foster greater coordination at the national level and cooperation at the international level. There will therefore certainly be a before and after Nagoya, even if only by the level of additional complexity that the Protocol may bring into the MSR consent regime, including, potentially, through an increased role for indigenous and local communities. UNCLOS and the Nagoya Protocol are products of their times and reflect the concerns and aspirations of the international community at a thirty-year interval, as is evidenced by the references of the Protocol, besides indigenous and local communities, to climate change198 and the role of women199 – three emerging issues that the international community is grappling with and which are absent from UNCLOS. However, while some of the provisions of UNCLOS may appear anachronistic, in particular, in light of the fast-paced progresses in life sciences and the boom of the marine biotechnology sector, one cannot but be surprised at the vision that it embodies in terms of equitable utilisation and sharing of benefits, when compared to the provisions of the more recent Protocol, qualified as a ‘masterpiece in creative ambiguity’.200 Experience gained in the decades of implementation of the law of the sea, as reflected in UNCLOS, can usefully inform the implementation of the Nagoya Protocol in the marine realm, in particular as regards the consent regime for MSR. At the same time, as the legal framework for all activities in the oceans and seas, UNCLOS must be interpreted and implemented in a manner which takes into account the environmental, economic, scientific and societal changes that have emerged since its conclusion, including with a view to contributing to progress for all peoples of the world, as UNCLOS aims to do.

 Nagoya Protocol Preamble.  Nagoya Protocol Preamble and Articles 12, 22 and 25. 200  Stefan Jungcurt et al., “Summary of the Tenth Meeting of the Conference of the Parties to the Convention on Biological Diversity: 18–29 October 2010”, Earth Negotiations Bulletin 9:544 (2010): 26. 198 199

Chapter 6.  The Nagoya Protocol and WTO Law Riccardo Pavoni* In the past two decades, the relationship between the Convention on Biological Diversity (CBD) and multilateral trade obligations administered by the World Trade Organisation (WTO) has no doubt been one of the most well-known case studies within the ‘trade-and-environment’ debate.1 Commentators have especially focused on the potential conflict with the WTO agreements arising from restrictions on trade in genetically modified organisms as well as from the CBD provisions on access to genetic resources and sharing of benefits resulting from their utilisation (ABS). Following the adoption of the Nagoya Protocol, both issues are now regulated under protocols to the CBD.2 As the purpose of these protocols is to operationalise the programmatic and frequently vague provisions of the CBD, it is foreseeable that, as already occurred with the Cartagena Protocol,3 the adoption *  Associate Professor of International Law, Faculty of Law, University of Siena. 1  E.g., Christopher D. Stone, “What To Do About Biodiversity: Property Rights, Public Goods, and the Earth’s Biological Riches,” Southern California Law Review 68 (1995): 577; Richard Tarasofsky, “The Relationship Between the TRIPs Agreement and the Convention on Biological Diversity: Towards a Pragmatic Approach,” Review of European Community and International Environmental Law 6 (1997): 148; Thomas Cottier, “The Protection of Genetic Resources and Traditional Knowledge: Towards More Specific Rights and Obligations in World Trade Law,” Journal of International Economic Law 1 (1998): 555; Riccardo Pavoni, Biodiversità e biotecnologie nel diritto internazionale e comunitario (Milan: Giuffrè, 2004), 185–236. 2  On transboundary movements of genetically modified organisms, see Cartagena Protocol on Biosafety (Montreal, 29 January 2000, in force 11 September 2003) 2226 UNTS 208. 3  See e.g. Peter-Tobias Stoll, “Controlling the Risks of Genetically Modified Organisms: The Cartagena Protocol on Biosafety and the SPS Agreement,” Yearbook of International Environmental Law 10 (1999): 82; Asif H. Qureshi, “The Cartagena Protocol on Biosafety and the WTO – Coherence or Inconsistency?,” International and Comparative Law Quarterly 49 (2000): 835; Riccardo Pavoni, “Assessing and Managing Biotechnology Risk under the Cartagena Protocol on Biosafety,” Italian Yearbook of International Law 10 (2000): 113; Sabrina Safrin, “Treaties in Collision? The Biosafety Protocol and the World Trade Organization Agreements,” American Journal of International Law 96 (2002): 606; Laurence Boisson de Chazournes and Makane M. Mbengue, “A propos du principe du soutien mutuel.

186   Riccardo Pavoni and implementation of the Nagoya Protocol will generate a new wave of enhanced policy and scholarly discussions on its compatibility with the world trade system. For the same reasons, it is unsurprising that trade-andenvironment quarrels were prominent in the negotiating process leading to the Nagoya Protocol and that the latter’s final text contains several provisions embodying compromise solutions in this area.4 In the present chapter, I take the view that those compromises translate into an agreement that leaves the issue of the relationship between the international biodiversity regime on ABS and WTO obligations largely unresolved and ambiguous. This does not mean that instances of actual conflict with WTO disciplines may never surface in the future. The measures enacted by the Parties for implementing the Nagoya Protocol will indeed be crucial for evaluating the latter’s potential to pave the way for laws and practices that are prima facie inconsistent with WTO rules. Therefore, when illustrating the interferences of the Nagoya Protocol with WTO obligations, I will conveniently use a broad notion of conflict of norms, i.e., one referred to situations where the Parties’ implementation of one instrument may lead to a breach of the other. More orthodoxically, these should be identified as ‘tensions’ among competing regimes, rather than ‘norm conflicts’ stricto senso, i.e., those arising from mutually-exclusive obligations set forth in the agreements themselves. However, the alternative between deviations from WTO disciplines that are imposed by an international agreement itself and those that are merely allowed by the latter is critical from the WTO perspective. In the case of a WTO dispute involving the second hypothesis, the international agreement would at best only be relevant for interpretative purposes, while the disputed national measures would most likely be found in breach of WTO law.5 After a preliminary consideration of the scope of the Nagoya Protocol and the nature of its obligations (section I), this chapter will present an overview of the main substantive trade issues arising from the Protocol. Essentially, these concern the relationship between the Protocol’s ABS regime and WTO agreements on trade in goods (section II.1) and that between the Protocol and WTO obligations in the field of intellectual property rights (IPRs) (section II.2). The next part of the chapter will revisit the systemic issue of the Les relations entre le Protocole de Cartagena et les Accords de l’OMC,” Revue Générale de Droit International Public 111 (2007): 829. 4  See Matthias Buck and Claire Hamilton, “The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation to the Convention on Biological Diversity,” Review of European Community and International Environmental Law 20 (2011): 47, 53–54, 56–58. 5  See further section I.

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interface between trade rules and the biodiversity regime in the light of the specific Nagoya Protocol’s clause on its relationship with other agreements6 (III.1) and of pertinent WTO negotiations (III.2). The chapter concludes with a summary of the reasons why the Nagoya Protocol fails to meet the expectation of an agreement laying down clear rules in the trade-and-biodiversity area (section IV).

I.  The Scope of the Protocol and the Nature of Its Obligations A preliminary point on the impact of the Nagoya Protocol on the WTO system concerns the extent to which the former covers tradeable goods and their commercialisation. This seems particularly important to determine: (i) whether the Protocol allows Parties to restrict access to, and thus export of, so-called ‘derivatives’ found within their jurisdiction; and (ii) whether it legitimates forms of benefit-sharing associated with the enjoyment of IPRs granted in respect of commercial products developed from genetic resources. Both issues were hotly debated during the negotiations and resulted in a quite unclear solution. According to the Protocol, derivatives are naturally occurring biochemical compounds, such as aromas, snake venoms or resins, which may not incorporate viable genetic material/DNA.7 They are substances derived from genetic resources, but not necessarily containing them. Industry, especially in the biotechnological sector, seems to have shifted much of its research and development activities from actual genes to these compounds. Hence, the insistence of developing and least-developed countries to have them covered by the Protocol. Their demands seem to have been accommodated, albeit in a very controversial way, i.e., by purportedly narrowing down the scope of the Protocol so that it would only apply to the ‘benefits arising from the utilisation’8 of genetic resources, to the exclusion of their commercialisation. Indeed, ‘utilisation of genetic resources’ is confined to ‘research and development . . . including through the application of biotechnology’,9 and in accordance with the CBD, ‘biotechnology’ is defined as technology ‘that uses biological systems, living organisms, or derivatives thereof, to make or modify

 Nagoya Protocol Article 4.  Cf. Nagoya Protocol Article 2.e. Quite exceptional in the history of treaty drafting, the Protocol provides this definition of ‘derivative’ in its Article 2, but then the term is not repeated in any other provision. 8  Nagoya Protocol Article 3. 9  Nagoya Protocol Article 2.c. 6 7

188   Riccardo Pavoni products’.10 The price paid by developing and least-developed countries to be entitled to share the benefits from research and development on derivatives would, therefore, appear very high: they would at once be denied the same entitlement with respect to the commercial profits arising from such derivatives and of any product resulting from genetic resources accessed within their territory. For our purposes, this would mean that the impact of the Nagoya Protocol on WTO rules would substantially be downsized. I believe, however, that this interpretation would be inaccurate and unreasonable. First, the expression ‘research and development’ is not straightforward, as it may well encompass research pursuing eminently commercial purposes and logics. Second, another provision of the Nagoya Protocol imposes the sharing of benefits stemming from the utilisation of genetic resources ‘as well as subsequent applications and commercialisation’.11 Third, in the context of an agreement essentially preserving the contractual freedom of the parties to ABS arrangements, it seems unreasonable to posit that such parties are deprived of the right to negotiate in respect of the revenues generated by commercial transactions. The main implication of the Protocol’s focus on ‘utilisation’ of genetic resources seems associated with monitoring and compliance duties of user country Parties, i.e., the user measures that Parties are to enact and enforce for ensuring that any utilisation of genetic resources within their jurisdiction respects the legislation of provider country Parties.12 Reference to ‘utilisation’ in this context implies that those duties do not extend to the commercialisation of products derived from genetic resources. Enforcement in this phase would only be a matter for parties to the ABS contractual transactions. However, even from this viewpoint, a certain tension remains between such a narrow scope of user measures and the obligation to equitably share the benefits arising from the ‘subsequent applications and commercialisation’13 of genetic resources. The Protocol’s provision at stake is formulated as a ‘Protocol Party-to-Protocol Party’ obligation, and not as an obligation incumbent upon ABS contractors. Therefore, compliance with it may also be claimed at the international level, and not only at the domestic level via contractual remedies.  Nagoya Protocol Article 2.d, emphasis added. Cf. CBD Article 2.  Nagoya Protocol Article 5.1. This is in line with CBD Article 15.7 (‘results of research and development . . . and the benefits arising from the commercial and other utilisation . . .’). Moreover, the illustrative list of monetary benefits in the Annex to the Nagoya Protocol includes ‘[l]icence fees in case of commercialisation’ (point 1.e). 12  Nagoya Protocol Articles 15, 16, and 17. 13  Nagoya Protocol Article 5.1. 10 11

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What is indisputable is that the Nagoya Protocol covers genetic resources and that, in accordance with the general principle of permanent sovereignty over natural resources,14 it reaffirms that access to such resources may be conditional on the prior informed consent (PIC) of the provider country.15 As spelled out below,16 this is sufficient to trigger tensions with the WTO agreements. As a matter of fact, there is no reason to doubt that, whenever they may be involved in commercial transactions (such as ABS contracts), natural resources – both living and non-living – do constitute products subject to the WTO disciplines on trade in goods.17 On the other hand, it should be recalled that the CBD has decisively affected the long-standing debate over the international law status of biological and genetic resources by subsuming them,18 regardless of their special features and importance for humanity as a whole, under the above-mentioned principle of permanent sovereignty. Such special characteristics include the fact that genetic resources are usually sought after for the intangible genetic information they provide, rather than for the physical living matter embodying the information. This constitutes an undeniable difference vis-à-vis natural resources, such as oil, minerals or animals used as foodstuffs, to which the principle of permanent sovereignty and WTO rules on trade in goods traditionally apply. However, it is highly unlikely that this would have any bearing on the applicability of the pertinent WTO regimes. Therefore, the reason why the existence of genuine conflicts of norms between the Nagoya Protocol and the WTO agreements should not be  United Nations General Assembly Resolution 1803 (XVII), “Permanent Sovereignty over Natural Resources” (14 December 1962); Nagoya Protocol third preambular paragraph and Article 6.1. 15  Nagoya Protocol Article 6. 16  Section II.1. 17  By analogy, one may recall in this connection the broad definition of ‘goods’ devised by the European Court of Justice: ‘By goods, . . . there must be understood products which can be valued in money and which are capable, as such, of forming the subject of commercial transactions’ (Court of Justice of the EU, Commission of the European Communities v Italian Republic (Case 7–68) [1968] ECR 423, 428). For a famous WTO precedent, dealing with the distinct but related issue of the applicability of the exception in GATT Article XX.g to ‘living resources’, and resolving it affirmatively, see United States-Import Prohibition on Certain Shrimp and Shrimp Products, Appellate Body Report (adopted 6 November 1998) WT/DS58/AB/R, paragraphs 129–134. 18  For a fine account of the evolution of the law in this area, see Mary E. Footer, “Intellectual Property and Agrobiodiversity: Towards Private Ownership of the Genetic Commons,” Yearbook of International Environmental Law 10 (1999): 48. See also Ikechi Mgbeoji, “Beyond Rhetoric: State Sovereignty, Common Concern, and the Inapplicability of the Common Heritage Concept to Plant Genetic Resources,” Leiden Journal of International Law 16 (2003): 821. 14

190   Riccardo Pavoni overstated is not associated with its subject-matter. It instead has to do with the nature of the Protocol as a largely enabling instrument allowing the parties to pass legislation that may be at variance with WTO rules. The Protocol does not itself impose WTO-inconsistent obligations. For instance, it does not explicitly foresee any special circumstances under which Parties are required to ban trade in genetic resources, nor does it establish any restriction on ABS transactions with non-Parties. Most importantly, the Protocol does not lay down a mandatory disclosure requirement for patents relating to genetic resources. Parties thus enjoy substantial discretion in shaping their ABS laws and practices under the guidance provided by the Protocol. It is in this light that the following account19 of the possible impact of the Nagoya Protocol on WTO rules on trade in goods and IPRs has to be considered. The point is crucial from the perspective of the WTO. The Doha Round negotiations relating to trade and environment are circumscribed inter alia to ‘the relationship between existing WTO rules and specific trade obligations set out in multilateral environmental agreements’ (MEAs).20 Despite extensive discussions on its meaning in the WTO Committee on Trade and Environment, the most accredited interpretation of this notion of ‘specific trade obligations’ is that it refers to those (rare) examples where an MEA itself obliges Parties to take measures incompatible with WTO rules.21 By contrast, when Parties have different options for implementing a traderelated principle or provision in an MEA, the most likely reaction of WTO dispute settlement bodies would be that WTO law requires that only the WTO-consistent or WTO-least inconsistent option be actually pursued. Failing that, the WTO Member’s restrictions at stake would, in principle, be considered as violations of WTO law unjustifiable under a purported need to comply with the MEA. This may also be taken as a particular reflection of the presumption against conflicts between international law rules and of the consequent necessity to interpret and implement them in a consistent manner.

 Sections II and III below.  WTO, “Doha Ministerial Declaration” (20 November 2001) WT/MIN(01)/DEC/1, paragraph 31.i, emphasis added. 21  The Report of the Chairman of the WTO Committee on Trade and Environment in Special Session circulated in April 2011, and the annexed WTO Draft Ministerial Decision on Trade and Environment, stated that the observations of the Committee’s Members converged on considering a ‘specific trade obligation’ set out in an MEA as ‘one that requires an MEA Party to take, or refrain from taking, a particular trade action [a trade-related action]’, WTO Committee on Trade and Environment Special Session, “Report by the Chairman, Ambassador Manuel A.J. Teehankee, to the Trade Negotiations Committee,” (21 April 2011) TN/TE/20, 7 (emphasis added, footnotes omitted). 19 20

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Surely, interpretation is not a one-sided exercise. Thus, that certain traderestrictive measures adopted by a WTO Member are within the scope of an MEA, such as the Nagoya Protocol, may have a bearing on the interpretation of the applicable WTO provisions. The Vienna Convention on the Law of Treaties provides that, in interpreting a treaty, ‘any relevant rules of international law applicable in the relations between the Parties’22 have to be taken into account. However, an unappealed WTO Panel Report in the EC-Biotech Products case endorsed a very narrow construction of this Vienna Convention provision, by stating that certain MEAs – such as the CBD and the Cartagena Protocol – may be considered in the interpretation of WTO law only when all the WTO Members are Parties to those MEAs.23 It is evident that this solution would substantially undermine any future interpretative use of the Nagoya Protocol at the WTO. Much more liberal in this respect was the approach of the Appellate Body in US-Shrimp, where the CBD, amongst other MEAs, was taken into account, although not all WTO members (including some of those involved in the dispute) were Parties thereto.24 The EC-Biotech Products Panel took the view that, in US-Shrimp, the Appellate Body merely used the CBD as an aid for clarifying the ordinary meaning of WTO provisions as per Article 31.1 of the Vienna Convention.25 Yet, the soundness of this position is very questionable.26

II.  Substantive Trade Issues 1.  The Nagoya Protocol and Trade in Goods For Parties to the Nagoya Protocol that are also WTO Members,27 the former gives rise to several issues regarding potential interferences with the WTO rules on trade in goods. Most of them can be considered as a perpetuation

 Vienna Convention on the Law of Treaties (Vienna, 23 May 1969, in force 27 January 1980) 115 UNTS 331, Article 31.3.c. See also Understanding on Rules and Procedures Governing the Settlement of Disputes (Annex 2 to the Agreement Establishing the World Trade Organisation, Marrakesh, 15 April 1994, in force 1 January 1995) Article 3.2. 23  European Communities-Measures Affecting the Approval and Marketing of Biotech Products, Panel Report (adopted 21 November 2006) WT/DS291/R, WT/DS292/R, WT/DS293/R, paragraphs 7.68, 7.70–7.75. 24  US-Shrimp, paragraphs 130, 168. 25  EC-Biotech Products, paragraphs 7.92, 7.94. 26  See, e.g., Margaret A. Young, “The WTO’s Use of Relevant Rules of International Law: An Analysis of the Biotech Case,” International and Comparative Law Quarterly 56 (2007): 907, 919–920. 27  WTO membership is increasingly expanding. As of 10 May 2012, WTO Members are 155. 22

192   Riccardo Pavoni and expansion of problems underlying the CBD, while others are specific to the Protocol. To the first category belong the trade-restrictive and trade-discriminatory effects that domestic ABS laws and practices may bring about. As illustrated below, such laws and practices may violate certain basic principles of the General Agreement on Tariffs and Trade 1994 (GATT), unless they are found to be permitted under one of the exceptions in GATT Article XX. As is well-known, this is the most important GATT provision for justifying trade-restrictive environmental and health measures.28 Provided the latter are not applied in an arbitrary or discriminatory fashion, Article XX.b allows measures ‘necessary to protect human, animal or plant life or health’, while Article XX.g excuses measures ‘relating to the conservation of exhaustible natural resources’. The tension between the Nagoya Protocol and the GATT arises especially in relation to potential export restraints on genetic resources. GATT Article XI prohibits bans on quantitative restrictions, such as quotas or licences, affecting the exportation or sale for export of any product29 destined for the territory of any WTO Member. Moreover, in accordance with the MostFavoured-Nation (MFN) principle,30 GATT outlaws any kind of discrimination as between WTO Members in respect of ‘customs duties’31 and ‘all rules and formalities’32 associated with exportation, so that any advantage or privilege granted by a WTO Member to any product destined for any country  For the pertinent jurisprudence, see especially Thailand-Restrictions on Importation of and Internal Taxes on Cigarettes, Panel Report (adopted 7 November 1990) DS10/R; United States-Restrictions on Imports of Tuna, (3 September 1991) DS21/R; United StatesRestrictions on Imports of Tuna, (16 January 1994) DS29/R; United States-Standards for Reformulated and Conventional Gasoline, Appellate Body Report (adopted 20 May 1996) WT/DS2/AB/R; US-Shrimp; European Communities-Measures Affecting Asbestos and Asbestos-Containing Products, Appellate Body Report (adopted 5 April 2001) WT/DS135/ AB/R; United States-Import Prohibition of Certain Shrimp and Shrimp Products, Recourse to Article 21.5 of the DSU by Malaysia, Appellate Body Report (adopted 21 November 2001) WT/DS58/AB/RW; Brazil-Measures Affecting Imports of Retreaded Tyres, Appellate Body Report (adopted 17 December 2007) WT/DS332/AB/R. 29  On the threshold question whether the Nagoya Protocol applies to products and to trade in products, see section I above. Exchange of genetic material between countries may take various forms, certain of which may be regarded as extraneous to any trade in products. As the following text in this section makes clear, the main problem with the WTO rules is generated by possible exports restraints or embargoes on genetic resources. At least in this case, the applicability of the WTO framework on trade in goods seems unquestionable. 30  GATT Article I. 31  GATT Article I.1. 32  GATT Article I.1. 28

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must be accorded ‘immediately and unconditionally’33 to the ‘like product’34 destined for all other WTO Members.35 While the prohibition of quantitative restrictions is inherently called into question by the CBD/Nagoya Protocol principle of PIC relating to access to – and thus normally to export of – genetic resources, the MFN rule may be encroached upon whenever CBD/ Nagoya Protocol Parties (that are also WTO Members) deny access to – and export of – genetic resources to certain WTO Members only, either in general or under favourable conditions accorded to others. As regards the prohibition of export restrictions, it is clear that the purpose of the Protocol is to lay down rules facilitating access to, and transnational exchanges of, genetic resources, rather than embargoes on them. It thus directs Parties to enact transparent, clear, fair and non-arbitrary PIC procedures.36 But it is equally evident that, while the same Parties may choose to waive their right to grant PIC thereby ensuring open and free access to genetic resources, they are also entitled to withhold consent altogether to bioprospecting activities in their territory or only to the subsequent exportation and commercialisation of genetic material. Of course, States may well adopt these trade measures on the basis of their sovereign rights over territorial natural resources. But as stated above,37 the CBD and the Nagoya Protocol strengthen such claims because, without mandating the trade-restrictive measures at stake, indubitably allow them by explicitly endorsing the basic principle of permanent sovereignty over biological resources. Genetic resources are indeed strategic natural resources for a country’s economy and sustainable development, as well as precious raw materials for the biotechnology and other industries. As such, there may be multiple environmental and economic reasons for curbing their exportation. As recalled below, some of these reasons may be in accordance with WTO rules, thereby making the pertinent restrictions legitimate barriers to free trade. Most importantly for the Nagoya Protocol, we are witnessing a mounting debate on the WTO legality of obstacles to the exportation of strategic natural resources, such as valuable raw materials threatened with depletion and extracted through environmentally-destructive processes. This debate has

 GATT Article I.1.  GATT Article I.1. 35  In addition, the MFN principle is specifically applied to export prohibitions and restrictions, insofar as the latter are forbidden unless ‘the exportation of the like product to all third countries is similarly prohibited or restricted’, GATT Article XIII. 36  Nagoya Protocol Article 6.3.a–d. 37  See section I. 33 34

194   Riccardo Pavoni been triggered by the China-Raw Materials dispute,38 where the WTO adjudicatory bodies found that the restrictions applied by China on the exportation of several raw materials, such as bauxite, zinc and coke, constituted inter alia a violation of GATT Article XI and were unjustifiable under any of the available derogations and exceptions.39 In particular, the Appellate Body largely confirmed the Panel’s interpretation to the effect that China could not invoke GATT Article XI.2.a as a basis for certain of its measures. According to this provision, export restrictions are lawful when they are ‘temporarily applied to prevent or relieve critical shortages of foodstuffs or other products essential to the exporting country’.40 The Appellate Body shared the Panel’s view that Article XI.2.a cannot normally excuse export restraints of a potentially indefinite duration allegedly taken to fight against the rapid depletion of exhaustible non-renewable resources, such as minerals.41 Indeed, according to the WTO bodies, the ‘non-renewability’ of mineral resources would impermissibly pave the way for permanent restrictions. A contrario, the ‘critical shortages’ clause seems available for renewable – but endangered – living resources, such as plant and animal species, and thus for export restraints on genetic resources. At any rate, the exceptions in Article XX.b and g remain the cornerstone for States invoking the WTO legality of measures targeting the exportation of genetic resources.42 Genuine and non-discriminatory environmental and

 China-Measures Related to the Exportation of Various Raw Materials, Panel Reports, WT/ DS394/R, WT/DS395/R and WT/DS398/R and, Appellate Body Report (adopted 22 February 2012) WT/DS394/AB/R, WT/DS395/AB/R and WT/DS398/AB/R. See Elisa Baroncini, “An Impossible Relationship? Article XX GATT and China’s Accession Protocol in the China-Raw Materials Dispute,” BioRes 6 (2012): 18 (although addressing other aspects of the dispute, this author’s thoughtful considerations are very pertinent in our context). 39  Another prominent dispute regarding the legality of Chinese export restrictions on seventeen rare earth minerals that are essential for the development of many high-tech and green energy products has recently set off following the request for consultations with China lodged by the United States, the European Union, and Japan. See China-Measures Related to the Exportation of Rare Earths, Tungsten and Molybdenum, (15 March 2012) WT/DS/431–433. For background, see ICTSD, “US, EU, Japan Challenge China on Rare Earths,” accessed 14 April 2012, http://ictsd.org/i/news/bridgesweekly/128249; ICTSD, “Rare Earths: Beijing Launches Group to Consolidate Industry,” accessed 14 April 2012, http://ictsd.org/i/news/bridgesweekly/130786. 40  Emphasis added. 41  China-Raw Materials, Appellate Body Report, paragraphs 336–337. 42  Note that the Appellate Body in Raw Materials importantly declared that Article XI.2.a and Article XX.g are not mutually exclusive as they may well apply cumulatively (China-Raw Materials, Appellate Body Report, paragraphs 333–334, 337). 38

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health regulations are likely to be found in accordance with those exceptions.43 Therefore, bans or restraints on access to genetic samples of certain species on reliance on scientific findings showing that the latter are threatened with extinction, as well as measures necessary to tackle health emergencies, are generally permissible under GATT Article XX.b and g. Moreover, the military applications of genetic engineering might give rise to embargoes on pertinent biological resources justified by the security exceptions in GATT Article XXI. However, the most evoked cases of export restraints on genetic resources that can be envisaged on the basis of the Nagoya Protocol seem far less uncontroversial from the viewpoint of WTO law. A country may indeed deny access to genetic resources on the grounds that a concomitant satisfactory arrangement on benefit-sharing has not been concluded. Or it may decide that corporations and researchers possessing the nationality of States which have not enacted so-called ‘user measures’ under the Protocol,44 i.e., measures requiring respect for the ABS legislation of provider countries, are barred from collecting and exporting ‘its’ genetic resources. Are these restrictions lawful under GATT Article XX.b and g? That is, are these measures necessary to protect animal or plant life or health, or relating to the conservation of natural resources? The WTO adjudicatory bodies might well answer in the negative, arguing that there is no immediate and substantial relationship between the object and purpose of the disputed measures and those specific environmental goals. That benefit-sharing and user measures are key requirements of the CBD/Nagoya Protocol regimes, ultimately intended to promote the conservation and sustainable use of biodiversity,45 would not defeat the above position. Moreover, the latter might find support in Article 9 of the Nagoya Protocol, under which Parties are merely to ‘encourage’ users and providers to channel benefits deriving from genetic resources into conservation and sustainable use projects. As demonstrated by the China-Raw Materials dispute,46 reliance by provider countries on the principle of permanent sovereignty over natural resources under the guise of

 By contrast, protectionist measures aimed at affording a competitive advantage on the domestic industry, and only incidentally and indirectly achieving environmental objectives, are not justifiable under Article XX’s environmental exceptions. According to the Panel, this was the case with some of the Chinese measures at hand in Raw Materials, see ChinaRaw Materials, Panel Reports, sections VII.D.2–VII.D.4. Notably, these findings were not appealed by China. 44  Nagoya Protocol Articles 15–16. 45  Nagoya Protocol Article 1. 46  China-Raw Materials, Appellate Body Report, paragraphs 300–306; see the critical remarks by Baroncini, “An Impossible Relationship?,” 21. 43

196   Riccardo Pavoni a sovereign ‘right to regulate trade in a manner that promotes conservation and public health’47 would not do any better. A deviation from the most-favored-nation principle that has been muchdiscussed in the past relates to the potential discriminatory treatment accorded to WTO Members which are not Parties to the MEA at issue. The Nagoya Protocol does not mandate, nor recommends, any ban or restriction on access to genetic resources for, and commercial transactions with, non-Parties. Parties shall simply “encourage non-Parties to adhere to th[e] Protocol and to contribute appropriate information to the Access and Benefit-sharing Clearing-House”.48 This is one of the best examples of the Protocol’s scheme aimed at avoiding and minimising frictions with the WTO system: it is indeed a very weak provision in the context of non-Parties clauses included in trade-related MEAs. A most pertinent precedent is the Cartagena Protocol, which prescribes that transboundary movements (i.e., import/ export) of living modified organisms between Parties and non-Parties shall be consistent with – if not the provisions, at least – the objective of the Protocol.49 The Nagoya Protocol’s drafters evidently truncated the Cartagena Protocol’s clause at hand and decided to retain only its softest part,50 i.e., one which is clearly harmless vis-à-vis WTO disciplines. As noted above, a distinguishing feature of the Nagoya Protocol is the promotion of enhanced proceduralisation and bureaucratisation of ABS laws and processes. Particularly important in this respect is the introduction of an internationally recognised certificate of compliance. This certificate shall serve as evidence that the genetic resources it covers have been accessed in accordance with PIC and that benefit-sharing under mutually agreed terms (MAT) has been stipulated, as required by the ABS legislation of the provider country.51 It shall contain minimum information exemplified by the Protocol, such as the issuing authority, the beneficiary of PIC, covered resources, confirmations of PIC and MAT, and whether commercial use is envisaged.52 Under normal circumstances, the internationally recognised certificate of compliance will correspond to the permit (or its equivalent) that Parties are to issue at the time of access to genetic resources.53

 China-Raw Materials, Appellate Body Report, paragraph 300.  Nagoya Protocol Article 24. 49  Cartagena Protocol Article 24.1. 50  Cartagena Protocol Article 24.2 is almost identical to Nagoya Protocol Article 24. 51  Nagoya Protocol Article 17.3. 52  Nagoya Protocol Article 17.4. 53  Nagoya Protocol Articles 6.3.e and 17.2. 47 48

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Thus, in trade jargon, the internationally recognised certificate of compliance may be just another export or import licence to which the above observations on quantitative restrictions largely apply.54 However, this certificate may also be regarded as a technical regulation with a possible significant impact on imports of genetic resources. As such, it would be covered by the WTO Agreement on Technical Barriers to Trade (TBT). Although the most typical examples of technical barriers relate to packaging, marking, labelling and similar requirements, TBT defines a technical regulation broadly, as a ‘[d]ocument which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory’.55 The Nagoya Protocol envisages a series of measures which user countries must take in order to monitor and enhance transparency about the utilisation of genetic resources.56 These measures include requiring users to disclose information about PIC, MAT and the source of the resources to relevant national authorities. Such information may derive from internationally recognised certificates of compliance, ‘where they are available’.57 This demonstrates that this certificate is not foreseen as a mandatory requirement by the Protocol. Likewise, nowhere does the Protocol explicitly provide for the possibility to clear the importation of genetic resources only if they are accompanied by such a certificate.58 As already noted, this is in line with the avoidance strategy followed by the Protocol when touching upon trade-sensitive issues. However, leaving aside diplomatic tactics and resulting cautious treaty language, nothing seems to foreclose a Nagoya Protocol Party from imposing the internationally recognised certificate of compliance as a condition for the importation of genetic resources and from enforcing this restriction at the border, via its customs authorities. Certainly, this would be a rather uncommon situation consisting of a country that requires observance of technical regulations in the interest of countries providing and exporting genetic resources. However, it may  GATT Article XI also applies, and is indeed usually applied, to import prohibitions and restrictions. 55  WTO Agreement on Technical Barriers to Trade (Annex 1A to the Agreement Establishing the World Trade Organisation) Annex 1.1, emphasis added. 56  Nagoya Protocol Article 17. 57  Nagoya Protocol Article 17.1.a.iii. 58  In this respect, a certain tension between the Protocol and TBT remains. Indeed, the scope of TBT includes voluntary standards, although the applicable obligations are significantly less stringent as compared to mandatory technical regulations, see TBT Article 4 and Annex 3. Again, it should be stressed that, either as a voluntary or mandatory standard, the decision to require certificates of compliance, however, falls to the Parties to the Nagoya Protocol. 54

198   Riccardo Pavoni well happen that a WTO complaint against the technical rules at issue be lodged by the countries of nationality of the (multinational ) corporations importing genetic material into the countries where they operate. Finally, the evolution of the Protocol regime might testify the transformation of the internationally recognised certificate of compliance into a de facto or quasi mandatory requirement, one which is in effect indispensable for meaningful access of gene-based products to the market of the Parties. In a controversial move, the WTO dispute settlement bodies have recently taken a similar view vis-à-vis a Unites States voluntary ‘dolphin-safe’ labelling scheme for tuna products.59 Under a TBT analysis, the internationally recognised certificate of compliance must essentially: (i) respect the principle of non-discrimination vis-à-vis national and foreign like products;60 (ii) “not be more trade-restrictive than necessary to fulfil a legitimate objective”,61 including environmental protection; and (iii) be based on existing international standards, except when such standards ‘would be an ineffective or inappropriate means for the fulfilment of the legitimate objective pursued’.62 As regards non-discrimination, domestic ABS laws should establish arrangements for access to ‘national’ genetic resources for utilisation within the jurisdictions in question which do not unreasonably disfavour imported genetic resources. Thus, permits functionally equivalent to the internationally recognised certificate of compliance for national utilisation seem indispensable, also considering that – at least explicitly – TBT does not envisage GATT-type environmental defences in respect of its non-discrimination clause. This stands in marked contrast to the obligation that technical regulations not be more-trade restrictive than necessary to fulfil a legitimate objective, as in this case the TBT broadly identifies ‘the environment’63 as one of these objectives, thereby creating ample room for justifying the certificate of compliance and similar technical requirements within the scope of the Nagoya Protocol. Finally, as

 However insisting that the scheme at stake was a de jure technical regulation, see United States-Measures Concerning the Importation, Marketing and Sale of Tuna and Tuna Products, Panel Report (15 September 2011) WT/DS381/R, paragraphs 7.113–7.145, and Appellate Body Report (16 May 2012) WT/DS381/AB/R, paragraphs 190–199. See Marie Wilke and Hannes Schloemann, “Not-so-voluntary Labelling in the WTO Tuna-Dolphin Dispute,” BioRes 5 (2012): 5; Mark J. Robertson, “The Fairy Tale of US ‘Dolphin Safe’ Labelling: False Claims, Unintended Consequences,” BioRes 6 (2012): 14. 60  TBT Article 2.1. 61  TBT Article 2.2. 62  TBT Article 2.4. 63  TBT Article 2.2. 59

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regards existing international standards, technical regulations which are in accordance with such standards are rebuttably presumed not to violate the ‘no-more-trade-restrictive-than-necessary’ obligation64 just discussed above. Here, an intriguing question is whether the internationally recognised certificate of compliance itself, or similar requirements developed by the Protocol’s governing or technical bodies, may be regarded as relevant standards for the purposes of TBT. In US-Tuna Products, the Panel took the view that the pertinent labelling scheme created by the Parties to the 1998 Agreement on the International Dolphin Conservation Program constituted an international standard under TBT.65 On appeal, the Appellate Body overturned this conclusion, reasoning that membership in the organisation/body created under the above agreement is not in fact “open to the relevant bodies of at least all [WTO] Members”,66 but essentially depends upon a non-automatic invitation of the existing Parties.67 Despite certain criticism of the narrow requirements adopted by the original Panel for the above finding,68 it is remarkable that this is the first time that WTO adjudicators have decided that a measure formulated under an MEA represents a pertinent WTO standard. There is no reason to believe that a similar conclusion should not be upheld for the internationally recognised certificate of compliance and comparable Nagoya Protocol’s technical rules, especially if they will be approved, refined or backed up by the Protocol’s governing body or technical bodies. The reason retained by the Appellate Body for disavowing the nature of international standard of the regulation at stake in US-Tuna Products, i.e., the lack of openness of the pertinent organisation/body, should not apply to the Nagoya Protocol. The only limitation foreseen by the latter for ratification and thus membership in its bodies is that a state (or regional economic integration organisation) must have previously consented to be bound by the CBD.69 This limitation appears reasonable and not capable of undermining the open nature of the Protocol.

 TBT Article 2.5.  US-Tuna Products, Panel Report, paragraphs 7.659–7.697. 66  A condition which derives inter alia from TBT Annex 1.4. 67  US-Tuna Products, Appellate Body Report, paragraphs 396–401. 68  See Wilke and Schloemann, “Not-so-voluntary Labelling in the WTO Tuna-Dolphin Dispute,” 7 (emphasising that the Panel required a pertinent standard to emanate from the decision-making powers of a body set up by the agreement at stake, rather than by the agreement itself). 69  Nagoya Protocol Article 33.1. 64 65

200   Riccardo Pavoni 2.  The Nagoya Protocol and Patents The interface between the Nagoya Protocol and IPRs protected under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights70 (TRIPS) basically refers to the well-defined issue of the legality of patents on genetic material and/or associated traditional knowledge in the absence of disclosure of the origin or source of the material and/or knowledge by patent applicants/holders. This lack of disclosure inevitably facilitates disregarding the key CBD/Nagoya Protocol principles of PIC and benefit-sharing in relation to genetic resources, thereby paving the way for accusations of bio-piracy directed at biotechnological and other gene-reliant industries. Moreover, various countries, especially developing and least-developed countries but also certain industrialised countries, have addressed this problem by amending their IPRs laws so as to introduce disclosure requirements deemed in line with the CBD. Although these national measures have never been challenged before the WTO dispute settlement bodies, they have generated an impressive amount of diplomatic practice and spurred law-making processes aimed at translating them into international agreements, thus into obligations for all the Parties thereto. The negotiations of the Nagoya Protocol have naturally been a hot spot for these claims. Before examining the Protocol’s outcome in this area, it seems appropriate to recall the pertinent TRIPS framework. TRIPS was a breakthrough in the international protection of IPRs, generally, and patents, particularly. As regards patents, it establishes the key principle of patentability of inventions ‘in all fields of technology’71 which, subject to the caveats recalled below, includes technology making use of genetic resources, such as especially biotechnology. The fundamental limit thereto is that the claimed invention must abide by the substantive requirements of novelty, inventive step and industrial applicability.72 ‘Disclosure’ is a familiar notion in patent law, but it is usually interpreted differently from the parallel term employed in the biodiversity context. TRIPS envisages as a condition on patent applicants that they “shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art”.73 The purpose of this condition is to allow both the invention to enter the public domain so as to facilitate ‘pure’ research not infringing the patent, and the reproducibility of the invention by an expert in order to check whether and  Annex 1C to the Agreement Establishing the World Trade Organisation.  TRIPS Article 27.1. 72  TRIPS Article 27.1. TRIPS represents the first international endeavour to harmonise the substantive requirements for patentability, even though the latter are not defined, thereby leaving significant scope for manoeuvre in that respect. 73  TRIPS Article 29.1. 70 71

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to what extent a claimed invention fulfils patentability requirements. States may accordingly take the view that, in the case of gene-based inventions, disclosure of the origin of genetic resources represents relevant due information under the classic disclosure condition, because it may shed light into the observance of the novelty and inventive step requirements (e.g., whether the latter are disproved by prior traditional knowledge). Nevertheless, TRIPS is silent on the scope of the condition at issue so that WTO Members and their IPRs bodies may decide that disclosure of genetic resources’ origin is simply unnecessary.74 It is also essential to remember that the whole disclosure-of-origin debate arose from the modern development in patent law according to which, thanks to a generous interpretation of the concept of invention and associated requirements, life forms, genes and biotechnological inventions embodying them may be patentable subject-matter. This is now well-established practice, at least in industrialised countries and regions. TRIPS is, however, rather flexible in that respect, as it provides that WTO Members may exclude from patentability “plants and animals other than micro-organisms, and essentially biological processes for the production of plants and animals other than non-biological and microbiological processes”.75 By acting upon this option, WTO Members may, therefore, rule out biotechnological patents consisting or making use of plant and animal genetic resources. Industrialised countries and regional organisations have reacted to this state of affairs in two distinct ways. First, they have insisted that biotechnological inventions are covered by TRIPS, because, for example, genes should be assimilated to microbiological material (hence to ‘micro-organisms’) or to chemical compounds.76 Secondly, and most controversially, such countries and organisations have increasingly concluded so-called ‘TRIPS-plus agreements’ with developing and least-developed countries. These agreements circumvent TRIPS’

 For a fuller account, see Pavoni, Biodiversità e biotecnologie nel diritto internazionale e comunitario, 228–232. 75  TRIPS Article 27.3.b. Members are nonetheless obliged to protect plant varieties ‘either by patents or by an effective sui generis system or by any combination thereof ’. For this purpose, they may recognize plant breeders’ rights pursuant to the International Convention for the Protection of New Varieties of Plants (as amended) (Paris, 2 December 1961, in force 10 August 1968) 815 UNTS 89. 76  For a landmark United States court decision, see Amgen, Inc. v Chugai Pharm. Co., 927 F.2d 1200 (Fed. Cir. 1991); in Europe, see e.g., Transgenic Plant/NOVARTIS (Case G 1/98) [2000] OJ EPO 111, paragraph 5.2. For a wide-ranging discussion, see Sabrina Safrin, “Hyperownership in a Time of Biotechnological Promise: The International Conflict to Control the Building Blocks of Life,” American Journal of International Law 98 (2004): 641, 645–646, 673–679. 74

202   Riccardo Pavoni flexibilities, for instance, by obliging Parties to grant patents in the field of plant and animal biotechnology at large.77 Importantly, those flexibilities include an optional exception, hitherto untested, to the patentability of inventions, the prevention . . . of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment.78

At any rate, whatever the scope for manoeuvre allowed by TRIPS, nothing prevents WTO Members from affording patent protection to gene-based inventions, regardless of the requirements arising from the CBD/Nagoya Protocol. The Nagoya Protocol addressed this misalignment between the biodiversity regime and TRIPS in a very cautious and ambiguous way, i.e., by making sure that no provision in itself could be interpreted as mandating deviations from the rights purportedly secured by TRIPS. Given the inconclusiveness of TRIPS in this area, such an outcome is fairly disappointing. The Protocol explicitly mentions the expression ‘intellectual property rights’ only three times. First, it provides that ABS contracts, i.e., MAT, may include terms on benefit-sharing, inter alia involving IPRs.79 It is thus clear that the Protocol does not impose IPRs-related benefit-sharing. Similarly, the other two pertinent references80 identically envisage the notion of ‘joint ownership of IPRs’ as an example of both monetary and non-monetary benefits that may accrue to provider countries pursuant to ABS transactions. In this context, problems might only arise if a given domestic ABS legislation (as opposed to particular  See e.g., US-Morocco Free Trade Agreement (Washington DC, 15 June 2004, in force 1 January 2006) Article 15.9.2; Partnership Agreement between the Members of the African, Caribbean and Pacific Group of States of the one part, and the European Community and its Member States, of the other part (Cotonou, 23 June 2000, in force April 2003) [2000] OJ L 317 Article 46(5) (this provision has been maintained unaltered in the subsequent revisions of the 2000 Agreement). For exhaustive information and analysis, see Antonello Tancredi, “La brevettabilità delle specie animali e vegetali nel regime TRIPs (e ‘TRIPs-plus’),” in Le nuove sfide per l’OMC a dieci anni dalla sua istituzione, ed. Gabriella Venturini, Giuseppe Coscia and Michele Vellano (Milan: Giuffrè, 2005) 173, 216–227. 78  TRIPS Article 27.2. See also TRIPS Articles 7, 8 and 30. 79  Nagoya Protocol Article 6.3.g.ii. 80  Nagoya Protocol Annex Points 1.j and 2.q. Although not expressly referred to, IPRs-related benefit-sharing is chiefly encompassed in other examples given in the Annex; see points 1.d (payment of royalties), 2.b (collaboration in biotechnological activities), 2.f (transfer of biotechnologies ‘under fair and most favourable terms’), and 2.k (access to scientific information relevant to conservation and sustainable use of biodiversity). On transfer of biotechnologies to developing and least-developed countries, see also the weak provision of Nagoya Protocol Article 23 (‘Parties undertake to promote and encourage . . .’). 77

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ABS transactions governed by contractual freedom) would sanction IPRsrelated benefit-sharing as a form of mandatory benefit-sharing indispensable for the valid conclusion of MAT, and thus for access to genetic resources and the issuance of an internationally recognised certificate of compliance. This legislation might be seen as an unjustifiable interference with the exercise of the exclusive rights conferred by patents on their owners.81 The WTO member in question might nonetheless seek to justify this prima facie unlawful restriction on the enjoyment of IPRs by submitting that TRIPS does not require the protection of gene-based inventions.82 It is, however, in relation to the disclosure-of-origin issue that the nonconfrontational posture of the Nagoya Protocol vis-à-vis IPRs is most visible. The draft protocol,83 made public in March 2010, foresaw ‘disclosure requirements’84 as a mandatory measure to ensure compliance with the ABS legislation of provider countries, and ‘intellectual property examination offices’85 as mandatory checkpoints for compliance review; the possession of an internationally recognised certificate of compliance by genetic resources’ users/patent applicants would provide evidence of fulfilment of disclosure requirements.86 Although the draft did not define the expression ‘disclosure requirements’, the linkage to the internationally recognised certificate of compliance made it clear that it was a broad expression encompassing the origin of genetic resources, as well as proof of PIC and benefit-sharing. Rightly so, as the international biodiversity regime should be concerned with respect for its basic principles, rather than simply with the technical legality of gene-based patents. This scheme has been significantly diluted in the Protocol provision on monitoring of the utilisation of genetic resources,87 first and foremost by removing all references to disclosure requirements and intellectual property   I.e., the exclusive rights relating to, inter alia, the use, sale or imports of products or processes protected by patents, see TRIPS Article 28. 82  It may also invoke TRIPS Article 30, according to which certain ‘limited exceptions’ to the enjoyment of patent rights are tolerated. For the interpretation of this provision, see Canada-Patent Protection of Pharmaceutical Products, Panel Report (adopted 7 April 2000) WT/DS114/R. 83  Revised Draft Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity in CBD Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing, “Report of the First Part of the Ninth Meeting of the Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing,” (26 April 2010) UN Doc UNEP/CBD/WG-ABS/9/3, Annex I. 84  UN Doc UNEP/CBD/WG-ABS/9/3, Annex I Draft Article 13.1.a. 85  UN Doc UNEP/CBD/WG-ABS/9/3, Annex I Draft Article 13.1.a.iv. 86  UN Doc UNEP/CBD/WG-ABS/9/3, Annex I Draft Article 13.3. 87  Nagoya Protocol Article 17. 81

204   Riccardo Pavoni offices. This convoluted and heavily qualified provision generally contemplates the designation of checkpoints for supporting compliance with provider countries’ ABS laws relating to genetic resources (and not to traditional knowledge). Such checkpoints would be empowered to receive information about the source of genetic resources, PIC and MAT (including from internationally recognised certificates of compliance),88 must be effective,89 and should perform functions relevant to the collection of genetic resourcesrelated information at ‘any stage of research, development, innovation, precommercialisation or commercialisation’.90 This language still allows Parties to voluntarily introduce disclosure requirements into their legislation and identify IPRs’ bodies as checkpoints. But the paradigm shift from mandatory to voluntary commitments is fundamental.91 Parties endorsing disclosure at IPRs’ offices will enact rules that are in tension with the WTO system and not backed by a clear mandate and authoritative guidance from the Protocol. While the negotiators evidently wanted or accepted to leave such problems unprejudiced, the solution at hand is regrettable. It reinforces the idea of international law as an increasingly fragmented system, where each particular law-making body should mind its own business for fear of interfering with competing regimes and processes. Yet, there is no principled reason why provisions on patents should not be included in an MEA when this is a key issue for the latter’s effective operation. In the present context, this appears all the more true, given the uncertainties about the status of genebased patents and associated disclosure obligations under TRIPS. This view that a disclosure requirement relating to genetic resources is an important tool for securing the effective operation of the CBD/Nagoya Protocol’s regimes is not uncontroversial. A few commentators92 and countries believe, for instance, that such requirement would unnecessarily burden IPRs’ offices with tasks that do not pertain to the patent system (i.e., that of promoting compliance with obligations protecting non-IPRs’ values and rules), be hardly enforceable, and would trigger major trade disputes. By contrast, my starting point is that, as illustrated below,93 patent disclosure requirements in the area of genetic resources are endorsed by the overwhelming majority of the international community as an essential means for ensuring mutual supportiveness between TRIPs and the CBD/Nagoya Protocol. Moreover,  Nagoya Protocol Article 17.1.a.i and iii.  Nagoya Protocol Article 17.1.a.iv. 90  Nagoya Protocol Article 17.1.a.iv. 91  See section I above. 92  See, for instance, Safrin, “Hyperownership in a Time of Biotechnological Promise: The International Conflict to Control the Building Blocks of Life,” 666–668. 93  See Section III.2. 88 89

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empirical evidence of the soundness of the above objections to IPRs-based disclosure of origin of genetic resources is missing. In general, whatever side of the debate one favours, the neutral and ambiguous position of the Nagoya Protocol towards this issue remains unfortunate.

III.  Whither the Trade and Biodiversity Debate? 1.  The Protocol’s Clause on the Relationship with Other Agreements The inconclusiveness of the Nagoya Protocol in its stance towards WTO issues is epitomised by Article 4, which purports to clarify the relationship between the Protocol and other international agreements. It could be intended as a ‘conflict clause’, i.e., a clause dictating which regime would prevail in case of competing application of incompatible treaties.94 But, as explained below, Article 4 fails to achieve that outcome. This is surprising, because the retention of such a clause in the Protocol’s operative text could be seen as evidence of a resolve to convincingly tackle the problem of treaty conflicts. Article 4 is indeed a distinctive feature of the Protocol as compared with the 2010 draft protocol. The latter contained a sole preambular paragraph recognising that ‘international instruments related to access and benefit-sharing should be mutually supportive with a view to achieving the objectives of the Convention [on Biological Diversity]’.95 Therefore, the draft adopted a minimal approach to the issue at hand focused on the notion of mutual supportiveness between competing regimes.96 This would have been in line with the general scheme of the Protocol in respect of trade issues. As illustrated above, the Protocol’s trade-related provisions were carefully drafted in order to avoid any direct, genuine conflict with the WTO system. Mutual supportiveness would have provided a theoretical backbone to this approach, while a conflict clause inserted in the operative text appears unnecessary. As it turned out, Article 4 is a masterpiece of erratic treaty drafting. It is a questionable attempt at composing a puzzle with pieces extracted from portions of provisions of various agreements, such as, especially, the CBD, the  See Vienna Convention on the Law of Treaties Article 30.2.  UN Doc UNEP/CBD/WG-ABS/9/3, Annex I Draft thirteenth paragraph of the preamble, and now Nagoya Protocol twentieth paragraph of the preamble. 96  See Boisson de Chazournes and Mbengue, “A propos du principe du soutien mutuel. Les relations entre le Protocole de Cartagena et les Accords de l’OMC,” 829; Riccardo Pavoni, “Mutual Supportiveness as a Principle of Interpretation and Law-Making: A Watershed for the ‘WTO-and-Competing-Regimes’ Debate?,” European Journal of International Law 21 (2010): 649. 94 95

206   Riccardo Pavoni International Treaty on Plant Genetic Resources for Food and Agriculture97 and the UNESCO Convention on Cultural Diversity.98 The first part of Article 4.1 reproduces verbatim CBD Article 22.1, i.e., the Nagoya Protocol shall not affect the rights and obligations of any Party deriving from any existing international agreement, except where the exercise of those rights and obligations would cause a serious damage or threat to biological diversity. This is an ambiguous savings clause granting conditional priority to existing treaties, such as the WTO agreements. Moreover, the expression ‘serious damage or threat to biological diversity’ normally refers to substantial ‘material’ damage to biodiversity, thereby appearing unsuited to apply to most trade-related measures that are likely to jeopardise the Protocol’s fundamental objective of benefit-sharing associated with genetic resources.99 Article 4.1 qualifies the above clause by declaring that the paragraph “is not intended to create a hierarchy”100 between the Nagoya Protocol and other international instruments. This is a useless specification, because the absence of a hierarchical relationship between the Protocol and other agreements already results from the preceding and subsequent parts of Article 4. Generally, normative hierarchy is one of the most controversial themes in contemporary international law.101 The neutral position taken by the Nagoya Protocol in this respect is trite. But at the same time it may weaken the growing conception of a (at least) de facto hierarchical superiority of environmental obligations in MEAs safeguarding the common interest of humanity, such as the CBD and its protocols, vis-à-vis essentially reciprocal trade obligations in WTO agreements. The main inconvenience with Article 4.1 is that its ambiguities adversely affect the remaining paragraphs of the provision. These are indeed interesting and partly innovative, but must of course be read together with the first paragraph. Article 4.2 establishes that nothing in the Protocol ‘shall prevent the Parties from developing and implementing other relevant international agreements, . . . provided that they are supportive of and do not run counter to the  International Treaty on Plant Genetic Resources for Food and Agriculture (Rome, 3 November 2001, in force 29 June 2004) 2400 UNTS 303.   98  Convention on the Protection and Promotion of the Diversity of Cultural Expressions (Paris, 20 October 2005, in force 18 March 2007) 45 ILM (2006) 269.   99  See section II above. 100  This is taken from the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (Rotterdam, 10 September 1998, in force 24 February 2004) 2244 UNTS 337 tenth preambular paragraph, and from the International Treaty on Plant Genetic Resources for Food and Agriculture eleventh preambular paragraph. 101  Most recently, see e.g., Erika de Wet and Jure Vidmar, eds., Hierarchy in International Law: The Place of Human Rights (Oxford: Oxford University Press, 2012).   97

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objectives’102 of the CBD and the Protocol itself. An a contrario reading of this provision implies that Nagoya Protocol Parties are bound not to develop and implement other agreements when this would be at variance with the CBD’s and Protocol’s objectives. Crucially, and similarly to Article 20 of the Convention on Cultural Diversity,103 Parties are thereby restrained in their future law-making activities relating to the implementation and development of other treaties. ‘To develop agreements’ is an ambiguous terminology, insofar as it is not entirely clear whether it covers the negotiation of brand new treaties.104 What is certain is that it does include amendments, revisions and review processes of existing treaties, such as the WTO agreements.105 In my view, the source of such an ambitious obligation which impinges on the contractual freedom of Protocol Parties is the principle of mutual supportiveness as reiterated in Article 4.3: ‘This Protocol shall be implemented in a mutually supportive manner with other international instruments relevant to this Protocol’. The use of the phrase ‘to implement’ highlights that mutual supportiveness is not simply regarded as an interpretative tool inviting harmonious and consistent constructions of competing regimes. The principle is instead retained in what I consider its ‘law-making dimension’, i.e., that of a guiding standard orientating the evolution of the law in accordance with the prevailing requirements of the international community.106 This does not only refer to the very treaty regime inspired by the principle of mutual supportiveness, as the wording of Article 4.3 seems to imply.107 It chiefly applies  Emphasis added. The concluding expression comes from CBD Article 16.5. Indeed, Nagoya Protocol Article 4.2, as a whole, builds upon, and marks a step beyond CBD Article 16.5. In this provision, CBD Parties recognise that patents and other IPRs ‘may have an influence’ on the implementation of the Convention and undertake the obligation to ‘cooperate in this regard subject to national legislation and international law in order to ensure that such rights are supportive of and do not run counter to its objectives’ (emphasis added). 103  This provision certainly influenced the drafting of Nagoya Protocol Article 4.2. Inter alia, it obliges Parties to the Convention on Cultural Diversity, ‘when interpreting and applying the other treaties to which they are Parties or when entering into other international obligations . . . [to] take into account the relevant provisions of th[e] Convention’ (Article 20.1.b); see also Convention on Cultural Diversity Article 21. For an articulated interpretation, see Pavoni, “Mutual Supportiveness as a Principle of Interpretation and LawMaking,” 657–660. 104  By contrast, Convention on Cultural Diversity Article 20.1.b unambiguously applies in this respect. 105  And this is crucial from our perspective, see section III.2 below. 106  Pavoni, “Mutual Supportiveness as a Principle of Interpretation and Law-Making,” 666–678. 107  The Convention on Cultural Diversity seems more clear also in this respect, as it requires the Parties to ‘foster mutual supportiveness between th[e] Convention and the other treaties to which they are Parties’ (Article 20.1.a) and subsequently sets out the ‘external’ undertakings. 102

208   Riccardo Pavoni to, and makes sense of the ‘external’ undertakings in Article 4.2, namely the commitments of the Parties relating to the promotion and safeguarding of the Protocol’s principles and rules in other international forums and lawmaking processes. 2.  The WTO Impasse Many WTO Members have taken the ‘external’ undertakings in the Nagoya Protocol seriously, even before formally becoming Parties to the latter. Soon after its adoption, the Protocol has triggered heated and wide-ranging debates in WTO forums, particularly in the TRIPS Council. For instance, at the March 2011 meeting of the Council, Brazil declared that the Nagoya Protocol had increased the importance of the discussion in the TRIPS Council on how WTO Members could establish a mutually supportive relationship between the TRIPS Agreement and the CBD,108

and accordingly that [t]he TRIPS Agreement had an essential role to play in ensuring prior informed [consent for] access to genetic resources, achieving equitable sharing of benefits arising from the use of traditional knowledge and genetic resources, and preventing erroneous patents.109

Similarly, South Africa said that ‘the relationship between the CBD and the TRIPS Agreement should be further articulated in light of developments and guidelines provided by the Nagoya Protocol’,110 while Indonesia went as far as urging ‘all [WTO] Members to take necessary steps to incorporate the principles of the CBD and the Nagoya Protocol into the TRIPS Agreement’.111 On the other hand, a few WTO Members rejected any suggestion of collision between the Protocol and TRIPS. In that light, Canada cautioned against using TRIPS as ‘an enforcement mechanism for the CBD’.112 At the same meeting, an overview of the Nagoya Protocol was offered by Japan, as the host country of the Nagoya Biodiversity Summit (the tenth meeting of the Conference of the Parties to the CBD).113 This was actually a second-best choice, as various WTO Members had insisted that it be the CBD Secretariat to make a presentation on the Protocol. However, the  WTO Council for Trade-Related Aspects of Intellectual Property Rights, “Minutes of Meeting Held in the Centre William Rappard on 1 March 2011,” (10 May 2011) IP/C/M/65, paragraph 59. 109   Ibid. 110   Ibid., paragraph 74. 111   Ibid., paragraph 75. 112   Ibid., paragraph 47. 113   Ibid., paragraphs 16–23. 108

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opposition to any involvement of CBD bodies in the workings of WTO committees (essentially) by the United States closed the door to the Secretariat.114 This episode exemplifies the dynamics of the WTO as regards its engagement with biodiversity (and comparable) issues. The turning point for that engagement was the 2001 Doha Ministerial Declaration which instructed the TRIPS Council, inter alia in the context of its review of TRIPS Article 27.3.b,115 to examine the relationship between TRIPS and the CBD, the protection of traditional knowledge and other relevant new developments.116 A large majority of the WTO membership eventually succeeded in translating this instruction into a prominent negotiating matter for the ongoing Doha Round. Such negotiations have mostly revolved around a proposal to amend TRIPS so as to provide for a mandatory disclosure requirement for patent applications involving genetic resources. Key countries, such as Brazil, China and India, have consistently been at the forefront of a broad coalition of supporters of the proposal that has expanded tremendously over the years. Some 110 Members have, at various stages, expressly endorsed the amendment, i.e., more than two thirds of the WTO membership.117 The proposed amendment has successively been refined118 and, following the Nagoya Protocol, timely adjusted in a way that now includes extensive references to the Protocol.119 It would introduce into TRIPS a new Article  The granting of observer status to the CBD Secretariat in the TRIPS Council has unsuccessfully been on the WTO agenda for almost twenty years now. 115  See section II.2 above. 116  WTO, “Doha Ministerial Declaration,” paragraph 19. 117  See WTO Council for Trade-Related Aspects of Intellectual Property Rights, “Minutes of Meeting Held in the Centre William Rappard on 26–27 October 2010,” (17 February 2011) IP/C/M/64, paragraph 22; Elisa Morgera and Elsa Tsioumani, “The Evolution of Benefit Sharing: Linking Biodiversity and Community Livelihoods,” Review of European Community and International Environmental Law 19 (2010): 150, 169. 118  For the original text, see WTO Council for Trade-Related Aspects of Intellectual Property Rights, “The Relationship between the TRIPS Agreement and the Convention on Biological Diversity and the Protection of Traditional Knowledge,” (24 June 2002) IP/C/W/356; for a subsequent text embodying the proposed amendment, see WTO General Council Trade Negotiations Committee, “Doha Work Programme – The Outstanding Implementation Issue on the Relationship between the TRIPS Agreement and the Convention on Biological Diversity,” (31 May 2006) WT/GC/W/564. Cf. Riccardo Pavoni, “Biodiversity and Biotechnology: Consolidation and Strains in the Emerging International Legal Regimes,” in Biotechnology and International Law, ed. Francesco Francioni and Tullio Scovazzi (Oxford: Hart Publishing, 2006), 29, 55–56; Pavoni, “Mutual Supportiveness as a Principle of Interpretation and Law-Making,” 669–672. 119  WTO Trade Negotiations Committee, “Draft Decision to Enhance Mutual Supportiveness between the TRIPS Agreement and the Convention on Biological Diversity,” (19 April 2011) TN/C/W/59. 114

210   Riccardo Pavoni 29bis entitled ‘Disclosure of Origin of Genetic Resources and/or Associated Traditional Knowledge’. The draft preamble inter alia stresses ‘the need for the TRIPS Agreement and the CBD to be implemented in a manner which is mutually supportive and does not run counter to their respective objectives’,120 recalls – either implicitly or explicitly – the Nagoya Protocol provisions on compliance with domestic ABS requirements and on monitoring the utilisation of genetic resources,121 and recognises that ‘the disclosure requirement in Article 29 of the TRIPS Agreement is incomplete without the disclosure of origin of genetic resources’.122 The overall purpose of the amendment would be to establish a mutually supportive relationship between TRIPS and the CBD, according to which WTO Members should ‘have regard to the objectives, definitions and principles’123 of TRIPS, the CBD, and the Nagoya Protocol, ‘in particular its provisions on prior informed consent for access and fair and equitable benefit sharing’.124 The core provision of the draft amendment provides: Where the subject matter of a patent application involves utilisation of genetic resources . . ., [WTO] Members shall require applicants to disclose: (i) the country providing such resources . . .; and (ii) the source in the country providing the genetic resources . . . [WTO] Members shall also require that applicants provide a copy of an Internationally Recognised Certificate of Compliance (IRCC). If an IRCC is not applicable in the providing country, the applicant should provide relevant information regarding compliance with prior informed consent and access and fair and equitable benefit sharing as required by the national legislation of the country providing the genetic resources . . .125

The remaining part of the draft envisages the WTO Members’ duty to publish the above information126 and sanctions for non-compliance. The latter would be imposed both at the pre-grant stage, in the form of an obligation not to process patent applications inconsistent with disclosure requirements,127 and at the post-grant stage, by way of criminal, administrative or civil remedies –  WTO Trade Negotiations Committee, “Draft Decision to Enhance Mutual Supportiveness between the TRIPS Agreement and the Convention on Biological Diversity,” (19 April 2011) TN/C/W/59. Crucially for our purposes (see section III.1 above), the draft amendment explicitly refers to Nagoya Protocol Article 4, as well as CBD Article 16.5, in this connection. 121  Nagoya Protocol Articles 15 and 17. 122  WTO Trade Negotiations Committee, “Draft Decision to Enhance Mutual Supportiveness between the TRIPS Agreement and the Convention on Biological Diversity,” (19 April 2011) TN/C/W/59. 123  Ibid., Draft Article 29bis.1. 124  Ibid., Draft Article 29bis.1. 125  Ibid., Draft Article 29bis.2, emphasis added, footnotes omitted. 126  Ibid., Draft Article 29bis.3. 127  Ibid., Draft Article 29bis.4. 120

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including compensation for damage and revocation of patents – against situations of failure to disclose, fraud or violation of ABS laws.128 The proposal has not been approved by the WTO Eighth Ministerial Conference held in Geneva in December 2011, which has confirmed the impasse of the Organisation in this and other fundamental matters.129 Technically, the current number of supporters would be sufficient for approving the decision at stake because Article X.1 of the WTO Agreement establishes that, failing consensus, a two thirds majority may apply in this case.130 However, an unwritten golden rule of the WTO system seems to require consensus by all means.131 This notion is well captured by a declaration made by the United States delegate at the October 2010 meeting of the TRIPS Council during the discussion of the disclosure-of-origin amendment. He stated that, given that the WTO is a ‘consensus-based organisation, the number of supporters on

 Ibid., Draft Article 29bis.5.  For an account, see ICTSD, “WTO Ministerial Conference: Chair Gavels Decisions, Maps Out Future,” accessed 14 April 2012, http://ictsd.org/i/wto/geneva2011/bridges-dailyupdates-geneva-2011/122583. The impasse also relates to the broader trade and environment negotiating agenda set out in WTO, “Doha Ministerial Declaration”, paragraph 31. Thus, the Draft Ministerial Decision on Trade and Environment circulated in April 2011 (WTO Committee on Trade and Environment Special Session, “Report by the Chairman, Ambassador Manuel A.J. Teehankee, to the Trade Negotiations Committee,” (21 April 2011) TN/TE/20) was not approved at the Eighth Ministerial Conference. When looking at the text of this draft, one wonders whether after all it was better not to adopt it. Rather than laying down a set of clear principles of international law applicable to cases of conflict/tension between MEAs and WTO rules, the draft is mostly concerned with procedural mechanisms for coordination among trade and environmental bodies and experts. 130  WTO Agreement Article X.3 would instead govern the entry into force of the decision, because the disputed amendment would undoubtedly “alter the rights and obligations of the Members”. Thus, the decision would take effect upon acceptance by two thirds of the Members and only for those Members accepting it. 131  A WTO written principle (“Doha Ministerial Declaration”, paragraph 47) which might explain the WTO impasse in question might be that of the ‘single undertaking’ in relation to negotiating outcomes, i.e., that finalisation of a negotiating round is dependent on agreement on each and every issues on the agenda; thus, for instance, adoption of the disclosure-of-origin amendment would be conditional on successful completion of other (thorny) negotiations, especially those relating to TRIPS and associated issues (i.e., establishment of a multilateral system of notification and registration of geographical indications for wines and spirits and reduction of agricultural subsidies, “Doha Ministerial Declaration”, paragraphs 13 and 18). However, at least in the context of the Doha Round, the principle of the single undertaking is not absolute: the Doha Ministerial Declaration contemplates the possibility of ‘early agreements’ that ‘may be implemented on a provisional or a definitive basis’ (“Doha Ministerial Declaration”, paragraph 47) and that ‘will be taken into account in assessing the overall balance of the negotiations’ (Ibid.). 128 129

212   Riccardo Pavoni one side was not sufficient to set aside profound and substantive disagreements among [WTO] Members’.132 According to the available documents, such ‘profound and substantive disagreements’ seems basically to only involve the United States itself, which for a plethora of reasons – such as alleged risks for sustained technological research and innovation – has consistently rejected the idea of patent law and patent offices as enforcers of disclosure-of-origin requirements. The attitude of the few United States allies in this area, such as Canada and Australia,133 is usually more nuanced and compromising. The European Union had sided with the proponents, with the only caveat that the amendment be carefully ‘calibrated’.134 In my view, failure of future efforts at enacting the disclosure-of-origin amendment to TRIPS would imply that a golden opportunity has been lost. The amendment would constitute an exemplary case of cross-fertilisation and mutual supportiveness between trade and environmental competing regimes which would greatly benefit the integrity of international law. From a different and much troubling perspective, failure would be deleterious to the image of the WTO. It could evoke (or exacerbate) the impression of an organisation taken hostage by a single country.

IV.  Conclusion The methodology and rules endorsed by the Nagoya Protocol for dealing with trade matters are unsatisfactory. Most of the issues have been ducked and the resulting text is fraught with ambiguities. This is so with respect to the scope of the Protocol, the purported conflict clause, the provision on non-Parties, the non-definition of standards for barring exports of genetic resources (note the lack of any reference to the precautionary principle), and – last but not least – the failure to envisage a mandatory disclosure requirement. Whether this was a wise approach is open to question. In my view, it was not. A disturbing implication of this approach is that the Protocol itself may be cited as an agreement unsupportive of trade-related measures and  WTO Council for Trade-Related Aspects of Intellectual Property Rights, “Minutes of Meeting Held in the Centre William Rappard on 26–27 October 2010,” (17 February 2011) IP/C/M/64, paragraph 55. 133  See e.g., WTO Council for Trade-Related Aspects of Intellectual Property Rights, “Minutes of Meeting Held in the Centre William Rappard on 7 June 2011,” (2 September 2011) IP/C/M/66, paragraphs 70–73. 134  WTO Council for Trade-Related Aspects of Intellectual Property Rights, “Minutes of Meeting Held in the Centre William Rappard on 26–27 October 2010,” (17 February 2011) IP/C/M/64, paragraph 47. 132

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initiatives undertaken by CBD/Nagoya Protocol Parties domestically and internationally. This has already occurred at the WTO, when the United States has pointed at the absence of a patent disclosure requirement in the Nagoya Protocol, and accordingly declared that ‘there [i]s no need for a patent-related disclosure requirement’135 in TRIPS. This position is too radical, insofar as such requirement is allowed by the Nagoya Protocol,136 as are sanctions for non-compliance, such as refusal or revocation of patents. However, it remains correct to the extent that it highlights that there exist no mandatory provisions in the Protocol about the disclosure of origin of genetic resources-related patents. As I have recalled, this voluntary nature of trade-restrictive commitments in the Nagoya Protocol has vital importance from the perspective of the WTO system. It has the fundamental consequence that, in case of disputes at the WTO in the area of ABS, the country that is the author of those measures would not be able to find relief in the Nagoya Protocol’s framework. The Protocol would remain in the background as an agreement that has been implemented by the WTO Member at stake in an unjustifiably trade-restrictive manner.

 WTO Council for Trade-Related Aspects of Intellectual Property Rights, “Minutes of Meeting Held in the Centre William Rappard on 1 March 2011” (10 May 2011) IP/C/M/65, paragraph 99. 136  Nagoya Protocol Article 17. 135

Part II – Regional Perspectives on Implementation Challenges

Chapter 7.  Implementing the Nagoya Protocol in Africa: Opportunities and Challenges for African Indigenous Peoples and Local Communities Peter Munyi* and Harry Jonas** The African continent is rich in biodiversity. African indigenous peoples and local communities are custodians of a wealth of traditional knowledge. On the basis of African regional instruments relating to biodiversity and traditional knowledge, as well as various experiences with access and benefit-sharing (ABS), the African Group was vociferous in its calls for strong provisions in the Nagoya Protocol to support indigenous peoples and local communities’ rights over their genetic resources and associated traditional knowledge. This chapter explores the issues present at the intersection of the implementation of the Nagoya Protocol, the conservation of biodiversity and the protection of communities’ customary use of biodiversity and traditional knowledge from an African perspective. Specifically, the chapter first provides an overview of African regional instruments of relevance for ABS, and analyses the African Group’s key proposals during the negotiation of the Nagoya Protocol with a view to illuminating the complexity of implementing ABS in the continent. This will be further explained with reference to the San-Hoodia case in order to underscore that some of these challenges are not unique to ABS, but transcend any instances of engagement with positive legal systems by communities. The chapter then argues that participatory legal empowerment, including community protocols as one methodology that is enshrined in the Nagoya Protocol, offers a means whereby indigenous peoples and local communities can overcome the inherent challenges associated with ABS to better engage a range of stakeholders towards more equitable outcomes. The development of a community protocol and subsequent non-disclosure agreement developed by the Traditional Health Practitioners of Bushbuckridge is used to   *  Peter Munyi, Law and Governance Group, Wageningen University & Research Centre. **  Harry Jonas, Natural Justice: Lawyers for Communities and the Environment.

218   Peter Munyi and Harry Jonas exemplify the issues. The chapter concludes by arguing that the region will provide useful insights into good practice relating to the implementation of the Nagoya Protocol, generally, and particularly its provisions on genetic resources over which indigenous peoples and local communities have rights, traditional knowledge, and community protocols.

I.  ABS in Africa Africa’s biological and cultural diversity is immense. Its biodiversity has been identified as a critical element in alleviating poverty, ensuring food security, fostering industrial innovation and developing new medicines.1 In postcolonial African states, the maximisation of the utilisation of biodiversity and genetic resources has ranked highly amongst priorities both at the continental and national levels. The African Union and its predecessor, the Organisation of African Unity, have provided platforms for articulating Africa’s common objectives and goals on the conservation of biodiversity and the sharing of benefits from the use of genetic resources. This has led to the development and adoption of international treaties, model laws and high-level declarations. Examples include the 1968 African Convention on the Conservation of Nature and Natural Resources (revised in 2003)2 and the 2001 African Model Legislation for the Protection of Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources (the African Model Law).3 Most recently, the 2011 African Union Assembly Decision on Africa’s participation in the tenth meeting of the Conference of the Parties (COP) to the Convention on Biological Diversity (CBD)4 encouraged its Members to become Parties to all international treaties on biodiversity, including the Nagoya Protocol.

 Kent Nnadozie et al., African Perspectives on Genetic Resources: A Handbook on Laws, Policies, and Institutions Governing Access and Benefit Sharing (Washington D.C.: Environmental Law Institute, 2003). 2  African Convention on the Conservation of Nature and Natural Resources (Algiers, 15 September 1968, in force 16 June 1969, 1001 UNTS 3). The revised African Convention on the Conservation of Nature and Natural Resources was adopted by the African Union Heads of States on 11 July 2003. 3  The African Model Legislation for the Protection of Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources was adopted in Ouagadougou on 10th June1998 by the OAU Heads of States. 4  African Union Assembly, “Decision on the Report on Africa’s Participation in the Nagoya Conference on Biodiversity,” 30–31 January 2011, Assembly/AU/Dec.352(16). 1

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The African Model Law provides evidence of the continent’s long-standing perspectives on ABS. Indeed, some of Africa’s viewpoints, as expressed in the African Model Law, were reflected in Africa’s positions throughout the Nagoya Protocol’s negotiations process.5 The Model Law was developed with a view to protecting Africa’s common biodiversity from ‘the devastating impact on species diversity by western industrial society’.6 The Model Law was also developed in the context of developing a common position at the World Trade Organisation (WTO), especially on the relationship between the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs)7 and the CBD, and the International Undertaking on Plant Genetic Resources for Food and Agriculture whose negotiations later led to the adoption of the International Treaty on Plant Genetic Resources for Food and Agriculture.8 The Model Law was aimed at, among other things, promoting the continuation of the socially positive and customary practices of indigenous peoples and local communities of sharing biodiversity and innovations. These practices were amongst those seen threatened by the advent of new global rules on trade and intellectual property rights (IPRs), as more particularly set out in the TRIPs Agreement. The Model Law proposed to extend the sharing of biodiversity to the new possibilities arising from the growing use by external interests of the biodiversity, knowledge and technologies of Africa’s local communities.9 Specific to the TRIPs Agreement itself, the Model Law was also seen as a response to the requirement that protection must be given to plant varieties either by patents or an effective sui generis mechanism,10 without undermining the rights of local communities. Notably, the African Model Law was not intended to be directly transposed into national legislation. Neither was it intended to have a direct effect on African countries, as it was only meant to provide a model and in all events  See submissions by Namibia on behalf of the African Group to the CBD Working Group on ABS, “Collation of Operative Text Submitted by Parties, Governments, International Organisations, Indigenous and Local Communities and Relevant Stakeholders in Respect of the Main Components of the International Regime on Access and Benefit-Sharing Listed in Decision IX/12, Annex I” (28 January 2009) UN Doc UNEP/CBD/WG-ABS/7/4–5.  6  Tewolde B.G. Egziabher, IPRs on Biological Diversity and Trade Agreements (Addis Ababa: Institute for Sustainable Development, 2000).  7  [See contribution by Pavoni to this volume (Chapter 6).]  8  Johnson A. Ekpere, The OAU Model Law: The Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources: An Explanatory Booklet (Lagos: Organisation of African Unity Scientific, Technical and Research Commission, 2000). [See also contribution by Chiarolla, Louafi and Schloen to this volume (Chapter 3).]  9  Ibid. 10  TRIPS Article 27.3.b.  5

220   Peter Munyi and Harry Jonas the African Union does not have powers to enact legislation that directly applies to its Member States. The Model Law has instead, provided a framework that has been drawn upon by a few African countries that have operationalised the ABS provisions of the CBD by enacting legislation or through administrative actions.11 A broader engagement with ABS, however, has been lacking in Africa, and may be due to the following factors. First, examples of successful ABS cases in an environment lacking robust ABS legal structures are few and far between. As such, each ABS case (as the San-Hoodia and Buschbuckridge cases discussed below demonstrate) has been a learning experience on how to execute ABS deals in the context of pre-existing legal frameworks. Secondly, countries, such as Kenya, have had a long history of adopting policies towards recognition of communities as legal entities capable of enjoying rights, which were actually convenient or expedient to prevailing political circumstances or the ruling class.12 Recognition of communities as legal entities is not always the case in other African countries, and where legal recognition is afforded, this may still accord limited rights and obligations to communities (as opposed to the rights of individuals, even within those communities), at least until recently.13 This traces its roots in part back to the colonial alienation and division of communities by geographical boundaries, post-independence disenfranchisement and relegation of customary law and communal property in favour of western-oriented laws and individual property respectively. As a result community rights have been de-emphasised in favour of market-responsive economic activities.14  These countries include Cameroon, Ethiopia, Kenya, Malawi, Namibia, Seychelles, South Africa and Uganda. 12  An example is Kenya’s treatment of the Endorois community, who had to seek redress from the African Commission on Human and Peoples’ Rights after they were forcefully evicted from their ancestoral land for a game reserve to be established (African Commission on Human & Peoples’ Rights, Centre for Minority Rights Development (CEMIRIDE) and Minority Rights Group International (MRG) (on behalf of the Endorois) v Kenya, Communication No. 276/2003). 13  The Constitution of Kenya, 2010 (Kenya, The Constitution of Kenya, 2010) contains explicit provisions recognising various aspects of community rights, such as right to culture, language and self-determination, including ownership of community land. The Constitution also goes even further to define ‘marginalised communities’. This is in contrast to the repealed Constitution of Kenya, 1963 (Kenya, The Constitution of Kenya, 1963) which emphasised individual rights and limited application of customary laws to personal law matters. 14  Abraham K. Sing’Oei, “The Endorois’ Legal Case and its Impact on State and Corporate Conduct in Africa,” accessed 7 June 2012, http://www.natureandpoverty.net/dutch-platformland-use-planning/find/?eID%3Ddam_frontend_push%26docID%3D1285+Korir+Sing% E2%80%99Oei+A,+The+Endorois+Legal+Case+and+its+Impact+on+State+and+Corpo rate+Conduct+in+Africa.&hl=en&gl=uk&pid=bl&srcid=ADGEESjoEuN0g4SkEJoiH61 IETSRrjUaRU7Ky3IjzDoir2vSqKkAyFXNjP6_XE85wg6ovrJJb1hBY7gTMZP4NGtdxws 11

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Subject to what is set out below, the adoption of the Nagoya Protocol provides an opportunity for African communities to engage in ABS activities. Some of the Protocol’s provisions draw communities further into the centre-stage of ABS processes, by requiring their participation, not only in granting access, but also in sharing benefits. To this extent, therefore, the Nagoya Protocol buttresses some of the provisions contained in the African Model Law, particularly those that oblige countries to include communities in the ABS decision-making chain. It is also a complement to key African regional treaties such as the 2003 African Convention on the Conservation of Nature and Natural Resources, which calls upon African countries to ensure not only the respect of the traditional rights of communities, but also their participation in the process and management of natural resources.15 In this context, therefore, the Nagoya Protocol can be seen to integrate the other instruments that Africa has developed to contribute to its wellbeing and advancement in general.

II.  The Nagoya Protocol and the African Group’s Negotiating Priorities Like most developing countries, African states’ priorities during the Nagoya Protocol negotiations revolved around three essential components: access, benefit-sharing and compliance. Securing benefit-sharing and effective compliance measures,16 while at the same time not compromising on the sovereign rights of countries relating to access, were paramount. The roles which African governments expect indigenous and local communities to play in ABS are well-articulated in the African Model Law, the objectives of which include the recognition, protection and support of the IC2RQBRZ_B7-bseE1BFh3sHNCrpI8Ly8x--beNVdpBX5v9EH-&sig=AHIEtbRIdmkFuu 8Pvgt3r3T8oIN7VvW_Lg. 15  African Convention on the Conservation of Nature and Natural Resources Article 17 reads as follows: ‘(1) The Parties shall take legislative and other measures to ensure that traditional rights and intellectual property rights of local communities including farmers’ rights are respected in accordance with the provisions of this Convention. (2) The Parties shall require that access to indigenous knowledge and its use be subject to the prior informed consent of the concerned communities and to specific regulations recognising their rights to, and appropriate economic value of, such knowledge. (3) The Parties shall take the measures necessary to enable active participation by the local communities in the process of planning and management of natural resources upon which such communities depend with a view to creating local incentives for the conservation and sustainable use of such resources.’ 16  Gurdial S. Nijar, The Nagoya Protocol on Access and Benefit Sharing of Genetic Resources: An Analysis (Kuala Lumpur: CEBLAW, 2011).

222   Peter Munyi and Harry Jonas inalienable rights of local communities including farming communities over their biological resources, knowledge and technologies. Separate from the ABS mechanisms themselves, the rights of the indigenous and local communities are also recognised and their application called for, including the right to grant, refuse and withdraw prior informed consent (PIC), and the right to benefit from their intellectual creations.17 It follows then that Africa’s priorities, insofar as indigenous and local communities are concerned, as expressed in the Nagoya Protocol negotiations closely mirror the aspirations expressed in the Africa Model Law. The proposals submitted by the African Group in April 200918 contained numerous provisions consistent with the text of the African Model Law that are illustrative of the African Group’s consciousness of the central role that indigenous and local communities play in giving effect to ABS mechanisms.19 On the scope of the international regime on ABS, the African Group had proposed that it should include, inter alia, fair and equitable sharing of all benefits arising from the commercial and other use of associated traditional knowledge of indigenous and local communities in accordance with CBD Article 8(j) acquired before and after the entry into force of the Convention (pre and post-CBD).20 This proposal, together with extending the scope to all IPRs associated with research and technology arising from the use of genetic resources, their derivatives, products and associated traditional knowledge of indigenous and local communities, had its founding in the African Model Law, the scope of which extends to: biological resources in ex situ and in situ conditions, and their derivatives; community knowledge and technologies; local and indigenous communities; and plant breeders.21 Similarly, the African Group’s proposal to exclude from the international regime traditional systems of access, use and exchange of genetic resources, their derivatives and products, and to access, use and exchange of knowledge and innovations by, and between, indigenous and local communities22 borrowed heavily from the African Model Law.23 Notwithstanding that the relevant language of the Nagoya Protocol is couched in a flexible form, the provision clarifying that the Protocol should neither extend to, nor curtail, customary exchanges of genetic resources and traditional knowledge between indigenous and local  African Model Law Part IV.  UN Doc UNEP/CBD/WG-ABS/7/4. 19  UN Doc UNEP/CBD/WG-ABS/7/5. 20  Ibid. 21  African Model Law Article 2.1. 22  African Model Law Article 2.2. 23  African Model Law Article 2.2 provides, among others, that the legislation shall not affect the traditional systems of access, use and exchange of biological resources; and, access, use and exchange of knowledge and technologies by and between local communities. 17 18

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communities reflects, to a large degree, the aspirations of the African Group (and other parties in the negotiations).24 Another case in point relates to the proposals to ensure compliance with the customary law and local systems of protection of indigenous peoples and local communities put forward by the African Group.25 In each of these proposals, reference was made to an innovative instrument – community protocols26 – to give full effect to the participation of indigenous and local communities in ABS activities. Whereas the concept of community protocols itself is not explicitly articulated in the African Model Law, the latter provides detailed procedures on decision-making processes of communities, akin to those that would otherwise be contained in community protocols.27 It is, therefore, notable that arising from articulations made on community protocols in indigenous and local communities’ consultations and fora on ABS,28 and with complementary support of the African Group, community protocols are now recognised in international law,29 as discussed in more depth below. To lay further emphasis on measures to ensure compliance, the African Group also put forward a candid proposal on a dispute resolution mechanism sensitive to the needs of indigenous and local communities. The proposed mechanism was intended to be directly accessible to indigenous and local communities, have regional offices to be cognisant of cultural, social, economic and environmental realities of communities, and draw on customary laws and practices in its dispute-adjudication process.30 To complement such a proposed dispute-resolution mechanism, was a proposed office of the ombudsman whose responsibilities were to be exercised on behalf of indigenous and local communities, and included the identification of breaches of communities’ rights and the provision of assistance to communities in seeking fair and equitable resolutions of disputes. More specifically, the ombudsman was also intended to see that justice is accessed by indigenous and local communities in foreign (mainly user country) jurisdictions by representing the indigenous and local communities themselves in these jurisdictions.31  Nagoya Protocol Article 12.4.  African Model Law Article 17. 26  Community protocols will be discussed in detail in section 6 below. For an overview, see “Community Protocols,” accessed 7 June 2012, http://www.community-protocols.org. 27  African Model Law Part IV. 28  E.g., CBD Working Group on ABS, “Report of the International Indigenous and Local Community Consultation on Access and Benefit Sharing and the Development of an International Regime,” (19 September 2007) UN Doc UNEP/CBD/WG8J/5/INF/13. 29  Nagoya Protocol Article 12.3.a. 30  UN Doc UNEP/CBD/WG-ABS/7/4, 27. 31  Ibid. [See also contribution by Young to this volume (Chapter 15).] 24 25

224   Peter Munyi and Harry Jonas While these proposals were ultimately not included in the final Protocol, the provision on an international compliance system for the Nagoya Protocol32 provides opportunities for further exploration of a single robust dispute resolution mechanism to address instances of non-compliance. The above-discussed negotiating positions should be contextualised with regard to a number of high-profile ABS cases that arose during the course of the negotiations in various parts of the world. The best-known case in Africa is the San-Hoodia case, discussed below, highlighting several implementation challenges related to ABS that were then reflected in the African negotiating position.

III.  Community Challenges: San-Hoodia Case The many inherent challenges that ABS entails for indigenous peoples and local communities can be illustrated by the Hoodia benefit-sharing agreement.33 Much has been written about the original benefit-sharing agreement,34 signed between the South African San Council and the Council for Scientific and Industrial Research in 2003. The agreement, which was considered visionary at its time, related to traditional knowledge of the San, indigenous peoples of Southern Africa, about hunger-suppressing properties of a desert succulent called Hoodia. The overarching challenge faced by the San communities was engaging with a totally novel legal issue (ABS) in a short period of time.

 Nagoya Protocol Article 30.  The following brief analysis draws from Kabir Bavikatte, Harry Jonas and Johanna von Braun, “Shifting Sands of ABS Best Practice: Hoodia from the Community Perspective,” accessed 7 June 2012, http://www.unutki.org/default.php?doc_id=137. It does not intend to critique the decisions taken at the time of the agreement, but aims to draw on the authors’ experience of how the story has unfolded to highlight the inherent challenges that ABS poses to communities. For more on the San Hoodia case, see Rachel Wynberg, Doris Schroeder and Roger Chennells, eds., Indigenous Peoples, Consent and Benefit Sharing: Lessons from the San-Hoodia Case (London: Springer, 2009). 34  For example, Rachel Wynberg, “Rhetoric, Realism and Benefit-sharing: The Use of Traditional Knowledge of the Hoodia Species in the Development of an Appetite Suppressant,” The Journal of World Intellectual Property 7 (2004): 851; Saskia Vermeylen, “Contextualising ‘Fair’ and ‘Equitable’: The San’s Reflections of the Hoodia Benefit Sharing Agreement,” Local Environment 12 (2007): 423; Saskia Vermeylen, “From Life Force to Slimming Aid: Exploring Views on the Commodification of Traditional Medicinal Knowledge,” Applied Geography 28 (2008): 224; Bavikatte, Jonas and von Braun, “Shifting Sands of ABS Best Practice”; Wynberg, Schroeder and Chennells, Indigenous Peoples, Consent and Benefit Sharing. 32 33

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First, ABS forced communities to define themselves. ‘The San’ are in fact many communities living in very different socio-economic contexts and their cultural heritage and traditional knowledge is non-uniform. For example, some of the Khwe communities living in, and around, the Okavango Panhandle in Angola, Namibia and Northern Botswana live in rural areas, as compared to the Khomani San, many of whom live in urban and semi-urban environments in South Africa’s Northern Cape, 2,000 kilometres away. To assert their ownership of the knowledge relating to Hoodia, the San decided to project a ‘pan-San’ identity, forging a notion of who or how they ‘are’ for the sake of the benefit-sharing agreement. The pressure of impending deadlines and financial windfalls limited the process of self-identification when it arguably should have been undertaken at a more appropriate pace to enable effective participation of the wider community. As much as possible, the self-identification process should also have been decoupled from the benefitsharing agreement itself to ensure that both were rooted in the community’s broader endogenous development plans and priorities. Of course in this situation this was not possible, leading to important decisions relating to the San’s identity being taken to meet the needs of the ongoing ABS negotiations. In addition, the knowledge about Hoodia’s properties is shared between the San and the Nama, a community indigenous to what is now Namibia. Yet the Nama were not included in the original benefit-sharing agreement, a decision that fostered inter-community mistrust and resentment.35 As traditional knowledge is often shared unequally within communities, and in many cases across communities and borders (variously defined), fundamental questions arise about the nature of ‘ownership’ of knowledge and concomitantly what constitutes PIC from the ‘community.’ Time and widespread participation is critical to ensure that the views of individuals within or across communities are taken into account when considering whether and/or how to engage a potential bioprospector. Second, and linked to the above point, is the fact that prior to the Hoodia issue arising, San communities had neither considered ABS nor mandated a particular body to manage and protect their traditional knowledge. The advent of an ABS agreement compelled San communities to be represented by an elected group to negotiate the agreement on their behalf. This led to the creation of a new body called the South African San Council, which, among other things, exacerbated existing tensions between ‘traditional’ and ‘modernist’ people in the South African San communities, especially the Khomani, and led to questions about the body’s representativeness and  A benefit-sharing agreement has since been signed between the San and the Nama (Working Group of Indigenous Minorities in Southern Africa, “Heritage and Intellectual Property Rights,” accessed 7 June 2012, http://www.wimsanet.org/our-work/heritage-and-ipr).

35

226   Peter Munyi and Harry Jonas transparency. Saskia Vermeylen’s research highlights the fact that while many people know of the Hoodia agreement, they lack any in-depth understanding about ABS, in general, and the agreement in particular. She also points out that the timing and structure of the negotiations intensified knowledge and power asymmetries in the communities.36 Third, the San Council negotiating team members themselves had a significant task, having to rapidly grasp a number of challenging concepts and specific IPR-related aspects of commercial agreements such as milestone payments and royalties. These were huge demands for the community members selected for the task. As non-lawyers with no prior knowledge about ABS working within a limited negotiations timeframe, they were severely disadvantaged in terms of making independent assessments of the most appropriate terms of the agreement and types of benefits for their communities. The net result is that they relied to a large extent on external expert advice. A strong reliance on external experts by communities in future benefit-sharing agreements raises questions of how ‘informed’ consent and the subsequently negotiated mutually agreed terms (MAT) can be. Fourth, in 2006, San from Botswana, Namibia and South Africa met to assess the governance challenges presented by the Hoodia agreement. The resulting Molopo Declaration states, among other things: •  all structures should respect San values, including respect for culture and consensus decision-making; •  San structures must strive to make sure the majority of funds are used to benefit San communities; •  administrative costs of all funds should be kept to a bare minimum, around 20% of total funds, depending on the level of income; •  corruption in any form is totally unacceptable. Good management of funds, transparency and accountability will be required; •  priorities will be different in Namibia, Botswana and South Africa. San Councils must strive to accommodate differences in the three countries; and •  projects that are environmentally sustainable and economically viable will be prioritised [in the allocation of benefits].37 The San have faced many institutional and community capacity challenges while attempting to fulfill the aspirations of the Molopo Declaration.  Vermeylen, “Contextualising ‘Fair’ and ‘Equitable’: The San’s Reflections of the Hoodia Benefit Sharing Agreement”. 37  The declaration is not available online but is largely reproduced in Bavikatte, Jonas and von Braun, “Shifting Sands of ABS Best Practice: Hoodia from the Community Perspective”. 36

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For example, attempting to manage the funds has been difficult. As in the case of the San Council, a new institution (the Hoodia Trust) was established to manage the funds. It suffered from questions of legitimacy and there continues to be a widespread lack of understanding of its role. Compounding this issue is the fact that Hoodia Trustees and San Council members have few financial management capabilities, members of both bodies lack experience with conducting public office, and terms of reference for the bodies’ members, codes of conduct, and dispute resolution mechanisms either do not exist or are not applied. Because the South African San Council is established as a Voluntary Association under South African law, it is not required to submit audited accounts to any governmental agencies. The result is that representatives are accountable only to their constituencies, who in turn are limited in their ability to either demand or fully comprehend financial accounts. These factors are intensified by the fact that many of the Council members are otherwise unemployed, increasing the likelihood of mismanagement of funds. Transparency, accountability, representativeness, cultural legitimacy, and authority of the ‘Hoodia governance’ system remain in question. Fifth, expectations were raised that the community would benefit financially. However, the original Hoodia benefit-sharing agreement amounted to little,38 with Unilever pulling out of a commercial license in late 2008. While it is difficult to measure how this has affected the community, the disappointment and lack of understanding about the latest developments is palpable when discussing it with community members. Finally, the agreement led to no increase in the conservation or customary uses of Hoodia. In fact, the opposite happened, with widespread reports of unsustainable harvesting of wild Hoodia across the region by a variety of different stakeholders at the height of the ‘Hoodia boom’ in 2007–2008. In sum, the Hoodia benefit-sharing agreement simultaneously represents a moral victory for the San community for recognition of their rights relating to traditional knowledge and a process that has arguably further undermined their traditional values and knowledge and resource governance systems. The deal asserted their rights to provide PIC for the use of their traditional knowledge, but the nature of the negotiation, the terms of the agreement, and the governance reforms that they have undertaken have led to a variety of negative impacts: they weakened the San’s traditional forms of authority; they increased the community’s reliance on external expert opinion; they led to largely misunderstood and, at times, corrupt new forms of governance; they raised and dashed hopes of newfound wealth; they exacerbated power

 The Hoodia Trust had received 587,305 South African Rands by the end of 2008, circa 58,000 US Dollars.

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228   Peter Munyi and Harry Jonas and information asymmetries in and across San communities; and they initially fostered mistrust between the San and Nama communities.39 As stated above, the Hoodia agreement was considered groundbreaking at the time. The experience since then, however, highlights certain lessons that other communities and NGOs are advised to consider when evaluating ABS as a legal and policy framework through which to protect their traditional knowledge and to support their ways of life. By increasing the participation among and across communities and spending more time evaluating the pros and cons of ABS, communities are likely to make more informed decisions about whether to either decide to spurn the framework or negotiate for more appropriate economic, cultural, social, and/or environmental benefits. As called for in the Nagoya Protocol, the San Hoodia case highlights the need for support to be given to communities relating to ABS and related legal frameworks to enable empowered communities to engage with outsiders on more equal terms. Before turning to evaluate community protocol as a reflexive and proactive tool, referenced in the Nagoya Protocol, that can assist communities with the above challenges, the next section explores the inherent difficulties communities face when engaging with positive legal frameworks.40

IV.  Communities and the Law Indigenous peoples’ and local and mobile communities’ diversity of worldviews, cultures and ways of life are helping to conserve and sustainably use the world’s biodiversity.41 The multiplicity of interrelated knowledge, innovations, practices, values, and customary laws are embedded within mutually supporting relationships between land, natural resource use, culture and spirituality.42 This connectivity underpins communities’ dynamic worldviews

 This has been addressed by the recent San-Nama Benefit-Sharing Agreement. The agreement is not available online, but reference to it is available at Working Group of Indigenous Minorities in Southern Africa, “Heritage and Intellectual Property Rights,” accessed 7 June 2012, http://www.wimsanet.org/our-work/heritage-and-ipr. For more information contact the Working Group of Indigenous Minorities in Southern Africa, accessed June 7, 2012, http://www.wimsanet.org/. 40  A distinction is made between indigenous peoples and local communities’ customary laws and ‘positive’ laws enacted by the State. 41  Luisa Maffi and Ellen Woodley, Biocultural Diversity Conservation: A Global Sourcebook (London: Earthscan, 2010). 42  Philippe Descola, “Society of Nature and the Nature of Society,” in Conceptualising Society, ed. Adam Kuper (London: Routledge, 1992), 107. 39

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and understandings of the laws of nature.43 This is also referred to as ‘collective biocultural heritage’, which is the knowledge, innovations, and practices of indigenous peoples and local and mobile communities that are collectively held and inextricably linked to traditional resources and territories, local economies, the diversity of genes, varieties, species and ecosystems, cultural and spiritual values, and customary laws shaped within the socio-ecological context of communities.

Biological diversity, therefore, cannot be seen as separate from cultural and linguistic diversity, because the diversity of life in all its manifestations is interrelated (and likely co-evolved) within a complex socio-ecological adaptive system. Ensuring that communities’ rights are enshrined in international and national laws is of paramount importance to ensuring respect and support for biological and cultural diversity (biocultural diversity) at the local level. As such, communities and their representatives are compelled to engage with the negotiations of multilateral environmental agreements and their protocols, as well as soft law instruments. Yet the harsh paradox is that even when hard-fought negotiations result in communities’ rights being enshrined in law, their local effects are often muted because of the complex socio-political contexts within which communities live.44 For example, Linda Siegele and colleagues45 detail a plethora of international rights relating to communities across a range of hard and soft law instruments agreed at the international level, including multilateral environmental agreements, human rights instruments, UN agencies’ policy documents and International Union for Conservation of Nature (IUCN) resolutions. However, their telling conclusion is that ‘good policy is just a starting point – good practice is more difficult to achieve’46 Similarly, Lorenzo Cotula and Paul Mathieu47  Iain Davidson-Hunt and Fikret Berkes, “Learning as You Journey: Anishinaabe Perception of Social-ecological Environments and Adaptive Learning,” Conservation Ecology 8 2003: 5. See also Merle Alexander, Preston Hardinson and Mathias Arhen, “Study on Compliance in Relation to the Customary Law of Indigenous and Local Communities, National Law, Across Jurisdictions, and International Law” (6 March 2009) UN Doc UNEP/CBD/WGABS/7/INF/5. 44  Fred Nelson, “Conservation and Citizenship: Democratising Natural Resource Governance in Africa,” Policy Matters 17 (2010): 233. 45  Linda Siegele et al., “Conservation and Human Rights, Who Says What?,” in Rights-based Approaches: Exploring Issues and Opportunities for Conservation, eds. Jessica Campese et al. (Bogor: Centre for International Forestry Research and International Union for Conservation of Nature, 2009), 47. 46  Ibid., 69. 47  Lorenzo Cotula, Legal Empowerment for Local Resource Control: Securing Local Resource Rights Within Foreign Investment Projects in Africa (London: International Institute for Environment and Development, 2007); Lorenzo Cotula and Paul Mathieu, eds., Legal 43

230   Peter Munyi and Harry Jonas highlight the gap between what is ‘on paper’ and what happens in practice in the context of local land tenure and projects intended to reduce emissions from deforestation and forest degradation (REDD).48 They underscore the fact that despite growing international recognition of communities’ rights to self-determine their futures and manage their natural resources,49 international rights are far from a panacea against local disempowerment or the denial of procedural and substantive justice. Against, this background, communities face a number of interrelated challenges when engaging with positive (state) legal systems. Three in particular have ramifications for communities seeking to assert their rights to self-determination and wellbeing, namely, legal disaggregation, the dynamic interplay between external definitions of a community and intra and intercommunity self-definitions, and the potential conflicts between customary and positive law. First, laws compartmentalise the otherwise interdependent aspects of biocultural diversity by drawing legislative borders around them and addressing them as distinct segments. While communities manage integrated land­ scapes,50 the State tends to view each resource and associated traditional knowledge through a narrow lens, implementing corresponding laws through agencies that separately address, for example, biodiversity, forests, agriculture, and indigenous knowledge systems.51 The result is that communities’ lives are disaggregated in law and policy, which effectively fragments and reduces their claims to self-determination into specific issue-related sites of struggle. The second overarching challenge relates to how the law affects the nature of whom or what is defined as ‘community’. In general, people have a variety of ways of establishing who is a member of a family or community and who is an outsider. Communities may define themselves in a number of different ways and in different contexts, based on multiple factors such as heritage, ethnicity, language, geographical proximity, and shared resources Empowerment in Practice, Using Legal Tools to Secure Land Rights in Africa (London: International Institute for Environment and Development, 2008). 48  Cotula, Legal Empowerment for Local Resource Control; Cotula and Mathieu, Legal Empowerment in Practice, Using Legal Tools to Secure Land Rights in Africa, 23. 49  E.g., Cynthia Morel, “Communication 276/2003 – Centre for Minority Rights Development (Kenya) and Minority Rights Group International on behalf of Endorois Welfare Council v. Kenya”, accessed 14 June 2012, http://www.unhcr.org/refworld/docid/4b8275a12.html. 50  Alan Watson, Lilian Alessa and Brian Glaspell, “The Relationship Between Traditional Ecological Knowledge, Evolving Cultures, and Wilderness Protection in the Circumpolar North,” Conservation Ecology 8 (2003): 2. 51  In South Africa, for example, the Department of Environmental Affairs has a mandate to manage the country’s biodiversity, but it shares responsibility to protect communities’ associated traditional knowledge with the Department of Science and Technology.

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or knowledge.52 State law, however, is insensitive to local, adaptive conceptions of community and tends to impose an over-generalised and homogeneous classification as a static and rigidly defined entity. This contradicts local realities and can further divide and weaken local institutions and social structures.53 However, this challenge can be overcome by using the law as the basis for adding a new dimension to local constructions of community that progresses the right to self-determination. For example, in Bushbuckridge, South Africa, a group of traditional healers spread across a large number of villages and from two different language groups came together to define themselves as a community of knowledge-holders in the context of new rights provided under South African ABS law.54 Although this type of law tends to place a disproportionate emphasis on the sharing of traditional knowledge as the means by which to characterise a community, the Bushbuckridge Traditional Health Practitioners are using its provisions to create and occupy a new legal space, within which they are asserting their rights to traditional knowledge and customary practices in line with their own terms, values and priorities.55 All communities are dynamic and issues of selfdefinition and fluid identity are neither new to traditional communities nor inherently destructive to their social structures. The critical determinant is whether they are able to engage adequately with legal and policy processes to avoid potential negative impacts of change and drive positive developments according to their own values and priorities.56 As a third and cross-cutting challenge inherent to engaging with legal frameworks, positive law (both international and domestic) may conflict with the customary laws that govern communities’ sustainable use of natural resources.57 For example, within an ever-increasing number of societies, the understanding of ‘property’ under positive law is based on the private rights of a person (human or corporate) to appropriate and alienate physical and intellectual property. In contrast, communities’ property systems tend to emphasise relational and collective values of resources. Such systems have been described as commonly characterised by collective ownership (where  Arun Agrawal and Clark C. Gibson, “Enchantment and Disenchantment: The Role of Community in Natural Resource Conservation,” World Development 27 (1999): 629. 53  Dawie Bosch, “Land Conflict Management in South Africa: Lessons Learned from a Land Rights Approach,” accessed 7 June 2012, http://www.fao.org/DOCREP/006/J0415T/ j0415t0a.htm. 54  South Africa, Regulations on Bio-prospecting, Access and Benefit Sharing, No. R. 138, 2008. 55  This example is elaborated below (section 7). 56  Cotula and Mathieu, Legal Empowerment in Practice, Using Legal Tools to Secure Land Rights in Africa. 57  Ibid. 52

232   Peter Munyi and Harry Jonas the community owns a resource, but individuals may acquire superior rights to or responsibilities for collective property), and communal ownership (where the property is indivisibly owned by the community).58 Furthermore, the implementation of positive law tends to overpower and contravene customary law. A system that denies legal pluralism59 has direct impacts on communities’ lives, for example, by undermining the cultural practices and institutions that underpin sustainable ecosystem management.60 While recognition of communities’ customary laws and traditional authority over resources is progressing in some jurisdictions,61 the challenge of legal pluralism goes beyond the mere co-existence of legal regimes, wherein customary law is applicable only to indigenous peoples within their territories. Instead, meaningful legal pluralism requires ‘incorporation directly or indirectly of principles, measures and mechanisms drawn from customary law within national and international legal regimes for the protection of traditional knowledge’.62 These three challenges, among others, highlight the fact that the implementation of international and national environmental laws such as on ABS has the potential to undermine the interconnected and adaptive systems that underpin biocultural diversity. The implementation of such laws compounds these challenges by requiring communities to engage with disparate stakeholders63 according to a variety of disconnected regulatory frameworks, many of which may conflict with their customary laws and traditional governance structures. Communities thus face a stark choice: to either spurn these inherently limited frameworks (something which is a virtual impossibility, considering the ubiquitous nature of State law) or engage with them at the potential expense of becoming complicit in the disaggregation of their otherwise holistic ways of life and governance systems. If the latter is chosen, the resultant challenge is for communities to draw upon and further develop

 Rebecca Tsosie, “Cultural challenges to biotechnology: Native American cultural resources and the concept of cultural harm,” Journal of Law, Medicine & Ethics 35 (2007): 396. 59  This type of system could be referred to as legal monoculture. 60  Leon Sheleef, The Future of Tradition: Customary Law, Common Law and Legal Pluralism (London: Frank Cass, 2000). 61  Donna L.V. Cott, “A Political Analysis of Legal Pluralism in Bolivia and Colombia,” Journal of Latin American Studies 32 (2000): 207. 62  This is arguably a huge challenge and most states are a long way from incorporating indigenous worldviews into legal and policy frameworks. 63  Tobin, B., and E. Taylor. 2009, “Across the Great Divide: A Case Study of Complementarity and Conflict Between Customary Law and TK Protection Legislation in Peru”. Initiative for the Prevention of Biopiracy, Year IV: 11. Examples include government agencies, conservation and development NGOs, private sector companies and researchers. 58

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appropriate means to effectively engage with domestic and international legal and policy frameworks, specifically in ways that accord with their biocultural heritage, support their integrated systems of ecosystem management, are commensurate with their customary laws, and recognise traditional forms of governance. In the absence of such approaches, the very act of using rights can be disempowering and disenfranchising.64 In efforts to circumvent these challenges, in the context of ABS, and secure communities’ rights over natural resources and traditional knowledge, and protect their ways of life, the International Indigenous Forum on Biodiversity and their supporters sought to secure a number of important biocultural rights in the Nagoya Protocol. Biocultural rights can be defined as rights of indigenous peoples and local communities over all aspects of their ways of life that are relevant to the conservation and sustainable use of biodiversity. These aspects include rights relating to, among other things, their knowledge, innovations and practices, natural resources, lands and waters, traditional occupations, and customary laws and systems of governance. Effectively, these are rights to self-determination, but specifically self-determination oriented towards stewardship of indigenous peoples’ and local communities’ traditional lands and waters.65 Ultimately, whether the Nagoya Protocol will help or hinder communities at the local level will only emerge over time. For communities to secure their biocultural rights through the Nagoya Protocol, the gains made through successful international advocacy must be capitalised on by the implementation of domestic ABS laws and policies and the concomitant improved exercise of rights at the local level. The next section explores locally-relevant means to achieve these ends.

 This is also supported by anecdotal evidence by public interest lawyers such as Fatima Hassan (former senior attorney, AIDS Law Project, South Africa) who argues that even when ordinary people do use the law and engage legal systems, the process is often both disempowering because of the asymmetrical ‘lawyer-client’ relationship and dehumanising because of the Kafkaesque nature of legal proceedings. 65  Harry Jonas, Kabir Bavikatte and Holly Shrumm, “Biocultural Community Protocols and Conservation Pluralism,” Policy Matters 17 (2010): 102; Kabir Bavikatte and Daniel F. Robinson, “Towards a People’s History of the Law: Biocultural Jurisprudence and the Nagoya Protocol on Access and Benefit Sharing,” Law, Environment and Development Journal 7 (2011): 35; and Kabir Bavikatte, “Stewarding the Commons: Rethinking Property and the Emergence of Biocultural Rights,” Common Voices 7 (2011): 16. 64

234   Peter Munyi and Harry Jonas

V.  ABS, Communities and Legal Empowerment The Nagoya Protocol places duties on Parties in relation to indigenous peoples and local communities, the genetic resources over which they have established rights and any associated traditional knowledge. Parties have agreed, inter alia, a number of obligations regarding indigenous peoples and local communities, including to: •  ensure that PIC is provided by indigenous peoples and local communities where they have ‘established rights’ over the genetic resources in question;66 •  ensure PIC and MAT are established prior to access to traditional knowledge, thus recognising communities’ right to govern the uses of and benefits arising from traditional knowledge, with reference to respect for customary laws, community protocols and procedures;67 •  support the development by indigenous and local communities of: community protocols; minimum requirements for MAT relating to traditional knowledge; and model contractual clauses relating to traditional knowledge,68 •  respect the right to free customary use and exchange of genetic resources and associated traditional knowledge within and among indigenous peoples and local communities;69 and •  support the joint development of codes of conduct, guidelines and best practices and/or standards.70 While some indigenous commentators have criticised both procedural and substantive aspects of the Nagoya Protocol,71 the details of which should be taken seriously, the fact that these standards are enshrined in the Nagoya Protocol is nevertheless important. Whether the Nagoya Protocol will promote social and environmental justice at the local level, however, is contingent on a number of factors, including how the provisions are translated into national legislation, the tenor of the associated governmental policy, the way  Nagoya Protocol Article 6.2.  Nagoya Protocol Articles 7 and 12.1. 68  Nagoya Protocol Article 12.3. 69  Nagoya Protocol Article 12.4. 70  Nagoya Protocol Article 21.e. 71  Nagoya Protocol on Access and Benefit Sharing: Substantive and Procedural Injustices relating to Indigenous Peoples’ Human Rights (Union of BC Indian Chiefs, “Nagoya Protocol – Joint Submission on Substantive and Procedural Injustices,” accessed 7 June 2012, http://www.ubcic.bc.ca/News_Releases/UBCICNews06061101.html#axzz1s5Jn0KPD). [See also contributions by Savaresi and by Burton to this volume (Chapters 2 and 10).] 66 67

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ABS is implemented, as well as the way companies approach the issues and the ability of communities to effectively use the law. While each of these factors is critically important and interlinked, this section focuses on how the communities use laws implementing the Nagoya Protocol and, drawing on the above two sections, on legal empowerment as a means to enhance their ability to do this. Legal empowerment is defined as ‘the use of legal tools to tackle power asymmetries and help disadvantaged groups have greater control over decisions and processes that affect their lives’.72 Evidence suggests that nonlawyers are equally equipped to use the law (and sometimes more adept at doing so) to solve local challenges when they are empowered in a legal context.73 Legal empowerment of the poor74 is based on the twin principles that law should not remain a monopoly of trained professionals and, in many instances, forms of alternative dispute resolution are more attuned to local realities than formal legal processes. Ideally, the act of using the law becomes as empowering as the outcome of the process itself.75 By organising themselves around rights and duties, communities initiate adaptive dialogue processes both internally and vis-à-vis outsiders. Building internal resilience to external influences and responding proactively and according to local values and priorities are both critical to a community’s well-being.76 A court victory handed to a community, for example, can be supremely useful, but a process that is driven by the community is tangibly more powerful.77 As such, effective legal empowerment is a combination of social mobilisation and legal action78 that acts as a positive feedback loop towards both aims.

 Cotula and Mathieu, Legal Empowerment in Practice, Using Legal Tools to Secure Land Rights in Africa. 73  Vivek Maru, “Between Law and Society: Paralegals and the Provision of Justice Services in Sierra Leone and Worldwide,” The Yale Journal of International Law 31 (2006): 427. 74  This is a reference to the United Nations Development Programme, “Initiative on Legal Empowerment of the Poor,” accessed 4 August 2010, http://www.undp.org/legalempowerment/. 75  Maru, “Between Law and Society: Paralegals and the Provision of Justice Services in Sierra Leone and Worldwide,” 427–476. 76  Suneetha M. Subramanian and Balakrishna Pisupati, Learning from the Practitioners: Benefit Sharing Perspectives form Enterprising Communities (Nairobi: UNEP and UN University, 2009). 77  ‘The most valuable, useful and transformative legal challenges are those that include communities and that mobilise and educate people so that communities use the law to give effect to their own voices and their own issues.’ Hassan, F. (draft in progress). 10 Year History of Treatment Action Campaign. Treatment Action Campaign: Cape Town, South Africa. 78  Cotula, Legal Empowerment for Local Resource Control: Securing Local Resource Rights Within Foreign Investment Projects in Africa. 72

236   Peter Munyi and Harry Jonas Negotiating within a strong rights-based framework is an important strategy for indigenous peoples and local communities, who by ‘negotiating in the shadow of the law’79 can change the dynamic of a negotiation, and introduce conditions of greater parity. In this context, rights and obligations can help the weaker party overcome an initially disadvantaged position. However, law is about more than just establishing due process. When used imaginatively, laws can be the platform for creating an enabling legal and political environment by negotiating ‘space to place new steps of change’80 and opening avenues of discussion between disparate groups towards previously unimagined relationships.81 In this sense, legal empowerment can enable communities to break free from the typical patronising dichotomy of either being ‘spoken at’ or ‘spoken for’. In the context of ABS, this means a transition from the kinds of relationship apparent in the San-Hoodia case where a community was on the back foot from the start when they first found out that the South African Council for Scientific and Industrial Research had patented knowledge relating to their traditional knowledge associated with hoodia, to one characterised by the ‘ABS Vision for Africa’,82 developed at a meeting of African stakeholders83 in Cape Town in 2006, from which the following excerpt is drawn: The other day a pharmaceutical giant sent its buyer to Africa to access genetic resources. He was struck by the adverts for locally produced cosmetics using the same ingredients. In his hotel he encountered a regional buyer interested in medicinal components of the same plant. He was surprised at how promptly the relevant information and regulations were furnished by the national competent authority, which then guided and introduced him to the community that owned and produced the ingredients. Getting out of his car the buyer could hear school children reading a text in their own local language. The community received him warmly. They took pride in showing him their land, animals and other indigenous plants which have traditional uses. When he mentioned the names of the genetic resources he was interested in, the community immediately knew which plants he was referring to. They walked him through a well-managed wild population of the  Cotula and Mathieu, Legal Empowerment in Practice, Using Legal Tools to Secure Land Rights in Africa. 80  Maya Angelou, “On the Pulse of Morning,” accessed 7 June 2012, http://www.ssc.wisc .edu/~oliver/soc220/Lectures220/Angelou.htm. 81  Ricardo Rozzi et al., “Ten Principles for Bio-cultural Conservation at the Southern Tip of the Americas: The Approach of the Omora Ethnobotanical Park,” Ecology and Society 11 (2006): 43. 82  “ABS Vision for Africa”, 2007, accessed 14 June 2012, http://www.abs-initiative.info/ milestones.html. 83  Capacity Development Initiative. The Cape Town Vision was developed by a cross section of ABS stakeholders including indigenous peoples and local communities, government, the private sector, academics, NGOs among others. 79

Implementing the Nagoya Protocol in Africa   237 actual plant and reached a new field where the plant is now cultivated, before he was shown the processing using modern technology. During negotiation with several stakeholders, the buyer observed that the community was well informed and that their representative knew which knowledge to share and which one to protect. After a few days, the committee, composed of men and women and the buyer, signed a new Material Transfer Agreement for the ingredients and for research on a new plant with clear benefits to the community. They shook hands. He thanked the community. They replied ‘You are welcome’ and they really meant it.84

By understanding the value of their knowledge and the framework for how they can share some knowledge while protecting other aspects of their collective biocultural heritage,85 communities are more able to engage others on their own terms. The ‘Vision for ABS in Africa’ thus highlights the critical need for the further development and sharing of communities’ methods and approaches to using rights and engaging with the law on their terms, according to their values, and in ways commensurate with their customary laws – in other words, endogenously. An endogenous approach to implementing the Nagoya Protocol involves communities approaching ABS as one of a range of means to achieve their future plans, according to local values and priorities.86 In contrast with other theories of development that emphasise varying degrees of external input, it draws on a body of experience that suggests that communities are more likely to remain cohesive and sustain their traditions, cultures, spirituality, and natural resources when they develop their future collectively and base their plans on the resources available within the community. Endogenous development does not reject the notion of external agencies providing assistance, but stresses that any interventions must be undertaken only after the free PIC of the community is given and when the activities are developed, driven, monitored, and evaluated by the community.87 Endogenous development theory supports the proposition that the more endogenous the legal education and rights-based approach, the more likely the process is to be genuinely empowering. Thus, while ABS is an external framework, often initially contrasting, if not at odds, with local approaches to the sharing of genetic resources and knowledge, by approaching it endogenously and on the basis of participatory legal empowerment,

  Ibid.  International Institute for Environment and Development, “Biocultural Heritage”, accessed 8 June 2012, http://biocultural.iied.org/. 86  ETC Foundation and COMPAS, Learning Endogenous Development: Building on Biocultural Diversity (London: Practical Action Publishing, 2007). 87  Ibid. 84 85

238   Peter Munyi and Harry Jonas it can become a useful means to promote their knowledge, innovations and practices and to derive local livelihoods.

VI.  Biocultural Community Protocols and ABS The Nagoya Protocol makes reference to an instrument that is increasingly being used by indigenous peoples and local communities to articulate their stewardship of the lands, waters and natural resources, asserting their rights and affirming responsibilities – namely, community protocols.88 Biocultural community protocols or ‘community protocols’,89 as described in the Nagoya Protocol, are a response to the challenges and opportunities set out above. Although each is adapted to its local context, a biocultural community protocol is a community-led instrument that promotes participatory advocacy for the recognition of, and support for, ways of life that are based on the customary sustainable use of biodiversity, according to standards and procedures set out in customary, national, and international laws and policies.90 In this sense, biocultural community protocols are community-specific declarations of the right to diversity and claims to legal pluralism. Their value and integrity lie in the process that communities undertake to develop them, in what they represent to the community, and in their future uses and impacts. The process of developing and using a community protocol is an opportunity for communities to reflect on their ways of life, values, customary laws, and priorities and to engage with a variety of supporting legal frameworks and rights. A biocultural approach to the law empowers communities to challenge the fragmentary nature of State law, engage with it from a more nuanced and integrated perspective and assess how certain laws may assist or hinder their plans for the future. A wide variety of community members are involved by integrating legal empowerment processes with endogenous development and communication methodologies such as group discussions, written documentation, various types of mapping and illustrations, participatory video and photography, performing arts, and locally appropriate monitoring and evaluation.91 Community protocols vary in how they are documented,  Nagoya Protocol Articles 12 and 21.  For the Initiative on Biocultural Community Protocols, see “Natural Justice: Lawyers for Communities and the Environment,” accessed 8 June 2012, http://www.naturaljustice.org. 90  Jonas, Bavikatte and Shrumm, “Biocultural Community Protocols and Conservation Pluralism,” 102–112. 91  Julie J. Taylor, “Naming the Land, San Countermapping in Namibia’s West Caprivi,” Geoforum 39 (2008): 1766; Arthur Hoole and Fikret Berkes, “Breaking Down Fences: Recoupling Social-ecological Systems for Biodiversity Conservation in Namibia,” Geoforum 31 (2009): 304; Terry N. Tobias, Chief Kerry’s Moose: A Guidebook to Land Use and Occupancy Map88 89

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shared, and utilised and have been highlighted as something meaningful and affirmative that a community can be proud of.92 The approach is intended to mobilise and empower communities to use international and national laws to support the local manifestation of the right to self-determination. Community protocols assist communities to establish a firm foundation upon which to develop the future management of their natural resources, including when engaging third parties, by setting out their values and customary procedures that govern the management of their natural resources. They also provide a vehicle for articulating their procedural and substantive rights to, among other things, be involved in decision-making according to the principle of free PIC, develop the specific elements of projects that affect their lands, and ensure that they are involved in the monitoring and evaluation of such projects. This provides clarity to the drivers of external interventions such as protected areas, ABS agreements, REDD projects, payment for ecosystem services schemes, and can help communities gain recognition for, among other things, their territorial sovereignty, community-based natural resource management systems and community conserved areas,93 sui generis laws, sacred natural sites,94 and globally important agricultural heritage systems. In this regard, community protocols enable communities to bridge the gap between the customary management of their biocultural heritage and the external management of their resources, as mandated by positive legal frameworks. They also help communities to minimise the power asymmetries that often characterise government-community relations and promote a more participatory and endogenous approach to the future governance of their territories, natural resources and biodiversity. By enabling a community to be proactive in relation to agencies and frameworks to which they have normally been reactive, protocols have the potential to shift the dynamic of conservation initiatives from merely attempting to ‘ensure’ communities’ participation to becoming inclusive, locally appropriate processes driven by legally empowered communities. These points are highlighted by the experiping, Research Design and Data Collection (Vancouver: The Union of BC Indian Chiefs and Ecotrust Canada, 2000); Nick Lunch and Chris Lunch, Insights into Participatory Video: A Handbook for the Field (London: Insight Share, 2005); Rick Davies and Jess Dart, The Most Significant Change Technique: A Guide to Its Use (London: CARE International, 2005); Kate Schreckenberg et al., “Social Assessment of Conservation Initiatives: A Review of Rapid Methodologies,” Natural Resource Issues 22, IIED, London. (London, IIED, 2010). 92  Ilse Köhler-Rollefson, Bio-cultural Community Protocols for Livestock Keepers (Rajasthan: Lokhit Pashu-Palak Sanstan, 2010). 93  Sarah Ryan et al., Australia’s NRM Governance System: Foundations and Principles for Meeting Future Challenges (Canberra: Australian Regional NRM Chairs, 2010). 94  Robert Wild and Christopher McLeod, eds., Sacred Natural Sites: Guidelines for Protected Area Managers (Gland: International Union for Conservation of Nature, 2008).

240   Peter Munyi and Harry Jonas ence of the Traditional Health Practitioners of Bushbuckridge, South Africa, discussed next.

VII.  Biocultural Community Protocol of the Traditional Health Practitioners of Bushbuckridge95 The Kruger to Canyons Biosphere Region (K2C) is part of UNESCO’s World Network of Biosphere Reserves. Bridging the Limpopo and Mpumalanga provinces in northeast South Africa, the K2C spans more than four million hectares and contains two national parks, namely the Kruger National Park and Blyde River Canyon Nature Reserve. The biosphere reserve is not only extremely biodiverse but also culturally diverse. Its buffer and transition zones are home to about 1.6 million people from different ethnic backgrounds and language groups. Yet despite the area’s conservation value, many of the local communities are economically poor and live in semi-rural areas. Traditional healers provide primary healthcare for many people in the region. They also play an important cultural role by promoting traditional values and acting as the custodians of the complex knowledge of plants growing in the biosphere region. In their capacity as holders of traditional knowledge, they acquired new rights under the South African Biodiversity Act96 and the Bioprospecting Access and Benefit-Sharing Regulations.97 In spite of this, few health practitioners knew of their rights. In March, 2009, the Biosphere Committee began supporting a group of healers based at the Vukuzenzele Medicinal Plants Nursery in Bushbuckridge who wished to host a series of meetings with other groups of healers to discuss these issues. Over the next five months, they held regular meetings to share views and learn more about South African law on the conservation of medicinal plants and the protection of traditional knowledge. On the basis of a number of shared concerns, more than 80 healers decided to form a governance structure under the name of Bushbuckridge Traditional Healers, with an Executive Committee to assist them in presenting their views to stakeholders. As mentioned above, the Bushbuckridge Traditional Healers come from two separate language groups, the Sepedi and Tsonga, yet see themselves as a single group because of their specialist knowledge and reliance on the same medicinal plants. They then worked with the Biosphere

 This section is adapted from Ana Persic and Harry Jonas, “The Bushbuckridge healers’ path to justice”, World of Science 8 (2010): 18. 96  South Africa, National Environmental Management Biodiversity Act No. 10 of 2004. 97  South Africa, Bioprospecting, Access and Benefit-Sharing Regulations No. R. 138 of 2008. 95

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Committee and Natural Justice,98 an NGO of lawyers who advise communities on environmental issues, to develop their own biocultural community protocol. This protocol was first presented to the local authorities and other stakeholders in the K2C in September 2009. In their seven-page bio-cultural protocol,99 the traditional healers set out a range of issues. First, they outline the contribution they make to the health of their communities. They explain that, although they share common knowledge of the main types of illnesses in the community, each has a specific way of treating those illnesses. Their specialisation in different ailments means that they also refer patients to one another. Since their patients are poor, the healers often provide healthcare regardless of whether the patient can pay. ‘Our ancestors prohibit us from pressuring people for money,’ they explain, ‘so we rely on goodwill and reciprocity.’100 The healers then explain their communities’ affinity with the surrounding biodiversity. We believe that only harvested leaves or bark that are taken in ways that ensure the survival of the plant or tree will heal the patient’. Because we harvest for immediate use, we never collect large-scale amounts of any particular resource. We protect biodiversity in other ways, such as guarding against veld fires and discouraging poaching of plants by muti hunters.101

Their customary practices, they underscore, promotes sustainable use of biodiversity that, in turn, supports the flourishing of their traditional knowledge. Yet just as the inextricable linkages present a virtuous relationship, so negative impacts on one or more components of the dynamic can threaten the others. The healers describe the threats posed to their livelihood by limited access to, or loss of, local biodiversity. The numbers of plants are falling due to overharvesting by herbalists or muti hunters who collect large quantities using unsustainable methods. The Mariepskop conservation area is important to us because of the great diversity of plants it sustains but difficult for us to access because we have, until recently, been unsure of the regulations relating to collecting medicinal plants and face  See http://www.naturaljustice.org.  The Biocultural Community Protocol of the Traditional Health Practitioners of Bush­ buckridge is available from Rodney Sibuyi, CEO of the Executive Committee, PO Box 1270, Thulamahashe 1365, Mpumalanga, South Africa, and from “Biocultural Community Protocol of the Traditional Health Practitioners of Bushbuckridge,” accessed 8 June 2012, http://naturaljustice.org/wp-content/uploads/pdf/South_Africa-Bushbuckridge_ Biocultural_Protocol.pdf. 100  Biocultural Community Protocol of the Traditional Health Practitioners of Bushbuckridge, 2. 101  Ibid., 3.   98   99

242   Peter Munyi and Harry Jonas logistical and cost-related barriers to travelling to those areas. We are excluded from the Bushbuckridge Nature Reserve, which is closer to us than Mariepskop but remains totally inaccessible.

They add that ‘private land is off-bounds to us.’102 Turning to the issue of their traditional knowledge, they say We have been visited by scores of researchers who generally provide us with few details of who they are working for and what our knowledge will be used for. We have not yet entered into any benefit-sharing agreements regarding our knowledge or material transfer agreements for the plants they have accessed. This has made us jaded about sharing information with researchers, whom we now distrust. We want our consent to be sought before our knowledge or plants are taken and to be acknowledged as the holders of the knowledge and benefit from any commercialisation.103

Based on their understanding of the law, the healers then decided that the conditions they posed for transferring their traditional knowledge would depend largely on the user. This means that students wishing to become healers will be expected to make arrangements with the local healers to set up a mentorship and can expect to pay a fee. Healers from other areas and academic researchers will be directed to the Executive Committee formed by the healers for due consideration of their proposal. ‘We know our rights’, the healers affirm, and ‘will require to see the letter from the Department of Water and Environmental Affairs stating that [researchers] can conduct the research.’104 Commercial bioprospectors will also be expected to apply to the Executive Committee as the first step in negotiations with the company towards a benefit-sharing agreement, monetary or otherwise. In the protocol, the healers propose working with traditional authorities to regulate access to communal lands by muti hunters to tackle the problem of over-harvesting. They also ask for better access to conservation areas. ‘Now we are clear about the procedures for accessing plants from Mariepskop,’ they say. ‘We want to be recognised by the Department of Agriculture, Forest and Fisheries as both contributing to, and benefiting from, the region’s biodiversity’.105 They also propose working with Department to establish a system that facilitates their access to the resources under its management. They call on the department to ‘explore the establishment of a medicinal plants conservation and development area on Mariepskop to increase the in situ cultivation of the most important medicinal plants.’106  Ibid., 4.  Ibid., 4. 104  Ibid., 5. 105  Ibid., 2. 106  Ibid., 2. 102 103

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Concluding their protocol, the healers appeal to the Biosphere Committee for assistance in evaluating how they could replicate successful communityrun medicinal plant nurseries in the area. They also ask the Mpumalanga Tourism and Parks Agency to set aside some land for the purpose. Similarly, the Department of Health and Social Development is invited ‘to speed up’107 its registration process for healers so that they can carry cards certifying them as traditional health practitioners. The Bushbuckridge Traditional Healers’ ongoing experiences illustrate a number of points about the nature of biocultural community protocols as a community-based response to the many challenges of engaging with ABS. As highlighted in the earlier parts of this chapter, the Bushbuckridge Traditional Healers have international and national rights that were otherwise unknown to them at the local level. The endogenous process of developing the Protocol served as an opportunity for the community to think through a number of interrelated issues and to learn about new legal and policy frameworks according to their own timeframe and in their own context. The process was not driven by outsiders. Learning about the laws that support their ways of life helped the traditional healers develop intra and inter-community awareness and mobilise towards a forward-looking strategy. By articulating their worldviews, concerns and suggested ways forward in the form of a protocol, they have reconstituted the terms of the debate about their local challenges, broadening it to include the inter-linkages between conservation, the medicinal plants trade, local prejudice, and shared traditional knowledge. In this sense, biocultural community protocols enable communities to communicate both a focused response to activities in and around their communities and an integrated and value-laden response to the broader trend towards the legal disaggregation of their ways of life and reification of their traditional knowledge. For the traditional healers, their protocol serves as an interface for constructive dialogue about their values and ways of life with government officials and the private sector in a manner that embodies both the resilience and vulnerabilities of their endemic ways of life. In doing so, they are reclaiming the law to make a strong moral and legal claim to their right to biocultural diversity. While only one of a range of approaches open to communities, community protocols represent a means by which communities can overcome some of the inherent challenges posed by ABS, and to address the asymmetrical power relations present in many community-government, as well as community-private sector interactions. By providing indigenous peoples and local communities a means to set out, for others, the intricacies of the issues at the local level, community protocols are a potentially complementary  Ibid., 6.

107

244   Peter Munyi and Harry Jonas approach for States who want to ‘implement ABS’. States can promote them by enshrining the provisions of the Nagoya Protocol – including on traditional knowledge and awareness raising108 – in national legislation and promoting encouragement by other non-legal forms of recognition.

VIII.  Conclusions This chapter illustrates that ABS contains inherent challenges, some of which transcend the framework and pertain to any community engagement with positive legal systems. It also highlights the fact that while the Nagoya Protocol did not go as far as some indigenous peoples and local communities’ representatives would have hoped, it nevertheless contains a useful number of rights relating to genetic resources and traditional knowledge. In this light, it underscores that the integrity of the implementation of these provisions is contingent on governmental support for communities’ rights and proactive community engagement. Community protocols are one way for communities to adopt such an approach, which entail a participatory process and legal empowerment as two core elements of the instruments’ development. While less attention has been paid to the private sector’s role in successful ABS, the post-Nagoya era of ABS will likely bring much more scrutiny to how companies engage with ABS, either striving for the highest standards or working to circumvent their obligations.109 Fostering trust and understanding as the basis for community-company relationships is crucial and a more active engagement with the science of engendering such interactions is a critical aspect of the current implementation challenges.110 Considering the wealth of genetic resources and associated traditional knowledge, as well as the number of governments who support the implementation of ABS, it is likely that African countries will, over the next few years, provide further experiences that highlight the challenges and opportunities offered to indigenous peoples and local communities under the Nagoya Protocol. Accordingly, any new cases of ABS in Africa should be scrutinised  Nagoya Protocol Articles 12 and 21.  See the following film for an example, Youtube, “Rooibos Robbery: A Story of Bioprospecting in South Africa,” accessed 8 June 2012, http://www.youtube.com/watch?v=GH5JFn-rnA. 110  E.g., the report on “Biocultural Dialogues” by Natural Justice on a series of case studies relating to community-company relations in the context of BioTrade (Natural Justice, UEBT, “Publication on Biocultural Dialogues,” accessed 8 June 2012, http://natural-justice .blogspot.co.uk/2012/05/uebt-publication-on-biocultural.html). [See also contribution by Oliva to this volume (Chapter 12).] 108 109

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and carefully analysed by a variety of stakeholders; they will contain important lessons. These cases will also provide opportunities to ‘audit’ the mechanisms through which ABS will be implemented with a view to determining whether the new set of international ABS norms are being operationlised in ways in which each country’s peculiarities are taken into account.

Chapter 8.  An Asian Developing Country’s View on the Implementation Challenges of the Nagoya Protocol Gurdial Singh Nijar* Biopiracy – the appropriation of genetic resources from a country without its authorisation – and the fact that the expected flow of benefits from the commercial utilisation of genetic resources had not materialised, despite the mandatory requirement for benefit-sharing included in the Convention on Biological Diversity (CBD),1 fuelled the clamour by developing countries for an international regime on access and benefit-sharing (ABS). The call, primarily by mega-diverse developing countries, to stem the leakages of benefits, morphed into a firm resolution by world leaders at the UN World Summit on Sustainable Development in Johannesburg in 2002, that a benefit-sharing regime be put in place under the auspices of the CBD.2 After some tentative starts, and the adoption of the Bonn Guidelines on ABS in 2002,3 a mandate was finally established in 2004 by the Conference of the Parties (COP) to the CBD, to negotiate an international ABS regime.4 The central thrust of developing countries’ endeavours has always been to tackle biopiracy, which results in depriving provider countries of its resources without duly sharing the benefits. The logic is simple: benefit-sharing serves as the incentive and can be the source of the required technological knowhow to conserve and sustainably use biodiversity. In other words, the three * Professor, Law Faculty, University of Malaya, Kuala Lumpur, Malaysia. Director, Centre of Excellence for Biodiversity Law (CEBLAW), Malaysia. Email: [email protected]; [email protected].  1   CBD Article 15.7 read alongside Articles 15.1 and 15.4–5.  2  “Report of the World Summit on Sustainable Development” (2002) UN Doc A/CONF.199/20, Resolution 2: Johannesburg Plan of Implementation, paragraph 44.o.  3  CBD Decision 6/24, “Access and benefit-sharing as related to genetic resources” (27 May 2002) UN Doc UNEP/CBD/COP/6/20.  4  CBD Decision 7/19, “Access and benefit-sharing as related to genetic resources (Article 15)” (13 April 2004) UN Doc UNEP/CBD/COP/DEC/7/19.

248   Gurdial Singh Nijar objectives of the CBD5 are integrally linked. Undermine one and all collapse. According to this logic, an international ABS regime had to put in place effective user measures; that is, countries with users in their jurisdiction, creating products out of genetic resources, had to ensure that these resources were not misappropriated in violation of the provider country’s legal and other requirements. Provider countries could manage compliance for resources accessed and used within such jurisdiction. However, only an international regime could reach users operating outside their jurisdiction. For four years, from 2004 to 2008, negotiations conducted in a Working Group under the CBD, and several other formats, yielded little. Developing and developed countries engaged in a seemingly never-ending waltz: the former insisting on benefit-sharing provisions only; the latter focusing exclusively on measures facilitating access. The final text of the Nagoya Protocol was delivered by the Japanese presidency of the CBD COP 10, in a sumitomo-lock ‘take-it-or-leave-it’ style, on the afternoon of the last day of the two-week COP held in Nagoya in October 2010. It is reported that the draft presented was the result of backroom deals,6 reflecting the negotiating positions of developed countries whilst ignoring those of developing countries.7 Others argue that, at least, a large part of the result of the negotiations was included.8 Whatever the view, undeniably, this is not a Protocol concluded through the usual negotiating process. Nor was it concluded, as suggested, at ‘ministerial informal consultations’.9 It remains  CBD Article 1.  Gurdial Singh Nijar, The Nagoya Protocol on Access and Benefit Sharing of Genetic Resources: An Analysis (Kuala Lumpur: CEBLAW, 2011). 7  Ibid., 32. 8  “Mixed reactions on new access and benefit-sharing treaty,” Third World Network, accessed on 17 May 2012, http://www.twnside.org.sg/title2/resurgence/2010/242-243/cover02.htm. 9  Thomas Greiber and Sonia Moreno, eds., An Explanatory Guide to the Nagoya Protocol on Access and Benefit-sharing: Draft 1.1 for Review (Bonn: International Union for Conservation of Nature (IUCN), 2012), 20. Apparently there was ‘a comprehensive compromise proposal for an ABS Protocol tabled by the COP 10 Presidency suggesting solutions on all unresolved issues’: Matthias Buck and Claire Hamilton, “The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from their Utilisation to the Convention on Biological Diversity,” Review of European Community & International Environmental Law 20 (2011): 50. This fact was not known to most developing countries which were active in the negotiations. When was it tabled? To whom? Who crafted the ‘comprehensive compromise proposal’? In fact the Like-minded Mega-diverse Countries (LMMC) and the like-minded Asia Pacific Group were handed a note late on 28th October, asking them to ‘come to the Presidency’s room for the handover of the final draft text of the ABS Protocol at 8.40. 29 October’: see further, Nijar, The Nagoya Protocol on Access and Benefit Sharing of Genetic Resources: An Analysis, 4. It is also inapposite to describe the final meeting by the Presidency as ‘a meeting with Ministers behind closed doors’ (Buck and Hamilton, “The Nagoya Protocol,” 50) as a 5 6

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a blot on the international multilateral rule-making process. From a developing country’s view, the effective implementation of the Protocol depends on a more inclusive and balanced interpretation of its final text, which can be achieved through the adoption of decisions by its governing body, the COP to the CBD acting as the Meeting of the Parties to the Nagoya Protocol (COP/MOP), which is explicitly mandated to keep under regular review the implementation of the Protocol and, to that end, must make decisions necessary to promote its effective implementation.10 In addition, Parties must implement the Protocol through national – administrative, legislative or policy – measures. The challenges are many and they are exacerbated by the negotiating history of the Protocol and the complexity of the subject matter. This chapter highlights a few of the more important challenges relating to the scope of the Protocol (derivatives), access and compliance, as well as several issues related to traditional knowledge (publicly available traditional knowledge, traditional knowledge accessed from various sources, traditional knowledge held by more than one community, and specificities of the prior informed consent of indigenous and local communities). The chapter also explores specific challenges related to the implementation of the Protocol in federal systems. It concludes by mapping the way forward, both in terms of developing national legislation and adopting COP/MOP decisions,11 offering potential solutions to key implementation challenges deriving from the final formulation of the Protocol, from a developing country’s perspective. To illustrate these challenges, Malaysia (which led the Like-minded Asia-Pacific Group in the negotiations) will be referred to as a case study.

I.  Implementation Challenges Related to the Protocol Wording This section will review several provisions of the Nagoya Protocol that may be challenging to implement from an Asian developing country perspective. The negotiating positions of the Like-minded Asia-Pacific Group will be discussed to shed light on developing countries’ understanding of the ABS significant number of ministers from developing countries were not informed of the meeting and consequently did not attend. 10  On the basis of the process embedded in Article 26.4 and Article 31 of the Nagoya Protocol. A comprehensive set of proposals as to the decisions that developing countries should pursue through the COP, as well as through national law, are set out in Gurdial Singh Nijar, The Nagoya Protocol on Access and Benefit Sharing of Genetic Resources: Analysis and Implementation Options for Developing Countries (Geneva: South Centre, 2011). 11  [On the need for international support for national implementation, see also contribution by Young to this volume (Chapter 15).]

250   Gurdial Singh Nijar issues and their position vis-à-vis the final text of the Protocol, with a view to explaining current implementation challenges. 1.  Derivatives and Access After rancorous and intense negotiations, it was finally agreed to include derivatives of genetic resources within the scope of the Protocol. According to the agreed definition, a derivative is a ‘naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity’,12 referring for instance to genetic resource extracts. The requirement for benefit-sharing from the use of derivatives was a major priority for developing countries – a demand consistently rejected by the developed world. To break the deadlock, a convoluted formula was adopted: the word ‘derivative’ is not used in the Protocol’s substantive provisions as per the developed world’s preference; rather, the expression ‘utilisation of genetic resources’ is used, which is defined as ‘to conduct research and development on the genetic and/or biochemical composition of genetic resources . . .’13 The term ‘utilisation of genetic resources’ appears verbatim in the provisions relating to benefit-sharing14 and monitoring to support compliance.15 However, a problem arises because the term is not used in precisely this formulation in the access provision of the Protocol.16 At one of the last negotiating sessions, it was agreed that the term would be used with its grammatical variations depending on the context.17 An open question is whether it applies to stand-alone derivatives; that is, extracts including metabolites from genetic resources, which no longer contain functional units of heredity and hence cannot be reproduced, such as gums, resins and snake venom. In other words, the issue at stake is whether access to derivatives, independently of the genetic resource, is subject to prior informed consent (PIC) and mutually agreed terms (MAT) on benefit-sharing, which are the twin fundamental requirements for access under the Protocol. This was, and remains, a contentious issue. Developing countries, as providers, are of the view that derivatives are the material industry seeks almost exclusively for their immense commercial value. A drug for instance can be developed from a genetic resource extract – a derivative, which can be accessed independently of the genetic resource. For example, a Japanese company can (and routinely does)  Nagoya Protocol Article 2.e.  Nagoya Protocol Article 2.c. 14  Nagoya Protocol Article 5 15  Nagoya Protocol Article 17. 16  Nagoya Protocol Article 6. 17  Meeting of the Interregional Negotiating Group, Montreal, 18–21 September 2010. 12 13

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engage a local Malaysian researcher to extract metabolites and active biochemical compounds and ship them to Japan for research and development. The Malaysian researcher would require PIC and MAT. From a developed country’s perspective, the Japanese will be exempt from seeking the PIC from Malaysia. Reaching the Japanese through an agreement (MAT) with the local researcher may be fraught with its own problems, as Malaysia would not be privy to the agreement between the Japanese and the Malaysian researcher. In any event, the Protocol is the instrument that should deal directly with, and resolve, such situations. The person who conducts research and development, and benefits as a result of this utilisation, should be the frontline party to the PIC and MAT. To resolve this issue, Malaysia could provide in its national law for PIC for access to such derivatives; this, in turn, could be ‘caught’ by the provisions of the Protocol, which require compliance with the domestic or other regulatory requirements of the provider country.18 However, it could be argued that such a law lies outside the scope of the Protocol; a user country could contend that the obligatory compliance measures required by the Protocol only cover matters within its scope. This relates back to the fundamental issue: whether Parties to the Protocol agree that stand-alone derivatives are covered. It is, therefore, crucial that competing interpretations be discussed and resolved. Although it may require reopening an old debate, such discussions are critical in order to deal with the biopiracy concerns that propelled the Protocol’s negotiation in the first place and allow effective implementation at the national level. 2.  ‘Fair and Non-arbitrary’ Access Another provision that may create difficulties for Asian developing countries provides that Parties’ PIC-related measures include ‘fair and non-arbitrary’ rules and procedures on accessing genetic resources.19 The provision was initially opposed by developing countries, along with a proposal by Canada referring to ‘non-discriminatory’ access. Developing countries argued that such provisions could be interpreted in the light of the requirements under the law of the World Trade Organisation (WTO)20 for national treatment and most favored nation treatment. However, a need could arise for developing countries to favor their nationals in access applications, especially researchers, for development purposes. The Europeans explained that the requirement for ‘fair and non-arbitrary’ rules and procedures on access refers to  Nagoya Protocol Article 15.  Nagoya Protocol Article 6.3.a and b. 20  [For a discussion of the relevance of WTO law in the context of the Nagoya Protocol, see contribution by Pavoni to this volume (Chapter 6).] 18 19

252   Gurdial Singh Nijar procedural requirements and does not extend to the WTO’s trade requirements, and developing countries accepted the reference on this understanding. The negotiating history, therefore, shows beyond doubt that the WTO’s twin requirements relating to ‘non-discrimination’ were rejected, including by the proposers of the provision. The ordinary meaning of the term also clearly supports this interpretation. If it is suggested that the term supports also the extended meaning, this ambiguity may be resolved by recourse to the preparatory work of the treaty and the circumstances of its conclusion in interpreting this provision, in accordance with Article 32 of the Vienna Convention on the Law of Treaties. It would, therefore, be inappropriate to suggest that ‘fair’ means ‘non-discriminatory’ according to WTO rules.21 In any event, provisions in, and/or interpretations of, other international instruments cannot trump the Protocol.22 Developing countries can thus maintain flexibility in their ABS law for measures that are not inimical to their national interest. 3.  Compliance Two provisions on compliance may create difficulties in implementation for Asian developing countries, namely those on monitoring and on measures on compliance with the national law of provider countries, which will be discussed in turn below. a.  Monitoring: Disclosure Requirements During the Protocol negotiations, developing countries recommended requiring, whenever a product was developed from a genetic/biological resource, mandatory disclosure of the country of origin of the resource, the PIC of the country and MAT, including adherence to its terms. Such disclosure should be required at critical junctures of the product development and commercialisation process. The cumulative thrust of these proposals was for mandatory disclosure of relevant information at appropriate checkpoints, including:  Thomas Greiber and Sonia Moreno, eds., An Explanatory Guide to the Nagoya Protocol on Access and Benefit-sharing, Draft 1.0 for Review, (Bonn: IUCN, 2011), 126. The latest draft (Greiber and Moreno, An Explanatory Guide to the Nagoya Protocol, Draft 1.1 for Review) has modified the approach somewhat. It states (Ibid., 103) ‘Deducing the term’s meaning from the negotiations’ text (UNEP/CBD/WG-ABS/9/ING/1), ‘fair’ has to do with the treatment the providing Party accords to different Parties that request access to its genetic resources’. While it still asserts the trade rules that ‘it is required that equal treatment in applications for access to genetic resources is accorded to similar domestic and foreign applicants and to similar foreign applicants of different Parties’, it has softened its approach and envisages that Parties may discriminate in favour of ‘advancing local, non-commercial biodiversity and ecosystem research and education’. 22  Nagoya Protocol Article 4.1. 21

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patent offices, product marketing or registration authorities and public funding agencies. These were also the checkpoints proposed by an expert meeting set up by the CBD COP.23 On the contrary, developed countries were ‘allergic’, as one delegate remarked, to the words ‘disclosure’ or ‘patent’.24 They also vehemently opposed the naming of any checkpoints, even indicatively. The challenge for developing countries then was to ensure that the Protocol would nonetheless provide for mandatory disclosure requirements for PIC and MAT, at existing bodies or institutions where such information could be required. Eventually, the Protocol obliges Parties to require users to provide the information on PIC and MAT,25 while it refers to checkpoints in functional terms – implying those points where the user would have to seek funding for research, or claim for a patent or for product registration. The result is an awkwardly-phrased and convoluted description that ‘Checkpoints must be effective . . . and relevant to the utilisation of genetic resources, or to the collection of relevant information at, inter alia, any stage of research, development, innovation, pre-commercialisation or commercialisation’.26 The intent is clear, and it is supported by recourse to the negotiating history. However, it is already argued by some of the main protagonists of the negotiations that there is no mandatory disclosure requirement and the criteria for checkpoints do not include disclosure.27 Now this lies at the nub of implementation – and perhaps even ratification – of the Protocol. Without effective ‘visible’ user measures, what is the incentive for developing countries to commit to the generalised (some argue,  CBD Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing, “Report of the meeting of the Group of Technical Experts on an Internationally Recognised Certificate of Origin/Source/Legal Provenance,” (20 February 2007) UN Doc UNEP/CBD/WGABS/5/7. 24  Gurdial Singh Nijar and Pei Fern Gan, The Nagoya ABS Protocol: A Record of the Negotiations, (Kuala Lumpur: CEBLAW, 2012), 331. Developed country negotiators now say that the LMMC was using the benefit-sharing obligations under CBD Article 15.7 to increase their negotiating leverage in other international fora such as the WTO, the World Intellectual Property Organisation (WIPO), the World Health Organisation (WHO), etc.: Buck and Hamilton, “The Nagoya Protocol,” 49. This is a strange assertion. First, it was logical and entirely appropriate for the LMMC to require mandatory disclosure requirements at the most effective checkpoints, one of which was identified as patent offices. Secondly, this was one of the checkpoints identified by the Group of Technical Experts established by COP 8 to inform the negotiating process (see UNEP/CBD/WG-ABS/5/7). Finally, developed countries were responsible for seeking to establish special rules relating to matters being discussed and, as yet, then unresolved in other fora such as the WHO. [On the latter point, see contribution by Wilke to this volume (Chapter 4).] 25  Nagoya Protocol Article 17.1.a.ii read alongside Article 17.1.a.i. 26  Nagoya Protocol Article 17.1.a.iv. 27  Buck and Hamilton, “The Nagoya Protocol,” 54. 23

254   Gurdial Singh Nijar rather vacuous) provisions of the Protocol, which include, however, elaborate and detailed, access requirements? Developing countries had proposed as a compromise that if no checkpoints were listed, Parties should establish effective criteria for checkpoints and notify the CBD Secretariat within a timeframe of their proposed checkpoint(s).28 Although this proposal was rejected during the negotiations,29 a decision along these lines by the Nagoya Protocol governing body (or the interim body laying the ground for its entry into force – the Intergovernmental Committee for the Protocol )30 could instill confidence in developing countries and pave the way for a greater number of ratifications. b.  Compliance Measures Contingent on National Law? A difficulty for developing countries lies in the interpretation of the Protocol to the effect that compliance measures by user countries are contingent upon the enactment of a law requiring PIC and MAT by the provider country. Developed countries argued that this requirement is needed to ensure awareness of the provider country’s legislation and related violations. While this may be a valid argument, it is well-known that the development of ABS laws in developing (and even developed) countries has been slow. Not all CBD Parties have national ABS laws, and others prefer to adopt administrative measures.31 Indeed, the Nagoya Protocol recognises the lack of capacity among developing, least developed and small island developing countries, to develop national ABS laws.32 Unlike the Protocol, the CBD includes no precondition that the requirements of PIC and MAT are to be fulfilled through a law or regulatory requirement. The Nagoya Protocol requires, more specifically, the adoption of ‘necessary legislative, administrative or policy measures.’33 A policy or administrative declaration or directive could therefore suffice, and awareness could easily be ensured by using existing mechanisms such as the international ABS clearing-house.34  Nijar and Gan, Nagoya Protocol, 319.  Nijar and Gan, Nagoya Protocol, 324. 30  This body was created through CBD Decision 10/1, “Access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation” (29 October 2010) UN Doc UNEP/CBD/COP/DEC/10/1, paragraphs 7–20. 31  As of February 2012, the CBD database on ABS measures listed 55 countries that had some legislation or regulations on ABS. Many of these laws, especially in developing countries, have yet to be fully operationalised. See Database on ABS Measures, accessed 15 February 2012, http://www.cbd.int/abs/measures/. 32  CBD Article 22. 33  Nagoya Protocol Article 6.3. 34  Nagoya Protocol Article 14. 28 29

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4.  Traditional Knowledge Associated with Genetic Resources The Group of Technical and Legal Experts on Traditional Knowledge Associated with Genetic Resources set up to inform the Protocol negotiations, concluded that a large part of the genetic resources sought by industry and researchers was because of their use-value indicated by traditional knowledge.35 The traditional knowledge-related provisions of the Protocol present a series of implementation challenges for Asian developing countries. Right from the outset of the negotiations of the Nagoya Protocol, developing countries approached genetic resources and traditional knowledge as inextricably linked. Most biopiracy cases, which provided the impetus for the development of an international ABS regime, involved traditional knowledge associated with genetic resources. Hence, during the initial stage of the negotiations, the term ‘associated traditional knowledge’ was invariably tagged to ‘genetic resources’,36 to underline their integral link. For the same reason, developing countries insisted that traditional knowledge should be dealt with as a cross-cutting issue and addressed in all the provisions relating to access, benefit-sharing, compliance and capacity building. However, in the final text of the Protocol, this important link and emphasis are missing, except in relation to benefit-sharing37 and compliance with domestic law, in the case such law on traditional knowledge is established.38 The provision on access to traditional knowledge associated with genetic resources is heavily qualified.39 In addition, the establishment of a global multilateral benefit-sharing mechanism to address benefit-sharing for transboundary traditional knowledge or for which it is not possible to grant or obtain PIC is contingent upon Parties first establishing the ‘need’ for such a mechanism.40 Situations where the same traditional knowledge is shared by indigenous and local communities in several Parties merely requires some best-effort cooperative endeavours to ‘implement the objectives of the Protocol’.41 Only two preambular paragraphs address explicitly the integral link between genetic resources and traditional knowledge: one underlining the ‘inseparable nature’ for indigenous and local communities of associated traditional knowledge to genetic  CBD Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing, “Report of the Meeting of the Group of Technical and Legal Experts on Traditional Knowledge Associated with Genetic Resources in the Context of the International Regime on Access and BenefitSharing,” (15 July 2009) UN Doc UNEP/CBD/WG-ABS/8/2. Traditional knowledge often provides the lead to genetic resources and potential properties (Ibid., 8, paragraph 13). 36  Nijar and Gan, Nagoya Protocol, 401. 37  Nagoya Protocol Article 5.5. 38  Nagoya Protocol Article 16. 39  Nagoya Protocol Article 7. 40  Nagoya Protocol Article 10. 41  Nagoya Protocol Article 11.2. 35

256   Gurdial Singh Nijar resources and another affirming that nothing in the Protocol must be construed as diminishing or extinguishing the existing rights of indigenous and local communities.42 The Protocol provision on access to traditional knowledge43 (leaving aside the purport of the qualifier ‘in accordance with domestic law’) is founded on the premise that indigenous and local communities have exclusive right to their traditional knowledge. For this reason, the provision requires that their PIC must be obtained for any access, in accordance with communities’ customary laws, community protocols and procedures where they exist.44 Where they do not, Parties are required to support efforts to develop them.45 Several difficult questions arise in relation to traditional knowledge under the Protocol, however, which remain open, as discussed below. a.  PIC and MAT of Indigenous and Local Communities There is a clear and unqualified obligation of Parties to take measures to share benefits arising from the utilisation of traditional knowledge fairly and equitably,46 with conspicuous omission of the otherwise ubiquitous qualifier – ‘in accordance with domestic legislation’. Nor is the provision diluted by requiring Parties to do so ‘with the aim of ensuring that benefits . . . are shared’ as is the case for genetic resources held by indigenous and local communities.47 This clear requirement for benefit-sharing must be done through MAT. MAT would subsume and signify PIC, as mutual agreement would not conclude unless PIC was forthcoming. Unlike the Protocol provision on benefit-sharing from traditional knowledge, the provision on access to traditional knowledge48 has both the above-mentioned qualifiers. This contradiction needs to be clarified. Some may assert that the two provisions are reconciled by the fact that the Nagoya Protocol only obliges Parties to share benefits through MAT.49 The State, through its competent national authority, could theoretically negotiate and conclude MAT incorporating benefitsharing, without the involvement of indigenous and local communities. This interpretation, however, should be dismissed, especially in the context of the preambular paragraphs of the Protocol which note the existence of the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP) and affirm that ‘nothing in this Protocol shall be construed as diminishing  Nagoya Protocol preambular paragraphs 22 and 27 (author’s numbering).  Nagoya Protocol Article 7. 44  Nagoya Protocol Article 12.1. 45  Nagoya Protocol Article 12.3 46  Nagoya Protocol Article 5.5. 47  Nagoya Protocol Article 5.2. 48  Nagoya Protocol Article 7. 49  Nagoya Protocol Article 5.5. 42 43

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or extinguishing the existing rights of indigenous and local communities’.50 UNDRIP, which has received universal endorsement,51 declares the rights of indigenous peoples to their traditional knowledge associated with genetic resources.52 Countries that have endorsed it have created a legitimate expectation that their administrative governance structures will not act in violation of those rights.53 In addition, the report of the Technical Expert Group Meeting on Traditional Knowledge makes clear that the right of indigenous and local communities to PIC may have acquired the status of customary international law.54 The Protocol further requires Parties, when implementing the Protocol, to take into consideration indigenous and local communities’ customary laws, community protocols and procedures with regard to traditional knowledge.55 Clearly this is a critical implementation issue that needs consideration and clarification by Parties through a COP/MOP decision.56 b.  Mode of Obtaining PIC Parties to the Nagoya Protocol need to establish a clear process for obtaining the PIC of indigenous and local communities with respect to their traditional knowledge. This is a formidable task, both in defining the time when PIC is required and identifying the way in which it can be secured. A solution, particularly for developing countries, would be to prescribe the process through law or regulations, keeping in mind the following preeminent factors: •  where communities’ customary laws, protocols, and procedures exist, then these should be followed;

 Nagoya Protocol two final preambular paragraphs.  The last two remaining countries that had voted against the adoption of UNDRIP in 2009, the USA and Canada, announced their approval in 2010 (Newsletter of the Secretariat of the Permanent Forum on Indigenous Issues, accessed 2 March 2011, http://www.un.org/ esa/socdev/unpfii/documents/MS_Dec_2010.pdf). 52  United Nations General Assembly “United Nations Declaration on the Rights of Indigenous Peoples,” (13 September 2007) UN Doc A/RES/61/295 (UNDRIP), Article 31. 53  Minister of Immigration & Ethnic Affairs v Teoh (1995) 183 CLR 273; and Mabo v Queensland (No 2) (1992) 175 CLR 1, 42. 54  UNEP/CBD/WG-ABS/8/2, para. 63. Gurdial Singh Nijar, “Incorporating Traditional Knowledge in an International Regime on Access to Genetic Resources and Benefit Sharing: Problems and Prospects,” European Journal of International Law 21 (2010): 461. 55  Nagoya Protocol Article 12.1. 56  Several, including developing, countries proposed making the provision ‘subject to’ domestic law. The softer ‘in accordance with’ was proposed and the objecting countries deemed this to mean the same as the former expression. After all, if it prescribed merely a mode of fulfilling the obligation, then the expression would be superfluous as the measures that they were to fulfill would have, in any event, to be accomplished through domestic law. 50 51

258   Gurdial Singh Nijar •  where none of these exist, new procedures should be established after consultation with communities, their representatives and leaders; •  existing leaders should, as a rule, be the conduit for securing the PIC of indigenous and local communities. Where none exist, then indigenous and local communities should be encouraged to establish representatives through a consultative process; and •  in situations where this cannot be accomplished, then only as a last and interim resort, the State acts on behalf of indigenous and local communities in a facilitative role, until a process is initiated and produces an indigenous or local community representative and/or a leader. In considering PIC, traditional knowledge must be viewed holistically. It must be recognised replete with its rituals, and sacred and spiritual values as attached to religious and other ceremonial functions through traditional or customary practices.57 The Technical Expert Group on Traditional Knowledge noted that traditional knowledge is always related to the cultural context in which it is developed. This implies the inclusion of all the above facets.58 Several obstacles may be anticipated to the operationalisation of the processes stated above. Developing countries have different approaches to traditional knowledge and the rights of indigenous and local communities. Some consider that its entire populace consists of indigenous and local communities.59 Hence the PIC from them as a distinct and identifiable entity does not apply. Others view indigenous and local communities as a distinct but integral part of the populace. Hence they should be subject to the normal law of the land, and abide by that. That law may, or may not, provide for ameliorative measures designed to deal with distinct minorities. Hence the rights are to be founded in, and accorded by, domestic law.60 Yet others view indigenous and local communities as holding special and distinct rights that must be respected and reinforced, where necessary, by domestic laws. Only in this last case will their rights be fully respected on the basis that they are autonomous entities located within the geographical boundaries of a Party.

 Gurdial Singh Nijar, In Defence of Local Community Knowledge and Biodiversity: A conceptual framework and the essential elements of a rights regime (Penang: Third World Network, 1996), 33. 58  UNEP/CBD/WG-ABS/8/2, paragraph 33. 59  This is the approach of the countries constituting the African group. 60  India’s domestic law, for example, requires the competent authority to consult with the concerned local body when considering and making a decision on an access application for genetic resources and associated traditional knowledge: Biodiversity Rules, 2004. Rule 14.3. The Rules have been made pursuant to India’s Biological Diversity Act, 2003. 57

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The domestic law’s role then would be to guarantee this autonomous status.61 For as long as this debate is unresolved at the national level, different interpretations, especially as regards the access-related provisions in the Protocol, are expected to persist. c.  Publicly Available and Diffused Traditional Knowledge The Group of Technical and Legal Experts on Traditional Knowledge argued that publicly available traditional knowledge must be subject to PIC and benefit-sharing through MAT. There is no exception to the obligation to seek access from indigenous and local communities to their traditional knowledge following PIC and in accordance with MAT. In particular, the CBD and the Protocol provide for no exception with regard to traditional knowledge that is in the ‘public domain’62 and, as a result, users seeking access to such knowledge must obtain PIC and MAT of indigenous and local communities. For every such access, there must be benefit-sharing.63 In addition, the provision sets no time limit, meaning that PIC and MAT would be needed regardless of the time of utilisation of traditional knowledge.64 This makes clear that concepts applicable to the conventional system of intellectual property rights (IPRs) do not apply to traditional knowledge. According to IPR law, knowledge in the public domain would not qualify as a ‘novel’ invention and could not be protected by IPRs. In addition, IPRs last for a given period of time after which the invention can be used without restriction. Legally, therefore, there appears to be no basis to qualify the clear provisions of the Protocol by a ‘mediate interpretation’ which envisages that only for some kinds of traditional knowledge, the access provisions would  As an example, the Sabah Biodiversity Enactment, No. 7, 2000, establishes a Biodiversity Centre with the purpose of, inter alia, ‘establishing or caused to be established a system for the protection of biological resources so that the indigenous and local communities shall, at all times and in perpetuity, be the legitimate creators, users and custodians of such knowledge, and shall collectively benefit from the use of such knowledge’ (section 9.1.j). 62  ‘Public domain’ is a concept that relates to one element for the grant of a patent, namely novelty or prior art. This expression appears in the International Treaty on Plant Genetic Resources for Food and Agriculture (International Treaty) which deals with access and benefit-sharing of specified plant genetic resources for food and agriculture. The Treaty excludes crops from the multilateral system of exchange crops that are not in the ‘public domain’ by an explicit provision: Article 11.2. It is commonly agreed that this expression ‘public domain’ refers to materials which are not protected by intellectual property rights (IPRs) (Gerald Moore and Witold Tymowski, Explanantory Guide to the International Treaty on Plant Genetic Resources for Food and Agriculture (Bonn: IUCN, 2005), 84. 63  Nagoya Protocol Article 5.5. 64  Nagoya Protocol Article 5.5 (if traditional knowledge is utilised then benefit sharing must ensue) and Article 7 (Parties’ measures relate to requiring PIC and MAT for traditional knowledge held by indigenous and local communities). 61

260   Gurdial Singh Nijar apply, while for the rest only the benefit-sharing provisions would apply.65 The Protocol already envisages dealing with such practical problems such as in cases where it is not possible to grant or obtain PIC.66 The fact that no patent can be claimed for a use widely known in the public domain does not exempt the person utilising the resource from sharing the benefits with the particular indigenous and local community.67 This conclusion was opposed by developed countries and industry.68 In the case of diffused traditional knowledge, where no community could be identified as the knowledge holder, developing countries proposed that the state could serve as custodian of its communities: the State would provide PIC; negotiate the benefits and hold them in trust for the communities; and use them for promoting, enhancing and protecting traditional knowledge.69 Developed countries resisted all these proposals, some arguing that CBD Article 8(j) only authorised indigenous and local communities, and not States, to be holders

 Greiber and Moreno, An Explanatory Guide, IUCN, 114.  Nagoya Protocol Article 10. 67  Greiber and Moreno, An Explanatory Guide, 113: ‘The Nagoya Protocol hence awards indigenous and local communities the right to grant access not only with regard to traditional knowledge still within their imminent control, but also with regard to such knowledge already publically (sic) available, or, to use intellectual property rights parlance, in the public domain.’ The authors refer to this position of the Protocol as a ‘paradigm shift in how we view the intellectual property rights system’. They question whether such a dramatic shift was intended, as well as whether it will be accepted. (Ibid., 113). The Report of the Group of Technical and Legal Experts reads as follows: ‘Furthermore, the experts recognised a critical distinction between traditional knowledge associated with genetic resources being in the ‘public domain’ versus being ‘publicly available’. It was pointed out that the term public domain, which is used to indicate free availability, has been taken out of context and applied to traditional knowledge associated with genetic resources that is publicly available. The common understanding of publicly available does not mean available for free. The common understanding of public availability could mean that there is a condition to impose mutually agreed terms such as paying for access. Traditional knowledge has often been judged to be in the public domain and hence freely available once it has been accessed and removed from its particular cultural context and disseminated. But it cannot be assumed that traditional knowledge associated with genetic resources that has been made available publicly does not belong to somebody. Within the concept of public availability, prior informed consent from a traditional knowledge holder that is identifiable, could still be required, as well as provisions of benefit-sharing made applicable including when a change in use is discernible from any earlier prior informed consent provided. When a holder is not identifiable, beneficiaries could still be decided for example by the state. The experts also felt that the phrase public domain in the context of traditional knowledge needs to be more correctly re-phrased as publicly available. One expert did not agree with this distinction.’ (emphasis added): UNEP/CBD/WG-ABS/8/2, paragraph 122. 68  Nijar and Gan, Nagoya Protocol, 409, 437. 69   Ibid., 421, 422. 65 66

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of traditional knowledge,70 and precluded them from serving as custodians or trustees. The proposals were not included in the Presidency’s draft of the Protocol that was eventually adopted. As a result, it appears that traditional knowledge that is publicly available and/or diffused can be accessed without PIC and MAT – a serious lacuna in the Nagoya Protocol that promotes, rather than controls, biopiracy. Can this be addressed by national law? The Protocol does oblige Parties to take user measures to ensure that traditional knowledge associated with genetic resources has been accessed in conformity with the domestic law of the Party where the indigenous and local community holding the traditional knowledge is located. This, if accepted, would only address the problem relating to publicly available traditional knowledge, but not the case of diffused traditional knowledge, that is, traditional knowledge that is so widespread that it is not possible to attribute ownership to any one or more communities. The issue is compounded by the fact that the monitoring measures to support compliance eschew reference to traditional knowledge.71 This arguably means that established checkpoints are not required to collect information on whether traditional knowledge was accessed and whether or not the PIC of the community in question was secured and MAT were developed, thereby rendering otiose the requirement for user measures for traditional knowledge.72 Such shortfalls need to be remedied, as much of the biopiracy cases involve access to publicly available traditional knowledge. The experience of India’s Traditional Knowledge Digital Library suggests that the revoked patents related to publicly available traditional knowledge, recorded in the scriptures and other ancient documents. By making available to patent examiners in the US Patent Office and the European Patent Office – on a contractual basis – the traditional knowledge of its indigenous and local communities, India aims to inform the examiner whether or not the claim in question relates to pre-existing traditional knowledge. The examiner is then obliged to reject the application on the ground of its lack of novelty. However, preventing the granting of patents on traditional knowledge does not imply that India waives its right to secure benefits from the utilisation of the traditional knowledge. This clearly does not follow – a classic non-sequitur. To provide another example, Peru’s Law provides a formula for the payment into a Fund of a percentage of profits arising from the commercialisation of collective

  Ibid., 428.  Nagoya Protocol Article 17 refers only to monitoring the utilisation of genetic resources. The definition of this expression refers only to genetic resources and derivatives, not to traditional knowledge (Nagoya Protocol Article 2.c). 72  Nagoya Protocol Article 16. 70 71

262   Gurdial Singh Nijar knowledge of indigenous and local communities that has entered the public domain in the last 20 years.73 A solution as regards publicly available traditional knowledge may lie in an expansive reading of the Protocol provision on access to traditional knowledge.74 It suggests that PIC is required for all traditional knowledge associated with genetic resources held by indigenous and local communities. This would include publicly available traditional knowledge where holders are ascertainable and known. It does not, however, solve the problem as regards diffused traditional knowledge where holders cannot be identified. In this case, there are practical implementation problems. Who gives this PIC? When is it to be given – especially since the traditional knowledge may have been accessed prior to the entry into force of the Protocol, or even of the CBD? These practical problems would persist even for continued or new uses of traditional knowledge. A way to resolve this may be to dispense with PIC, and require the person wishing to utilise the traditional knowledge to enter into a benefit-sharing agreement through MAT. This, however, assumes that the holders can be identified. This was the solution of choice in the now famous Hoodia case: The San peoples’ traditional knowledge was being utilised for a commercial purpose and became the subject matter of an agreement between a State body – South Africa’s Council for Scientific and Industrial Research – and a commercial entity. The San tribes were spread across jurisdictions and their PIC was never sought. The matter was resolved when the San tribes formed a Council, foregoing PIC and negotiating a benefit-sharing agreement.75 The MAT subsumed and signified the PIC of the holders. This solution disconnects access from MAT and should be restricted to genuine cases of access to traditional knowledge when no ‘prior’ informed consent could be secured. In Brazil, the PIC obtained from three Kraho communities was challenged by other Kraho communities and the research had to stop. Brazil’s Provisional Act 2186-16/2001 included no mechanisms to resolve the problem.76 The Protocol only addresses cases where the traditional knowledge is shared by several communities in several Parties. Guidance by the COP/MOP may be desirable to facilitate implementation.  Law 27.811 of Peru (2002). Ley que Establece el Régimen de Protección de los Conocimientos Colectivos de los Pueblos Indígenas Vinculados a los Recursos Biológicos. See also J. Santilli, Agrobiodiversity and the Law: Regulating Genetic Resources, Food Security and Cultural Diversity (New York: Routledge, 2012), 189. 74  Nagoya Protocol Article 7. 75  For a full account, see Rachel Wynberg, Doris Schroeder and Roger Chennells, eds., Indigenous Peoples, Consent and Benefit Sharing: Lessons from the San-Hoodia Case (New York: Springer, 2009). [See also contribution by Munyi and Jonas to this volume (Chapter 7).] 76  J. Santilli, Agrobiodiversity and the Law, 180. [See also contribution by Lago to this volume (Chapter 10).] 73

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Some commentators propose the creation of collective mechanisms such as national benefit-sharing funds which could then be used to finance conservation and sustainable use activities of indigenous and local communities, to fulfill the exhortation in Article 9 of the Protocol.77 The Protocol provisions need clarification to ensure that user measures will be applied to the use of publicly available traditional knowledge associated to genetic resources. This could well result in additional ratifications, especially by provider developing countries.78 Parties developing ABS laws may also resort to include provisions denying access to those countries not providing for such user measures.79 d.  Traditional Knowledge Accessed from Various Sources Complex issues arise when traditional knowledge is accessed indirectly, from publications or ex situ collections, such as the botanical gardens or national genebanks. The Protocol’s applicability is not limited to traditional knowledge that is accessed within the geographical jurisdiction of a provider country or from the wild. Nor should there be such a limitation, as a matter of principle. To provide an example, the Kew Gardens helped in the collection of some 2000 species of plant genetic resources from the oldest rainforest in the world, located at Mount Kinabalu in Sabah, Malaysia. The collections from the Kinabalu Project are also housed at the Kew Gardens in London. Insofar as their use is informed by traditional knowledge, the PIC and MAT requirements of the Protocol should apply; the same should apply for access to genetic resources generally. If ‘prior’ informed consent is not possible for practical reasons, at the very least the benefit-sharing provisions should apply. The Protocol foresees the establishment of a global multilateral fund to deal with situations when it is not possible to grant or obtain PIC, providing a possible solution.80 Could the relationship clause81 provide a solution, on the assumption that Kew Gardens may be considered an international organisation? The provision bristles with contentious issues and is, therefore, unlikely to help clarify the point.

 J. Santilli, Agrobiodiversity and the Law, 169–170.  At least a key megadiverse country has indicated that it is unlikely to sign and/or ratify the Protocol absent such a provision (personal communication with author, September 2011). 79  A typical provision being contemplated by the national ABS law by a Party to the CBD reads as follows: ‘The competent authority may refuse access to biological resources where the applicant is from, or otherwise based or operating in, jurisdictions which do not have adequate and effective measures to address situations of non-compliance with this Act.’ 80  Nagoya Protocol Article 10. 81  Nagoya Protocol Article 4.3. 77 78

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II.  Another Implementation Issue: Federal versus State Power Distribution Additional implementation problems are posed by federalism.82 Typically, powers are distributed through lists: a list where the state has exclusive jurisdiction, a list where the federal government has exclusive jurisdiction and a concurrent list of areas on which both the federal and the state governments may legislate. In addition, other specific provisions allow the federal government to legislate in respect of matters in the state list, for example to implement a treaty or international obligation, or to harmonise laws between two or more states. Land, including biological or genetic resources, is usually within a state’s exclusive jurisdiction, and an important contributor to the state’s revenues. Agreeing on a national ABS law with states/provinces is often a laborious and time-consuming task, which involves completing the necessary stakeholders’ consultations, securing any relevant consent and resolving implementation problems. This implies that countries may be without national ABS laws for a period of time, during which countries with users in their jurisdiction do not need to enforce compliance measures. This means that user countries would take no action in respect of genetic resources accessed without the consent of the provider country. However, this would result in violation of the CBD provisions, which stipulate unambiguously that countries determine conditions for access to their biological/genetic resources and access is subject to the PIC of the Party providing the resources83 and, where granted, is conditional upon reaching MAT.84 Malaysia’s Constitution, for instance, is based on a federal system. Land is the exclusive preserve of the state. Two states that house the world’s oldest Borneo rainforest of 150 million years – Sabah and Sarawak – have enacted their own biodiversity and ABS laws.85 The Federal Government’s efforts to promulgate a national ABS law, which started in the early 1990s, have been plagued by a state versus federal standoff. There is now a fresh attempt to enact a national ABS law and Malaysia, as other federal countries, must overcome these problems if it is to ratify the ABS Protocol. Potential solutions could include the following.  Only 24 of the countries in the world have federal systems. However their citizens make up 40 percent of the population. Federal states include: Brazil, India, Canada, Australia, the US, Mexico, Argentina, and Malaysia: Santilli, Agrobiodiversity and the Law, 194. 83  CBD Article 15.5. 84  CBD Article 15.4. 85  Sabah (Malaysia), Biodiversity Enactment, No. 7, 2000; Sarawak (Malaysia), Biodiversity Centre Ordinance, 1997 (Amended 2003, Regulations 1998, Revised 2004). 82

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Firstly, it could be considered that genetic resources and associated traditional knowledge are not related to land as such and, therefore, do not fall within exclusive state jurisdiction. The Andean Community countries, for example, treat genetic resources and associated traditional knowledge as part of the national patrimony of the country.86 The government exercises an overarching jurisdiction that supersedes the right of landowners on whose land the genetic resources are located. Traditional knowledge may have no link with the land but be associated with the use of genetic resources. However, a problem with this approach is illustrated by the Federal Constitution of Malaysia,87 according to which the state retains the residual power to legislate on matters that are not enumerated in any of the lists; and genetic resources and associated traditional knowledge fall within this category. Secondly, the resources can be treated as being associated to land and, therefore, within the exclusive jurisdiction of the state. In that case, a federal law can be enacted to implement an international treaty even in respect of matters under exclusive state jurisdiction.88 An example from Malaysia is the International Trade in Endangered Species Act 2008,89 enacted to implement the Convention on International Trade in Endangered Species and applying to the whole of the country. This, however, deals with a prohibitive act focusing on enforcement. Even so, the two states of Sabah and Sarawak have their own state laws dealing with the same subject matter. ABS is seen as a source of revenue, and states may be reluctant to forgo their jurisdiction. Thirdly, under the Federal Constitution of Malaysia90 a federal law can be enacted to promote uniformity of the laws of two or more states but it needs to be adopted also at the state level. However, this will make it a state law and it can then be amended at will.91 An example of such a law is the National Forestry Act 1980 which has not been adopted by the two states of Sabah

 Andean Community, Common Regime on Access to Genetic Resources (Decision 391, 2 July 1996, in force 17 July 1996) (Decision 391), Article 6: The genetic resources and their by-products which originated in the Member Countries are goods belonging to or the heritage of the Nation or of the State in each Member Country, as stipulated in their respective national legislation. Those resources are inalienable, not subject to prescription and not subject to seizure or similar measures, without detriment to the property regimes applicable to the biological resources that contain those genetic resources, the land on which they are located or the associated intangible component. http://www.wipo.int/wipolex/en/text .jsp?file_id=223610, accessed 28 May 2012. [On the Andean Community, see contribution by Cabrera to this volume (Chapter 11).] 87  Malaysia, Constitution of Malaysia, 1957, Article 77. 88  Malaysia, Constitution of Malaysia, 1957, Article 76.1.a. 89  Malaysia, International Trade in Endangered Species Act No. 686 of 2008. 90  Malaysia, Constitution of Malaysia, 1957, Article 76.1.b. 91  Malaysia, Constitution of Malaysia, 1957, Article 76.3. 86

266   Gurdial Singh Nijar and Sarawak. They maintain their own forestry laws, which have significant differences with the national law. Finally, states may formally agree on principles upon which to base their state ABS law. This agreement could delineate common elements to be included into state laws. An example is Australia’s Nationally Consistent Approach.92 This approach depends on the continued political willingness of states not to deviate from the agreed principles and elements. The constitutional issue does not arise in relation to lands within the direct jurisdiction of the federal government. A federal ABS law can easily be enacted with respect to such lands.93

III.  Conclusion This chapter has addressed the numerous interpretation and implementation issues raised by the Nagoya Protocol. It is only natural that a new international treaty would give rise to a multitude of problems. Differing interpretations are to be expected when compromises are struck to forge consensus amongst States with widely divergent national interests. On the other hand, the exercise to negotiate an international treaty was initiated to provide greater clarity and legal certainty to the more generic ABS related provisions in the CBD. Undoubtedly, to a limited extent this has been achieved, especially with regard to the inclusion of derivatives within the scope, obligations on compliance, and the provisions regarding the rights of indigenous and local communities to their traditional knowledge associated with genetic resources. Nonetheless many serious issues remain unresolved. Legal certainty and clarity were sacrificed in the rush to conclude the Protocol within the deadline set by the CBD COP in the face of a lack of resolution among negotiators on the most fundamental issues. This inevitably makes implementation doubly challenging, as Parties have to deal with a Protocol replete with provisions completely at odds with their negotiating positions and their countries’ interests. This chapter charts the way forward for developing countries in this regard.

 The Nationally Consistent Approach for Access to and the Utilisation of Australia’s Native Genetic and Biochemical Resources, accessed 28 May 2012, http://www.environment.gov. au/biodiversity/.../nca/.../understanding.pdf. 93  An example is Australia, Environment Protection and Biodiversity Conservation Act, No. 91, 1999, including the Environment Protection and Biodiversity Conservation Amendment Regulations, accessed on 28 May 2012, 2005, http://www.comlaw.gov.au/Details/ F2005L03473/Amends. 92

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There are two pathways for developing countries to recapture any lost ground in the negotiations of the Nagoya Protocol: through implementation via national law, and/or decisions of the Nagoya Protocol governing body at the international level.94 A key aspect relates to compliance measures. The Protocol requires Parties to take measures to ensure that users within their jurisdiction have complied with the domestic ABS law or regulatory requirements of the provider country, in particular that PIC has been obtained and MAT established. The domestic law can make the grant of PIC conditional upon the fulfillment of certain conditions such as: •  the requirement for PIC and MAT for access to derivatives, including stand-alone derivatives; •  the establishment of effective checkpoints and effective compliance and monitoring measures by the user country. The law could also explicitly require mandatory disclosure at designated checkpoint(s); •  the requirement for PIC and MAT for publicly available traditional knowledge; and •  the requirement for PIC and MAT for traditional knowledge where the holder cannot be ascertained. At the international level, the Nagoya Protocol governing body could adopt a decision establishing these requirements, which could produce a level playing field for all providers and users. Further, to inspire confidence that there will be adequate and effective recourse after the resources leave the jurisdiction of provider countries, the Protocol governing body through its decisions should: •  establish criteria as to what constitutes effective measures to address situations of non-compliance with domestic law or regulatory requirements,95 and require user country Parties to designate checkpoint(s) within a prescribed time period; •  assess the adequacy of the checkpoint(s) from the perspective of supporting compliance through the monitoring of the utilization of genetic resources;96 •  formulate the kind of information required to be disclosed at the designated checkpoint(s); and

 For a detailed account of the measures see Nijar, The Nagoya Protocol . . . Implementation Options for Developing Countries. 95  Nagoya Protocol Articles 15–16. 96  Nagoya Protocol Article 17. 94

268   Gurdial Singh Nijar •  clarify that provider countries are not encumbered by WTO trade rules (‘national treatment’ and ‘most favoured nation treatment’) in making decisions on access. These decisions have the potential to restore the balance among the interests of different Parties to the Protocol and provide for greater clarity and legal certainty with regard to the implementation of the Protocol and the CBD, as well as to hopefully curb biopiracy – the reason why Parties embarked on the exercise to establish an international regime in the first place.

Chapter 9.  Challenges in the Implementation of the Nagoya Protocol from the Perspective of a Member State of the European Union: The Case of Spain Alejandro Lago Candeira* and Luciana Silvestri** Following an illustration of the uniqueness of Spanish biodiversity and Spain’s key commitment to the ABS negotiations, this chapter analyses the challenges Spain will face when implementing the Nagoya Protocol. These obstacles mainly relate to: access to genetic resources1 and associated traditional knowledge;2 fair and equitable benefit-sharing;3 and compliance.4 Additional complexities arise from Spain’s membership to the European Union (EU) and Spanish internal division of competences. As a consequence, the external challenges that Spain could face if it were to decide to ratify and implement the Protocol earlier than the EU will be discussed. In addition, certain internal challenges that could arise from the distribution of competences between the central government and the regional level will be addressed. Substantive challenges related to ownership of genetic resources, the traditional knowledge of local communities, channelling benefits towards biodiversity conservation, and compliance measures are also analysed.

  * Director of the UNESCO Chair for the Environment at the Rey Juan Carlos University (Madrid). Although the writers are part of the Spanish delegation in different environmental negotiations, in particular in those related to ABS and biodiversity issues, the views expressed in this article are personal and cannot be attributed to the institutions for which the authors work or advise. The comments expressed cannot be interpreted as the official position of Spain in these matters. ** PhD fellow and researcher in the field of environmental law at the UNESCO Chair for the Environment at the Rey Juan Carlos University (Madrid).   1  Nagoya Protocol Article 6.   2 Nagoya Protocol Article 7.   3 Nagoya Protocol Article 5.   4 Nagoya Protocol Articles 15, 16 and 17.

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I.  Spain As a Case Study 1.  Spain’s Dual Role As a Provider and User Country In order to understand the particular position Spain has in comparison to most EU Member States, it is necessary to consider some facts about its biodiversity. Spain is one of the most biodiverse countries in Europe. It has been singled out as one of the twenty-five biodiversity hotspots in the world.5 Its biodiversity richness responds to a unique geographical situation, a rich geological diversity, a great climatic variability and the existence of islands – all of which contribute to high rates of biodiversity and endemism.6 In Spain there are 8,000–9,000 taxa of vascular plants (around 85% of the total listed in the EU). Of those, 1,500 are native, thus half of the taxa endemic to Europe is Spanish. The results for fauna are comparable given the fact that 70,000 of the 142,000 species of animals in Europe are found in Spain, with mammals and birds, the two best-known groups, accounting for 79% and 74% of the European total, respectively. This data places Spain at the top of the European biodiversity or natural assessments indices, thereby making it one of the EU Member States with the largest and most numerous tracts of land in a natural or semi-natural state.7 Previous figures show that Spain is significantly different from the rest of Europe as it hosts most biodiversity in the continent. This uniqueness characterises Spain as a great provider of genetic resources. As such, Spain, in practice, shares common interests with traditional provider countries and, in particular, with Latin American countries. On the other hand, Spain also hosts some users of genetic resources, working in the promising and emerging field of marine biotechnology. Nevertheless, Spain still lags behind the leading EU countries in the biotech sector, like Denmark, France, Germany, Netherlands, Sweden or the UK.8 2.  Spain’s Key Role in the Negotiation of the Nagoya Protocol Spain has actively committed to the support and development of the Convention on Biological Diversity (CBD). This should be seen against the  See Conservation International, “The Biodiversity Hotspots,” accessed 10 June 2012, http:// www.biodiversityhotspots.org. 6  Spain, Royal Decree, No. 1274, 2011 (Decree 1274/2011) (approves Biodiversity and Natural Heritage Strategic Plan). 7  Autonomous Body for National Parks (Spain), The Nature of Spain (Madrid: Ministry of Environment, 2002), 18–20. 8  EU working document, “Competitiveness of the European biotechnology industry,” accessed 10 June 2012, http://ec.europa.eu/enterprise/sectors/biotechnology/files/docs/biotech_ analysis_competitiveness_en.pdf. 5

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background of the EU position in the ABS negotiations, that has been generally unbalanced towards a ‘user approach’, due to the specific weight of the biotech industries in some Member States, the exceptional (in the EU context) provider-user approach of Spain, and also the absence of knowledge, interest or involvement of European environmental NGOs, that are generally active in other areas covered by the CBD. Spain’s commitment has been especially critical in the negotiations on access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation (ABS), particularly in four different phases of the ABS negotiations. Firstly, when holding the Presidency of the EU, Spain played a key role in advancing the final negotiations and approval of the Bonn Guidelines9 in April 2002. The Spanish Presidency was able to convince other EU Member States and the European Commission of the benefits of this new instrument, at a time when some Member States and the Commission were reluctant to support even a non-binding regime. The approval of the Bonn Guidelines was an important step in spelling out key processes and obligations for CBD Parties and stakeholders usually involved in the ABS transactions. Nevertheless, ‘megadiverse countries’ considered the Bonn Guidelines clearly insufficient due to their voluntary character and limited scope (for instance, they did not cover compliance measures for user of genetic resources).10 Secondly, during the seventh meeting of the CBD Conference of the Parties (COP) in 2004, Spain volunteered to host the fourth meeting of the CBD Working Group on ABS which took place in early 2006 in Granada, preceded by the meeting of the CBD Working Group on Article 8(j), which Spain also funded. This initiative was crucial to overcome tension between Parties with regard to the activities to be carried out during the intersessional period and related financial burdens that represented the divergence of priorities between developed and developing states. Developed states’ main priority was to make substantial progress during the intersessional period in the programme of work on protected areas, while developing states, led by the group of Like-minded Megadiverse countries (LMMC), were interested in developing and adopting a legally binding instrument on ABS, as requested in the Plan of Implementation of the World Summit on Sustainable Development.11  CBD Decision 6/24, “Access and benefit-sharing as related to genetic resources” (27 May 2002) UN Doc UNEP/CBD/COP/6/20. 10  See CBD, “Cancun Declaration of Like-Minded Megadiversity Countries,” (21 March 2002) UN Doc UNEP/CBD/COP/6/INF/33, in particular subparagraph h. 11  United Nations, “Report of the World Summit on Sustainable Development” (2002) UN Doc A/CONF.199/20, Resolution 2: Johannesburgh Plan of Implementation, paragraph 44.o.  9

272   Alejandro Lago Candeira and Luciana Silvestri Thirdly, the enthusiasm shown by the Spanish Minister of Environment at the opening of the Granada meeting on ABS, when she advocated for the negotiation of a legally binding instrument on ABS – something impossible to accept at the EU level at that time – highlighted the tension towards the unbalanced EU negotiating position. That declaration was the starting point for Spain’s renewed effort to convince most of the EU of the relevance of ABS, with a view to balancing the EU negotiating position and underscoring the need for an international legally binding instrument as the only meaningful way forward to conclude the international ABS regime negotiations. Finally, the Council of the EU that took place in March 2010 (four years after that initial declaration in Granada) concluded that the EU negotiating position favoured a legally binding ABS regime12 – something that, not by coincidence, happened again under the Spanish Presidency.13 The fourth phase makes reference to the consistent and reliable financial support Spain provided during the entire ABS negotiation. This was particularly crucial in the difficult, and busy, year of 2010, where the number of meetings multiplied in order to successfully conclude the negotiation of the Protocol in Nagoya. The generous contribution of different countries, including Spain, enabled a transparent process, allowing the direct involvement of all relevant stakeholders. In this regard, Spain’s contribution focused in particular on enabling the participation of indigenous and local communities’ representatives in the negotiations.

II.  Challenges in the Implementation of the Nagoya Protocol for Spain as a Member State of the European Union The challenges associated with the implementation of the Nagoya Protocol in Spain as a Member of the European Union stem from the fact the Protocol is a mixed agreement, i.e., an agreement that is signed and concluded by both the EU and its Member States, with third Parties. Mixed agreements are a common legal phenomenon as the EU has become a legitimate global actor on the international level: its external competences have increased in

 Council of the EU, “Council conclusions on biodiversity post-2010,” accessed 7 June 2012, http://www.eu-un.europa.eu/articles/en/article_9571_en.htm. 13  Council of the EU, “Council conclusions on biodiversity post-2010 – EU and global vision and targets and international access and burden sharing regime,” accessed 10 June 2012, http://www.countdown2010.net/2010/wp-content/uploads/Council-Conclusions-newbiodiversity-target.pdf. 12

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practice and have been recognised by the continuous amendments of the EU Treaties.14 Mixity occurs as a result of the existence of shared –internal and external – competence between the EU and its Members States.15 It also appears as an answer to the division of competences, when no clear-cut indication of relevant competences is made prior to the negotiation of an international agreement or when the potential outcomes of international negotiation are likely to impact European competences. The latter appears to justify the mixity of the Nagoya Protocol. In July 2009 the European Commission requested a negotiating mandate from the Council of the EU16 for the final stage of the negotiations.17 This was quite a preventive mandate, as there was no formal ABS policy at EU level and the legal justification presented by the European Commission to the Council consisted of a long list of EU legislation that could be potentially affected by the ABS negotiations. This was, apparently, due to the fact that elements and institutions under discussion in the ABS negotiations were not completely defined. The Council, on 29 October 2009, granted a mandate to the European Commission for participating in the ABS negotiations, on matters falling under EU competence; therefore, excluding matters falling under EU Member States’ exclusive competence and, in particular, issues related to indigenous and local communities and traditional knowledge. That mandate was extended in 2010 to cover the negotiations that took place in Nagoya in October 2010.18 Two main questions emerge with regard to the legal consequences of mixity in respect to the implementation of the Nagoya Protocol in Spain. The first relates to the internal division of competences between the EU and its Members States for the adoption of main measures related to access to genetic resources and to associated traditional knowledge, benefit-sharing, and compliance. The second question relates to the possibility of an early ratification by Spain and the potential international responsibility of the EU and its Members States for the fulfilment of obligations under the Protocol vis-a-vis third Parties. Focus on these challenges should not be understood as if there were no other implementation difficulties; nevertheless, emphasis  Treaty on the Functioning of the European Union (TFEU) [2010] OJ C83/47 Article 218.  Marc Maresceau, “A Typology of Mixed Bilateral Agreements,” in Mixed Agreements Revisited: the EU and its Member States in the World, ed. Christophe Hillion and Panos Koutrakos (Oxford: Hart Publishing, 2010), 14. 16  Based on Treaty establishing the European Community [2006] OJ C321E/1 Article 300.1 (currently TFEU Article 218). 17  Namely, for the eighth and ninth meetings of the ABS Working Group (held in Montreal, Canada in November 2009 and Cali, Colombia in March 2010, respectively). 18  Council of the EU, “Council Conclusions on Convention on Biodiversity (Nagoya),” accessed 7 June 2012, http://www.eu-un.europa.eu/articles/en/article_10202_en.htm. 14 15

274   Alejandro Lago Candeira and Luciana Silvestri will be placed on those obstacles that appear to be particularly relevant at this premature stage of execution of the Protocol. 1.  The Need to Clarify Internal Division of Competences between the EU and Spain for the Implementation of Obligations under the Nagoya Protocol As Spain prepares to ratify the Nagoya Protocol, it is crucial to understand whether it can proceed to ratify it on its own or if, on the contrary, it has to wait for the EU to do so, or even for the EU to adopt EU-level rules for the fulfilment of the obligations under the Nagoya Protocol. In order to answer this question, an analysis of the internal division of competences between the EU and Spain, for the implementation of obligations under the Nagoya Protocol,19 and an assessment of the possible measures to comply with the Protocol obligations is needed. The analysis of the internal division of competences will be preceded by an evaluation of the nature of the obligations assumed by the Parties under the Protocol, which will help elucidate competence issues and the inter-linkages between respective competences. This, in turn, will shed light on the possibility of an early ratification by Spain and of potential international responsibility for the fulfilment of obligations under the Nagoya Protocol. The obligations set forth by the Nagoya Protocol seek to address equity issues within the framework of biodiversity conservation and the sustainable use of its components. The Protocol20 recalls the three objectives of the CBD (conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilisation of genetic resources)21 as intrinsically intertwined. This reflects the understanding that the availability of biological resources depends on their conservation and sustainable use; this, in turn, is difficult to achieve if benefits are not recognised, and provided, for the local guardians of nature and the countries of origin of such resources.22 It emanates from the primary aim of the Protocol, benefit-sharing arising from the utilisation of genetic resources with a view to contributing to the conservation of biodiversity and the sustainable use of its components, that  Particularly obligations contained in Nagoya Protocol Articles 5.2–3, 5.5, 6.2–3, 7, 13.1–2, 15.1–2, 16.1–2 and 17.1. 20  Nagoya Protocol Article 1. 21  CBD Article 1. 22  CBD, “Addressing the fair and equitable sharing of the benefits arising out of genetic resources: options for assistance to developing country Parties to the Convention on Biological Diversity,” (9 February 1998) UN Doc UNEP/CBD/COP/4/22. See also Valérie Boisvert and Franck-Dominique Vivien, “The Convention on Biological Diversity: A conventionalist approach,” Ecological Economics 53 (2005): 464. 19

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the nature of obligations under the Nagoya Protocol is mainly environmental. This is not to say, however, that other interests, such as scientific research, intellectual property rights (IPRs), technology transfer, etc., have not been fundamental in shaping the legal regime, but rather to highlight that the overarching framework of the Protocol is environmental protection. Once it has been accepted that the Nagoya Protocol entails commitments that mainly pursue environmental goals, the internal division of competences between the EU and the Member States, in relation to the environment, should be examined, particularly in relation to the power to legislate on environmental issues. Shared competence between the Union and its Member States applies to environmental policy,23 and When the Treaties confer on the Union a competence shared with the Member States in a specific area, the Union and the Member States may legislate and adopt legally binding acts in that area. The Member States shall exercise their competence to the extent that the Union has not exercised its competence. The Member States shall again exercise their competence to the extent that the Union has decided to cease exercising its competence.24

Environmental policy is thus an area of shared competences, on which both the EU and its Member States can legislate and adopt legally binding acts. Member States can exercise this power provided the Union has not exercised it in relation to a particular environmental issue. Spain is, therefore, competent to take all necessary legislative, administrative or policy measures in order to comply with its commitments under the Nagoya Protocol as the EU has not yet exercised its own competence on the matter. However, in case the Union exercises its competence and, indeed, adopts legally binding acts in regards to the obligations set forth by the Protocol, Spain, as the rest of the Members States, would have to conform to Union’s law, which prevails over Member States’ law according to long-standing case law of the Court of Justice of the EU.25 Nevertheless, it is not easy for the Union to exercise such competence. When it exercises shared competences, such as is the case for environmental policy, the EU has to justify its intervention since

 TFEU Article 4.2.e.  TFEU Article 2.2. 25  ‘It follows (. . .) that the law stemming from the Treaty, an independent source of law, could not, because of its special and original nature, be overridden by domestic legal provisions, however framed, without being deprived of its character as [Union] law and without the legal basis of the [Union] itself being called into question’ (Case 6/641 Costa v ENEL [1964] ERC 585). 23 24

276   Alejandro Lago Candeira and Luciana Silvestri the Union shall act only if and in so far as the objectives of the proposed action cannot be sufficiently achieved by the Member States, either at central level or at regional and local level, but can rather, by reason of the scale or effects of the proposed action, be better achieved at Union level.26

This lays down the principle of subsidiarity to which the Union’s action needs to adjust to. Consequently, when adopting legislation on areas of shared competences, such as the field of the environment, the EU has to demonstrate that it is better suited than Member States in fulfilling commitments under the Protocol. Likewise, the potential exercise of this competence by the EU would be limited by the principle of proportionality27 and, therefore, ‘the content and form of Union action shall not exceed what is necessary to achieve the objectives of the Treaties.’28 Lastly, even if the Union were to adopt ABS legislation, and as a consequence Spain would have to adjust its own regulation, Spain would still be capable of ‘maintaining or introducing more stringent protective measures [provided] such measures [are] compatible with the Treaties’.29 It follows that Spain is in principle legally competent to take legislative, administrative or policy measures pursuant to the fulfilment of the obligations of the Nagoya Protocol.30 In any case, however, Spain would be obliged, as the rest of the Members States, to comply with the duty of loyal cooperation towards the EU.31 This entails effective compliance with procedural obligations in relation to information and consultation with the Union.32 Now that it has been clarified how competences would work vis-a-vis the implementation of the Nagoya Protocol, it is useful to briefly overview if, and how, these rules would operate in the particular case of main commitments the Parties assume under the Nagoya Protocol, in relation to access to genetic resources and to associated traditional knowledge, benefit-sharing and compliance.  According to the Treaty on European Union (TEU) [2010] OJ C83/13 Article 5.3.  TEU Article 5.1. 28  TEU Article 5.4. 29  TFEU Article 193. 30  The Council of the EU has now confirmed the mixed character of the Nagoya Protocol, inviting both, Member States and the Commission, to ‘sign at the earliest opportunity the ABS Protocol and to start preparations for its timely ratification and implementation’ (Council of the EU, “Council Conclusions on Convention on Biological Diversity: follow up to Nagoya Conference,” accessed 7 June 2012, http://www.eu-un.europa.eu/articles/en/ article_10510_en.htm, paragraphs 1 and 21). 31  TEU Article 4.3. 32  Christophe Hillion, “Mixity and Coherence in EU External Relations: the Significance of the Duty of Cooperation,” in Mixed Agreements Revisited, ed. Christophe Hillion and Panos Koutrakos (Oxford: Hart Publishing, 2010), 105. 26 27

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The first core area of obligations refers to the duty to adopt legislation or regulatory requirements in case Parties decide to require prior informed consent (PIC) for access to genetic resources under their jurisdiction.33 As this power is based on the sovereign rights Parties exert over their natural resources – a right that has not been expressly conferred to the EU to any extent – it appears that such decision falls within the sphere of retained powers of Member States. Hence, each Member State, including Spain, is empowered to unilaterally decide if it should require PIC for the access to its genetic resources. Provided Spain opts to require PIC, it is also empowered to adopt the legislation or legal requirements that it perceives as best suited to its national interests; that is to say, to decide which access requirements it will impose and what they will look like (types, number, etc.). That said, nothing prevents the possibility that, in a coordinated manner, Spain, other Member States and the EU decide to act uniformly on this front, regulating in a similar fashion access to their genetic resources. Yet, this is a question of opportunity and discretion and not a legal requirement. On the other hand, the EU could only limit or interfere in the exercise of the above-mentioned Member States’ competence (i.e., the decision on the type and number of access requirements) if it were to decide to legislate on that issue based on its shared competence on environment – which is, on the other hand, limited by the above-mentioned principle of subsidiarity (such action requires justification) – or pursuant to its exclusive competence based on ‘the establish[ment] of the competition rules necessary for the functioning of the internal market’.34 For the same reasons, Spain would be competent to designate one or more competent national authorities responsible for granting access and for advising on applicable procedures and requirements for obtaining PIC and entering into mutually agreed terms (MAT).35 As for traditional knowledge, Parties are obliged to adopt measures to ensure that traditional knowledge that is held by indigenous and local communities is accessed with the PIC, or approval and involvement of these communities, and that MAT are established.36 In this case, Member States do not exercise sovereignty over the traditional knowledge of these communities.37 However, they are still empowered to legislate as they have  Nagoya Protocol Article 6.  TFEU Article 3.1.b. 35  Nagoya Protocol Article 13. 36  Nagoya Protocol Article 7. 37  Matthias Buck and Clare Hamilton, “The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the 33 34

278   Alejandro Lago Candeira and Luciana Silvestri not conferred competence – exclusive or shared – to the Union in this regard.38 The second core set of responsibilities refers to fair and equitable benefitsharing obligations. The Nagoya Protocol mandates Parties to take legislative, administrative or policy measures, as appropriate, in order to comply with benefit-sharing obligations in relation to the utilisation of genetic resources.39 Here again, it appears that Member States are competent to legislate as this obligation is aimed at biodiversity conservation and the sustainable use of its components and, therefore, Spain is entitled to act individually and in accordance with its best national interest. This will continue to be the case until the Union eventually exercises its shared competence paying due respect to the principle of subsidiarity40 or legislates based on its exclusive competence for ‘the establish[ment] of the competition rules necessary for the functioning of the internal market’.41 As for benefit-sharing, in relation to traditional knowledge associated with genetic resources, Parties are obliged to take legislative, administrative or policy measures in order to ensure these benefits are shared in a fair and equitable way with the concerned communities.42 Competence to regulate access to traditional knowledge held by indigenous and local communities has not been conferred to the Union; hence, the EU cannot exercise competence in that area.43 The third major set of duties is related to compliance and refers to a set of measures Parties have to take as users of genetic resources and traditional knowledge in order to ensure that the utilisation occurring within their jurisdiction is in accordance with the domestic ABS legislation or regulatory requirements of the other Party. For that purpose, Parties must take appropriate, effective and proportionate measures to provide that genetic resources and traditional knowledge utilised within their jurisdiction have been accessed in accordance with PIC and that MAT have been established.44 In addition, Parties shall take measures to address situations of non-compliance45 and designate one or more checkpoints that would collect or receive relevant information related to the PIC, the source of the genetic resource, the establishment Convention on Biological Diversity,” Review of European Community and International Environmental Law 20 (2011): 48. 38  TEU Article 5.1–2. 39  Nagoya Protocol Article 5. 40  TEU Article 5.3. 41  TFEU Article 3.1.b. 42  Nagoya Protocol Article 5.5. 43  TEU Article 5.1–2. 44  Nagoya Protocol Articles 15.1 and 16.1. 45  Nagoya Protocol Articles 15.2 and 16.2.

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of MAT and the utilisation of the genetic resources.46 There is no provision requiring the designation of a checkpoint in relation to the monitoring and/or control of traditional knowledge. In respect to compliance,47 it seems clear that Member States are competent to take measures aimed at ensuring compliance with domestic legislation or regulatory requirements on access and benefit-sharing of the other Party, which in turn seeks to address an environment-related issue. Consequently, Spain is entitled to act individually; its competence to legislate would only be limited were the Union to exercise its own competence with due respect of, and in accordance to, the principle of subsidiarity48 or based on its exclusive competence stipulated for ‘the establish[ment] of the competition rules necessary for the functioning of the internal market’.49 In practice, Spain could fulfil this particular obligation by establishing a general prohibition on utilising genetic resources and/or associated traditional knowledge that have been accessed illegally, i.e., access that has infringed ABS national rules of the providing country. This prohibition should be complemented by measures (procedures, definition of illegal conducts, sanctions, etc.) that address cases of non-compliance. Furthermore, Spain must ensure close collaboration with countries providing genetic resources and/or traditional knowledge in case there is sufficient evidence of a violation of the law of the providing country. Secondly, the Nagoya Protocol mandates the designation of a checkpoint that would collect or receive, as appropriate, relevant information related to prior informed consent, to the source of the genetic resource, to the establishment of mutually agreed terms, and/or to the utilisation of genetic resources.50

The Protocol also establishes that checkpoints must be effective and relevant to the utilisation of genetic resources, or to the collection of relevant information at, inter alia, any stage of research, development, innovation, precommercialisation or commercialisation.51 In this respect, and in consideration of the key characteristics, potential checkpoints should have, in accordance with the Protocol, the fulfilment of such an obligation seems to be achievable at the national level. For instance, Spain could designate its national patent office and/or any public agency in charge of granting public funds for research activities for the above-mentioned purposes. As a consequence of such actions, Spain would be in full compliance  Nagoya Protocol Article 17.1.a.i and iv.  Nagoya Protocol Articles 15.1–2 and 16.1–2. 48  TEU Article 5.3. 49  TFEU Article 3.1.b. 50  Nagoya Protocol Article 17.1.a.i. 51  Nagoya Protocol Article 17.1.a.iv. 46 47

280   Alejandro Lago Candeira and Luciana Silvestri of the Protocol and no additional measure from the EU side would be needed. That said, it is worth mentioning that the Union could adopt complementary measures that could increase the effectiveness of national systems. One of these control measures at EU level could take place when granting European public funds to research that utilises genetic resources. In any case, it is worth noting that the selection of the checkpoint has the potential to raise new challenges as some of them, for instance customs or other procedures related to products approval, would clearly fall under Union exclusive competences,52 while others, for example patent offices, fall under Member States’ competence. In conclusion, the nature of the duties Spain will assume under the Nagoya Protocol does not prevent the individual exercise of its competences and the concrete measures the country could take in order to fulfil those duties, pursuant to the limits of its competence, are appropriate, effective and proportionate as required by the Protocol. As a result, it can be advanced that Spain could proceed to ratify the Nagoya Protocol without any delays as it is fully capable and competent to adopt necessary measures to comply with all obligations set under the Protocol and, therefore, no international responsibility risks seem to be feared. The topic, however, will be further analysed in the next section. 2.  The Ratification Process of the EU and Its Member States for the Fulfilment of Obligations under the Nagoya Protocol: The Case of Spain The EU and Spain signed the Nagoya Protocol on 23 June 2011 and 21 July 2011 respectively. As a result, Spain has undertaken, and the EU is now finalising, a strategic assessment on the potential impacts and opportunities the Protocol’s implementation entails. As such, the next expected step in the process is the ratification of the Protocol: both the EU and Spain have initiated their own internal procedures to that end. These processes, at least at the European level, usually take up to three years.53 As a mixed agreement, the Nagoya Protocol raises questions on the need to coordinate respective ratification processes. It is worth underlining that these procedures are likely to overlap in time; nevertheless, one may reasonably speculate that Spain, which has manifested its willingness to become a Party to the Protocol in a shorter timeframe, might be ready to deposit its instrument of ratification before the EU. It will now be discussed if such early  TFEU Article 3.1.a.  Frank Hoffmeister, “Curse or Blessing? Mixed Agreements in the Recent Practice of the European Union and its Member States,” in Mixed Agreements, ed. Christophe Hillion and Panos Koutrakos (Oxford: Hart Publishing, 2010), 256.

52 53

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ratification is legally possible and what consequences and risks exist, in terms of responsibility under international law associated with such a decision.54 In relation to the possibility of an earlier ratification, the EU Treaties, the case law of the Court of Justice of the EU and practice can provide relevant guidance. Moreover, the above analysis55 on the internal allocation of competences between the EU and its Member States is critical in order to understand the degree of inter-linkage between them and how this affects possibilities of an earlier ratification. The rules for negotiation and conclusion of international agreements by the EU56 do not detail how the Union and its Member States must coordinate their own conclusion procedures. It is for that reason that an extensive practice has developed in the area,57 as shown below. Such practice confirms that there is no legal obligation in the EU Treaties requiring the EU or its Member States to wait for each other’s ratification process to end before depositing their own ratification instrument.58 When that has been the case, it has actually resulted from practical reasons and the nature of the  It is a legitimate concern of the Parties to a multilateral agreement, for whom in most cases it will be difficult to understand division of competences between the EU and its Member States, to understand who is responsible for the performance of specific duties and who should be held responsible in the case of a breach of an obligation under the agreement (Hoffmeister, “Curse or Blessing?,” 259). In order to solve such legal uncertainties, it has been required from the EU to unambiguously and firmly specify internal allocation of competences so that it results in a clear understanding of responsibilities. Such guidance to third Parties on the internal distribution of responsibilities is provided through a declaration of competence made by the EU. The EU Treaties provide no rules for how declaration of competences should be prepared and adopted; as a result, there is abundant practice in this area. In the case of the Nagoya Protocol, CBD Article 34.2 states that, in the case a regional economic integration organisation becomes Party to the Convention or any protocol and one or more of its Member States do it as well, ‘the organisation and its Member States shall decide on their respective responsibilities for the performance of their obligations under the Convention or protocol, as the case may be’. Furthermore, the organisation according to CBD Article 34.3 shall ‘declare the extent of [its] competence with respect to the matters governed by the Convention or the relevant protocol . . . and . . . inform the Depositary of any relevant modification in the extent of [its] competence’. Consequently, it is expected that by the time the EU deposits its instrument of ratification, acceptance or approval, it will also provide its competences declaration that will help delimitate liabilities vis-à-vis third Parties as it clarifies its respective competence in relation the obligations set forth by the Protocol, which in turn will help elucidate what responsibilities fall under Member States’ competence, including Spain. 55  Section II.1. 56  TFEU Article 218. 57  Ivan Smyth, “Mixity in Practice – A Member State Practitioner’s Perspective,” in Mixed Agreements Revisited, ed. Christophe Hillion and Panos Koutrakos (Oxford: Hart Publishing, 2010), 315. 58  Hoffmeister, “Curse or Blessing?,” 256. 54

282   Alejandro Lago Candeira and Luciana Silvestri obligations included in the agreement, all of which have made impossible unilateral action from either side, as the Union’ and Member States’ respective competences have appeared to be intrinsically intertwined.59 At times, such as in the case of the Euro-Mediterranean Agreement between the European Community and its Member States and Algeria, the Union waited for all Member States to end their domestic ratification processes, before depositing its own instrument of ratification.60 The main reason behind this was the need to avoid international responsibility as the EU could have been held responsible for issues falling under the competence of the Member States that had not yet ratified the instrument.61 In other circumstances, the Union has become Party to an international agreement, without counting on all Member States’ ratifications to be completed, such as in the case of the UN Convention against Transnational Organised Crime.62 Under certain circumstances, the EU has attempted to speed up national ratification processes by inserting in its own decision to ratify, clauses urging Member States to proceed with fast ratification.63 Finally, there are cases where Member States have deposited their instruments of ratification without waiting for the Union’s decision in that direction. Such is the case of the Cartagena Protocol on Biosafety where the Netherlands and Spain deposited their instruments of ratification on 8 January 2002 and 16 January 2002, respectively, whereas the EU ratified on 27 August 2002.64 In conclusion, as these examples suggest, practice in the field of ratification varies and responds to practical reasons and/or to the high degree of interdependence between the Union and its Members States’ obligations under the agreement. As concluded above,65 the nature of the duties Spain will assume under the Nagoya Protocol does not prevent the individual exercise of its competences. Such competences do not seem to be closely intertwined with those of the  Hillion, “Mixity and Coherence in EU External Relations,” 103.  Council Decision 2005/690/EC of 18 July 2005 on the conclusion of the Euro-Mediterranean Agreement establishing an Association between the European Community and its Member States, of the one part, and the People’s Democratic Republic of Algeria, of the other part, [2005] OJ L265/1. 61  Hoffmeister, “Curse or Blessing?,” 256. 62  Council Decision 2004/579/EC of 29 April 2004 on the conclusion, on behalf of the European Community, of the United Nations Convention Against Transnational Organized Crime [2004] OJ L261/69. 63  An example can be found in Council Decision 2006/515/EC of 18 May 2006 on the conclusion of the Convention on the Protection and Promotion of the Diversity of Cultural Expressions [2006] L201/15 recital 5. 64  CBD, “Parties to the Protocol and signature and ratification of the Supplementary Protocol,” accessed 10 June 2012, http://bch.cbd.int/protocol/parties/. 65  Section II.1. 59 60

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EU and, as such, this inter-linkage does not prevent Spain from ratifying the Protocol on its own. Likewise, as Spain is in a position to adopt concrete appropriate, effective and proportionate measures in order to fulfil obligations under the Protocol, it is hard to envisage any international responsibility concerns on this front. In any case, regardless of the degree of connection between the Union’s and Member States’ obligations under the agreement, there is always a duty of loyal cooperation between them, which applies to all stages of concluding mixed agreements, as clarified by the Court of Justice of the EU.66 The extent of such cooperation, however, varies depending on the type, nature and degree of mixity involved in a particular agreement.67 It can range from total coordination of conclusion processes and the joint deposit of respective instruments of ratification where Union and Member State competences are intrinsically intertwined in the framework of the implementation of the agreement,68 to an obligation to use best endeavours to reach a common position with the Union and effectively comply with the obligation to inform and to consult69 in other cases. The latter seems to apply to the Nagoya Protocol and, consequently, Spain is obliged to duly inform and consult with the EU on the steps it might take on this front.

 ‘Where it is apparent that the subject-matter of an international agreement falls in part within the competence of the [Union] and in part within that of the Member States, it is important to ensure close cooperation between the Member States and the [Union] institutions, both in the process of negotiation and conclusion and in the fulfilment of the commitments entered into. That obligation to cooperate flows from the requirement of unity in the international representation of the [EU]’ (Opinion2/00 Cartagena Protocol on Biosafety [2001] ECR I-9713, paragraph 18). 67  Hillion, “Mixity and Coherence in EU External Relations,” 103. 68  Jenö Czuczai, “Mixity in Practice: Some problems and Their (Real or Possible) Solution,” in Mixed Agreements Revisited, ed. Christophe Hillion and Panos Koutrakos (Oxford: Hart Publishing, 2010), 233. 69  ‘This duty of loyalty incumbent on Member States is, therefore, an obligation to achieve a result to act in the Union interest. This obligation is fulfilled through specific-result or besteffort obligations expressed through the duty of loyal cooperation, the latter being a means to comply with the general duty of loyalty. The nature of the specific obligation depends on the particular facet of the Union interest, which may consist in the effective implementation of common rules . . ., the preservation of their effet utile, the facilitation of the exercise of Union competence or, only in the field of external relations, in the requirement of unity of external representation for both the Union and the Member States’ (Eleftheria Neframi, “The Duty of Loyalty: Rethinking its Scope through its Application in the Field of EU External Relations”, Common Market Law Review 47 (2010): 325. See also Hillion, “Mixity and Coherence in EU External Relations,” 104–105). 66

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III.  Internal Challenges for Spain 1.  The Development of an ABS System in Spain The Spanish Strategy for the Conservation and Sustainable Use of Biodiversity, adopted in 1999, expressly stated, for the first time, the need to regulate access to genetic resources. The Strategy was divided into two parts, the first one containing a diagnosis of the situation of biodiversity in Spain, and the second comprising a set of proposed measures to implement the three objectives and different areas of the CBD. The latter part the Strategy proposed the development of: •  specific regulations for access to Spanish genetic resources; •  an administrative system to monitor access to Spanish genetic resources that already included a differentiation between access for commercial and non-commercial purposes, which is similar to that found in the Nagoya Protocol; and •  a network of gene banks and botanical gardens, which would include information on access to ex situ collections and in situ genetic resources. It was also planned that, in the future, information on associated traditional knowledge could be incorporated into the network, which would include a database identifying potential users and research institutions in the country so as to ensure that when national resources were accessed, at least the initial stages of research and development could take place in the country through these institutions. That information was seen as a prerequisite in order to channel any access to Spanish genetic resources through local/national research institutions, not only with their direct involvement. Even though the approval of the Bonn Guidelines could have been the right moment for implementing the measures foreseen in the Spanish Strategy for Biodiversity, only some piecemeal activities, such as awarenessraising campaigns aimed at communicating the Bonn Guidelines to Spanish users of genetic resources were budgeted, but not undertaken. The organisation of the fourth meeting of the CBD Working Group on ABS in Granada also meant to raise public awareness in Spain and take advantage of the political momentum created to further develop the measures foreseen in the Biodiversity Strategy. However, most of these developments never occurred. ABS regulation in Spain was eventually advanced by Law 42/2007 on natural heritage and biodiversity. Although preparatory drafts of this law contained multiple specific provisions within a specific chapter on ABS and traditional knowledge, the final text of the law only includes a single article

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on ABS.70 Two related provisions also addressed the protection of traditional knowledge71 and establishment of a network and inventory of banks of germplasm in Spain.72 The provision regarding access to genetic resources refers to the international framework, stating that the regulation of ABS would be made in accordance with the CBD and the International Treaty on Plan Genetic Resources for Food and Agriculture.73 It states that the central government is entitled to regulate access to genetic resources that are located in Spanish territory,74 through a royal decree based on the legitimate exercise of Spanish sovereign rights over genetic resources. Complementarily, the law establishes that, in case the central government decides to regulate access to genetic resources (in situ and ex situ), the competence to grant PIC and negotiate MAT pertains to the Autonomous Communities (the regional level of public administration in Spain).75 Finally, the law recognises that when accessing genetic resources, other limitations (independent conditions/requirements that do not pertain, strictly speaking, to ABS regulation) could exist and compliance with them is mandatory.76 Examples of these are restrictions related to protected species or habitats. As a result, Autonomous Communities cannot proceed to regulate access to genetic resources in their own territories until basic and common national regulation is enacted by the central government. As mentioned above, the Law foresees the creation of a network and inventory of Spanish banks of germplasm.77 This network aims to prioritise the conservation of Spanish wild species and, in particular, of endemic and threatened species. This network78 is now in its final stage of development and it is expected to play a key role in the ABS national system. The Law also addresses the protection of traditional knowledge, by referring, in an unspecific manner, to the role that public administrations will play in:79

 Spain, Natural Heritage and Biodiversity Act, No. 42, 2007 (Law 42/2007) Article 68.  Law 42/2007 Article 70. 72  Law 42/2007 Article 60. 73  Law 42/2007 Article 68.1. [On the International Treaty, see contribution by Chiarolla, Louafi and Schloen in this volume (Chapter 3).] 74  Law 42/2007 Article 68.2. 75  Law 42/2007 Article 68.2. See Section III.2 below. 76  Law 42/2007 Article 68.3. 77  Law 42/2007 Article 60. 78  The network is called REDBAG (detailed information, only in Spanish, available at Red Española de Bancos de Semillas, “redbag,” accessed 10 June 2012, http://www.redbag.es/). 79  Law 42/2007 Article 70. 70 71

286   Alejandro Lago Candeira and Luciana Silvestri •  preserving and promoting the knowledge and practices of customary utilisation that are of interest for the conservation and sustainable use of the natural heritage and biodiversity; •  promoting the fair and equitable sharing of the benefits derived from its utilisation; and •  promoting the development of inventories of traditional knowledge, in particular those of ethnobotanic character. There are no doubts Spain counts on an extensive and unique traditional knowledge associated to its genetic resources.80 This emerges as a consequence of an unparalleled combination of rich biodiversity and the distinctive cultures and peoples the country features. Nevertheless, traditional knowledge associated with genetic resources as envisioned by the Protocol – at least in relation to indigenous communities – does not seem to fit into the Spanish setting, as there are no indigenous communities in the country. As a consequence, the only traditional knowledge related to genetic resources that could require Spain’s actions – always in relation to the Protocol – is that held by local communities. Governmental action will, however, depend on future definition and interpretation of the term ‘local communities,’81 which has the potential to expand or narrow down the range of situations – existence and number of local communities – covered and of interest for the country. The latest public document that refers to access to genetic resources in Spain is the new Biodiversity Strategic Plan,82 whose development was foreseen in Law 42/2007 and that has been adopted in line with the CBD Strategic Plan for 2011–2020. The Spanish biodiversity strategic objectives include regulating ‘access to genetic resources and benefit sharing derived from their utilisation’.83 In a way, the document, therefore, reiterates what was already stated in the previous Biodiversity Strategy of 1999, since most of the actions that had been planned and included in the 1999 strategy are still pending. In addition, the 2011 strategy proposed to: •  identify potential Spanish users of genetic resources; •  establish an administrative system for the access to Spanish genetic resources, which would in turn fulfil what is mandated in Law 42/2007;  Ramón Morales, et al., “Biodiversity and Ethnobotany in Spain,” Boletín Real Sociedad Española de Historia Natural, 9 (2011): 157207. 81  [See contribution by Savaresi to this volume (Chapter 2).] 82  Decree 1274/2011. 83  Decree 1274/2011 Objective 2.7. 80

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•  guarantee the adequate transfer of technology and the fair and equitable sharing of the benefits arising from the sustainable use of genetic resources; •  create an interministerial working group for the development and monitoring of the measures related to access to genetic resources; •  guarantee the coherent management of shared genetic resources (genetic resources occurring across borders), in particular with Portugal, in principle through a common ABS system or, if not possible, through similar measures across the border; and •  promote awareness amongst users on the obligations they might have in relation to the access to genetic resources from other jurisdictions. Against this background, undoubtedly the first challenge is to identify the diverse community of institutions, mainly research institutions, involved in the realisation of these activities, particularly technology transfer. 2.  The Administrative and Competence Division in Spain: Environmental Protection As a Shared Competence Spain is organised, according to its Constitution, as a quasi-federal state composed of 17 Autonomous Communities at the regional level. The Constitution determines that environmental protection is a shared competence between the central government and the Autonomous Communities, with the central government being responsible for the enactment of basic and common environmental legislation.84 Autonomous Communities must respect basic legislation enacted at the central level and are entitled to develop more stringent requirements. They are also competent to management their own environment.85 These overlapping competencies tend to generate numerous conflicts; as a consequence, 50% of all environmental rules adopted by the central government are brought before the Spanish Constitutional Court because of conflicts arising over unclear/overlapping competences between the two levels of the administration.86 ABS legislation has already provided some examples of such competence conflict. Different Autonomous Communities (for instance Catalonia, Andalusia and the Canary Islands) tried to include in their respective biodiversity legislation specific provisions regulating access to genetic resources in their territories. These attempts were rather limited in scope, because they  Spain, Spanish Constitution, 1978 Article 149.1.23.  Spanish Constitution Article 148.1.9. 86  Blanca L. Cutanda, Derecho Ambiental Administrativo (Madrid: La Ley, 2010), 104. 84 85

288   Alejandro Lago Candeira and Luciana Silvestri did not adopt a holistic approach comparable to that of the Nagoya Protocol. These developments took place both before and after the adoption of the new national biodiversity law of 2007. Indeed the latest example of a potential conflict concerns the recent regulation adopted in Andalusia on the conservation and sustainable use of wild flora and fauna and their habitats,87 which unlawfully asserts the competence of the government of Andalusia to regulate access to genetic resources in its territory.88 The Autonomous Community has not waited – as it is required – for the national regulation on ABS to be in place; as a consequence, the recent regulation is likely to be challenged by the central government before the Spanish Constitutional Court. This, in turn, could be used by the Autonomous Community as an opportunity to obtain a clear statement from the Court forcing the central government to regulate ABS as the only way to unblock the exercise of the legitimate competences of the Autonomous Communities. 3.  The Opportunities and Challenges the Nagoya Protocol Brings to the Internal Development of the ABS System in Spain As it has been shown, Spain has had a historical interest in regulating, at the central level, access to its genetic resources in accordance with the CBD and the International Treaty on Plant Genetic Resources. It is very important to keep this interest alive, since it is a well-known fact that ABS issues are not, in general, a political priority. One of the reasons behind this is the complexity of ABS issues: it is difficult to convey to policy-makers the need for the development of a national ABS system as politicians usually cherish short-term political gains, and the interests of public administrations and research institutions, probably have a very low political visibility or relevance to them. It is also true that the present uncertain situation created at the EU level by the entry into force of the Lisbon Treaty and the present internal fight on who should go first (whether the EU or the Member States) in ratifying the Protocol is not helping interested Member States to pioneer on this issue. However, as suggested above, in Spain political pressure could come from the Autonomous Communities, while political momentum has been generated at the national level from the adoption of the Nagoya Protocol as such. The main challenges related to the Nagoya Protocol provisions on access to genetic resources and traditional knowledge, benefit-sharing obligations and compliance measures are also challenges in view of the internal division  Spain, Andalusia, Decree 23/2012, 14 February 2012, that regulates the conservation and sustainable use of wild fauna and flora and their habitats. 88  Decree 23/2012 Article 34. 87

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of competences in Spain. As discussed above, the basic competence for the development of the access regulation is already clarified in Law 42/2007.89 In principle the central government through a royal decree is entitled to legislate on basic conditions for access to genetic resources in the country. These conditions could include a common system of access to genetic resources in Spain based on the direct participation of Spanish research institutions in any access to in situ genetic resources and equivalent conditions to access Spanish genetic resources in ex situ conditions. Research institutions appear as the key pillar for a successful national ABS system as they are the main stakeholder group that understands the value of genetic resources and whose direct involvement could also have a very positive impact on the funding of their activities. At the same time, an ABS system based on a good network of identified and reliable research institutions could reduce the administrative burden and procedures of the public administration, which is also an important consideration for policy-makers. As the competent authorities to grant PIC and negotiate MAT are the Autonomous Communities, the national government could also, via regulation, harmonise the format of key official documents, such as is the case of the final permit to be issued by the Autonomous Communities. Furthermore, the government should require to be officially informed about all permits that have been granted in order to forward this information to the international ABS clearing-house. In developing national legislation, an important issue will be to determine its scope: will all the genetic resources, terrestrial and marine, be covered? Will domestic ABS law only apply to certain genetic resources or to certain areas? This is another important challenge related to the issue of ownership of genetic resources. It could be said, for simplicity purposes, that the legal status of natural resources and genetic resources in Spain is undefined. Spain does not have a constitutional provision, as other countries do, asserting State ownership over its natural and/or genetic resources. The only relevant constitutional provision asserts that the State’s public property or public domain includes coastal areas, beaches, the territorial sea and natural resources of the exclusive economic zone and the continental shelf, or any other determined by law,90 which is the case of inland waters.91 Spain, therefore, has two main options. First, it could use this opportunity to clarify the ownership of genetic resources as public property by law, according to the Constitution. However, this does not seem to be a realistic possibility. Second, it could simply skip the question of ownership and focus  Law 42/2007 Article 68.2.  Spanish Constitution Article 132. 91  Spain, Water Law, No. 29, 1985. 89 90

290   Alejandro Lago Candeira and Luciana Silvestri on areas and resources over which the State clearly has public property or public domain. This approach would mean in practical terms that all marine genetic resources would be covered by the domestic ABS framework, and in principle would be managed by the central government, as would land and genetic resources obtained in protected areas or public land. A third possibility would be to regulate access to target species (endemic, endangered or threatened), which in a sense would be a mix of the previous two options. The issue of access to traditional knowledge associated with genetic resources also generates numerous challenges. As mentioned before, Spain counts on a rich traditional knowledge heritage, some of which is held by ‘local populations’ – which is the term used in the definition of traditional knowledge under Spanish law.92 As noted above, further work at the international and national levels is needed with regard to the traditional knowledge of local communities. Inaction on this front has the potential to negatively affect Spain, since the Nagoya Protocol only requires protection of traditional knowledge in third-country jurisdictions if this has been accessed in breach of the national legislation of the country where the knowledge originates from.93 This means that as Spain has not regulated access to traditional knowledge, it will not be able to claim misappropriation of traditional knowledge by third Parties, or at least not under the Nagoya Protocol. The best course of action, therefore, appears for the time being to regulate, in general terms, access to traditional knowledge and update regulation in light of future international developments as they occur. The second main area, benefit-sharing obligations, in principle should not be difficult to implement, at least when it comes to benefits arising from Spanish genetic-resources as Spain is sovereign to determine what to do and how to distribute those benefits. The only limitation in this regard established by the Nagoya Protocol is the encouragement to direct benefits towards the conservation of biodiversity.94 The determination of research institutions as the cornerstone of the ABS national system would send a clear signal that benefit-sharing is mainly related to the involvement and participation of these institutions. Of course that would not impede that MAT should include general clauses that could direct part of the economic benefits generated by the final user to specific public funds already in place to support biodiversity conservation at the regional or national level. The same kind of provision could be included with regard to specific national or regional funds and projects related to biotechnology development in Spain. As to the  Law 42/2007 Article 3.  Nagoya Protocol Article 16. 94  Nagoya Protocol Article 9. 92 93

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benefits arising from the utilisation of genetic resources from other jurisdictions, Spain, as a user country, will be able to fulfil its obligation under the Protocol mainly through the fulfilment of the specific provisions related to compliance measures. In this regard, the main challenge foreseen is the establishment of appropriate measures at the different levels of the administration (national and regional). The national government must establish basic legislation applicable in all the Spanish territory. A possible system to comply with compliance obligations95 would be the enactment of a general prohibition to utilise genetic resources and/or traditional knowledge associated to genetic resources that have been acquired in third countries without complying with the ABS regulations of those countries. This prohibition must be complemented by the requirement to submit information relevant to the utilisation of genetic resources to the designated checkpoints. As mentioned above,96 there are different options, particularly with regard to the selection of checkpoints. National government could designate the national patents office as the Spanish ABS checkpoint, which would ensure effective and coherent application of the law across the entire territory. It is advisable that the Autonomous Communities also establish complementary checkpoints according to their competencies in order to increase the effectiveness of control. Checkpoints are to receive relevant information on the utilisation of genetic resources occurring within their jurisdiction. This information will be later provided by the checkpoint to ‘relevant national authorities, the Party providing PIC and the ABS clearing-house’97 so that they can control the legality of a particular access to genetic resources by contrasting available data. Nevertheless, it has to be noticed that amongst the three mentioned ‘controllers’, there is one that is ‘more interested and better suited’98 to check the legality of such access – the providing country. For this reason, it is highly recommendable that Spain designates an institution responsible for monitoring the utilisation of Spanish genetic resources abroad. Of course, as involvement of Spanish research institutions is the key element of a successful access regime, once again it would make sense to give them a role also in monitoring the utilisation of Spanish genetic resources.  Primarily Nagoya Protocol Articles 15, 16 and 17.  Section II.1. 97  Nagoya Protocol Article 17.1.a.iii. 98  The country providing genetic resources is the most interested party in ensuring its national legislation on access to genetic resources is honoured. In addition, it is best suited to check if access to its genetic resources was lawful or not because it counts on direct and reliable information on facts that occur within its jurisdiction and under its own legal system. 95 96

292   Alejandro Lago Candeira and Luciana Silvestri An important challenge that still remains in this area, relates to compliance measures related to traditional knowledge. If compliance with access measures regarding genetic resources will entail a certain degree of complexity, the difficulties increase exponentially in the case of traditional knowledge. First of all, this is because genetic resources are clearly identified and defined as the object of regulation, whereas this is not the case for traditional knowledge. That, in conjunction with the lack of measures to control or monitor the utilisation of traditional knowledge included in the Nagoya Protocol,99 makes the obligation concerning compliance with measures on access to associated traditional knowledge in the Nagoya Protocol,100 for the time being, dependent on the conclusion of the ongoing negotiations in other international fora, notably in the World Intellectual Property Organisation (WIPO) or the World Trade Organisation (WTO), and from the experience of other countries that have been dealing with this issue in an effective manner. In this sense many countries, including Spain, would have to learn how to differentiate what is and what is not ‘traditional’ knowledge. The first step in this regard for Spain could be the exchange of views and experience with neighbouring countries, such as Portugal which regulated traditional knowledge in an extensive manner in 2002.101 Finally, the careful development, at this preliminary stage of implementation of the Nagoya Protocol, of a balanced user-provider national ABS system could be an important comparative advantage for Spain. The Protocol is so loyal to the bilateral ABS approach embedded in the CBD that it has established a similar approach to compliance, which is a clear diversion from the normal practice in international law where compliance measures normally are harmonised and applied in the same way by all Parties. It appears quite likely that a certain degree of harmonisation will nonetheless occur through best practice and on a reciprocal basis. In this sense, the development of an effective compliance regime at the national level would not only be the best ‘business card’ for Spanish research institutions or companies when bioprospecting abroad, but also a good example to be followed by others in developing their own national ABS systems.

 As mentioned above, Nagoya Protocol Article 17 on monitoring access to genetic resources does not include any reference to traditional knowledge. 100  Nagoya Protocol Article 16. 101  Portugal, Decree-Law establishing a Legal Regime for the Registration, Conservation, Legal Safeguarding and Transfer of Autochthonous Plant Material as well as Associated Knowledge, No. 118, 2002.   99

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IV.  Conclusions—Making Sense of the Implementation Challenges of the Nagoya Protocol in a Multilevel Context? Spain’s in-depth engagement in the international negotiations on ABS, and its unique biodiversity features within the European context, contribute to its balanced view on ABS as both a provider and user country. Nevertheless, for different reasons, these have not yet materialised into a complete domestic ABS regulatory system. The conclusion of the Nagoya Protocol seems to be a unique opportunity to create the political and technical momentum to put in place a balanced and effective ABS system in Spain. The above analysis of the relevant multi-level competences within the EU shows that the key entry point in operationalising the Nagoya Protocol should be at the Member State level. There are no legal impediments preventing Member States of the EU to proceed to early ratification and, as a consequence, to develop national ABS legal regimes. Spain is fully capable and competent to adopt necessary measures to comply with all obligations prescribed by the Protocol. In any case, it is also clear that if Spain opts to do so, it will have to comply with the duty of loyal cooperation towards the EU and, therefore, must inform and consult on domestic measures with the relevant EU institutions. The opposite conclusion (i.e., that the EU should go first in the process of ratification or even in conjunction with Member States) would have very negative consequences on the pace of the development of environmental policy at the EU level and on the degree of involvement of individual Member States in international environmental negotiations (and also in their implementation). This could even lead to a race to the bottom, where Member States, interested in a specific area of environmental policy, and the EU as a whole will be forced to follow the pace of other Member States without an interest in developing such a policy at all. But the immediate superior level (the EU) will not be the only challenge for Spain in the adoption of measures implementing the Nagoya Protocol. Spain will have also to deal with the complexities of its constitutional system, in particular with the competences of the Autonomous Communities at the regional level. Here the challenge will be to harmonise the system as much as possible, adopting key compliance measures at the national level, while respecting the level of autonomy and leaving opportunities for the development of the basic legislation by the Autonomous Communities. The above analysis also highlighted significant substantive challenges and important developments that are still pending at different levels with regard to traditional knowledge associated with genetic resources, particularly in relation to the elusive group of ‘local communities.’ Nonetheless, the main challenge for the implementation of the Nagoya Protocol is the mere existence

294   Alejandro Lago Candeira and Luciana Silvestri of this multilevel competences context, which has the potential to become the perfect trap in maintaining the status quo and prolonging political inertia. For that reason, the Nagoya Protocol and, in general, biodiversity issues require determined technical bureaucrats and politicians with the vision and the ambition to change reality – both of which seem to be threatened species at the time of writing.

Chapter 10.  Implementation of the Nagoya Protocol in Juscanz Countries: The Unlikely Lot Geoff Burton* This chapter explores the role of the JUSCANZ group of countries in the negotiations of the Nagoya Protocol and in shaping its implementation. In particular, it shows the contribution to the final shape of the Protocol of lessons learned in the implementation of the Bonn Guidelines on access and benefit-sharing (ABS)1 by certain JUSCANZ Members. The chapter also shows JUSCANZ Members’ negotiating limitations derived from their individual domestic legal systems. The chapter then assesses current implementation challenges flowing from JUSCANZ’s contribution. In doing so, it focuses on selected aspects of the Nagoya Protocol, namely the issue of ‘pure’ or non-commercial research,2 the use of indigenous peoples’ and local communities’ traditional knowledge associated with genetic resources, the resolution of the ‘derivatives’ issue and the creation of internationally recognized certificates of compliance.3 The chapter begins by examining the make-up of JUSCANZ as a group, explaining how it functions and how it is perceived. It then describes its Members’ contribution to the above-mentioned four key features of the Protocol. It examines, in more detail, JUSCANZ Members’ approach to the issues of access for non-commercial research and traditional knowledge and outlines the challenges they face in implementing those aspects of the Protocol. In doing so it focuses in more depth on the five member countries more closely involved in traditional knowledge issues: Australia, Canada, Norway, New Zealand and the United States. The chapter takes as its starting point that the disparate nature of JUSCANZ’s Members means that they have taken no cohesive or uniform * Adjunct Senior Fellow, United Nations University Institute of Advanced Studies. 1  CBD Decision VI/24, “Access and benefit-sharing as related to genetic resources” (2002) UN Doc UNEP/CBD/COP/6/20. 2  Nagoya Protocol Article 8. 3  Nagoya Protocol Articles 5, 6, 7, 11 and 12.

296   Geoff Burton approach to issues but acknowledge that each, in its own way, has taken an approach with some striking underlying similarities. The chapter examines why this is so, the implications for implementing the Protocol and what challenges are to be overcome.

I.  The Who and How of JUSCANZ JUSCANZ stands for Japan, the United States, Canada, Australia and New Zealand. Within the context of the Convention on Biological Diversity (CBD) this grouping includes other developed countries: principally Norway and Switzerland. From time to time its meetings have also included Mexico, Korea, and Singapore. The group sits within the United Nations system of regional groupings as a sub-set of Western European and Others.4 JUSCANZ might be understood as those ‘western’, economically developed countries that are not part of the European Union (EU). This understanding helps explain the membership of Switzerland, Norway, Japan and Mexico. JUSCANZ does not consider itself a negotiating group but, rather, an information-sharing group. As such, its Members have the flexibility to support each other where a consensus negotiating position exists or to follow their individual national interests where it does not. Consequently, the coordination difficulties faced by the EU, the African Group or the Group of Latin American and Caribbean countries (GRULAC) in settling or changing a position during negotiations do not apply to JUSCANZ. In understanding the role of JUSCANZ it should also be noted that the United States, the largest and usually most influential country in JUSCANZ, cannot directly participate in CBD negotiations. Although it is a signatory to the Convention, the United States did not ratify it and is, accordingly, confined to observer status under CBD processes. Thus the US is confined to lobbying countries, making statements at the end of formal discussions by CBD Parties and to relying on like-minded countries to advance shared positions during negotiations. As a result, developed country leadership largely rests with the 27-Member EU and the European Commission. The CBD is distinctive among multilateral environmental treaties for the emergence of informal negotiating groups involved in negotiating major issues. These include: the group of developing countries (Group of 77 and China),5 the Association of Small Island States, and the Group of Like-minded

 The other groupings are Africa, Asia-Pacific, Central and Eastern Europe (CEE) and Latin American and Caribbean (GRULAC). 5  See: http://www.g77.org/ (accessed 14 June 2012) for examples of its collective positions. 4

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Mega-diverse Countries (LMMC).6 Confusingly, some countries belong to more than one grouping. For example the Group of 77 and China draws its membership from across regional groups, as does the LMMC. This can lead to delicate ethical situations. For example, during negotiations at the CBD’s Open-ended Inter-Sessional Meeting on the Multi-Year Programme of Work,7 Mexico8 was, simultaneously, a Member of JUSCANZ, GRULAC and the LMMC. As such, it faced a conflict of interest as the remainder of JUSCANZ held a consensus-based negotiating position contrary to those of both GRULAC and the LMMC. Mexico dealt with this difficulty by volunteering to only attend the information-sharing part of JUSCANZ’s daily coordination meetings and to absent itself before the start of any broader discussion about negotiation positions. It maintained this ethical position despite some pressure from other Parties to the CBD.9 Compared to such complexities and competing priorities, the informal nature of JUSCANZ means its Members are free to nuance their approaches to issues in line with their perceived national interests and circumstances. Nevertheless JUSCANZ has degrees of like-mindedness. These are affinity elements based on Member’s historic ties and their similar economic interests. In the case of Canada, the US, Australia and New Zealand, they are predominantly English-speaking, post-colonial societies inheriting commonlaw legal systems and political philosophies from Britain. For Norway and Switzerland, membership is not linked to common history but rather to the fact that both countries are not part of the EU and would not otherwise sit within a regional grouping. Nevertheless, Norway and Switzerland are both developed economies and hold similar views on environmental, trade and economic issues to those held by the four former British colonies. Japan also has close ties with the US and possesses a highly developed economy that reduces its affinity with other Asian nations. Mexico is a post-colonial society, but its historic ties lie with Spain and Latin America. However, it sees itself as a developed country and has strong ties to the US through the North American Free Trade Agreement and its membership of the Organisation of Economic Cooperation and Development, the World Trade Organisation (WTO) and related bodies. During the course of the negotiations for the Nagoya Protocol Mexico’s engagement with JUSCANZ  This sub-grouping includes Bolivia, Brazil, China, Colombia, Costa Rica, Democratic Republic of Congo, Ecuador, India, Indonesia, Kenya, Madagascar, Malaysia, Mexico, Peru, Philippines, South Africa and Venezuela. 7  Montreal, Canada, 17–20 March 2003. 8  [Cabrera discusses Mexico’s implementation challenges in his contribution to this volume (Chapter 11).] 9  This was arranged with the chair of JUSCANZ. Author’s recollection as chair of JUSCANZ in 2003 and as the JUSCANZ representative on the Bureau of the CBD. 6

298   Geoff Burton declined as a consequence of its natural alignment with GRULAC and the LMMC. JUSCANZ is also distinguished from other negotiating blocks by the presence of indigenous peoples within most of their territories. This applies to the US (Native Americans, Inuit and Native Hawaiians), Canada (First Nations, Inuit and Metis), Australia (Indigenous and Torres Strait Islander Peoples), New Zealand (Maori), Norway (Sami) and Mexico (Pueblos Indigenas). Accordingly, JUSCANZ Members have a direct interest in the utilisation of traditional knowledge associated with genetic resources. A feature of the indigenous peoples living within JUSCANZ Members’ territory is that their traditional knowledge is largely based on oral traditions. This distinguishes them from countries like India whose traditional knowledge has a long written tradition. As well, it is important to note that indigenous citizens of JUSCANZ Members play a significant role within nongovernment indigenous representative bodies represented at CBD meetings. This can lead to a divergence of policy views between the International Indigenous Forum on Biodiversity (IIFB) and that of JUSCANZ Members. This will be discussed later in more detail. The combination of economic development, biodiversity and indigenous populations has had an impact on JUSCANZ Members’ inputs into the negotiation of the Nagoya Protocol and its predecessor, the Bonn Guidelines. It also affected the way other competing regional and political groupings saw its Members and sometimes led to misperceptions as shown in the next section. 1.  Perceptions and Policy Innovation: Certificates of Compliance and Derivatives The G-77/China and other developing countries view JUSCANZ in similar terms to the EU – that is, as a group of developed countries and, therefore, principally as users of genetic resources, i.e., not as ‘provider countries’.10 Such perceptions are not accurate as the US, Australia and Mexico are each mega-diverse countries. For example, of the world’s 17 mega-diverse countries, Australia has the highest level of endemism among non-fish vertebrate species and fifth highest level among plant species.11 Mexico and the US have a diversity of terrestrial and marine ecosystems, while in Canada and New  [On a European country being both provider and user country, see contribution by Lago to this volume (Chapter 9).] 11  Australian Government Department of Sustainability, Environment, Water, Population and Communities, “Biodiversity Theme Report,” accessed 4 March 2012, http://www.envi ronment.gov.au/soe/2001/publications/theme-reports/biodiversity/biodiversity01-3.html, Figures 1 and 2. A more complete picture of Australian endemism can be found in Arthur D. Chapman, “Numbers of Living Species in Australia and the World” (Report for the Australian Biological Resources Study, 2nd edition, Canberra, Australia, September 2009), 10

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Zealand the possession of significant proportions of unsettled, or lightly settled land, taken together with their extensive marine curtilages, offer them considerable biodiversity for exploration and research. Norway, a small country in terms of overall territory but with an extensive coastline, has become a base for Arctic marine research based at Svalbard.12 Thus many JUSCANZ countries are naturally users and providers of genetic resources. The ability of JUSCANZ Members to understand the interests of genetic resource providers and of its users has assisted in the development of key innovations now included in the Nagoya Protocol. In particular, as early implementers of the Bonn Guidelines, some JUSCANZ Members provided useful lessons to the negotiation of the Protocol. For example, Australian and Mexican officials13 refined the concept of internet-based international recognition of national permits as evidence of lawful use during informal discussions at the 2004 International Expert Workshop on Access to Genetic Resources and Benefit-Sharing hosted by Canada and Mexico.14 The new Australian conceptual approach initiated at that meeting was subsequently unveiled at the second International Expert Workshop on ABS held in Cape Town in 2005.15 Australia subsequently introduced this concept into its own ABS law in December 2005. In the following year, it began placing ABS permit information on the Internet to provide international verification of compliance with Australian law.16 The information, thus, published gave verifiable evidence to industry, governments, non-government bodies and to the scientific accessed 4 March 2012, http://www.environment.gov.au/biodiversity/abrs/publications/ other/species-numbers/2009/pubs/nlsaw-2nd-complete.pdf. 12  Foreign research stations based in Svalbard include: the British research station, Harland House; the Italian research station, Dirigibile Italia; the Korean Arctic Station at Ny-­ Ålesund; the Chinese Yellow River research station; the Polish Polar research Station at Polar Bear Bay (Isbjørnhamna); Hornsund fjord; and the Russian research facility at the Barentsburg Observatory. 13  These talks were held between Jose Carlos Fernandez-Ugalde of Mexico and the author. See, also, José C. Fernández-Ugalde, “Elements for the Design of a Certificate of Legal Provenance”, in Proceedings of the International Expert Workshop on Access to Genetic Resources and Benefit Sharing (Final Report, Environment Canada and CONABIO, 24–27 October 2004); and Geoff Burton, “National Access Laws: Challenges, Benefit-sharing, Monitoring and Enforcement – Disclosure of Information: Patent Applications, in Proceedings of the International Expert Workshop on Access to Genetic Resources and Benefit Sharing” (Final Report, Environment Canada and CONABIO, 24–27 October 2004). 14  Ibid. 15  Geoff Burton and Ben Phillips, “Developing a System of Virtual Certificates of Origin and Provenance” (paper presented at International Expert Workshop on ABS, Cape Town, September 2005). 16  See Australia, Environment Protection Biodiversity Conservation Regulations, 2000, Part 8A and Australia, Environment Protection Biodiversity Conservation Act, No. 91, 1999, section 515A: this authorises and requires internet publication of permits.

300   Geoff Burton research community that the named individuals and organisations had been granted access to identified Australian biological resources for the purpose of research and development on its genetic and biochemical make-up, and that prior informed consent (PIC) had been given and mutually agreed terms (MAT) were established in accordance with Australian law. The Australian approach to the creation and use of virtual certificates of compliance was later described in its submission17 to the CBD.18 With some refinements, this on-line system of virtual certificates of compliance has been operating for six years. Demonstrating that this innovation was practical and generated no unintended consequences helped give credibility to the conclusions of the CBD’s Group of Technical Experts on an Internationally Recognised Certificate of Origin/Source/Legal Provenance established in 2006.19 It reported that the common elements of all certificate proposals were that: •  a certificate would be a public document issued by a competent national authority; •  it would serve to provide evidence of compliance with national ABS legislation; •  it could be required for presentation at specific checkpoints in user countries; •  all genetic resources subject to national legislation would be covered. It also found that under the proposal for a certificate of legal provenance, certificates would be recorded in an international clearing-house. Australia’s piloting of a successful national system of certificates of compliance facilitated its consideration as a preferred option and assisted its ultimate acceptance by the CBD Conference of the Parties (COP) in Nagoya in 2010 as a key part of the Protocol. Under the Protocol, an internationally recognised certificate of compliance is created when an access permit is sent  Australia, National Submission on Certificates of Origin, Source or Legal Provenance, in CBD, “Compilation of Submissions Provided by Parties, Governments, Indigenous and Local Communities, International Organisations and Relevant Stakeholders regarding an Internationally Recognized Certificate of Origin/Source/Legal Provenance” (20 October 2002) UN Doc UNEP/CBD/GTE-ABS/1/3. 18  Specifically, to the CBD Ad Hoc Open-Ended Working Group On Access And BenefitSharing, held in Geneva, 21–25 January 2008. 19  CBD Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing, “Report of the Meeting of the Group of Technical Experts on an Internationally Recognised Certificate of Origin/Source/Legal Provenance,” (20 February 2007) UN Doc UNEP/CBD/WGABS/5/7. 17

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to the ABS clearing-house for publication. This must show a national competent authority has granted it with PIC and that MAT have been established.20 It addresses a primary Protocol implementation challenge: how do users and providers know that specific genetic resources have been lawfully obtained and are made available on established terms? This innovation then becomes the cornerstone of ‘user’ country compliance in the Protocol and the source of legal certainty for all involved.21 2.  Derivatives The way in which the divisive issue of ‘derivatives’ was addressed is the second example of the benefit of combining the perspective of both a user and a provider of genetic resources. Developing countries had long expressed concern that products derived from genetic resources could not be regulated and hence their sovereign rights over their natural resources could not be safeguarded. In their view, benefits arising from products derived from research on genetic resources would be lost to developed economies. The nub of the problem was that value, generally, lay not in genes themselves but in the proteins genes produced, whereas the language of the CBD does not address this.22 This issue was a continuing concern during negotiations for the Bonn Guidelines and, later, during the negotiations for the Nagoya Protocol. Perceived inadequacies in the CBD definitions of ‘genetic resources’ and ‘genetic material’23 made finding a resolution difficult without reopening the terms of the CBD. Developed countries such as the United States pointed out that any measure encompassing derivatives of genetic resources was fraught with difficulties and unintended consequences. In its view, encompassing derivatives would logically include all the elements of commodity trade such as grains, timber, fish, honey, seeds and wildflowers. It would also include all man-made products, ranging from biochemical extracts to chairs and was thus an unworkable proposition. Prompted by the international experts’ policy dialogue hosted by Canada and Mexico at Cuernavaca in 2004, Australia began to focus on the intent of  Nagoya Protocol Articles 6.3.e, 14.2.c, 17.2, 17.3 and 17.4.  Nagoya Protocol Articles 15 and 16. For a full background discussion of the proposed link between certificates of compliance and ‘user’ country compliance measures, see Brendan Tobin, Geoff Burton and José C. Fernandez-Ugalde, “Certificates of Clarity or Confusion: The search for a practical, feasible and cost effective system for certifying compliance with PIC and MAT” (UNU IAS Report, 2008). 22  [See contribution by Glowka and Normand to this volume (Chapter 1).] 23  CBD Article 2. 20 21

302   Geoff Burton utilisation rather than focusing on defining the nature of the material to be utilised. Taking this approach, Australia sought to resolve the issue of derivatives in relation to the subject-matter scope of the Protocol by defining the purpose that lies behind taking genetic resources. It concluded that the intention was to research the genetic and biochemical makeup of organisms and develop what was discovered in that process. To this end, it then included a definition of ‘access to genetic resources’ in its ABS law that said in part ‘access to genetic resources’ means: ‘. . . the taking of a biological resource for the purpose of research and development on its genetic and biochemical make-up . . .’ This definition of ‘access’ in Australia’s ABS law made it clear that commodity use was excluded from consideration but that all scope for scientific research and discovery was covered. This definition has been in force since 200524 and has generated no legal difficulties. The focus on the ‘intent’ behind the taking of resources opened the door to a more productive dialogue during the negotiation of the Nagoya Protocol. The creative compromise solution eventually reached, and reflected, in the Protocol was to define the term ‘utilisation’ (of genetic resources) in terms of its intended use. Thus it is defined in the Protocol as meaning . . . to conduct research and development on the genetic and or biochemical composition of genetic resources including through the application of biotechnology . . .25

The definition adopted in the Protocol can be criticised for not making it clear that ‘utilisation’ applies to the proteins that genes produce. The counter to this argument is several-fold. Firstly, the reference to the application of biotechnology provides sufficient scope to cover the study of the operation of genes and necessarily includes its internal processes, means of communication, production of proteins and the interaction of RNA and DNA. Secondly, in order for research and development to take place, biological material containing genes must be collected and accessed for ‘utilisation’ to occur. Thirdly, under CBD Article 3, States have sovereign rights over their natural resources. Therefore, the taking of biological material to utilise its genetic and biochemical composition lies within the scope of national law and of the CBD in the exercise of countries’ sovereign rights. Fourthly, and finally, the overarching principles of the CBD, are conservation, sustainable use and

 Australia, Environment Protection Biodiversity Conservation Regulations, 2000, Regulation 8A.03 (Meaning of access to biological resources). 25  Nagoya Protocol Article 2.c. 24

Implementation of the Nagoya Protocol in Juscanz Countries   303 . . . the fair and equitable sharing of benefits arising out of the utilisation of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and by appropriate funding.26

Therefore ‘appropriate access’ requires taking biological material at some point in order to access its genetic make-up. Taking these four rebuttals together, any narrow, or constrictive, interpretation of the Protocol’s definition of ‘utilisation’ would appear to run counter to the objectives of the Convention, and to the objective of the Protocol.27 This being the case, the only available conclusion must be that the utilisation of genetic resources and its biochemical composition must include its internal processes, means of communication, production of proteins and the study of the interaction of RNA and DNA. Moreover, the intention of both the CBD and the Protocol is that the outcome of research and development will be shared fairly and equitably. To take a narrow view and exclude everything produced by genes would, accordingly, run counter to the objectives of the CBD and its Nagoya Protocol. Such a view cannot therefore be supported. While both the Australian and the later Protocol definitions relating to the intent of the use of genetic resources are not without criticism, they demonstrate the advantage JUSCANZ had in having Members who were demonstrably both providers and users of genetic resources, and also have the resources to pioneer these innovative legal solutions. This situation facilitated discussions among JUSCANZ Members and, consequently, made a positive contribution to subsequent negotiation debates leading to the adoption of the Protocol. The value of experience amongst JUSCAZ in the operation of a domestic ABS system is seen in other ways, as the next section shows.

II.  Approach to Supporting Pure or Non-commercial Research During the negotiation of the Bonn Guidelines and later of the Nagoya Protocol, it was made clear by JUSCANZ that the establishment of norms for the utilisation of genetic resources should avoid creating obstacles to the conduct of ‘pure’ or basic research. Stakeholders including the Smithsonian Institution, Royal Botanic Gardens Kew, the International Plant Exchange Network and Botanic Gardens Conservation International along with the administrators of the Micro-Organisms Sustainable Use and Access Regulation International

 CBD Article 1 (emphasis added).  CBD Article 1 is repeated in Nagoya Protocol Article 1.

26 27

304   Geoff Burton Code of Conduct also made this point in side-events, corridor discussions, and in submissions to their respective governments and to the CBD.28 The subsequent negotiated language of the Bonn Guidelines reflects this concern by stating Taxonomic research, as specified in the Global Taxonomic Initiative, should not be prevented, and providers should facilitate acquisition of material for systematic use and users should make available all information associated with the specimens thus obtained.29

There is further reference in the Bonn Guidelines,30 where it identifies the specific needs of taxonomic and systematic research as matters for consideration when considering granting PIC. JUSCANZ Members, like many Members of the EU, have close ties to the scientific research community. Foremost for the United States was the policy support provided by its Smithsonian Institution for the US’s engagement on ABS matters.31 Understanding the importance and interests of ‘basic science’ was easier for those involved in taxonomy and systematics. Thus Australia and Demark had vied to host the Global Biodiversity Information Facility Secretariat.32 Mexico and Australia had established similar taxonomic research institutions.33 Canada, through the University of Guelph, leads the world in the development of DNA barcoding of species.34 Norway has undertaken major genetic resources for food and agriculture conservation action in its establishment of international seed vault at Svalbard in the Arctic.35 Australia has taxonomic staff located at the Royal Botanic Gardens, Kew;36 it has created the Atlas of Living Australia; and it introduced the notion of  E.g., CBD Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing, “Position Paper Submitted by the Swiss Academy of Sciences,” (13 July 2010) UN Doc UNEP/CBD/ WG-ABS/9/INF/16. 29  Bonn Guidelines, Part 1 Section E sub-paragraph 11(l). 30  Bonn Guidelines, Section IV paragraph 34. 31  The Smithsonian Institution has been routinely included in US delegations to ABS working groups for both the Bonn Guidelines and the Protocol. 32  The Australian Government Department of the Environment supported the bid with a funding undertaking, led by the late Dr Ebbe Nielsen who died en-route to the OECD meeting. Author’s direct knowledge. 33  Mexico’s National Commission for Knowledge and Use of Biodiversity and the Australian Biological Resources Study. 34  Bold Systems, accessed 31 May 2012, http://www.co1bank.uoguelph.ca/. 35  Ministry of Agriculture and Food, “Svalbard Global Seed Vault,” accessed 31 May 2012, http:// www.regjeringen.no/en/dep/lmd/campain/svalbard-global-seed-vault.html?id=462220. 36  Australian Government Department of the Environment, Water, Heritage and the Arts, “The 50th Australian Botanical Liaison Officer,” accessed 31 May 2012, http://www.envi ronment.gov.au/biodiversity/abrs/publications/other/biologue/31/index.html#ablo. 28

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rapid-attack taxonomy and citizen science.37 The Swiss Academy of Science has developed extensive guidelines for its scientific community when undertaking non-commercial and commercial research.38 The US and its partners are building the global Encyclopedia of Life.39 With this level of engagement in mind there was considerable sympathy for the views expressed by representatives of the scientific and research community that the Protocol should not impede the conduct of ‘public good’ or non-commercial science. Representatives of the scientific community within the EU reinforced this view.40 1.  JUSCANZ and the EU—Engagement by Other Means When the co-chairs of the negotiations of the Nagoya Protocol changed the format and dynamics of the negotiation process, the voice of the international research community went beyond influencing government delegations at home or in corridor discussions. The co-chairs introduced a modified ‘Vienna setting’ to assist the negotiation process, termed an Inter-regional Negotiating Group. It was established in March 2010.41 The setting comprised five representatives for each UN region; two representatives each for indigenous and local communities, civil society, industry and public research. The arrangement restricted the number of negotiators at the table to representatives of the negotiating groups and opened the way for representatives of key stakeholders to participate (albeit at the invitation of the co-chairs).42

 Atlas of Living Australia: sharing biodiversity knowledge, accessed 31 May 2012, http:// www.ala.org.au/. 38  Swiss Academy of Sciences, “Access and Benefit Sharing: Good Practice for Academic Research,” accessed 31 May 2012, http://abs.scnat.ch/. 39  Encyclopedia of Life, accessed 31 May 2012, http://eol.org/. 40  “Preserving International Access to Genetic Resources for Non-commercial Biodiversity Research” (Report of an International Workshop on Access And Benefit-Sharing In NonCommercial Research, Museum Koenig, Bonn, Germany, November 17–19, 2008), accessed 31 March 2012, http://www.cbd.int/abs/doc/cbol-dfg-bonn-abs-article-en.pdf. The development of the International Plant Exchange Network (IPEN) is an example of the result of the detailed engagement of European taxonomic institutions with their governments to address the implications of the implementation of the CBD (BGCI, “History of IPEN,” accessed 30 March 2012, http://www.bgci.org/resources/History_of_IPEN/). 41  This was during the ninth session of the Ad hoc Open-ended Working Group on Access and Benefit-Sharing in Cali, Colombia (CBD Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing, “Report of the First Part of the Ninth Meeting of the Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing,” (26 April 2010) UN Doc UNEP/CBD/WG-ABS/9/3). 42  Leave to make interventions by these invited non-parties was usually arranged beforehand with the exception of indigenous and local communities. This latter group was more directly 37

306   Geoff Burton The co-chairs invited the United Nations University, with the support of representatives of the scientific community,43 to represent the broader research community, which44 encouraged countries to include a provision for simplified access for non-commercial scientific research. Suggested text was explored with the EU, individual JUSCANZ Members and other negotiating groups including GRULAC. While developing countries and the LMMC were not unsympathetic, they were concerned that such a provision might create a loophole in the system of PIC and MAT; where research might be designated non-commercial to avoid inconvenience and then any commercialisation could only be undertaken illegally and thus ‘bio-piracy’ encouraged. Research representatives45 responded that any simplified system would include provision for change of purpose. Moreover, they were able to advise that change of purpose safeguards already existed and had been working satisfactorily in the Australian jurisdiction for some years under its ABS law. Reference was thus made to the Australian ABS Statutory Declaration for non-commercial research – a legal document to be signed by the researcher and subject to criminal penalty for untruthfulness, where the researcher: •  confirms that the research is non-commercial; •  undertakes to provide a copy of his research to the access provider; •  will offer a taxonomic duplicate of any sample collected to a public national collection; •  will not pass on any sample or extract to a third party without permission; and •  will not to carry out, or allow others to carry out, research or development for commercial purposes on any genetic resources or biochemical compounds comprising or contained in the biological resources unless a benefit-sharing agreement has been entered into with each access provider.46 Although the wording on non-commercial research in the draft Protocol text was not finalised before the conclusion of negotiations, enough of a common engaged in the ING discussions as issues around the utilisation of traditional knowledge associated with genetic resources and were given special latitude. 43  Undertaken through United Nations University representative, Mr Geoff Burton. 44  With the support of representatives of the Berlin Natural History Museum (Dr Christoph Hauser), the Swiss Academy of Science (Dr Susette Biber-Klemm) and others. 45  Mr Geoff Burton, Dr Christoph Hauser and Dr Susette Biber-Klemm. 46  A copy of this document can be down loaded at Australian Government Department of Sustainability, Environment, Water, Population and Communities, “Permits – accessing biological resources in commonwealth areas,” accessed 30 March 2012, http://www.envi ronment.gov.au/biodiversity/science/access/permits/index.html.

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view was eventually included in the final provision of the Protocol on simplified measures on access for non-commercial research purposes, taking into account the need to address a change of intent for such research.47 For JUSCANZ Members, the international nature of scientific collaboration was a well-understood feature of their national taxonomic research institutions and support for simplified access for non-commercial research was easier to obtain than for countries whose colonial experience included the removal of species under the name of ‘Economic Botany’, with no resulting economic benefits being shared. Confidence among parties for the implementation of such a provision was increased by the knowledge of its successful introduction and operation by Australia. This understanding placed other JUSCANZ Members in the position to undertake initiatives of their own that go directly to other challenges in implementing the Protocol. These initiatives are discussed below. 2.  Switzerland Switzerland has taken a multi-pronged approach to addressing the challenge of implementing the Protocol in domestic law and facilitating its operation. Firstly, it financially supported the development of a guide to the implementation of the ABS aspects of the CBD and its Bonn Guidelines,48 which aimed to assist non-commercial researchers in companies, research institutions and communities as well as governments.49 The Swiss government has continued its support for an updated and revised version to assist users to prepare for the entry into force of the Nagoya Protocol.50 Secondly, and more specifically the Swiss Academy of Science has provided comprehensive guidance for researchers,51 which is supported by the further publication of a model ABS contract designed for the academic community.52

 Nagoya Protocol Article 8.a.  State Secretariat for Economic Affairs SECO, “ABS-Management Tool: Best Practice Standard and Handbook for Implementing Genetic Resource Access and Benefit-sharing Activities,” accessed 31 May 2012, http://www.iisd.org/pdf/2007/abs_mt.pdf. 49  The International Institute for Sustainable Development will release the updated version in mid 2012. 50   The updated ABS-MT can be downloaded from the website of the CBD Secretariat. This is published in English, but may also be re-published in Spanish and French. 51  Swiss Academy of Sciences, “Access and Benefit Sharing: Good Practice for Academic Research,” accessed 31 May 2012, http://abs.scnat.ch/. 52  Swiss Academy of Sciences, “Sample ABS Agreement for Non-Commercial Research,” accessed 2 April 2012, http://abs.scnat.ch/downloads/index.php. 47 48

308   Geoff Burton Thirdly, Switzerland has established national focal points for the Protocol and is in the process of preparing to implement its responsibilities when the Protocol comes into force.53 And fourthly, Switzerland’s patent law already requires that patent applications contain information regarding the source of the genetic resource the inventor or applicant directly relies on for the development of his or her invention, including reference to terms on which the resource is provided.54 This same obligation applies to the disclosure of the source of traditional knowledge of indigenous and local communities when used in a similar way.55 Switzerland does not require PIC for access to its own genetic resources. Taken together, this combination of government and non-government measures facilitate Swiss researchers, their collaborators (and companies) to access and utilise genetic resources abroad. 3.  Australia Australia introduced simplified procedures for non-commercial research, in 2005 as part of its national ABS laws. The simplified procedure involves the grant of a non-commercial access permit (two pages) and an accompanying Statutory Declaration (discussed above).56 No fees are sought for noncommercial scientific research and only a nominal AU$50 fee is charged for commercial research. This principle of encouraging non-commercial research through simplified procedures was also included in Australia’s intergovernmental agreement between its nine national, state, and territory governments. The Nationally Consistent Approach for Access to the Utilisation of Australia’s Native Genetic and Biochemical Resources contains explicit reference to the needs of noncommercial research in its General Principles 12. facilitate continued access for non-commercial scientific research, particularly taxonomic research; and 14. recognise the differences between commercial scientific research and noncommercial scientific research and their needs . . .57  For a full description of the Swiss government’s progress on preparing for the introduction of the Nagoya Protocol, see Swiss Information System Biodiversity, “From CBD to Bonn Guidelines to Nagoya Protocol,” accessed 2 April 2012, http://www.sib.admin.ch/en/ nagoya-protocol/implementation-in-switzerland/index.html. 54  Switzerland, Loi fédérale du 25 juin 1954 sur les brevets d’invention (Loi sur les brevets, LBI), No. 232.14, 1954, accessed 2 April 2012, http://www.admin.ch/ch/f/rs/c232_14.html. 55   Ibid. 56  Australian Government Department of Sustainability, Environment, Water, Population and Communities, “Permits for non-commercial purposes,” accessed 6 June 2012, http:// www.environment.gov.au/biodiversity/science/access/permits/non-commercial.html. 57  This was agreed by the Council of Australian Governments in October 2002 (Australian Government Department of the Environment and Heritage, “Nationally consistent 53

Implementation of the Nagoya Protocol in Juscanz Countries   309

Australia’s experience over the succeeding decade is that the bulk of applications are for non-commercial scientific research. Australia’s national competent authority advises that in this light, Australia is further simplifying access to its genetic and biochemical resources for non-commercial research. This is consistent, not only with Australia’s experience, but also its desire to maximise the volume of research and development undertaken. Its success with simplified access permits also means that consideration is currently being given to the introduction of a single, all-purpose ABS access permit. This would be based on the existing simplified access permit but contains a universal condition that should the research lead to a possible commercial outcome, then a detailed benefit-sharing contract must be entered into.58 Australia does not, therefore, need to change its national legislation to provide for simplified access to genetic resources for non-commercial scientific research to accord with the Protocol. Its existing arrangements already do so. 4.  Norway Norway has played a significant role in the evolution of ABS both during the development of the Bonn Guidelines and later through the development of the Nagoya Protocol. This level of engagement is mirrored by Norway’s introduction of its own ABS law – the 2009 Nature Biodiversity Act,59 which provides some guidance to Norway’s contribution to the final form of the Protocol. The Nature Biodiversity Act contains a simplified access provision. This states that the collection of biological material for use in public collections and for use and further breeding or cultivation in agriculture or forestry does not require a permit.60 In addition, the Act provides that any person receiving genetic material derived from a public collection must not claim, in Norway or abroad, any intellectual property rights (IPR) or other rights to the material that would limit use of the material, such as use for food or agriculture, unless the material has been modified in a way that results in a substantial change.61 This has the affect of ensuring continued public access approach for access to and the utilisation of Australia’s native genetic and biochemical resources,” accessed 3 April 2012, http://www.environment.gov.au/biodiversity/publica tions/access/nca/pubs/nca.pdf). 58  Author’s discussion with Australia’s ABS National Competent Authority, Director, Protected Area Policy and Biodiscovery Section, Department of Sustainability, Environment, Water, Population and Communities, 25 March 2012. 59  Norway, Act Relating to the Management of Biological, Geological and Landscape Diversity (Nature Diversity Act), No. 100, 2009. 60  Nature Biodiversity Act Section 58. 61  Nature Biodiversity Act Section 59.

310   Geoff Burton to, and use of, the material collected. It also includes a proviso that, if IPR have been claimed and no benefit-sharing has been established, contrary to the intention of the Act, then legal measures may be taken.62 Thus Norway already has a simplified access provision for non-commercial scientific research consistent with the Nagoya Protocol. 5.  The United States The US supported facilitating access to biological resources in the interests of science and research during both the negotiation of the Bonn Guidelines and the Nagoya Protocol. In this regard its scientific institutions, notably the Smithsonian Institution and its National Institutes for Health, influenced it. As its nation’s leading taxonomic body, the Smithsonian has been engaged in the internal US government policy debates on the issue of access and is usually represented on US delegations. A continuing theme of US delegation interventions during the Protocol negotiations was the importance of not impeding international taxonomic collection and taxonomic research. Domestically, the US had introduced a system of Cooperative Research and Development Agreements in the late 1980s to assist the commercialisation of collaborative, private-sector research, with US (federal) agencies. These are, in essence, benefit-sharing agreements or contracts. The most famous is, perhaps, the one with Yellowstone National Park and Diversa Corporation. This agreement led to the patenting of Taq Polymerase and the invention of an economic Polymerase Chain Reaction – the foundation of modern biotechnology.63 What is not so well known is that the US National Parks Omnibus Management Act 1998, while expressly authorising ‘negotiations with the research community and private industry for equitable, efficient benefit-sharing arrangements’ in connection with research conducted in national parks, the Act also encourages national parks to be places for scientific research by public-sector, as well as private-sector, researchers. Thus, For collections aimed solely at basic research and education, the superintendent of each national park has authority to issue research permits addressing the resources and needs of the park the superintendent oversees.64  Nature Biodiversity Act, Section 59.  For a good study of that agreement, see Kerry T. Kate, Laura Touche and Amanda Collis, “Benefit-Sharing Case Study: Yellowstone National Park and the Diversa Corporation” (Submission to the Executive Secretary of the CBD by the Royal Botanic Gardens, Kew, April 22, 1998), accessed 3 April 2012, http://www.cbd.int/doc/case-studies/abs/cs-absyellowstone.pdf. 64  This is a direct quote from the United States submission to WIPO Intergovernmental Committee On Intellectual Property And Genetic Resources, Traditional Knowledge And Folklore, Fourth Session Geneva, December 9–17, 2002 Access to Genetic Resources Regime 62 63

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This then shows that from the beginning of international negotiations towards the establishment of an international regime on genetic resources the United States (at least in respect of its national parks) had already implemented a simplified access system for ‘basic’ research. The United States State Department, while being responsible for ensuring that US federal agencies do not take action to adversely affect the operation of the Convention, does not readily explain the United States policy towards the CBD – at least on its public websites. The only public explanation found of its objectives in attending the tenth meeting of the CBD COP in 2010 was to work with the Parties to develop a practical, workable regime on [ABS] for genetic resources that fall under the [CBD]; to emphasise science-based decision making in all aspects of biodiversity conservation; and, to develop an ambitious yet measurable and achievable post-2010 strategy.65

The importance to the Smithsonian Institution of avoiding placing barriers in the way of ‘pure’ or non-commercial (often taxonomic) research is emphasised by the Institution’s involvement in three major taxonomic and biodiversity mapping projects: the Encyclopaedia of Life, that aims to collate all knowledge about life on Earth, and its related projects; the International Barcode of Life, which aims to use DNA identification (DNA barcoding) to uniquely identify species and their distributions; and the Consortium for the Barcode of Life, which aims to establish an international standard for barcoding species, to accelerate its use as a technology and to gather such speciesrelated information into public databases. All of these efforts are global in nature and require facilitated access to species and the unimpeded movement of specimen and extracts. The United States, through its National Cancer Institute, conducts a global bioprospecting programme to screen collected biodiversity against cancer and other disease targets. Such collections are made under standardised access and benefit-sharing agreements with providing countries. It is important to note that these agreements are consistent with the terms of the CBD and the Protocol.66 Although the US is under no obligation to implement the provisions of the Protocol, the US government nonetheless has put contractual and administrative provisions in place for its agencies to meet CBD and Protocol requirements of the United States National Parks, accessed 5 June 2012, (6 December, 2002) WIPO/ GRTKF/IC/4/13. 65  US Department of State Diplomacy in Action, “Tenth Conference of the Parties to the Convention on Biological Diversity,” accessed 5 April 2012, http://www.state.gov/r/pa/prs/ ps/2010/10/150020.htm. 66  Technology Transfer Centre, Partnering with Industry for Improved Public Health, “The Letter of Collection,” accessed 8 April 2012, http://ttc.nci.nih.gov/forms/.

312   Geoff Burton for commercial and non-commercial scientific research. Private-sector and public-sector research conducted outside of the US government has no such protections. Non-US collaborative partners and non-US providers of genetic resources may find this fact a disincentive. To address this concern the US biotechnology industry has issued best-practice guidelines to its members to instil confidence that they are acting consistently with the terms of the CBD.67 6.  Canada Canada welcomed the adoption of the Nagoya Protocol.68 However since then it has been engaged in a consultation process to determine whether it should accede to it.69 As no decision has been taken at the time of writing, it is difficult to determine how Canada will proceed to ensure that its researchers have access to genetic resources from outside Canada – whether for non-commercial or for commercial research purposes. Continued delay may put Canada’s public research community and its biotechnology industry at a disadvantage compared to that of Europe and Japan, who already signed the Protocol and are in the process of ratifying it. Among the challenges facing the domestic implementation of the Protocol in Canada, the handling of the traditional knowledge of indigenous and local communities is particularly significant as the experience of JUSCANZ shows in the next section.

III.  JUSCANZ and Traditional Knowledge: Rocks and Hard Places One of the foremost features of the CBD is that it confirms that countries have national sovereignty over their natural resources. Indeed, the move away from the concept of biological resources being the common property  These guidelines may be viewed at Biotechnology Industry Organisation, “Guidelines for Bio Members Engaging in Bioprospecting,” accessed 9 April 2012, http://www.bio.org/sites/ default/files/Guidelines%20for%20BIO%20Members%20Engaging%20in%20Bioprospect ing_0.pdf. 68  Environment Canada, “Canada Welcomes New Biodiversity Protocol in Nagoya,” accessed 9 April 2012, http://www.ec.gc.ca/default.asp?lang=En&n=714D9AAE-1&news=BBF61B61– CF9D-44A4–85C5-3DA641B78AA9. 69  New Brunswick Environmental Network, “Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation to the Convention on Biological Diversity, September 2011,” accessed 2 June 2012, http://nben.ca/en/ public-consultation-archives/category/58-nagoya-protocol-on-access-to-genetic-resourcesand-the-fair-and-equitable-sharing-of-benefits-arising-from-their-utilization-to-theconvention-on-biological-diversity-september-2011. 67

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of humankind to being the sole property of nation States underpins the idea that in return for providing access to the genetic content of their natural resources, countries are entitled to secure a fair and equitable share in the benefits from the use of those resources. Indigenous peoples, however, challenge this idea of national sovereignty in two ways. Firstly, some indigenous and local communities lay claim to land, and to primacy to its use over the authority held by the nation-State. This claim is argued on the basis that the land is theirs by birthright and culture, and that this precedes the creation of the nation-State in which they live. Moreover, many claim that the land and its resources were taken from them by force or by laws made against their interests and without their consent and, further, that in some cases national boundaries between States often divide indigenous and local communities denying them common nationality. Others argue that agreements reached between governments and indigenous peoples and local communities over land and its associated resources have not been fully or properly implemented. For many JUSCANZ Members with indigenous peoples and local communities, this represents a continuing issue. It is a source of tension domestically, and it complicates their actions as Parties to international agreements. Secondly, some indigenous and local communities argue that they have lost many of the defining and sustaining features of their communities’ existence through colonisation and that their remaining asset lies in their traditional knowledge. This argument has particular resonance among indigenous peoples whose knowledge lies in an oral tradition. For such peoples, traditional knowledge and distribution and possession go to their social coherence, function and identity. Indigenous peoples also point to their own traditional land management practices as supporting conservation and sustainable use of its physical resources in the form of soil and water quality, biodiversity and the stability and resilience of whole ecosystems. They argue that this contribution has not been valued and that the colonisation of their lands has been accompanied by its degradation and without any reasonable compensation to its traditional custodians for their loss of amenity and for the damage done. Moreover, the growing interest in natural products, including functional foods, nutraceuticals and traditional medicine, sustains the notion that their knowledge has economic and social value to the wider community.70

 The evolution of the positions adopted by the IIFB over time can be examined at Indigenous Portal, “IIFB Statement on Agricultural Biodiversity,” accessed 5 June 2012, http://www .indigenousportal.com/Environment/Organisations/International-Indigenous-Forum-onBiodiversity.html.

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314   Geoff Burton With these factors in mind, indigenous peoples and their representatives come to engage with the processes of the CBD aware of the fact that international agreements may provide them with a means of establishing obligations upon governments that would not otherwise be obtainable through local or national political means, or that can be used as an adjunct to facilitate domestic or national processes. The very visibility of international fora is also a means for injustices or grievances to be exposed and made the subject of international scrutiny. As such, this can be a means to put pressure on national governments to change existing national laws and practices – even in respect of issues that are not yet resolved at the international level. It is also not unusual for sympathetic non-government groups to provide support to the arguments put forward by indigenous and local communities. Indigenous peoples are also aware that international processes can be self-reinforcing and mutually supportive. Thus negotiations on the United Nations Declaration on Rights of Indigenous Peoples (UNDRIP)71 could be undertaken while negotiations within the framework of the CBD for an international regime on genetic resources were being conducted, and while parallel negotiations were being conducted at the World Intellectual Property Organisation’s (WIPO) Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Folklore (IGC). Thus language accepted in one forum is likely to influence its adoption in another or at least influence debate on it. The key to this approach is to have a voice in each relevant forum. Indigenous peoples’ representatives are assisted in this regard by being recognised as having a legitimate voice in the negotiations, albeit usually as observers. In practice the co-chairs in both the WIPO IGC and the ABS Working Group undertaking the negotiations of the Nagoya Protocol have provided the representatives of indigenous peoples and local communities considerable scope to make interventions. The IIBF is the recognised body representing the interest of indigenous peoples and local communities at the CBD, with support from non-government bodies such as the Third World Network, the Tulalip Tribe and a growing, and significant, number of other indigenous organisations.72 Together with the United Nations Permanent  United Nations General Assembly “United Nations Declaration on the Rights of Indigenous Peoples,” (13 September 2007) UN Doc A/RES/61/295. 72  The variety and number of indigenous peoples’ organisations and sympathetic non-government organisations attending the Protocol negotiations is illustrated at CBD Ad Hoc OpenEnded Working Group on Access and Benefit-Sharing, “Report of the Eighth Meeting of the Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing,” (20 November 2009) UN Doc UNEP/CBD/WG-ABS/8/8. It includes: the African Indigenous Women Organisation, ALMACIGA-Grupo de Trabajo Intercultural, Andes Chinchasuyo, Asia Indigenous Peoples Pact Foundation, Asociación 71

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Forum on Indigenous Issues, an advisory body to the UN Economic and Social Council, the IIBF has been one of the two leading indigenous bodies influencing multilateral negotiations. This puts indigenous representatives who attend the same negotiations at an advantage, particularly if there is continuity of representation, whereas national governments usually send different officials (drawn from different agencies) to overlapping negotiations under different international treaties or processes. What is noticeable, however, is that the adoption of the Nagoya Protocol in 2010 with its recognition of, and extension of, the rights of indigenous peoples is the third significant advance of indigenous peoples’ interests with the adoption of the Bonn Guidelines in 2002 and UNDRIP in 2007. As to the latter, it should be noted that at the time of the 2006 vote, the four countries that voted against it were all JUSCANZ countries – the United States, Canada, Australia and New Zealand. Yet each has now endorsed the Declaration: Australia in 2009,73 the US in 2010,74 Canada75 and New Zealand also

Ixacavaa De Desarrollo e Información Indígena, Association OKANI, Baikal Buryat Center for Indigenous Cultures, Berne Declaration, Call of the Earth, Llamado de la Tierra Canadian Friends Service Committee (Quakers), Church Development Service (Evangelischer Entwicklungsdienst), CIHR Team in Aboriginal Anti-Diabetic Medicines, CIHR Team in Aboriginal Anti-Diabetic Medicines, Confederación de Pueblos Autóctonos de Honduras, Consejo Autonomo Aymara, Consejo Regional Otomí del Alto Lerma, Dena Kayeh Institute, ETC, Femmes Autochtones du Québec Inc. Quebec Native Women Inc., Foundation for Aboriginal and Islander Research Action Fridtjof Nansen Institute, Fundacion Para la Promocion del Conocimiento Indigena, INBRAPI, Indigenous Information Network, Indigenous Peoples Council on Biocolonialism, Indigenous World Association, Institute for Biodiversity Network, Institute for European Studies, League for Pastoral Peoples and Endogenous Livestock Development, L’Unissons-nous pour la Promotion des Batwa, Malaysian Biotechnology Corporation, Mohawk Nation, Movimento dos Pequenos Agricultores, NAADUTARO Pastoralists’ Survival Options, National Aboriginal Health Organization, Native Women’s Association of Canada, Natural Justice (Lawyers for Communities and the Environment), Nepal Indigenous Nationalities Preservation Association, (NINPA), Russian Association of Indigenous Peoples of the North (RAIPON), Saami Council Stakeholder Forum for a Sustainable Future, Tebtebba Foundation, The Mountain Institute, Third World Network, Tulalip Tribes. 73  The Hon Jenny Macklin MP, “Statement on the United Nations Declaration on the Rights of Indigenous Peoples,” accessed June 5, 2012, http://www.jennymacklin.fahcsia.gov.au/ statements/Pages/un_declaration_03apr09.aspx. 74  Reuters, “Obama backs U.N. indigenous rights declaration,” accessed 5 June 2012, http:// www.reuters.com/article/2010/12/16/us-obama-tribes-idUSTRE6BF3RF20101216. 75  Aboriginal Affairs and Northern Development Canada, “Canada’s Statement of Support on the United Nations Declaration on the Rights of Indigenous Peoples,” accessed 4 April 2012, http://www.aadnc-aandc.gc.ca/eng/1309374239861.

316   Geoff Burton in 2010.76 What has changed is that these countries themselves have changed their views as a result of intra-national debates, international debate, and pressure to resolve outstanding issues for their indigenous populations. Canada’s statement in its endorsement of the Declaration indicates how far it has come in accepting the arguments put forward by indigenous and in interpreting UNDRIP in a manner consistent with Canadan laws.77 The divergence of views between the indigenous peoples of JUSCANZ and their governments is exemplified in the struggle to find a common view on the CBD provisions on traditional knowledge related to the in-situ conservation of biodiversity and customary sustainable use of biological resources – CBD Article 8(j) and 10(c), as the next section shows. 1.  CBD Articles 8(j) and 10(c) and JUSCANZ The economic and moral importance of traditional knowledge associated with genetic resources is reflected in the provisions of CBD on traditional knowledge, and customary use. The responsibilities and obligations of these provisions are couched in terms of giving individual countries considerable leeway in their implementation; nevertheless fulfillment of these provisions would require some countries to break new ground in policy and law. The qualified wording of CBD Article 8(j), notably its references to ‘he approval and involvement of the holders’ of traditional knowledge and of ‘encouraging’ benefit-sharing from the utilisation of traditional knowledge and culture served two purposes: firstly, the phrases could not be taken to be an acknowledgement of, or creation of, any sovereign or enforceable rights; and secondly, it imposed no obligation on countries to ensure that utilisation of their indigenous peoples’ traditional knowledge occurred with  The Official Website of the New Zealand Government, “Supporting UN Declaration restores NZ’s mana,” accessed 5 April 2012, http://www.beehive.govt.nz/release/supporting-un-dec laration-restores-nz039s-mana. 77  The Government of Canada said in part in its statement that: ‘In 2007, at the time of the vote during the United Nations General Assembly, and since, Canada placed on record its concerns with various provisions of the Declaration, including provisions dealing with lands, territories and resources; free, prior and informed consent when used as a veto; selfgovernment without recognition of the importance of negotiations; intellectual property; military issues; and the need to achieve an appropriate balance between the rights and obligations of indigenous peoples, States and third parties. These concerns are well known and remain. However, we have since listened to Aboriginal leaders who have urged Canada to endorse the Declaration and we have also learned from the experience of other countries. We are now confident that Canada can interpret the principles expressed in the Declaration in a manner that is consistent with our Constitution and legal framework’ (Aboriginal Affairs and Northern Development Canada, “Canada’s Statement of Support on the United Nations Declaration on the Rights of Indigenous Peoples,” accessed 4 April 2012, http:// www.aadnc-aandc.gc.ca/eng/1309374239861). 76

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fair and equitable benefit-sharing. Moreover, Article 8(j) does not clearly link traditional knowledge with associated genetic resources nor does it acknowledge that indigenous peoples might be owners of genetic resources or be entitled to be considered so.78 Nonetheless, these and other provisions of the Convention, for instance on supporting local populations to develop and implement remedial action in degraded areas,79 created a sense of opportunity for indigenous and local communities, who saw in these provisions an opportunity to pursue their interests in relation to land (and sea), its resources and the social and economic valuing of their knowledge and culture. In short, they saw the international recognition of their cultures and their connection with the land as a source of ‘rights’ to be further clarified at the international level and crystallised at the national and local level. The debate that ensured over the next 18 years would be couched in terms of ‘rights’. During the period from 2002, when negotiations were mandated to develop an international regime on ABS,80 until the adoption of the Nagoya Protocol eight years later, these implied concerns were resolved or changed in their character. For the Protocol refers to: •  recognition that indigenous and local communities may have established rights over genetic resources;81 •  obligations on countries to secure fair and equitable benefit-sharing from the utilisation of traditional knowledge associated with genetic resources;82 •  ‘prior informed consent’ of indigenous and local communities;83 •  recognition of indigenous and local communities’ customary laws and community protocols;84 •  the need to avoid restriction of customary and use and exchange of genetic resources;85 and •  the need to ensure that countries must act to secure compliance with the PIC and MAT of indigenous and local communities.86  [On this point, see contribution by Glowka and Normand in this volume (Chapter 1).]  CBD Articles 10.d. 80  UN General Assembly Resolution “Convention on Biological Diversity” (30 January 2001 2002) UN Doc A/RES/57/260 paragraph 8, following on from the “Plan of Implementation of the World Summit on Sustainable Development” (4 September 2002) UN Doc A/ CONF.199/20, Resolution 2: Johannesburg Plan of Implementation, paragraph 44.o. 81  Nagoya Protocol Articles 6 and 7. 82  Nagoya Protocol Articles 5.4 and 6.2. 83  Nagoya Protocol Articles 6 and 7. 84  Nagoya Protocol Article 12. 85  Nagoya Protocol Article 12. 86  Nagoya Protocol Article 16. 78 79

318   Geoff Burton JUSCANZ played a role in this evolution and, in doing so, has made the Protocol clearer by agreeing to include explicit responsibilities and obligations relating to the utilisation of traditional knowledge and genetic resources. This affects all Parties with indigenous peoples and local communities in their territories, and makes the task of implementation clearer, if not easier. It has not been an easy process, however, as the next section shows. 2.  JUSCANZ: Policy Tensions and Policy Evolution Within JUSCANZ the underlying issues of indigenous rights presented a number of challenges to its Members – challenges that have since evolved over the life of the Convention and the development of its Protocols with some, but not all, moving to resolution. It is useful at this point to outline, briefly, the circumstances faced by each of the affected Members. For Canada, with its three main indigenous groups of peoples (First Nations, Metis and Inuit) the period since the entry into force of the CBD has been difficult. To a large extent, questions over who owns land, who should own land, and the nature and content of title to land are still unresolved. Before Canada’s Confederation in 1867, treaties were made with First Nations and that these treaties continued in operation after Confederation with Treaty-making continuing today.87 Indigenous land rights’ issues in Canada involve a body of treaty law, statute law, common law and constitutional law together with the operation of concepts of native title extinguishment and the Honor of the Crown (in right of Canada). The addition of concepts and obligations arising from negotiations under the CBD that could affect the Canadian government’s negotiations with its indigenous and local communities being added to this complex mix has coloured Canada’s involvement in the development of the Nagoya Protocol. Thus, early references in draft text of the Bonn Guidelines to the expression ‘prior informed consent’, in reference to access to traditional knowledge and culture linked to genetic resources, produced a cautious, or even negative, response as it was understood by Canada to imply the creation of a right for indigenous  Aboriginal Affairs and Northern Development Canada, “Government of Canada Progress Report (2006–2012) – With Strong Resolve: Advancing our Relationship with First Nations Peoples and Communities,” accessed 1 April 2012, http://www.aadnc-aandc.gc.ca/ eng/1327173357543, 12: ‘To date, 23 comprehensive land claim agreements and 2 selfgovernment agreements have been ratified and brought into force. These agreements cover approximately 40 percent of Canada’s landmass, impact 96 Aboriginal communities and more than 100,000 First Nation members . . . . the Government has also established the Specific Claims Tribunal Act and put in place practical measures to ensure faster processing of claims. Since 2007, approximately 70 specific claims have been settled through negotiated agreements with First Nations totaling, $1.03 billion.’

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communities to control resources that might not be possible to implement in Canada for constitutional reasons88 or which might be contrary to Canadian law and practice. This caution was echoed among other JUSCANZ Members, notably Australia, the US and New Zealand. The concern of these governments was that the phrase was associated with the exercise of sovereign rights over resources and might be taken to imply the creation or broadening of any such right held by indigenous peoples. This difficulty was first overcome during the negotiations of the Bonn Guidelines by adding a reference to respecting ‘established’ legal rights and making it clear that national action was ‘subject to domestic law.’89 This was the result of acceptance of compromise language proposed by JUSCANZ Member Australia with Mexico’s support. The US, Canada, Australia and New Zealand have indigenous peoples with differing legal status and aspirations. Accordingly, each country has an obligation to include the interests of indigenous peoples as part of the interests of all their peoples and to represent those interests as part of their whole-ofgovernment negotiating positions. As well, in the case of the Canada and the United States, it had been a feature of their delegations to the negotiations on the Nagoya Protocol that they included representatives from among their indigenous peoples. New Zealand, with smaller resources, from time to time also included Maori members. In contrast such was the political situation in Australia that for much of the 2000s Australian indigenous representatives declined invitations to be included in Australian government delegations. Although, for part of that period, and prior to its abolition in 2005, a representative of the Aboriginal and Torres Strait Islander Commission attended the negotiations.90 During this period, indigenous peoples from Australia, the US and New Zealand were also represented through non-governmental bodies attending the negotiations, notably the IIFB that usually included indigenous peoples from the four JUSCANZ countries most affected. This enabled indigenous representatives to highlight differences between the details of national negotiating positions and the stated aspirations of indigenous peoples, and often specifically those of Canada, Australia and New Zealand. But, it also facilitated dialogue with the respective national delegations.

 Canada, Constitution Act, 1982, Sections 25 and 35.  Bonn Guidelines paragraph 31. 90  This body was an Australian statutory body established in 1989 and abolished in 2005 (Sydney Morning Herald, “ATSIC abolished after bill passes Parliament,” accessed 5 June 2012, http://www.smh.com.au/news/National/ATSIC-abolished-after-bill-passes-Parliament/ 2005/03/16/1110913660843.html). 88 89

320   Geoff Burton How then did change in national positions concerning indigenous peoples occur? It occurred incrementally and reflected a degree of goodwill by both government officials and the representatives of indigenous non-governmental bodies, both domestically and internationally. In 2000 Australian and Canadian officials encouraged indigenous representatives to offer textual suggestions to countries engaged in the negotiations with the understanding that, if accepted by a negotiating country, these suggestions would be formally negotiated. To the extent that such suggestions were not inconsistent with its wholeof-government negotiating positions (and where they were viewed as having merit) the Australian, New Zealand and Canadian delegations were prepared to put those suggestions forward or support their discussion. It should also be noted that all three countries conducted internal consultations with indigenous peoples before settling their whole-of-government negotiation briefs. An early indication of the potential for cautious collaboration came in 2002 when drafting language was inserted into the Bonn Guidelines that distinguished indigenous peoples and local communities from ‘stakeholders’.91 This reflected the point made by indigenous representatives that indigenous peoples were rights holders92 – even if the nature and extent of those rights were still in flux. The improving rate of progress among JUSCANZ countries when addressing indigenous peoples’ issues is illustrated by their submissions to the CBD Working Group on ABS in the later part of the 2000s. For example Norway provided submissions93 on the protection of indigenous peoples’ traditional knowledge in 2009, that are now reflected in the Protocol where it requires countries to: •  introduce rules and measures to set out criteria for obtaining the consent of indigenous peoples and local communities for the use of their traditional knowledge;94 •  adopt measures aimed at preventing the use of misappropriated genetic resources and traditional knowledge;95

 Bonn Guidelines paragraphs 11, 14, 16, 19 and 43.  [See contribution by Savaresi in this volume (Chapter 2)]. 93  See Norway’s submission, “CBD Notification 2009-050 – Decision IX/12 on Access and Benefit-sharing: submissions of views and proposals for the eighth meeting of the Ad Hoc Open-ended Working Group on Access and Benefit-sharing,” accessed 11 April 2012, https://www.cbd.int/abs/submissions/abswg-08-norway-en.pdf. 94  Nagoya Protocol Article 6.3.f. 95  Nagoya Protocol Article 16. 91 92

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•  obtain the PIC of indigenous peoples and local communities and the approval and involvement of the holders of traditional knowledge in accordance with their traditional practices;96 and •  document traditional knowledge subject to the PIC of indigenous peoples and local communities.97 Canada also provides an example of growing integration of indigenous peoples’ interests with whole-of-government policy when it included in its 2009 submission to the CBD Working Group on ABS that ‘associated traditional knowledge’ meant ‘knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity that are associated with an in-situ genetic resource and not in the public domain.’98 Canada went on to assert that countries should include requirements in national legislation that:99 •  require transparency when a traditional knowledge is being accessed; •  traditional knowledge is only obtained with the approval and involvement of the holders of the knowledge;100 •  access to associated traditional knowledge is based on mutually agreed terms and address access, use and benefit-sharing;101 and •  domestic arrangements so introduced follow extensive consultation with indigenous peoples and local communities.102 Change was occurring in Australia with the election of the Rudd government in late 2007. This facilitated Australia adopting a more flexible approach in the negotiations, particularly where obligations concerning traditional knowledge and indigenous peoples’ genetic resources were concerned. One of the first acts of the incoming government was a national public apology by the Prime Minster on behalf of the Australian government and of the Parliament

 Nagoya Protocol Article 7.  Nagoya Protocol Article 7.   98  “Canadian Submission to the Convention on Biological Diversity in Preparation for the 8th Meeting of the Working Group on Access and Benefit Sharing,” accessed 11 April 2012, https://www.cbd.int/abs/submissions/abswg-08-canada-en.pdf.   99  Ibid. 100  This can be achieved pursuant to, or consistent with, Nagoya Protocol Articles 5, 7, 12.2, 12.3, 16, 17 and 18. 101  Cf. Nagoya Protocol Articles 5, 7, 12.3. 102  Cf. Nagoya Protocol Articles 12.1, 12.3 and 16.1.   96   97

322   Geoff Burton for the actions and policies of previous governments;103 thus, freeing it from earlier policy positions. This change in attitude also included reversing its position on UNDRIP. Nevertheless non-governmental indigenous groups, like the IIFB, maintained pressure on Australia, Canada, Norway, New Zealand and the United States. This pressure did not stop with the impending adoption of the Protocol. An illustration of this continuing pressure can be seen in the 2010 Joint Statement of Grand Council of the Crees.104 This statement was signed by over 35 indigenous and civil-society organisations seeking to align the draft text for the Protocol with UNDRIP. It offered detailed reasons and specific textual amendments to recognise various indigenous rights and to create obligations on countries to establish and protect such rights within their respective jurisdictions.105 The Statement also shows the degree to which JUSCANZ Members’ actions were negatively regarded at the time, with specific criticism of the US, Canada, Australia and New Zealand, describing their negotiations as ‘efforts to lower human rights standards and other standards and show no regard for [UNDRIP]’.106

IV.  Implementing the Nagoya Protocol and Its Traditional Knowledge Provisions Within JUSCANZ, Australia, Japan, Norway and Switzerland have signed the Protocol and are proceeding through their ratification processes. The United States, New Zealand and Canada have not. The markedly different cases of the three non-signatories will be addressed first, followed by a discussion of the implementation challenges in Australia and Norway.

 The full text of the Prime Minister’s Speech illustrates the extent of the change in attitude (Australian Government Department of Families, Housing, Community Services and Indigenous Affairs, “Apology to Australia’s Indigenous Peoples,” accessed April 12, 2012, http://www.fahcsia.gov.au/sa/indigenous/progserv/engagement/Pages/national_apology .aspx). 104  This statement and its list of signatories can be viewed at CBD Ad Hoc Open-Ended Working Group On Access And Benefit-Sharing, “Concerns Relating To CBD Process, Revised Draft Protocol And Indigenous Peoples’ Human Rights” (22 September 2010) UN Doc UNEP/CBD/WG-ABS/9/INF/21. 105  Ibid.: The textual criticism identifies specific language put forward by Australia, Canada and New Zealand and argues that the wording advanced is inconsistent with UNDRIP or weakens the implementation of the CBD and the intent the Protocol. 106  Ibid., paragraphs 81–82. 103

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1.  United States The US has not ratified the CBD. For some years now, the US legislature has been showing an uncooperative and increasingly isolationist tendency towards the adoption of multilateral instruments. In such circumstances it is unlikely that the United States will act to ratify the Convention and its protocols in the foreseeable future. Nevertheless, as previously demonstrated, US government agencies act consistently with the terms of the CBD. The introduction of the Nagoya Protocol, however, presents fresh challenges for US agencies. Agencies may be unable to deliver permit information to the international ABS clearing-house107 for material collected within their jurisdiction. Where they can do so, such information cannot constitute a certificate of compliance. For potential users of US genetic resources, this lack of public transparency may be a disincentive to deal with such agencies. Collaborators with US researchers from outside the US may find that the contractual documentation required by the US is no longer compatible with the obligations under which their research is funded and genetic resources are utilised in their home jurisdictions or third countries. For material being accessed within the US, and for material accessed from other jurisdictions by US publically funded researchers, the existence of the simplified non-commercial access provision108 will, however, continue to give support for the use of Cooperative Research and Development Agreements and National Cancer Institute agreements and licensing arrangements. The lack of any US policy or legislative framework for the protection of traditional knowledge associated with genetic resources creates a disincentive for the utilisation of that knowledge. This is particularly so in third-country jurisdictions, which require the production of evidence that the information has been obtained with the PIC of the holders of the knowledge and based on MAT. Being outside the new global system for the equitable utilisation of genetic resources is a risk for US-based biotechnology and pharmaceutical industries. This risk will increase as the number of countries ratifying the Nagoya Protocol increases. Even at a lower rate of ratification, this risk is still significant if the bulk of major markets for their products (including the EU, Scandinavian countries, Brazil, India, Japan, China and much of South East Asia, the remainder of GRULAC and Australia) ratify the Protocol.

 Nagoya Protocol Article 14.  Nagoya Protocol Article 8.a.

107 108

324   Geoff Burton To manage this risk it will be expected that both the Biotechnology Industry Association109 and the US Pharmaceutical Research and Manufacturers Association will be guided by the International Federation of Pharmaceutical Manufacturers and Association’s Guidelines for Members on Access to Genetic Resources and Equitable Sharing of Benefits Arising out of their Utilisation of December 2011.110 These set out explicit support for the Protocol, its national implementation and for the conduct of its members to: •  obtain PIC to access and use genetic resources from a country and/or an indigenous people in accordance with the law; •  disclose the intended nature and field of use of the genetic resources when obtaining PIC; •  comply with the laws of provider countries and gain necessary approvals from their competent authorities for collecting material based on agreements reflecting MAT; •  avoid taking action that might impede the traditional use of such genetic resources; and •  agree that any disputes are dealt with through arbitration under international procedures or as, otherwise, agreeable between the parties. In this way, the risk to US companies operating in a State that is not a Party to the Protocol will be reduced, although not eliminated. Companies will also be subject to greater scrutiny if they are otherwise unable to demonstrate legal certainty over their use of genetic resources from within the US and its Pacific territories and for any use of traditional knowledge held by US indigenous peoples. 2.  Canada Canada found itself in a difficult situation and undertook a lengthy consultation process prior to the adoption of the Protocol. At the time of writing it has made no decision to accede to the Protocol.

 See reference to support for the CBD and the Protocol by Biotechnology Industry Organisation, “Bio Commends Department of Commerce for Promoting Robust Intellectual Property Standards and Policies Abroad,” accessed 12 April 2012, http://www.bio.org/ search/node/nagoya%20Protocol. 110  International Federation of Pharmaceutical Manufacturers and Associations, “Guidelines for IFPMA Members on Access to Genetic Resources and Equitable Sharing of Benefits Arising out of their Utilisation,” accessed 5 June 2012, http://www.ifpma.org/fileadmin/ content/Innovation/Biodiversity%20and%20Genetic%20Resources/IFPMA_Guidelines_ GeneticResources_111206.pdf. 109

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Its difficulties lie, primarily, in the unresolved complexity of the legal status of its indigenous peoples over the ownership and management of living resources and associated traditional knowledge and with the high expectations of its indigenous peoples in the resolution of this complexity. The extent of the divergence in views can be seen in the Maritime Aboriginal Peoples Council’s submission Implementation of the Nagoya Protocol within Canada to the first meeting of the Intergovernmental Committee preparing for the entry into force of the Nagoya Protocol in 2011. The submission shows that indigenous peoples in Canada are seeking clearer and more extensive rights over resources than currently exist, and see the implementation of the Protocol and UNDRIP as two legal and moral tools to make this happen.111 Implementing the Protocol also involves Canada’s provinces, territories and local governments and the differing proportions of privately owned land among them. Thus, already prior to the adoption of the Protocol, the Canadian government had established a federal/provincial/territorial working group on ABS. This group produced a discussion paper identifying three options to implement what would become the Nagoya Protocol: a common implementation approach endorsed by all levels of government; an independent approach taken by each government; or a single national policy and legislation.112 Three options for dealing with associated traditional knowledge were also set out: voluntary mechanisms and tools; existing regulatory measures supported by new regulatory and voluntary measures; or new ABS-specific legislation and regulations.113 Each of these options involves fundamental questions of Canadian governance and the legal rights of its peoples. Until these questions are determined and their practical implications are mapped, and then agreed, it will be difficult for Canada to accede to and implement the Protocol. The unfortunate downside to this situation is that the interests of all rights holders and stakeholders are going to be impaired. Canada risks being excluded from the global system being established by the Protocol and missing out in the sharing in benefits produced by that system. Given a choice, users outside of Canada may prefer to go to other sources providing greater legal certainty or may choose to collaborate with other scientists operating in jurisdictions that support compliance with provider requirements. Without any supporting ABS legal framework in Canada, both  Roger Hunka – Maritime Aboriginal Peoples’ Council, “Implementation of the Nagoya Protocol within Canada,” accessed 14 April 2012, http://mapcorg.ca/home/wp-media/ NagoyaProtocol-Eng.pdf. 112  Biodiversity Canada, “Access to genetic Resources and Sharing the Benefits of Their Use in Canada: Opportunities for a New Policy Direction,” accessed 13 April 2012, http://www .biodivcanada.ca/default.asp?lang=En&n=936B63F8-1&toc=show. 113  Ibid. 111

326   Geoff Burton providers and users of Canadian genetic resources and associated traditional knowledge would have to rely on private contracts. This would be less attractive, less certain and less transparent, leaving providers and users vulnerable to charges of ‘bio-piracy’ or inequitable dealing. 3.  New Zealand New Zealand’s implementation problem is it cannot even accede to the Protocol until its resolves Treaty of Waitangi Claim 262. This is a claim over the ownership of natural resources made by Maori Iwi (tribes). The Treaty of Waitangi,114 made in the first half of the nineteenth century, is a foundational document for New Zealand. It sets out the rights and privileges of Maori and extends to them the privileges of being British subjects. The Treaty of Waitangi Act 1975 established a Waitangi Treaty Tribunal115 as a permanent commission of inquiry charged with making recommendations on claims brought by Māori relating to actions or omissions of the Crown, which breach the promises made in the Treaty of Waitangi. Claim 262 relates to rights over flora and fauna. It will be difficult for New Zealand to accede to the Protocol until that matter is resolved and a domestic ABS policy is established in light of that resolution.116 This latter issue may, however, then be determined quite quickly as New Zealand’s Ministry of Economic Development has been liaising with Australia over its ABS system since the early 2000s and extensive domestic consultations have been undertaken. Australian officials regularly visit New Zealand and New Zealand is an ex-officio member of Australia’s ABS implementation coordinating body: the Biodiscovery Working Group. Further impetus to establishing a shared or trans-Tasman approach to ABS comes from the 1983 free trade agreement between the two countries.117 Australia and New Zealand also share a common system of law and have a history of shared scientific collaboration in the natural sciences. At this time there is no clear indication when this matter will be resolved. This is unfortunate for New Zealand crown research institutes, its nascent biotechnology and its university sectors. New Zealand researchers, like their Canadian counterparts, are placed at a disadvantage, although it should be

 Treaty between Her late Majesty Queen Victoria and the Maori people of New Zealand, Waitangi, 6 February 1840, 115  Australia, Act No 114 of 10 October 1975, Section 4. 116  [For a discussion of bilateral agreements on ABS, see contribution by Young in this volume (Chapter 15).] 117  This is the Australia New Zealand Closer Economic Relations Trade Agreement (Canberra, 28 March 1983, in force 1 January 1983). 114

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noted that it is the practice of those institutes to involve Maori and their management of Māori culture, nature and its benefits. The area of traditional knowledge protection set out within the Nagoya Protocol has important implications for New Zealand. However, the current domestic policy hiatus over the extent and nature of Māori cultural and physical relationship with the land and nature also offers some opportunities, allowing New Zealand to now take the Protocol into account in resolving that issue. In July 2011 New Zealand’s Waitangi Tribunal released its report on claim 262, titled ‘Ko Aotearoa Tēnei’ – meaning, ‘This is New Zealand.’ The 298-page report recommends wide-ranging reforms to laws and policies affecting Māori culture and identity and calling for the Crown-Māori relationship to move beyond grievance to a new era based on partnership.118 It also offers the New Zealand government specific recommendations concerning bioprospecting. It recommends that New Zealand’s Department of Conservation develop a bioprospecting regime to government-owned land, to be administered consistently with the principles of the Treaty of Waitangi and incorporating existing Māori advisory arrangements, but raising that arrangement to be a joint decision-making body.119 The report also recommends reforming intellectual property law to create a Māori advisory body to advise on prior art and ordre publique associated with Matauranga (Māori cultural knowledge associated with certain species).120 This also includes establishing a register of Māori interest in species and publicly disclosing whether inventions are derived from Matauranga or associated species when applying for patents.121 If the New Zealand government chooses to accept these recommendations, the way would be open to accede to the Protocol. 4.  Australia Having already developed a domestic ABS framework, the key decisions facing Australia are its choice of compliance measures. There are currently a number of measures in that regard, which are under discussion both domestically (and internationally), including:

 Waitangi Tribunal, “Ko Aotearoa Tēnei: A Report into Claims Concerning New Zealand Law and Policy Affecting Māori Culture and Identity,” 2011, accessed 5 June 2011, http:// www.waitangitribunal.govt.nz/scripts/reports/reports/262/05AC7023-0EEA-4ECC-8B6EAB136A2EA7F8.pdf. 119  Ibid., 96. 120   Ibid. 121   Ibid., 97. 118

328   Geoff Burton •  disclosure of source (where known) in patent applications; •  a similar provision in patent law where traditional knowledge associated with genetic resources is used in the development of an invention; •  new penalty provisions for non-compliance with Australian requirements including unlawful sourcing of biological material and the unlawful use of associated traditional knowledge; •  penalties for the use of traditional knowledge associated with genetic resources without PIC of the holders of the knowledge or the establishment of MAT, where these are required; •  a requirement for researchers to comply with the laws and regulatory requirements of the providers of genetic resources and any associated knowledge as a condition for the receipt of public research funds. Where the material or knowledge is from another jurisdiction, researchers must meet the obligations set by that jurisdiction; and •  a requirement that where research is publically funded, any consequent publication of research or patent application include a statement about the source of the material used and compliance with applicable law.122 At the time writing the Australian government is consulting with stakeholders before deciding which measure, or suite of measures, to adopt. It is likely, however, that Australia will choose a bundle of soft and harder measure that may include an offence to knowingly use unlawfully obtained genetic material, a possible due diligence obligation when seeking to use material, and an obligation for recipients of public research funds to comply with requirements of the resource provider and to report on having done so.

V.  Conclusion JUSCANZ as a group of diverse but connected countries provides a sample of the differences and particular national circumstances facing many countries contemplating the implementation of the Nagoya Protocol. Countries such as Canada and New Zealand face unresolved issues concerning the legal status and rights of their indigenous peoples, making negotiation of the Nagoya Protocol difficult and its accession problematic pending a domestic resolution to some of those issues. For others, such as Australia, Norway and Switzerland, being early implementers of the Bonn Guidelines has given them an advantage in being able to help shape the Protocol and, in so doing, creating a comparative advantage.  These areas of discussion have been identified to the author in discussion with Australian government officials.

122

Implementation of the Nagoya Protocol in Juscanz Countries   329

Australia was able to implement two key aspects of a functioning ABS regime prior to the adoption of the Protocol. Firstly it was able to demonstrate a practical method for providing legal certainty, clarity and transparency through its Genetic Resources Information Database providing international verification of compliance with Australian law. The second was its adoption of a solution to the problem of ‘derivatives’ by focusing on defining scope in terms of intent. This led it to introduce a definition encompassing the biochemical makeup of genetic resources when taken from a biological resource for research and development. Norway and Switzerland have included a compliance measure in their domestic ABS legislation that requires applicants seeking patent protection to declare the source of the invention. These countries are now placed to take advantage of the Protocol’s benefits and, in doing so, to model best practise to other countries. For the United States, its continuing inability to ratify the CBD has meant that it is handicapped to advance its own interests in biodiversity-based research. In particular, its biotechnology and pharmaceutical companies may find themselves disadvantaged by the creation of a global trading system in research and development on genetic resources that does not include the US. This situation may prove to be an illustration of the dangers of being a non-Party to the Protocol. But for the JUSCANZ group of countries as a whole, it has been the questions surrounding the utilisation of the traditional knowledge of indigenous and local communities and the recognition that some indigenous peoples may have rights over genetic resources that represent a broad-based stumbling block. This has made negotiations a source of political pressure and makes accession particularly difficult for Canada and New Zealand. The experience of Australia and other JUSCANZ countries is that traditional knowledge is shared across communities and countries making national approaches difficult and achieving equitable outcomes problematic. On a more positive note, it is also clear from the examination of the circumstances and early initiatives in Norway, Switzerland and Australia that the successful operation of the Nagoya Protocol can build upon the key elements that have been already tested and found to work.

Chapter 11.  The Implementation of the Nagoya Protocol in Latin America and the Caribbean: Challenges and Opportunities Jorge Cabrera Medaglia* This chapter1 identifies the main challenges and opportunities for the implementation of the Nagoya Protocol in Latin American and Caribbean countries. Following an initial reflection on the implementation of ABS measures at the national level prior to the adoption of the Nagoya Protocol, the current domestic legal frameworks on ABS in force in selected countries (Brazil, Colombia, Costa Rica, Peru, Panama, Mexico and Venezuela) are analysed with a view to identifying the challenges and opportunities arising from the rights and obligations enshrined in the Nagoya Protocol. Since the entry into force of the Convention on Biological Diversity (CBD) on 29 December 1993, one of the most controversial regulatory and public policy issues, both in the international and national context, has been that of access to genetic resources and the equitable sharing of the benefits arising from their utilisation. Since the promulgation of the first domestic ABS measures – the Philippines’ Executive Order No. 247 on bioprospecting in 1995 and Decision 391 of the Andean Community on ‘The Common Regime for Access to Genetic Resources’ – the countries that have established national ABS frameworks have chosen a wide range of mechanisms to regulate access to biological and genetic resources and benefit-sharing at the national level. Some countries have developed new stand-alone laws on ABS whilst others have amended, revised or updated existing general biodiversity-related laws to introduce and give effect to ABS concepts. Yet others have promulgated administrative guidelines as they are still in the process of considering legislative options. Others have adopted a package of measures combining a *  Professor of environmental law at the University of Costa Rica. 1  Part of this article is based on the paper written by Jorge Cabrera Medaglia, Frederic PerronWelch and Olivier Rukundo, “Overview of National and Regional Measures on Access to Genetic Resources and Benefit-Sharing: Challenges and Opportunities in Implementing the Nagoya Protocol” (CISDL Biodiversity & Biosafety Law Research Programme, December 2011).

332   Jorge Cabrera Medaglia national strategy, legislation or regulations, and guidelines. These packages, however, in many countries remain incomplete due to ongoing legislative or administrative development at different levels of government (e.g., regional, national/federal and state/provincial level).2 Against this background, it should be observed, at the outset, that even after 19 years since the entry into force of the CBD, a large number of Parties to the Convention continue to face challenges in the adoption and implementation of functional national ABS laws and measures. According to the CBD Secretariat, to date, only 60 countries have some type of laws, measures or instruments to regulate access to their genetic resources and the fair and equitable sharing of benefits arising from their utilisation. Furthermore, documentation of such implementation is relatively scarce. The information available indicates that the development of national measures has proven difficult for many countries due to a number of factors including a lack of technical expertise, budgetary constraints, weak government structures and political support, local social conflict and conflict over ownership of genetic resources.3 Capacity building and awareness-raising have taken place over the past seven years but progress has remained slow. In light of the adoption of the Nagoya Protocol,4 it is important for countries that have, or are in the process of putting in place, national ABS measures to share their experiences in implementation. This will be instrumental in appraising and illustrating the different options and approaches to ABS that countries have experimented. Furthermore, these practical national experiences will greatly assist in highlighting regulatory gaps, the strengths  Valérie Normand, “Level of National Implementation of ABS” (paper presented to the International Expert Workshop on Access to Genetic Resources and Benefit-Sharing, Cuernavaca, Mexico, October, 2004). 3  CBD Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing, “Analysis of Existing National, Regional and International Legal Instruments Relating to Access and BenefitSharing and Experience Gained in their Implementation, Including Identification of Gaps. Note by the Executive Secretary,” (10 November 2004) UN Doc UNEP/CBD/WG-ABS/3/2. 4  A growing body of literature has emerged since the adoption of the Nagoya Protocol, including: Matthias Buck and Claire Hamilton, “The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from their Utilisation to the Convention on Biological Diversity,” Review of European Community & International Environmental Law 20 (2011): 47; Union for Ethical Biotrade, “Nagoya Protocol on Access and Benefit Sharing, Technical Brief ” (2010); Gurdial S. Nijar, The Nagoya Protocol on Access and Benefit Sharing of Genetic Resources: Analysis and Implementation Options for Developing Countries (Geneva: South Centre, 2011); Thomas Greiber and Susana P. Moreno, eds., An Explanatory Guide to the Nagoya Protocol on Access and Benefit-sharing: Draft 1.1 for Review (Bonn: International Union for Conservation of Nature (IUCN), 2012); and Evanson Kamau, Bevis Fedder and Gerd Winter, “The Nagoya Protocol on Access to genetic resources and benefit sharing: what is new and what are the implications for provider and user countries and the scientific community” Journal of Environment and Development 6 (2011): 247. 2

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and weaknesses of different approaches to ABS, and the further need for international rules. Indeed scarce research has been conducted on the potential implications – both positive and negative – of the Nagoya Protocol on the implementation or revision of national ABS laws and measures. In light of the above, the interface between the Nagoya Protocol and the national ABS laws and related measures must be further explored to identify opportunities, challenges, and key considerations for the implementation of ABSrelated measures and laws. The domestic ABS frameworks in Latin American and Caribbean countries offer an ideal case study to that end.

I.  National and Regional Implementation of ABS Measures in Latin America and Caribbean Latin America is an area of high biological and cultural diversity and, similarly, intense activity for the development of ABS frameworks. At the regional level, both the Andean Community and the Central American countries have developed ABS measures, although the latter is still in draft form. In addition to countries discussed below (Brazil, Colombia, Costa Rica, Peru, Panamá, México and Venezuela), several other Latin American countries are in various stages of creating and implementing ABS measures such as Bolivia, Ecuador, Argentina (at the provincial level), and Guyana. There appears to be a lesser degree of activity in the Caribbean with some initiatives in Cuba (a general regulation for research on biological resources), Dominica (a draft ABS law) and Saint Lucia (as part of a more comprehensive biodiversity law). The laws and policies described in this section generally pre-date the adoption of the Nagoya Protocol in October 2010. Nonetheless, some of the key provisions of the Protocol were already reflected in certain domestic ABS measures: for instance, requirements to obtain the prior informed consent (PIC) from indigenous and local communities in cases of utilisation of traditional knowledge and to establish intellectual property offices as checkpoints of utilisation of genetic resources. The following sections will first illustrate regional ABS instruments and then focus on domestic instruments in the selected group of Latin American countries. 1.  Andean Community Already in 1993, the Andean Community5 issued Decision 345 on a Common Regime on Plant Breeder’s Rights. The Decision first expressed the commitment  The Andean Community has its origins in the 1969 Andean Subregional Integration Agreement (Cartagena Agreement). Its membership comprises Bolivia, Colombia, Ecuador and Peru. Venezuela withdrew from the Andean Community Agreement.

5

334   Jorge Cabrera Medaglia to establish a common regime on ABS in the region. This commitment came to fruition, in 1996, when the Andean Community created the first regional approach to a common access regime in the form of Decision 391, a Common Regime on Access to Genetic Resources.6 Once approved, the Decision was directly applicable in the Member States of the Andean Community but different factors such as social protests, technical ambiguities, legal differences at the domestic level, and institutional limitations forced the Andean countries to develop national policies and regulations to facilitate the implementation of Decision 391 at the national level.7 Decision 391 establishes both general principles and concrete access rules. Among the principles, it recognises national sovereignty over genetic resources; the right of indigenous, Afro-Americans, and local communities to decision-making authority over their traditional knowledge; the importance of regional cooperation among Andean countries; and the precautionary principle. The access regulations apply to genetic resources, their by-products, their intangible compounds (traditional knowledge, innovations and practices) and the genetic resources of migratory species found within the national territory for natural reasons. The access procedure includes an application, a contract, an official resolution and registration in a public list. The access contract is signed by the National Authority and the applicant, but Decision 391 also requires the contract to take into account the rights and interests of the providers of the genetic resources, by-products of the resources, biological resources containing them, and their intangible compounds.8 In any case, the applicant can be required to sign accessory contracts with other agents involved in providing access: the landowner where the genetic resource is sought, the entity responsible for ex situ conservation, and the owner of the biological resource containing the genetic information. When accessing traditional knowledge, the contract for access must include an annex on the equitable sharing of benefits between the knowledge provider and the user.

 Andean Community, Common Regime on Access to Genetic Resources (Decision 391, 2 July 1996, in force 17 July 1996) (Decision 391). 7  Santiago Carrizosa, “Diversity of Policies in Place and in Progress,” in Accessing Biodiversity and Sharing the Benefits: Lessons from Implementing the Convention on Biological Diversity, ed. Santiago Carrizosa et al. (Gland: IUCN Environmental Policy and Law Paper No. 54, 2004), 10. For instance, Peru, Bolivia and Ecuador have developed detailed ABS measures based on Decision 391. 8  Decision 391 Article 34. 6

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Applications and contracts may include elements such as the following: •  participation of local people in research activities; •  support for research inside the country; •  transfer of environmentally-friendly technology and knowledge (including biotechnology); •  supply of information about antecedents and state of the science concerning resources and products; •  capacity-building measures; •  deposit of collected materials in national institutions; •  mention of the country of origin in publications; •  communication of results of the research to national authorities; •  conditions of transfer of accessed material to third parties. Following the provisions in Decision 391, the governing body of the Andean Community (Board of the Cartagena Agreement)9 approved Resolutions 414 and 415,10 which provide an application form and a model contract containing the elements necessary to regulate access to genetic resources and benefit-sharing. According to the Complementary Provisions of Decision 391, intellectual property rights (IPRs) applications could operate as a tracking mechanism. National patent offices of the Andean countries must ask the applicant to submit the access contract when the product or process they want to protect might have been developed from genetic resources or by-products thereof. IPRs already granted will be void when the access has not observed the legal provisions.11 Furthermore, in 2000, the Board of the Cartagena Agreement issued Decision 486 on Industrial Property that developed certain compliance  Board of the Cartagena Agreement Resolutions 414 and 415 (22 July 1996).   Ibid. 11  Note, however, that the implementing legislation of the Agreement on Commercial Promotion between Peru and the United States (Peru, Law [that] Amends, incorporates and regulates miscellaneous provisions on the implementation of the Trade Promotion Agreement signed between Peru and United States, No. 29316, 2009, accessed 18 June 2012, http:// www.wipo.int/wipolex/en/text.jsp?file_id=179604) has amended the substantive requirement of having an access contract for genetic resources with the Peruvian State or a license contract with the indigenous communities for the use of their traditional knowledge, as a condition for being able to obtain a patent that uses genetic resources or traditional knowledge. In the case that there is no contract, a sanction exists to penalise the applicompetent national authorityt, but this is not a cause for annulment or invalidity of the patent. Board of the Cartagena Agreement Decision 486 (Common Provisions on Industrial Property, 14 September 2000) is modified in two fundamental moments of the IPR process: the patent application and the declaration of annulment of patent that has already been granted.  9 10

336   Jorge Cabrera Medaglia provisions anticipated in provisional stipulations of Decision 391. Accordingly, applications to patent inventions, including genetic material or traditional knowledge originating in countries of the Andean region, should present the corresponding access contract or the respective license or authorisation of use of traditional knowledge.12 These provisions, however, do not limit patenting in other jurisdictions. In addition, in July 2002, the Andean Community adopted a Regional Biodiversity Strategy,13 which points out the legal and institutional difficulties found by Andean countries in implementing Decision 391. The Strategy proposes, among other measures, to specify the subject matter under Decision 391, consolidate the administrative mechanisms, build scientific capacity, establish financial support, and create an information system. To date, Andean countries have each been interpreting the Decision in a different manner.14 This makes it difficult to apply the regulation in a uniform way and according to Lapeña and Ruiz Müller, has been one of the main challenges in fostering research and adding value to genetic resources in the Andean region.15 Several initiatives and projects have been developed to support the national implementation of Decision 391, including capacity-building activities and a draft guide to the Decision. Some experts have also suggested the need for a review of the Decision based on the difficulties experienced in its implementation, but so far there is no formal process to amend this regional instrument. Nonetheless, an analysis of national measures in force in the Andean countries, as well as of several ABS measures in the Latin American region (for instance, in Panama andCosta Rica), indicates that Decision 391 has informed the process of drafting domestic ABS legal frameworks (e.g., the reference to the accessory contracts; the exceptions of the scope of the measure, etc). a.  Brazil16 Brazil is a megadiverse country and one of the richest countries of the world in terms of its biodiversity (and associated traditional knowledge) and has  Decision 486 Article 26.  Regional Biodiversity Strategy for the Andean Countries Decision 523 (7 July 2002), accessed 27 May 2012, http://www.comunidadandina.org/ingles/normativa/D523e.htm. 14  Isabel Lapeña and Manuel R. Müller, eds., Acceso a Recursos Genéticos, Propuestas e Instrumentos Jurídicos (Peru: SPDA, 2004). 15  Ibid. 16  John Kleba, “A socio-legal inquiry into the protection of disseminated traditional knowledge-Leaning from Brazilian cases,” in Genetic Resources, Traditional Knowledge and the Law: Solutions for Access to Genetic Resources and Benefit-Sharing, ed. Evanson Kamau and Gerd Winter (London: Earthscan, 2009), 119; J. Santilli, “Brazil’s Experience in Imple12 13

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also developed considerable technological capacities in the field of biotechnology. Legal developments on ABS in Brazil have attracted significant international attention. The Brazilian ABS legal system has evolved over time: since 1994, there have been several initiatives17 to regulate access to Brazilian genetic resources but no law has yet been approved. Currently, the different proposals are being evaluated by commissions under the Congress. In the meantime, the States of Amapa and Acre have passed their own laws regulating access to genetic resources.18 The project between Bioamazonia and Novartis to access, research and develop the genetic heritage of Brazil that was disclosed in June 2000 provoked very strong opposition from some sectors. To mitigate this situation, the federal government passed a Provisional Measure19 addressing elements involved in access to genetic resources. The Provisional Measure establishes a council for managing Brazilian genetic heritage – Conselho de Gestao do Patrimonio Genetico. Its main tasks are to implement national policies on access to genetic resources and traditional knowledge, and develop technical and administrative activities for providing or denying access. It has been difficult to implement the original Provisional Measure, making it necessary to draft complementary legal measures clarifying the original terms and scope, including: the treatment of specific types of basic research; the clarification of the activities to be covered by the measure and, therefore, requiring an ABS permit; the establishment of further exceptions; the determination of the appropriate authority to deal with basic/non-commercial research; the implementation of ‘disclosure of origin’ in patent applications, etc. These changes have created some controversy and negative reactions from some sectors (mostly the research sector and private companies), which complain about the lack of clarity in the requirements to be met for each menting its ABS Regime – Suggestions for Reform and the Relationship with the International Treaty on Plant Genetic Resources,” in Genetic Resources, Traditional Knowledge and the Law, ed. Kamau and Winter, 187 and also World Intellectual Property Organisation, “Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore: Policies, Measures and Experiences Regarding Intellectual Property and Genetic Resources: Submission by Brazil,” (19 February 2010) UN Doc WIPO/GRTKF/IC/16/INF/9. 17  Brazil, Access to Genetic Resources, Bill No 306/95, 1995, introduced by Senator Marina Silva and amended by Senator Osmar Dias (Brazil, Access to Genetic Resources, Bill No 4579/98, 1998), introduced as companion legislation by Deputy Jacques Wagner. The Executive power formulated a third bill in response to Senator Marina's bill. It proposes an amendment to the Constitution. 18  See Jorge Cabrera Medaglia, A Comparative Analysis on the Legislation and Practices on Access to Genetic Resources and Benefit-Sharing (ABS): Critical Aspects for Implementation and Interpretation (Bonn: IUCN, 2004). 19  Brazil, Medida provisoria No. 2186-16, 2001.

338   Jorge Cabrera Medaglia type of permit, the scope of the legislation, and the overly bureaucratic and time-consuming procedures in place. The system has improved over the past few years, but the nature of the Provisional Measure (in principle a ‘provisional’ legal solution which has been in place for 11 years) and the difficulties encountered in its implementation make it difficult to conclude ABS agreements in Brazil. Besides the Provisional Measure, the Brazilian legal framework includes the Industrial Property Law,20 decisions by the Industrial Property National Institute (the Brazilian patent office) and by the Council,21 which are the executive bodies of the system. In addition, the Provisional Measure is complemented with a number of decrees and resolutions making the legal framework very complex.22 In terms of implementation, a growing number of permits have been granted particularly for non-commercial research and also for commercial research or commercial research utilising traditional knowledge.23 Brazilian legislation defines access to associated traditional knowledge as acquisition of information on individual or collective knowledge or practice associated to the genetic heritage, from an indigenous community or local community for the purpose of scientific research, technological development or bioprospecting with a view to its industrial or other application.24

The Provisional Measure then defines local community as a human group, including descendants of Quilombo communities, differentiated by its cultural conditions, which is traditionally organised along successive  Brazil, Industrial Property Law, No. 9.279, 1996.  The Council is a collective inter-ministerial body that holds monthly meetings. It is chaired by the Ministry of Environment. Its membership includes representatives of 19 other bodies or entities of the federal administration, all of them holding the right to vote: Ministry of Environment; Ministry of Science and Technology; Ministry of Health; Ministry of Justice; Ministry of Agriculture, Livestock and Supply; Ministry of Defence; Ministry of Culture; Ministry of External Relations; Ministry of Development, Industry and Foreign Trade; Brazilian Institute for the Environment and Renewable Natural Resources; Research Institute Botanical Garden of Rio de Janeiro; National Council for Scientific and Technological Development; National Institute for Amazon Research; Emílio Goeldi Museum of Pará; Brazilian Agricultural Research Corporation; Oswaldo Cruz Foundation; National Foundation for Indigenous People; Industrial Property National Institute and Palmares Cultural Foundation. The Industrial Property National Institute, therefore, takes part in all Council deliberations. Other than these regular members, some representatives of civil society hold a standing invitation to Council meetings with the right to speak, such as the Brazilian Association of Biotechnology Companies and the Brazilian Society for the Advancement of Science. 22  For further information see MMA, accessed 5 April 2012, http://www.mma.gov.br/cgen. 23  Ibid. 24  Medida Provisioria Article 7.V. 20 21

The Implementation of the Nagoya Protocol in Latin America   339 generations and having its own customs and preserves its social and economic institutions.25

A broader definition is, however, provided by Decree 6040/2007, which institutes the National Policy for Sustainable Development of Traditional Peoples and Communities: traditional Peoples and Communities are culturally differentiated groups, who identify themselves as such, possess their own forms of social organisation, occupy and use territories and natural resources as a condition for their cultural, social, religious, ancestral and economic reproduction, using knowledge, innovations and practices that are generated and transmitted through tradition.26

Access to the genetic heritage requires prior authorisation from the Council. Depending on the location where the resources are expected to be collected (indigenous territory, protected area, private land, land indispensable for national security, or jurisdictional water, continental shelf or Exclusive Economic Zone), different agents are to take part in authorising or denying PIC; these agents include indigenous communities, the competent authority within the protected area, landowners, or the Brazilian maritime authority, respectively. Expeditions for accessing genetic resources must be coordinated by a national institution. Foreign institutions or persons are not allowed to develop such activities by themselves. If the access is for commercial purposes, the Provisional Measure27 establishes that the applicant, besides obtaining the authorisation, must sign a contract that sets out how the benefits arising from the commercialisation of the resources are to be distributed. The Provisional Measure also indicates some ways for sharing the benefits: royalties, technology transfer, free licenses to products or process, and human capacity building.28 The contract must include, among other elements, information on the resources accessed, benefit-sharing provisions, rights and obligations, IPRs, contract cancellation clauses and an indication of jurisdiction for dispute settlement in Brazil. According to Chapter 8 of the Provisional Measure, non-compliance may be punished with different types of penalties such as: fines; confiscation of samples and products; suspension of the sale of products; closure of establishments; suspension or cancellation of the inclusion in the registry, patent, license or authorisation; prohibition of contracting with the public administration; and restriction of tax incentives.

 Medida Provisioria Article 7.III.  Santilli, “Brazil’s Experience in Implementing its ABS Regime”. 27  Medida Provisioria Article 16. 28  Medida Provisioria Article 25. 25 26

340   Jorge Cabrera Medaglia The IPR application procedure in Brazil may work as a monitoring mechanism. The Provisional Measure requires that the origin of the genetic material and the associated traditional knowledge be specified when applying for IPRs for a process or product obtained using samples of components of the genetic heritage.29 However, this only applies to genetic resources from Brazil, which is not sufficient to fulfil the compliance obligations set out in the Nagoya Protocol. The Provisional Measure thus created a legal regime based on two main instruments: authorisation to access genetic resources and associated traditional knowledge and benefit-sharing contracts. The environmental ministry is the responsible authority for authorising access to genetic resources for the purpose of scientific research with no potential for economic use and which does not involve access to associated traditional knowledge. On 15 September 2009, the Ministry of Environment and the Ministry of Science and Technology signed a technical cooperation agreement granting the National Council for Scientific and Technological Development the competence to authorise access to the genetic patrimony for research purposes. The partnership between the two ministries aims at accelerating the administrative procedures for requests that do not involve access to associated traditional knowledge. When access to genetic resources is aimed at research with the potential for commercialisation or economic use, or if it involves access to associated traditional knowledge, the Council is responsible. If access to traditional knowledge held by indigenous peoples or traditional communities is involved the authorisation of access depends on their previous acquiescence, without which the Council can not grant authorisation. When there is a prospect of commercial use, a benefit-sharing contract must be signed with the indigenous peoples or local communities. Under the current law, benefit-sharing contracts are only required when authorisation is requested for access to genetic resources and traditional knowledge for the purposes of commercial or economic use. The provisional measure provides that the authorisation of access to genetic resources for bioprospecting purposes requires that a benefit-sharing contract be signed in advance. In addition, a presidential decree30 stipulates that, if the provider agrees, the benefit-sharing contract could be drawn up and signed at a later date as long as it is prior to the development of any commercial product or patent application. The Council grants authorisation of access to traditional knowledge for the purpose of scientific research with the prior consent of the communities or indigenous peoples’ organisations. Benefit-sharing is  Medida Provisioria Article 31.  Brazil, Presidential Decree, No. 6159/2007, 2007.

29 30

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required however, once a possibility of economic exploitation has been identified. In 2006 the Council approved Resolution 21 exempting four kinds of research and scientific activities from the need for authorisation. To further improve the current system, the Brazilian government is currently discussing a draft presidential decree to establish a specific procedure to regularise instances of access that occurred without the prior authorisation of the Council. Presently, administrative fines are due when access occurs without authorisation. In the draft under discussion, such fines would not apply, or would be reduced, when the applicant voluntarily fills a request to regularise the research. Patent requests pending the regularisation of access are suspended until the publication of the decree establishing the specific procedure before Council. The revision of Brazil’s ABS legislation is still underway and several draft bills have been discussed by stakeholders. Considering the need to improve regulations, a public consultation was initiated in 2006 involving local and traditional communities, and academic and governmental sectors with a view to replacing the current Provisional Measure. The consultation process includes complex questions related to traditional knowledge and benefitsharing. b.  Colombia The 1991 Colombian Constitution establishes that the State has responsibility for the movement of genetic resources into and out of the country and only the State is authorised to provide genetic resources.31 Additionally, the Constitution establishes that the exploitation of natural resources in indigenous territories should only take place if the cultural, social and economic integrity of communities is respected.32 However, despite the fact that the ownership of genetic resources is vested in the State, indigenous peoples have rights over their territories, including the right to grant PIC and to be part of an accessory contract with the applicant. Law 99 of 199333 made the Ministry of Environment the responsible body for the protection and management of biological and genetic resources. In implementing the general provisions of the Andean Community Decision 391, the Colombian government identified the Ministry of Environment as the national authority entitled to grant access to genetic resources.34 The Direction  The exclusive right of the Colombian State as a legitimate holder of the genetic resources has been affirmed through judicial decisions of the highest tribunals: Sentence of the Constitutional Court C-137 of 1996, l. 32  Colombia, Constitution, article 81. 33  Colombia, Law No. 99, 1993, Organisation of the National Environmental System Law. 34  Colombia Ministry of Environment, Resolution No. 620, 1997. 31

342   Jorge Cabrera Medaglia of Permits and Environmental Licenses is competent for the approval or rejection of ABS applications as well as for the signature of the ABS agreements.35 The main steps for access include: the filing of an application; its study and approval or rejection by the national authority; and, in the case of approval, the access contract. The entire process is public, although the State may grant confidentiality for information susceptible to unfair competition. The procedure is intended to guarantee transparency and to facilitate civil society participation.36 The application must specify the genetic resources to be researched, the access activities required, the proposed geographical area, the identification of the supplier of the biological and genetic resources, the state of the art regarding the genetic material and its application, the CV of the lead scientist of the project, and a copy of the research project. If the research project includes access to traditional knowledge, the application must identify the provider. The application must also identify a national institution as a research partner. The national authority then considers the technical, economic and legal viability of the proposal. The approval of an application is communicated through an administrative resolution and the process moves to a negotiation phase.37 Pursuant to Decision 391 and Resolutions 414 and 415 of the Andean Community, an access contract establishes the conditions for access to genetic resources, their derivatives and traditional knowledge. It also sets up the distribution of monetary and non-monetary benefits. If the bioprospecting activities imply access to traditional knowledge, the contract must include an annex containing the provisions for benefit-sharing that have been previously approved by the provider. Depending on the resources to be accessed and their location, the applicant may be required to sign additional agreements with the steward, landowner and the provider of the biological resources where the resources are found and, if necessary, with ex situ conservation institutions. A national research partner must be identified as part of the mechanism for technology transfer.38 The application of the domestic legal regime on access to genetic resources in Colombia has not been free from difficulties, also, due to the low policy profile of genetic resources and the lack of technical expertise. Although the State and international agencies have sponsored at least two technical and

 Colombia, Resolution No. 1393, 2007. Order 309 of 2000 introduced a more flexible regime to grant research permits related to biodiversity. 36  Andean Community Decision 391, Articles 18–19. 37  Andean Community Decision 391, Ttitle V, Chapter I, Articles 16–31. 38  Colombia, Resolución del Consejo Nacional de Política Económica y Social, No. 3533, 2008. 35

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comprehensive assessments,39 the government has yet to take decisive steps to implement the recommendations. A substantial redefinition of the institutional framework and capacity building continues to be postponed. While research on biological resources for scientific purposes is regulated, in relation to certain specific institutions,40 the relevant rules and procedures lack clarity and have caused some controversies in Colombia.41 A policy document recommends the elaboration of a sui generis system for the protection and recognition of traditional knowledge.42 As a result, only two applications were concluded by the end of 2004. In 1997, one application by BioAndes of Colombia S.A. to study plants, animals and microorganisms in national parks with commercial purposes was rejected, while in 2004 another application to access the genetic resources of the South American dolphin Sotalia fluviatilis for academic purposes was accepted. In 2004 and 2005 no ABS application was submitted. From 2007 to 2011 more than 41 ABS contracts have been signed, all of them for basic research (just one application for a commercial agreement has been submitted and is pending), 26 more applications are under review, and 16 were withdrawn. Due to the difficulties experienced in the implementation of the Andean Community Decision 391 and the local measures put in place, a process to amend the current system was initiated with the support of the National University of Colombia (upon request of the Ministry of Environment), which includes not only amendments to national measures but also a proposal to amend the Andean Community Decision 391.43 c.  Costa Rica Costa Rica’s Biodiversity Law of 1998 applies to the components of biodiversity that are under the sovereignty of the State, as well as to the processes and activities carried out under its jurisdiction or control, independently from those effects manifested inside or outside national jurisdiction.44 This Law specifically regulates the use and management of the components of biodiversity  National University of Colombia, Institute of Socio-Legal Research, “Access to Genetic Resources: Technical and Legal Proposal,” (Bogotá, 2003) and Institute Alexander Von Humboldt, “Technical Proposal for Policy on Access and Sustainable Use of Genetic Resources in Colombia,” (Bogotá, 2004). 40  Colombia, Decree No. 309, 2000. 41  Gabriel Nemoga et al., La Investigación sobre Biodiversidad en Colombia (Bogota: Universidad Nacional de Colombia, 2010). 42  One example of a community experience regulating traditional knowledge by the Guambiano Indigenous Peoples is discussed by Nemoga et al., La Investigación sobre Biodiversidad en Colombia. 43  Nemoga et al., La Investigación sobre Biodiversidad en Colombia. 44  Costa Rica Biodiversity Law, No. 7788, 1998. 39

344   Jorge Cabrera Medaglia as well as the associated knowledge, benefit-sharing and derived costs from this utilisation. The Biodiversity Law establishes that the biochemical and genetic properties of the components of wild or domesticated biodiversity are part of the public domain.45 The State authorises the exploration, research, bioprospecting, and use of biodiversity components which constitute part of the public domain, as well as the use of all genetic and biochemical resources, through access standards established in the Law.46 Likewise, all research or bioprospecting programs on the genetic or biochemical material of biodiversity that are to be carried out in Costa Rican territory require an access permit,47 unless they fall into one of the exceptions provided by the Law.48 These exceptions include: access to human genetic resources; the non-profit exchange of genetic and biochemical resources and the associated traditional knowledge of indigenous peoples and local communities; and research by Costarican public universities, which had one year (until 7 May 1999) to establish their own controls and regulations for research implying non-profit access to biodiversity.49 If none of these exceptions apply, all sectors (pharmaceuticals, agriculture, plant protection, biotechnology, ornamental, herbal, etc.) that wish to access genetic components are subject to the Law and must follow its access procedures. The definitions of access and bioprospecting in the Law also restrict its scope by clarifying that uses of biological resources are only covered to the extent that the intention of the user is to obtain biochemical or genetic information of the materials collected. The access regulations apply to genetic resources in public or private lands, terrestrial or marine environments, under ex situ or in situ conditions, and in indigenous territories. In addition, the decision-making rules of indigenous people should be taken into account for access in their territories as should their sui generis intellectual rights. Similarly in accordance to the Biodiversity Law it is recognised that communities and indigenous peoples have the right to oppose access to their resources and associated knowledge for cultural, spiritual, economic or other reasons.50

 Costa Rica, Biodiversity Law, Article 6.  Costa Rica, Biodiversity Law, Chapter V. 47  In accordance with Costa Rica, Biodiversity Law, Articles 62 and 69. 48  Costa Rica, Biodiversity Law, Article 4. 49  Only one university, the University of Costa Rica, developed its own ABS regulations: Reglamento de Acceso a la Biodiversidad en Actividades de Docencia, Acción Social e Investigación Sin Fines de Lucro de la Universidad de Costa Rica, published in La Gaceta Universitaria, No. 13-99 e. 50  Costa Rica, Biodiversity Law, Article 66. 45 46

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According to the access procedure of the Biodiversity Law,51 the competent body that grants access in the first place is the Technical Office of the recently created National Biodiversity Administration Committee within the Ministry of Environment, Energy and Telecommunications. The Committee is entrusted with preparing ABS policies and can revoke the rulings of the Technical Office on access issues. The main duty of the Technical Office is to process, reject, and audit applications to access biodiversity, and coordinate with Conservation Areas, the private sector, indigenous peoples, and peasant communities on actions that relate to access. It is responsible for organising and updating a register of applications for access to the components of biodiversity, ex situ collections, and of the natural and legal persons who work on genetic manipulations. The Technical Office is expected to collect and update regulations related to the fulfilment of treaties and guidelines on biodiversity issues.52 The Committee is expected to act as the mandatory consultative body for all application procedures for the protection of IPRs related to biodiversity.53 The requirements and procedures to access genetic and biochemical components and the protection of the associated knowledge include PIC, benefitsharing, the protection of associated traditional knowledge, contributions to conservation, and the protection of confidential information. The Biodiversity Law in particular stipulates that up to 10 percent of the royalties must go to the conservation area, private owner, or indigenous territory, in addition to the payment of administrative expenses.54 The Technical Office must also always be consulted in processes where IPRs are granted for components of biodiversity and its decision on these matters is binding.55 However, this consultation process has been diminished as part of the implementation package of the Free Trade Agreement between Central America, Dominican Republic and United States. As a result, the opposition on grounds of lack of compliance with the patent requirements is limited.56 In addition, the processing of applications seems to be allowed even if no certificate of compliance was produced. A constitutional action has thus been brought against this limitation and is pending in the Constitutional Court.57  Costa Rica, Biodiversity Law, Chapter V, sections I and II.  Costa Rica, Biodiversity Law, Chapter V sections I and II. 53  Costa Rica, Biodiversity Law, Chapter V. 54  Costa Rica, Biodiversity Law, Article 76. 55   Costa Rica, Biodiversity Law, Article 80. 56  Costa Rica, Regulation of Clause 6 of Article 78 of the Law on Biodiversity, Decree No. 34958-COMEX-MINAET, 2008. 57  Jorge Cabrera Medaglia, “The Disclosure of Origin Requirement in Central America: Legal Texts, Practical Experience and Implementation Challenges,” in Triggering the Synergies 51 52

346   Jorge Cabrera Medaglia Lastly, the Biodiversity Law establishes the grounds for the protection of traditional, indigenous and community knowledge and for the establishment of a participatory process for the determination and registration of these sui generis intellectual community rights. The process of consultation has not yet been initiated, but a process and methodology for the consultation has been developed and agreed. The law also establishes a system of fines for illegal access and there is a section on the framework for sanctions.58 Most of the bioprospecting in the country has been conducted by the National Biodiversity Institute. The Institute was created in 1989 as a nongovernmental, non-profit association and it has been declared of public interest. Its mission is to promote awareness of the value of biodiversity, and contribute to the conservation and sustainable use of biodiversity to improve the quality of life.59 In 1991, the Institute developed the concept and practice of ‘bioprospecting’ as one answer to the need for sustainable use of Costa Rica biodiversity to benefit society. The Institute has a formal agreement with the Ministry of Environment that allows it to carry out specific activities related to the national biodiversity inventory and use of biological resources in the country’s protected areas. Research is carried out in collaboration with investigation centres, universities, and national and international private companies by means of investigation agreements that include key elements, such as: access limited in time and quantity; equity and compensation, including research budget; benefit-sharing (royalties and milestone payments etc.); technology transfer and training; non-destructive activities; and up-front payment for conservation. The agreements specify that 10 percent of the research budgets and 50 percent of the future royalties are donated to the environment ministry to be reinvested in conservation. The research budget supports the scientific infrastructure in the country as well as added-value activities for the conservation and sustainable use of the biodiversity. The Institute has signed over more than 60 bioprospecting agreements. Several permits have been granted for the Technical Office of Committee. More than 180 permits have been granted since 2005 and, until 2010, mostly for basic non-commercial research, although a number have been granted for commercial research.60 The Costa Rican experience thus provides some of the most relevant examples of obstacles, as well as achievements, with respect to the regulation on access to genetic resources, intellectual property, and traditional knowledge. Between Intellectual Property Rights and Biodiversity, ed. Alexander Werth and Susanne Reyes-Knoche (Eschborn: GTZ, 2010), 270. 58  Costa Rica, Biodiversity Law, Article 112. 59  See http://www.inbio.ac.cr, accessed 5 April 2012. 60  See MINAET, accessed 5 April 2012, http://www.conagebio.go.cr.

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The income contributed by the biodiversity prospecting programme reaches several million U.S. dollars overall and makes important contributions to technology, capacity-training, equipment, the National System of Conservation Areas and, more importantly, to the creation of national research and negotiation capacities. Although this last aspect stands out as the most important in relation to acquired benefits, it is important to point out that eco-tourism contributed around $700 USD million in just one year, making bioprospecting’s economic return seem relatively small. In contrast to other countries, where regulations to date have concentrated more on controlling than promoting access, creating high transaction costs and complicated bureaucratic procedures, leading to an absence of access applications without which it is not possible to share benefits, the Biodiversity Law in Costa Rica has created the necessary legal guarantees, and an ABS regime that is sufficiently flexible and transparent. In addition, the Biodiversity Law made a connection between ABS and conservation. The regulations on access are, therefore, based on the idea of conserving biodiversity, its sustainable use and the fair distribution of its benefits. It should be noted, however, that almost all the permits issued under the Biodiversity Law so far have focused on collecting resources on protected or private areas as well as marine areas of the country. Almost no ABS initiatives have been proposed and carried out in indigenous territories and, thus, no benefits have directly accrued to indigenous groups. d.  Mexico Mexico lacks a specific and comprehensive regulatory framework for genetic resources. Legal initiatives currently under consideration by the Congress aim to fill this gap, but have not yet been finally approved. Rules on access to genetic resources are, however, scattered in different federal laws. The General Law on Ecological Equilibrium and Environmental Protection61 recognises that the use of genetic resources is considered of public interest. Due to this, the State can regulate individual actions on behalf of the higher interests of society. According to the General Environmental Act,62 scientific collection of biological resources (including genetic resources) for non-biotechnological purposes requires the authorisation of the Secretariat of Environment and Natural Resources. Research results must be available to the public.63 When the resources are to be used for the purposes of biotechnology, the forest law conditions authorisation on the prior consent of  Mexico, General Law on Ecological Equilibrium and Environmental Protection, 1988 (Mexico Environmental Law). 62  Mexico Environmental Law, Article 87. 63  Mexico Environmental Law, Article 87. 61

348   Jorge Cabrera Medaglia the landowner where the resource is sought.64 The benefits arising from the use of the resources must be shared with such owner.65 The prior consent of the land owner is also required by the Wildlife General Act66 when collecting activities for scientific purposes. This requires users to submit reports about their activities and to deposit samples of biological material in national research institutions. As to the requirements for scientific collections, if the user changes his purpose from scientific to biotechnological applications, he must submit a new declaration stating the new purpose and setting the stage for new consent and benefit-sharing agreements.67 The provisions of the Sustainable Forestry Development Act,68 regulating collection for scientific, commercial and biotechnological purposes, follow the access scheme in the General Act. The forest law, however, adds a simplified procedure in case of collections done by the owner of the land or by public agencies. The novel element is that the Act recognizses the right of indigenous people over local varieties and related traditional knowledge. It then declares void any registration including patents that do not acknowledge the right of indigenous people to the ownership, knowledge and use of local varieties. If traditional knowledge is to be used, there must be recognition of the ownership on behalf of the communities, an access agreement and proof of PIC. The Mexican Intellectual Property Right Law or the Plant Varieties Federal Law does not contain a disclosure of origin requirement. Finally, the Mexican Criminal Code explicitly includes illegal collection and traffic of genetic resources, which are punishable by imprisonment and a fine. Furthermore, ‘additional punishment will be applied . . . when the . . . described activities . . . are executed with a commercial purpose.’69 Overall, conflicts of land tenure and resource use in rural areas have hindered the establishment and enforcement of an efficient domestic ABS regime in Mexico. Due to uncertainty and distrust felt by some social sectors, including indigenous peoples, bioprospecting activities have been occasionally difficult to carry out.

 Mexico Environmental Law, Article 87bis.  Mexico Environmental Law, Article 87bis. 66  Mexico, General Wildlife Act, 2000. 67  Mexico, Official Mexican Standard, No. 126, 2000. 68  Mexico, General Law on Sustainable Forest Development, 2003. 69  Mexico, Criminal Code, as amended in 2002, Article 420. 64 65

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e.  Panama70 Panama’s General Environment Law71 mandates that the National Environmental Authority is the competent body to regulate and control the access and use of biogenetic resources in general, with the exception of human genetic resources. In order to fulfil this function, it envisions the development and introduction of legal tools and/or economic mechanisms.72 The Genetic Resources Access Department was then created as a part of the National Office for Protected Areas and Wildlife of the National Environmental Authority, with the responsibility of processing biological and genetic resource access applications (commercial, industrial and non-commercial).73 The General Environment Law establishes that the right to use natural resources does not grant users the right to use genetic resources contained in them.74 This provision formed the starting point for the subsequent regulation on ABS. The Law then defines genetic resources as a set of hereditary molecules within organisms whose primary function is the generational transfer of the information on natural heredity of live organisms. Its expression is the collection of cells and tissues that form the live organism.75

Similarly, it defines biological surveying as The exploration of wild natural areas in the search of species, genes or chemical substances derived from biological resources with the goal of obtaining medicinal, biotechnological and other product76

The General Environment Law further indicates that natural resources are in the public domain and of social interest without infringing upon the rights legitimately acquired by individuals.77 It also stipulates that the Comarcas (specific indigenous territories) and the municipalities where natural resources exist, and are used or extracted, have the responsibility of contributing to their protection and conservation according to the parameters established by the National Environmental Authority together with the indigenous authorities, in conformity with applicable law.78

 Elia Guerra, “Acceso a recursos genéticos y distribución de beneficios” (study prepared for the Natural Patrimony Office of the ANAM, 11 March 2004). 71  Panama, General Law on Environment, No. 41, 1998. 72  Panama, General Law on Environment, Article 4. 73  Panama, Resolution No. AG-0208-2007, 2007. 74  Panama, General Law on Environment, Article 72. 75  Panama, General Law on Environment, Article 2. 76  Panama, General Law on Environment, Article 2. 77  Panama, General Law on Environment, Article 62. 78  Panama, General Law on Environment, Article 63. 70

350   Jorge Cabrera Medaglia The implementing decree to the General Environmental Law79 is remarkable in two respects. First, it defines certificate of origin or provenance as the legal recognition on the part of the National Environmental Authority of the origin or provenance of the genetic or biological resource whose genetic heredity makes up the genetic materials where processes or other products are derived.80

Second, it prescribes that access contracts should include the obligation of the applicant to declare the origin and provenance of the genetic resources in all the publications or summaries that incorporate genetic or biological resource collected.81 In the same manner, the certificate of origin and provenance for the genetic and/or biological resource or material used in the development of the invention should be presented in all invention patent applications that are taken to the General Office of Intellectual Property and/ or any patent office of member countries to the World Intellectual Property Organisation.82 Lastly, Panama has created83 a sui generis system for the protection of traditional knowledge, limited to indigenous communities and targeted fundamentally to folklore and other traditional cultural expressions. IPRs and indigenous community traditional knowledge on their creations such as clothes, tools, drawings, designs, figures and graphics, among others, are regulated and protected. These also include cultural elements such as their music and dance. This protection is implemented through a registry system and through promotion and commercialisation of their rights,84 as well prohibitions and sanctions.85 In addition, the Criminal Code of 2007 punishes crimes against the collective rights of indigenous communities and their

 Panama, Decree implementing General Law on Environment Article 71 and regulating access to genetic resources No. 257, 2006. This decree was subsequently amended by Decree No. 25 of 2009. 80  Panama, Decree No. 25, Article 3. 81  Panama, Decree No. 25, Article 19.e. 82  Panama, Decree No. 25, Article 19.g. 83  Panama, Special Intellectual Property Regime with Respect to the Collective Rights of Indigenous Peoples to the Protection and Defence of their Cultural Identity and Traditional Knowledge, No. 20, 2000; and Panama, Decree No. 12, 2001. 84  From 2002 to 2009, ten registries were granted. The protected material includes designs or textiles of molas, bags, necklaces, traditional dress, wood works, baskets, hammocks and musical instruments. 85  See in general the provisions of the Special Intellectual Property Regime with Respect to the Collective Rights of Indigenous Peoples to the Protection and Defence of their Cultural Identity and Traditional Knowledge, No. 20, 2000. 79

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traditional knowledge, with four to six years in prison for those who violate these registered collective rights.86 In practice, no access permit has been granted in accordance with the implementing legislation of 2006.87 Given the recent enactment of new ABS regulations, there are no current patent applications that would meet the obligation related to the submission of the certificate of origin or provenance. f.  Peru In 1997, Peru enacted the Law on the Conservation and Sustainable Utilisation of Genetic Resources, which addresses, in a general manner, indigenous peoples’ rights and scientific research but does not contain detailed provisions on ABS. In August 2002, Peru established a sui generis system of protection covering only the collective traditional knowledge related to biodiversity.88 PIC is the main condition to be fulfilled to obtain access to the collective traditional knowledge and is to be obtained from the representative organisations of the indigenous peoples. Indigenous peoples may refuse access.89 It is also necessary in the cases of commercial and industrial applications to sign an agreement that ensures benefit-sharing.90 The license must be in written form and registered with the National Institute for the Protection of Intellectual Property; in the absence of certain clauses of the license agreement required by law, the Institute must refuse to register the license.91 The Law also provides for three types of registers of collective traditional knowledge: a) the National Public Register; b) the National Confidential Register; and c) local registers of collective knowledge. Indigenous peoples possess rights, including the right to decide over its use and dissemination, over their knowledge whether in a register or not. A fund for the development of indigenous peoples is created to compensate all the indigenous peoples for their contribution to the preservation of this knowledge.92 The fund has been created but no money has yet been accrued. In addition, the Law for the Protection of Access to the Peruvian Biodiversity and to the Collective Indigenous Knowledge (the anti-bio-piracy Law) creates a National Commission for the Prevention of Bio-piracy93 to avoid  Panama, Criminal Code, No. 14, 2007.  Darío Luque and Leonardo Uribe, personal communications with the author. 88  Peru, Law No. 27811 Introducing a Protection Regimen for the Collective Knowledge of Indigenous Peoples Related to Biological Resources, 2002. 89  Peru, Collective Knowledge Law, Article 6. 90  Peru, Collective Knowledge Law, Article 7. 91  Peru, Collective Knowledge Law, Article 21. 92  Peru, Collective Knowledge Law, Article 8 and final provisions. 93  Peru Law No. 28216 of 2004 for the Protection of Access to the Peruvian Biodiversity and to the Collective Indigenous Knowledge. 86 87

352   Jorge Cabrera Medaglia and prevent illegal access and appropriation of the biological resources and traditional knowledge. The Commission is fully operational and has been very active searching for foreign patent applications involving, or using, national genetic resources or traditional knowledge.94 In 2008, ABS regulations were issued95 that followed closely the main provisions of Andean Community Decision 391.96 The regulations cover all the genetic resources of which Peru is the country of origin, their derivative products, their intangible components and the migratory species found for natural reasons in the Peruvian territory.97 The regulations recognise and protect the rights of the indigenous peoples to decide about their innovations, practices and knowledge associated to genetic resources.98 The ABS regulations do not cover human genetic resources and their derivative products, indigenous peoples’ and local communities’ traditional and customary use of genetic resources, the species included in Annex I of the International Treaty on Plant Genetic Resources for Food and Agriculture, the use of genetic resources for cultivation purposes within Peru, and activities implying the economic use of non-timber natural resources to produce natural products (nutraceuticals and functional foods).99 In addition, a regional norm on access to genetic resources and to associated traditional knowledge in the territories of the farmer and native communities of Cusco100 essentially establishes an institutional mechanism to prevent and address cases of bio-piracy in the region, as well as promoting the conservation of, and research on, genetic resources.101 The Ministry of Environment is the national competent authority on ABS; it approves the national policy, guidelines and norms for the management of the genetic resources.102 It also establishes the strategy for international negotiations in coordination with other bodies and holds, among others, the  Manuel Ruiz, La protección jurídica de los conocimientos tradicionales: algunos avances políticos y normativos en América Latina (La Paz: IUCN, 2006).   95  Peru, Regulation on Access to Genetic Resources, No. 087-2008-MINAM, 2008. This was, subsequently, converted into Peru, Decree No. 003-2009-MINAM, 2009.   96  E.g., the definitions are the same contained in Decision 391 Article 1.   97  Peru, Regulation on Access to Genetic Resources, Article 4.   98  Peru, Regulation on Access to Genetic Resources, Article 6.   99  Peru, Regulation on Access to Genetic Resources, Article 5. 100  Peru, Ordinance on Bio-piracy, No. 048-2008-CR/GRC.CUSCO, 2008. 101  Other relevant norms are Peru, Law Declaring Crops, Native Breeds and Usufruct Wildlife Species part of the Nation’s Natural Heritage, No. 28477, 2005 which declares, as natural heritage of the Peruvian nation a list of 35 native crops and wild fauna species; and the National Directorial Resolution No. 1986/INC, 23 December 2009 which declared, as national cultural heritage, the knowledge, practices and technologies associated to the traditional cultivation of maize in the Sacred Valley of Incas in the Andes of Peru. 102  Peru, Ministerial Decree No. 003-2009, Article 13.   94

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register of the access contracts and national research entities.103 However, the permitting process and the signature of access contracts are the responsibility of administrative and execution authorities104 (so far the agricultural, fisheries and protected areas authorities). Following Andean Community Decision 391, the ABS regulations provide for access contracts (between the national competent authority and the applicant), accessory contracts (between the applicant and relevant stakeholders, such as private owners, indigenous peoples etc), framework contracts (between research centres and the national competent authority), and material transfer agreements to be signed by the ex situ conservation centres (the model of these agreements must be approved in advance by the ministry). In accordance to the Regulations, the access contracts and the accessory contracts must include, among others: a prohibition to claim property over the material per se or its derivatives; an obligation not to transfer the material without the authorisation of the competent authority; recognition of the origin of the material; training and infrastructure; information exchange; technology transfer; economic benefits; and research reports.105 In practice, just one formal ABS contract with the Korean Institute of Biosciences and Biotechnology is known, which had the objective of conducting research on the medicinal plants traditionally used in the Amazonian Region. This contract implied the development of complex institutional arrangements with the participation of three different Peruvian entities.106 g.  Venezuela ABS in Venezuela was initially carried out in conformity with Andean Community Decision 391 and currently with the Biodiversity Law,107 and other relevant legislation, which establishes similar provisions to those in Decision 391. According to the law, all persons seeking access to genetic resources must follow as administrative procedure including application, the conclusion of a contract, the issuance of a public resolution and registration. Factors such as the conservation of endemic species, ecosystem preservation, and human health protection can justify limitations to access. Concerning the use of traditional knowledge associated with genetic resources, the State

 Ministerial Decree No. 003-2009, Article 13.  Ministerial Decree No. 003-2009, Articles 14–15. 105  Ministerial Decree No. 003-2009, Article 23. 106  Isabel Lapeña et al., Incentivos y Desincentivos para la participación de Perú en el Sistema Multilateral de Acceso del Tratado Internacional Sobre Recursos Fitogenéticos para la Alimentación y la Agricultura, (Rome: Bioversity International, 2010). 107  Venezuela, Biological Diversity Law, 2000, Title r VII. 103 104

354   Jorge Cabrera Medaglia commits itself to promote and protect the collective rights of indigenous peoples and local communities.108 A guarantee is required in order to ensure compliance with the contract.109 In addition, contravention of the access legislation may be punished with a fine.110 The law also includes provisions that may act as a tracking mechanism. The applicant must provide information about the results, and research conclusions must be provided to the Ministry of Environment. IPRs will not be granted when samples have been acquired illegally or when they make use of the knowledge of indigenous and local communities. The National Office of Biodiversity examines IPRs based on national genetic resources granted outside the country, with the purpose of claiming the corresponding royalties or the withdrawal of the right. In 2001, the norms for the coordination of the competences for processing ABS contracts were approved, creating the National Commission on ABS with advisory functions.111 Legal provisions also aim to improve the coordination between the National Authority and other authorities from which other types of permits are required in order to facilitate the entire process for obtaining all the authorisations.112 In addition to the Biodiversity Law, two other pieces of legislation are of relevance for traditional knowledge protection, which address the rights to indigenous peoples in general. They do not specifically regulate the protection of traditional knowledge or genetic resources, but provide for: the recognition of indigenous rights over the traditional knowledge and its lands; the requirement of PIC; the requirement to provide benefit-sharing; the limitations to apply for IPRs on traditional knowledge; and the voluntary register of intangible heritage.113 In practice, Venezuela has granted access to different projects and signed several framework agreements with national universities and research centres to carry out bioprospecting activities for non-commercial purposes. In

 Venezuela, Biological Diversity Law, Title VII.  Venezuela, Biological Diversity Law, Article 74. 110  Venezuela, Biological Diversity Law, Article 116. 111  Resolution No. 95 of 24 August 2001. 112  Ibid. 113  Venezuela, Law on the Cultural Heritage of Indigenous Peoples, No. 39.115, 2009 and Venezuela, Organic Law on Indigenous Peoples and Communities, 2005. 108 109

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light of these projects, Febres114 and Cabrera115 have highlighted some shortcomings in the Venezuelan domestic legal framework, such as the lack of criteria to implement legislation, weakness in the implementation of monitoring systems, and limited coordination between authorities.

II.  Trends, Challenges and Opportunities in Implementing the Nagoya Protocol in Latin America and the Caribbean The above analysis of the normative developments in the region and their implementation leads to the identification of certain general trends in Latin America and the Caribbean. Overall, there is a high level of legislative action in the region on ABS issues, with some countries having put in place a plurality of ABS measures such as Peru, Brazil and Venezuela, including specific legislation on traditional knowledge issues. To some extent the region has also been a pioneer both in the development of legal frameworks on ABS (e.g., Andean Community, Costa Rica and Brazil) and associated traditional knowledge (e.g., Peru and Panama). This trend may be expected to continue in the near future, as there is a growing interest in the enactment of new legislation as demonstrated by the recent adoption of the Ecuadorian ABS regulations116 and the existence of several drafts and initiatives to create ABS measures. On the other hand, several ABS draft measures have been discussed for several years without getting closer to final adoption, such as the Nicaragua Biodiversity Draft Law (which includes a chapter on ABS). A variety of factors, among others, may explain these delays, such as change of priorities and authorities, internal divergences on the content of the law, and lack of technical support. Even where legal developments have materialised, however, the level of implementation of ABS measures is still low.117 These challenges have, nonetheless, allowed identification of certain important lessons, including the identification of difficulties in controlling access to genetic resources,   María Elisa Febres, “Avances Normativos de Venezuela en Materia de Acceso a Recursos Filogenéticos” (paper prepared Protection of Access to the Peruvian Biodiversity and to the Collective Indigenous Knowledge for the Seminario Regional sobre Acceso a los Recursos Fitogenéticos en la Región Andina, Lima, 2003). 115  Cabrera Medaglia, Jorge Comparative Analysis on the Legislation and Practices on Access to Genetic Resources and Benefit-Sharing (ABS). 116  Ecuador, Reglamento Nacional al Régimen Común de Acceso a Recursos Genéticos en aplicación de la Decisión 391 de la Comunidad Andina, No. 905, 2011. 117  Jorge Cabrera Medaglia and Silva Lopez, Addressing the Problems of Access: Protecting Sources, While Giving Ssers Certainty (Bonn: IUCN Environmental Policy and Law Paper No. 67/1, 2007). 114

356   Jorge Cabrera Medaglia the high transaction costs associated to the permitting process and the lack of certainty created by these frameworks.118 On that basis, some countries in the region are recently experiencing a growing level of implementation (Costa Rica, Brazil, Venezuela, Colombia), which is demonstrated by the number of ABS contracts/permits granted. In some of these countries most of the permits/contracts issued (sometimes around 90%) correspond to basic research and for nationals (including public universities and research centers). This means that, contrary of to the initial expectations of the CBD parties, the main users of the ABS systems come from basic research centres and universities, and thus, generally, provide non-monetary benefits and rarely monetary compensation. In addition, it is now clear that ABS relationships may take place between stakeholders located in the same country and they do not necessarily involve user and providers from different countries. Eventually this finding may lead to the development of specific procedures for noncommercial research and may also facilitate the implementation of the ABS measures in the research community, which traditionally have viewed the ABS procedures as a burden for the research and development process.119 Finally, the lack of capacity to negotiate ABS agreements persists – at least in certain countries, as highlighted in the case of Panama and the Dominican Republic. The legal and practical process for obtaining PIC and mutually agreed terms (MAT) for certain stakeholders, especially indigenous and local communities, also remains a critical aspect for a functional ABS system in the region. Several capacity-building initiatives have thus taken place, such as the recent ABS capacity-building project funded by the Global Environment Fund,120 aimed at increasing the capacity to develop and implement ABS measures and to negotiate ABS contracts and arrangements. Other countries are in the process of preparing and submitting proposals to receive support for ABS-related activities (Guatemala, Costa Rica, etc).  Medaglia, A Comparative Analysis on the Legislation and Practices on Access to Genetic Resources and Benefit-Sharing; and Cabrera Medaglia and López Addressing the Problems of Access. 119  [For a perspective from the research community, see contribution by Dederwaerdere et al. in this volume (Chapter 13).] 120  For instance the Global Environment Facility Project titled “Strengthening the Implementation of ABS regimes in Latin America and the Caribbean” started in April 2011 and will continue until April 2014. Countries involved include Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, Guyana, Panama and Peru. The project objectives are: to strengthen the capacity of the countries to develop, implement and apply CBD provisions related to access to genetic resources and benefit-sharing as well as to traditional knowledge associated with these resources and to increment the understanding and the negotiation skills of countries regarding ABS agreements/contracts, in a way that will contribute to align bioprospecting projects and national ABS decisions with the CBD. 118

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On the basis of these preliminary remarks, the following subsections will compare and assess existing national legal frameworks in the region in the light of the core requirements of the Nagoya Protocol, with a view to identifying more specific implementation challenges. The following subsections will focus in turn on access to genetic resources, benefit-sharing, traditional knowledge, and compliance. 1.  Access: Legal Certainty, Clarity and Transparency of Domestic Requirements The Nagoya Protocol obliges provider countries, if they decide to establish ABS measures at the national level, to provide for legal certainty, clarity and transparency.121 Most of ABS regulations in the region per se, theoretically, provide for legal certainty, clarity and transparency of domestic requirements (Costa Rica, Peru, Panama, Bolivia, etc.). Some ABS measures refer to legal certainty and transparency as principles guiding the interpretation of the measures (Peru). However, in some cases difficulties have emerged related to the national institutional arrangements in place to handle access requests, due to lack of internal coordination and appropriate capacity to decide on the applications received. Sometimes, the interpretation of the provisions, the determination of the scope of the ABS measures and the timeframe for the issuance of a final decision, have created practical difficulties in the operation of domestic ABS systems. The procedure for obtaining a permit is, generally, precisely described as well as the criteria the applicant must fulfil, including the potential restrictions and limitations on obtaining genetic resources. The requirement for PIC and benefit-sharing agreements is also clearly expressed. However, certain key domestic requirements are very vague; a case in point is Panama’s legal requirements on how to obtain PIC and MAT. 2.  Fair and on-Arbitrary Rules and Procedures on Access The Nagoya Protocol obliges provider countries, if they decide to establish ABS measures at the national level, to provide for fair and non-arbitrary rules and procedures.122 Based on the existing ABS legislation in the region, it appears that most countries provide for non-arbitrary rules and procedures for accessing genetic resources. In most countries, the applicant can either be a local or a foreigner person, but natural persons are often required to be affiliated to an institution/legal person. However, in some cases, a foreign applicant must be affiliated to or represented by a local person (Costa Rica)  Nagoya Protocol Article 6.3.a.  Nagoya Protocol Article 6.3.b.

121 122

358   Jorge Cabrera Medaglia or affiliated with a national research institution, at least for some types of ABS applications (Brazil and Venezuela). The latter is also reflected at the Andean Community level. Moreover, most domestic ABS frameworks point out that the access should be approved or refused by a decision in writing of the competent national authority. In some cases, more than one competent national authority exists; one granting access to genetic resources for commercial purposes (or when traditional knowledge is involved) and the other dealing with access for non-commercial purposes or with export permits (e.g. Brazil) or for different types of genetic resources (marine, domesticated, located in protected areas, as in Peru). In most countries, the competent national authority is required to process applications and notify its decision within a reasonable time (such as Costa Rica and Ecuador), but in practice timelines are not always strictly followed. If the competent national authority rejects the application, the decision must provide reasons and the applicant should have the opportunity to appeal (Costa Rica and Ecuador). Finally, a few countries addressed the issue of transboundary genetic resources or associated traditional knowledge, especially Peru and Ecuador. In the case of the Andean Community, it is mandatory for the country negotiating an ABS contract – involving genetic resources of which they are countries of origin – to take into account the interest of other countries of origin, with the possibility for the latter to provide its opinion and information to the competent authority of the country considering the application.123 3.  Clear Rules and Procedures for PIC and MAT The Nagoya Protocol obliges provider countries, if they decide to establish ABS measures at the national level, to provide clear rules and procedures for PIC and MAT.124 Most of ABS regulations in the region provide for PIC and benefit-sharing agreement between the applicant and the provider. Some countries also require the applicant, under certain circumstances, to sign a contract (sometime called accessory contract) with the provider of the genetic resources or associated traditional knowledge; this is the case in Panama, Venezuela, Colombia, Peru, Brazil (for commercial purposes or for accessing traditional knowledge) and Costa Rica (PIC contract). The picture is quite varied in the region as to the precision of access procedures. The procedures to obtain PIC and MAT often are not precise when PIC and MAT are also required from other stakeholders (such as indigenous  Decision 391, second final provision.  Nagoya Protocol Article 6.3.c–g.

123 124

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and local communities). For instance, in Panama very little detail is provided as to the content of PIC and MAT. Other domestic ABS frameworks, however, are more precise. Costa Rican legislation, for example, describes the content of PIC and points out that the applicant has to meet with representatives of the place of access and with the indigenous and local communities in order to discuss the terms and implications of access to genetic resources and the terms of the protection of traditional knowledge. Costa Rican legislation also describes the minimum content of MAT and provides for the elaboration of a model contract by the relevant author. 4.  Fair and Equitable Benefit Sharing Parties to the Nagoya Protocol are called upon to take measures relating to benefits arising from the utilisation of genetic resources, as well as subsequent applications and commercialisation, so that they are shared with the provider country. Those benefits should be shared with indigenous and local communities that are holders of genetic resources under domestic legislation.125 Similarly, benefit-sharing measures should be developed in order that benefits from the utilisation of traditional knowledge are shared fairly and equitably.126 Most domestic ABS frameworks in the region provide for the establishment of a benefit-sharing agreement between the applicant and one or several providers, or proof that benefit-sharing has been established with relevant providers (e.g., Costa Rica, Panama, Colombia and Brazil). The applicant and the competent national authority thus enter into this agreement with a State agency, indigenous and local communities or other owners. Sometimes more than one contract is necessary – one with the State agency and one with the provider of genetic resources or associated traditional knowledge. Benefitsharing mechanisms also exist when traditional knowledge is accessed, as well as in the case of genetic resources located in the land or territories of indigenous and local communities (e.g., Brazil, Panama and Costa Rica). In most cases indigenous peoples have established rights over their territories, including by constitutional provisions (e.g., Brazil, Ecuador and Bolivia). In addition, before the competent national authority approves an access permit, it must be satisfied that the established benefit-sharing agreement is fair and equitable to all parties. A large number of ABS regulations refer to monetary and non-monetary benefits to this end, and some list examples (e.g., Costa Rica, Peru, Bolivia, Ecuador and Colombia). Although almost all the ABS measures adopted in the region, at least, include biodiversity conservation

 Nagoya Protocol Article 5.2.  Nagoya Protocol Article 5.5.

125 126

360   Jorge Cabrera Medaglia as one of their objectives, only few countries also provide that some of the benefits be directed to biodiversity conservation (notably, Costa Rica). 5.  Traditional Knowledge Associated with Genetic Resources The Nagoya Protocol calls on countries to take measures aimed at ensuring that traditional knowledge held by indigenous and local communities is accessed with PIC, or prior approval and involvement of these communities, and that MAT are established. The Protocol also imposes an obligation upon countries to establish mechanisms to inform potential users of traditional knowledge associated with genetic resources about their obligations. Furthermore, countries are requested to support the development by indigenous and local communities of community protocols, minimum requirements for MAT, and model contractual clauses for benefit-sharing arising from the utilisation of traditional knowledge associated with genetic resources. The Protocol also contains a specific obligation for countries to take into consideration customary laws, community protocols and procedures of indigenous and local communities.127 Safeguarding or protecting the interests of indigenous and local communities over their knowledge and practices has already often been one of the objectives of ABS legislation in the region. It was reflected in the Andean Community common regime, as well as in the requirements in the domestic ABS regimes in Peru, Colombia and Brazil, striving to recognise and protect the rights of the indigenous peoples to make decisions about their innovations, practices and knowledge associated with genetic resources. In some Latin American countries, specific legislation, additional to the broader ABS measures, exists to guarantee the right of indigenous peoples over their traditional knowledge or genetic resources located in their lands (e.g., Venezuela, Panama, Peru, Ecuador, Bolivia, Colombia, etc.). Furthermore, most ABS legislation in the selected countries requires the applicant to obtain the PIC of local communities for access to genetic resources on land that is owned or managed by communities with established rights over those resources. According to Brazilian legislation, for instance, even if PIC is only given by the State or a State agency, the PIC process must provide for the active involvement of local communities and respect the customary laws, practices and protocols of local communities. These developments may be a result of the growing jurisprudence of the Inter-American Court on Human Rights safeguarding the right to the indigenous peoples to their healthy environment, the right over their ancestral lands and the right

 Nagoya Protocol Article 12.

127

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to be consulted and participate in the decision making process for activities which may impact their land and territories.128 Nonetheless, very few laws set out detailed procedures for obtaining PIC of indigenous and local communities. Costa Rican legislation describes the content of the PIC and points out that the applicant has to meet with representatives of the place of access and with the indigenous and local communities in order to discuss the terms and implications of access to genetic resources and the terms of the protection of traditional knowledge. Ecuador’s regulations provide for the future development of a PIC Protocol (in general for all the possible stakeholders). Another common trait to most ABS laws in the region is the requirement that affected indigenous and local communities are involved in the negotiation of benefit-sharing arrangements, including by entering into a benefitsharing agreement with the applicant. Very few other countries, however, have developed model contractual clauses applicable to the negotiations involving indigenous and local communities; Costa Rica and Peru appear to be the exception rather than the rule in that regard. Finally, specific recognition of customary law or community protocols is provided indirectly in some domestic ABS systems (and in the Constitutions of Ecuador and Bolivia), but detailed guidance on these is lacking. 6.  Compliance The compliance measures under the Nagoya Protocol are essentially premised on a set of obligations for Parties to take appropriate, effective and proportionate measures so as to ensure that the utilisation of genetic resources and associated traditional knowledge are based on PIC and in accordance with MAT. These measures are one of the main innovations of the Protocol.129 The Protocol leaves a great degree of discretion to Parties as to the types of measures they may adopt to meet this obligation. The Protocol only stipulates that countries shall designate one or more checkpoints to monitor and enhance transparency on the utilisation of genetic resources. There is no specificity or explicit obligation to designate a specific type of checkpoint, nor does the Protocol prescribe any specific obligation as to the type of information that would be collected or received by the designated checkpoint(s). The Protocol only states in an indicative manner that relevant information related to PIC, to the source of the genetic resources, to the establishment of MAT, and/or to the utilisation of genetic resources could, as appropriate, be collected or  See the relevant jurisprudence on human rights and indigenous peoples at Inter-American Court of Human Rights, accessed 27 May 2012, http://www.corteidh.or.cr. 129  [See contribution by Glowka and Normand to this collection (Chapter 1).] 128

362   Jorge Cabrera Medaglia received by a designated checkpoint. Hence, the Protocol makes it the prerogative of each Party to determine which measures they may wish to adopt to meet their compliance obligations. However, the Protocol does require the checkpoint(s) to be effective and possess functions relevant to collecting designated information.130 Most regulations in the region require the competent national authority to ensure that PIC has been obtained and MAT have been regularly established before granting access to genetic resources. The competent national authority must also be satisfied that the benefit-sharing agreement is fair and equitable to all parties. Almost all of the regulations reviewed in this chapter provide for enforcement mechanisms and sanctions in case of non-compliance with their provisions. Bioprospecting or exporting biological resources without a permit is generally considered an offence, which can be subjected to a fine or even imprisonment. Administrative sanctions, cancellation or revocation of the permit, and the seizure of the samples are also often foreseen. Furthermore, some regulations established monitoring mechanisms (inspections in-situ, registers, co-operation mechanisms between authorities and the applicant) and an obligation for the user to submit periodical progress reports. In Peru, ABS regulations create a monitoring mechanism in order to ensure the fair and equitable distribution of benefits. Not all the ABS measures include a provision recognising the right of access to justice in cases of breach of the contractual obligations (between the applicant and the provider), but this legal recourse is usually found in more general legislation in force in the country (civil and procedural codes, etc.). Nonetheless, express references are lacking in the legislation as to the requirement to provide for co-operation in cases of alleged violation of another contracting Party’s requirements or to encourage the adoption of contractual provisions on dispute settlement in MAT; this was provided for in the model contracts elaborated at the level of the Andean Community but few cases can be found at the national level (like Costa Rica). Some countries require a certificate of legal provenance (in practice requiring PIC and MAT) whilst others require more general information on the source and origin of the genetic resources, which could nonetheless serve to collect information regarding the utilisation of genetic resources (through an innovation for which a patent is sought). In some countries, checkpoints have been established. In most countries, the patent office (or the Plant Variety Protection Office, in the case of Costa Rica, Ecuador and Peru) is required to receive information, including a copy of the contract, the ABS permit or a certificate of compliance, but generally 130

 Nagoya Protocol Article 17.1.a.iv.

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only for genetic resources accessed in the country and for those accessed in foreign jurisdictions. This departs from what is required by the Andean Community and is not sufficient to implement the Nagoya Protocol. Overall, the exact scope and legal consequences for cases of non-compliance with the disclosure requirement varies between the countries.

III.  Conclusions What emerges from the above comparison is a series of implementation challenges – but also opportunities and lessons learned – for Latin American and Caribbean countries in operationalising the Nagoya Protocol. 1.  Challenges a.  Defining Ownership Ownership of genetic resources will have to be fleshed out in order to meet the Protocol’s obligations related to genetic resources owned by indigenous and local communities. Users of genetic resources need to be sure that a provider has the authority to provide such resources. Such authority does not, in many cases, rest only with the government but also with those who have private, or other rights. or tenure over the land or resources. Therefore, questions of ownership and tenure, invariably, have an important bearing on the practicalities of ABS and are important elements of national legislation on the basis of which competent national authorities ‘determine access’ to resources. The definition of property rights over genetic resources will then have implications for the right to participate in the decision-making processes on ABS and be the recipient of potential benefits. b.  Understanding the Term ‘Utilisation’ The Nagoya Protocol contains a somewhat broad definition of utilisation of genetic resources, capturing major types of utilisation of genetic resources.131 On the basis of its wording alone, the Protocol does not clarify which uses fall under its scope nor does it provide an operational definition of the term ‘derivative.’132 The operative provisions of the Protocol, in addition, do not create clear obligations upon user countries to implement national laws obliging their private company users of genetic resources, from other countries, to share a fair and equitable part of the benefits arising out of utilisation of genetic resources. Despite the adoption of the Nagoya Protocol, therefore,  Nagoya Protocol Article 2.c.  Nagoya Protocol Article 2.e.

131 132

364   Jorge Cabrera Medaglia the problem of establishing a functional system on the basis of clear obligations upon private parties still remains, and national regulation may provide useful information in the implementation phase to that end. In that regard, the experience of those Latin-American countries regulating ‘derivatives’ (Panama) or biochemicals (Costa Rica) may be relevant. c.  Making Operative Pic Requirements With regard to PIC,133 there appear to be difficulties for making relevant requirements operative and ensuring legal certainty in the region. This is one of the most complex and difficult aspects to obtain access to genetic resources, particularly because of practical difficulties in obtaining PIC in specific instances.134 More clarity on PIC and MAT requirements, especially where indigenous and local communities are concerned, would thus be necessary to create functional domestic ABS systems. In particular, implementation challenges for Latin American and Caribbean countries may be foreseen with regard to the interaction between community protocols and customary law, on the one hand,135 and national legal instruments, on the other hand, even when the role of communities’ customary laws is recognised in the constitutions of some countries in the region. d.  Dealing with Special Considerations Implementing the provisions of the Nagoya Protocol on special considerations136 will require legal and institutional development in the region. In relation to access and utilisation of all the genetic resources for food and agriculture, very few Latin-American and Caribbean countries provide specific procedures or have created different conditions (Peru, in the case of the use of genetic resources for breeding purposes within the country). Things are different, however, in the countries that are a Party to the International Treaty on Plant Genetic Resources for Food and Agriculture and have provided specific consideration in their domestic ABS frameworks (e.g., Costa Rica, Peru and Ecuador). Nonetheless, in some countries the synergistic implementation of CBD provisions on ABS and those of the International Treaty have been complicated (as in the case of Costa Rica). Some doubts also  Nagoya Protocol Article 6.2.  Lene Lange, “CBD: Status, Pitfalls, Actions Needed and Perspectives” (paper presented at JBA-UNU/IAS Symposium on Access to and benefit-sharing of genetic resources – How industry and Government are coping with the current situation, Tokyo, 2005); and Joshua Rosenthal, “Politics, culture and governance in the development of prior informed consent and negotiated agreements with indigenous communities” (unpublished paper, on file with author). 135  Nagoya Protocol Article 12.t. 136  Nagoya Protocol Article 8.c. 133 134

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arose regarding the legal space provided by ABS measures to implement the Multilateral System under the International Treaty.137 Peru and Ecuador, for instance, only exclude Annex I crops and forages from the scope of their domestic ABS measures, but not non-Annex I crops. In light of the Nagoya Protocol provisions on basic research,138 it can be noted that not all countries in the region differentiate between commercial and non-commercial research and when they do, determining whether an application is for basic research or for commercial purposes has proven difficult. Accordingly, one of the criticisms of ABS legal frameworks from sectors involved in basic research (universities and other research centers) concerns the lack of, or insufficient recognition of, the intrinsic advantages of basic research and its contribution to the conservation and the sustainable use of biodiversity.139 Latin American and Caribbean countries will thus face several challenges from a legal certainty perspective: they will need to consider providing for flexibility for basic research, while establishing a clear differentiation for access for commercial purposes.140 They will also consider guaranteeing the protection of the rights of the provider when a commercially valuable result is obtained from an activity initially considered as basic research. Similarly, they will consider how to provide certainty to users so that it will be, eventually, possible to seek commercial results in cases of change of intent.141 Finally, expedited access to pathogens142 is a completely new issue for most countries in the region; currently there are no examples of specific domestic measures (e.g., exemptions, facilitate procedures or quicker response times) developed in the context of domestic ABS systems. However, more general legislation regarding emergencies could also apply.

 [See contribution by Chiarolla, Louafi and Schloen to this volume (Chapter 3).]  Nagoya Protocol Article 8.a. [See contribution by Dedeurwaerdere et al. to this volume (Chapter 13).] 139  Alejandro Grajal, “Biodiversity and the Nation State: Regulating Access to Genetic Resources Limits Biodiversity Research in Developing Countries,” Conservation Biology 13 (1999): 6. 140  Santiago Carrizosa et al., eds., Accessing Biodiversity and Sharing the Benefits: Lessons from Implementing the Convention on Biological Diversity (Gland: IUCN Environmental Policy and Law Paper No. 54, 2004). 141  Rosenthal indicates: “It may also be useful to consider a two phase approach to preserve elements of both the freedom to academic research and the flexibility to pursue industrial development of potential discoveries, while offering security to providers” (Rosenthal, “Politics, culture and governance”). 142  Nagoya Protocol Article 8.c. [See contribution by Wilke to this volume (Chapter 4).] 137 138

366   Jorge Cabrera Medaglia e. Drafting and Implementing ‘Compliance Measures’ Few of the national ABS measures in the region contain clear compliancerelated provisions. As stated above, the Protocol leaves a great degree of latitude to Parties as to the types of measures they may adopt to meet their compliance obligations, so it will be incumbent on countries to put in place adequate compliance mechanisms within their national ABS frameworks. As a result, the compliance provisions of the Protocol will be largely informed by the type of measures that countries will adopt at the national level. 2.  Opportunities The Nagoya Protocol also presents some interesting opportunities for the region. It could, for instance, provide the basis for strengthening national competent authorities and using information technologies relevant for the notification of the permit/internationally recognised certificate. It may also create new opportunities for strengthening research and development on genetic and biochemical resources in the countries of the region, most likely through partnerships with users. The need to clarify the subject-matter scope of national ABS frameworks,143 including the definitions of ‘utilisation’ and ‘derivatives’ may have a positive impact on legal certainty leading to a more coherent and homogenous interpretation and implementation of ABS measures by national authorities. In addition, the need to appropriately address non-commercial research in national ABS frameworks should take into account the fact that most of the ABS permits/contracts in Latin American and Caribbean countries are for basic research and mostly concern nationals. Thus, the design of a proper system to facilitate basic research and effectively differentiate between commercial and non-commercial access, while factoring in the potential change of use and intent, may lead to increased acceptance of domestic ABS frameworks by the research community, particularly at the national level. Furthermore, the adoption of the Nagoya Protocol provides new impetus for the adoption of national ABS laws in countries where these are still missing, and for the updating of dated draft laws that do not reflect the innovative provisions of the Protocol. Finally, capacity building and cooperation between national competent authorities and other relevant stakeholders may take place as a result of the process of developing new measures required to implement the Protocol. The region can also benefit from the growing jurisprudence regarding the indigenous peoples’ human rights, especially in relation to the rights over  Carrizosa et al., Accessing Biodiversity and Sharing the Benefits; Cabrera Medaglia and López, Addressing the Problems of Access.

143

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their lands and territories and the right to participate in any decision-making affecting them. Accordingly, the relevant cases of the Inter-American Court of Human Rights can shed light on implementation options concerning key provisions of the Nagoya Protocol related to the rights of indigenous and local communities,144 including the right to grant PIC for using genetic resources located within their lands. In this regard, attention should be paid to the Court’s recognition of the special meaning of communal property of ancestral lands for the indigenous peoples, including the preservation of their cultural identity and its transmission to future generations, as well as the steps that the state has taken to make this right fully effective.145

Accordingly, conservation obligations on the State flow from indigenous peoples’ relationship with their ancestral lands, considering ‘the fundamental basis of their cultures, their spiritual life, their integrity, and their economic survival.’146 In addition, the Court has ruled that indigenous lands must be delimited and titled with the full participation of the community concerned, taking into account the community’s customary laws, values and customs.147 Finally, the Court also held that states must put in place three safeguards vis-à-vis indigenous peoples: mechanisms for their effective participation in decision-making; benefit-sharing; and environmental and social impact assessments.148 In this context, the Court pointed out that the duty to actively consult indigenous peoples requires the State to both develop and disseminate information, ensure constant communication between the parties, and ensure that consultations are held in good faith, through culturally appropriate procedures, with the objective of reaching agreement.149 3.  Lessons Learned Several lessons that can be learned from the regulatory experience on ABS in Latin America and the Caribbean could play a role in the implementation of the Nagoya Protocol in the region and beyond.

 Nagoya Protocol Articles 5, 7 and 9. [See contribution by Savaresi to this volume (Chapter 2).] 145  Inter-American Court of Human Rights, Case of the Yakye Axa Indigenous Community v Paraguay, Judgment of 17 June 2005, Series C No. 125. 146  Inter-American Court of Human Rights, Case of the Mayagna (Sumo) Awas Tingni Community v Nicaragua, Judgment of 31 August 2001, Series C No. 79. 147  Ibid. 148  Inter-American Court of Human Rights, Case of the Saramaka People v Suriname, Judgment of 28 November 2007, Series C No. 172. 149  Ibid. 144

368   Jorge Cabrera Medaglia First of all, regional legally binding instruments such as the Andean Community Decision 391 can have a significant impact on the legislation of Members, and often non-Member countries, and even serve to promote the drafting of other regional initiatives.150 A regional approach can be particularly useful in addressing the issue of transboundary genetic resources or associated traditional knowledge. It can lead to the operation of a relatively homogenous network of national ABS frameworks, avoiding legal loopholes or the existence of less rigorous national measures in the region. It can further facilitate regional cooperation and capacity-building activities. Difficulties experienced in the region as a result of the regional legally binding instrument, however, should equally be considered. These include the fact that the inflexibilities and deficiencies of the Decision have limited the possibilities of the country members to create and implement innovative ABS measures, including in light of well-documented lessons learned in other regions since Community Decision 391 was adopted in 1996.151 Second, the drafting and implementation of national ABS measures adopted in the region prior to the adoption of the Nagoya Protocol can provide useful lessons learned in implementing the Protocol provisions on the right to provide PIC when access to genetic resources located in indigenous lands is sought or when the use of traditional knowledge is sought, as a few countries in the region have already developed sui generis systems for the protection of traditional knowledge. Lessons learned in the drafting and application of domestic requirements for the disclosure of origin in patent applications can provide food for thought for countries contemplating the implementation of the compliance provisions of the Protocol. Moreover, the limited success of institutional coordination to deal with ABS applications and associated transactions costs can also be usefully taken into account in assessing different implementation options. Finally, the need to build capacity, especially for the negotiation of the usually complex terms of ABS contracts, appears paramount.

 Such as the Central American Protocol on ABS, although this is not yet in force. See Nemoga et al., La Investigación sobre Biodiversidad en Colombia. 151  The amendment of the CAN Decision has been suggested. On this regional initiative, see Jorge Cabrera Medaglia, “The Central American Regional Protocol on access to genetic and biochemical resources,” In Trading in Knowledge. Developing perspectives on Trips, Trade and Sustainability, ed. Cristophe Bellmann, Graham Dutfield and Ricardo Meléndez (London: Earthscan, 2003). 150

Part Iii – Cross-cutting Implementation Challenges

Chapter 12.  The Implications of the Nagoya Protocol for the Ethical Sourcing of Biodiversity María Julia Oliva* In the context of policy related to access and benefit-sharing (ABS), the phrase ‘to implement’ immediately suggests incorporating international rules into national legal requirements and procedures. From the perspective of companies working with biodiversity – and particularly those committed to the ethical sourcing of biodiversity – the phrase ‘to implement’ also has another relevant meaning. An ‘implement’ is a tool, which emphasises the need and importance of international and domestic legal provisions becoming instruments that promote and facilitate the operationalisation of access and benefit-sharing. This chapter aims to examine the Nagoya Protocol from the latter perspective – as an implement to operationalise ABS. It begins with an explanation of the ethical sourcing of biodiversity and its links to ABS. On the basis of the challenges and opportunities faced by companies working to respect legal and ethical requirements on access and benefit-sharing, the chapter will consider to what extent the Nagoya Protocol has established clear and practical approaches on critical issues such as the scope of international ABS provisions, ABS related to traditional knowledge, a possible multilateral benefit-sharing approach, monitoring, the role of voluntary standards, and technology transfer. The chapter will identify questions left unanswered by the Nagoya Protocol and conclude with the identification of possible ways forward.

* María Julia Oliva is Senior Adviser on Access and Benefit-sharing at the Union for Ethical BioTrade (UEBT). The chapter contains the personal views of the author, based on her work and exchanges with UEBT members, but may not reflect the positions of UEBT or its members.

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I.  Ethical Sourcing of Biodiversity The ethical sourcing of biodiversity is based on the recognition of sustainable development opportunities arising from the respect for equity and sustainability principles in the collection, cultivation, production and commercialisation of ingredients and other products derived from biodiversity. Increased trade or use of biological resources does not in itself advance sustainable development. It could lead to unsustainable harvest or collection rates, negative changes in ecosystems and the rise of social inequities. Yet, as has been recognised in the context of the Convention on Biological Diversity (CBD), work with natural ingredients and other products from biodiversity – if these are procured and elaborated with respect for ecological, social, cultural and economic principles – can promote local livelihoods, recognise traditional practices and values, and provide incentives for the conservation and sustainable use of biodiversity.1 Ethical sourcing of biodiversity is thus a reflection of business engagement towards sustainability. It is also a response to increasing expectations from consumers in regards to biodiversity-based ingredients and products, as well as to companies’ own strategic interests.2 For companies in the food, cosmetics and pharmaceutical sectors, for instance, sourcing policies and practices that conserve biodiversity and preserve the long-term potential of ecosystems is a way to ensure the availability of critical ingredients and inputs. Ethical sourcing of biodiversity also enhances traceability and strengthens supply chains, including by advancing the equitable sharing of benefits among different actors. Efforts towards the ethical sourcing of biodiversity do not take place within a single framework. Some companies have developed their own approaches to ethical sourcing of biodiversity, with different objectives, priorities, scopes and accountability mechanisms. Other companies use guidelines providing recommendations on social or environmental sound practices in a range of biodiversity-related activities or sectors.3 Some of these initiatives have verification or certification systems to support claims linked to the ethical  E.g., CBD Decision 8/17, “Private-sector engagement” (15 June 2006) UN Doc UNEP/CBD/ COP/ 8/31 and CBD Decision 9/6, “Incentive measures” (9 October 2008) UN Doc UNEP/ CBD/COP/9/29. 2  See trends in biodiversity awareness among consumers and in business reporting on bio­diversity in the UEBT Biodiversity Barometer, accessed 17 May 2012, http://www.ethicalbiotrade.org. 3  E.g., the BioTrade Principles and Criteria of the United Nations Conference on Trade and Development (UNCTAD), accessed 17 May 2012, http://www.unctad.org/en/docs/ ditcted20074_en.pdf, and the International Standard for Sustainable Wild Collection of Medicinal and Aromatic Plants (ISSC-MAP), which has now merged with the FairWild standard (http://www.floraweb.de/map-pro/, accessed 17 May 2012). 1

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sourcing of biodiversity. For example, the Ethical BioTrade standard provides both guidance and independent verification of ethical sourcing practices. As an internationally recognised standard,4 managed by the Union for Ethical BioTrade (UEBT),5 it is a useful reference of the link between access and benefit-sharing and the ethical sourcing of biodiversity. Equity, recognizing the value of biodiversity, and respecting the rights of actors in biodiversity-based activities are crosscutting considerations in the Ethical BioTrade standard. Additionally, Principle 3 of the Ethical BioTrade standard specifically addresses the fair and equitable sharing of the benefits derived from biodiversity. It requires UEBT members to work towards equitable benefit-sharing in all policies and practices linked to natural ingredients. For sourcing activities, benefit-sharing requirements include balanced and informed negotiations, the payment of equitable prices, and activities that contribute to the sustainable development goals at the local level. For research and development, benefit-sharing under the Ethical BioTrade standard requires, for instance, engaging groups with rights over resources, establishing conditions for the use of these resources, and sharing the resulting benefits. The Ethical BioTrade standard also recognises that – in addition to the ethical requirements established for UEBT members – certain countries may have legislative or regulatory requirements linked to the sourcing of biodiversity. Consequently, as part of its benefit-sharing requirements, the Ethical BioTrade standard expressly calls for organisations gradually comply with applicable legal requirements on access and benefit-sharing. The links between Ethical BioTrade and evolving legal rules on access and benefitsharing explain the interest of companies committed to ethical sourcing of biodiversity in the Nagoya Protocol.

 With regard to standard setting, verification, and impact assessment, UEBT is a full member of the ISEAL Alliance (the global association for social and environmental standards), and thus meets the internationally recognised best practices. 5  UEBT is a non-profit, membership based organisation. UEBT has two categories of members, trading and affiliate. Trading members are companies or other types of organisations involved in natural ingredient supply chains. Through their commitment to the Ethical BioTrade standard, Trading members gradually ensure that their sourcing practices promote the conservation of biodiversity, respect traditional knowledge and assure the equitable sharing of benefits along the supply chain. Affiliate members may be NGOs or governmentrelated agencies that support the principles of Ethical BioTrade in their work.  For the list of members, see UEBT website, accessed 17 May 2012, http://www.ethicalbiotrade.org/. UEBT has a Memorandum of Understanding with the CBD Secretariat, with a view to raising the awareness of cosmetic and food companies on access and benefit-sharing principles (Memorandum of Understanding between the CBD and UEBT, 18 August 2011, accessed 17 May 2012, http://www.cbd.int/doc/agreements/agmt-union-biotrade-2011-08-18-mou-en.pdf). 4

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II.  Nagoya Protocol: Key Issues and Implications The Nagoya Protocol, as an instrument for putting in practice access and benefit-sharing, has been recognised as a fundamental step for realising CBD objectives.6 For companies working with biodiversity, the Nagoya Protocol also presents an opportunity for more awareness, guidance and legal certainty for ethical practices. One of the most important expectations arising from the Nagoya Protocol referred to the clarification of critical concepts and obligations on access and benefit-sharing. Moreover, companies considered it fundamental for international ABS rules to rectify some of the misconceptions on how biodiversity is used and valued in most scientific and commercial processes, in order to ensure more practical and effective norms at the national level. In short, from a business perspective, the Nagoya Protocol presented an opportunity to overcome concerns and promote proactive approaches and policies on ABS. Evaluated against these expectations, the Nagoya Protocol should be considered as a positive development. It contains clarification on issues such as the definition of ‘utilisation of genetic resources,’ the rights of indigenous and local communities in relation to traditional knowledge and the need for workable access regulations at the national level. Another important aspect of the Nagoya Protocol is the consideration of possible tools facilitating the operationalisation of benefit-sharing, ranging from the potential global multilateral benefit-sharing mechanism7 to the promotion of standards and other voluntary norms.8 Indeed, the implementation of the Nagoya Protocol – through a better-defined and more level playing field – has the potential for turning the uncertainties and risks currently faced by companies working with biodiversity into opportunities and incentives to invest in biodiversity-based products and ideas. Yet the provisions of the Nagoya Protocol do not – in themselves – provide for practical and effective solutions to realising the objectives of the Protocol or the aspirations of companies committed to ethical practices in their biodiversity-based activities. The Nagoya Protocol leaves a number of issues unresolved. Indeed, access and benefit-sharing requirements and procedures must be defined and developed through domestic laws and regulations, which may strike different balances between comprehensiveness and complexity, support and demands, and the engagement of different stakeholders.  E.g., CBD Secretariat, “A new era of living in harmony with Nature is born at the Nagoya Biodiversity Summit,” press release, 29 October 2010, accessed 17 May 2012, http://www .cbd.int/doc/press/2010/pr-2010-10-29-cop-10-en.pdf). 7  Nagoya Protocol Article 10. 8  Nagoya Protocol Article 20. 6

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Nevertheless, many of the opportunities and challenges of implementation can already be gleaned in the Nagoya Protocol, including the questions it does and does not clarify, and the manner in which ABS principles are addressed and elaborated upon. 1.  Scope of Access and Benefit-sharing In the run-up to the Nagoya Protocol, most companies working with natural ingredients derived from biodiversity have struggled to determine the relevance of access and benefit-sharing to their activities. The CBD links access and benefit-sharing obligations to the use of ‘genetic resources,’ but the definition of this term has been recognized as ambiguous and, in practice, impossible to distinguish from the use of biological resources more broadly.9 The scope of ABS obligations is equally unclear in many national laws and regulations implementing the CBD, which also differ significantly between themselves.10 As a result, there was no clarity and limited guidance for companies in identifying when to seek compliance with legal requirements established by these rules or, even when these rules do not exist, adopt relevant ethical commitments. To compound these difficulties, national ABS rules generally have not provided a clear, practical or effective framework for improved practices and have proved extremely challenging for both business and research organisations to navigate. With the Nagoya Protocol, a new definition for the ‘utilisation of genetic resources’ significantly clarifies what types of activities fall under the scope of international ABS requirements – yet there are also some fundamental questions that remain unanswered. ‘Utilisation of genetic resources,’ which triggers international ABS requirements, is defined as conducting research and development on ‘the genetic and/or biochemical composition of genetic material.’11 The reference to ‘biochemical’ is significant, as there is a range of natural biochemical compounds that result from genes, including proteins and amino acids, which are used in research and product development.  Tomme Young, “Genetic Resources and Utilisation of Genetic Resources: a Legislative View” (paper presented to the International Expert Workshop on Access to Genetic Resources and Benefit Sharing, Cuernavaca, Mexico, October, 2004). 10  For example, South African ABS legislation (South Africa, Biodiversity Act, 2004) applies to ‘indigenous biological resources,’ defined broadly to include derivatives, chemical compounds and products obtained through use of biotechnology. The scope of access and benefit­sharing is equally broad in the Common Regime of the Andean Community (Andean Community, Common Regime on Access to Genetic Resources (Decision 391, 2 July 1996, in force 17 July 1996)), but the Peruvian regulation, for example, excludes the use of nontimber forest resources for the development of natural products. [On the Andean and Peruvian ABS provisions, see contribution by Cabrera to this volume Chapter 14).] 11  Nagoya Protocol Article 2.c.  9

376   María Julia Oliva The term ‘biochemical’ also appears in another new definition offered by the Nagoya Protocol: ‘derivatives’ are defined as naturally occurring biochemical compounds resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity.12 Though the expression ‘derivatives’ does not appear in the substantive provisions of the Nagoya Protocol, it can be interpreted as a way to expressly expand the applicability of international requirements on access and benefitsharing to activities linked to naturally occurring compounds, such as antibodies, vitamins, enzymes, active compounds and metabolites.13 Through these clarifications in the Nagoya Protocol, the relevance of international ABS requirements can now be clearly seen to expand to research and development to identify and make use of new bioactive compounds and natural ingredients for food, supplement and cosmetics products.14 Research on the use of extracts and molecules from plants, as well as the development and production of pharmaceuticals, cosmetics or nutraceuticals are thus subject to prior informed consent and mutually agreed terms, including on fair and equitable sharing of benefits. The point is far from theoretical, as these compounds constitute the basis for a wide range of products. Flavonoids, for example, are among the biochemical compounds found to have unique skin care properties and now widely used in cosmetic formulations. Alkaloids, such as those found in the seeds of coffee, cola and guaraná, are another biochemical compound broadly used, for instance in functional foods and beverages. Even if the Nagoya Protocol has confirmed the relevance of access and benefit-sharing for these activities, there are still areas of uncertainty. The expression ‘research and development’ as an element of the definition of ‘utilisation of genetic resources’ is not defined. Research and development, in both the technical and ordinary understanding of the term, encompasses a potentially vast number of activities. For example, research and development on plant-based substances may entail anything from identifying new biochemical pathways to treat cancer, to looking at whether a seed oil is interesting as part of a moisturiser or whether an exotic fruit pulp can safely be incorporated as an ingredient in smoothies.  Nagoya Protocol Article 2.e.  CBD Conference of the Parties, “Report of the Meeting of the Group of Legal and Technical Experts on Concepts, Terms, Working Definitions and Sectoral Approaches” (12 December 2008) UN Doc UNEP/CBD/WG-ABS/7/2. This international definition is also relevant in the context of the frequent references to derivatives in national legislation and regulatory requirements on ABS. 14  UEBT, “Technical Brief on Nagoya Protocol on Access and Benefit-sharing,” 2010, accessed 17 May 2012, http://ethicalbiotrade.org/news/wp-content/uploads/UEBT_ABS_Nagoya_ Protocol_TB.pdf. 12 13

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These activities involve inherently different approaches to using biodiversity. For instance, in pharmaceuticals, once a useful plant-based biochemical substance is isolated, it will generally be synthesised for its further use. In most drugs, it will become the active ingredient and be the only one originally derived from biodiversity. In food and cosmetics, there is great value in the use of natural ingredients, which continue to be sourced from biodiversity. In some moisturisers, more than 75% of the ingredients come from nature, and play roles as varied as emollient, emulsifier, surfactant, preservative, antioxidant, stabiliser, colouring agent, gelling agent or active ingredient. All these natural ingredients will be used for their properties, but these properties will not necessarily be unique or define the product. There are also disparate risks, market opportunities, levels of investment and innovation, supply chains and legal and regulatory frameworks depending on specific research and development activities. Some research and development involves lengthy, complex and costly processes, with their results protected through patents or other intellectual property rights. In other cases, processes are standard and outcomes are not protected. In the example of the smoothie, it may be a local company that merely looks at the biochemical composition of the fruit pulp to determine appropriate procedures for pasteurisation. Requiring this company to undergo a comprehensive ABS process does not necessarily make sense, particularly if there will be no requirements for other companies that would build on the development of a successful ingredient and include it in their own drink products.15 In the implementation of the Nagoya Protocol, it is critical to determine how national ABS requirements can be effectively established in relation to various activities. Biodiversity-based activities should respect the rights of countries and communities and promote the fair and equitable sharing of benefits, as well as conservation and sustainable use efforts. Yet it is also imperative to have practical approaches and procedures that respond to practices and circumstances in the use of biological resources in the various sectors. In order to do this, domestic ABS legislation will need to draw more defined lines to ensure that requirements advance the objectives of access and benefit-sharing without undermining broader efforts to value biodiversity, improve livelihoods, and promote the ethical sourcing of biodiversity. Taking into consideration the CBD, as well as the Nagoya Protocol, it is clear that the international ABS regime is only concerned with a fraction  Nagoya Protocol Article 5.1 requires sharing of benefits arising from the utilisation of genetic resources as well as subsequent applications and commercialisation. However, as per Article 6.1 and the need for benefit-sharing to be on the basis of mutually agreed terms, it is not clear that such benefit-sharing requirements extend beyond the company or organisation that sought access to genetic resources for research and development.

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378   María Julia Oliva of the range of activities covered by the term ‘research and development.’ Though equity, sustainable use and benefit-sharing are concepts widely applicable to all biodiversity-based activities, the rationale and requirements of access and benefit-sharing at the national level should relate to more specific circumstances, more specific types of research and development. Further defining ‘research and development’ is thus a step towards more workable and effective ABS requirements at the national level. As per the rationale of access and benefit-sharing, the research and development activities covered are those that seek to identify and capture the value and benefits in genetic and biochemical compounds. That is, access and benefit-sharing can be said to refer to research and development conducted with the specific purpose of identifying new properties of these compounds, finding novel commercial applications for these properties, and excluding others from similar applications through patents or other intellectual property rights. Again, such a definition would not seek to discharge other types of biodiversity-based activities and products from sharing the resulting benefits, but it would ensure that more complex and comprehensive ABS requirements apply where they are needed and can be effective. 2.  Traditional Knowledge The CBD calls on countries to respect, preserve and maintain the knowledge of indigenous and local communities relevant for the conservation and sustainable use of biodiversity, with the approval and involvement of the holders of such knowledge, as well as encourage the equitable sharing of resulting benefits.16 The Nagoya Protocol expressly establishes ABS requirements for the utilisation of traditional knowledge associated with genetic resources.17 In addition, by linking traditional knowledge with the scope of the international regime, access requirements, transboundary cooperation and compliance,18 the Nagoya Protocol is seen to more clearly set out ABS requirements in relation to traditional knowledge. Nevertheless, as will be discussed below, there is no definition of ‘utilisation of traditional knowledge,’ which leaves open elemental questions as to how different types of knowledge and types of use are addressed. Provisions on traditional knowledge that can be highlighted include, for example, the need for countries to take measures, in accordance with national laws, to ensure there is prior informed consent of relevant indigenous and

 CBD Article 8(j).  Nagoya Protocol Article 7. 18  Nagoya Protocol Articles 1, 6, 11 and 16. 16 17

Implications for the Ethical Sourcing of Biodiversity   379

local communities, and that mutually agreed terms have been established.19 Furthermore, the Nagoya Protocol requires countries also to take measures so that the benefits arising from the utilisation of traditional knowledge are shared in a fair and equitable way with indigenous and local communities holding such knowledge.20 This provision is critical both due to its recognition that rights over traditional knowledge vest on the indigenous and local communities that hold it, as well as for its exclusion of traditional knowledge more widely held as part of the cultural heritage of countries and their populations. Another important provision on traditional knowledge in the Nagoya Protocol, from the perspective of companies working with biodiversity, refers to the importance of community protocols.21 Indigenous and local communities already use such protocols to affirm their rights regarding land, resources and traditional knowledge. More recently, there have also been efforts from business to see how community protocols can be used as a basis for community engagement. Community protocols, as an endogenous and empowering process that outlines the communities’ core values and customary laws, have been found valuable as the basis of a dialogue between the indigenous or local community and companies working with biodiversity.22 The obligation in the Nagoya Protocol for countries to support the development of community protocols23 could thus lead to the development and adoption of the type of concrete tools business needs for putting ABS in practice. In spite of strong provisions on traditional knowledge, the lack of definition of ‘utilisation of traditional knowledge’ in the Nagoya Protocol prolongs uncertainties as to whether and how access and benefit-sharing requirements apply in different circumstances. Traditional knowledge is still widely acknowledged to provide useful information on the properties and management of the components of biodiversity.24 Yet there are various ways in which traditional knowledge associated with genetic resources may be utilised. In the textbook case, traditional healers provide researchers with insights into  Nagoya Protocol Article 6.  Nagoya Protocol Article 5. 21  Nagoya Protocol Article 12. 22  María Julia Oliva, Johanna von Braun and Gabriela Salinas, “Biocultural Community Protocols and Ethical BioTrade: Exploring Participative Approaches to Sourcing of Biodiversity in Peru,” in Participatory Learning and Action, ed. K. Swiderska et al. (London: IIED, 2012). 23  Nagoya Protocol Article 12. 24  E.g., Herbert Kolodziej and Anne Elizabeth Hagerman, “Polyphenols, Ethnomedicine and Benefit-sharing,” Planta Medica 77 (July 2011): 1064. According to this editorial, ‘there is continuing effort to investigate the chemical and biological basis for the activities of indigenous medicinal plants. The picture that emerges from numerous scientific studies is one of efficacy for many ethnomedicinals.’ 19 20

380   María Julia Oliva medicinal properties that lead to new pharmaceuticals. In other cases, the observation of traditional uses of a plant may have generated researchers’ interest in its biochemical composition, but the properties sought, found and commercialised may not relate to those uses. Research and development may be taking place without awareness of the existence of related traditional knowledge, perhaps through random screening. Yet another scenario is traditional knowledge related not to biochemical properties, but to methods to propagate the plant, which are used in production rather than in research and development activities. Traditional images and references to traditional knowledge are also sometimes used in marketing, without necessarily having been considered in the research and development process. Following the rationale for access and benefit-sharing, as well as the definition of ‘utilisation of genetic resources’ in the Nagoya Protocol, the focus of the ‘utilisation of traditional knowledge’ would be on its consideration in the research and development on the genetic or biochemical composition of genetic resources. Traditional knowledge would be utilised when it is providing research and development activities with indications of specific properties of the genetic or biochemical composition of biological resources, which are additionally defined, explained or realised through practical applications. This is not to say that other uses of traditional knowledge should be conducted without the prior informed consent of indigenous or local communities, or without equitable compensation and sharing of benefits. It is, nevertheless, useful to further define different situations with distinctive challenges and opportunities in order to ensure that ABS obligations at the national level are both practical and effective. More clarity is also needed in how to define the holders of the traditional knowledge for the purposes of access and benefit-sharing. It is to be expected that identifying the beneficiaries to collective rights would involve some conceptual and practical difficulties.25 Currently, however, the lack of clarity on ways to identify and engage with the holders of traditional knowledge in biodiversity-based activities is in fact proving a disincentive for their utilisation by companies committed to ethical practices on biodiversity. In cases in which an indigenous or local community provides particular traditional knowledge to a researcher, there is no question that it is this community’s prior informed consent that is required, and that it should share in resulting benefits. Nevertheless, these well-defined and paradigmatic situations of the utilisation of traditional knowledge are few. More common circumstances include traditional knowledge obtained through one of many communities holding the relevant information or practices, often across national  [For a human rights perspective on identifying right-holders under the Protocol, see contribution by Savaresi to this volume (Chapter 2).]

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borders; consideration of traditional knowledge through accounts in academic or other publications; or the consideration of traditional knowledge that is thoroughly disseminated in a country or region. Again, national legislation and regulatory requirements would need to further define the situations covered in access and benefit-sharing. This is the only way to develop a framework that is workable and that effectively addresses the most consequential situations for indigenous and local communities. For example, prior informed consent, insofar as it is envisaged as a bilateral negotiation, may only be relevant if the traditional knowledge is distinctively associated with one or several indigenous or local communities and is not widely known outside of these communities. In benefit-sharing, as well, the Nagoya Protocol focuses on the utilisation of traditional knowledge held by indigenous and local communities.26 To be successful, benefitsharing requirements would also need to make provision for the different types and degrees of utilisation of traditional knowledge, establish some basis for the discussion of mutually agreed terms, and provide practical tools that allow users to share benefits even when it is not possible to identify or cover all holders of the traditional knowledge (for instance, through fixed fees or contribution to funds). 3.  A Multilateral Mechanism for Benefit-sharing The Nagoya Protocol calls on countries to consider the need and modalities for a global multilateral benefit-sharing mechanism.27 This provision recognizes that addressing often-complex ABS scenarios requires innovative approaches.28 In particular, it envisages a potential approach to addressing ABS in specific circumstances that would not be adequately or effectively addressed by bilateral arrangements. From the perspective of companies working with biodiversity, this provision is an important acknowledgement of the need for specific tools and pro-active approaches to facilitate putting in practice benefit-sharing. A multilateral benefit-sharing mechanism could be a useful approach for activities subject to benefit-sharing principles and requirements, but facing challenges in fulfilling these obligations. The Nagoya Protocol states that the multilateral mechanism would be established to address the fair and equitable sharing of benefits derived from the utilisation of genetic resources and traditional knowledge that occur in  Nagoya Protocol Article 5 has been interpreted, however, as addressing benefit-sharing only with regards to traditional knowledge held by indigenous or local communities, leaving outside of its scope traditional knowledge that is no longer identified with specific indigenous or local communities or is held as the common heritage of a nation. 27  Nagoya Protocol Article 10. 28  See also Nagoya Protocol preambular paragraph 12. 26

382   María Julia Oliva transboundary situations or for which it is not possible to grant or obtain prior informed consent. The exact nature of the latter cases would need to be addressed by the governing body of the Nagoya Protocol, when discussing modalities of the multilateral mechanism. Nevertheless, it is important to note that the prospective multilateral mechanism would be more valuable as a way to facilitate compliance with existing ABS requirements, rather than as an approach to create additional obligations. For instance, according to the CBD and the Nagoya Protocol, the obligation to share the benefits arising from the utilisation of genetic resources, as well as subsequent applications and commercialisation, is in relation to the country providing such resources.29 The transboundary nature of certain genetic resources or associated traditional knowledge does not currently require users of genetic resources, or the countries of origin of genetic resources with which they are negotiating, to include other countries of origin in their ABS arrangements. A multilateral approach should not seek to create such an obligation. A global multilateral mechanism would be a valuable platform, however, to allow provider countries to exchange information, conduct technological collaboration and establish ways to share monetary benefits deriving the utilization of shared resources. In addition, a multilateral mechanism could provide a way to promote benefit-sharing beyond legal obligations. More and more, even if there is no national legislation or domestic requirements in place, companies working with biodiversity recognise benefit-sharing as imperative from ethical, corporate responsibility or marketing perspectives.30 Taking this trend into account, a multilateral mechanism for benefit-sharing could provide a way for companies to engage in benefit-sharing, even in circumstances where it is not legally required. For example, such circumstances might include the utilisation of genetic resources accessed before the entry into force of the CBD or the utilisation of genetic resources from jurisdictions that have chosen not to establish any access or benefit-sharing requirements. Whether to facilitate compliance with legal or ethical requirements on benefit-sharing, countries should preserve the nature of benefit-sharing as an incentive and way to recognise local contributions to the conservation and sustainable use of biodiversity. The challenge would be that, given its global approach, benefits garnered through the multilateral mechanism might not necessarily be directed towards those countries or communities linked to the genetic resources or associated traditional knowledge being used. As a result,  CBD Article 15 and Nagoya Protocol Article 5.  Research shows that consumers, more and more, expect information on how companies address biodiversity in their policies and practices. E.g., the outcome of consumer surveys in UEBT, Biodiversity Barometer 2011, accessed 17 May 2012, http://www.ethicalbiotrade .org/dl/BAROMETREpourWeb_2011_EN.pdf.

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benefit-sharing would thus not actually provide an incentive for sustainable use or conservation. Converesely, benefit-sharing is likely to have significantly higher impacts if shared with the country and communities involved in collection or cultivation, or research and development. These are important points for the Parties to the Nagoya Protocol to consider as they define the need and modalities for the global multilateral mechanism. 4.  Monitoring Compliance Advancing compliance with ABS requirements is at the core of the Nagoya Protocol, with monitoring mechanisms recognised as critical to gathering the information necessary to identify and act upon cases of misappropriation or misuse. At the same time, monitoring mechanisms also raise opportunities to better understand the utilisation of genetic resources, as well as to collect information and provide incentives that encourage respect for both legal and ethical ABS requirements. In this regard, the Nagoya Protocol requires countries to take measures to monitor the utilisation of genetic resources, including the designation of one or more checkpoints linked to research, development or subsequent application and commercialisation.31 It also foresees a process for ABS permits to become internationally recognised certificates of compliance, which could serve as evidence that access has taken place in accordance with prior informed consent and that mutually agreed terms have been established.32 Such monitoring mechanisms would enhance transparency and promote legal certainty – issues considered essential from the perspective of companies committed to ethical practices with regards to biodiversity. In some sectors, business-to-business requests for information on compliance with access and benefit-sharing are becoming commonplace. For example, in the cosmetics sector, supplier questionnaires often include inquiries on the existence and observance of ABS requirements in national legislation. In this context, and given the central role of companies working with biodiversity in putting in practice ABS requirements, it was important for the Nagoya Protocol to not only provide a clear and consistent basis for these activities, but also actively seek to facilitate good practices. Of course, the success of the monitoring provisions of the Nagoya Protocol will largely depend on the approach and measures taken in implementation at the domestic level. For example, a checkpoint in countries where the utilisation of genetic resources is taking place could serve as a source of information and support on compliance. It could provide companies and organisations with, or direct  Nagoya Protocol Article 17.1.  Nagoya Protocol Article 17.2–4.

31 32

384   María Julia Oliva them to, guidance on ABS requirements relevant to their activities, as well as to facilitate contacts with the appropriate focal points or authorities. It could gather and share information on trends on the utilisation of genetic resources, as well as the types of problems, gaps and bottlenecks found in relation to compliance with national ABS requirements. Yet – to a significant extent – the effectiveness of checkpoints is linked to that of requirements and procedures in provider countries. If there were no procedures in place in provider countries, corresponding procedures in user countries would not function. It will be impossible for checkpoints to gather information, provide guidance, or facilitate compliance. Moreover, the situation would create unacceptable lack of clarity and legal certainty for companies working with biological resources. 5.  Voluntary Norms The Nagoya Protocol requires Parties to encourage, as appropriate, the development, update and use of voluntary norms such as codes of conduct, guidelines and standards in relation to access and benefit-sharing.33 These voluntary norms, whether developed by companies, associations, non-governmental organisations or multi-stakeholder processes, could be constructive and valuable tools to support implementation of access and benefit-sharing. For one thing, more specific guidelines are required to ensure appropriate guidance for wide range of types of genetic resources, users and purposes for their utilisation in a variety of sectors, including agriculture, biotechnology, pharmaceutical, and personal care.34 In addition, these types of tools reflect bottom-up approaches to operationalising international or national ABS requirements, which are therefore more likely to be known and implemented, as well as to prove more practical and effective. For example, norms such as the Ethical BioTrade standard already address access and benefit-sharing, in relation to both legal and ethical requirements relevant to natural ingredients in the food, cosmetics and pharmaceutical sectors.35 Such standards provide not only guidance on access and benefitsharing, but also constitute the basis for independent verification of compliance. In Ethical BioTrade, qualified verification bodies such as Rainforest Alliance or Ecocert periodically visit UEBT members or potential members, in order to assess their biodiversity management system, including on ABS issues, and report on how the company is advancing towards its implementation.  Nagoya Protocol Article 20.  CBD Secretariat, “Existing instruments, guidelines, codes of conduct and tools addressing ABS”, accessed 17 May 2012, http://www.cbd.int/abs/instruments/. 35  UEBT, “STD01 – Ethical BioTrade Standard”, 2012, accessed 17 May 2012, http://www .ethicalbiotrade.org/verification/standard.html. 33 34

Implications for the Ethical Sourcing of Biodiversity   385

Of course, not all voluntary norms will be sound, useful or widely recognised. In the context of standards, for example, organisations such as the ISEAL Alliance establish best practices for their design and implementation, ensuring that these systems are accessible, effective and bring about significant positive change. As ABS issues are included in standards dealing with social and environmental issues, guidance and best practices within such organisations may also be established. In addition, the Nagoya Protocol calls on its governing body to consider the adoption of specific codes of conduct, guidelines, best practices and/or standards.36 Such periodic assessment and adoption of voluntary norms would not make them binding, of course, but it would increase the legitimacy – and thus the utilisation – of tools and guidance considered to be particularly constructive or effective in the implementation of access and benefit-sharing. 6.  Transfer of Technology The Nagoya Protocol establishes obligations for countries towards cooperation in research and development, as well as towards the transfer of technology to developing countries, as a means to advance the objectives of the Protocol and the CBD.37 Since the 1992 Rio Declaration on Environment and Development, there has been widespread recognition that development, transfer, adaptation and diffusion of technology and the building of related capacity is crucial for achieving sustainable development.38 With the Nagoya Protocol, there is a renewed emphasis on the potential of capturing the value of biodiversity for sustainable development. For example, the list of possible benefits in the Nagoya Protocol includes research funding, sharing of research and development results, and participation in research and development.39 Consideration of both monetary and non-monetary benefits – and specifically of the transfer of technology – confirms the experience of many companies working on ethical sourcing of biodiversity: these are the types of benefits that have the most direct, long-term and positive impact for sustainable development at the local level.  Nagoya Protocol Article 20.  Nagoya Protocol Article 23. 38  United Nations General Assembly, “Report of the United Nations Conference on Environment and Development” (12 August 1992) UN Doc A/CONF.151/26 (Vol. I): Rio Declaration on Environment and Development (Annex I), Principle 9 calls upon States to cooperate to strengthen capacity building for sustainable development through technology transfer; and Agenda 21 (Annex II) provides further important guidance on the transfer of environmentally sound technology, cooperation and capacity building, including in regards to biotechnology. 39  Nagoya Protocol Annex I. 36 37

386   María Julia Oliva In implementing their obligations on technology transfer, it is important for Parties to the Nagoya Protocol to consider the role of business in technology transfer. For example, the CBD strategy on the implementation of the work program on technology transfer, which may be a useful reference in terms of possible approaches to promote the transfer of technology, points to the need for: assessing priority technology needs; establishing programs that enhance access to capital markets, in particular for small and medium enterprises in recipient countries; and establishing incentives for business such as tax breaks or deferrals, subsidised export credits or loan guarantees, and facilitated access to technologies developed by public research institutions.40 Consideration of the link between ABS and transfer of technology is also an opportunity to more broadly move towards a more pro-active framework on the utilisation of genetic resources. Pioneering companies working with natural ingredients are already embracing biodiversity as a powerful concept for promoting innovation, improving policies and practices along their supply chains and ensuring positive impacts at the local level. Fair and equitable benefit-sharing is a central concept in this approach. The implementation of the Nagoya Protocol, which is taking place in the context of international and national efforts to promote a green economy,41 is an opportunity to emphasise the potential of biodiversity for sustainable development. National legislation and regulatory requirements should focus on strategically identifying opportunities to add value to biodiversity in a sustainable and equitable manner, raising awareness and promoting the engagement of companies in these efforts, and develop supportive norms, tools and partnerships.

III.  Conclusions The mere adoption of the Nagoya Protocol, which seemed far from certain at times during its negotiation, reaffirms the importance of access and benefitsharing as a pillar of law, policy and practice on biodiversity. Moreover, from the perspective of companies committed to ethical sourcing of biodiversity, the Nagoya Protocol has also taken positive steps such as further defining the scope of international ABS requirements, requiring legal certainty and transparency in national ABS legislation, and recognising the importance of both  CBD Decision 9/14, “Technology transfer and cooperation” (9 October 2008) UN Doc UNEP/CBD/COP/9/29. 41  The green economy is one of the themes of the 2012 UN Conference on Sustainable Development: United Nations General Assembly, “Implementation of Agenda 21, the Programme for Further Implementation of Agenda 21 and the Outcomes of the World Summit on Sustainable Development” (31 March 2010) UN Doc A/RES/64/236, paragraph 20. 40

Implications for the Ethical Sourcing of Biodiversity   387

monetary and non-monetary benefits derived from the use of biodiversity. Inevitably, the Nagoya Protocol does leave issues unresolved, as well as raises new questions. Its outcomes also ultimately depend on how ABS requirements and procedures are defined and developed at the domestic level. Indeed, the success of the Nagoya Protocol will depend on the establishment of legal and regulatory arrangements at the national level and – even more so – on how these arrangements translate into practices that contribute to conservation, sustainable use and equity at the local level. The importance of considering existing users’ practices on the ground in any new or revised rules cannot be overstated in this regard. Access and benefit-sharing should identify and address problems with compliance but should also work to promote and facilitate good practices, providing users with a clear and practical framework that recognises and addresses current challenges and opportunities in the use of biodiversity. This chapter has noted some issues that may be usefully clarified at the domestic level, including the definition of research and development in a way that targets concerns about misappropriation of genetic resources, while encouraging activities that are adding value to and sharing the benefits of biodiversity. Similarly, it may be necessary to define the different types and degrees of utilisation of traditional knowledge, establish some basis for the discussion of mutually agreed terms, and provide practical tools that allow users to share benefits. In these, and other issues, it is fundamental for legal requirements on ABS to adopt practical, bottom-up approaches, which build on existing experiences. Of course, such an outcome cannot be achieved without appropriate engagement of all stakeholders, including the private sector. Pioneering companies are already turning biodiversity into the heart of their sustainability strategies, recognising that addressing ecological, cultural and equity issues along their supply chains makes business sense. More such business commitment is needed. At the same time, it is fundamental, as the ratification and implementation process of the Nagoya Protocol moves forward, for governments to engage with companies working on ethical sourcing practices, ensuring discussions include their viewpoints and capitalise on their experiences, thus paving the way for national ABS requirements that are workable, effective and make a difference for biodiversity and local livelihoods.

Chapter 13.  Governing Global Scientific Research Commons under the Nagoya Protocol Tom Dedeurwaerdere,* Arianna Broggiato,** Selim Louafi,*** Eric W. Welch,**** and Fulya Batur***** In the twentieth century, there has been a tremendous increase both in the quantities of biological resources that are exchanged for research purposes and in the global interdependencies of these exchanges.1 For example, in the field of microbial resources only, over 1,2 million samples are exchanged on a yearly basis between collections of samples of microorganisms, that are members of the World Federation of Culture Collections, situated both in developed and developing economies. Further, over 200,000 new samples are still deposited each year in these collections and used in research laboratories, collected in countries from all geographical regions of the world.2 Similar patterns can be observed in other sectors of biodiversity-related research and innovation, whether with microbial, plant or animal genetic resources.3 The positive impact of these changes on biodiversity-based innovation has, however, been attenuated by a set of counterbalancing factors. Major     * Research Associate at the National Foundation for Scientific Research, Belgium (F.R.S.FNRS), and Professor at the Université catholique de Louvain.     ** Post-Doctoral fellow at the Université catholique de Louvain.    *** Senior Researcher at CIRAD-Agricultural Research for Development.    **** Professor at University of Illinois at Chicago. ***** PhD Research Fellow at the Université catholique de Louvain. 1  Brownyn Parry, Trading the Genome (New York: Columbia University Press, 2004). 2  Tom Dedeurwaerdere et al., The Use and Exchange of Microbial Genetic Resources Relevant for Food and Agriculture (Rome: CGRFA Background Study Paper no. 46, October 2009). 3  Devin M. Bartley et al., The Use and Exchange of Animal Genetic Resources for Food and Agriculture (Rome: CGRFA Background Study Paper no. 43, July 2009); Jarkko Koskela et al., The Use and Exchange of Forest Genetic Resources for Food and Agriculture (Rome: CGRFA Background Study Paper no. 44, January 2010); Devin M. Bartley et al., The Use and Exchange of Aquatic Genetic Resources for Food and Agriculture (Rome: CGRFA Background Study Paper no. 45, September 2009); Ximena Flores Palacios, Contribution to the Estimation of Countries’ Interdependence in the Area of Plant Genetic Resources (Rome: CGRFA Background Study Paper no. 7, rev.1, December 1997).

390   Tom Dedeurwaerdere et al. obstacles in this regard are, first, the lack of sufficient incentives for promoting research into sustainable use and conservation of biodiversity, which have no direct high commercial value output,4 and the hampering of international cooperation by an overly strong focus on direct monetary benefits at the expense of non-monetary benefits, in the discussion on access and benefit sharing (ABS).5 In recognition of these obstacles, policy-makers have increasingly focused on alternative methods for promoting science and innovation, based on the networking of research infrastructures into global scientific research commons. In this chapter, we aim to show in what respect these scientific research commons have become an essential tool for promoting scientific research and innovation based on biodiversity. In particular, this chapter aims to highlight the social motivations that play a role in the complex non-monetary incentive mechanisms that drive science and innovation in the research commons (such as reputational benefits, intrinsic values and reciprocity relationships) and analyse under what conditions these can be taken into account in a more effective way in the implementation of the Nagoya Protocol, with a view to improving the production and use of public research resources in a global context. Through this analysis, the main goal of the chapter is to contribute to better global regulation of the scientific research commons in the specific context of the obligations under the Nagoya Protocol on Access and Benefit-sharing. We will first present survey results on access and use patterns in some major examples of global science commons, and analyse some of the main nonmonetary benefits that are provided. Then we will apply the insights resulting from these surveys to evaluate possible scenarios for the implementation of key articles of the Nagoya Protocol that will have an impact on future regulation and governance of the scientific research commons. For this purpose, we will more specifically analyse the Nagoya Protocol provisions on simplified access measures for biodiversity-related research,6 a multilateral

 Tom Dedeurwaerdere et al., “An Evolutionary Institutional Approach to the Economics of Bioprospecting,” in Biodiversity Economics: Principles, Methods, and Applications, ed. Andreas Kontoleon and Unai Pascual (Cambridge: Cambridge University Press, 2007): 417; Jerome H. Reichman et al., Intellectual Property and Alternatives: Strategies for Green Innovation (Chatham House Energy, Environment and Development Programme Paper No. 08/03, 2008). 5  Sikina Jinnah and Stefan Jungcurt, “Could Access Requirements Stifle Your Research?” Science 323:5913 (2009): 464. 6  Nagoya Protocol Article 8.a. 4

Governing Global Scientific Research Commons under the Nagoya Protocol   391

benefit-sharing mechanism,7 transboundary cooperation,8 and best practices, standardisation and guidelines.9 The chapter is organised as follows. The first section will explain the concept of the commons and its application to the specific case of scientific research commons. The second section will present the survey on access and use patterns in the global scientific research commons, by focusing on the particular case of globally networked public collections of genetic resources. The third and fourth sections will analyse, on this basis, how to create the best possible institutional fit with the access and use patterns highlighted through the surveys, by discussing respectively a set of institutional and legal options for implementing the Nagoya Protocol in the scientific research commons.

I.  Theoretical Models of Global Scientific Research Commons Much thought has been given over the last two decades to the positive role of non-State collective action for the provision of commons in modern economies. The provision of commons by non-State collective actors is increasingly seen as a necessary complement to the traditional institutional toolkit, in response to the insufficiencies of a unilateral focus on market mechanisms or government only. Such solutions have been especially prominent in policies that aim to address global environmental challenges, but have recently gained additional momentum in the context of digital knowledge resources and organisation of scientific research. This growing interest in the commons has led to broaden the concept of the historical commons, originally mainly related to natural resources, to new types of goods, such as knowledge goods and urban infrastructure. Two basic features characterise both the historical and the newly emerging commons. The first is related to the physical and socially constructed characteristics of the commons as non-private goods. The second is related to the mechanisms of non-State collective decision-making, which is an important institutional modality for managing these goods. First, commons can be characterised as non-private goods; that is, goods that are not easily subjected to exclusive control over access and use.10 From a technical perspective, within political economy, the designation of commons as non-private goods covers goods that are both non-excludable and  Nagoya Protocol Article 10.  Nagoya Protocol Article 11.  9  Nagoya Protocol Article 20. 10  Yochai Benkler, The Wealth of Networks: How Social Production Transforms Markets and Freedom (New Haven: Yale University Press, 2006).  7  8

392   Tom Dedeurwaerdere et al. non-depletable, and goods which have only one of these two characteristics.11 In this broad understanding, the concept of commons includes pure public goods, such as sunlight, which is both non-excludable and non-depletable upon joint consumption, and impure public goods, which only have one of these features. Examples of impure public goods that are non-exclusive and depletable are environmental goods such as the living resources in the open seas, where it is difficult or costly to exclude users, but which are exhaustible. Examples of impure public goods that are non-depletable, but nevertheless exclusive are digital knowledge pools, where it is easy to exclude users through digital fences, even though the knowledge resources are non-exhaustible upon joint consumption. From an empirical perspective, however, the possibility to exercise exclusive control over access and use is not only based on the physical nature of the goods. Indeed, it is important to recognise that the characteristics of the commons are both physically and socially constructed. An important case in point is the knowledge commons, where the cost and difficulty of exclusion will vary according to the institutional frameworks for intellectual property protection that have been put into place. Second, many of the commons – especially those belonging to the impure public goods category – are not only provided by the State. Rather, commons are increasingly provided by a wide variety of non-State collective actors or by hybrid forms of collective decision-making, combining non-State collective actors with State actors and/or individual market actors. For example, the seminal work of Elinor Ostrom and her colleagues focused on communitybased management of natural resources, as regulated by a clearly defined group of local users.12 Ostrom’s work accordingly sought to establish the possibility of a sustainable intermediate economic alternative for managing natural resource commons, situated midway between market-regulated exchanges of private goods, on the one hand, and pure public goods that typically depend on State-based governance of resources, on the other hand. In a similar way, recent scholarship on the commons has shown the importance of collective decision-making in social networks for providing knowledge goods on a nonexclusive basis,13 or of mixed economies in open access communities on the Internet.14 Empirically, the focus in all these cases is on the mechanisms of decision-making for managing goods on a non-exclusive basis and not on  Elinor Ostrom, Understanding Institutional Diversity (Princeton: Princeton University Press, 2005). 12  Elinor Ostrom, Governing the Commons – The Evolution of Institutions for Collective Action (Cambridge: Cambridge University Press, 1990). 13  Benkler, Yochai, The Wealth of Networks. 14  Lawrence Lessig, Remix: Making Art and Commerce Thrive in the Hybrid Economy (New York: Penguin Press, 2008). 11

Governing Global Scientific Research Commons under the Nagoya Protocol   393

the formal ownership scheme underlying the administration of such goods, which varies in practice from a purely private property regime to various forms of collective ownership, including direct State ownership. Many essential knowledge assets for scientific research can be characterised as commons, whether these are biological research materials conserved in in-situ environments, which are depletable, but from which it is difficult to exclude users, or research results, which are pure public goods. Moreover, non-State collective action potentially can play an important role in the provision of these assets, as the field of the knowledge commons faces many similar governance challenges as the natural resource commons, such as access restrictions resulting from privatisation of knowledge assets (such as databases or scholarly literature) or free riding by opportunistic players that benefit from the research commons without contributing in a fair and equitable manner. In the past, it was difficult to imagine commons-based management and production of goods on a global scale, due to such factors as the costs of exchange and the lack of global institutional frameworks.15 Arguably, the first major instance of formally managed commons on a transnational scale was the organisation of modern scientific research during the seventeenth century in Europe, through the organisation of science academies and associations operating on an international scale.16 In recent decades, however, digital networks have dramatically expanded the opportunities for building and sustaining different kinds of research commons on a global scale. In the life sciences, in particular, the genomics revolution and the development of new techniques for the handling and long-term maintenance of living biological samples17 have led to a tremendous increase of initiatives for networking collections of biological materials on the global scale,18 and for digitally integrating the associated genomic databases. Nonetheless, overall these initiatives remain poorly integrated, with the risk that they may succumb to adverse economic and political pressures over time. Therefore, new

 Robert O. Keohane and Elinor Ostrom, Local Commons and Global Interdependence (London: Sage, 1995). 16  Paul A. David, “The Historical Origins of ‘Open Science’: An Essay on Patronage, Reputation and Common Agency Contracting in the Scientific Revolution,” Capitalism and Society 3 (2008): 67–69. 17  Rita Colwell, “The future of microbial diversity research,” in Biodiversity of Microbial Life, eds. James Staley and Anna-Louise Reysenbach (New York: Wiley, 2002): 521; Raymond Cypess, Biological Resource Centres: Their Impact on the Scientific Community and the Global Economy (Manassas: American Type Culture Collection, 2003). 18  Parry, Bronwyn, Trading the Genome; Kerry T. Kate and Sarah A. Laird, The Commercial Use of Biodiversity (London: Earthscan, 2002). 15

394   Tom Dedeurwaerdere et al. governance institutions are needed for organising the collections of biological samples on the global scale.19 Systematic research on generic design principles of governance of knowledge commons has identified a set of design principles of successful governance arrangements.20 First, this research has shown that in knowledge commons participants are driven more by social motivations (especially reputational and social identity-related motivations) and intrinsic motivations (such as the science ethos or personal values related to biodiversity conservation) than by the prospect of direct monetary rewards. As a result, global scientific research commons will be governed by a set of mixed incentive schemes, which include both self-interested behavioural incentives (such as direct reciprocity or monetary rewards) and other-regarding behaviour incentives (such as the community norms and personal values). The adoption of distributed modular architectures based on a division of labour amongst geographically distributed components, each specialising in different sub-tasks, but sharing the common norms of the network organisation, is a second major institutional feature bearing on the success of commons-based knowledge production in digital networks.21 Distributed modular architectures enable many participants to effectively pool their efforts and contributions, notwithstanding the fact that these contributions may vary in quality, focus, timing, and geographical location.22 The latter is typically the case for the genetic resource collections of microbial, plant and animal samples where, due to the high costs of long-term preservation and documentation of the genetic-resources, and the maintenance of the associated information databases, no single centralised collection can hold all, or even an important subset, of the resources.

 Robert Cook-Deegan and Tom Dedeurwaerdere, “The Science Commons in Life Science Research: Structure, Function, and Value of Access to Genetic Diversity,” International Social Science Journal 188 (2006): 313. 20  Benkler, Yochai, The Wealth of Networks; James Boyle, The Public Domain: Enclosing the Commons of the Mind (New Haven: Yale University Press, 2008); Charlotte Hess and Elinor Ostrom, Understanding Knowledge as a Commons: From Theory to Practice (Cambridge: MIT Press, 2007); Lawrence Lessig, The Future of Ideas: The Fate of the Commons in a Connected World (New York: Random House, 2001). 21  Benkler, The Wealth of Networks; Lessig, The Future of Ideas. 22  Yochai Benkler, “Coase’s Penguin, or, Linux and The Nature of the Firm,” The Yale Law Journal 112 (2002): 406. 19

Governing Global Scientific Research Commons under the Nagoya Protocol   395

II.  Access and Use Patterns in Global Scientific Research Commons 1.  Survey on Sharing Arrangements with Genetic Resources for Food and Agriculture amongst Researchers in the US and Europe The Nagoya Protocol contains a wide variety of provisions, which could potentially contribute to the further institutional development of the global scientific research commons, as will be discussed further below, whether it is in relation to specific science-related provisions in the Protocol or more general provisions related to codes of conduct or transboundary cooperation. The main question addressed in this chapter, in this context, is how to create a better institutional fit between future institutional developments of scientific research commons under the Nagoya Protocol and the complex governance features of science commons that contribute to research into conservation and sustainable use of biodiversity. To address this question, a better understanding is needed, in particular, of the role of social networks and community norms in shaping the motivations of the participating scientists, in addition to the analysis of specific features of the genetic resources that play a role in the selection of the institutional frameworks.23 In 2011, a survey was administered to researchers that use genetic resources for food and agriculture (GRFA) in the US and Europe, with the view to collecting data to understand access and use patterns, to identify the determinants of use, and to investigate existing benefit-sharing practices and arrangements. In the US, the survey was administered to government and university researchers that work with eight different aquatic, microbial, livestock, and insect GRFA. The European data were collected from researchers in one single European government-sponsored organisation. The resulting data includes 126 usable responses (55% response rate) from European researchers and 385 usable responses from the US (38.8% response rate). In addition to individual-level data, the surveys also collected project-level data on GRFA exchange practices for 237 projects undertaken by the European respondents and 731 by the US respondents.24  See above footnote 3 and also Marie Schloen, Selim Louafi and Tom Dedeurwaerdere, “Access and benefit-sharing for genetic resources for food and agriculture. Current use and exchange practices, commonalities, differences and user community needs. Report from a multi-stakeholder expert dialogue” (Rome: FAO, Commission on Genetic Resources for Food and Agriculture. Background Study Paper No. 59, 2011). However, the analysis of the particular characteristics and properties does not allow specifying what are the existing community norms and social networks to build upon in effectively implementing a certain institutional regime. 24  Although the same survey instrument has been administered in the two countries, the sample selection for each is markedly different. In particular, the European study is a single case 23

396   Tom Dedeurwaerdere et al. Government

47

32

USForeign

University

72

78

Industry

Farm/others 2

8

17

2

Researchers who send/received GRFA   EuropeForeign 29

7

Government

11

12

University

3

3

Industry

8

86

Farm/others

Figure 2:  Percentage of respondents who send/received GRFA (Source: original survey data from USDA CIRAD funded research on the exchange and use of GRFA).

Descriptive findings show that researchers in both countries exchange GRFA with partners in different sectors – government, university and industry (cf. figure 1). Among researchers who send and receive GRFA internationally, materials come from multiple sectors, indicating that there is a broad set of sources and exchange patterns among partners who do not necessarily share the same objectives. Project-level data also show that in many instances researchers obtain materials from a variety of sources from different sectors. Researchers likely identify a wide range of collaborators and partners that are able to effectively provide access to resources in ways that increase their chances of obtaining GRFA for undertaking their research. Overall, this points to the existence of a relatively distributed GRFA exchange network. Active exchange of GRFA appears to be beneficial both for the foreign and the national entities, in that there are substantial two-way flows in all sectors, illustrating a certain level of interdependence among the various stakeholders, where no single entity is a self-sufficient user of GRFA. In addition, the study of a large publicly funded research organisation that has a broad array of international projects mainly dealing with plant genetic resources for food and agriculture, while the US survey covers a wider range of institutions and types of genetic resources. Hence, these two samples may generalize to somewhat different populations and care should be taken when using the results to make comparisons between the US and Europe.

Governing Global Scientific Research Commons under the Nagoya Protocol   397 Table 1:  Restrictions on access and use, and expected reciprocity (Source: original survey data and from USDA CIRAD funded research on the exchange and use of GRFA). Questions

France Yes No

Restrictions During the last two years, did a person or 19% on Access organisation in a foreign country request genetic resources from you that you did not supply? During the last two years, did you request 15% [%Species%] genetic resources from a foreign-based source that you did not receive?

81%

Yes

US

No

9%

91%

85%   2%

98%

31%

69% 18%

82%

30%

70% 10%

90%

28%

72% 16%

84%

43%

57% 24%

76%

80%

20% 59%

41%

32%

68% 15%

85%

Restrictions For the genetic resources you obtained on Use during the last two years on each of the project you named, which of the following are true? I agree not to provide the materials to others I agree not to use the materials for commercial purpose Reciprocity For the genetic resources you obtained during the last two years on each of the project you named, which of the following are you expected to provide in return? Expected to provide storage of the material Expected to provide research or technical services Expected to provide information on project results Expected to provide education or training

existence of private partners shows also that the exchange network likely accommodates both commercial and non-commercial uses of material. Table 1 shows that few researchers have denied GRFA access to a person or an organisation in a foreign country. More surprisingly, despite a context where access to GRFA appears to be more and more restrictive for major users, few researchers have eventually failed to receive material they requested from their foreign-country partners. In addition, the table shows that few restrictions are imposed on (or are accepted by) researchers regarding third-party transfer and commercial purpose.

398   Tom Dedeurwaerdere et al. These results tend to demonstrate that in order to access material, university and government researchers have the capacity to mobilise resources within the GRFA network that undoubtedly go beyond legal or market-based approaches. This capacity likely arises because users are embedded in trustbased collaborative relationships that also recognise non-monetary benefits that accompany these exchanges. Existence of non-monetary benefits is clearly confirmed by the survey results, which show that reciprocity explicitly plays a role in the exchange process. Most important, in accordance with the generally recognised research norm in which the exchange of materials and knowledge are part of the same process of inquiry, there is a high level of expected provision of information in return for receiving GRFA. 2.  Global Exchange in the Microbial Research Commons The in-situ conservation of microorganism is not sufficient for organising systematic research into microorganisms and their applications for a number of reasons, in particular because they replicate frequently and need special equipment for their study.25 Microorganisms that are isolated from the environment are typically conserved and made available for systematic comparative research by public culture collections, which are formally organised to acquire, conserve and distribute microorganisms and information about them to foster research and education. The main features of the exchange practices found in the survey of the plant genetic resource collections discussed above also characterise these international exchanges amongst the public culture collections. First, as illustrated in figure 2 below, the researchers and managers exchanging the resources come from various sectors, including both research organisations and gene banks, and commercial and non-commercial entities. The two-way flow of resources is also clearly present, as most entities are both providers and recipients of resources. A vast amount of new microorganisms from in-situ sources are collected every year in various regions of the world by culture collection managers or affiliated researchers, characterised and deposited in culture collections for long-term conservation. A quantitative assessment conducted in 200926 of the entire accession databases of a representative set of nine collections (totalling more than 15,000 single accessions, covering the years 2005, 2006,  Tom Dedeurwaerdere et al., The Use and Exchange of Microbial Genetic Resources Relevant for Food and Agriculture (Rome: CGRFA Background Study Paper no. 46, October 2009): 28–29. 26  Ibid., 23–25. 25

Governing Global Scientific Research Commons under the Nagoya Protocol   399

and 2007) has shown that new deposits of resources from in-situ environments in the culture collections are mostly from national depositors, that is researchers working in a collection or in a research laboratory situated in the same country (between 45% and 100% of the new deposits) (see Table 1). However, a substantial proportion of the new deposits by these national depositors come from foreign countries (over 40% in five of the eight collections for which data was available, four of these being countries of the Organisation for Economic Cooperation and Development – OECD). This suggests that national depositors often collect in other countries and deposit the resulting material in their national collections. Direct deposits from foreign countries also represent an important subset. For instance, the survey showed that every year depositors from India, the Philippines, China, Brazil, Colombia and Uruguay, directly deposit strains from their countries in OECD collections.27 A remarkable fact that was found in this quantitative assessment is the lack of restrictions on the further distribution and use of the microorganisms which have been deposited and where the collections are using formal deposit forms. Eight of the nine collections used formal deposit forms for all new deposits in 2005, 2006 and 2007 and between 98% and 100% of these deposits came without any restrictions attached.28 This survey did not include questions on the expected public good benefits. However, some of these reciprocity features are also clearly present in the case of the microbial collections. Samples are deposited with the clear expectation that these samples will be stored in the long-term storage facilities and will be maintained under the very demanding quality assurance systems of the public culture collections. Agreements for providing research and technical services, to provide information on project results, or to provide education and training, are mostly based on bilateral agreements, such as, for example, the agreements between the Belgian and the Moroccan collections for training in bio-information and management (BCCM – CCMM collaboration)29 and the agreement for access to samples between the national Japanese and Thailand culture collections (NITE-BIOTEC agreement).30

 Ibid., 28.  Ibid., 7. 29  BCCM Newsletter, edition 13-03, May 2003, accessed 4 March 2012, http://www.bccm .belspo.be/newsletter/13-03/index.htm. 30  BIOTEC News, 2005, accessed 4 March 2012, http://www.biotec.or.th/EN/index.php/infocenter/news/news2005/104-biotec-signed-mou-with-dob-nite. 27 28

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Figure 3:  Exchange patterns amongst microbial collections in a sample of 240 culture collections that are members of the World Federation for Culture Collections. (Source: Tom Dedeurwaerdere, Per M. Stromberg and Unai Pascual, Social Motivations and Incentives in ex-situ Conservation of Microbial Genetic Resources (Cambridge: Open Book Publishers, 2012).

III.  Institutional Options for Standardised ABS Approaches in Global Research Commons The above-mentioned surveys on exchange practices in the scientific research commons highlight two important features of the research commons. First, in spite of general similarities, the agreements used in the exchange are tailor-made for the various sub-sectors of exchange. Therefore, any standard agreement that would be established on mutually agreed terms could only be based on a minimal set of common conditions, because the specific agreements will be different in their details. This reflects the heterogeneity of the research infrastructures, both in relation to the type of material that is conserved, their funding structures, and the requirements of their national policy frameworks. Second, the ongoing transformation from an informal exchange regime to a formal one is not necessarily leading to more restrictive access and use conditions, but can be managed in a way, which is supportive of the scientific research commons. As can be seen from the survey of the microbial collections, it is possible to design formal license conditions, such

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as deposit forms for the public ex-situ collections, that allow facilitating use and re-use of research resources along the innovation chain. For the design of a worldwide scientific research commons, however, sufficient guarantees have to be provided for reciprocity in the exchanges, and for fair benefit-sharing based on mutually agreed terms. Therefore, to put the global research commons on a solid legal and institutional basis, a more systematic approach is needed, based on a better understanding of the costs and benefits of alternative institutional frameworks. The main issue that has to be addressed in this context is the creation of a better fit between the proposed formal institutional arrangements for building the scientific commons and the norms and goals of the scientific communities.31 In particular, to foster wide acceptance of the envisioned system, and thereby accelerate scientific progress, any formal arrangements need to be committed to facilitate the exchange of materials, data and published research results, and need to be easy to implement by regulatory bodies, as well as by both parties involved in the exchange (providers and recipients). This raises a double set of problems. On the one hand, institutional frameworks that rely excessively on monetary incentives or formal control can ‘crowd out’ the social norms of communalism and the intrinsic values that drive scientific communities.32 Crowding out occurs when internal motivations, such as social norms and personal values, are conflicting with external incentives, mainly monetary/ economic incentives or formal sanctions. In those cases of conflicting incentives, individuals might stop to contribute to collective goods or decrease their cooperation with other individuals that contribute to such goods. This is especially relevant for the bulk of public domain resources, which are exchanged for public research purposes on the basis of the social norms of science. On the other hand, without a formal arrangement of some kind for regulating the exchanges, the benefits might be restricted to the researchers  Arti K. Rai, “Regulating scientific research: intellectual property rights and the norms of science,” Northwest University Law Review 94 (1999): 77; Tom Dedeurwaerdere, “The Role of Law, Institutions and Governance Processes in Facilitating Access to Genomics Research,” in Gene Patents and Clearing Models. From Concepts to Cases, ed. Geertrui Van Overwalle (Cambridge: Cambridge University Press, 2009), 365; Paul David and Michael Spence, Towards institutional infrastructures for e-Science: the scope of the challenge (Oxford: University of Oxford – Oxford Internet Institute Research Report No. 2, 2003); Partha Dasgupta and Paul David, “Toward a New Economics of Science,” Research Policy 23 (1994): 487. 32  Bruno S. Frey and Reto Jegen, “Motivation crowding theory: a survey of empirical evidence,” Journal of Economics Surveys 15 (2001): 589; Bruno S. Frey and Margit Osterloh, eds., Successful Management by Motivation (New York: Springer, 2002); Mark Lepper and David Greene, eds., The Hidden Costs of Reward: New Perspectives on the Psychology of Human Motivation (New York: Lawrence Erlbaum, 1978); David and Spence, Towards institutional infrastructures. 31

402   Tom Dedeurwaerdere et al. who have access to the networks of professional relationships. In the latter case, those benefits would not reach the scientific community beyond a club of most advanced researchers. Such crowding out has been clearly observed in the case of the implementation of the Convention on Biological Diversity, which has hampered international cooperation built on the norms of public science.33 In contrast, patenting in academic life science research does not appear to have led to similar crowding-out effects.34 The goal of the further harmonisation of the institutional frameworks should therefore be to provide the broadest access possible to essential research materials – within the constraints set by biosecurity and quality management requirements, while maximising the reciprocity benefits of access and exchange which motivated the practice of exchange to start with.35 To examine the contribution of possible harmonisation frameworks to the implementation of the Nagoya Protocol in the specific area of scientific research, three main institutional options for building standardised ABS approaches for networks of public collections will be considered. The specific focus on public collections is related to the research interest of this chapter on the institutional design of the scientific research commons. In this context, we qualify a collection as public if the resources conserved in these collections are held in public domain-like conditions; that is, without exercising exclusive legal ownership rights over the resources. A typical example falling under this definition are the government-funded members of the World Federation of Culture Collections, who are holding the microbial materials ‘in trust’ for the global scientific research community. Similar cases of public availability of resources exist in many other cases of public sector or non-profit ex-situ collections of genetic resources, such as the plant genetic resources held by the collections of the Consultative Group on International Agricultural Research (CGIAR). The first option that will be considered is a full-fledged intergovernmental organisation based on a binding international treaty, much like the existing arrangement under the FAO’s International Treaty on Plant Genetic Resources for Food and Agriculture  Jinnah and Jungcurt, “Could Access Requirements Stifle Your Research?”  Wesley Cohen and John Walsh, “Access – or not – in academic biomedical research,” in Working Within the Boundaries of Intellectual Property: Innovation Policy for the Knowledge Society, eds. Rochelle Dreyfuss, Diane Zimmerman and Harry First (New York: Oxford University Press, 2010), 16. 35  Cook-Deegan and Dedeurwaerdere, “The Science Commons”; Peter Dawyndt, Tom Dedeurwaerdere and Jean Swings, “Exploring and exploiting microbiological commons: contributions of bioinformatics and intellectual property rights in sharing biological information. Introduction to the special issue on the microbiological commons,” International Social Science Journal 188 (2006): 249; Jerome Reichman, Paul Uhlir and Tom Dedeurwaerdere, Global Intellectual Property Strategies for the Microbial Research Commons (Cambridge MA: Cambridge University Press: forthcoming). 33 34

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(International Treaty).36 The second option, on the opposite, is a purely science-driven non-governmental organisation, building upon existing institutions such as the World Federation for Culture Collections, the International Union of Microbial Sciences and the relevant scientific societies in microbiology. Finally the third option, in between these two extremes, is a framework agreement between willing governments37 that would contractually establish a common position, notwithstanding underlying differences of the various national laws. An example of this third option that will be analysed is the International Rice Genome Sequencing Project (IRGSP) (1998–2002). 1.  Example of a Treaty-based Global Research Commons: The Global Crop Commons Established under the International Treaty on Plant GRFA (2004) By far the most directly relevant international agreement affecting the common pooling and management of genetic resources is the International Treaty on Plant Genetic Resources for Food and Agriculture.38 The Treaty establishes a multilateral ABS system that consists in pooling the genetic material listed in the Annex I of the Treaty and coming from various countries. This material is indeed included in the gene pool by the States that have ratified the Treaty and the institutions under their control. But these samples could also come into the gene pool from international institutions as well as from natural and legal persons within the jurisdiction of the Parties. These samples are pooled in that they are administered under a common set of rules that are contained in a contractual instrument, namely the Standard Material Transfer Agreement (SMTA). The rules apply for each and every individual transfer of material coming from this pool between two legal entities, called the provider and the recipient. The use of SMTA is, however, compulsory only if the material is used or conserved for research, breeding and training for food and agriculture. Finally, the rules regulate not only how to obtain access to the plant genetic material but also how to share the results of research and breeding on that material.39  International Treaty on Plant Genetic Resources (Rome, 3 November 2001, in force 29 June 2004) 2400 UNTS 379. [See also contribution by Chiarolla, Louafi and Schloen in this volume (Chapter 3).] 37  Reichman, Uhlir and Dedeurwaerdere, Global Intellectual Property Strategies for the Microbial Research Commons, where this idea was first developed in the specific context of the microbial research commons. 38  Michael Halewood, Isabel Noriega and Sélim Louafi, eds., Crop Genetic Resources as a Global Commons: Challenges in International Law and Governance (London: Earthscan, 2012). 39  Daniele Manzella, “The Design and Mechanics of the Multilateral System of Access and Benefit Sharing,” in Crop Genetic Resources as a Global Commons. Edited by Halewood, Noriega and Louafi. Earthscane. Forthcoming. 36

404   Tom Dedeurwaerdere et al. The multilateral system might qualify as the most advanced expression of the need for cooperation in the management, conservation and distribution of plant GRFA. By managing globally, in a coordinated and coherent way, a distributed, but still common, pool of genetic resources, the International Treaty creates the global conditions for attenuating the effects of centrifugal forces (intellectual property, sovereignty and so on) and provides an enabling framework for different actors to cooperate across existing geographical, organisational and disciplinary boundaries. It is designed to address the specific features and needs of the agricultural sector when it comes to access to plant genetic resources for food addressing, in particular: i) the existence of important ex-situ collections; ii) the interdependence between countries in their use and exchange of PGRFA; and iii) the collective nature of the innovation process (plant improvement and breeding).40 Through the establishment of the multilateral system, Parties, ‘in the exercise of their sovereign rights,’41 have agreed to facilitate access to specific plant GRFA and to share the benefits arising from the utilisation of these resources, as laid down in the Treaty and as operationalised through the SMTA. In a highly politicised context about sovereignty over genetic resources, the Treaty has led to a new way of exerting this national sovereignty. Through the establishment of the multilateral system, Parties have agreed to defer a part of their responsibility for plant GRFA management from the national level to the international level. The underlying rationale is that they will all gain more by having access to all the resources of the multilateral system than they would have by restricting access to their own. Moreover, the SMTA is a very operational instrument that applies directly (that is, without the necessary involvement of State or administrative representatives) to the stakeholders involved in the exchange of plant GRFA. It does not necessarily require any administrative steps at the national level even in the case of reporting procedures. Hence, the direct link that is established between the stakeholders and the Governing Body of the Treaty (through its Secretariat) provides an opportunity to reinforce the global commons nature of the resource exchanged and the responsibilities attached to its management, beyond or next to the State. In addition, as a viral license agreement,42  Marie Schloen, Selim Louafi and Tom Dedeurwaerdere, Access and benefit-sharing for genetic resources for food and agriculture. Current use and exchange practices, commonalities, differences and user community needs. Report from a multi-stakeholder expert dialogue (Rome: CGRFA Background Study Paper: 46, May 2011), accessed 3 March, 2012, http:// www.fao.org/docrep/meeting/022/mb336e.pdf. 41  As International Treaty Article 10.2 explicitly states. 42  This notion has been coined in the software sector to describe a software made freely available through a license that permits modification and distribution as long as the modified 40

Governing Global Scientific Research Commons under the Nagoya Protocol   405

the SMTA allows for the monitoring and control of the flow and use of plant GRFA. Together with the Treaty’s compliance mechanism, the SMTA functions as a certificate of compliance and generates the knowledge needed to operationalise the sharing of benefits. Striking the proper balance between open availability and private enclosure was contentious during the Treaty negotiations, and continues to be to this date.43 In a context of hyper-ownership,44 the Treaty manages to ensure a wider circulation of plant GRFA worldwide by reducing dramatically the transaction costs associated with the exchange of genetic resources. By moving away from the bilateral and case-by-case approach, the Treaty indeed contractually reconstructs a common good. Social value is underlined in the reciprocity aspects of the non-monetary benefit-sharing mechanisms. Capacity building, the exchange of information, and access and transfer of technology are very often catchwords in international texts. In the context of the Treaty, it is argued that these components are key for maintaining the overall political coherence of the Treaty by promoting other values than the monetary ones that will likely remain quite low. These components are indeed taking on their full meaning in the context of implementing the Multilateral System: they are the means and the vehicle through which a wider conception of benefits could be generated, a broader range of stakeholders could be encouraged and a wider range of concerns could be dealt with.45 The use of GRFA indeed usually generates important external effects that go far beyond the individual provider and recipient of the respective genetic material, sometimes even independently of whether the product reaches the market place. These external effects may, for example, contribute to the creation of important public goods such as rural development and poverty alleviation, environmental protection, food security and cultural diversity. The fact that an important part of agricultural and food production relies on the use of species of exotic origin, and that software is distributed under the same license through which the source code was originally obtained. 43  Christine Frison, Tom Dedeurwaerdere and Michael Halewood, “Intellectual Property and Facilitated Access to Genetic Resources under the International Treaty on Plant Genetic Resources for Food and Agriculture,” European Intellectual Property Review 32 (2010): 1. 44  Safrin uses this term in her article to refer to the increased legal enclosure of genetic material (Sabrina Safrin, “Hyperownership in a time of biotechnological promise: the international conflict to control the building blocks of life,” American Journal of International Law 98 (2004): 641. 45  Selim Louafi, “Collective action challenges in the implementation of the Multilateral System of the International Treaty, What roles for the CG Centres?” in Crop Genetic Resources as a Global Commons, edited by Halewood, Noriega and Louafi. Earthscane, forthcoming.

406   Tom Dedeurwaerdere et al. countries are usually not self-sufficient with regard to GRFA, increases the relevance of these non-monetary spillover effects.46 The Multilateral System established with the International Treaty illustrates the option of an international treaty for a standardised ABS approach for research. However, the Multilateral System poses major challenges of implementation to governments at various levels – the global level as much as the national levels. It should be indeed mentioned that, to date, there has not been more vigorous engagement in the Treaty’s multilateral system by a number of key actors. The most relevant contributing factors are related to two underlying issues:47 •  insufficient policy reinforcement of the plant GRFA commons – there are no boundaries and no direct reciprocity requirements (non-contributors can equally benefit from the system as contributors); •  the mandatory financial benefit-sharing provision suffers from a design situated somewhere between multilateralism and bilateralism that undermines some actors’ enthusiasm for participating in the multilateral system as conservers, users, providers and recipients of germplasm and information. While mandatorily shared financial benefits are directed to the Multilateral System and decoupled from the countries, communities or legal individuals that actually provide the resources, the triggering mechanism (i.e., the requirement to share benefits) remains linked to the use of a specific sample accessed from the Multilateral System. 2.  Example of a Self-regulatory Solution: The Global Microbial Commons Established under WFCC and ECCO A second model for standardised ABS approaches takes a bottom-up approach to some of these problems, by formalising science community driven practices through self-regulation. The self-regulatory solution developed within the World Federation for Culture Collections (WFCC) is an example of this second model. More than 80% of the WFCC collections belong to public sector entities (universities or governments). The remaining are semi-governmental

 Marie Schloen, Selim Louafi and Tom Dedeurwaerdere, “Access and benefit-sharing for genetic resources for food and agriculture. Current use and exchange practices, commonalities, differences and user community needs” (Rome: CGRFA Background Study Paper no. 59, July 2011). 47  Halewood, Noriega and Louafi, eds., Crop Genetic Resources as a Global Commons. 46

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(8%) and, in a few cases, private non-profit (4%) or private industry collections (1%).48 Historically, most microbial materials have been exchanged informally between the culture collections and between researchers in universities and public research institutions, i.e., without formal written agreements on the moment of accessing such resources. Nevertheless, for resources exchanged between the culture collections, a minimal tracking system was put into place, mainly for scientific reasons, by attributing numerical identifiers to each single microbial sample which is recorded in the documentation on the exchange history of the sample. The main advantage of these informal networks (clubs or loose networks of scientists) is to lower transaction costs compared to the use of formal material transfer agreements (i.e., costs related to negotiations to be undertaken, contracts to be drawn up, inspections to be made, arrangements to be made to settle disputes, and so on),49 while allowing the use of the research materials in the recipients’ laboratory with few, if any, strings attached to them arising from concerns about potential future commercial applications.50 At the same time, the tacitly recognised quality management standards observed by trusted members of the club guarantee the authenticity and integrity of the materials exchanged. However, since the adoption of the CBD and the globalisation of intellectual property regimes under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), culture collections increasingly use formal Material Transfer Agreements (MTAs) for the distribution of microbial materials. In particular, to put the existing collaborative networks between the culture collections on a sound legal basis, some WFCC members have developed formal MTAs that formalise the basic norms and benefits of the informal club system, along with the new obligations and responsibilities that have arisen in the context of the CBD. These formal MTAs are, however, only a first step in the attempt to build a truly global microbial commons and are hampered by the wide variety of license conditions which are currently adopted, and the lack of transparency in access procedures in developing countries, involving sometimes lengthy delays in obtaining genetic materials.51 Scientists from both developed and developing countries have  Scott Stern, Biological Resource Centers: Knowledge Hubs for the Life Sciences (Washington: The Brooking Institution, 2004), 15. 49  Ronald Coase, “The Problem of Social Cost,” Journal of Law and Economics 3 (1960): 1. 50  Dedeurwaerdere et al., The Use and Exchange of Microbial Genetic Resources Relevant for Food and Agriculture. 51  Carolina Roa-Rodríguez and Thom Van Dooren, “Shifting Common Spaces of Plant Genetic Resources in the International Regulation of Property,” The Journal of World Intellectual 48

408   Tom Dedeurwaerdere et al. repeatedly expressed concern about the harm that such restrictive access regulations may have on basic scientific research.52 The main initiative for a more standardised approach to the formalisation of the distribution of samples by the culture collections is the standard MTA adopted by the regional culture collection network in Europe. In February 2009 the European Culture Collection (ECCO) adopted a core Material Transfer Agreement.53 The main purpose of the agreement is to make biological material from ECCO collections available under the same core conditions, which are to be implemented by ECCO members either as such or integrated into their own more extended MTAs. The common contracts contain a similar viral license clause to the clause included under the MLS of the ITPGRFA discussed above, which specifies that recipients can only distribute materials under the same conditions as the conditions under which they received the material. Indeed, recipients must not transfer the material to any others, except to those acting as intermediaries and those involved in legitimate exchanges, under the conditions that they use the same licensing conditions. Legitimate exchange is defined as the transfer of the material between scientists working in the same laboratory or between partners in different institutions collaborating on a defined joint project, for non-commercial purposes. This also includes the transfer of material between culture collections for accession purposes.54 The ECCO MTA requires the material to be used only for non-commercial purposes. If the recipient desires to use the material or modifications of the material for commercial purposes, it is the responsibility of the recipient, in advance of such use, to negotiate the terms of any benefit-sharing with the appropriate authority in the country of origin of the material (as indicated by Property 11 (2008): 176; CBD Ad Hoc Open-Ended Working Group on Access and BenefitSharing, “Analysis of Gaps in existing national, regional and international legal and other instruments relating to access and benefit-sharing,” (13 September 2007) UN Doc UNEP/ CBD/WG-ABS/5/3. 52  S. Jinnah and S. Jungcurt, “Could Access Requirements Stifle Your Research?”; CBD Group of Legal and Technical Experts on Concepts, Terms, Working Definitions and Sectoral Approaches, “Concepts, Terms, Working Definitions and Sectoral Approaches Relating to the International Regime on Access And Benefit-Sharing – Submission from the international workshop on the topic of ‘Access and Benefit-sharing in Non Commercial Biodiversity Research’, Bonn, 17–19 November 2008,” (29 November 2008) UN Doc UNEP/CBD/ ABS/GTLE/1/INF/2. 53  Official website of the ECCO, accessed May 23, 2012, www.eccosite.org (text of the ECCO core Material Transfer Agreement for the supply of samples of biological material from the public collection, accessed May 23, 2012, http://www.eccosite.org/MTA_core.html). 54  ECCO core Material Transfer Agreement for the supply of samples of biological material from the public collection, 10 February 2009, Preamble, Definition, accessed 23 May 2012, http://www.eccosite.org/MTA_core.html.

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the collection’s documentation). In principle, the ECCO agreement does not require that the collection be involved in the benefit-sharing negotiations.55 The MTA adopted by the BIOTEC culture collection, at the National Centre for Genetic Engineering and Biotechnology in Thailand,56 is an example of a science-friendly MTA used in a developing country, bearing many similarities to the ECCO standard MTA. BIOTEC uses two standard material transfer agreements, one for the general distribution of materials to customers (MTA1), and the other for the exchange of materials between biological research centres. This second MTA allows recipient collections to further distribute the materials to third parties (MTA2). MTA1 requires the material to be used only for research and education. The material may be distributed to co-workers, as long as it remains under the recipient’s direct supervision. Its release to colleagues in other institutions (or outside of the recipient’s direct supervision) is only allowed with BIOTEC’s written permission and after an MTA1 has been signed between the third party and BIOTEC. If the recipient wants to use the material for commercial purposes, BIOTEC will, in advance of such use, negotiate with the recipient to establish the terms of a commercial license. The MTA2 is quite similar, with the main difference relating to the part of the agreement covering other public collections. Thus, the MTA2 allows further distribution of the material by public collections that receive material from BIOTEC under the recipient’s direct supervision or the recipient’s explicit agreement. As with ECCO’s core MTA, this second model facilitates the exchange and distribution of strains by the scientific community. 3.  Example of a Framework Agreement: The International Rice Genome Consortium The genesis and culmination of rice genome mapping is a prominent example of how science commons represent a prerequisite for further research and innovation within the world of high sunk cost bound specialised biotechnology research. From a governance perspective, the Rice Genome Consortium illustrates a hybrid solution in between the self-regulatory solution of the science communities and a full-fledged international treaty between contracting governments. In this example, science organisations, private  ECCO core Material Transfer Agreement for the supply of samples of biological material from the public collection, 10 February 2009, Article 7, accessed 23 May 2012, http://www. eccosite.org/MTA_core.html. 56  Official website of the National Centre for Genetic Engineering and Biotechnology (BIOTEC) in Thailand, accessed 23 May 2012: www.biotec.or.th; the text of the MTA, accessed 23 May 2012, http://www.biotec.or.th/germplasm/Forms/MTA%20Eng_TLO%20Rev%20 v.3.pdf. 55

410   Tom Dedeurwaerdere et al. companies and governments join into a collaborative agreement for making research results available to the greatest extent possible to the global research community. The example of the International Rice Genome Sequencing Project demonstrates that socially useful innovation may not always be sufficiently incentivised through public license conditions, but that it sometimes temporarily needs partially open mechanisms, where all parties recognise the role played by unpatented sequencing technology and the access to other research teams’ provisional research results in achieving their final objective. Involved public actors included within their realm powerful nations who could invest in such a gargantuan project, while also having a great social interest in doing so. Igniting the race was Japan, with its Rice Genome Research Program dated as early as 1991, followed in its footsteps by the current Beijing Genomics Institute in 1993. Finally emerging from a recognised need for cooperation was a consortium of publicly funded laboratories regrouped within the International Rice Genome Sequencing Project, under Japanese leadership and a commitment on the final release of research results into openly accessible databases.57 On the other side of the spectrum, two private agrobiotechnology giants initiated sequencing projects with a commitment for proprietary mapping, with even a prospect for the sale of resulting information to other biotech and seed companies. Interestingly, all private sponsored research results also winded up in the international public consortium databases, either because demand for proprietary information remained too low, or because collaborations were established with public institutes who shared their sequences on GenBank.58 The complete rice genome sequence was made available on line through the National Centre for Biotechnology Information (NCBI) database in December 2004, leading to the completion of the full map-based sequences for all examined rice varieties in August 2005, exemplifying the instigating potential of partially open innovation systems in upstream research. Based on this same model, and following in the footsteps of the ‘Rosetta stone of all cereals’, an international consortium was established in 2005 for the sequencing of wheat. This new cooperation includes members of the academic community and representatives of public research institutes, but also those of the private sector, all committed to ensuring that the sequence of

 Takuji Sasaki and Ben Burr, “International Rice Genome Sequencing Project: the effort to completely sequence the rice genome,” Current Opinion in Plant Biology 3 (2000): 138. 58  Carl Pray and Anwar Naseem, “Intellectual Property Rights on Research Tools: Incentives or Barriers to Innovation? Case Studies of Rice Genomics and Plant Transformation Technologies,” AgBioForum 8 (2005): 108. 57

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the wheat genome and the resulting DNA-based tools are available for all to use without restriction.

IV.  Implications for the Implementation of the Nagoya Protocol in Scientific Research Commons The three options analysed above, the International Treaty on plant genetic resources, the self-regulating system of exchange of microbial resources, and the framework agreement for rice genome mapping are innovative and advanced solutions to manage commons of genetic resources. However, even if it fulfils the objective of ABS and provides for a strong reciprocity between the Parties, the International Treaty is limited in scope, as its Multilateral System applies only to plant genetic resources included in its Annex I.59 On the other hand, the self-regulatory system of microbial commons needs to evolve in the future in order to comply with the Nagoya Protocol, by adapting the currently used deposit forms for newly deposited materials and the standard MTA’s to the newly codified requirements under the Protocol (such as by explicitly mentioning the formal approval by the recognised national authorities on the deposit forms, or by integrating explicitly the obligation of benefit-sharing over modified materials as already envisioned in the ECCO standard MTA). The objective of this chapter is to evaluate how and to what extent, in implementing the Nagoya Protocol, it is possible to safeguard the nonexclusive access and use conditions that govern much of the present relationships between biodiversity scientists both in developing and developed countries, by further building on formally codified MTAs used both in the self-regulatory regime of the microbial commons and in the International Treaty. The latter would not require, however, a negotiation of an ad hoc international legal instrument for research, which would be costly and of unpredictable result. Instead, it can be accomplished through the implementation of the science-friendly provisions of the Protocol in combination with a further standardisation of the diverse arrangements of the scientific research commons into a set of minimal conditions based on mutually agreed terms as specified below. 1.  Non-commercial Research The research community is arguably the stakeholder group most affected by access and benefit sharing under the CBD and the Nagoya Protocol: access  International Treaty Article 11.1.

59

412   Tom Dedeurwaerdere et al. 2,500 2,000

Developing countries Developed countries

1,500 1,000 500 0 1973 1976 1979 1982 1985 1988 1991 1994 1997 2000 2003 2006

Figure 4:  Global seed exchange network (Source: Derek Byerlee et al., “Crop improvement in the CGIAR as a global success story of open access and international collaboration,” International Journal of the Commons 4 (2010): 452).

in almost all cases is undertaken with no commercial intent at the time of access.60 For example, it has been demonstrated that at the time when the entry into force of the CBD was approaching (end of 1993), the amount of exchange of plant genetic resources in food and agriculture for public research purposes, within the Consultative Group on International Agricultural Research, dropped considerably (see figure 3) as a result of the reaffirmation of national sovereignty over genetic resources under the CBD, in conjunction with the fear of legal uncertainty over intellectual property rights.61 In reaction, in order to preserve the global seed exchange network established by the CGIAR, the FAO adopted in 1994 a set of ‘in trust’ agreements, which re-established the confidence between developing and developed countries over the global public nature of the CGIAR resources, in combination with a formal mandate to negotiate a specific international instrument to regulate plant genetic resources for food and agriculture. As stated above, scientists in other fields of research have also repeatedly expressed concerns about the harm that restrictive access regulations might have on research. These potential negative impacts of the CBD on science  Matthias Buck and Claire Hamilton, “The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation to the Convention on Biological Diversity,” Review of European Community & International Environmental Law 20 (2011): 59. 61  Michael Halewood, “Governing the management and use of pooled microbial genetic resources: Lessons from the global crop commons,” International Journal of the Commons 4 (2010): 403. 60

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made the scientific community push for a simplified procedure for scientists accessing genetic resources for non-commercial purposes under the international ABS regime, to avoid burdens and obstacles. At the same time many parties were concerned that special treatment for research could create loopholes in the system of ABS compliance to the detriment of countries providing genetic resources.62 The result of these conflicting interests is the compromise reached in Article 8.a of the Nagoya Protocol. The rationale of this provision is to create legislative conditions to promote and encourage research which contributes to conservation and sustainable use of biological diversity, i.e., to the first and second objective of the CBD. To this end, Article 8.a of the Nagoya Protocol singles out the adoption of simplified measures to access genetic resources for non-commercial purposes as a tool to promote and encourage this research. Other tools are possible as well, but legislation in provider countries, if adopted, ‘shall’ provide for simplified measures to access genetic resources for non-commercial research that contribute to conservation and sustainable use of biological diversity. Moreover, when such simplified procedure is adopted in drafting national ABS legislation, it needs to take into account and define the issue of ‘change of intent.’ Nevertheless, some crucial concepts in this provision still need to be clarified through practice or further legislative development: where does the limit between commercial and non-commercial research lay? How to demonstrate that research is aimed at the conservation and sustainable development of biodiversity? And how to identify a change of intent? In particular the definition of research activities pursuing non-commercial objectives at the point of access in provider countries and, therefore, falling under the simplified access procedure for non-commercial purpose in the Nagoya Protocol,63 still needs to be clarified. Non-commercial research is usually understood as publicly available, determined by non-commercial intentions and not generating monetary benefits for profit or personal gain, while commercial research is intended as characterised by restrictive access, generating market products, benefiting the users and generating monetary benefits.64 The problem is that, in most situations, when accessing the  Buck and Hamilton, “The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation to the Convention on Biological Diversity,” 59; Evanson C. Kamau, Bevis Fedder and Gerd Winter, “The Nagoya Protocol on Access to Genetic Resources and Benefit Sharing: What is New and what are the Implications for Provider and User Countries and the Scientific Community?” Law, Environment and Development Journal 6 (2010): 256. 63  Nagoya Protocol Article 8.a. 64  CBD Group of Legal and Technical Experts on Concepts, Terms, Working Definitions and Sectoral Approaches, “Concepts, Terms, Working Definitions and Sectoral Approaches Relating to the International Regime on Access And Benefit-Sharing – Submission from 62

414   Tom Dedeurwaerdere et al. materials, there cannot be a clear-cut separation between commercial and non-commercial research activities with the same material, or with the genetic information derived from that same material, because this distinction might arise at a later stage. At the time of accession it is not possible to foresee any possible future commercial implication, therefore the materials is usually accessed with no commercial intent. To analyse the regulation of the scientific research commons under the Nagoya Protocol, we contrast two options for defining utilisation for noncommercial research and discuss the implications of these two options for the scientific research commons. A first option is to consider as non-commercial utilisation all research activities that are in the exploratory phase of research, which is defined here as all research activities that do not involve the sale of a genetic resource, its components or derivatives for profit-making purposes; and whose research results remain in the public domain. Both basic and applied research activities, research and development, and research on subsequent applications would fall under such a definition. Any exercise of exclusive ownership rights, such as intellectual property rights, would be considered as commercial utilisation under this first option, as this would take the research results out of the public domain. Therefore, under this option, non-commercial research would cover research with materials and their components, including the genetic components, only under the conditions that no exclusive ownership rights are claimed on these materials and components, as a way to foster unrestricted access, use and re-use of these materials during the exploratory phase of research. An example of such an approach can be found in the national legislation of South Africa.65 In 2009, the South African government amended its 2004 Biodiversity Act and introduced a distinction between the ‘discovery phase’ and the ‘commercialisation phase’ of bioprospecting. As such, this amendment acknowledges the unpredictability of the scientific process and allows for benefit-sharing agreements to be made at a later stage in the research process, once results are clearer and potential value is easier to evaluate. The ‘discovery phase’ now only requires a notification to be made to the relevant minister, while prospective ‘commercial users’ need to apply for a permit, the international workshop on the topic of ‘Access and Benefit-sharing in Non Commercial Biodiversity Research’, Bonn, 17–19 November 2008,” (29 November 2008) UN Doc UNEP/CBD/ABS/GTLE/1/INF/2; CBD Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing, “Report of the Meeting of the Group of Legal and Technical Experts on Concepts, Terms, Working Definitions and Sectoral Approaches,” (12 December 2008) UN Doc UNEP/CBD/WG-ABS/7/2. 65  Brendan Coolsaet et al., Study for the Implementation in Belgium of the Nagoya Protocol (unpublished, 2012).

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linked to a benefit-sharing agreement, before entering in the ‘commercialisation phase.’66 The public domain conditions considered in this first option are typically satisfied in the case of publicly accessible gene banks for plant, microbial or animal genetic resources, which are directly funded by the government or which are maintained as public research infrastructures for depositing materials or data related to the scholarly publication process. One example analysed in this chapter is the case of the public microbial culture collections that are members of the World Federation for Culture Collections, which are formally organised to acquire, conserve and distribute microorganisms and information about them to foster public research and education. Another example, in the field of data, is the International Nucleotide Sequence Database Collaboration, which stores, on a public database, all the genetic sequences that have to be deposited prior to any scholarly publication on that sequence. A second option would be to consider as utilisation of genetic resources, for non-commercial research only, the research activities at the stage of basic research, which would generate no monetary benefits for profit or personal gain (such as through the sale of services, for example), and whose research results remain in the public domain. Activities at the research and development stage and activities leading to the development of subsequent applications are considered as commercial under this option. Basic research activities conducted in a private company would also be excluded from noncommercial utilisation. Many of the options proposed or adopted for the implementation of the Nagoya Protocol provision on non-commercial research67 are a variation or a combination of these two basic options.68 For example, in Brazil, the Genetic Patrimony Management Council, responsible for granting access to the country’s genetic resource, established a list of the types of research and scientific activities exempted from access requirements.69 In Australia, access for non-commercial purposes such as taxonomy is free, while the permit fee

 South Africa, National Environment Laws Amendment Act No. 14 of 27 May 2009, Sections 29 and 38–39. 67  Nagoya Protocol Article 8.a. 68  Brendan Coolsaet et al., Study for the Implementation in Belgium of the Nagoya Protocol (unpublished, 2012). 69  Juliana Santilli, “Brazil’s Experience in Implementing its ABS Regime – Suggestions for Reform and Relationship with the International Treaty on Plant Genetic Resources for Food and Agriculture,” in Genetic Resources, Traditional Knowledge & the Law. Solutions for Access & Benefit Sharing, eds. Evanson Kamau and Gerd Winter (London: Earthscan, 2009), 187. 66

416   Tom Dedeurwaerdere et al. for commercial purposes is AUD $ 50.70 In Costa Rica, biodiversity related research conducted in public universities has been left out of the ABS law’s scope, except if it has commercial purposes.71 However, not all of these combinations of the options used for defining the notion of non-commercial would allow preserving the practices of the plant genetic resources for food and agriculture and microbial collections that were surveyed above. In particular, under the second option described above, any distribution for purposes other than basic research of material that was legally acquired from a provider country would not fall under noncommercial use and, therefore, require to re-negotiate the mutually agreed terms with the provider country, even if there is no intent of commercialisation of the genetic resource itself, its components or derivatives. This would also apply to the utilisation of genetic sequence data at the research and development stage even if it would have been deposited on a public database. In contrast, under the first option, such downstream uses under public domain-like conditions would be allowed and considered as part of the exploratory phase of research. Some of the existing practices within the scientific research commons already share, on an informal basis, the rationale of the first option for defining the non-commercial use provision of the Nagoya Protocol. On the one hand, the above-described survey shows that under current circumstances, only a limited number of researchers from the provider countries ask for restrictions on the downstream uses of the deposited materials, and this is confirmed in the microbial sector also in cases of developing countries: about 80–100% of the acquisitions in the surveyed collections came without any conditions. On the other hand, they promote rapid and easy access to genetic resources for research purposes, while organising non-commercial benefitsharing through promoting a global publicly accessible research infrastructure and a set of bilateral capacity-building efforts with developing country collections. For example, as we saw in the case of the microbial collections, the practice of the microbial sector is very much supportive of distributing genetic resources without impairments, thereby also contributing to uses of these resources by depositors from the countries of origin providing the resources that often do not have the capacity for long-term storage of these resources. However, as explained above, these benefit-sharing arrangements are often incomplete or based on informal arrangements between researchers  Geoff Burton, “Australian ABS Law and Administration. A Model Law Approach?” in Genetic Resources, Traditional Knowledge & the Law, eds. Kamau and Winter, 271–310. [See also contribution by Burton to this volume (Chapter 10).] 71  Costa Rica, Biodiversity Law No 7788 of 30 April 1998, Article 4. [See also contribution by Cabrera to this volume (Chapter 11).] 70

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from the provider countries and culture collections. Therefore, a further formalisation of these initiatives is needed. The main contribution, in this context, of the Nagoya Protocol’s provision on simplified procedure to access materials for non-commercial purposes72 is that it can potentially clarify, when further specified in national legislation, under what non-commercial use conditions facilitated access would be granted. However, to make the Nagoya Protocol and the scientific research commons mutually supportive, the implementation of a proper simplified access procedure for non-commercial research, though certainly an important building block, will not be sufficient if it only covers the set of activities contemplated under Nagoya Protocol Article 8.a – that is, the activities in the scientific research commons that contribute to biodiversity conservation and sustainable use. An additional option for governing the research commons under the Nagoya Protocol would be, therefore, to implement the facilitated access procedure for all non-commercial research with genetic resource, not only limited to biodiversity research, in combination with a set of up-front nonmonetary and monetary benefits, such as support for capacity building for research with the genetic resource in the provider country, preferential access to the research results and to the genetic material conserved in ex-situ collections, training for the use of the genetic sequence databases and the provision of technical services. 2.  Possible Future Research-related Developments of the Nagoya Protocol The Nagoya Protocol contains possible future scenarios73 for collaboration on the management of genetic resources and for benefit-sharing, which might possibly also apply to some areas of activities of the research commons. The Protocol obliges parties to consider the need for, and modalities of, a global multilateral benefit-sharing mechanism to address the fair and equitable sharing of benefits derived from the utilisation of genetic resources and associated traditional knowledge that occur in transboundary situations, or for which it is not possible to grant or obtain prior informed consent.74 Moreover, the Protocol prescribes an obligation to collaborate in cases where the same genetic resources are found in situ within the territory of more than one Party, with a view to implementing the Protocol.75

 Nagoya Protocol Article 8.a.  Nagoya Protocol Articles 10 and 11. 74  Nagoya Protocol Article 10. 75  Nagoya Protocol Article 11. 72 73

418   Tom Dedeurwaerdere et al. a.  Global Multilateral Benefit-sharing Mechanism The language of the Protocol, when referring to the global multilateral benefit-sharing mechanism, is very vague and the result of compromise:76 it provides for a procedural obligation on Parties to ‘consider the need for and modalities of a global multilateral benefit-sharing mechanism’77 and not for a compulsory setting up of such mechanism. The eventual mechanism, therefore, would likely be only voluntary and complementary to the Nagoya Protocol. Moreover it would be multilateral, not bilateral. The crucial issue of this provision is national sovereignty: it focuses on cases where sovereignty is not clear or difficult to be addressed. In order to avoid excessive costs of tracking, therefore, a global mechanism is to be established in the future. The scope of the provision can be interpreted narrowly or extensively. In the wider sense, it might re-open the issue of the temporal or geographical scope of the Protocol; whereas in the narrow sense, it could address genetic resources that are in user countries’ jurisdiction but of unknown origin or legal status, or even to cover materials in ex-situ collections that were collected after the entry into force of the CBD but before the entry into force of the Nagoya Protocol.78 It is important to underline that the benefits shared through this mechanism must be used to support the conservation of biodiversity and the sustainable use of its components globally. This means that the benefit-sharing is not going to the provider or providers. This could represent a disincentive for countries to build up such a mechanism. The very first reflections on this mechanism in 201179 did not find any agreement on two basic questions: if the mechanism is needed and how it would be articulated. However, a consistent opinion was expressed in favour of a step-by-step approach to build up a flexible instrument. Agreement was expressed in recognising that the mechanism is meant to be complementary to the system based on prior informed consent and mutually agreed terms – not an alternative to it.80 It can be argued that the concept of transboundary situations applies to scientific research commons when accessed in-situ, but they have become de facto transboundary research resources based on the need to share resources amongst many researchers in transboundary situations. For example, in  Buck and Hamilton, “The Nagoya Protocol,” 59.  Nagoya Protocol Article 10. 78  Buck and Hamilton, “The Nagoya Protocol”, 60. 79  Morten W. Tvedt, A Report from the First Reflection Meeting on the Global Multilateral Benefit-Sharing Mechanism (Oslo: Fridtjof Nansen Institute, June 2011), accessed 4 March 2012, http://www.fni.no/abs/publication-47.html. 80  Ibid. 76 77

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case of microbial genetic resources, taxonomic type strains always have to be deposited in two different collections in two different countries upon publication. b.  Transboundary Cooperation The Nagoya Protocol81 prescribes collaboration in cases where the same genetic resources are found in-situ within the territory of more than one Party, with a view to implementing the Protocol. As in the case of the provision on the global multilateral benefit-sharing mechanism, the language is vague: there is no definition of what the ‘same’ genetic resources mean. In the context of scientific research commons, the case of the same genetic resource found in two countries would be the case of plants only (characterised by great genetic stability), and not of microbial strains (most strains within a same species are not exactly the same, and small genetic differences lead to different properties because of the relatively small size of the genome of a microbe) and animals (different individuals within a breed). Therefore the article probably also has a very restrictive scope for the design of access agreements for research purposes. As opposed to the global multilateral benefit-sharing mechanism, where benefits do not go to the individual country, the issue is left open in the case of transboundary cooperation. If, however, a similar approach to that for the multilateral mechanism would be adopted through interpretation also for transboundary cooperation – that is, benefits from transboundary cooperation would only be devoted to conservation and sustainable use globally – this would probably decrease the incentive for countries to start negotiating further details on cooperation in transboundary situations of access to and utilisation of genetic resources. c.  Best Practices, Guidelines and Standards in Relation to Access and Benefit Sharing Agreements for Research with Public Knowledge Assets The results of our analysis in this chapter demonstrate that a strict differentiation between commercial and non-commercial research intent does not correspond to how science commons are organised. Many research activities are conducted under public domain-like conditions (without any ownership claims that would restrict access and use of the research results and basic research materials) and it is often difficult to clearly separate uses of public resources with a commercial intent and uses with non-commercial intent. Therefore, as explained above, further work on the overall implementation of the Nagoya Protocol will be needed to build a regime that will be supportive of the scientific research commons that organises research under  Nagoya Protocol Article 11.1.

81

420   Tom Dedeurwaerdere et al. public domain-like conditions and underpins much of the contemporary biodiversity-related research in the public section organisations that were surveyed in this chapter. A possible contribution would be to further strengthen our proposition of a broad interpretation of the notion of non-commercial research under the Protocol,82 by exploiting the Nagoya Protocol provision calling on Parties to encourage, develop and use guidelines and best practices.83 Such recog­ nised best practices could crystallize agreement amongst stakeholders about standardised licence conditions for access to genetic resources for research purposes under mutually agreed terms, which could contribute to the periodical stock-taking by the Protocol governing body.84 Best practices could, for example, specify a minimal set of clauses to be included in the contracts, while leaving sufficient flexibility to adapt a contract to the various research specific contexts.

V.  Conclusion Sharing of basic research assets in so-called scientific research commons has proven key to research contributing to the conservation and sustainable use of biodiversity, and in the life sciences more generally. As a result, in practice, many research assets are accessed and exchanged under public domain-like conditions. This chapter aimed to show that it is possible to build upon these practices in the implementation the Nagoya Protocol, so as to ensure that this implementation is supportive both of the scientific research commons and the objective of fair and equitable access and benefitsharing. In particular, we showed that this is possible by further building upon the standard contracts for the access of public research assets that are currently in use in many areas of the scientific research commons, by adopting a broad interpretation of the notion of non-commercial research under the Protocol85 in combination with appropriate benefit-sharing conditions for capacity building and technical services with basic research assets in the provider countries. In addition, to take this vision forward, this chapter discussed three institutional options for building standardised ABS approaches in global research commons. In the current context of the development of national ABS legislation under the Nagoya Protocol, the most feasible institutional option, in the short term, is to build framework agreements between  Nagoya Protocol Article 8.a.  Nagoya Protocol Article 20.1. 84  Nagoya Protocol Article 20.2. 85  Nagoya Protocol Article 8.a. 82 83

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willing governments that would establish such a common position,86 based on mutually agreed terms, and thereby put the self-regulatory practices of the science communities on more solid legal and institutional ground.

 [See discussion of bilateral agreements in the context of the implementation of the Protocol in the contribution by Young in this volume (Chapter 15).]

86

Chapter 14.  The Role of Private International Law under the Nagoya Protocol Claudio Chiarolla* Until the adoption of the Nagoya Protocol there was no private international law of access and benefit-sharing (ABS). Likewise, the literature on this topic is virtually non-existent. The objective of this chapter is thus to analyse the role of private international law under the Nagoya Protocol. In particular, it will set forth possible options for implementing ABS measures concerning the Nagoya Protocol’s provisions on: jurisdictional issues; the law applicable to ABS obligations of contractual as well as non-contractual nature; and the recognition and enforcement of foreign judgments and arbitral awards in the context of ABS-related disputes. This paper concludes by comparing a narrow vis-à-vis an extensive interpretation of the Protocol’s provisions relevant to private international law. Such comparison will help clarify the institutional capacities that may be required for implementing the relevant Protocol’s obligations. In particular, the narrow interpretation of the Protocol’s private international law-related provisions suggests that the latter should not be expected to play an important role in countering bio-piracy and – more generally – in the implementation of the Protocol. However, private international law would still be accorded a certain prominence as a tool for resolving disputes that concern compliance with contractual ABS obligations. On the contrary, the extensive interpretation of such provisions indicates that private international law can play a prominent role in relation to all compliance-related obligations under the Nagoya Protocol. Consequently, * Research Fellow on International Governance of Biodiversity at Institut du développement durable et des relations internationales (Iddri) Paris. The author wishes to thank Matthias Buck, Veit Koester, Jimena Nieto Carrasco, Gerry Maher, and Pierre Barthélemy for their invaluable feedback. The author also wishes to thank the organisers and the participants in the workshop “The 2010 Nagoya Protocol on Access and Benefit-sharing: Implications for International Law and Implementation Challenges”. Any remaining mistakes are the sole responsibility of the author, who may be contacted at the following email: claudio [email protected].

424   Claudio Chiarolla the capacity development strategy for the Nagoya Protocol should provide for strengthening the institutional capacities that are necessary to resolve questions of jurisdiction, applicable law, and recognition and enforcement of foreign judgments and arbitral awards, both in the context of contractual as well as non-contractual ABS disputes.

I.  An Introduction to the Intersection between International Environmental Law and Private International Law At the outset, it is useful to explain the reasons and extent of the intersection between international environmental law and private international law. When a legal dispute concerns cross-border relationships, private international law intervenes to regulate private relationships across national borders. For instance, private international law is particularly important in the field of international commercial transactions, where it helps providing a predictable legal framework for the parties that undertake contractual obligations. On the other hand, international environmental law encompasses ‘the entire corpus of international law, public and private, relevant to environmental issues or problems.’1 Therefore, there can be a remarkable scope of interaction between these two bodies of law including, for example, in the case of non-contractual obligations arising out of environmental damage.2 Besides, in the field of sustainable development treaties, such and the Convention on Biological Diversity (CBD) and its Nagoya Protocol, economic development concerns are as prominent as those for environmental protection. Since private entities and individuals play an important role in economic activities, which – in return – have an impact on the environment, the interaction between international environmental law aiming at sustainable development and private international law is even broader than it could be expected. This is because both contractual as well as non-contractual aspects of the relationship between two or more parties may constitute the subject matter over which competing legal formants exercise their influence with the view to producing sustainable development outcomes by shaping the law.3 While  Patricia Birnie and Alan Boyle, International Law and the Environment, (Oxford: Oxford University Press, 2nd edn, 2002), 1–2. 2  See, for instance, Regulation (EC) No. 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable to non-contractual obligations (Rome II), Article 7. 3  On the concept of legal formants, see Pier Giuseppe Monateri, “Legal Formants and Competitive Models: Understanding Comparative Law from Legal Process to Critique in Cross-System Legal Analysis” (17 December 2008), accessed 3 June 2012, http://ssrn.com/ abstract=1317302: ‘The theory of legal formants, also known as the dynamic approach to 1

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some of these aspects are prominently linked to private international law, others are only marginally linked to it, such as questions concerning access to justice or the respect of national sovereignty while promoting compliance with international obligations. However, they all raise interesting points for reflection and – jointly with the analysis of the most fundamental private international law questions for ABS policy-makers (and -takers) – allow this chapter to contribute to an increased understanding of the current evolution of the ‘international ABS regime’ under the Nagoya Protocol. Until the adoption of the Nagoya Protocol, one may safely argue, there was no private international law of ABS.4 Whether and the extent to which the Nagoya Protocol enshrines obligations that would require Parties to establish a private international law framework for ABS, in particular, in relation to compliance issues, is an open question. Such question per se was never openly considered before by scholars.5 Besides, with the exception of a few submissions tabled at the meeting of the CBD Group of Technical and Legal Experts on Compliance,6 only incidentally – and not in a comprehensive manner – was the role of private international law discussed during the ABS negotiations. In particular, the attention has focused on private international law in connection with the elaboration of Article 18 of the Protocol on ‘Compliance with mutually agreed terms.’ This is not surprising, despite its comparative law, focuses on law as a social activity: a formant of the Law is a group, a type of personnel, or a community, institutionally involved in the activity of creating Law.’ 4  For an synthetic explanation of the background to the negotiations of the Nagoya Protocol see, for instance, Claudio Chiarolla, Intellectual Property, Agriculture and Global Food Security: The Privatisation of Crop Diversity (Cheltenham: Edward Elgar, 2011): 134–137. 5  However, on private international law-related questions see, for instance, Christine Godt, “Enforcement of Benefit-Sharing Duties in User Countries” in Genetic Resources, Traditional Knowledge and the Law – Solutions for Access and Benefit Sharing, ed. Evanson C. Kamau and Gerd Winter (London: Earthscan, 2009); 419–38; and Hiroji Isozaki, “Enforcement of ABS Agreements in User States” in Genetic Resources, Traditional Knowledge and the Law, eds. Kamau and Winter (London: Earthscan, 2009): 438–54. 6  The Group of Technical and Legal Experts on Compliance in the context of the International Regime on Access and Benefit-sharing met from 27 to 30 January 2009, in Tokyo, Japan. See the submissions from Canada, in CBD Group of Technical and Legal Experts on Compliance in the Context of the International Regime on Access and Benefit-Sharing, “Compilation of Submissions by Parties, Governments, International Organisations, Indigenous and Local Communities and Relevant Stakeholders on Compliance in the Context of the International Regime on Access and Benefit-Sharing,” (19 December 2008) UN Doc UNEP/CBD/ABS/GTLE/2/2, 5–9 and Japan, in CBD Group of Technical and Legal Experts on Compliance in the Context of the International Regime on Access and Benefit-Sharing, “Compilation of Submissions by Parties, Governments, International Organisations, Indigenous and Local Communities and Relevant Stakeholders on Compliance in the Context of the International Regime on Access and Benefit-Sharing,” (21 January 2009) UN Doc UNEP/CBD/ABS/GTLE/2/2/ADD1.

426   Claudio Chiarolla overarching implications for the functioning and balance between the three pillars of the Protocol (i.e., access to genetic resources and traditional knowledge, benefit-sharing and compliance with domestic ABS requirements). In particular, it seems that Parties have preferred not to open this Pandora’s Box in Nagoya, especially in light of the many other outstanding issues that had to be solved in the negotiations.7 However, the current focus on early ratification and entry into force of the Nagoya Protocol and the consequent attentional shift from international negotiations to domestic implementation, require an increased understanding of ABS issues among governments, stakeholders and the general public. Therefore, the objective of this chapter is to analyse the role of private international law under the Nagoya Protocol. In particular, it will set forth and consider possible options for implementing ABS measures concerning the Nagoya Protocol’s requirements on: jurisdictional issues; the law applicable to ABS obligations of contractual as well as non-contractual nature;8 and the recognition and enforcement of foreign judgments and arbitral awards. Besides, this analysis will help clarify the institutional capacities that may be required for implementing the above options. For the purpose of this analysis, it is useful to define some basic concepts and expressions in a conventional manner. In accordance with the CBD, ABS generally refers to the following two issues: the way in which genetic resources and traditional knowledge may be accessed; and how the benefits that result from their use are shared between the people or countries using such resources and knowledge, on the one hand, and the people or countries that provide them, on the other hand. In accordance with CBD Article 15, the Nagoya Protocol reiterates that, as a general rule, ABS shall be subject to the prior informed consent (PIC) of the provider country ‘that is the country of origin of such resources or a Party that has acquired the genetic resources in accordance with the Convention, unless otherwise determined by that Party.’9 This formulation conveys the idea that the provider country shall be a ‘qualified’ or ‘legitimate’ provider. Therefore, the PIC is the permission given by the competent national authority of a ‘legitimate’ provider country to a user prior to accessing genetic  Claudio Chiarolla, Lucien Chabason and Raphaël Billé, “COP 10 in Nagoya: a success for global biodiversity governance?” IDDRI Synthèses 6 (2010), and Claudio Chiarolla, “Making Sense of the Draft Protocol on Access and Benefit Sharing for COP 10,” IDDRI Idées pour le débat 7 (2010). 8  In accordance with Rome II Article 2.1, the concept of ‘non-contractual obligations’ refers to ‘damage [which] shall cover any consequence arising out of tort/delict, unjust enrichment, negotiorum gestio or culpa in contrahendo.’ Besides, such concept may also cover noncontractual obligations arising out of strict liability. See Rome II Preamble paragraph 11. 9  Nagoya Protocol Article 6.1. 7

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resources, in accordance with the applicable national legal and institutional framework. The Protocol also reiterates that the ‘benefits arising from the utilisation of genetic resources as well as subsequent applications and commercialisation’ shall be shared with the provider country ‘upon mutually agreed terms.’10 Therefore, mutually agreed terms (MAT) are the agreement reached between the provider of genetic resources and the user of such resources on their conditions of access and use, and on the benefits to be shared between both parties. Besides, when it is not capitalised, the term ‘parties’ refers to the parties of an ABS agreement. Therefore, between such parties there is a contractual relationship that is regulated by the MAT. On the other hand, when the term ‘Parties’ is capitalized, it refers to the State Parties to an international treaty, namely, the Nagoya Protocol and/or the CBD. Dutfield explains that the term biopiracy is generally used to ‘describe the ways that corporations from the developed world claim ownership of, free ride on, or otherwise take unfair advantage of, the genetic resources and traditional knowledge and technologies of developing countries.’11 Claims of bio-piracy against companies have focused on the lack of appropriate steps to ensure that: •  the PIC is obtained from the country of origin of generic resources or from the legitimate holders of traditional knowledge; •  benefits are shared from the commercialisation of products derived from such resources or traditional knowledge; and •  patents are not illegally granted for knowledge and over resources in violation of prior legal rights of sovereign countries and/or indigenous and local communities. Within the purview of what is generally termed as biopiracy, the two more specific concepts of ‘misappropriation’ and ‘misuse’ of genetic resources and/or traditional knowledge have emerged. Neither the CBD nor the Protocol defines these concepts. However, it can be useful to distinguish them on the basis of working definitions.12 On the one hand, ‘misuse’ of genetic  Nagoya Protocol Article 5.1.  Graham Dutfield, “What is biopiracy?” (paper presented at the International Expert Workshop on Access to Genetic Resources and Benefit Sharing, Cuernavaca, Mexico, October 24–27, 2003). 12  As regards relevant national-level ABS legislation, for instance, the Act of 19 June 2009 No. 100 Relating to the Management of Biological, Geological and Landscape Diversity of Norway (Norway, Nature Diversity Act, No. 100, 2009) contains provisions on the enforcement by the Norwegian state of the PIC requirements of provider countries. In particular, section 60.1 of the Nature Diversity Act states: ‘The import for utilisation in Norway of 10 11

428   Claudio Chiarolla resources and traditional knowledge may be generally understood as a use that violates the MAT between the user and the provider(s) or holder(s) of such resources and knowledge. Therefore, in cases of misuse, the assumption is that there is a contractual relationship between the parties. Thus, the responsibility that arises from the breach of the MAT derives from a contractual obligation (i.e. non-compliance with MAT).13 On the other hand, ‘misappropriation’ of genetic resources and traditional knowledge could be defined as the appropriation (and subsequent utilisation) of such resources and knowledge, which occurs in violation of the applicable domestic ABS legislation or regulatory requirements of a Party to the Protocol.14 In cases of misappropriation, the assumption is that there is no genetic material from a State that requires consent for collection or export of such material may only take place in accordance with such consent. The person that has control of the material is bound by the conditions that have been set for consent. The state may enforce the conditions by bringing legal action on behalf of the person that set them.’ See Morten W. Tvedt and Ole K. Fauchald, “Implementing the Nagoya Protocol on ABS: A Hypothetical Case Study on Enforcing Benefit Sharing in Norway,” The Journal of World Intellectual Property 14 (2011): 386. Besides, Tvedt also distinguishes situations where genetic material is collected or exported without PIC from situations where PIC has been obtained in the form of a public act, but the terms of such consent are not complied with. See Morten W. Tvedt, Norsk Genressursrett. Rettslige betingelser for innovasjon innenfor bio- og genteknologi (on Norwegian Genetic Resource Law) (Cappelen: Akademisk Forlag, 2010), 148–149. 13  Non-compliance with MAT may occur, for instance, when PIC and MAT are initially obtained for non-commercial research purposes. Subsequently such research may lead to commercial R&D and the user, who is required to conclude a new commercial benefitsharing agreement, refuses or abstains from negotiating such agreement. From the provider’s point of view, ABS arrangements often include a public act (the PIC) – see Nagoya Protocol Article 6.d – i.e., a non-contractual act, which is not concerned by the rules of private international law. However, the ABS agreement that is subsequently established is a private law contract. Therefore, even if a party to the MAT is a public authority, which acts in accordance with its institutional mandate (with regard to the granting of PIC), when such authority concludes an ABS contract, it will act in its capacity as a private law party to the contract. In other words, the conclusion of an ABS contract may not be considered as acta iure imperii. 14  See, for instance: “Submission by the European Union”, in CBD Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing, “Collation of Contributions Submitted by Parties, Governments, International Organisations, Indigenous and Local Communities and Relevant Stakeholders on Compliance, Fair and Equitable Benefit-Sharing,” (8 November 2009) UN Doc UNEP/CBD/WG-ABS/8/6/Add.4, which states that ‘Misappropriating genetic resources means to acquire, either intentionally or negligently, genetic resources in violation of applicable domestic legislation of a Party that requires prior informed consent and mutually agreed terms for access to its genetic resources.’ See also: “Submission by Switzerland for WG-ABS 9 regarding the need for definitions in the [international regime on] ABS,” accessed 3 June 2012, http://www.cbd.int/abs/submissions/abswg-09-switzerland-en .pdf, which defined ‘Misappropriation of genetic resources’ as ‘access to genetic resources without prior informed consent and/or mutually agreed terms pursuant to the national access legislation of the country providing the genetic resources and the access provisions

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contractual relationship between the user(s) of genetic resources and traditional knowledge and the Competent National Authority(ies) of the provider country and/or the legitimate provider(s) or holder(s) of such resources and knowledge. Therefore, the responsibility that arises from the breach of applicable domestic ABS legislation or regulatory requirements derives from noncontractual obligations (i.e., non-compliance with domestic ABS legislation or regulatory requirements). The definition of misappropriation that is used in this paper reflects a narrow interpretation of such concept. This interpretation appears to be in line with the obligations to ‘address situations of non-compliance’ under Articles 15 and 16 of the Protocol. However, it is fully acknowledged that some Parties have argued that in the absence of domestic ABS legislation, the question of the direct applicability of the Nagoya Protocol and the CBD at the national level should be answered in the positive. In the proponents’ view, such direct application would entail the default users’ obligations to obtain PIC and establish MAT, even in the absence of a domestic ABS regulatory framework in the provider country. During the Protocol’s negotiations, this proposition received the support of many developing countries, especially in the African Group, which could face important capacity constraints in the expeditious implementation of a fully functional national ABS system.15 The opposite view is that a Party would need to enact a domestic ABS regulatory framework in order to require PIC and ‘activate’ its right to benefit-sharing. Therefore, in light of Article 6 of the Protocol, which requires Parties that wish to exercise benefit-sharing claims for the use of their genetic resources to articulate this through a domestic ABS framework, as well as of the compliance provisions of Articles 15 and 16 of the Protocol, it appears that the narrow interpretation has eventually prevailed. In the following sections, this paper analyses the key provisions of the Nagoya Protocol that relate to private international law. The employed methodology is to raise and consider key questions of private international law with the view to clarifying its most important implications for implementing set out in the [international regime on] ABS in force at the time of access.’ As regards the misappropriation of traditional knowledge, WIPO submissions define it as ‘any acquisition, appropriation or utilisation of traditional knowledge by unfair or illicit means. Misappropriation may also include deriving commercial benefit from the acquisition, appropriation or utilisation of traditional knowledge when the person using that knowledge knows, or is negligent in failing to know, that it was acquired or appropriated by unfair means; and other commercial activities contrary to honest practices that gain inequitable benefit from traditional knowledge.’ See World Intellectual Property Organisation, “Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore. The Protection of Traditional Knowledge: Revised Objectives and Principles,” (8 April 2005) UN Doc WIPO/GRTKF/IC/8/5, Annex Article 1.2. 15  “A Brief Analysis of Resumed ABS 9,” Earth Negotiations Bulletin 9(527) (2010), 15.

430   Claudio Chiarolla the Protocol. Section I outlines the nature and functions of private international law. Section II considers jurisdictional issues concerning ABS disputes and their relationship with the access to justice requirements of the Protocol. Section III considers identifying the procedural rules that determine the law applicable to the responsibility of natural and legal persons that may arise from contractual ABS obligations (e.g., non-compliance with MAT) as well as from non-contractual ABS obligations (e.g., non-compliance with domestic ABS legislation or regulatory requirements). Section IV considers identifying the procedural rules that the Protocol Parties may apply in order to recognise and enforce foreign judgments and arbitral awards in ABS disputes. Finally, Section V concludes by comparing the narrow interpretation of the private international law provisions of the Protocol vis-à-vis their extensive interpretation with the view to clarifying the institutional capacities that may be required for implementing them.

I.  The Nature and Functions of Private International Law Private international law regulates private relationships of contractual as well as non-contractual nature across national borders when a legal dispute that concerns such relationships has a ‘foreign’ element – i.e., the cross-border dimension of the relationship. In general, it is understood as a set of domestic procedural rules that determine the following three matters: i. the power of the forum court to resolve the dispute (i.e., whether it has jurisdiction) and the conditions under which it may decline to exercise its jurisdiction; ii. the substantive rules of law which are applicable to resolve the dispute (i.e., applicable law); and iii. the ability to recognise and enforce a judgment from an external forum within the jurisdiction of the adjudicating forum (i.e., recognition and enforcement of foreign judgements and arbitral awards).

II.  Jurisdiction and Access to Justice in ABS Disputes In general, rules of private international law are of domestic nature.16 This means that the decision of whether the courts of a particular country have  Dan Jerker B. Svantesson, “The Relation between Public International Law and Private International Law in the Internet Context” (paper presented at Australasian Law Teachers Association Conference, Hamilton, New Zealand, July 2005), 1. However, States have

16

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jurisdiction over a dispute is subject to domestic legislation. Therefore, the question of where to sue for the alleged ‘misappropriation’ of genetic resources and traditional knowledge or for their ‘misuse’ is of fundamental importance, particularly in light of expectations that the chosen forum might assert its jurisdiction over the dispute.17 In the case of contractual disputes, a general rule is that the defendant shall be sued in the courts of the place where such person is domiciled.18 Besides, the parties of an ABS contract19 may include an express jurisdiction clause to specify where they wish to bring suit.20 If a dispute arises on the performance of an ABS contract, the Nagoya Protocol sets out certain obligations for State Parties in accordance with the following terms: Each Party shall ensure that an opportunity to seek recourse is available under their legal systems, consistent with applicable jurisdictional requirements, in cases of disputes arising from mutually agreed terms. Each party shall take effective measures, as appropriate, regarding access to justice [. . .].21

The above provisions do not seem to provide specific guidance on how the courts of the forum should decide whether they have jurisdiction over ABS adopted international or regional instruments for cooperating on jurisdictional matters. For instance, in Europe, see Council Regulation (EC) No. 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, which entered into force on 1 March 2002 and repealed the Brussels Convention (Convention of 27 September 1968 on Jurisdiction and the Enforcement of Judgments in Civil and Commercial Matters); and the Lugano Convention (Convention of 16 September 1988 on jurisdiction and the enforcement of judgments in civil and commercial matters), which applies to Member States of the European Free Trade Association (EFTA), i.e., Norway, Iceland, Liechtenstein and Switzerland. See, also, Emily M. Weitzenböck, “Determining Applicable Law and Jurisdiction in contractual disputes regarding virtual enterprises” (proceedings of the 8th International Conference on Concurrent Enterprising: Ubiquitous Engineering in the Collaborative Economy, Rome, Italy, 17–19 June 2000), 27–34. 17  However, as explained at the outset of this paper, situations of 'misappropriation', which are subject to compliance measures under Articles 15 and 16 of the Protocol, are conceptually different from situations of 'misuse' relating to contracts under Article 18. Nonetheless, the above question of jurisdiction is relevant for both cases. See below for further explanations. 18  See, for instance, Council Regulation (EC) No. 44/2001 Article 2. Weitzenböck, “Determining Applicable Law and Jurisdiction in contractual disputes,” 28. 19  In this chapter, the general expression ‘ABS contract’ is equated to the concept of ‘MAT’ in the sense that such terms may be considered, together and a whole, as an ABS contract. 20  Nijar notes that the ‘parties may wish to bring an action for breach of the contract in the jurisdiction of the user. This would especially avoid any problem relating to the recognition and enforcement of judgment if the action was brought in a jurisdiction foreign to the user.’ Gurdial Singh Nijar, The Nagoya Protocol on Access and Benefit Sharing of Genetic Resources: Analysis and Implementation Options for Developing Countries (Geneva: South Centre, 2011), 12. 21  Nagoya Protocol Articles 18.2–3 on ‘Compliance with Mutually Agreed Terms.’

432   Claudio Chiarolla disputes. However, they do establish the duty of Parties to provide for judicial remedies, including access to their courts and tribunal, to nationals of other Parties. Therefore, the ground rule established by the Protocol is that the forum courts, which are seised of a dispute arising from MAT, should assert their jurisdiction unless the complaint is apparently based on dubious jurisdictional grounds (e.g., where none of the parties to the MAT have real connection with the forum).22 Therefore, the expression ‘consistent with applicable jurisdictional requirements’ can be understood as a safeguard clause, which merely suggests that the availability of recourse to courts will depend on the applicable rules on choice of jurisdiction, as established in contracts and accepted by the named court, or in the absence of a contractual clause, by non-contractual private international law rules of the seised forum.23 The issue of ‘access to justice’ is conceptually distinct (and independent) from the question of jurisdiction, However, it is useful to consider the Protocol’s ‘access to justice’ requirements in parallel with the latter, since in practice both issues contribute to determine whether ‘an opportunity to seek recourse is available’ under the legal systems of a Protocol Party.24 Some authors have argued that since the Protocol’s reference to ‘access to justice’ is inspired by the Aarhus Convention,25 it follows that the standards of the  See the submission of Canada, in UNEP/CBD/ABS/GTLE/2/2, 7, which states: ‘Common law courts in Canada have jurisdiction when the defendant is present in the forum. They also have jurisdiction where there is a real and substantial connection between the contract and the forum. Examples of real and substantial connection to the forum are found in the rules of court in the common law provinces permitting the service of defendants outside the territory of the forum and also in the jurisprudence. In addition, British Columbia and Saskatchewan adopted the Uniform Law Conference of Canada’s Court Jurisdiction and Proceedings Transfer Act that provides a list of presumptive real and substantial connections to the forum’, emphasis added. Interestingly, the Court Jurisdiction Act (Canada, Court Jurisdiction and Proceedings Transfer Act [SBC 2003, c. 28], 29 May 2003) section 10.i.i provides that a real and substantial connection between British Columbia and the facts on which a proceeding is based is presumed to exist if the proceeding concerns, inter alia, ‘a claim for an injunction ordering a party to do or refrain from doing anything in British Columbia.’ 23  See the submission from the European Community and its Member States, in UN Doc UNEP/CBD/ABS/GTLE/2/2, 21. 24  Nagoya Protocol Article 18.2. 25  See United Nations Economic Commission for Europe Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters Article 9.3. In particular, Koester notes that ‘Article 9 on Access to Justice [. . .] provides for a review procedure before a court of law or another independent and impartial body established by law to safeguard the rights afforded in the Convention. The procedures shall, inter alia, provide adequate remedies, including injunctive relief as appropriate, and be fair, equitable, timely and not prohibitively expensive.’ The author also emphasises that 22

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latter may need to be applied in order to facilitate such access, including access to legal aid in an inexpensive manner.26 However, on the one hand, it should be stressed that a legal obligation to respect the ‘access to justice’ standards of the Aarhus Convention may exist only in the context of the relationships between State Parties and the citizens of other State Parties. On the other hand, such obligation would only amount to a (rather strong) moral or ethical prescription in the context of the relationship between State Parties and non-parties or the citizens of non-parties. As the European Union and its Member States noted the notion of ‘access to justice’ is underpinned by social equity issues, which look beyond purely procedural matters. This is to address the concerns of some Parties as to the high costs of litigating, especially in a developed country. In this regard the Hague Conference has adopted a Convention on International Access to Justice (24 Parties), which provides that nationals of any Contracting State shall be entitled to legal aid for court proceedings in civil or commercial matters on the same conditions as if they were nationals. . . . the Convention on Civil Procedures (45 Parties) also has provisions on legal aid.27

Indeed, one of the most important constraints that limits the utilisation of the tools, provided for by the above Conventions, is their small number of state Parties. Besides, the effectiveness of the provisions of Article 18 of the Nagoya Protocol (on compliance with MAT) has to be reviewed by the Protocol governing body (the COP/MOP) four years after its entry into force.28 Such review process may provide an opportunity to pursue establishing an ABS ombudsman along the lines indicated by a proposal tabled during the Protocol’s negotiations.29 ‘the scope of [the above provision of the Protocol] is unclear. This is because it is not specified whether such expression [i.e., ‘access to justice’] will also cover access to legal aid, which is a relevant matter since most often it will be the Party granting access to genetic resources and traditional knowledge that will be the weaker Party.’ See Veit Koester, “The Nagoya Protocol on ABS: Ratification and Implementation Challenges for the EU and its Member States,” IDDRI Studies 3 (2012), section 5. 26  Nijar “The Nagoya Protocol,” 13. 27  See the submission from the European Community and its Member States, in UNEP/CBD/ ABS/GTLE/2/2, 21. 28  Nagoya Protocol Article 18.4. 29  Nijar, “The Nagoya Protocol,” 13. The text proposed by the African Group for establishing an ombudsman states that: ‘The International Regime on ABS shall establish an international ABS ombudsman’s office. The ombudsman’s office shall be responsible for provider countries, indigenous and local communities to identify breaches of their rights and to provide aid in seeking fair and equitable resolution of disputes. The ombudsman’s office shall be empowered to take action on behalf of indigenous and local communities through the binding Dispute Resolution Mechanism. The ombudsman’s office shall also where necessary

434   Claudio Chiarolla Thus, at least in general terms, the Protocol enshrines basic principles for determining jurisdiction and access to justice standards in relation to contractual disputes that arise from MAT. However, while compliance with domestic ABS legislation or regulatory requirements must be provided under Articles 15 and 16 of the Protocol, these provisions are silent on jurisdiction and access to justice standards in cases of non-contractual disputes on ABS. Parties have the duty to cooperate in cases of alleged violation of domestic ABS legislation or regulatory requirements.30 Besides, they have the obligation to take appropriate, effective and proportionate measures to address situations of non-compliance with the user measures that are referred to in relation to ABS for genetic resources,31 ABS for traditional knowledge32 and providing information at designated checkpoints.33 Thus, it can be argued that the above measures would fall short of meeting the requirements of appropriateness, effectiveness and proportionality unless the concerned Parties provide that an opportunity to seek recourse is available under their legal system in cases of disputes arising from non-compliance with such user measures. The specific situation of non-compliance that is referred to above is not direct compliance with the domestic ABS framework of the provider Party, but compliance with the domestic legal, administrative or policy measures taken by a user Party,34 where genetic resources or traditional knowledge are utilised. Under normal circumstances, Parties are expected to enforce their own laws. Therefore, an opportunity to seek recourse should be provided not only for allegations of inaction by a competent body of a user country to apply and enforce the relevant user country measures, but also with the view to providing a remedy to or redress for the violation of such measures by users. On the one hand, this case is different from contractual disputes, where the responsibility to pursue contractual rights rests with the parties to the contract (as well as with any third party beneficiaries). On the other hand, represent indigenous and local communities in proceedings in foreign jurisdiction, take deposition from indigenous and local communities and provide evidence of customary law and practice as and where appropriate.’ See CBD Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing, “Collation of Operative Text including Related Explanations and Rationale Submitted by Parties, Governments, International Organisations, Indigenous and Local Communities and Relevant Stakeholders in Respect of the Main Components of the International Regime on Access and Benefit-Sharing Listed in Decision IX/12, Annex I,” (28 January 2009) UN Doc UNEP/CBD/WG-ABS/7/5, 45. 30  Nagoya Protocol Articles 15.3 and 16.3. 31  Nagoya Protocol Article 15.2. 32  Nagoya Protocol Article 16.2. 33  Nagoya Protocol Article 17.1.a.ii. 34  Nagoya Protocol Articles 15 and 16.

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not only government entities, but also legal persons that sustain the damage, which arises from the violation of a non contractual-obligation, should be provided with access to judicial remedies in the jurisdictions of the Parties. In terms of locus standi,35 the most challenging issue is to provide for a broad entitlement of stakeholders to appear in courts, in particular indigenous and local communities and relevant civil society organisations, while at the same time preventing spurious claims.36 Therefore, the notion of ‘effective’ and ‘appropriate’ measures37 would not be met absent the possibility for foreigners to challenge both the violations of domestic user measures38 and the public authorities’ inaction on their enforcement. Consistently, it may be concluded that the same jurisdictional principles and access to justice standards, which apply to contractual disputes arising from MAT, should be applied, mutatis mutandis, to non-contractual disputes. This would promote consistency and coherence in the general application ABS enforcement standards offered within the jurisdiction of each Party. In particular, even though such disputes are legally and structurally different from eventual disputes that arise under Article 18, relevant standards could be applied to cases of alleged misappropriation of genetic resources and traditional knowledge with the view to promoting the enforcement of relevant user measures.

III.  Applicable Law As mentioned at the outset, the second key function of private international law is to provide the procedural rules to be used by a competent jurisdictional authority for identifying the law applicable to the merits of a dispute. Therefore, the applicable law will determine the substantive rules of law that are applicable to resolve the dispute at stake. For analytical purposes, it is useful to distinguish disputes concerning cases in which MAT have been established (contractual disputes) from cases in which MAT have not been established (non-contractual disputes).

 Locus standi can be defined as the right of a party to bring an action in courts or to be heard in a given forum. 36  Such broad-based entitlements for the locus standi of stakeholders in the context of ABS disputes would provide more transparency than the solution that was eventually implemented in the Multilateral System of the FAO International Treaty on Plant Genetic Resources for Food and Agriculture through the Third Party Beneficiary mechanism. [See contribution by Chiarolla, Louafi and Schloen in this volume (Chapter 3).] 37  Such notion is contained in Nagoya Protocol Articles 15.2 and 16.2. 38  Those that are to be taken under Nagoya Protocol Articles 15 and 16. 35

436   Claudio Chiarolla If the MAT have been established, the following question arises: how should the competent jurisdictional authority identify the law applicable to the MAT? Such a question is important because the resolution of all other questions of contract interpretation – for instance, whether benefits are shared in accordance with the MAT; or how to qualify the nature of acts of ‘misuse’ in violation of the MAT – will depend on the applicable law. Two sub-cases can be identified. Firstly, in the MAT, the parties may have expressly chosen the applicable law by including a choice of law clause. On the one hand, if the applicable law chosen by the parties is the law of the provider (that is the country of origin of the genetic resources or traditional knowledge), the chosen law is normally to be used for interpreting the contract. However, ‘mandatory norms of a law’, other than that of the forum chosen by the parties, can prevent the chosen law from being applied if there is a close link between the contract and the country of that law. This is because, by definition, mandatory norms are imperative provisions of law, which must be applied to an international relationship irrespective of the law that governs the relationship. . . . mandatory rules of law are a matter of public policy (ordre public) and moreover reflect a public policy so commanding that they must be applied even if the general body of law to which they belong is not competent by application of the relevant rule of conflict of laws . . . In matters of contract, the effect of a mandatory rule of the law of a given country is to create an obligation to apply such a rule, or indeed simply a possibility of so doing, despite the fact that the parties have expressly or impliedly subjected their contract to the law of another country.39

On the other hand, if the applicable law chosen by the parties is not the law of the provider, can such law (or some elements of it) still be applied to interpret the MAT? Similarly to the previous case, mandatory norms (in particular, those of the provider country) may apply to the contractual relationship even if the parties have contractually chosen a different applicable law. For instance, this may occur when the parties have disregarded key requirements  Pierre Mayer, “Mandatory Rules of Law in International Arbitration,” Arbitration International 2 (1986): 74–75. On the concept of ordre public see also, for instance, UNCTADICTSD, Resource Book on TRIPS and Development: An authoritative and practical guide to the TRIPS Agreement (New York: Cambridge University Press, 2004), 375, 379 and note 621, which states that: ‘The term ordre public, derived from French law, [. . .] expresses concerns about matters threatening the social structures which tie a society together, i.e., matters that threaten the structure of civil society as such. [. . .] Ordre public encompasses, according to European law, the protection of public security and the physical integrity of individuals as part of society. . . . [It] is a legal expression with a long tradition in the area of international private law, where it serves as a last resort when the application of foreign law leads to a result which would be wholly unacceptable for the national legal order’. See Rainer Moufang, “The Concept of ‘Ordre Public’ and Morality in Patent Law,” in Patent Law, Ethics and Biotechnology, ed. Geertrui V. Overwalle (Brussels: Bruylant, 1998), 71.

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of the ABS law of the provider country that can be regarded as mandatory norms because of their fundamental importance.40 Secondly, the Protocol establishes that its Parties shall encourage providers and users of genetic resources and/or traditional knowledge [. . .] to include provisions in mutually agreed terms to cover [. . .] dispute resolution including [. . .] the applicable law.41

However, providers and users may still avoid choosing the applicable law. In such cases, each different jurisdictional authority may apply the private international law rules of its forum in order to identify the applicable law. Therefore, if a dispute arises, the absence of a choice of law clause creates legal uncertainty with regard to how the contract may be interpreted. The following paragraphs consider the choice of law applicable to the responsibility arising from non-contractual obligations. Such responsibility should arise when the PIC of a provider country is not obtained prior to the utilisation of genetic resources and traditional knowledge, and MAT are not established in accordance with the applicable domestic ABS legislation or regulatory requirements.42 In cases of non-contractual disputes on ABS, the following questions arise: does the Protocol provide for the extraterritorial application of ‘domestic ABS legislation or regulatory requirements of the other party’ and, if so, to what extent?43 In other words, to what extent should the law of a Party, which is entitled to benefit-sharing (e.g., as the  If the law of the provider country were to require that the parties shall compulsorily reference it as the applicable law to the MAT, a different choice of law clause would be against that law. While such violation of the ABS law of the provider country may trigger different remedies, the choice of law requirement per se would unlikely be regarded as a mandatory norm. However, the illegal choice of law clause of the contract would be void. Besides, the contract may still be valid if the deletion of the illegal clause ‘does not defeat the purpose of the broader agreement.’ See “Contract Law” accessed 29 May, 2012, http://law.jrank.org/ pages/12504/Contract-Law.html#ixzz1cMBb6CzB. To put it in another way, a competent jurisdictional authority could deem the contract to be voidable only in part, while applying the law of the provider country for its interpretation. 41  Nagoya Protocol Article 18.1.b. 42  However, the Nagoya Protocol gives Parties, when they act as providers of genetic resources, a discretional choice on whether or not to require PIC from the users of such resources. Obviously, if a providing Party has decided not to make PIC and MAT requirements compulsory for the users, the above responsibility shall not arise. See also the explanations concerning the implicit validity of sovereignty claims vis-à-vis the decision of a Party not to assert its sovereign rights in the form of a compulsory PIC requirement at the end of this section of the present study. Besides, the question of whether the provider country should be a ‘legitimate’ provider (i.e., ‘the country of origin of the genetic resources or a Party that has acquired such resources in accordance with the Convention’) is further considered below. 43  Nagoya Protocol Articles 15.1 and 16.1. 40

438   Claudio Chiarolla country of origin from which the genetic resources or traditional knowledge are misappropriated), be applicable to qualify alleged acts of ‘misappropriation,’ including those which occur in a third country? Finally, what does the expression ‘the other party’ mean in the context of the Protocol’s compliance obligations? The provisions of the Nagoya Protocol that concern compliance with domestic legislation44 state that: ‘Each Party shall take appropriate, effective and proportionate legislative, administrative or policy measures’ to provide that: •  genetic resources utilised within its jurisdiction have been accessed in accordance with PIC and that MAT have been established, as required by the domestic ABS legislation or regulatory requirements of the other Party; and that •  traditional knowledge associated with genetic resources utilised within its jurisdiction has been accessed in accordance with the PIC or approval and involvement of indigenous and local communities and that MAT have been established, as required by domestic ABS legislation or regulatory requirements of the other Party, where such indigenous and local communities are located. As further considered in the conclusions of this paper, there can be two possible interpretations of the role of private international law under the Protocol. With regard to the possible ‘choice of law’ function of the above provisions, a narrow interpretation would predict that the Protocol does not purport developing a private international law of ABS. Therefore, the scope of the Protocol’s private international law-related provisions would be limited to ‘neutral’ references to the inclusion of private international law elements in the MAT (e.g., in the form of jurisdiction and applicable law clauses). A corollary of the above is that such provisions would only refer to elements that can be defined contractually by the parties. However, the Protocol would not directly define the law applicable to users’ responsibilities that may arise from ABS-related obligations of non-contractual nature. In accordance with such narrow interpretation, the private international law clauses of the Protocol would bear implications for users and providers of genetic resources and traditional knowledge under a particular ABS contract. However, the references to the ‘domestic ABS legislation or regulatory requirements of the other party’45 would not constitute choice of law provisions, which may be directly applied in cases of non-contractual disputes. This  Nagoya Protocol Articles 15 and 16.  Nagoya Protocol Articles 15.1 and 16.1.

44 45

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interpretation is consistent with the idea that the Protocol would not establish an obligation to exercise jurisdiction in such disputes. It would only establish the Parties’ general duty to cooperate, ‘as far as possible and as appropriate, [. . .] in cases of alleged violation of domestic ABS legislation or regulatory requirements referred to [. . .] above.’46 It would follow that no question of applicable law would arise, in terms of private international law, with regard to non-contractual ABS obligations. This is because, in accordance with the above-described interpretation, at the domestic level, the Protocol does not explicitly provide for making dispute settlement available to resolve disputes between users of genetic resources (and/or associated traditional knowledge) and alleged right holders in the country of origin.47 However, at the international level, the above interpretation may not exclude that some kind of dispute resolution mechanism be made available to par­ties under the Protocol provision on procedures to address cases of non-­compliance.48 However, the question of the applicable law would only be indirectly relevant in this context, since non-compliance procedures concerns compliance by Parties with their obligations under the Protocol and not compliance by users with the domestic legislation of the provider country. However, the extensive interpretation of the role of the private international law-related provisions of the Protocol may be also legitimately set forth. As emphasised in the previous section, Parties have obligations to take appropriate, effective and proportionate measures to address situations of noncompliance with user measures on ABS for genetic resources,49 ABS for traditional knowledge50 and providing information at checkpoints.51 Aside from the latter,52 the former two provisions define situations of non-compliance by cross-referencing the positive obligations to promote compliance under Articles 15.1 and 16.1 of the Protocol. It was also emphasised above that the required user measures could be deemed not to meet the requirements of appropriateness, effectiveness and proportionality if the concerned Parties do not provide for an opportunity to seek recourse under their legal system in cases of non-compliance with such user measures.

 Nagoya Protocol Articles 15.3 and 16.3.  An EU leading negotiator has highlighted that ‘the wording and negotiating history of the clause seem to point very strongly in the direction of this interpretation.’ Matthias Buck (16/11/2011), personal communication. 48  Nagoya Protocol Article 30. 49  Nagoya Protocol Article 15.2. 50  Nagoya Protocol Article 16.2. 51  Nagoya Protocol Article 17.1.a.ii. 52  The scope of such provision appears to refer specifically to non-compliance with disclosure obligations at checkpoints. 46 47

440   Claudio Chiarolla On the one hand, it is clear that it may be possible to enforce compliance only with relevant user measures, while it is not possible to seek directly the extraterritorial enforcement of domestic ABS legislation or regulatory requirements of a foreign country in their integrity.53 On the other hand, it may be argued that the Protocol, by virtue of its references to ‘the domestic ABS legislation or regulatory requirements of the other Party’, does purport a choice of law rule. Such rule would stipulate that the courts of the forum should give extraterritorial application to the domestic law of a foreign country (e.g., the alleged country of origin) in order to determine the conditions under which a responsibility for non-contractual ABS obligations should arise – i.e., by qualifying the disputed facts in the merit.54 To conclude, in this limited sense, the Protocol appears to provide grounds for the extraterritorial application of the ‘domestic ABS legislation or regulatory requirements of the other Party’ as the law applicable to non-contractual ABS obligations, namely, obligations that require the users of genetic resources and traditional knowledge to obtain PIC and establish MAT. In particular, the responsibility that arises out of acts of misappropriation should be established on the basis of the ABS legislation or regulatory requirements of the other Party that prohibits such acts.55 Besides, it shall be applied to the facts of the case to the extent that the claim of the physical or legal person or community sustaining the damage is based on the above requirements and that a factual connection exists between the misappropriated genetic resources and/or traditional knowledge and ‘the other Party.’ Thus, the meaning of the expression ‘the other Party’ is of pivotal importance, as the criteria to be prescribed for identifying the law applicable to non-contractual ABS obligations may depend on its interpretation. The issues under consideration are as follows: what does the Protocol prescribe concerning the kind of factual connection that would be required in order to trigger the application of law of the claimant’s party to a non-contractual

 For instance, only the remedies and sanctions provided for in the law of the user country could be enforced against the user, while the remedies and sanctions provided for in the law of the provider country could not be applied extraterritorially. 54  Besides, in establishing eventual breaches of domestic measures of a user Party taken under Nagoya Protocol Articles 15 and 16, the question may arise on whether the forum courts should give particular consideration to any legal and factual findings by competent administrative or judicial bodies of ‘the other Party.’ 55  While the term ‘responsibility’ is used here in its general meaning (i.e., ‘the state or fact of having a duty to deal with something [. . . or] the state or fact of being accountable or to blame for something’, see: Oxford Dictionaries Online, accessed 14 February 2012, http:// oxforddictionaries.com/definition/responsibility), this use does not exclude the arising of such responsibility in the context of claims for damages. 53

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ABS dispute? And what does it prescribe in terms of how to assess whether such factual connection is established? The comparative analysis of the Nagoya Protocol Articles 15.1 (compliance with domestic requirements on ABS for genetic resources) and 16.1 (compliance with domestic requirements on ABS for traditional knowledge) can be useful for clarifying what the above factual connection may consist of. At first glance, Article 16.1 is more precise than Article 15.1, because the former states that the domestic ABS legislation or regulatory requirements that are referred to are those of the ‘other Party where [the concerned] indigenous and local communities are located.’ Irrefutably, all Parties have the obligation to take user measures to provide that traditional knowledge associated with genetic resources utilised within their jurisdiction has been accessed in accordance with PIC or approval and involvement of indigenous and local communities and that MAT have been established.56 Therefore, if a claim is brought to court to enforce compliance with such user measures, the Protocol provides that the law that determines whether responsibility arises for the alleged violations is the law of the Party where the concerned indigenous and local communities are located.57 Thus, Article 16.1 of the Protocol appears to provide a basic principle of private international law, which allows Parties to identify the applicable law. Besides, since Article 16 does not establish a distinction between the responsibilities arising from contractual obligations vis-à-vis non-contractual obligations, there is no reason to believe that such private international law principle should not apply to the latter case. The same conclusions apply, mutatis mutandis, to Article 15 of the Protocol, which is almost identical in its structure and purpose (but not subject matter) to Article 16. It is unfortunate that such provision is far less clear than Article 16.1. In particular, Nijar notes that the use of the expression “the other Party” departs from the language used elsewhere in the Protocol (for example in Article 5.1) . . . that the resources accessed must be those that are provided by the countries of origin of such resources or the Parties that have acquired the resources in accordance with the CBD. Concerns have been raised that departing from this CBD formula may countenance biopiracy as the following example shows. Resources may have been accessed illegally from a country of origin X, by another country Y. If a user accesses these from country Y (‘the other Party’) in compliance with the ABS law of country Y, the user country may argue that it does not have to ensure compliance with the ABS requirements of the country of origin X.58

 Nagoya Protocol Article 7.  Nagoya Protocol Article 16.1. 58  Nijar, “The Nagoya Protocol,” 7. 56 57

442   Claudio Chiarolla Therefore, Nijar’s suggestion to adopt a COP/MOP decision that ‘brings this provision in line with. . .the CBD and the other provisions of the Protocol as to the country whose ABS law must be complied with’ may be regarded with some interest.59 However, a leading EU negotiator has strongly disagreed with Nijar on this point: in his view, ‘the other Party’ in Article 15.1 ‘is the Party that has factually provided the material and given the PIC.’60 Thus, the appropriate reference point would not be Article 16.1 of the Nagoya Protocol or CBD Article 15.3, but the Party that has provided the PIC as clarified in Article 17.3 of the Protocol – i.e., where the material was obtained. This argument would highlight that the creation, content and legal evidence provided by the internationally recognised certificate of compliance is closely related to the Protocol’s rules on decision-making for access to genetic resources, as articulated in Article 6, which are the reference point for Article 15 measures on compliance with domestic ABS legislation. Therefore, some parties may uphold that the decision to refer in Article 15 to ‘the other Party’ and not to ‘country of origin’ was eventually taken on the consideration that it is beyond the ability of individual users of genetic resources and of ‘user countries’ to assess the validity of sovereignty claims that are implicit in decisions of Parties providing genetic resources under their domestic ABS frameworks. Against the backdrop of the above alternative interpretations of Article 15.1, it is interesting to further consider the difference that exists in terms of clarity and precision between Article 15.1 and Article 16.1. In particular, in light of the latter’s further specification that ‘the other Party,’ which this article refers to, is the ‘Party where. . .indigenous and local communities are located.’61 While the Protocol does not consider monitoring the utilisation of traditional knowledge, it seems that a provision that is less ambiguous than Article 15.1 was eventually adopted in relation to compliance with domestic ABS requirements for traditional knowledge.62 This is a positive outcome, because it will reduce the possibility that spurious claims are submitted for adjudication by actors that are not legitimately entitled to do so and clearly identifies the law that should provide for such entitlements.

  Ibid.  Matthias Buck (16/11/2011), personal communication. 61  It can be argued that at the tenth COP to the CBD in Nagoya some countries only felt comfortable with leaving their compliance obligations with the domestic ABS requirements for genetic resources more ‘constructively ambiguous’ than the compliance requirements for traditional knowledge. This could indirectly be explained – at least in part – by the fact that monitoring obligations only apply to the utilisation of genetic resources. See, in particular, Nagoya Protocol Article 17. 62  Nagoya Protocol Article 16.1. 59 60

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However, regarding the provisions on compliance with domestic ABS requirements for genetic resources, concerns for legal certainty are poorly addressed. As shown above by Nijar, in terms of the criteria used to identify the country, whose ABS law must be complied with, the current formulation of Article 15.1 potentially leaves scope for contradictory outcomes. Namely, it leaves scope for considering a Party in compliance with the Protocol, even if such Party only takes measures to promote compliance with the legislation of intermediary countries – i.e., regardless of whether the concerned genetic resources have been legally acquired in the first place. In practice, legal actions may be possible only in the jurisdiction of the Parties that adopt an expansive interpretation of Article 15. On the contrary, the narrow interpretation would allow user countries to close the door to the possibility of litigation in the case of non-contractual ABS disputes.63 In accordance with this interpretation, the case presented in Nijar’s example should be directly settled between the alleged Party abusively acting as provider of genetic resources and the Party claiming to be the country of origin of the misappropriated genetic resources. This is because the disputed claim would be a claim concerning the sovereign rights of States over their genetic resources. It would seem beyond the abilities of a private person and also beyond the legal realm of user Parties to assess the implicit validity of underlying sovereignty claims each time a Party provides genetic resources under the Protocol.64

While this legitimate concern does require further consideration, the validity of sovereignty claims may somehow be regarded as ‘implicit’ only if the provider Party has expressly granted the right to utilise genetic resources to the user in the form of ‘a permit or its equivalent as evidence of the decision to grant prior informed consent.’65 This would be evidence of the fact that the provider Party conclusively intends to exercise its jurisdiction over the concerned genetic resources. Therefore, the very existence of conflicting sovereign claims over genetic resources, which would require both users and  Such interpretation postulates that the Protocol does not provide for making dispute settlement available to resolve non-contractual ABS disputes. While this conclusion is inconsistent with an earlier interpretation of the Protocol’s access to justice requirements, as described in the previous section, an important goal of this chapter is precisely to show that different interpretations are actually possible and that they may lead to inconsistent practical results. The extent to which such divergent interpretations (and their practical effects on domestic ABS implementing legislation) may put in jeopardy the effectiveness and efficiency of the Nagoya Protocol is an open question that should deserve careful consideration. However, this matter is beyond the scope of this contribution. 64  Mathias Buck (16/11/2011), personal communication. Emphasis added. 65  Nagoya Protocol Article 6.3.e. 63

444   Claudio Chiarolla user Parties not to interfere in disputes concerning other Parties’ sovereign rights, is underpinned by the idea that a Party, whether legitimately or illegitimately, has actually taken the decision to require (and grant) PIC. However, the utilisation of genetic resources may also occur in cases where no PIC is granted, i.e., where no permit or its equivalent is issued at the time of access by a provider Party. Insofar as genetic resources fall under the scope of the Protocol, two different situations can be envisaged. This may occur either because the providing Party has decided not to require PIC from users or because a user may have illegally acquired the genetic resources from a country that does require PIC. The first situation does generally entail a legitimate ‘utilisation’ of genetic resources. However, a Party’s decision not to assert its sovereign rights in the form of a compulsory PIC requirement leaves undetermined the genetic resources over which that Party intends to exercise its rights, notably by granting an express authorisation for their utilisation. On the one hand, the freedom of the Parties to provide unfettered access to genetic resources within their jurisdiction must be respected. On the other hand, a conflict of sovereignty would not necessarily arise between a Party claiming that a particular genetic resource was misappropriated by a user and the providing Party.66 This is because the decision of a Party to provide unfettered access to genetic resources within its jurisdiction per se does not entail a claim of sovereignty over the totality of such resources in the same way (and to the same extent) that such sovereignty claim is entailed by the decision of a Party to require (and eventually grant) PIC over specific genetic resources that allegedly belong to that Party. In sum, the freedom to provide unfettered access to generic resources does not (and should not) diminish the sovereign rights of the Parties that do require PIC and from which genetic resources may have been illegally acquired. In accordance with the principle that was first enunciated by William Blackstone, ‘. . . every right when withheld must have a remedy and every injury its proper redress.’67 Therefore, every country, which may legitimately assert to be the country of origin of allegedly misappropriated genetic resources, may feel entitled to seek redress for non-compliance with its domestic ABS legislation or regulatory requirements, notably by seeking to enforce the user measures specified in Article 15 of the Protocol. Indeed, many developing countries do expect that appropriate, effective and proportionate legal remedies will be provided in user countries.

 Emphasis added.  William Blackstone, Commentaries on the Laws of England, Book III (Oxford: Clarendon Press, 1832), 82.

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In conclusion, in the absence of PIC and MAT, the filing of a complaint against a user or an intermediary in their respective jurisdictions, in many cases, may not concern a conflict between the sovereign rights of Parties over genetic resources, but a mere violation of the applicable law. Appropriate, effective and proportionate legal remedies should be provided to redress such violations in all Parties.

IV.  Recognition and Enforcement of Foreign Judgments and Arbitral Awards In international disputes, the successful party may need to enforce the judgment or arbitral award in a jurisdiction that is different from the one that has granted the judgment. Therefore, the key question for the Parties to the Protocol is as follows: which obligations does the Protocol establish in relation to facilitating the recognition and enforcement of foreign judgments and arbitral awards? The Protocol states that: ‘Each Party shall take effective measures, as appropriate, regarding: [. . .] the utilisation of mechanisms regarding mutual recognition and enforcement of foreign judgments and arbitral awards.’68 This leaves no doubts that the Parties have the express duty to participate effectively in the above mechanisms or establish them, when they are not yet established. However, in practice, different cases may be distinguished. If MAT have been established between the parties, they may provide for a jurisdictional clause. In such clause, the parties may establish that the provider country (or any other country) is the jurisdiction to which they subject the disputes concerning the MAT. If the designated jurisdictional authority does not belong to the country of the unsuccessful party, the judgment may need to be executed in the latter country (or in any other country in which the unsuccessful party holds property and other assets). In such cases, the recognition and enforcement of a foreign judgment will depend on the existence of a bilateral agreement between the county where the recognition and enforcement are sought and the country whose courts have granted the judgment.69 Thus, it also can be argued that the Parties to the Protocol may fulfill their relevant  Nagoya Protocol Article 18.3.b.  In absence of such agreement, it will depend on the domestic law of the former country, jointly interpreted with the principles of comity, reciprocity and res judicata, and in accordance with the General Principles of International Law. See, for instance, U.S. Department of State, “Enforcement of Judgments”, accessed 29 May 2012, http://travel.state.gov/law/ judicial/judicial_691.html. In particular, under the general principles of law, the court of the country where the recognition and enforcement is sought may examine a foreign judgment on the grounds that: the foreign court properly accepted jurisdiction over the defendant; the

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446   Claudio Chiarolla obligations by establishing such mutual recognition agreements, if they are not yet established.70 However, the assessment of the extent to which the Parties may actually be required to do so under international law demands evidential elements other than those merely provided by the Protocol’s provisions. Mutatis mutandis, the above duty to cooperate also applies when the recognition and enforcement is sought for foreign judgments that concern disputes in cases of misappropriation. If MAT are established, the parties may have agreed to include an alternative dispute resolution clause. In such clause, the parties may establish that an arbitral tribunal is the exclusive jurisdiction to which they will subject any disputes concerning the MAT. The recognition and enforcement of a foreign arbitral award is generally easier than the enforcement of a domestic foreign judgment, because a larger number of countries have ratified the 1958 New York Convention on the Recognition and Enforcement of Foreign Arbitral Awards. 71 However, in certain instances, the MAT may have not been established – e.g., in cases of misappropriation. In other cases, the parties may not have included an alternative dispute resolution clause. However, if the litigants/ parties agree to do so, they may establish an ex-post arbitration agreement and submit the dispute to arbitration after the latter has arisen. In these cases, the rules of the 1958 New York Convention will also apply.72 defendant was properly served; the proceedings were not vitiated by fraud; and the judgment does not offend the public policy of the recognising state. 70  The group of technical and legal experts (TEG) on compliance also noted that ‘it may be difficult to enforce [a foreign] judgment across jurisdictions. Enforcement will usually depend on national laws. International efforts to create a mechanism for the recognition and enforcement of foreign judgements have not been very successful’ (CBD Ad Hoc Open-Ended Working Group on Access and Benefit-Sharing, “Report of the Meeting of the Group of Legal and Technical Experts on Compliance in the Context of the International Regime on Access and Benefit-Sharing,” (10 February 2009) UN Doc. UNEP/CBD/ WG-ABS/7/3, 11. See also the relevant Conventions on “International Legal Co-Operation and Litigation” under the Hague Conference on Private International Law, accessed 3 June 2012, http://www.hcch.net/index_en.php?act=text.display&tid=10#litigation. 71  The New York Convention has currently 146 Parties. Information on its status of ratification can be found at UNCITRAL, accessed 30 November 2011, http://www.uncitral.org/ uncitral/en/uncitral_texts/arbitration/NYConvention_status.html. The Convention also requires the courts of the Contracting States to recognise arbitration agreements made in writing and to refuse to allow a dispute to be litigated before them when it is subject to an arbitration agreement. See New York Convention Article 2. 72  On the role of New York Convention in the context of dispute settlement, see also Claudio Chiarolla, “Plant Patenting, Benefit Sharing and the Law Applicable to the FAO Standard Material Transfer Agreement,” The Journal of World Intellectual Property 11 (2008): 8.

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V.  Conclusions: Two Possible Interpretations of the Role of Private International Law under the Protocol This section concludes by comparing the narrow interpretation of the Protocol’s private international law-related provisions vis-à-vis their extensive interpretation with the view to clarifying the institutional capacities that may be required for implementing such provisions. The Protocol enshrines basic principles for determining jurisdiction and access to justice standards in relation to contractual disputes that arise from MAT. It also establishes the duty of State Parties to provide for judicial remedies, including access to their courts and tribunal, to nationals of other State Parties. Therefore, the ground rule is that the forum courts, which are seised of a dispute arising from MAT, should assert their jurisdiction over the dispute unless the complaint is apparently based on dubious jurisdictional grounds. However, the narrow interpretation of the Protocol’s private international law provisions postulates that the Protocol does not purport developing a private international law of ABS. The scope of application of the above provisions would be limited to ‘neutral’ references to the inclusion of private international law elements in the MAT (e.g., jurisdiction and applicable law clauses). Besides, the ‘access to justice’ requirements of the Protocol would apply only to disputes concerning compliance with MAT (i.e., in cases of misuse); therefore, excluding cases of misappropriation where non-contractual obligations are involved. A corollary is that private international law provisions would only cover elements that can be defined contractually by the parties to an ABS agreement. It follows the possible non-relevance of such private international law provisions to ABS disputes of non-contractual nature. Therefore, in terms of private international law, no question of applicable law may arise with regard to non-contractual ABS obligations. This is because the Protocol would not provide for making dispute settlement available to resolve disputes of non-contractual nature between users of genetic resources (and/or associated traditional knowledge) and other possible right holders. Against this backdrop, it could be maintained that the Protocol does not directly identify the law applicable to define the users’ responsibilities that may arise from ABS-related obligations of non-contractual nature. As above explained, this interpretation is consistent with the idea that the Protocol would not establish an obligation to exercise jurisdiction in cases concerning non-contractual disputes. Nevertheless, the Parties would be obliged under Articles 15 and 16 to address instances of misappropriation through appropriate, effective and proportionate measures, other than jurisdictional

448   Claudio Chiarolla measures, including the general duty to cooperate, ‘as far as possible and as appropriate, [. . .] in cases of alleged violation of domestic ABS legislation or regulatory requirements.’73 However, the extensive interpretation of the Protocol’s provisions that may be relevant from a private international law perspective may be also legitimately set forth. Such interpretation arises primarily from the question of whether the Protocol, by virtue of its references to ‘the domestic ABS legislation or regulatory requirements of the other Party’ (in its compliance provisions), does purport a choice of law rule. In particular, the application of such rule would require the extraterritorial application of the domestic law of a foreign country (e.g., the country of origin) to the responsibility arising not only from contractual obligations, but also from non-contractual ones. This chapter has highlighted that Parties have obligations to take appropriate, effective and proportionate measures to address situations of noncompliance with user measures that are to be taken in accordance with the Protocol’s compliance provisions. Therefore, the above user measures may meet the requirements of appropriateness, effectiveness and proportionality only if the concerned Parties do provide for an opportunity to seek recourse under their legal system in cases of non-compliance. While the extraterritorial enforcement of domestic ABS legislation or regulatory requirements of a foreign country is not required by the Protocol, the Protocol does purport a choice of law rule. Such rule would postulate that the courts of the forum shall give extraterritorial application to the domestic law of a foreign country in order to determine the conditions under which a responsibility for (contractual as well as non-contractual) ABS obligations may arise. In this limited sense, the Protocol provides for the extraterritorial application of the ‘domestic ABS legislation or regulatory requirements of the other Party’ as the choice of law rule that should be applied by the forum court to all cases of non-compliance. In particular, such requirements must be applied to the facts of the case if the claims of the legal person sustaining the damage are based on such legislation and a factual connection exists between the genetic resources or traditional knowledge and the other Party. In sum, while Article 18 (on compliance with MAT) specifies the treatment of contractual ABS obligations, Article 15 (on compliance with domestic ABS requirements for genetic resources) and Article 16 (on compliance with domestic ABS requirements for traditional knowledge) make clear that the ‘domestic ABS legislation or regulatory requirements of the other Party’ should be referred to in the context of non-contractual ABS disputes (e.g., in cases of misappropriation).  Nagoya Protocol Articles 15.3 and 16.3.

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Finally, with regard to the recognition and enforcement of foreign judgments and arbitral awards, State Parties have an obligation to effectively participate in relevant existing cooperation mechanisms. However, the Parties may disagree on the extent to which the above obligation may also entail the duty to establish such mechanisms, where they do not exist, and participate in newly established ones. The narrow interpretation of the Protocol’s private international law provisions suggests that the latter should not be expected to play an important role in countering biopiracy and – more generally – in the implementation of the Protocol. However, private international law would still be accorded a certain prominence as a tool for resolving disputes that concern compliance with contractual ABS obligations. On the contrary, the extensive interpretation of such provisions indicates that private international law can play a prominent role in relation to all compliance-related obligations under the Nagoya Protocol.74 Consequently, the capacity development strategy for the Nagoya Protocol should provide for strengthening the institutional capacities that are necessary to resolve questions of jurisdiction, applicable law, and recognition and enforcement of foreign judgments and arbitral awards, both in the context of contractual as well as non-contractual ABS disputes.

 Emphasis added. For the purpose of this study, the compliance-related obligations that are referred to above exclude consideration of the norms that will be adopted in accordance with Nagoya Protocol Article 30, which concern the procedures and mechanisms to promote compliance by Parties with the Protocol.

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Chapter 15.  An International Cooperation Perspective on the Implementation of the Nagoya Protocol Tomme Rosanne Young* This chapter offers a perspective on the use of global and other internationallevel mechanisms to enable the successful implementation of the Nagoya Protocol. It begins with an illustration of the evolution of the legal analysis of the concept of access and benefit-sharing (ABS), and then considers international tools for aiding countries to address the challenges of implementing the Nagoya Protocol. It considers the roles of the ABS clearing-house and related provisions, its proposals regarding compliance and benefit-sharing mechanisms, and its call for regular evaluation of regime effectiveness, as well as exploring less formal international implementation tools, such as models and guidelines, that can serve to operationalise other provisions of the Protocol. It concludes with a brief mention of other possible instruments and tools, particularly the potential for development of multilateral and bilateral agreements, instruments and activities for the implementation of the Nagoya Protocol.

I.  Introduction to International Discussions on ABS Throughout the years since the ABS concept first came under discussion (in the negotiations leading to the adoption of the Convention on Biological Diversity – CBD), legal experts have noted the challenges that would have to be addressed in order for an ABS regime to operate in a legally enforceable manner. These challenges were expressed in various ways depending on the stage of negotiation or implementation of the ABS regime. Including the * International consultant on environmental and conservation law and policy, originator of the International Research Institute for Sustainability, and former Senior Legal Officer of IUCN.

452   Tomme Rosanne Young present, there have been five relatively distinct phases of such international discussion – each using the approach most appropriate to the then-current status of ABS in general. First, during the negotiations leading to the adoption of the CBD provision on ABS (Article 15), experts expressed their views argumentatively, with many legal experts from highly developed countries stating that an ABS regime could never function as a legally enforceable means of compelling benefit sharing.1 Second, after the CBD’s adoption, ABS-related efforts focused entirely on finding ways of implementing Article 15 as it stood, seeking to maximise its effectiveness, despite deficiencies in the text and in the standard rhetoric about the meaning and functionality of ABS. In this period, efforts focused on what individuals and Parties could do to promote the effective operation of ABS, both as a matter of national legislation and in terms of practicalities of scientific and technological capacity. With little regulatory experience in any country addressing these issues, attention focused on former and current practices involving the commercial use of wildlife resources, generally letting those practices provide a status quo to be maintained or enhanced through the CBD’s ‘access’ provisions, and presuming that the responsibility to share benefits under the CBD was super-imposed over them. The authors of this period took varying positions regarding the levels of difficulty in imposing this responsibility, but generally saw it as a relatively simple problem of legal drafting.2 This era included a wide range of positive statements – that ABS would work and provide developing countries with ‘green gold’ – and proposals for how to do it. Few commented on the various obstacles that could prevent ABS from becoming an effective tool for conservation and development.  The full set of documentation of the early negotiations of the CBD, including negotiation of the provisions that ultimately became Article 15 are no longer available online. A few publications such as Walter Reid et al., Biodiversity Prospecting: Using Genetic Resources for Sustainable Development (Washington DC: World Resources Institute, 1993) provide some insights into particular legal and practical concepts to be addressed, and strongly impacted on positions taken in those negotiations. The author of this chapter has files, which she is generally willing to share, containing a large number of the documents circulated during the CBD negotiations and earlier, in preparation for presenting a final draft Convention for adoption at the United Nations Conference on Environment and Development (1992) UN Doc A/CONF.151/26/Rev.1. 2  E.g., Françoise Burhenne et al., A Guide to the Convention on Biological Diversity (Gland: International Union for Conservation of Nature (IUCN), 1994); Lyle Glowka, A guide to designing legal frameworks to determine access to genetic resources (Gland: IUCN, 1998); and Kate Ten Kate and Sarah Laird, The Commercial Use of Biodiversity: Access to Genetic Resources and Benefit Sharing (London: Earthscan, 1999). For a contrary contemporaneous view, see Tomme Young, Implementation of the Convention on Biological Diversity in Developing Countries, (Rome: FAO (loose leaf ), 1995). 1

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A third era of analysis arose during the negotiation of the 2002 Bonn Guidelines on ABS.3 This process provided another opportunity for experts to identify elements and issues that might inhibit the functionality of the ABS concept and to call on the CBD Working Group on Access and BenefitSharing, established in 2000, to clarify them. At the same time, however, the Bonn Guidelines reflected the positive approach of assuming ABS could become fully functional on the basis of CBD Article 15 and various national and private sector practices, without the need for any re-sculpting.4 After the 2002 UN Summit on Sustainable Development, ABS analysis began to shift to what became an almost total focus on functionality, or rather non-functionality, in an attempt to identify the factors that were rendering the ABS concept inoperable. Concerns arose from a more issue-specific legal analysis of ABS, including how a court in a developed country might legitimately refuse to enforce ABS contracts, permits or other documents. This discussion was based on formal construction of those documents and application of relevant commercial and contract law, but also considered allegations regarding the lack of formal legal ABS enforcement claims to date – possibly as a result of the claimants’ impression that ABS cannot be enforced through formal mechanisms.5 The goal at this point was to enable the Nagoya Protocol negotiators to more clearly understand and address the legal challenges and obstacles that had formed the world’s experience with ABS. These discussions arose out of a generally expressed perception that ABS was non-functional, and the multitudinous opinions regarding which factors were preventing functionality – across a range of situational factors and claims. Some negotiators and their analysts claimed that negotiations in individual ABS transactions often failed because one or more parties to the

 CBD Decision VI/24, “Access and benefit-sharing as related to genetic resources” (2002) UN Doc UNEP/CBD/COP/6/20. 4  Informational documents submitted to the CBD Secretariat for circulation at relevant meetings (INF documents) are still online on the CBD website (http://www.cbd.int, accessed 9 May 2012). INF documents in many of these meetings demonstrate the global-action focus and positivist approach of analysis during this period. See also Tomme Young, IUCN Position Paper for the CBD Working Group on ABS, (Bonn: IUCN, 2001) emphasising the importance of mutual commitments by countries on user-side and on provider side of each transaction. 5  Documents for the 7–10th meetings of the CBD Conference of the Parties (COP) and some meetings of its Subsidiary Body for Scientific, Technical and Technological Advice (SBSTTA) included some relevant to ongoing ABS discussions. The CBD held eight more meetings of the Ad-hoc Working Group on ABS, after the initial Bonn meeting in 2001. See also Tomme Young et al., Covering ABS: addressing the need for sectoral, geographical, legal and international integration in the ABS regime: papers and studies of the ABS project (Bonn: IUCN, 2009), especially chapters 8–11. 3

454   Tomme Rosanne Young proposed transaction were not clear about their expectations.6 Other experts stated that developing countries had no particular desire to implement ABS;7 while still others blamed the inability or unwillingness of providers and provider countries to enforce ABS at the time of genetic resource utilisation. Expression of this view contributed to the belief expressed by many users of genetic resources that ABS compliance was optional.8 The negotiations did not begin from a blank slate, however. Although often restating and negotiating specific language from CBD Article 15, it became clear during this phase of the discussions that the new negotiations would begin from CBD Article 15, for an important reason: the CBD was already binding on nearly 200 Parties, and could be changed only by amendment to the CBD (which was unlikely). Unless or until the Nagoya Protocol is ratified by all CBD Parties, CBD Article 15 continues to be the only ABS provision that is binding on those CBD contracting Parties who are not also Parties to the Protocol.9 Thus, analyses during this phase necessarily drew upon the language of CBD Article 15 and of the Bonn Guidelines, as well as on the practical experiences of users and providers. One of the key factors in the negotiations leading to the Nagoya Protocol was the issue of compliance. On one hand, provider-side analysts were strongly asserting that genetic-resource users were generally failing  Bioprospektion zu fairen Bedingungen? Erfahrungen eines Access & benefitsharing-Projektsim Amazonastiefland Ecuadors (unattributed presentation notes, http://www.probenefit.de/files/ Worrle_202006_Vortr_Strobl.pdf, accessed 11 May 2012). 7  Preston T. Scott, “User and provider country measures in the context of the international regime: Some thoughts and observations” (Presentation at the International Expert Workshop on Access to Genetic Resources and Benefit-Sharing, Cape Town, South Africa, 20–23 September 2005). Claims of decreasing industrial interest in genetic resources are seldom coupled with supporting statistics or other impartial or credible evidence. See e.g., Leonard Hirsch, “Provider and User Country Measures – Do Two Wrongs Ever Make a Right?” (Paper presented at the International Expert Workshop on Access to Genetic Resources and Benefit Sharing, Cape Town, South Africa, 20–23 September 2005). 8  E.g., Christine Frison and Tom Dedeurwaerdare, Infrastructures publiques et régulations sur l’Accès aux ressources génétiques et le Partage des Avantages qui découlent de leur utilisation pour l’innovation dans la recherche des sciences de la vie: Accès conservation et utilisation de la diversité biologique dans l’intérêt général (Service Public Fédéral Santé Publique, Sécurité de la Chaîne Alimentaire et Environnement, Belgium Environmental Directorate, 2006); Fernando Latorre, Review of the Experience of Implementation by UK Stakeholders of Access and Benefit-sharing Arrangements under the Convention on Biological Diversity (London: DEFRA and Royal Botanic Gardens Kew, 2005); K. Holm-Müller, C. Richerzhagen and S. Täuber, Users of Genetic Resources in Germany (Frankfurt: German Federal Agency for Nature Conservation, 2005). Some of these studies, particularly Frison, state specific conclusions regarding users’ attitudes on the basis of very small samples (1 to 3 users). 9  CBD Article 28 on Protocols is particularly short, and does not suggest that any protocol could be considered to bind a State that has not ratified it. 6

An International Cooperation Perspective   455

to comply with ABS requirements, and that the countries of those users (and/or the countries in which ‘utilisation of genetic resources’10 was taking place) were not complying with their basic obligations to adopt measures to operationalise ABS at the national level.11 On the other hand, users and many user countries noted that insurmountable legal obstacles stood in the way of adoption of the kinds of legislation that provider countries were calling for. This situation led to a relatively intensive analysis of developed country legal obstacles, preventing the adoption of direct national benefitsharing and ABS compliance mechanisms on the ‘user side’. International-level challenges of a new legal concept (or a means of internationally addressing an existing legal issue), however, can never be fully addressed until a significant number of countries with different national situations have adopted implementing legislation, owing to the need to investigate the manner in which each country’s law will address the issue. During this third phase of ABS development, however, only a small percentage of countries had adopted ABS-implementing laws. Accordingly during this period, initial efforts were made to identify and investigate some national-level issues that might become obstacles to ABS functionality and that might be resolvable through international discussion. This initial list of issues included the following: ABS transactional costs;12 indigenous and local communities’ customary law issues;13 sectoral frameworks for ABS;14 administrative, judicial and informal remedies available to providers in situations of misuse or misappropriation of genetic resources;15 national  CBD Article 15 focuses on the ‘benefits arising from utilization of genetic resources’. This indicates that the country in which utilisation occurs may play a very important role in any functional ABS system. This is particularly true where the utilisation occurs outside the legal jurisdiction of the provider country, regardless of whether it occurs in the country of citizenship of the user, or some other country in which the transferee or the user’s research facilities are located. 11  CBD Article 15.7. 12  CBD Ad Hoc Open Ended Working Group on Access and Benefit Sharing, “Comparative Study of the Real and Transactional Costs Involved in the Process of Access to Justice Across Jurisdictions” (2009) UN Doc UNEP/CBD/WG-ABS/7/INF/4. 13  CBD Ad Hoc Open Ended Working Group on Access and Benefit Sharing, “Study on Compliance in Relation to the Customary Law of Indigenous and Local Communities, National Law, Across Jurisdictions, and International Law” (2009) UN Doc UNEP/CBD/ WG-ABS/7/INF/5. 14  CBD Ad Hoc Open Ended Working Group on Access and Benefit Sharing, “Access and Benefit-Sharing Arrangements Existing in Specific Sectors” (2008) UN Doc UNEP/CBD/ WG-ABS/6/INF/4/REV1. 15  CBD Ad Hoc Open Ended Working Group on Access and Benefit Sharing, “Analytical Study on Administrative and Judicial Remedies Available in Countries with Users Under their Jurisdiction and in International Agreements” (2007) UN Doc UNEP/CBD/WGABS/5/INF/3. 10

456   Tomme Rosanne Young measures to support prior informed consent;16 claims of misappropriation or misuse of genetic resources;17 legal certainty for users of genetic resources;18 and the legal relationships between international instruments potentially affecting ABS.19 The present volume is among the first to address a new, fifth phase in ABS analysis. Once again, as in the first phase, it is necessary to turn away from the various ‘roads not taken’ by the negotiators, and take a positive approach looking at what can now be done (rather than what cannot be done) to make ABS functional, incorporating the Nagoya Protocol as a major part of that analysis. In this process, it is no longer helpful to dwell on the legal and textual shortcomings of the Protocol,20 or indeed of the ABS concept. Overall, forward progress must be based on a return to the positivism of the early phases of ABS implementation, informed by the analyses and knowledge generated in phases 3 and 4. This chapter seeks to analyse a critical aspect of that positivism – to identify opportunities inherent in the variety of tools potentially available under the Nagoya Protocol, and how they can be developed and applied to enable parties to fully realise the ABS regime, with a view to suggesting opportunities for action at the international level addressing some of the most significant challenges to formal enforcement.

II.  Post-Nagoya Implementation of ABS: The Process of Legal Regime Development The Nagoya Protocol does not actually create an ABS regime, but calls for its creation through myriad paths of ‘implementation’ and ‘regime development,’  CBD Ad Hoc Open Ended Working Group on Access and Benefit Sharing, “Measures to Support Compliance with Prior Informed Consent of the Contracting Party Providing Genetic Resources and Mutually Agreed Terms on which Access was Granted, in Contracting Parties with Users of such Resources under their Jurisdiction” (2005) UN Doc UNEP/ CBD/WG-ABS/4/INF/1. 17  CBD Ad Hoc Open Ended Working Group on Access and Benefit Sharing, “Analysis of Claims of Unauthorised Access and Misappropriation of Genetic Resources and Associated Traditional Knowledge” (2005) UN Doc UNEP/CBD/WG-ABS/4/INF/6. 18  CBD Ad Hoc Open Ended Working Group on Access and Benefit Sharing, “Summary Analysis: Legal Certainty for Users of Genetic Resources under existing Access and BenefitSharing Legislation and Policy” (2005) UN Doc UNEP/CBD/WG-ABS/3/INF/10. 19  CBD Ad Hoc Open Ended Working Group on Access and Benefit Sharing, “Study on the Relationship between an International Regime on Access and Benefit-Sharing and other International Instruments and Forums that govern the use of Genetic Resources” (2009) UN Doc UNEP/CBD/WG-ABS/7/INF/3/Part.1. 20  The unusual process by which the final text was adopted is described in the Introduction to this volume. 16

An International Cooperation Perspective   457

including international action of various sorts, national legislation addressing both ‘user country’ responsibilities and ‘provider country’ responsibilities, and private negotiation between the individuals, entities, institutions or governments that are the specific user, middleman and provider in each individual ABS transaction. This chapter considers aspects of all three levels of the ABS regime development, identifying both the pathways to fulfillment of the Nagoya Protocol and the critical challenges to be met. At any level, legal regimes are interconnected webs. Thus, the completion and implementation of any single sub-component of a regime, without the rest of the overall regime may not, in itself, achieve any ABS objective. Before resorting to any specific element of implementation under the Nagoya Protocol, therefore, the Protocol Parties must build a comprehensive plan of implementation, which addresses all aspects of the framework – determining how they will function, how they will interact and how they can avoid gaps, overlaps, loopholes and other obstacles to effectiveness. The following discussion briefly considers regime-planning issues most relevant to the subsequent discussion of international tools for implementation. It begins by listing basic regime challenges that the plan must address, turning next to the question of whether and how to shortcut that process. It ends with a short analysis of the pathway to careful integration of the elements of the ABS regime. 1.  Process Challenges to Be Faced in Protocol Implementation In planning the elements of an ABS regime, it is necessary to be clear about the objectives of that regime. This analysis must go beyond rhetoric – consider what the regime does, rather than what its negotiators say. Thus, although the objective provisions of the Nagoya Protocol did not eliminate existing uncertainties relating to the CBD’s third objective, an examination of the basic framework of the Protocol provides a strong indication of the elements of the regime that were most essential in the eyes of the negotiators. Hence, the regime must develop and integrate mechanisms to enable functional achievement of six key component-objectives, which together make up the ABS regime,21 namely: (i) access, (ii) benefit-sharing; (iii) terms and requirements; (iv) compliance; (v) capacity development; and (vi) streamlining. Technically ‘access’ is perceived to call for one or more mechanisms by which users obtain genetic resources of other countries. Although many  Although numerous legal questions remain open regarding the nature of these components (Elisa Morgera, Matthias Buck and Elsa Tsioumani, Commentary on the Nagoya Protocol on Access and Benefit-sharing (Boston: Martinus Nijhoff, forth. 2013), the following elements seem clearly to form the apparent understanding of the Nagoya negotiators regarding the specifics of ABS.

21

458   Tomme Rosanne Young elements of ‘access’ remain unagreed, Parties have generally accepted that it is necessary, in order to address access concerns that access should meet the following key requirements. First, access should be provided in a manner that is ‘legally certain’ (that is, that the user should be able to be confident that his ‘access’ and other permitted post-access activities will not result in claims of ‘misappropriation’, ‘misuse’ or ‘bio‑piracy’ later, so long as s/he has complied with the relevant access legislation). Second, access should be undertaken in compliance with clear and unambiguous requirements, including national legislation of the ‘provider country’, and the contents of ‘mutually agreed terms’ (MAT) established between user and provider. The Protocol’s ‘benefit-sharing’ mechanisms, too, while recognized to have certain agreed components, are generally not concretely defined. They are generally recognized to contemplate sharing the following types of benefits arising from utilisation of a provider’s genetic resources: • results of research regarding genetic resources; • results of research regarding traditional knowledge associated with genetic resources; • benefits arising out of utilisation of genetic resources; • benefits arising out of commercialisation of genetic resources; • benefits arising out of ‘subsequent applications’ of genetic resources; • benefits arising out of utilisation of traditional knowledge associated with genetic resources; • benefits arising out of commercialisation of traditional knowledge associated with genetic resources; and • benefits arising out of ‘subsequent applications’ of traditional knowledge associated with genetic resources. The Protocol’s various ‘terms and requirements’ mechanisms relate to the fact that ABS is generally perceived to have both a governmental and a private/transactional component. The key mechanisms in this category are: prior informed consent (PIC) – the duty to obtain consent of the Party (country) providing access or of the individual or official authorized by that Party; and mutually agreed terms (MAT) established between the ABS contract party providing access and those obtaining access.22 PIC and MAT comprise – a  CBD Article 15.3. Note that, under CBD, for this purpose, the ‘country providing access’ must be either a ‘country of origin of such resources’ or a CBD Party that has ‘acquired the genetic resources in accordance with this Convention.’ Also according to the Convention, ‘country of origin of genetic resources’ means ‘the country which possesses those genetic resources in in-situ conditions’ and ‘in-situ conditions’ means ‘conditions where genetic resources exist within ecosystems and natural habitats, and, in the case of domesticated or

22

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formal and/or legally certain restatement of the particular obligations and objectives as agreed in each formalised ABS relationship.23 Another potential element within the ‘terms and conditions’ mechanism is, at present, entirely speculative. Presumably, the ABS regime will eventually include certain international understandings regarding what terms and rules apply where the PIC and MAT are silent or ambiguous on a particular point, or where the user did not comply with PIC or MAT, but utilised genetic resources or associated traditional knowledge from which benefits have arisen. The ‘compliance’ mechanism is designed to clarify what ABS requires and what will happen in cases of non-compliance with those requirements. Within this mechanism, the negotiations considered two separate, somewhat discrete, elements, recognizing that both come into play in virtually every ABS contract.24 First, individual compliance at the level of specific ABS contracts and permits and other requirements, including the user’s obligations when he/it is within the provider country’s jurisdictional boundaries, and when he is under the jurisdiction of another country. Second, the Protocol Parties’ compliance with commitments, generally discussed in the context of three types of national obligations: (i) to take action and/or adopt relevant legislation governing its status when it is provider country and when it is a user/utilisation country; (ii) to enforce all relevant national ABS legislation (there are strongly disputed views about this one); and (iii) to comply with specific nationally accepted Protocol obligations (reporting, etc.). cultivated species, in the surroundings where they have developed their distinctive properties’ (CBD Article 2). This raises two points that may be relevant to further work on the issues described in this chapter. First, based on a literal interpretation of the CBD, PIC and MAT are national instruments, but at the level of national legislation are sometimes delegated in whole or in part to communities and/or individuals. Second, CBD Article 15 does not make any specific statement about what happens where genetic resources being utilised or accessed came from a country that is not a country of origin of those resources, and/or that did not acquire those resources in accordance with the Convention. To avoid potential interpretational problems in developed country courts, the Protocol implementation processes will probably need to address both situations, i.e., consider how to integrate the devolution of PIC/MAT responsibility and authority to communities and individuals, and also develop a mechanism that addresses potential use of genetic resources in a non-origin country that did not acquire the resources in a way that makes it a ‘country providing resources’ under the CBD. 23  CBD Articles 15.3–5 and 15.7. 24  ABS, as addressed in both the CBD and Nagoya Protocol, is entirely focused on international situations – that is, where a user from one country utilizes genetic resources from another country. All such contracts involve both a direct user-compliance set of issues as well as the international questions of whether both countries are meeting their national legislative/enforcement commitments. See Morten W. Tvedt and Tomme Young, Beyond Access: Exploring Implementation of the Fair and Equitable Sharing Commitment in the CBD (Bonn: IUCN, 2007), 7–27.

460   Tomme Rosanne Young ‘Capacity development’ constitutes the fifth mechanism that is mandated in the Protocol, calling on Parties (individually and collectively), to bring together competent legal/legislative experts and other experts to devise solutions to the challenges which have interfered with ABS functionality in the past, and which enable widespread dissemination and application of those solutions. The sixth and final mechanism specified in the Protocol relates to ‘streamlining.’ This is a process by which effective practices that will develop during the initial years can become standards that allow ABS permits, approvals, documents and practices to be addressed with increasing efficiency as the regime develops. These six basic areas (access, benefit-sharing, terms/requirements, compliance, capacity, and streamlining) represent the elements of an effective, internally consistent, ABS framework. A high level of advance preparation is essential to the development of these elements as an integrated whole, particularly because global institutional development takes a very long time, so that it has rarely proven possible or beneficial to revise or reshape globallyagreed institutions, once they are in place. 2.  Traditional Knowledge Associated with Genetic Resources One of the most significant elements of the Nagoya Protocol is its impact on the international legal treatment of ‘traditional knowledge associated with genetic resources’ (also known as ‘associated traditional knowledge’). Associated traditional knowledge is often considered to be one part of ‘the knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity’, which is addressed in CBD Article 8(j). Holders of this view assume that the Nagoya Protocol’s coverage of ‘traditional knowledge associated with genetic resources within the scope of the Convention’,25 means that its protection of associated traditional knowledge includes only such knowledge that is within the textual scope of CBD Articles 8(j) and 10(c). Another view, however, notes that the various CBD activities relating to traditional knowledge have specifically addressed a wider range of material, including traditional knowledge relating to the medicinal and other uses of particular genetic resources. Within that ambit, essentially all associated traditional knowledge would legitimately be considered a subset of the body of traditional knowledge ‘relevant for the conservation and sustainable use

 Nagoya Protocol, Article 3, emphasis added.

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of biological diversity.’26 For present purposes, this chapter will not attempt to resolve these divergent views, or even analyse them, but merely note that divergences exist, and must probably be addressed en route to a final, agreed framework for the implementation of the Protocol. Either way, the Nagoya Protocol has elevated the status of associated traditional knowledge. If associated traditional knowledge protection is limited to a subset of the knowledge mentioned in the text of CBD Article 8(j), then that subset has been elevated from the hortatory language of Article 8(j) offering no protection, to the status of a legally protected resource. If all associated traditional knowledge within the broader approach is protected, then the Protocol gives textual validation to the normative work of the CBD COP in addressing all types of traditional knowledge. In essence, the Nagoya Protocol places specific obligations on Parties, regarding the recognition of the rights of ‘authorised’ holders of associated traditional knowledge, protection of those rights and in some cases, enforcement of those protections.27 The Nagoya Protocol, however, does not make any claim linking associated traditional knowledge to sovereign rights, suggesting that, legally, it may be necessary to formally adopt national laws containing the required or recommended protection of associated traditional knowledge, in order for associated traditional knowledge rights to be formally ‘recognised’ by courts or agencies, and/or protected under the Protocol.28 Most relevant for present purposes, the Nagoya Protocol generally provides parallel but virtually identical clauses on associated traditional knowledge and genetic resources, in a range of contexts. The division of these points into separate parallel clauses may suggest that, had the negotiations continued, a fuller treatment of the unique or challenging aspects of associated traditional knowledge might have been included in the Protocol. As it stands, however, the Protocol’s final lack of specific instructions on associated traditional knowledge or its special definitions or objectives presents an important challenge for Protocol implementation.

 See generally “Report of the Working Group on the Implementation of Article 8(j) and Related Provisions”, (2000) UN Doc UNEP/CBD/COP/5/5 and the succeeding six meetings of that Group, accessed 11 May 2012, http://www.cbd.int/meetings/. 27  [See contribution by Savaresi to this volume (Chapter 2)]. 28  The sovereign rights of States, particularly where specifically recognised in an international instrument, exist until relinquished, regardless of whether formally ‘exercised’ in legislation or in some other way or not at all. Discussed in detail in Tvedt and Young, Beyond Access, 127. And see CBD Articles 3 and 15.1; and Peter Börkey, Matthieu Glachant and François Lévêsque, Voluntary Approaches for Environmental Policy: An Assessment (Paris: OECD, 1999). When applied in relation to indigenous and traditional communities, however, this issue often becomes somewhat complex. 26

462   Tomme Rosanne Young 3.  Other Legislative Areas Relevant to ABS Implementation For its implementation, it is essential to consider how any new legal regime will affect and/or be affected by other laws and legal regimes. Especially at national level, any new legal regime must be designed in a way that does not create unintended loopholes, contradict, or needlessly duplicate other regulatory frameworks. Moreover, ABS regulation and compliance must necessarily coordinate to ensure that it does not unduly conflict with other important national priorities. The same is true, to a more limited extent, at the international level where countries have already entered into a large number of international binding instruments and agreed to priorities across a range of sectors – commercial, as well as social and environmental. As noted, the above-described view of the six elements of the ABS framework,29 while relying on national legislation of the provider country and of the user country for its primary operational mandates, also calls for international action to enable (and possibly to compel) implementation and compliance. As a result, the implementation plan for the creation of a functional and enforceable ABS regime must recognise, coordinate with and consider all of the following areas of law (with a view to avoiding legal complications): • general environmental and sustainability law; • social-welfare law and laws protecting the poor and indigenous persons and communities; • property law – which varies from country to country, including each country’s law on the following types of property: land and other immobile property; movable property; government or nationally owned property (including national trust); intellectual and industrial property; other types of intangible property; and un-ownable property. All countries have laws addressing all of these types of property in some form. In many countries, however, one or more of the listed types are not formally called ‘property’ under the law; • administrative law – especially, the rights and duties of provider countries and of providers; • commercial law – including especially the creation of legally binding instruments involving payment for goods, services or other matters; • contract law and contractual enforcement – a very complicated specialty (often oversimplified, to the detriment of some contractual parties), which is different in all countries; • diplomatic and trade law;  Listed above under section I.1 above.

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• transboundary legal action: availability of national and international courts and tribunals to address misappropriation and most actions for misuse of genetic resources; • international commercial law: the need to coordinate with currently accepted commercial mechanisms across national borders, with particular attention to certain types of international business transactions; • general public international law; and • international enforcement – judicial, arbitration, mediation, and conciliation. Coordination across such a large number of complex specialty areas will clearly require expert advice, recognising that few ‘qualified experts’ cover multiple areas of specialised expertise. At a minimum, available expertise must include specialised commercial issues, as well as environmental and social welfare matters. Moreover, it is not enough simply to write a statement, mandate or prohibition into national law – the draftsperson at the national level must have some specialised knowledge about drafting legislation in a way that makes it practically functional. Finally, and perhaps most importantly, the cross-border nature of ABS legislation means that those preparing national ABS frameworks will need to have some understanding of how enforcement and compliance actions can be undertaken in other countries. Relatively few provider countries have drafted their national ABS legislation, or even their MAT, with an eye to the manner in which those instruments would be viewed in the legal system of another country. In general, however, it is possible to improve the provider’s chances of success in a foreign country’s courts, by giving due attention to a few key elements of national legislative drafting and contract/MAT drafting, at the earliest stages of the provider country’s legislative and regulatory development.30 4.  Learning from International Experiences: Identifying Useful Shortcuts to a Functional Regime Throughout the international discussions on the concept of ABS since before the Rio Conference on Environment and Development of 1992, one critical  The Internet appears to be the situs of a veritable ‘model-writers’ derby’, wherein model laws and contracts of unstated provenance are published by authors and other publishers who have never negotiated legislation or contracts of the type presented in the model. Although well-meaning, these have contributed to the problems of expectations, ineffectiveness and uncertainties that have plagued ABS negotiations in the past. These challenges have been documented in the unattributed presentation entitled “Bioprospektion zu fairen Bedingungen?”.

30

464   Tomme Rosanne Young element has been the attempt to identify ‘shortcuts’ and possible institutional methods that could be borrowed from other areas of international law to save costs and time. Most of these proposals involve either modeling particular elements of ABS after elements of other international instruments, or tying particular elements of ABS into the work already being undertaken by existing institutions. The thinking regarding the former option is that it will save the cost and time involved in detailed institutional development, while allowing those negotiating national, bilateral or global elements of the system to work with a conceptual model they already understand. With regard to the latter option, the perception is that the savings might even be greater (especially if another agency takes on responsibility for a particular ABS element or action), so that the overall cost of the ABS regime will be lowered permanently. If properly used, both of these approaches may save costs and time; however, such a saving is not automatic. In many cases, efforts to utilise an existing framework to implement an element of the ABS regime, have proven very costly and time-consuming, providing little benefit to CBD and ABS processes.31 Integration of any element of the Nagoya Protocol with the work of any national or international regime focused on objectives different from those of the Protocol can only be undertaken after careful analysis. The quick adoption of a new element that does not function well could cause the entire failure of the ABS regime. In general, two factors determine whether another framework or regime element can provide a useful model for ABS: comparability (similar general structure) and functionality (similar underlying factors that motivate effectiveness). These challenges underlie all proposals to shortcut any aspect of a new legal regime, whether at national or international level. For the comparability analyses, of course, the questions are relatively simple, asking how the other regime is similar to or different from ABS. The functionality analysis, however, is more challenging as it must look to the underlying factors (especially incentives and sources of funding) that drive implementation. Framework developers must examine why and how all or part of the other experience is relevant to ABS, what incentives underlie its functionality, and  Since 2002, for example, efforts have been expended in an attempt to link ABS implementation with international patent processes. See CBD Ad Hoc Open Ended Working Group on ABS, “Technical Study on Disclosure Requirements related to Genetic Resources and Traditional Knowledge: Submission by the World Intellectual Property Organisation (WIPO)” (2003) UN Doc UNEP/CBD/WG-ABS/2/INF/4. This and other heroic efforts of Shakeel Bhatti (then at WIPO) aside, the result of that work has not provided any direct impact on the Nagoya Protocol. Other WIPO reports on the ABS-intellectual property relationship are available at http://www.wipo.int/tk/en/genetic/proposals/index.html (accessed 11 May 2012).

31

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whether and to what extent it is successfully achieving its objectives. Answers to these questions cannot be predicted on the basis of surface similarities, and even where elements seem very similar on the surface, they may be discovered to be incompatible at the deeper practical level. To date, the most common attempts to use such shortcuts have arisen with regard to the ‘monitoring’ aspects of the ABS regime, although other potential shortcut concepts may arise or be suggested by ABS participants in future. In part as an example of how other systems have fared as models for one aspect of ABS implementation, this chapter discusses some of the proposed monitoring shortcuts under the heading ‘ABS Monitoring’ below. Its discussion may also help clarify the manner in which shortcuts can be effective in addressing the range of other legal issues that arise in the course of developing the Protocol’s implementation framework. 5.  Identifying Needs and the Level at Which They Must Be Met Since the earliest negotiations leading to the adoption of the CBD, the ABS regime has always been defined by its strong commitment to decentralised implementation. Ostensibly to alleviate concerns regarding the costs of an ABS system, negotiators took the position that implementation of the ABS regime would occur overwhelmingly at transactional and national levels. They were often assuming, however, that with regard to the most difficult issues (the nature of ABS and of rights in genetic resources and associated traditional knowledge, the type of rights and protections addressed in ABS contracts) necessary law already existed, in the form of national law on property, contracts and commercial matters.32 In effect, it was believed that individual contracts and existing contract law (described in its simplest form) would be easily able to serve as the basic framework for the ABS regime.33 These general assumptions were, unfortunately, not based on legal analysis or

 Glowka, A guide to designing legal frameworks to determine access to genetic resources.  Michael Gollin, “Elements of Commercial Biodiversity Prospecting Agreements” chapter 10 in The Commercial Use of Biodiversity, ed. Ten Kate and Laird. See also Sarah Laird, Equitable Biodiversity Research Relationships in Practice: Written Agreements Between Communities and Researchers (Waterbury Center, VT: World Wildlife Federation, 1999) providing a 3-page summary of ‘what a contract must include’ that omits any reference to or discussion of legal issues standards for functionality and legal certainty or contractual law obstacles to be addressed); and Brendan Tobin, “Biodiversity prospecting contracts: the search for equitable agreements”, chapter 9 in Biodiversity and Traditional Knowledge: Equitable Partnerships in Practice, ed. Laird, (listing in less than a page the ‘key contractual provisions’ without reference to content of such provisions or legal issues underlying them).

32 33

466   Tomme Rosanne Young legislative experience, and left many commercial, contractual, property and legislative experts mystified.34 Over the various stages of ABS analysis, it became generally accepted that ABS could not be implemented solely using a decentralised approach. No basic floorplan for multilevel ABS implementation, however, was ever drawn up. For such a plan one would need, at minimum, to identify which elements of ABS can be addressed (without the need for enabling provisions or further international consensus) at national and transactional levels, which must be enabled by international means, and which may be dealt with at either level. A number of elements that appear to require implementation action at the purely national level. These include identification of how genetic resources and associated traditional knowledge fit within national property laws (i.e., what type of property are they); clarification of who holds ownership and/or the right to grant access to the genetic resources and associated traditional knowledge, etc.); determination of who (or what community or entity) is authorised to issue prior informed consent to ABS transactions and who (or what community or entity) must be included in discussions regarding sharing of benefits; determination of the exact types of resources (genetic, biological, ‘biochemical’)35 that are covered by each relevant law; legal requirements and/ or minimum provisions with regard to MAT, or some national determination of which person, community or entity is authorised to agree to MAT; responsibilities of users to obtain PIC and MAT; responsibilities of users to comply with PIC and MAT; responsibilities of users to share benefits with the appropriate person, community or entity in the provider country (where no PIC/MAT have been obtained); and tracking of genetic resources and associated traditional knowledge to the extent called for in the Protocol (through checkpoints, record-keeping, etc.). At the international level, the Nagoya Protocol identifies several elements that must be addressed internationally, including monitoring and tracking of genetic resources and other elements described below. Based upon an examination of the ABS concept, it seems clear that relevant parties need to come to some agreement regarding how it will address types of resources that are  See Tomme Young, and Shakeel Bhatti, “ABS Contracts and Contract Law”, in Contracting for ABS: The Legal and Scientific Implications of Bioprospecting Contracts, ed. Tomme Young et al. (Bonn: IUCN, 2009): 3. 35  Although numerous national laws (adopted pre-Nagoya) include ‘biochemical’ resources within the coverage of ABS, there is no current agreement on the meaning of this term, and it was not included in the Nagoya Protocol. See, Costa Rica, ABS Regulations – Normas Generales para el Acceso a los Elementos y Recursos Genéticos y Bioquimicos de la Biodiversidad (Decreto No. 31 514, 2003), issued pursuant to the Organic Law on the Environment (N° 7554 of 4 Oct. 1995), §§ 46–47; and the Biodiversity Law (N° 7788 of 30 April 1998), § 62. 34

An International Cooperation Perspective   467

included in provider-country national ABS law, but not covered by the CBD or the Nagoya Protocol (i.e., national laws that include biological resources or ‘biochemical resources’, or national laws whose definition of genetic resources is broader than the definition in the CBD and Nagoya Protocol) or not covered under the ABS law of the user country. Similarly, in addition to basic questions involving ‘misappropriation’ of genetic resources (taking and/or utilizing genetic resources without PIC or MAT) and/or ‘misuse’ of genetic resources (utilizing genetic resources in violation of PIC or MAT) relevant levels of agreement could provide an important basis for dispute resolution, in post-access transactions in which the genetic resources and associated traditional knowledge are transferred to some other person, entity, or country; failure to obtain PIC; or failure to comply with MAT. Broad international principles that apply to claims against users who did not obtain PIC, would be of great benefit to the global ABS regime, if they could be agreed at the global level. Finally, it seems obvious that basic elements of national jurisprudence could also play a significant role in ABS implementation, although such elements vary greatly from country to country. Thus, broad or global acquiescence to basic jurisdictional rules (for example, ‘what evidence must be shown to sustain a claim that a user had taken access to genetic resources and associated traditional knowledge without PIC’? And ‘what evidence is sufficient to prove that claim?’) could be a major contribution to the functional implementation of ABS.36 Beyond these points, other critical questions relating to ABS remain too ambiguous to enable developed-country attorneys to state with confidence that ABS could be enforced in their countries.37 Many of these are matters of first impression in areas of contractual and commercial law.38 As such, they may be susceptible of resolution at either national or international levels, although it will be best if parties agree about which level applies in specific instances. In such cases, it would seem essential, in the development of an internally consistent, loophole-free ABS regime, to clarify key standards and the manner in which they are used, giving each country leeway in how the standards are applied in their national courts. In this connection, ABS also offers opportunities for regional, sub-regional and bilateral development, although none of these is required under the Protocol. This approach offers  These questions are only indicative. Similar questions apply to compliance with MAT and other matters. 37  E.g., Morten W. Tvedt and Ole K. Fauchauld, “Implementing the Nagoya Protocol on ABS: A Hypothetical Case Study on Enforcing Benefit Sharing in Norway”, The Journal of World Intellectual Property 14 (2011): 383. 38  Tomme Young, “Applying Contract Law to ABS” and “Contract Provisions and Experience” in Shakeel Bhatti, et al., eds., Contracting for ABS: The Legal and Scientific Implications of Bioprospecting Contracts (Bonn: IUCN, 2009) 39 and 79 respectively. 36

468   Tomme Rosanne Young some of the best hope for effective ABS implementation, especially in the areas of compliance and tracking. In general, based upon legal and legislative scholarship over the past 18 years, the ABS regime has numerous needs that cannot be met by multiple (often inconsistent) national legislative measures alone, and many others for which some international-level work may be either necessary or advisable. This is particularly the case of the development of guidance to enable countries to adopt provider-side measures that have some chance of being enforced in the courts of the user-country.39 The time has come to move beyond the generalities that have been offered in the past, and to take positive measures to develop specific legislative provisions and standards that will be sufficient to implement ABS.40 It is not within the scope of this chapter to create a full-fledged plan for implementation of ABS. Rather, the following sections look at international activities for implementation of the Protocol, including both measures that must (according to the Protocol) be addressed at the global level, and several kinds of action that may be addressed internationally with positive results for implementation of the ABS regime.

III.  International ABS Implementation Tools The Nagoya Protocol includes reference to a number of potential tools on a global, regional, or other international level. If used in an appropriate way, these tools may go far toward enabling a balanced, implementable ABS regime. The discussions in Nagoya made it clear that many, if not all, CBD Parties hoped that the ABS regime would be globally agreed in a way that would enable consistent and streamlined access to and utilization of genetic resources, no matter which countries or persons are involved in the ABS transaction. Although it contains reference to particular tools for enabling such an approach, however, the language of the Protocol indicates that few of its provisions regarding international implementation activities and tools are mandatory.

 As noted above, developed countries generally operate under a ‘strict rule of law’ approach, particularly with regard to commercial legal issues, such as contracts, property transactions and commerce. In these countries, a few words may make the difference between whether a contract or foreign law is enforceable in the country’s courts or not. See Young, “Applying Contract Law to ABS” and “Contract Provisions and Experience”. 40  The few available models for ABS contracts or legislation are generally insufficient to sustain a legal action for benefit sharing in courts in the US, for example. See Young, “Contract Provisions and Experience”. 39

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The following discussion considers only the international tools for Protocol implementation, recognizing that the best way to ensure inter-operability among national ABS laws will probably involve some level of development at the global level, but noting that the current level and nature of divergence among national ABS legislation could not be reasonably included in this discussion. The sub-sections will begin with international tools that are mandatory: the ABS clearing-house, the monitoring framework, and determinations by the Protocol governing body – the meeting of its Parties (COP/ MOP). Attention will then turn to particular non-mandatory international activities mentioned in the Protocol, and finally briefly to some elements of the Protocol that seem to imply international action. 1.  The ABS Clearing-House The ABS clearing-house is one of the primary international tools that is mandatory under the Nagoya Protocol.41 It is formally given responsibilities in two ways, directly and indirectly, as briefly described below. a.  Direct Responsibilities of the ABS Clearing-House First, the Nagoya Protocol describes a number of specific informationgathering facets of the ABS clearing-house, as follows: serving as a means for sharing of information related to access and benefit sharing; and in particular providing access to information made available by each Party relevant to the implementation of this Protocol.’42 The ABS clearing-house’s unequivocal duty to provide access to information is at the heart of many elements of ABS as set out in the Protocol. As discussed in the next section, this duty can have a major impact on the commercial aspects of ABS transactions. The Protocol goes on to list particular types of information that must or may be included in the ABS clearing-house. Mandatory information includes: ABS legislative, administrative and policy measures; national focal point and competent national authority information; and ‘[p]ermits or their equivalent issued at the time of access as evidence of the decision to grant prior informed consent and of the establishment of mutually agreed terms.’43 Non-mandatory information includes: ‘[r]elevant competent authorities of indigenous and local communities, and information as so decided’, model contractual clauses; ‘[m]ethods and tools developed to monitor genetic resources; and [c]odes of conduct and best practices’.44  Nagoya Protocol Article 14.  Nagoya Protocol Article 14.1 (emphasis added). 43  Nagoya Protocol Articles 14.2.c. 44  Nagoya Protocol Articles 14.3.c–d. 41 42

470   Tomme Rosanne Young b.  Less Directly-stated Elements of the ABS Clearing-House’s Role In addition to those elements mentioned above, however, the ABS clearinghouse appears to be called upon to undertake a number of other activities, if it is to satisfy its various roles within the Protocol. Depending on how well it addresses these indirect elements, the ABS clearing-house can be an important international forum for determining how ABS operates. For example, the Protocol specifically alludes to the ABS clearing-house’s duty to receive notifications of the issuance of a permit or its equivalent as evidence of the decision to grant prior informed consent.45 Based on this function, coupled with the general duty to ‘provide access to information made available by each Party’,46 one may infer that the ABS clearing-house will post internationally recognised certificates of compliance online. From there, it may be only a short hop to development of some level of verification of postings (at minimum contacting the country purported to have issued the permit or internationally recognised certificate of compliance), determination of confidentiality issues and even possibly online tracking of the status of permits and internationally recognised certificates of compliance that have been posted. All of these are issues that could create loopholes that impair ABS functionality. As such, it appears that they must be addressed at some level, if there is to be a realistic international system for addressing compliance and/or raising claims of non-compliance under the Protocol. The ABS clearing-house process may serve as a forum for addressing these concerns through international consensus discussions in a manner that can be recognised by courts in strict-rule-of-law legal systems. The solutions provided by the ABS clearing-house may be more basic and less technical, however, but still useful. For example, the permit-posting duty of Parties (and the related role of the ABS clearing-house) is not entirely clear. The Protocol does not require the submission of ABS permits, equivalents or internationally recognised certificates of compliance, calling only for notification of the ABS clearing-house, without specifying what these notifications should include, or what the ABS clearing-house will do with them.47 On the other hand, the Protocol specifically requires submission of every ABS permit or internationally recognised certificate of compliance to

 Nagoya Protocol Articles 14.1 and14.2.c (joining the ABS clearing-house’s duty to make available information with every Party’s duty to provide either an ABS permit or an internationally recognised certificate of compliance for each grant of access : ‘. . . each Party shall make available to the Access and Benefit-sharing Clearing-House . . . (c) Permits or their equivalent issued at the time of access as evidence of the decision to grant prior informed consent and of the establishment of mutually agreed terms’ (emphasis added). 46  Nagoya Protocol Article 14.1. 47  Nagoya Protocol Article 6.3(e). 45

An International Cooperation Perspective   471

the ABS clearing-house.48 Given this inconsistency, it is possible that Parties will need to collectively adopt some specific practice – either a notification format (or at least the minimum contents of notification) or a general agreement that the permit must be posted in each case. Other issues may be more technical or otherwise more difficult. Two of these are validation and confidentiality. Regarding these issues, the need for clear legal guidance or generally agreed practices is urgent. The Nagoya Protocol, although indicating that a permit or its equivalent shall be made available to the ABS clearing-house, does not indicate who is responsible to do so.49 This creates an immediate question of validation. If a purported permit (or equivalent) is submitted by any person or entity other than the issuing agency, however, there may an immediate need to validate it – i.e., to ensure that the permit was actually issued by the proper authority, and that the document posted is a true and correct copy of it.50 This is potentially very important. If the documents posted in the ABS clearing-house are not validated, then an unscrupulous person could use the ABS permit to evade his responsibilities under ‘user-side measures’ that may be adopted in the country with jurisdiction over that person.51 A related question of importance also affects the ABS clearing-house’s receipt and posting of permits – whether any of the information contained in it may be considered confidential. At present, there is no international law of confidentiality. Thus, the confidentiality of information in a permit must be determined under national law – although national law on confidentiality varies greatly from country to country. Unfortunately, the Protocol is not clear about which national law would apply – that of the user country, the provider country or the country with other jurisdiction over the user or transferor. If this point is not appropriately addressed and decided with regard to every ABS permit or situation, it can create commercial uncertainty – specifically, it could result in a situation in which one country submitted the  Nagoya Protocol Article 14.2(c).  Nagoya Protocol Article 15.2. 50  For an analysis of this issue as applied to the Cartagena Protocol’s Biosafety Clearing-House, see Tomme Young, “Access to Information and the Biosafety Clearing-House”, Chapter 8 in Legal Aspects of Implementing the Cartagena Protocol on Biosafety, eds. Marie-Claire Cordonier Segger et al. (Cambridge: Cambridge University Press, forthcoming 2012). 51  In addition, many countries limit the ability of governmental officers and employees to contact officials of other countries in any way. Solutions to the need for verification exist, if one is willing to examine experiences under national and global systems that work through computer connections. In this era of computer fraud, however, it is critical to not to overlook or oversimplify this potential problem area. For a description of problems of permit validation under CITES, see Monika Anton et al., eds, Proceedings of the International Expert Workshop on the Enforcement of Wildlife Trade Controls in the EU (Bonn: IUCN and TRAFFIC International, 2002). 48 49

472   Tomme Rosanne Young entire permit to the ABS clearing-house, without redacting any information, while other countries and/or the user may submit only a redacted version, claiming that any public posting of the other information violates the user’s rights to keep certain information confidential. In most countries, commercial uncertainties of this type are much more likely to be decided in court than more general uncertainties in environmental laws. If a formal claim were brought in such a situation, the issue could ultimately be addressed either in an environmental tribunal with no prior experience with commercial confidentiality questions, or in a commercial tribunal which understands the confidentiality issue but has no understanding of ABS.52 By addressing the problem in the Parties’ discussion of ABS clearing-house modalities at the international level, the Protocol could create a negotiated ‘win-win’ solution and avoid the worst possible outcome: a judge-made solution that none of the Parties would have wanted. Another critical question affecting the ABS process may also be relatively easily resolved through the ABS clearing-house. Over the past twenty years, users have noted problems in determining when/whether an ABS permit/ equivalent is ‘final’ – i.e., when/whether all rights of appeal by persons who oppose the permit have been exhausted, and when/whether the issuing government’s rights to alter or withdraw the permits have expired.53 Any effort to research this question finds multiple differing constructions across the range of national and international agencies and tribunals. If a permit (or equivalent) is posted on the ABS clearing-house, it should be clear whether that permit may still be appealed or withdrawn. One of the simplest ways to ensure clarity on this issue would be to address the point in the ABS clearinghouse’s operating modalities (discussed below). Another potentially important role for the ABS clearing-house is found in consideration of the Protocol’s awareness-raising provisions. In particular, the Protocol places an affirmative obligation on all Parties to ‘take measures to raise awareness.’54 Although the selection of possible measures is discretionary (each country may determine which measures to adopt), the Protocol’s list of such measures includes the following: (f ) Promotion of, as appropriate, domestic, regional and international exchanges of experience; [and]

 As further discussed, this type of problem has been encountered in national implementation of the Cartagena Protocol. 53  The Protocol specifically calls for the inclusion of some appeal and related rights. Nagoya Protocol, Articles 6.3.g.i and 18.2. See also UN Docs UNEP/CBD/WG-ABS/3/INF/10, 15–21. 54  Nagoya Protocol Article 21. 52

An International Cooperation Perspective   473 (g) Education and training of users and providers of genetic resources and traditional knowledge associated with genetic resources about their access and benefit-sharing obligations.55

Both of these activities can be greatly aided through appropriate use of the ABS clearing-house. In addition, of course, as shown by the examples of the CBD’s Clearinghouse Mechanism and the Cartagena Protocol’s Biosafety Clearing-House, the ABS clearing-house is often intended to be a tool for interlinking key participants in the ABS regime. These participants include national focal points and competent national authorities of various countries,56 as well as individual or community ‘providers’, ‘ABS experts’ of various types (scientific, legal, administrative) and various categories of users of genetic resources and associated traditional knowledge. If it is to achieve this objective, the ABS clearing-house should evaluate the successes and failures of the Convention Clearing-House and Biosafety Clearing-House and other national focal points/competent national authorities’ mechanisms.57 c.  Setting the Modalities of the ABS Clearing-House Although the predecessors of the ABS clearing-house (the Convention’s Clearing-House Mechanism and the Cartagena Protocol’s Biosafety ClearingHouse) have been underutilised and have been developed rather haphazardly, without a clear mandate,58 their experience can provide a wealth of information regarding whether and how the information-sharing elements of the CBD and the Cartagena Protocol have worked, what objectives they have achieved and whether some original goals for these mechanisms have been relinquished. Better understanding of these matters could ensure that the ABS clearing-house provides the maximum benefit to the operationality of the Nagoya Protocol, particularly with regard to its ‘implied functions’ – i.e., those elements that are not directly mentioned in the Protocol, but which are inferred from other points. One such element is the interconnection of national focal points and competent national authorities – not only interconnecting the Nagoya Protocol’s national focal points/competent national authority group, but also enabling  Nagoya Protocol Article 21.1.f–g.  Nagoya Protocol Article 13. 57  Tomme Young et al., “Evaluation of FAO Corporate Strategic Objective B-1: International instruments concerning food, agriculture, fisheries and forestry, and the production, safe use and fair exchange of agricultural, fishery and forestry goods” (2009) 38–54, accessed 9 May 2012, http://typo3.fao.org/fileadmin/user_upload/oed/docs/Strategic%20Objective %20B1_2009_ER.zip. 58  Young, “Access to Information and the Biosafety Clearing-House”. 55 56

474   Tomme Rosanne Young this group to connect to experts and to users, directly and vice versa. Perhaps even more important, and certainly unmentioned in the Protocol, is the idea that each national focal point would communicate with his country’s national focal points of other international instruments. Such interconnection has been suggested by the governing bodies of many multilateral environmental agreements, in resolutions seeking coordination among international instruments and bodies, and complaining at the fact that many of the efforts of international processes overlap and some even conflict with one another. Unfortunately, early research into the effectiveness of this kind of national level inter-MEA national focal points connection processes has shown that such processes are generally not functional and do not provide the expected coordination: One of the most consistent findings throughout country visits was the fact that national delegates to, and national focal points of, international instruments lack one essential type of capacity to enable them to do their job – sufficient time. . . .  Within this limit, the focal points are responsible for, inter alia, the following: • maintaining awareness of developments in their assigned instrument; • responding to inquiries from the international instrument’s Secretariat and others, asking about the country’s implementation and situation; • informing national legislative bodies regarding the commitments made and other actions required or recommended vis-à-vis their assigned instrument, including the impact of such actions on national law, practice, policy and other matters; • reviewing national legislative and regulatory decisions potentially affecting or conflicting with implementation of their assigned instrument and liaising to avoid unintentional conflicts and to help resolve or address those which seem unavoidable; • liaising with focal points of other relevant or potentially relevant instruments to maximise implementation synergies and avoid conflicts or ambiguities; • reading, digesting and gaining necessary technical advice regarding the documents prepared and circulated in advance of each meeting relevant to their assigned instrument; • obtaining policy and other input from all affected governmental and private sectors into preparation of positions and instructions for national delegations; and • informing other ministries, departments and stakeholders of the developments, actions, decisions and requirements of their assigned instrument.  . . . This was generally reckoned to require more work than could be reasonably undertaken, particularly when one considers that most national focal points have been given that task as an ‘add on’ to their ‘regular duties’ – which are, in many cases, already a more-than-full-time workload. In particular, the last two bullet points were recognised to be essential. Nearly all focal points interviewed, as well as an overwhelming majority of survey respondents indicated that they seek input from other sectors and ministries prior to leaving to participate in the [COP or other] meeting, and that they

An International Cooperation Perspective   475 inform the same group of the results following the meeting. During country visits, however, a serious gap in this process was evident. Although most focal points and agencies claimed to include other ministries in the various preparations for and responses to processes for which they are responsible, very few had themselves been included in the processes of other instruments or had any specific knowledge about relevant developments in those instruments.59

Similar findings have been identified in other studies,60 where goals such as ‘streamlined reporting’, ‘awareness raising’ and ‘information-sharing’ face their first challenge in the discovery that national focal points of mutually relevant international instruments often have little or no contact with their counterparts within their own country. Although many of the above-described issues could eventually grow to become obstacles to the Protocol implementation, they currently appear to present only small internal inconsistencies. As such, it might still be possible to resolve them relatively easily, in the course of addressing the COP/MOP’s obligation to negotiate the modalities of operation of the ABS clearing-house.61 That low-pressure forum could resolve in a practical way, the solutions to many elements of Protocol operationality, without raising those issues to a level of diplomatic argument that often prevents the adoption of practical solutions. As noted above, some such matters include the form for ‘notification’ to the ABS clearing-house, standards for confidentiality determination, and verification of permits and other instruments that might be given legal recognition by the courts of countries other than the country granting the permit or instrument, etc. 2.  ABS Monitoring The prevailing view under the Nagoya Protocol assumes that the ABS regime will operate through a system of monitoring and/or tracking of genetic resources and associated traditional knowledge from the initial  Young et al., “Evaluation of FAO Corporate Strategic Objective B-1”.  Tomme Young, “Reporting Harmonisation Prospects Among the ‘Rio Conventions’: an element of the ten-year Strategic Plan and Framework to enhance the implementation of the UNCCD” (Prepared for UNCCD COP 9, Buenos Aires, 2010, available from the author). See General Assembly Resolutions A/RES/57/257 (2002) paragraph 4; A/RES/64/73 (2009) paragraph 14 (UNFCCC), A/RES/57/260 (2002) paragraph 10, and A/RES/64/203 (2009) paragraph 18 (both CBD) and A/RES/57/259, (2002) paragraph 15 and A/RES/64/202 (2009), paragraph 6 (UNCCD) – expressing the need to harmonise international conservation reporting as part of a call to ‘promote complementarities’ among the Rio Conventions. See also, “Proceedings of the Governing Council/Global Ministerial Environment Forum at its Twenty-Fourth Session” (2007) UN Doc UNEP/GC/24/12. 61  Nagoya Protocol Article 14.4. 59 60

476   Tomme Rosanne Young ‘access’ through all types of utilisation, to ensure that the benefits arising from utilisation of genetic resources and associated traditional knowledge are properly shared with the government, entity or individual that provided access to those resources. In terms of implementation at the international level, the most important aspects of the Protocol’s monitoring provisions are: i) the focus of monitoring provisions on the utilisation of genetic resources: ii) the creation and possible use of the internationally recognised certificate of compliance, and iii) the possible use of other existing international processes to implement ABS monitoring. The following sections briefly consider each of these aspects. a.  Focus on Utilisation The Protocol is notable in that its monitoring provisions focus solely on ‘monitoring the utilisation of genetic resources’,62 rather than tracking the resources themselves. In keeping with general principles of international law, each country has the exclusive sovereign duty and right to control and oversee all human activities within that country and similar rights over all of its physical resources, with little or no responsibility to accede to any other authorities’ wishes with regard to them, except as it formally agrees in international conventions and similar undertkings.63 Thus, the duties described in the Protocol in relation to monitoring would only make sense if they are duties of the country in which utilisation occurs – i.e., to govern activities (utilisation of genetic resources) within their borders. This aspect of Protocol implementation is challenging, in that it implies that those countries must know or oversee what private or institutional users are doing in their laboratories. One source of developed countries’ concern about the user-measures was the possibility that they might be required to inspect private facilities to determine whether they are ‘utilising genetic resources’, and to determine the source of all biological material involved in such utilisation. Not only would these kinds of governmental activities be enormously costly, but they would also involve a level of government incursion into private activities not permissible in many western developed countries.  Title and language of Nagoya Protocol Article 17 (emphasis added).  For example, under the CBD, Parties agree to control impacts of actions within their borders, to the extent that they may cause harm outside those borders (other countries or areas beyond national jurisdiction). CBD Articles 3 and 14. To date, few cases refer to this provision, but where such a case has been brought, it has focused on potentially damaging impacts of human activities, rather than of natural conditions. E.g., ICJ, Pulp Mills on the River Uruguay (Argentina v. Uruguay) Judgment of 20 April 2010, accessed 11 May 2012, http://www.icj-cij.org/docket/files/135/15877.pdf?PHPSESSID=88f61db6e146a327071f6d5 efffc9599.

62 63

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b.  Legal Mechanisms for ABS Monitoring From the earliest discussions on ABS, practical analysis of monitoring needs in the ABS process has emphasised, inter alia, monitoring costs – both in terms of time and money.64 Ultimately, negotiators appear to have recognised that, in practical terms, a compliance-oriented ABS regime could enforce benefit-sharing obligations only to the extent that it includes effective tracking or monitoring. To this end, the Protocol monitoring system is built on two foundational components: the internationally recognised certificate of compliance (or equivalent), and a series of relevant ‘checkpoints,’ which would collect or receive a variety of types of information, possibly including ‘relevant information related to prior informed consent, to the source of the genetic resource, to the establishment of mutually agreed terms, and/or to the utilisation of genetic resources, as appropriate’65 The Protocol leaves broad leeway for Parties regarding their individual determinations about what constitutes a ‘checkpoint’ for monitoring purposes. This open phrasing does not render checkpoints optional; in fact, based on a literal interpretation, the Protocol imposes a strong obligation on any country with jurisdiction over the utilisation (possibly including transborder movement)66 of genetic resources, when it states that

 E.g., Brendan Tobin et al., “The Feasibility, Practicality and Cost of a Certificate of Origin System for Genetic Resources: Preliminary Results of Comparative Analysis of Tracking Material in Biological Resource Centres and of Proposals for a Certification Scheme” (2005) UN Doc UNEP/CBD/WG-ABS/3/INF/5. Challenges to its optimistic conclusion came quickly thereafter: International Chamber of Commerce (ICC), “Issues for consideration by the Group of Technical Experts concerning a Certificate relating to genetic resources” (2007) UN Doc UNEP/CBD/WG-ABS/5/INF/4. See also CBD Ad Hoc Open Ended Working Group on ABS, “Extract from the Report of the Twelfth Regular Session of the Commission on Genetic Resources for Food and Agriculture, Rome, 19–23 October 2009” (2009) UN Doc UNEP/CBD/WG-ABS/8/INF/7 and CBD Ad Hoc Open Ended Working Group on ABS, “Study on the Identification, Tracking and Monitoring of Genetic Resources” (2009) UN Doc UNEP/CBD/WG-ABS/7/INF/2. 65  Nagoya Protocol Article 17.1(a)(i). 66  The Protocol does not specifically identify who or what is being tracked, requiring only ‘measures, as appropriate, to monitor and to enhance transparency about the utilisation of genetic resources’: Nagoya Protocol Article 17.1 (emphasis added) and stating what those measures ‘shall include’, without mentioning who or what they shall apply to. As presently defined, the term ‘utilisation of genetic resources’ is extremely broad, covering all activities involved in ‘conduct[ing] research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology’: Nagoya Protocol, Article 2(c). Unlike most other references to ‘utilisation of genetic resources’ in the Protocol, however, Article 17.1 does not also refer to the ‘commercialisation and subsequent application’ of genetic resources. If the coverage of Article 17.1 requirements is ever brought before a tribunal, that body may be forced to set a clear dividing 64

478   Tomme Rosanne Young Each Party shall . . . require users of genetic resources to provide the information . . . [and] take appropriate, effective and proportionate measures to address situations of non-compliance.67

In earlier ABS discussions, as well as during the Protocol negotiations, several experts suggested applying mechanisms from other sectors to ABS implementation, as means of lowering the cost of regime implementation and individual transaction costs: intellectual property protection, the Convention on International Trade in Endangered Species (CITES) and certification systems. Alas, as described below, the assumptions related to all of these options were demonstrably false. In the ABS context, all three of the above suggestions fall under the analysis of their comparability and functionality. i)  Patent Filings One of the most common proposals to shortcut ABS obligations relates to the integration of ABS with patent and other intellectual property protections, at national and international levels.68 Initially, these proposals arose out a provision thought to be closely related to ABS – (CBD Article 16 on transfer of technology), in which the CBD specifically calls on Parties to take patent and intellectual property rights into account.69 Thus early regime thinkers, seeking ways to create a framework to govern the rights to genetic informaline, determining which commercialisation-directed activities constitute ‘development’ and which do not. 67  Nagoya Protocol Article 17.1.a.ii (emphasis added). 68  Adopting such a system well after most ABS discussions had concluded that it does not satisfy CBD Article 15 (and after the option was virtually ignored in the final Nagoya Protocol), Germany has recently enacted its ABS patent law (Germany Patent Act (as amended by the Act on Improvement of Enforcement of Intellectual Property Rights of 31 July 2009), which provides, as translated in the website of the relevant agency, that ‘If an invention contains biological material of herbal or animal origin or such material is being used the patent shall include a declaration about the geographical origin if that place is known. The inspection of the registration as well as the validity of the rights based on patents remains unaffected.’ (Ibid., paragraph 34a) Although considered by the German agency posting this notice to be ‘a significant step with the ratification of Article 15 of the CBD’, experts have noted two facts that diminish this significance. First, the existence of the European Patent Organisation and its relationship to Member States’ patent offices, virtually negates any practical value of this decision. Second, of course, the law does not contain any basis for confirming the validity of patent declarations of this type (especially declarations that no animal or herbal material is contained in the invention), nor does it include any protection for the provider or vehicle for him/it to seek benefit-sharing. 69  In the relevant part, CBD Article 16.2 notes that ‘[i]n the case of technology subject to patents and other intellectual property rights, such access and transfer shall be provided on terms which recognise and are consistent with the adequate and effective protection of intellectual property rights.’

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tion, turned to the only existing legal framework addressing rights to information – patent rights and other intellectual property rights. Several factors, however, indicate that patent law does not provide a shortcut to ABS implementation, even in the realm of ‘user-country measures’. First, reliance on the patent system poses serious questions of comparability. In its normal application, the patent system places strong demands on the users (patent applicants and holders), including requirements of detailed disclosure, but those demands are offset by the benefits that the users get from their compliance with the system. A patent applicant will disclose information in his patent application where he hopes that his patent will prevent any person from using the disclosed information without paying for a right to use it. The ABS filing would not have this result for the patent applicant, and might even limit the scope of his resulting patent. The filing requirement is, in fact, intended to provide a basis for a foreign provider to know about and challenge the patent or seek benefits from the patent-holder. As such, there would be little incentive for a patent applicant to make such a disclosure. For the same reasons, it is clear that, if ABS implementation relies on a patent system for compliance purposes, then it is relevant to consider how intellectual property claims are brought, and who has the burdens of paying for and asserting them. A patent-based ABS system would impose its most significant demands and costs on the provider (developing country, rural person or community, other indigenous and local communities), who alleges non-payment or other misappropriation or misuse of genetic resources. Normally, the provider has few or no funds with which to seek recourse in the country of the user, and would find it difficult and costly to bring a case applying the law of that country. Moreover, the patent-issuance institutions are funded by patent application fees, placing the issuing agency and the applicant on the ‘same side’ in terms of their best interests. As a result, patenting results are strongly skewed in favor of patent issuance, leaving responsibility and costs of determining that issuance was inappropriate to be borne by those who would challenge the patent. ii)  Utilising CITES and Customs Control Entities for ABS Monitoring Over time, the ABS discussions grew to include many persons who were not fully aware of the nature of the challenges underlying ABS. Many of these persons assumed that the control of cross-border utilisation of genetic resources would be relatively simple – operating through control of the crossborder traffic in biological specimens and materials. This led many people to assume that ABS, too, could be very simple, by applying the elementary system created under CITES to control the movement of specimens, parts and

480   Tomme Rosanne Young products/derivatives of endangered or threatened plants and animal species listed through that Convention’s processes. To most ABS negotiators, this simplistic approach was clearly inappropriate. It was clear to them that involvement of CITES management bodies in ABS enforcement would not be particularly practical, especially because the concept of ‘genetic resources’ includes many species and sub-species that are not threatened or endangered, and not protected by any law. Indeed, one can legally purchase and remove samples of most biological organisms in any country without any record being made. However, the legality of this purchase would not, in most cases, eliminate the obligation of the purchaser to comply with ABS, if he intended the utilisation of the sample’s genetic resources.70 In response, it was suggested that the CITES shortcut should be seen as a ‘customs shortcut’, and that CITES’s relationship with customs officials would be tapped to take responsibility for ABS monitoring. This idea led to detailed analysis and discussions, until one particularly useful presentation demonstrated that CITES operates through a detailed time-consuming and paper-filled process, not likely to provide any shortcutting, streamlining or cost-saving, but broadly extending the current procedures to virtually all specimens of any species (beyond the approximately 10,000 species to which CITES currently applies).71 Also, the CITES approach would vastly extend the duties of CITES officers and customs officials with regard to matters outside their agency’s current mandate, without necessarily providing any clear financial basis for staffing to cover this increased workload. The success of a CITES-modeled or -implemented approach, then, would depend on the willingness of each country’s ABS officials to redirect some portion of their national ABSimplementation budget to CITES management authorities and customs and other officials who would take on these added duties. It was clear, upon reviewing the extent of effort needed in each country to implement and comply with the CITES process, that implementation of ABS through coordination with CITES or even adopting the CITES approach would require expensive and detailed processes for all genetic resources (many of which are not endangered or listed under CITES), calling on underfunded environmental agencies and customs bodies in user countries to provide the  Felix Bloch, “The ‘Brazilian Clause’: A Recent Attempt to Create Linkages Between the CBD and CITES,” Review of European Community and International Environmental Law 10 (2001): 268. 71  Irina Sprotte, “The Permit and Certificate System of CITES” (paper presented at the European regional meeting on an internationally recognised certificate of origin/source/legal provenance: report of an International Workshop hosted by the German Federal Agency for Nature Conservation (Bundesamt für Naturschutz), Isle of Vilm, Germany, October 24–29, 2006). 70

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manpower for these additional responsibilities, with little incentive for those bodies to want to take on these tasks.72 iii)  Certification Systems Another group of negotiators, in considering the monitoring issue, focused on another buzzword that was prominent in international discussions at the time – ‘voluntary certification’. As used in international discussions, the concept of voluntary certification was believed to offer several advantages. It is a private-sector process and, as such, is presumed to be less costly in terms of governmental expenditure of time and money. It operates through commercial incentives and thus does not rely on a compliance mechanism. It is a flexible mechanism, more easily adjusted than national or international legislative, regulatory or other measures. It could also be applied to both the ‘product’ and ‘process’ of ABS – i.e., one could create certification of both genetic resources and the activities involved in accessing them (aka ‘bioprospecting’).73 The basic assumptions relating to certification proved to be entirely unfounded when applied in the ABS context. For these purposes, there is a critical distinction between ‘certification’ and the requirement of a ‘certificate’: the two are virtually unrelated and entirely dissimilar.74 While often implemented through non-governmental means, certification systems have proven costly, where the goal is effectiveness, and require significant oversight and relatively direct links to market mechanisms.75 The pockets out of which costs are paid may shift, but the costs of voluntary certification systems are actually significantly greater than those of mandatory governmental oversight, where such oversight is possible. Where oversight is not possible, however, certification systems are essentially ineffective. In addition, the incentive mechanism underlying all existing functional certification systems relies on commercial and consumer involvement. Such  Ibid.  Lyle Glowka, Towards a Certification System for Bioprospecting Activities (study commissioned by the Swiss State Secretariat for Economic Affairs, Bern, 2001). 74  Tomme Young, An Examination of the Pros and Cons of IUCN Involvement in Environmental Certification Systems and Standards Development (Bonn: IUCN, 2004). 75  The International Standardisation Organisation (ISO) has developed numerous papers and other resources on the prerequisites for effective standardisation in the area of social responsibility: http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail .htm?csnumber=42546, accessed 11 May 2012. See also Börkey, Glachant and Lévêque, Voluntary Approaches for Environmental Policy: An Assessment. Both conclude that a strong and direct market or similar financial connection is the most significant factor in successful certification systems, and that where the market impact is unclear or indirect the system will not function, particularly where objective verification of compliance with the standard is uncertain or impossible. 72 73

482   Tomme Rosanne Young systems are less likely to function where the underlying issue is not tightly bound to consumer awareness, understanding and demand. Recent decades have shown a lack of clear understanding of ABS, even among CBD experts and negotiators. This suggests, at minimum, that it is too early to call for voluntary certification with regard to ABS. As ‘voluntary mechanisms’, the certification systems’ underlying standards are in the hands of the particular interest group sponsoring the system. As such, the greatest challenge faced by those seeking to create and apply certification to social and environmental matters is the need for participation by NGOs, indigenous and rural communities and other affected sectors.76 Finally, evaluation of the effectiveness of certification systems has shown that such systems have virtually no noticeable impact on products and processes that are not externally verifiable. Thus, for example, it is easy to verify through testing that a particular tool or part meets international standards as to size, weight and composition; by contrast, it is often almost impossible to verify that a biological specimen in hand was collected, caught or killed legally using particular approved methods.77 iv)  Internationally Recognised Certificate of Compliance The other international aspect of the Protocol provision on monitoring relates to the internationally recognised certificate of compliance. The use of the internationally recognised certificate of compliance is not required per se, as the Protocol allows each country to use its own permit instead of the internationally recognised certificate of compliance. Still, however, the Protocol does appear to indirectly mandate the international process to develop the form of the internationally recognised certificate of compliance, and also, potentially, to determine the level of detail of information provided in filling out that form. The Protocol only begins this process, by identifying the following basic minimum data that must be in the internationally recognised certificate of compliance: • issuing authority; • date of issuance; • the provider; • unique identifier of the certificate; • the person or entity to whom prior informed consent was granted;  Note, for example, the ISO’s work on a standard for corporate social responsibility, http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=42546, accessed 11 May 2012, where this issue was intensively addressed with no clear outcome. 77  Young, An Examination of the Pros and Cons of IUCN Involvement in Environmental Certification Systems and Standards Development. 76

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• subject-matter or genetic resources covered by the certificate; • confirmation that mutually agreed terms were established; • confirmation that prior informed consent was obtained; and • commercial and/or non-commercial use.78 Given that the Protocol allows national permits to substitute for the internationally recognised certificate of compliance, one can reasonably infer that national legislation may require additional information, or may vary as to the extent of detail needed under all of these headings. Nothing in the Protocol suggests otherwise. In addition, the Protocol contains the qualifier ‘when it is not confidential’ in describing these minimum requirements, but contains no indication of which country’s rules regarding data confidentiality will apply, and how they will be determined. The combination of these two facts could lead to potential challenges for the functionality of the ABS regime, as discussed above. Thus, it may be useful for the Parties to clarify questions with regard to the internationally recognised certificate of compliance, such as whether other information about individual ABS transactions be posted in the ABS clearing-house, in addition to that listed in Protocol,79 or what rules will be used to determine which information must be kept confidential. As discussed above, it may also be essential to develop the process of verification of the validity of an internationally recognised certificate of compliance that is provided to any agency (other than the issuing agency) or to the ABS clearing-house. This latter process should also clarify the point at which such verification (if any) will be undertaken. Another question that might be considered is what procedures must be used to protect confidentiality. This issue has come up in multi-national negotiations relating to GMOs, in recent years,80 and might also affect the implementation of the ABS regime. As noted above, it seems clear that the ABS clearing-house is expected to play a significant role in monitoring, including especially with regard to permits and internationally recognised certificates of compliance.81 In addition,

 Nagoya Protocol Article 17.4.   Ibid. 80  See On-site team report, “Evaluation visit: Mexico”, (2004, available from the author), a preliminary report feeding into J. Harstaad et al., Evaluation of GEF Support for Biosafety (Washington DC: Global Environment Facility Evaluation Office, Evaluation Report No. 28, 2006) wherein it was noted that commercial entities seeking permission to introduce GMOs into Mexico had unilaterally determined not to provide the Mexican government with confidential information needed to evaluate the application, citing their belief that the Mexican government’s system for protecting confidential information was not sufficiently protective of such information. 81  Nagoya Protocol Article 17.2. 78 79

484   Tomme Rosanne Young however, the COP/MOP’s duties with regard to implementation will clearly involve fleshing out the internationally recognised certificate of compliance’s content and promoting uniformity among Parties, as discussed in the next section. v)  Summary – The Mechanics of ABS Monitoring The mechanics of monitoring are among the most important issues to be addressed in the ABS framework, requiring attention at both national and global levels. To date, the nature of checkpoints and the types of measures that could satisfy the Protocol provision on monitoring have been the issue on which utilisation countries, competent national authorities and national focal points have most often sought the author’s guidance and analysis. Given that these issues bear a close relationship to the issue of compliance as addressed throughout the Protocol negotiations, it will be important for Parties and affected persons and entities to develop a strong level of mutual understanding. The basic answers commercial entities have reached with developed countries regarding what can be legally done within their country in connection with monitoring and compliance must take full account of the concerns and interests expressed by less-developed countries, and must be fully understood by those countries as well – recognising that: (i) the success of ABS depends in large measure on whether users and user-countries see ABS as an attractive option, or at least do not dispute that it is worth the effort involved in ABS implementation, but (ii) the ultimate determination of that success will be whether developing countries perceive it, and are willing to provide and streamline access to genetic resources, in light of it. For purposes of promoting this international approach to ABS, it is possible that guidelines regarding the issues described in the above sections, particularly checkpoints and their operation might be welcomed, not only by developing countries, but also by commercial entities wishing to know exactly how the Protocol will impact them. Such guidelines could enable the certification of checkpoints, and provide a worthy use for the certification concept within the ABS regime. 4.  Negotiations after Entry into Force The time-pressure behind the adoption of the Protocol had at least one obvious impact on the Protocol’s contents – it encouraged the negotiators to leave many items for later discussion. Each instance of such procrastination arose out of two factors: either the matter was legally and/or technically complex, requiring the adoption of lengthy text or other instruments that could not be completed in time; or the matter was so controversial that final agreement on it would require the attention of a great number of delegates for more than

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the time available; or both. Ultimately, delay was perceived as the greatest threat, in light of strong mandates being pressed in the COP meeting, and the delegates began to convert these key controversial provisions into matters to be addressed in further negotiations or discussions after the Protocol was formally adopted and in force. The decision to adopt the Protocol while such issues were still unagreed was not unprecedented, as it had been used in the negotiation of the International Treaty on Plant Genetic Resources for Food and Agriculture (International Treaty), which specifically left the Standard Material Transfer Agreement to be negotiated later.82 Through that recent experience, the CBD Parties had already become aware of at least three potential pitfalls of reliance on post-adoption negotiations to finalise matters relevant to the adopted instrument. Firstly, as those negotiations made clear, some controversial issues, whether or not they have been resolved in the main negotiations, will be re-opened in the context of the post-adoption negotiations.83 Secondly, follow-up negotiations may involve negotiators who have not been given plenipotentiary responsibility, leading to a situation in which input and approval from national capitals may be needed before any negotiated point may be declared final.84 Thirdly, the number of meetings involved, and the fact that they are not viewed as ‘high-profile’ negotiations, may mean that little funding is available to help delegations from developing countries to participate, particularly if there are many separate negotiations of particular matters and instruments. Not only can this render negotiating sessions ‘non-representative’, but it can also affect the availability of translation and interpretation, further reducing ‘representativeness.’  [See contribution by Chiarolla, Louafi and Schloen in this volume (Chapter 3)].  For example, the SMTA negotiations did not appear to accept the primary compromise of the main International Treaty negotiations – namely the limitation of the Treaty’s coverage to crops and forages listed in Appendix 1. Ultimately, many international collections of plant genetic material believe that, as a result of the SMTA’s adoption, all genetic resources are covered by the Treaty. This position, as often expressed in the CBD, has been cited as a key reason that the CBD Parties have generally been able to agree to adopt any decision or instrument stating that the Treaty is ‘consistent’ or ‘in harmony with’ the CBD. Young, et al., “Evaluation of FAO Corporate Strategic Objective B-1”. 84  The well-known difficulties with the famous ‘invasive species guidelines’ recommendation of CBD Decision VI/23 “Alien Species that Threaten Ecosystems, Habitats or Species” (2002) UN Doc UNEP/CBD/COP/6/20, provides a painful reminder of the potential intransigence of problems created in these circumstances. A COP delegate, after agreeing to specific language, announced in the COP’s final plenary that he had not had his government’s agreement to that language, and refused to join in the consensus adoption of the decision. The remainder of the COP opted to adopt the decision over his formal objection, in spite of CBD COP Rules of Procedures, which require consensus decisions. Despite the passage of more than 10 years, the matter has not yet been resolved. 82 83

486   Tomme Rosanne Young The author assumes that the decision to delay a number of issues for subsequent negotiations reflects the delegates’ confidence that the COP/MOP will find a way to surmount the above pitfalls. Many of these discussions have already commenced at the time of writing, without waiting for the Protocol to enter into force. This chapter will not address these nascent discussions, however, for two reasons. First, as a purely legal matter it may be premature to consider pre-entry-into-force negotiations to be final on any point. At minimum, all such matters remain open until formally decided by the COPMOP, which does not convene until entry into force of the Protocol. In addition, of course, there is no assurance that, once it convenes, the COP-MOP will be composed of delegates who agree with these preliminary decisions. Second, as a practical matter, it may be useful for the Protocol’s parties (once the Protocol is in force) to consider the needs and incentives of users in greater detail. As of the date of this writing, the Protocol has been ratified or accepted by a total of four developing countries,85 and signed by 92 countries, of which only 27 are deemed developed countries (25 EU Member and affiliate States and two other developed countries). One may assume that user-side influence in post-Nagoya ABS negotiating processes may not be very great unless/until a significant number of developed countries will agree to be bound by the Protocol, or at least until the COP/MOP views the involvement of such countries to be a priority. Until then, current negotiations may over-emphasise ‘provider-side’ positions, giving an indication of potential controversies that may not actually exist. In terms of creating an ABS regime that achieves the objectives of provider countries, it may be important to reverse this trend and consider whether and how new rules, guidelines and other decisions might impact developed countries, and whether in fact they can provide any incentive to encourage those countries to become Parties to the Protocol. The following sections will briefly discuss five primary areas in which the Protocol proposes post-adoption negotiations: (1) possible development of compliance mechanisms; (2) possible development of model instruments and enactments; (3) regular evaluation of the ABS regime; (4) COP/MOP powers to alter the regime; and (5) bilateral negotiations. To a large extent, each of these issues all arose from the compliance discussions within the Protocol negotiations, and each include some element of ‘compliance’; however, the following discussion will attempt to examine them independently.

 As of 11 May 2012, Gabon (acceptance), Jordan, Rwanda and Seychelles have submitted formal acceptance/ratification documents to the Protocol.

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a.  Compliance Compliance was apparently, the most contentious issue in the negotiations. It was also one of the areas in which the negotiating countries’ delegations had the most limited understanding of each others’ domestic situations. In each country, compliance is a complex issue, and each country’s legal system is different from every other country’s legal system.86 As such, it is neither surprising that the Parties were unable to agree on legally effective compliance provisions, nor unexpected that they were unwilling to drop the issue. Although compliance concerns arose in some way in the discussion of virtually every clause in the Protocol, the final Protocol included two primary compliance provisions, both calling for future negotiations. Those provisions discuss respectively: (i) a generally applicable compliance process and (ii) a more specific ‘global mechanism’. i)  General Compliance Process The main Protocol provision relating to compliance calls on Parties to ‘consider and approve cooperative procedures and institutional mechanisms to promote compliance with the provisions of this Protocol and to address cases of non-compliance’.87 The clause also indicates an apparent consensus among delegates with regard to the meaning of the term compliance, and its relationship to what the Protocol refers to as ‘inter-country dispute settlement procedures’ – a process that focuses on whether each country has met its legal obligations under the international convention.88 The Protocol thus makes clear that its discussion of ‘compliance’ is completely independent of its provisions with regard to ‘inter-country dispute settlement procedures’.89 Within the negotiations, however, questions of national implementation measures and individual compliance with them were not separated. As a result, it is useful, in considering future implementation efforts at the national level, to keep both provisions in mind. The provision regarding dispute settlement procedures does not provide any possibility for action against misappropriating users or other compliance  Although national legal systems are grouped by academic comparatists in families (such as ‘common law’, ‘civil law’, ‘religious law’, ‘central planning systems’, etc.), from a practitioner’s perspective these groupings are only minimally effective when attempting to apply law in one or more countries. The only rule in those situations is that every country’s law is unique to that country. 87  Nagoya Protocol Article 30. 88  Ibid. 89  Inter-country dispute settlement procedures are addressed in Nagoya Protocol Article 27. Such provisions are common to most international instruments. Within the ambit of environmental and natural resources, however, such provisions have almost never been used. See Young, et al., “Evaluation of FAO Corporate Strategic Objective B-1”. 86

488   Tomme Rosanne Young with national ABS measures, and provide no vehicle for redress, where a provider or provider country alleges that benefit-sharing is owed. As a result, the primary situations in which application of dispute settlement procedures would address ABS implementation would be one of the following: (i) where one country formally claims that another has failed to take the measures it committed to in the Protocol thereby preventing persons or entities from other countries from obtaining access or receiving their rightful benefit-share; or (ii) where one country alleges that there has been a violation of an ABS arrangement between the governments or countries directly. Regarding the rest of the concept of compliance – as more broadly conceived in the negotiations – the Protocol also reflects a strong support for, alternative dispute resolution processes when it calls on Parties to encourage providers and users of genetic resources and/or traditional knowledge associated with genetic resources to include provisions in mutually agreed terms to cover, where appropriate, dispute resolution including . . . (c) [o]ptions for alternative dispute resolution, such as mediation or arbitration.90

This lone reference does not address the particular challenges of alternative dispute resolution processes, which have been shown to be effective in many types of commercial dispute situations (when seeking a declaration of status, or order to pay money, for example), but have little value where the claimant is seeking to compel other types of action. Accordingly, it may be very useful for the COP/MOP or other bodies to develop specialised guidance for Parties seeking to use alternative dispute resolution, and to work with international bodies, such as the Permanent Court of Arbitration to develop rules and guidelines for the application of conventional commercial arbitration mechanisms to ABS. It is reasonable to expect that any discussion of compliance mechanisms in the post-adoption period will have to address challenges of inter-functionality of national laws of user countries, provider countries, and others – challenges for which no easily available solution has yet been agreed. As resources, there have been many analyses of newer efforts to create and apply international compliance mechanisms, particularly in environmental law.91 It is possible  Nagoya Protocol Article 18.1.  See, e.g. Veit Koester and Tomme Young, “Compliance with International Conventions: The Role of Public Involvement”, Environmental Policy and Law 37 (2007): 399. Some elements of the recently adopted Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety (Nagoya, 15 October 2010, UN Doc. UNEP/ CBD/BS/COP-MOP/5/17) tread a similar path between national obligations under international instruments and the actions of private persons, companies and communities – based on negotiations which often blurred the distinction between the two in a manner similar to the combination of issues addressed in compliance discussions of the Nagoya Protocol

90 91

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that Protocol Parties will propose to use one of these existing mechanisms as a model for the Nagoya Protocol compliance mechanism. In making this type of choice, however, Parties are strongly encouraged to carefully scrutinise these mechanisms to determine how well they are achieving their objectives, and particularly, how effective they have been in settling complaints under individual agreements seeking compensation or other benefits, before selecting one compliance mechanism to use as a template. It is also necessary to consider the different nature of compliance in situations where a commercial relationship is being created, as compared with compliance related to environmental or social provisions. ii)  Global Multilateral Benefit-Sharing Mechanism The issue of compliance is much more narrowly addressed in another Protocol provision, which discusses the possible creation of a global multilateral benefit-sharing mechanism. Under this clause, the Protocol calls on Parties (not mentioning the COP/MOP, but presumably addressing it) to ‘consider the need for and modalities of a global mechanism to address the fair and equitable sharing of benefits derived from the utilisation of genetic resources and traditional knowledge associated with genetic resources.’92 The scope of this proposed mechanism, however, is severely limited by the proviso that it applies only to utilisations ‘that occur in transboundary situations or for which it is not possible to grant or obtain prior informed consent.’93 Of course, it is not yet known what parameters will determine whether a particular utilisation of genetic resources or associated traditional knowledge will be deemed to happen in a ‘transboundary situation’ or what factors must be present in a situation, to enable the determination that it was ‘not possible to grant or obtain prior informed consent’ to that utilisation. Given that most genetic resources are found in multiple locations, and a significant number have more than one country of origin, the global mechanism (if it is ever created) could apply to a very large percentage of the planet’s genetic resources and traditional knowledge. If the global mechanism is eventually created, the inclusiveness of its scope could be a very important source of controversy, because the mechanism is not intended to partition benefits among countries of origin, but rather to direct the use of those benefits to help achieve the CBD’s objectives. Although most of this clause is expressed very generally, the Protocol’s provision related to the global mechanism includes one very specific limit: on ABS. Thus, the negotiations and results of the Supplementary Protocol may also have an important impact on future ABS compliance discussions. 92  Nagoya Protocol Article 10. 93  Ibid.

490   Tomme Rosanne Young [t]he benefits shared by users of genetic resources, and traditional knowledge associated with genetic resources through the multilateral mechanism, shall be used to support the conservation of biological diversity and the sustainable use of its components globally.94

It therefore appears that the decision to create a global mechanism could have a life-changing impact on ABS, always assuming that appropriate modalities and standards could be developed to govern the mechanism’s operation. In this connection, the temptation exists to attempt to utilise the International Treaty’s Multilateral System of Access and Benefit-sharing95 as a template for the creation of such a mechanism. In doing so, however, one should keep in mind that the International Treaty was built on the foundation of a preexisting network of research centres under the Consultative Group on International Agricultural Research, which, at the time of the Treaty’s negotiations, already had under their belts more than three decades of operation virtually identical to the operation they now undertake via the Multilateral System of Access and Benefit-sharing. Moreover, although the CGIAR centres have received and hold many accessions of plant genetic material, they constitute only a fraction of the world’s plants, animals and microorganisms. Great care should be taken before deciding to emulate the Treaty’s mechanism or any element thereof. In addition to the Treaty’s mechanism, other instruments have adopted mechanisms that may resemble the global mechanism proposed by the Nagoya Protocol. Among these, two stand out to the author (but many others may exist): the International Seabed Authority under the UN Convention on the Law of the Sea96 and the Global Mechanism under the UN Convention to Combat Desertification.97 It is clear that intensive analysis will be necessary to determine the most effective way that the global benefit-sharing mechanism could operate, in the event that the Protocol Parties should agree to create such a mechanism. b.  Model Laws and Contracts – Pre-agreed Enforceability One of the biggest challenges to functional compliance with the ABS regime involves making sure that ABS contracts, permits and other instruments are legally enforceable. Throughout the Protocol negotiations, many CBD Parties and observers focused on the legal quality of ABS instruments and legislation  Ibid., emphasis added.  International Treaty, Article 10. 96  [See contribution by Charlotte Salpin to this volume (Chapter 5)]. 97  United Nations Convention to Combat Desertification in those Countries Experiencing Serious Drought and/or Desertification, Particularly in Africa, Paris, 14 October 1994, in force 26 December 1996, 1954 UNTS 3), Articles 21.4 et seq. 94 95

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in developing countries, noting that in many countries no legislation had been adopted governing ABS, or that legislation was so general that it could not be formally applied in the courts of a developing country or international tribunals. In 2009, although many national legislative documents were filed in the Convention Clearing-House Mechanism’s database of national ABS legislation, fewer than 25 countries had actually adopted basic operational elements of provider-side ABS operations.98 Internationally, it became clear that the various national legislative and contractual documents could be functional parts of an international ABS regime only if they were recognised as legally valid in the courts of other countries. In addition, many participants noted that contracts, permits and other instruments adopted in individual ABS transactions were lacking in basic legal elements that would be necessary if one were to attempt to enforce them in other countries’ courts or other tribunals or processes.99 In most similar situations, the legal solution would be to take measures to ensure that ABS documents are drafted with the goal of inter-operability in many legal systems in mind. One of the most important and effective ways for achieving this would be the international development of model instruments of assured enforceability in user countries. Before turning to the key questions regarding models, it is necessary to sketch out the commercial background issue. The lack of clear and detailed legislation and contract provisions has epitomised the users’ concerns relating to their ‘legal certainty’ regarding the rights they obtain via ABS. Where contract provisions and relevant legislation are unclear, commercial actors cannot be certain that the rights they have obtained are legally unambiguous. In complying with ABS, they risk investing money and time to gain rights that they will not be able to exercise, apply, defend and interpret legally. Contrary to some claims, a focus on ‘enforceability’ is not a way to promote lawsuits and legal actions – in fact, it is exactly the opposite. Studies in the United States and other countries have indicated that if a particular subarea of commercial practice is governed by laws that are highly detailed and clear, this actually decreases the number of law suits in that area, especially when many different jurisdictions have ruled in the same way. Parties can

 Delegates of user countries and other observers initially stated that this lack of legislative action was indicative of the countries’ lack of interest in ABS: Scott, “User and provider country measures in the context of the international regime”. Later, it was noted that the lack of clear ABS legislation could create undue stresses on users and the need to agree on model or default legislation, adopted at the international level, was suggested: Tomme Young and Morten W. Tvedt, “Balancing Building Blocks of a Functional ABS System” (2009) UN Doc UNEP/CBD/WG-ABS/8/INF/2. 99  Young, “Applying Contract Law to ABS”. 98

492   Tomme Rosanne Young determine without going to court what the judge would decide on their claim, and thus save the cost of legal action. In ABS, there is little or no basis for understanding what a court would do if faced with an ABS claim. In the few cases in which ABS was actually claimed, the courts have generally decided the case on other grounds.100 Given this situation, after more than 20 years of the existence of ABS, we cannot rely on the courts to sketch out even the broadest overview of ABS enforceability. It is relatively risky for any country to rely on another country’s courts or international tribunals to interpret the first country’s laws, policies or regulations. As a result, in the Protocol negotiations, many users and user-countries suggested the creation of model legislation and model contract provisions, which would be written in a way that made their legal interpretation clear and could help guide those adopting ABS legislation and negotiating ABS contracts, permits and MAT. Some delegations even proposed that these models be adopted as ‘default provisions’ – i.e., when a country had no ABS law, or a user had not obtained MAT, then the courts in the user country could apply the model provisions to fill the gaps. This issue was closely linked to the issue of legislative inter-operability, both because national contractual law varies from country to country, and because the ABS compliance discussions often referred to the possibility and/ or expectation that the user country would enforce the requirements of the provider country, with respect to users who were utilizing foreign genetic resources within the user country. In many countries, the problem with ABS requirements is not that the country’s courts will not apply them, but rather that they cannot. Thus, for example, in order to enforce the ABS requirements set out in the laws of developing countries, an enforcement agency in the U.S. would have to take actions inconsistent with ‘private property’ or ‘privacy’ rights that are guaranteed by the US Constitution. It would be ‘unconstitutional’ for agencies to take such actions, or for US courts to order them to do so. Similarly, in the EU, many countries must first determine whether a foreign court’s decision or other mandated action is ‘inconsistent with public policy’. If so, that EU Member State’s courts could not formally enforce that

 Tomme Young, “Analysis of Claims of Unauthorised Access and Misappropriation of Genetic Resources and Associated Traditional Knowledge” (2005) UN Doc UNEP/CBD/ WG-ABS/4/INF/6.

100

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judgment within their country.101 These same problems arise in attempts to enforce arbitral awards, as well.102 Thus, users and user countries had often noted that the lack of clear provider-country legislation would be a major obstacle to both contractual and ABS compliance action. Along with the various ‘model contract’ proposals, proponents also suggested that the enforceability of national provider-side requirements and specific ABS contracts could be greatly enhanced if the Parties adopting such requirements had guidelines and other assistance to promote their enforceability. On the provider-side, many negotiators drew back from these proposals, fearing that they might be used to circumvent national practices and authorities in the provider country. On the other hand, their legal specialists were clear about the need to ensure that legal documents drawn up in provider countries would be valid and enforceable by courts, arbitrators and other tribunals in the user country. This argument underscored the potential value of mechanisms of ‘pre-determined enforceability’ – i.e., agreed models that the user country would formally recognise as ‘enforceable’ in their courts. Unfortunately, the Nagoya negotiators were not able to resolve the basic question in this area – i.e., whether or not standard or model contractual and/or legislative clauses would be a valuable addition to the ABS framework. Thus, they could not begin to consider proposed models or the means by which models would be proposed, created, adopted or used within the ABS framework. The basic idea of such instruments (whether for guidance or as tools of pre-determined enforceability) would, however, not die. Ultimately, Parties adopted several provisions relating to models and other guidance, including general clauses calling on Parties to take the following actions, to: • ‘encourage, as appropriate, the development, update and use of sectoral and cross-sectoral model contractual clauses for mutually agreed terms’;103

 Several examples can be found in recent German cases under the New York Convention (Convention on Recognition and Enforcement of Foreign Arbitral Awards (New York, 10 June 1958, in force 7 June 1959)), where the court determined that it could not enforce an arbitral award, because that award violated German public policy. See, e.g. Bundesgerichtshof (BGH) 23 February 2006, III ZB 50/05, Case 876: MAL 16 (3); NYC V (2), published in: SchiedsVZ 2006, 161; http://www.dis-arb.de (DIS – Online Database on Arbitration Law accessed 11 May 2012); and see Oberlandesgericht Köln, 15 February 2000, 9 Sch 13/99). A contrary finding was made by a regional appellate court, in Bayerisches Oberstes Landesgericht, 23 September 2004 4Z Sch 5/04. 102   Ibid. 103  Nagoya Protocol Article 19.1. 101

494   Tomme Rosanne Young • ‘encourage, as appropriate, the development, update and use of . . . voluntary codes of conduct, guidelines and best practices and/or standards in relation to access and benefit-sharing’;104 • ‘periodically take stock of the use of sectoral and cross-sectoral model contractual clauses’;105 • ‘periodically take stock of the use of voluntary codes of conduct, guidelines and best practices and/or standards’;106 • ‘consider the adoption of specific codes of conduct, guidelines and best practices and/or standards’;107 and • ‘support, as appropriate, the development by indigenous and local communities, including women within these communities, of model contractual clauses for benefit-sharing arising from the utilisation of traditional knowledge associated with genetic resources.’108 Given that these options are stated very generally and flexibly, it is possible that COP discussions of these matters could lead to the development of models and other standards that enhance the user’s legal certainty regarding his rights to the genetic resources or associated traditional knowledge. Some have suggested that models could be sector-specific. In developing model instruments however, it will be necessary to remember that many of the most important negotiators would face financial constraints that could prevent them from participating, if there are too many of these negotiations. Hence, it may be appropriate to instead convene a single ‘model development committee’, at the international level, whose task would involve the development of a range of instruments and clauses, and promoting or developing consensus among the Protocol Parties regarding their acceptance.109

 Nagoya Protocol Article 20.1.  Nagoya Protocol Article 19.2. 106  Nagoya Protocol Article 20.2. 107  Ibid. 108  Nagoya Protocol Article 12.3(c). 109  Another Protocol clause relevant to this issue and the need for models is found in Nagoya Protocol, Article 18.3, on access to justice and mutual recognition and enforcement of foreign judgments and arbitral awards. The characteristics of ‘measures’ necessary to comply with this requirement are not spelled out in any way, although there has been significant international development on both of these issues. See the Aarhus Convention (The UNECE Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters (Aarhus, 25 June 1998, in force 30 October 2001, 2161 UNTS 447)) and the New York Convention cited above. 104 105

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c.  Regular Evaluation Yet another clause requiring further negotiations after the Protocol’s entry into force is found in its provision calling for quadrennial review of the Protocol’s effectiveness, possibly with particular attention to the effectiveness of compliance with MAT.110 The first such evaluation is to be undertaken four years after the Protocol enters into force.111 A separate provision within the Protocol calls for review on the same schedule of the effectiveness of its provision on compliance with MAT.112 It seems likely that these reviews will be integrated, at least in the first review.113 As discussed in the next section, a provision calling for effectiveness review of any institution or process creates the implication that the institution or process will be revised or adjusted to take account of the results of that review – i.e., to make the institution or process more effective. d.  COP/MOP Development As noted above, it is arguable from the Protocol provisions for effectiveness review that Parties expect to re-consider and/or renegotiate the regime and/ or its processes, forms, instruments and other components on the basis of the results of that review. Toward this end, the Protocol is very broad in the powers and responsibilities given to the COP/MOP to make recommendations on any matters necessary for the implementation of the Protocol and to establish such subsidiary bodies as are deemed necessary for its implementation.114 This empowerment would seem to enable the COP/MOP to take or suggest adjustment to the operation of the ABS regime, as described above.115  Nagoya Protocol Article 18.  Nagoya Protocol Article 31. 112  Nagoya Protocol Article 18.4. 113  Nagoya Protocol Article 31 allows the COP/MOP to set a different schedule for the overall review of the Protocol’s effectiveness following the first review, whereas Article 18.4 does not include such flexibility. Common practice in the CBD suggests that, unless some Party insists on the quadrennial schedule, Parties will feel free to adjust that schedule. In addition, experience has shown that such scheduled reviews are generally first raised in the year mentioned in the instrument, but undertaken after that. In the end, the results of the review may be discussed one-three meetings (as many as six years) after its first discussion by the COP. 114  Nagoya Protocol Article 26.4.a–b. 115  The ability of the COP/MOP to act in this way would also be impacted by the Rules of Procedure. It is currently expected that, like the Cartagena Protocol, the Nagoya Protocol will use the CBD Rules of Procedure and will be unable to resolve the so-called ‘Rule 40.1 problem’ under which the CBD COP is obliged to operate only by consensus in all substantive decision-making (because CBD Parties were unable to reach agreement on voting procedures). See Report of the First Meeting of the Conference of the Parties to the Convention on Biological Diversity, (1995) UN Doc UNEP/CBD/COP/1/17, paras 28–32. 110 111

496   Tomme Rosanne Young e.  Bilateral Negotiations In two provisions, the Protocol recognises a number of situations for which global agreement would be an unwieldy way to seek solution, recognising the possibility of bilateral, regional or subregional negotiations as a potentially effective way to resolve challenges to the functionality of the regime. One of these provisions is relatively narrow and specific, while the other provides a much broader authority for countries to make ABS work through bilateral or other means. The more specific of these provisions addresses transboundary cooperation,116 focused particularly on ‘instances where the same genetic resources are found in situ within the territory of more than one Party’ or where ‘the same traditional knowledge associated with genetic resources is shared by one or more indigenous and local communities in several Parties’. In these situations, Parties are encouraged to ‘cooperate’ toward implementation of the Protocol. This provision suggests the beginning of the process Vogel refers to as the ‘biodiversity cartel’ – a formal jointure among two or more provider countries which are both countries of origin of specifically or generally similar species, under which those countries seek to improve the value of their genetic resources or associated traditional knowledge, and strengthen their position in negotiations and later in compliance actions, by joining forces as a marketing ‘cartel’ relating to those resources.117 While the Protocol did not go this far, its provisions on transboundary cooperation certainly leave this option open to provider countries. Speaking more broadly, however, the Protocol specifically authorises bilateral and other multilateral ABS negotiations between user and provider countries, where it permits the Parties develop ‘other specialized ABS agreements’.118 Although most often understood as referring to the International Treaty and other pre-existing global instruments, the reference to ‘specialised ABS agreements’ is ultimately essential as indirect support for bilateral negotiations between user countries and provider countries. Negotiations of this type have been ongoing since well before the adoption of the Protocol, with several of the most prominent user countries (including the USA and

Similar, but briefer discussions were held on this issue in the three ensuing COP meetings. The voting provisions of Rule 40.1 relating to non-consensus situations have remained bracketed through COP-10. 116  Nagoya Protocol Article 11. 117  Joseph H. Vogel, “Reflecting Financial and Other Incentives of the TMOIFGR: The Biodiversity Cartel”, In A Moving Target: Genetic Resources and Options for Tracking and Monitoring their International Flows, eds Manuel Ruiz and Isabel Lapeña (Bonn: IUCN, 2007): 49. 118  Nagoya Protocol Article 4.

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Japan)119 working directly with individual provider countries at the government level. The result of such bilateral negotiation has proven very useful for both users and providers who are uncertain regarding the process they must undergo to complete ABS compliance in the provider country, and may also give providers some assurance regarding how the user-country will view and protect their interests. A range of key issues has been included among the elements in such bilateral discussions and agreements. One of the most critical relates to the level and nature of compliance and oversight that users can expect when holding an ABS permit, including regulatory oversight of his activities in both provider and user countries. Another key element would involve agreeing on the legal processes of both countries that will be relevant and expected in cases of misappropriation or misuse of genetic resources or associated traditional knowledge. On some occasions, such negotiations may also consider any special relationship the two countries have with regard to genetic resources or associated traditional knowledge. In this connection, the countries might negotiate special rights for the user country’s users with regard to the provider country’s genetic resources (exclusive access, etc.). Another possibility might involve the creation of a more streamlined process for completion of ABS procedures, in light of the user country’s commitments in the bilateral agreement. In general, there are great prospects for the development of real, on-theground ABS experience through the negotiation and application of bilateral agreements, especially in light of the fact that those agreements can be crafted to address only the specific ABS concerns of the two countries, and to integrate those concerns with bilateral agreement on other substantive issues. These negotiations can help the ABS process address the critical challenge posed by post-access transfer – that is, the sending, selling or trading of genetic resources or associated traditional knowledge to another user, possibly outside the first user country. They might also address key incentive issues such as the situations in which ABS compliance is sometimes a de-facto penalty (where known users sometimes become easy targets of public allegations such as ‘biopiracy’).120 If a sufficient number of publicly available bilateral agreements on these or other key points are developed, they may

 Information on how these countries have sought to assist in implementation of ABS at the bilateral level has always been readily and cheerfully provided by their ABS national focal points, as then-listed in the CBD’s ABS database, soon to be the ABS clearing-house. 120  Discussed in CBD Ad Hoc Open Ended Working Group on Access and Benefit Sharing, “Summary Analysis: Legal Certainty for Users of Genetic Resources under Existing ABS Legislation and Policy”. 119

498   Tomme Rosanne Young form the basis for courts and other tribunals to identify globally accepted ‘standard practices’ in ABS.121 5.  Other Potentially Needed International Tools Finally, in considering the potential international activities that can help make the ABS regime functional, it is notable that many clauses in the Protocol refer to particular instruments, procedures or concepts that have not yet been clarified. It could be essential to implementation of the regime to provide some kind of example or guideline in these areas, or if possible to adopt a format or specific agreement about what minimum provisions would satisfy a specified Protocol requirement. The following are a few examples of areas in which international work could improve the regime’s operationality. a.  Emergency and Special Cases The Protocol negotiations included sometimes heated discussion regarding certain special situations, which some negotiators sought to designate as ‘exceptions’ to ABS process requirements. Although many such proposals were originally tabled, none were formally granted the status of exception, and only three issues were specifically discussed in the Protocol under the heading of ‘Special Considerations’: (i) ‘research’ that ‘contributes to the conservation and sustainable use of biological diversity’; (ii) ‘cases of present or imminent emergencies that threaten or damage human, animal or plant health’ and (iii) ‘the importance of genetic resources for food and agriculture and their special role for food security’. Only the first122 of these issues (research) is a potential implementation challenge, in that it is mandatorily directed at ‘each Party’, and thus requires countries, when acting individually ‘[i]n the development and implementation of its access and benefit-sharing legislation or regulatory requirements,’ to [c]reate conditions to promote and encourage research which contributes to the conservation and sustainable use of biological diversity, particularly in developing countries, including through simplified measures on access for

 Discussed in detail in Young, “Applying Contract Law to ABS” and Young, “Contract Provisions and Experience”. 122  The other two provision in Nagoya Protocol Article 8 regarding health emergencies and food security are potentially less controversial, since they do not require any affirmative action by Parties, but rather call only for ‘due regard’ to the former and ‘consideration’ regarding the latter (see). Either of these could benefit from further international discussion, however. [On these issues, see contributions by Wilke and by Chiarolla, Louafi and Schloen in this volume (Chapters 4 and 3)]. 121

An International Cooperation Perspective   499 non-commercial research purposes, taking into account the need to address a change of intent for such research.123

This provision is not directly linked to either side of the ABS implementation spectrum (i.e., it is not addressed to either the ‘access side’ or the ‘utilisation side’ of the ABS transaction).124 This lack of specificity could lead to inconsistencies within the ABS regime. For example, a country that provides access may have adopted only limited special provider-side measures for non-commercial biodiversity researchers, while the country of the user may have adopted user-side measures that release all non-commercial biodiversity researchers from most ABS-related obligations. Another concern expressed during the negotiations derived from the fact that the above-quoted excerpt is nearly identical to the basic access provision of the CBD.125 This CBD provision, despite its goal of enhancing access and its call to limit access restrictions, led to more detailed national legislative and regulatory procedures than any other clause of CBD Article 15 or the Bonn Guidelines. In fact, it was the international legal source of most of the regulatory burden that the Nagoya Protocol seeks to streamline, using similar language. Given that many developing countries have not found their existing ABS procedures to be satisfactory and do not believe that users are complying with them, it is possible that any ‘simplified’ or streamlined provider-side measures will still involve significant delay for researchers. It thus appears, that, for such a streamlined process to be effective, it is probably essential that it (or guidelines for it) be developed. In this context, it is important to look at the existing legislation that claims to streamline ABS processes for certain researchers, and to determine how it has operated in practice, and what results have been obtained.

 Nagoya Protocol, Article 8.  As noted elsewhere, the Protocol does not have separate provisions for ‘predominately provider countries’ and/or ‘predominately user countries.’ On the contrary, in fact, all countries are obligated to adopt both access-side legislation (laws and procedures governing access to the genetic resources in the country) and provider-side legislation (laws and procedures governing users of genetic resources that had been obtained from other countries). 125  CBD Article 15.2, calling on Parties to ‘[c]reate conditions to facilitate’ (the Protocol says ‘to create conditions to promote and encourage’) actions that were already ongoing at the time the instrument was adopted. Following adoption of the CBD, many countries acted relatively quickly to impose moratoria on access to or removal of genetic resources: this is discussed in Tomme Young, Implementation of the Convention on Biological Diversity in Developing Countries, (Rome: FAO (loose leaf ), 1995). 123 124

500   Tomme Rosanne Young b.  Components of Mutually Agreed Terms The Protocol’s provisions governing MAT do not contemplate the development of internationally agreed models or other tools. They do, however, recommend some possible provisions for MAT (dispute settlement clause, terms on benefit-sharing; terms on subsequent third-party use; and terms on changes of intent).126 The Protocol also specifically encourages Parties to ‘support, as appropriate, the development . . . of community protocols and minimum requirements for MAT related to the use of associated traditional knowledge.127 These components are among the most complex and controversial elements of ABS practice. As of this writing, there has been no example of an ABS legal instrument at the national level embodying these elements in a manner that is agreed to be formally enforceable or to support compliance. It thus appears that an international process could be extremely valuable to support the development of guidance or examples to assist countries in these endeavours.128 c.  Incentives for Non-Parties One of the most common elements in recent years, in the negotiation of international conventions, especially those focused on environmental and social themes, has related to the so-called ‘free-rider’ problem (countries willing to share in the global benefits derived from the instrument, without committing themselves to be part of the solution). In general, there are few incentives for countries holding this mind-set to adhere to such conventions. ‘Free-rider’ countries often seem to be motivated to enter into international agreements only where they feel assured that some commercial, financial, or trade benefit will only come to them if they adhere to the agreement. Few international environmental/social instruments can provide this kind of assurance, particularly for user-countries. Like other environmental instruments, the Nagoya Protocol includes a provision calling on Parties to help decrease the number of free-rider countries. It specifically requires Parties to ‘encourage non-Parties to adhere to [the] Protocol and to contribute appropriate information to the [ABS] ClearingHouse.’129 Unlike the majority of environmentally and socially oriented conventions, however, the Nagoya Protocol may contain the seeds of a commercial  Nagoya Protocol Article 6.3.g.  Nagoya Protocol Article 12.3.a–b. 128  With regard to these clauses, it is also useful to consider Nagoya Protocol Article 18.2 calling on Parties to ensure that an opportunity to seek recourse is available in disputes arising from MAT. 129  Nagoya Protocol Article 24. 126 127

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incentive to encourage countries to comply. Specifically, if provider countries can find ways to effectively control access to genetic resources and/or associated traditional knowledge, and especially to control the cross-border movement of those resources, then they may be able to provide a real incentive, encouraging even recalcitrant user countries to join the Protocol. That incentive could arise out of a national decision by each provider country to allow access to and/or removal of genetic resources and/or associated traditional knowledge only by those users who were formed and/or will operate under the jurisdiction of a country that is a Party to the Protocol. In particular, the limit on access permission could restrict access, granting it only to users from countries that have adopted user-side ABS legislative measures. If countries wish to use this avenue to ‘encourage non-Parties to adhere’, they will probably benefit from the development at the international level of legislative guidance or model legislation, as well as of guidance on administrative practices, to ensure that those provisions do not violate other international instruments, and also to ensure that they do not give so much leeway to such instruments that the effectiveness of the legislation as encouragement is compromised. d.  Integrating the Operations of Other Instruments Prior to the adoption of the Protocol, most international instruments with mandates related to ABS were frankly waiting for the Nagoya Protocol negotiations to be completed before taking any action related to genetic-resource or associated traditional knowledge issues.130 Despite this level of deference, however, the Protocol went to notable lengths to avoid creating or encouraging any conflict or hierarchy between international provisions potentially affecting genetic resources and associated traditional knowledge.131 In this connection, however, the Protocol proposes a kind of international activity that has been virtually unprecedented in modern international law, by not only requiring Parties to implement it ‘in a mutually supportive manner  WIPO’s Intergovernmental Committee on these issues, for example, was relatively clear in stating that it was delaying any formal text development in the first nine months of 2010, because it was waiting for the conclusion of the CBD Protocol negotiations on ABS. 131  Nagoya Protocol Article 4.1–2. Depending on how they are judicially interpreted, the different standards expressed under these clauses may contradict the sentence in clause 1 that reads ‘This paragraph is not intended to create a hierarchy between this Protocol and other international instruments.’ Two additional standards are set forth in Nagoya Protocol Article 4.3–4, with the latter indirectly suggesting an exception for the ‘specific genetic resource covered by and for the purpose of the specialised instrument.’ In this regard, it is not clear from the author’s notes whether the use of the singular (‘genetic resource’) was intended to limit the operation of this clause to species-specific instruments, or was merely a typographical error or other matter overlooked in the rush to complete the instrument. 130

502   Tomme Rosanne Young with other international instruments’ on relevant topics, but specifically to pay ‘[d]ue regard’ to ‘useful and relevant ongoing work or practices’ under such instruments and ‘relevant international organisations’.132 In general, to date, efforts to develop coordination among international instruments (especially among environmental and conservation-based instruments) have been of dubious value. A few such efforts have been undertaken involving instruments under the umbrella of the UN Environmental Programme (UNEP), through that Programme’s efforts to convene meetings of Secretariat staff members of more than one instrument.133 These efforts have faced setbacks, however, when Parties pointed out that the meetings were ‘ultra vires’ – i.e, undertaken by the staffs of the various instruments and programmes, without legal mandate from all of their respective Conferences of Parties.134 Although this technical/legal impairment has since been resolved, it indicates the high level of care that must be addressed in assuring that treaty secretariat staff do not confuse their level of responsibility and undertake meetings and commitments without Member-State support. In implementing the Protocol provision on relationships, Parties should also keep in mind the propensity of each instrument’s COP to maintain a heightened awareness of its own autonomy, leading to the possibility that the work of any coordinating meeting will not necessarily be ratified by the COPs whose secretariats are represented in the meeting. Based on these factors, it is legally indubitable that the coordination activities set out above will need careful preparation, especially procedures and guidance at the international level regarding how such ‘mutual supportive implementation’ can be undertaken and overseen without violating the rights and sovereignty of the Parties under any instrument covered by that provision (particularly if the other instruments involved do not include a similar clause). It may be useful, of course, for the COP/MOP to provide an interpretation of the Protocol provision on relationships, specifically considering such key questions as whether it is limited only to such instruments (and annexes thereto) as they stood at the time of the negotiation. If not, there is a possibility that it will create a ‘race to decide’ – with each post-Protocol  Nagoya Protocol Article 4.3.  Calls for collaborative or synergistic work among the three Rio Conventions, and for interMEA information accessibility, date back to 1992 at the UN Conference on Environment and Development. From 1992 to the present, these issues have focused on data-gathering and sharing (see Agenda 21 (1992) UN Doc A/CONF.151/26/Rev.1 vol. 1, Annex II, chapter 40). See also UNEP World Conservation Monitoring Centre, Synergies and Cooperation: A status report on activities promoting synergies and cooperation between Multilateral Environmental Agreements, in particular biodiversity-related conventions, and related mechanisms (Cambridge: UNEP-WCMC, 2004). 134  Discussed in Young et al., “Evaluation of FAO Corporate Strategic Objective B-1”. 132 133

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decision of a relevant body potentially hamstringing the Protocol with regard to the subject of that decision. e.  Communication, Capacity and Assistance – The ‘Ombudsperson’ Finally, the Protocol includes a wide range of provisions that directly or indirectly point to the need for capacity development, enhanced communications and other forms of assistance for Parties. Although often not referenced directly, most elements of the Protocol’s agreed operation (and of the positions of the Parties on matters such as the value of patent-filing laws as ‘user measures’) depend upon a high level of official communication among the parties to the Protocol, and also among parties to particular ABS contracts or permits. For officials in many countries, national law places heavy restrictions on their contacts with their ‘opposite numbers’ in other countries. Often, even in informal contacts, they may be found to have violated their duty regarding which governmental information may be communicated to foreign persons. Like virtually all international environmental instruments negotiated in the last three decades, the Nagoya Protocol includes a strong call for capacity building, and a recognition that many developing countries may be at a capacity disadvantage.135 The ABS regime represents a major commitment to building sustainable capacity – both the ability to utilise genetic resources (or collaborate with outside utilities) and the recognition of the need to conserve those resources. Another Protocol provision which could provide a basis for the establishment of a global-level supporting institution for the ABS regime concerns technology transfer.136 These challenges appear to be relatively easy to satisfy through the development of some global mechanism or institution both to serve as an intermediary between government officials and their foreign counterparts, and to provide (or link relevant persons to able to provide) advice and assistance capable of helping with implementation and practical application of the Protocol. Within the negotiations, these activities were sometimes spoken of in the context of an ‘international ABS ombudsperson’.137 According to many participants in the Nagoya negotiations, the concept of an ABS ombudsman is still alive, within the general mandates for ongoing attention to compliance as set forth above. Side discussions on this issue at the time raised the possibility that these tasks would be undertaken by a UN body (sometimes  Nagoya Protocol Article 22.  Nagoya Protocol Article 23. 137  Earlier drafts from the Protocol negotiations are not all available online. One such draft did reference an ‘ombudsperson’ in what was then Article 15. Annex to Report of the Meeting of the Interregional Negotiating Group, (2010) UN Doc UNEP/CBD/WG-ABS/9/ING/1. 135 136

504   Tomme Rosanne Young presumed to be UNEP), by the Protocol’s secretariat, or by the creation of a parallel volunteer body along the lines of the Intergovernmental Panel on Climate Change. The most useful example of the relationship between a nationally implemented international instrument and international supporting providers, however, is neither an ombudsman, a UN body, an instrument secretariat, nor any officially created institution. The most effective example of an external support body for an international environmental convention is TRAFFIC International,138 which was created as a joint effort of two large international non-governmental agencies, WWF139 and IUCN,140 to support the national and international implementation and operation of CITES. TRAFFIC provides a full range of ombudsman-type services to CITES Parties, while continuing to be independent of governments and the UN. At present, it is not clear that any sufficiently neutral and sufficiently expert international organisation is deeply enough involved in or committed to the ABS regime to fund such a support body, although it may be possible to find a body willing to take on the role, if appropriate funding were available.

IV.  Conclusion The Protocol offers many opportunities for international processes to provide real assistance in the implementation of the ABS regime. The most important of these include the framing and operative-development of key tools, such as the ABS clearing-house and the monitoring system (checkpoints and certificates), all of which will need to have their basic elements ‘fleshed out’, through the adoption of modalities at the international level that may provide a practical means of clarifying many elements of ABS which are currently unclear and might pose obstacles to smooth operation of the regime. Highlighting more difficulties, yet extremely important, the Protocol specifically stated that it was leaving several key areas of controversy (compliance, model instruments, emergency and special cases, etc.) for future negotiation and/or action. Some issues, including its relationship with other international instruments, are expressed in ways that are very innovative, and on which there is no pre-existing legal basis. These issues, too, may require special international attention.  TRAFFIC, http://www.traffic.org/ (accessed 11 May 2012).  Worldwide Fund for Nature, http://www.worldwildlife.org/home-full.html, accessed 11 May 2012. 140  International Union for the Conservation of Nature, http://www.iucn.org/, accessed 11 May 2012. 138 139

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Although Parties and experts have placed much reliance on global negotiations to address these crucial elements of the regime, it is possible that bilateral negotiations offer the best hope for developing countries seeking to implement the regime in a beneficial manner. This approach is also potentially beneficial to developed countries seeking to support their users in attempting to comply with ABS requirements.

Conclusions Elisa Morgera, Matthias Buck and Elsa Tsioumani Up to date, access and benefit-sharing for genetic resources and associated traditional knowledge have been mostly a niche of legal scholarship and practice. Following the adoption of the Nagoya Protocol and with States moving towards implementation, it seems increasingly important to place ABS in context with a view to better understanding and systematically analysing its many connections to related areas of international and domestic law. Questions of mutual supportiveness and the need to interpret the Protocol in light of relevant rules of international law will be central to an effective implementation of the Protocol. In addition, there are several, significant implications that the innovative provisions of the Nagoya Protocol may have on different areas of international law in terms of cross-fertilization, cross-implementation or even cross-compliance. Equally, possible tensions or negative impacts arising from the Protocol on other areas of international law merit broad analysis. The Protocol also raises significant questions in relation to national law, its interaction with the customary law of indigenous and local communities, as well as supra-national and sub-national law. The implementation challenges raised by the Protocol in different regions and among different stakeholders will vary depending on priorities and circumstances, but the underlying need for implementing measures to be inter-linked and inter-operable will be a common goal at all levels of regulation and governance. Overall, the contributions to this collection amply demonstrate that a partnership-based approach to implementation seems essential: the vast majority of contributors agree that the international ABS rules enshrined in the Protocol can only succeed on the basis of incentives, trust and pragmatism, allowing for a certain degree of experimentation on the ground and the possibility to complement international obligations with bottom-up approaches or initiatives by indigenous and local communities, the research community or the private sector. With a view to contributing to a systematic debate on the interpretation, implementation and broader implications of the Nagoya Protocol on Access

508   Elisa Morgera, Matthias Buck and Elsa Tsioumani and Benefit-sharing, these concluding remarks will summarize the findings of the preceding chapters, following the structure of the collection, and outline an emerging agenda for further research on ABS that encompasses all the relevant levels of regulation and their interactions.

I.  Implications for International Law The innovations of the Nagoya Protocol are multiple. As Glowka and Normand (Chapter 1) illustrate, the Nagoya Protocol places an unprecedented emphasis on equity and on the link between benefit-sharing and biodiversity conservation: on this basis, it can be argued that ABS is now firmly positioned as a tool for sustainable development. The Protocol responds to the need for greater legal certainty for both users and providers of genetic resources. Regarding users’ interests, it obliges each Party requiring prior informed consent (PIC) to take specific measures with respect to the legal and institutional framework needed to regulate access and produce documentary evidence of the decision to grant PIC, including through the international ABS clearing-house established by the Protocol. When it comes to providers, the Protocol sets out clear standards on access frameworks of Parties requiring PIC and benefit-sharing; it clarifies the activities triggering benefit-sharing, further suggesting that benefits can be both monetary and non-monetary; and, importantly, it also clearly links utilization of traditional knowledge to an obligation to channel resulting benefits to indigenous and local communities holding the knowledge. In that regard, the Protocol breaks new ground by establishing the need for community PIC (and/or communities’ prior approval and involvement) in relation to access to traditional knowledge associated with genetic resources, as well as to genetic resources that are held by indigenous and local communities. It also seeks to ensure that community-level customary laws and procedures related to traditional knowledge associated with genetic resources are respected as States implement their obligations under the Protocol. Other far-reaching innovations of the Protocol are those designed to ensure that users comply with provider country requirements on PIC and on benefit-sharing: these provisions respond to the difficulty for provider countries to prevent misappropriation and/or misuse of genetic resources once they are exported and utilised in another country – a difficulty which is compounded by the lack of international measures to address possible violations of ABS regulatory requirements of the provider country or the breach of contractual agreements between individual users and providers. Against the backdrop of these innovative features, the other chapters exploring the implications of the Nagoya Protocol for different areas of

Conclusions   509

international law (Part I) have identified specific areas for mutual supportiveness between the Protocol and other relevant international instruments, as well as possible future synergies in the context of implementation or international law-making. Focusing on human rights questions, Savaresi (Chapter 2) points out that the Protocol provides opportunities to adopt a human rights-based approach to biodiversity conservation. A restrictive interpretation of the Protocol’s wording, in contrast, would raise concerns in relation to the rights of individuals and groups that are recognized under other instruments in international law. She concludes that future Parties to the Protocol that are Parties to human rights instruments must interpret and apply the Protocol in the light of their international human rights obligations. In particular, instruments that specifically spell out rights of indigenous peoples and local communities will be used as a yardstick to evaluate implementation of the Protocol at the national level. These instruments should guide implementation of the provisions regarding prior informed consent of indigenous and local communities for access to genetic resources and traditional knowledge, as well as the Protocol provisions on benefit-sharing with communities. Another important finding of this chapter concerns the possible cross-compliance between the Protocol and human rights instruments: human rights monitoring bodies could arguably become involved in scrutinizing whether nationallevel implementation of the Nagoya Protocol complies with applicable human rights instruments. Chiarolla, Louafi and Schloen (Chapter 3) underscore that the Nagoya Protocol allows existing patterns of use, exchange and benefit-sharing concerning genetic resources for food and agriculture to continue, but not to be abused to circumvent users’ benefit-sharing obligations. They conclude that the provisions of the International Treaty on Plant Genetic Resources for Food and Agriculture, as a specialized ABS instrument, will prevail over those of the Nagoya Protocol in respect of plant genetic resources covered by the Treaty’s Multilateral System on ABS and accessed for the purpose of research, breeding and training for food and agriculture. In addition, they argue that nothing in the Protocol prevents Parties from using the standard material transfer agreement developed in the framework of the International Treaty also for the transfer of crops that are not formally included in the Treaty’s Multilateral System. The authors further conclude that the Nagoya Protocol provisions strengthen farmers’ rights recognized under the International Treaty: where domestic ABS laws afford indigenous and local communities with the right to grant PIC for access to their genetic resources and traditional knowledge, the potential inclusion of such resources to the Multilateral System now clearly requires the PIC of relevant communities or their approval and involvement.

510   Elisa Morgera, Matthias Buck and Elsa Tsioumani In the context of global health governance, Wilke (Chapter 5) underscores that the Nagoya Protocol does not apply in situations covered by specialized ABS agreements only if that coverage is effective. In other words, the benefitsharing obligations established by the Protocol would still apply where an actor knowingly escapes the realm of a specialized ABS agreement by engaging in unauthorized transfer or receipt. In addition, the Protocol remains applicable to pathogens not covered by the Global Influenza Surveillance and Response System developed in the framework of the World Health Organisation. The author further highlights the broad approach of the Protocol provision on health emergencies: it extends beyond health emergencies caused by biological pathogens and beyond health emergencies that have a particular international status or have been declared of international concern; and it applies both to material with pathogenic potential and to material with antipathogenic properties. Salpin (Chapter 6) reflects on cross-implementation opportunities between the Nagoya Protocol and the law of the sea. As regards marine areas within national jurisdiction, she shows that a number of matters left to mutually agreed terms (MAT) under the Nagoya Protocol are specifically addressed in UNCLOS. In the exclusive economic zone, UNCLOS provides for a series of benefits to be shared in the context of marine scientific research, such as sharing of information, participation in research projects and training. The compliance measures undertaken for implementing the Protocol, in turn, could help ensuring respect for the rights of coastal and researching States under UNCLOS. The author also highlights that the prominent role of indigenous and local communities under the Nagoya Protocol is absent from UNCLOS and may thus introduce a new level of complexity to marine scientific research. While the previous chapters mostly highlight opportunities for positive interaction between the Nagoya Protocol and other instruments of international law, Pavoni (Chapter 6) underscores tensions with the law of the World Trade Organisation (WTO). As an enabling instrument that visibly seeks to avoid frictions with the WTO system, the Nagoya Protocol does not impose WTO-inconsistent obligations on Parties, but leaves it to them to pass legislation that may be at variance with WTO rules. The compromise language of the Protocol arguably allows Parties to voluntarily introduce disclosure requirements in their domestic legislation and identify patent offices as checkpoints, which – in the uncertainty surrounding the status of gene-based patents and associated disclosure obligations under TRIPs – means that future Protocol Parties may find themselves in a WTO law dispute without the possibility to justify their measures on the basis of an authoritative mandate from the Protocol. Pavoni thus concludes that the Nagoya Protocol is a missed opportunity for shielding environmental measures taken in the common interest

Conclusions   511

of humanity against essentially reciprocal trade obligations under the WTO. This is considered particularly troubling, as the WTO so far has shown very little appetite for mutual supportiveness with the international biodiversity regime.

II.  Regional Perspectives on Implementation Challenges All regional perspectives stress that the most serious implementation challenges arising from the Nagoya Protocol concern its provisions on the traditional knowledge of indigenous peoples and local communities and the genetic resources held by them. In Africa, one of the earliest and most-studied cases of ABS transaction (the San-Hoodia case) has proved the difficulties of striking fair ABS deals related to traditional knowledge, as well as possible related pitfalls, such as weakening communities’ traditional forms of authority, increasing their reliance on external expert opinion, and exacerbating power and information asymmetries. Against this background, Munyi and Jonas (Chapter 7) emphasise the role of the Nagoya Protocol in supporting legal pluralism and legal empowerment with a view to strengthen communities’ bio-cultural rights – that is, the rights related to all aspects of communities’ ways of life that are relevant to the conservation and sustainable use of biodiversity. To that end, the chapter explores a more recent case study in which African communities have utilised community protocols to respond proactively to users, according to the community’s vision of its procedural and substantive rights related to ABS on the basis of customary, national and international law. The chapter concludes by stressing that community protocols require support from the State, initially through capacity building and ultimately through their recognition under domestic law. From the perspective of a developing country in Asia, Nijar (Chapter 8) highlights implementation challenges arising from the ambiguities of the Protocol text. He stresses the need for further common ground to be reached at the international level (through the work of the Protocol governing body) towards a widely shared interpretation of key provisions, including in relation to derivatives and measures for overseeing compliance of users with applicable ABS requirements. He also singles out challenges related to traditional knowledge that is widely known and used or in situations where it is accessed from ex situ collections – both situations are not explicitly addressed in the Protocol. The author then emphasises the role of national ABS laws in guaranteeing autonomous and holistic decision-making on access to traditional knowledge by communities, arguing that the State should act on their behalf

512   Elisa Morgera, Matthias Buck and Elsa Tsioumani only as a last resort and on an interim basis until communities enhance their capacity and procedures to deal with ABS transactions themselves. As regards Europe, the case study on Spain by Lago and Silvestri (Chapter 9) shows that one important challenge to the prompt and effective implementation of the Protocol may result from the need to resolve multi-level competence questions. As a Member State of the European Union, Spain must respect relevant EU law and loyally cooperate with the Union when developing its domestic ABS system. Internally, the Spanish central government faces an additional layer of internal challenges in implementing the Protocol in a quasi-federal setting. In addition, substantive challenges arise from the protection of the traditional knowledge of local communities, which implies both the question of clarifying ownership of genetic resources and that of identifying relevant communities, while ensuring the proactive involvement of research institutions that are expected to play a central role in domestic ABS systems. Although developed countries that are part of JUSCANZ, as Burton (Chapter 10) highlights, are able to build on their experience as early implementers of the Bonn Guidelines, they still face significant challenges in operationalising the Protocol provisions on traditional knowledge and genetic resources held by indigenous and local communities. This is due to the varying legal status of these communities under domestic law and ongoing disputes in some JUSCANZ countries about ownership over natural resources traditionally held by these communities. While these key legal and political questions await a resolution, Burton cautions that JUSCANZ countries risk being excluded from the benefit-sharing opportunities created by the Nagoya Protocol, with researchers and operators in JUSCANZ countries consequently suffering a significant competitive disadvantage vis-à-vis their counterparts in countries that can more readily implement the Protocol. Countries in Latin America and the Caribbean, as illustrated by Cabrera (Chapter 11), have already engaged in legislative experimentation on ABS, at the regional and national level, including with regards to access to and benefit-sharing from the use of traditional knowledge. Nonetheless, implementation of these early ABS frameworks has been limited, partly because of authorities’ limited capacity to evaluate access applications and to ensure that benefit-sharing arrangements were fair to all parties. In addition, these early domestic provisions were framed in general terms (without detailed procedures on how to obtain PIC from indigenous communities, for instance, or clarifications as to the interactions between customary laws and national ABS instruments), creating uncertainty among different operators. Other practical difficulties were encountered in controlling access to genetic resources and in incurring high transaction costs associated with the permitting process,

Conclusions   513

with little attention paid to non-commercial research and non-monetary benefits.

III.  Cross-cutting Ιmplementation Challenges The reflections on cross-cutting implementation challenges (Part III) stress the role of different stakeholders in the operationalisation of the Protocol, often underscoring the usefulness of legal and quasi-legal tools such as codes of conduct, model laws and contractual clauses, as well as of bilateral agreements. Oliva (Chapter 12) emphasises the Protocol’s openness to consider the bottom-up development of model contractual clauses, codes of conduct and community protocols. She notes that these approaches can be particularly useful in allowing stakeholders to experiment with possible solutions to the several questions that remain unresolved in the Protocol, such as its openended provisions on traditional knowledge. In addition, Oliva stresses that the Protocol provisions should be interpreted and applied in ways that fuel collaboration among and support compliance by different stakeholders, including the private sector. The chapter also points to tools under the Protocol, such as the multilateral benefit-sharing mechanism, that can support ethical practices by private sector operators willing to go beyond legal requirements at the international level. Dedeurwaerdere and colleagues (Chapter 13) underscore the importance of building on the basic incentives that stimulate research into biodiversity conservation and sustainable use, which generally has no direct high commercial value. They also point to the usefulness of building on virtuous research practices, such as the networking and increasing integration of research infrastructure into global scientific research commons that thrive on non-monetary benefits. The authors thus caution against an excessive focus on monetary incentives or formal control mechanisms in ABS transactions, while noting the usefulness of some formal arrangements to maximize access to quality research material and reciprocity of benefits while reducing transaction costs. The authors support an extensive interpretation of the Nagoya Protocol’s provision allowing for simplified access for non-commercial research, combined with a standard set of up-front non-monetary and monetary benefits. They further welcome the opportunities created by the Nagoya Protocol for bottomup approaches to effective implementation, which may allow to place virtuous research practices on solid legal and institutional ground, through bilateral agreements between willing governments or at the multilateral level. Chiarolla (Chapter 14) shows that private international law will play a role in determining which domestic courts have jurisdiction on specific ABS

514   Elisa Morgera, Matthias Buck and Elsa Tsioumani disputes – a matter which the Protocol does not address explicitly, although it creates an international obligation to provide opportunities for legal recourse to nationals of other Parties. This obligation should arguably include the possibility for foreigners (including community or NGO representatives) to challenge a violation of domestic user measures and public authorities’ inaction on enforcement. In addition, Chiarolla argues that international private law will be relevant in the case of the recognition and enforcement of foreign judgements and arbitral awards, on the basis of the Protocol’s express obligation for Parties to establish and participate effectively in relevant bilateral agreements or other mechanisms. In terms of applicable law, Chiarolla considers the potential benefits (based on an extensive interpretation of the Protocol) of an extraterritorial application of the laws of countries of origin of genetic resources when the responsibility for misuse or misappropriation is before a national court of a user country or intermediary country. The author also stresses that a restrictive interpretation of the Protocol on this point would reduce the role of private international law in the Protocol’s implementation to resolving disputes concerning compliance with contractual ABS obligations. Young (Chapter 15) affirms the need to support the ‘interoperability’ of national ABS regimes for the effective implementation of the Protocol through international action. She points to the potential role of the ABS clearing-house to contribute not only to compliance, but also to networking and awareness raising. She also stresses the importance of model laws and contractual clauses as forms of ‘pre-agreed enforceability’ to ensure acceptability of ABS transactions in different legal (notably, constitutional) systems. Interestingly, Young also notes that the Protocol leaves the door open for bilateral, regional or sub-regional agreements that can facilitate the resolution of open issues related to the functionality of the international ABS regime between specific user and specific provider countries. Such agreements may provide additional layers of certainty to users, as well as additional guarantees with regard to minimum user country measures to reassure providers, more streamlined processes for ABS procedures, and coordination and cooperation in enforcement issues.

IV.  A Renewed Research Agenda on Global Environmental Law and ABS The findings outlined above, while being sometimes tentative in nature, already provide a wealth of useful insights. They also articulate questions that must be addressed in fully exploring the implications of the Nagoya Protocol and its innovative regulatory and governance approaches.

Conclusions   515

Particularly the contributions to Part I of this volume show that further, in-depth international law studies appear necessary to understand the opportunities for mutual supportiveness, or even cross-fertilisation or crosscompliance between the Nagoya Protocol and other relevant instruments of international law. Several specific questions have been raised with respect to the international law on human rights, food and agriculture, health, the sea and trade, but others could arise in relation to investment protection, development cooperation and interactions between bilateral and multilateral initiatives for the implementation of the Protocol. Significantly, these questions not only concern the fine details of a coherent interpretation of different international regimes and the practice of States and international bodies in their mutually supportive operation. They also point to broader questions related to the role of international law in ensuring equity in the relations among States and between States and indigenous peoples and local communities. Focusing more specifically on international biodiversity law, it seems also worth further studying whether the Nagoya Protocol (on the basis of the tight link it establishes with the other two objectives of the CBD – conservation and sustainable use) or a broader understanding of benefit-sharing could have an impact on the future development or interpretation of other areas of work of the CBD and even of other biodiversity-related conventions, for instance in relation to the management of protected areas or the sustainable use of forest biodiversity. Comparative studies will also be useful to better understand how domestic ABS systems address key implementation challenges. One area for comparative research certainly concerns the role of indigenous and local communities under the Protocol, as highlighted by several chapters in this volume. Another key area regards measures for ensuring compliance by users of genetic resources and associated traditional knowledge with applicable ABS requirements, which was only addressed in few regional studies in Part II of this volume. While the consideration of the innovative provisions of the Protocol on compliance may still be in very early stages, national legislative solutions will be particularly worth studying as essential building blocks of inter-State collaborative enforcement actions to ensure fair and equitable benefit-sharing between States and towards communities. Across the board, comparative studies will be useful also to international lawyers, in providing lessons learnt that may be taken into account in the further development of the international ABS regime, or assisting in understanding instances of non-compliance. Furthermore, transnational environmental law studies will likely find in the Nagoya Protocol a remarkably fertile ground for research. As most contributions to this volume underline, effective implementation of the

516   Elisa Morgera, Matthias Buck and Elsa Tsioumani Protocol is expected to rely on a plurality of legal orders and a multiplicity of legal relations between different actors at various levels as a result of dynamic interactions between customary, national and international law, as well as between the legal or quasi-legal contributions of the private sector, the research community, NGOs, international organisations and networks of experts. The Protocol itself embodies several tools that may be useful conduits for these creative partnerships, such as community protocols, codes of conduct, model contractual clauses, the international ABS clearing-house and capacity-building activities. Lessons learnt and best practices from this plethora of approaches will then be considered and possibly incorporated at the international level through the regular meetings of the governing body of the Nagoya Protocol. In truth, the Nagoya Protocol could provide the ideal case study for better understanding global environmental law – law that reflects the mutual interactions between international and national law, that is challenged and enriched by the customary laws of indigenous peoples and local communities, and that benefits from the innovations of the private sector and other stakeholders that rely on all these levels of regulation.

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Index Access  1–2, 4–11, 13–17, 21, 23–30, 32, 34, 36–38, 40–41, 43, 45, 48–49, 53, 56, 61–64, 68–72, 74, 83, 85, 89, 91–92, 94–97, 104, 108–109, 111–114, 116–118, 120–121, 123–126, 128, 129 n. 20, 132–135, 137, 143–144, 147, 151–154, 157–163, 165, 168–173, 177, 180, 185, 187, 189, 193, 195–196, 198, 203, 205, 208, 210, 217, 221–222, 234, 236, 241–242, 247–251, 254–256, 259, 261–264, 267–269, 271, 273, 276–279, 284–292, 295, 300, 302–303, 306–313, 318, 321, 323–324, 331–332, 334–355, 356 n. 120, 357–366, 368, 371, 373–387, 390–393, 395–400, 402–405, 407–408, 410–417, 419–420, 423, 425–427, 430–435, 442, 443 n. 63, 444, 447, 451–452, 457–458, 460, 466–470, 473, 476, 484, 488, 494, 497–499, 501, 507–509, 511–513 Access to justice  13, 36, 53, 56, 61–64, 68, 71–72, 74, 362, 425, 430–435, 443 n. 63, 447, 494 n. 109 Additional Protocol to the American Convention on Human Rights in the area of Economic, Social and Cultural Rights  59 n. 37 Ad Hoc Open-ended Informal Working Group to study issues relating to the conservation and sustainable use of marine biological diversity beyond areas of national jurisdiction  164 n. 102, 180 n. 188 Africa  14, 218–222, 224, 236, 244, 296 n. 4, 511 African Convention on the Conservation of Nature and Natural Resources  218, 221 n. 15 African Model Legislation for the Protection of Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources  218 African Charter on Human and Peoples’ Rights  60 n. 42 Agreement for the Implementation of the Provisions of the United Nations

Convention on the Law of the Sea of 10 December 1982 relating to the Conservation and Management of Straddling Fish Stocks and Highly Migratory Fish Stocks  173 n. 150 Agreement on Technical Barriers to Trade  197 Agreement on Trade-Related Aspects of Intellectual Property Rights  200, 219, 407 American Convention on Human Rights  59 n. 37 Animal genetic resources  85, 91, 115, 201, 389, 415 Archipelagic waters  154, 158, 164, 172 n. 146 Area (the)  156 n. 39, 167, 172 n. 146, 174–176, 179, 182 Argentina  166 n. 110, 264 n. 82, 333 Australia  14 n. 42, 138, 143, 166 n. 110, 212, 295–302, 304, 307–309, 315, 319, 321–323, 326–329, 415 Avian influenza  124 n. 5 Benefit-sharing  1–2, 3 n. 12, 4–7, 9–10, 14, 16–17, 21–28, 30–32, 33 n. 49, 34–35, 39, 41–43, 45, 49, 83, 96–98, 101, 111–114, 116–118, 123–126, 132–135, 137, 139–145, 147, 152, 163–166, 171–173, 177–178, 180–182, 187, 195–196, 200, 202–203, 205–206, 217, 221, 224–227, 242, 247–248, 250, 255–256, 259–260, 262–263, 269, 273–274, 276, 278–279, 288, 290, 295, 309–311, 316–317, 321, 331, 335, 339–340, 342, 344, 346, 348, 351, 354, 356 n. 120, 357–362, 367, 371, 373–387, 391, 395, 405–406, 408–409, 411, 414–420, 423, 426, 429, 437, 451, 457–458, 460, 473, 477, 478 n. 68, 488–490, 494, 498, 500, 507–510, 512–513, 515 Benefits monetary  5, 22–23, 25, 31–32, 34, 96, 97 n. 47, 98, 163–166, 188 n. 11, 202, 242, 342, 356, 359, 382, 385, 387, 390, 394, 401, 405, 413, 415, 417, 508, 513

536   Index non-monetary  5, 16, 23, 25, 28, 31–32, 34, 45, 96, 163–164, 202, 342, 356, 359, 385, 387, 390, 398, 405–406, 417, 508, 513 Bilateral agreements  201, 399, 445, 497, 513–514 Bolivia  7 n. 26, 297 n. 6, 333, 334 n. 7, 357, 359–361 Bonn Guidelines  6–7, 15, 23–27, 32–35, 40, 68, 77, 151, 247, 271, 284, 295, 298–299, 301, 303–304, 307, 309–310, 315, 318–320, 328, 453–454, 499, 512 Botswana  226 Brazil  16, 140 n. 67, 166 n. 110, 208–209, 262, 264 n. 82, 297 n. 6, 323, 331, 333, 336–341, 355–356, 358–360, 399, 415 Breeders’ rights  92, 93 n. 28, 98, 112 n. 112, 201 n. 75 Bushbuckridge  217, 231, 240, 241 n. 99, 242–243 Business and ABS  2, 3 n. 12, 16, 21, 24–27, 30, 33 n. 49, 34, 41, 43, 83, 114, 116–118, 125, 152, 171, 205, 217, 247, 259 n. 62, 279, 295, 311, 371, 373–381, 383– 385, 387, 423, 451, 473, 494, 498, 507 Cameroon  220 n. 11 Canada  14 n. 42, 65 n. 75, 69 n. 100, 155 n. 36, 208, 212, 251, 257 n. 51, 264 n. 82, 295–299, 301, 304, 312, 315–316, 318–319, 321–322, 324–325, 328–329, 425 n. 6, 432 n. 22 Caribbean  14, 16, 202 n. 77, 296, 331, 333, 355, 363–367, 512 Cartagena Protocol on Biosafety  282 Checkpoints  8, 37–39, 46, 103–104, 167, 171, 203–204, 252–254, 261, 267, 278–280, 291, 300, 333, 361–362, 383–384, 434, 439, 466, 477, 484, 504, 510 China  132, 138, 194, 209, 296–298, 323, 399 Choice of law  436–438, 440, 448 Coastal state  14, 151, 153–154, 156–167, 170–173 Colombia  16, 297 n. 6, 331, 333, 342–343, 356, 358–360, 399 Commission on Genetic Resources for Food and Agriculture  13, 43, 47, 84, 87, 90, 117 n. 137, 178 n. 185 Common heritage of mankind  3, 89, 165, 175, 179 Commons  17, 182, 390–395, 400–402, 403 n. 37, 404, 406–407, 409, 411, 414, 416–420, 513 Community protocol  10–11, 15, 41, 217–218, 223, 228, 234, 238–239, 241, 243–244, 256–257, 317, 360–361, 364, 379, 500, 511, 513, 516

Compliance  5, 7–8, 10–11, 14–17, 25–26, 28–30, 34–35, 37–39, 41–42, 46, 49–50, 60, 72, 74, 79, 81, 103–104, 118–119, 160, 164, 168, 170–172, 188, 196–199, 203–204, 210, 221, 223–224, 248–252, 254–255, 261, 264, 266–267, 269, 271, 273, 276, 278–279, 285, 288, 291–293, 295, 299–317, 323, 325, 327–329, 335, 340, 345, 354, 357, 361–362, 366, 368, 375, 378, 382–384, 387, 405, 413, 423, 425–426, 429, 431 n. 17, 433–434, 438–443, 446–449, 451, 454–455, 457, 459–460, 462–463, 467 n. 36, 468, 470, 476–477, 479, 481–484, 486–490, 492–493, 495–497, 500, 503–504, 510–511, 513–515 Conciliation  163, 463 Conference of the Parties  8, 26, 69, 101 n. 63, 178, 208, 218, 247, 271, 300, 453 n. 5 Conflict of norms  186 Consent (prior informed)  4–6, 11, 14–15, 23, 25, 53–54, 67–70, 97, 104, 151, 173–174, 177–178, 189, 208, 210, 222, 226, 249–250, 260 n. 67, 262–263, 277, 279, 300, 317–318, 333, 340, 347–348, 376, 378, 380–383, 417–418, 426, 443, 456, 458, 466, 469–470, 477, 482–483, 489, 508–509 Consultative Group on International Agricultural Research  48, 87, 402, 412, 490 Continental shelf  154, 159–160, 164, 171, 173, 175, 289, 339 Convention Concerning the Protection of the World Cultural and Natural Heritage  63 n. 56 Convention for the Protection of the Marine Environment of the North-East Atlantic  63 n. 56 Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters  62 n. 53, 432 n. 25, 494 n. 109 Convention on Biological Diversity Article 1  4 n. 15, 248 n. 5, 274 n. 21, 303 nn. 26–27 Article 2  151 nn. 11–12, 152 n. 20, 154 n. 33, 173 n. 153, 188 n. 10, 301 n. 23, 458 n. 22 Article 4  177 Article 8(j)  3 n. 11, 4, 39–40, 78 n. 147, 222, 260, 271, 316–317, 378 n. 16, 460–461 Article 15  23, 27–29, 151, 177, 382 n. 29, 426, 452–454, 455 n. 10, 459 n. 22, 478 n. 68, 499 Article 19  23 n. 9

Index   537 Convention on Civil Liability for Damage Resulting from Activities Dangerous to the Environment  63 nn. 56, 61 Convention on Environmental Impact Assessment in a Transboundary Context  62 n. 53 Convention on International Trade in Endangered Species of Wild Fauna and Flora  265, 478 Conventions on Jurisdiction and the Enforcement of Judgments in Civil and Commercial Matters  431 n. 16 Convention on Recognition and Enforcement of Foreign Arbitral Awards  446, 493 n. 101 Convention on the Protection and Promotion of the Diversity of Cultural Expressions  206 n. 98, 282 n. 63 Convention on the Protection and Use of Transboundary Watercourses and International Lakes  63 n. 56 Convention on the Transboundary Effects of Industrial Accidents  62 n. 53, 63 nn. 56, 61 Costa Rica  16, 297 n. 6, 331, 333, 336, 343, 346–347, 355–362, 364, 416 Cuba  333, 356 n. 120 Democratic Republic of Congo  297 n. 6 Denmark  270 Diffuse traditional knowledge  15 Disclosure  25, 46, 104, 190, 200–201, 203–205, 209–213, 217, 252–253, 267, 308, 337, 348, 363, 368, 479, 510 Discretion – . . . to grant or withhold consent  160, 162, 164 Dispute settlement  30, 36, 95, 163, 190, 198, 200, 339, 362, 439, 443 n. 63, 447, 487–488, 500 Distributive justice  134–135, 147–148 Division of competence  15, 269, 273–275, 281 n. 54 Doha Ministerial Declaration  209, 211 n. 131 Dominica  333 Duty of loyal cooperation  276, 283, 293 Ecuador  297 n. 6, 333, 334 n. 7, 356 n. 120, 358–362, 364–365 Ethical Biotrade  119, 371 n. *, 373, 384 Ethical sourcing of biodiversity  16, 371–373, 377, 385–386 Ethiopia  220 n. 11 European Convention for the Protection of Human Rights and Fundamental Freedoms  59 n. 37 European Social Charter  59 n. 37, 60 n. 42

European Union  15, 127 n. 13, 194 n 39, 212, 269, 272, 296, 433, 512 Exclusive Economic Zone  154, 289, 339, 510 Ex situ collection  11, 48, 89, 106–107, 263, 284, 345, 401–402, 404, 417–418, 511 “Fair and reasonable”  141 n. 68, 165, 170 “Fair and equitable”  4–5, 8, 10, 21, 23, 26, 31–33, 41–42, 45, 49, 54, 71, 73, 93–94, 102, 123, 125, 143–144, 146, 151, 153, 164, 177, 210, 222–223, 269, 271, 274, 278, 286–287, 303, 313, 317, 332, 359, 362–363, 373, 376–377, 379, 381, 386, 393, 417, 420, 489, 515 Farmers’ rights  13, 84, 93 n. 28, 98–100, 110–112, 121, 509 Fisheries  150, 155, 169, 173, 242, 353 Food security  1, 3, 13, 47–48, 83, 85, 88, 92–93, 94 n. 32, 96, 100, 103, 108, 116, 121, 218, 405, 498 France  166 n. 110, 270 General Agreement on Tariffs and Trade 1994  192 General Assembly  43, 60 n. 42, 66, 150, 164 n. 102, 174, 178–181 Genetic resources  1, 3–11, 13–17, 21–50, 53–54, 68–69, 71, 73–74, 77, 80, 83–94, 97, 99–104, 108–110, 113–114, 116–121, 123–124, 126–127, 129, 131–133, 135– 137, 143–144, 147, 150–158, 161, 163– 164, 166–167, 169, 171–175, 177–182, 185, 187–190, 192–198, 200–201, 203– 206, 208–210, 212–213, 217–218, 222, 234, 236–237, 244, 247–248, 250–251, 252 n. 21, 253, 255–257, 258 n. 60, 259 n. 62, 260 n. 67, 261–267, 269–271, 273–274, 276–280, 284–293, 295, 298–304, 306, 308–309, 311–312, 314, 316–318, 320–321, 323–324, 326, 328–329, 331–337, 339–344, 346–350, 352–355, 356 n. 120, 357–364, 367–368, 374–376, 377 n. 15, 378–384, 386–387, 389, 391, 394–395, 396 n. 24, 402–405, 411–413, 415–420, 426–429, 431, 434–445, 447–448, 454–461, 463, 465–469, 473, 475–481, 483–484, 485 n. 83, 488–490, 492, 494, 496–498, 499 nn. 124–125, 501, 503, 507–509, 511–512, 514–515 Guyana  333, 356 n. 120 H5N1  124–125, 128, 132, 138, 145, 147 Health emergency  125, 128–130, 133 High seas – freedom of the . . .  175, 180 Hoodia  224–228, 236, 262

538   Index Human rights  11–13, 22, 53–68, 70–74, 79–81, 229, 322, 361 n. 128, 366, 509, 515 India  93, 140 n. 67, 166 n. 110, 209, 258 n. 60, 261, 264 n. 82, 297 n. 6, 298, 323, 399 Indigenous peoples  1, 11, 13, 15–16, 40, 53–54, 56, 61–62, 64–71, 73 n. 119, 74–78, 80–81, 217–219, 223–224, 228–229, 232–234, 236, 238, 243–244, 257, 295, 298, 313–321, 324–325, 328–329, 340–341, 344–345, 348, 351–354, 359–360, 361 n. 128, 366–367, 509, 511, 515–516 Indonesia  73 n. 119, 124–125, 208 Innovation  8, 12, 16, 21, 28, 32, 34, 37, 39, 40 n. 81, 68, 83, 91–92, 98–99, 204, 212, 218–219, 222, 228–229, 233, 238, 253, 279, 298–301, 321, 334, 339, 352, 360–362, 377, 386, 389, 390, 401, 404, 409–410, 454 n. 8, 460, 508, 516 Intellectual property rights  4, 14, 22, 25, 30, 39, 43, 78, 90–92, 98, 111, 125, 140, 141 n. 68, 186, 202, 219, 221 n. 15, 259 n. 62, 260 n. 67, 275, 309, 335, 337, 378, 402 n. 35, 412, 414, 478 n. 69, 479 International Convention for the Protection of New Varieties of Plants  92 n. 24, 201 n. 75 International Convention on the Elimination of All Forms of Racial Discrimination  72 n. 118 International cooperation  37 n. 72, 166, 169–170, 172–173, 176, 179 n. 187, 182, 390, 402, 451 International Covenant on Civil and Political Rights  59 International Covenant on Economic, Social and Cultural Rights  59 International Health Regulations  45, 129–130 International Labour Organisation Convention 169 Concerning Indigenous and Tribal Peoples in Independent Countries  64 n. 67 International private law  436 n. 30, 514 International Treaty on Plant Genetic Resources for Food and Agriculture  13, 27, 43, 48, 83, 85, 90 n. 18, 102, 115 n. 127, 178 n. 185, 182, 206, 109 n. 100, 219, 259 n. 62, 352, 364, 402–­403, 435 n 36, 485, 509 Internal waters  154, 158, 164, 172 n. 146 Inter-operability  491–492 Intent – change of . . .  30–31, 163, 307, 365, 413, 499–500

Japan  138, 166 n. 110, 194 n. 38, 208, 251, 296–297, 312, 322–323, 410, 425 n. 6, 497 Jurisdiction  7, 11, 14, 25, 35–36, 41–43, 50, 58, 71, 90, 106, 109–110, 124, 152–154, 157, 159, 164, 166, 168–169, 171–172, 174–175, 177–182, 187–188, 198, 223, 232, 248, 262–267, 277–278, 287, 290–291, 306, 322–323, 325, 328, 336, 339, 343, 363, 382, 403, 418, 424, 430–432, 434, 435, 438–439, 441, 443–447, 449, 455 n. 10, 459, 471, 476–477, 491, 501, 510, 513 Kenya  76 n. 137, 220, 297 n. 6 Korea  296 Latin America  14, 297, 331, 333, 355, 360, 363, 367, 512 Legal regime development  456 Local communities  1–2, 6­7, 9–11, 13–16, 23, 25, 28, 39–42, 53–54, 62, 68–80, 84–85, 99–100, 110, 112–114, 121, 131 n. 28, 162, 169, 183, 217–219, 221–224, 228 n. 40, 233–234, 236, 238, 240, 243–244, 249, 255–263, 266, 269, 272–273, 277–278, 286, 290, 293, 295, 300 n. 17, 305, 308, 312–314, 317–318, 320–321, 329, 333–334, 340, 344, 352, 354, 356, 359, 360–361, 363–364, 367, 374, 378–381, 427, 433 n. 29, 434 n. 29, 435, 438, 441–442, 455, 460, 469, 479, 494, 496, 507–512, 515–516 Madagascar  297 n. 6 Malawi  220 n. 11 Marine living resources  155 Marine genetic resources  150–151, 156, 167, 290 beyond areas of national jurisdiction  14, 152, 166, 174, 177, 179–182 Marine scientific research  14, 149, 150 n. 5, 156 n. 37, 510 Maritime zones  157, 172, 180 Malaysia  15, 249, 251, 263–265, 297 n. 6, 315 n. 72 Mexico  16, 89, 166 n. 110, 264 n. 82, 296–299, 301, 304, 319, 331, 333, 347, 348, 483 n. 80 Misappropriation  17, 24, 34–35, 290, 383, 387, 427–429, 431, 435, 438, 440, 446–448, 455–456, 458, 463, 467, 479, 497, 508, 514 Misuse  17, 24, 34, 383, 427, 428, 431, 436–437, 455–456, 458, 463, 467, 479, 497, 508, 514 Monitoring  8, 11, 16–17, 26, 28, 37, 46, 49–50, 73, 79, 81, 135, 170–172, 188,

Index   539 203, 210, 238, 239, 250, 252, 261, 267, 279, 287, 291, 292 n. 99, 340, 355, 362, 371, 383, 405, 442, 451, 465–466, 469, 475–477, 479–484, 504, 509 Mutually agreed terms  5–6, 17, 23, 54, 68, 71, 104, 113, 135, 141 n. 68, 153, 196, 226, 250, 260, 277, 279, 300, 371, 356, 376, 377 n. 15, 379, 381, 383, 387, 400–401, 411, 416, 418, 420, 421, 425, 427–428, 431, 437, 456 n. 16, 458, 469, 470 n. 45, 477, 483, 488, 493, 500, 510 Mutual supportiveness  13, 45–46, 48, 55, 58, 104–105, 136–137, 152, 166, 204–205, 207, 212, 507, 509, 511, 515 Nagoya  101 n. 63, 141–142, 146, 182–183, 244, 248, 272–273, 300, 426, 442 n. 61, 468, 486, 488 n. 91, 493, 503 Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety  488 n. 91 Nagoya Protocol on Access and Benefit-Sharing Article 1  27 n. 27, 34 n. 52, 144 nn. 82, 87, 151 n. 16, 195 n. 45, 274 n. 20, 378 n. 18 Article 2  28 n. 29, 29 n. 30, 254 n. 33, 173 n. 153, 187 nn. 7, 9, 188 n. 10, 250 nn. 12–13, 261 n. 71, 302 n. 25, 363 nn. 131–132, 375 n. 11, 376 n. 12, 477 n. 66 Article 3  28 n. 28, 40 n. 83, 44 n. 112, 134 n. 34, 177 n. 179, 184 n. 8, 460 n. 25 Article 4  44 nn. 108, 113, 46 nn. 122–124, 47 n. 126, 48 n. 133, 49 n. 141, 57 nn. 25, 28, 66 n. 87, 80 n. 158, 101 n. 62, 102 n. 65, 103 nn. 68–69, 106 nn. 81–82, 107 nn. 89, 91–92, 108 n. 94, 109 n. 99, 101, 114 n. 122, 115 n. 125, 118 n. 143, 120 n. 150–152, 126 n. 11, 136, 143 n. 79–81, 144 n. 83, 145–146, 152 n. 18, 177, 187 n. 6, 207 nn. 102–103, 210 n. 120, 252 n. 22, 263 n. 81, 496 n. 118, 501 n. 131, 502 n. 132 Article 5  31 n. 43, 41 nn. 87–88, 71 n. 109, 113 nn. 115–116, 153 n. 24, 163 nn. 95–96, 164 n. 98, 188 nn. 11, 13, 250 n. 14, 255 n. 37, 256 nn. 46–47, 49, 259 nn. 63–64, 269 n. 3, 278 nn. 39, 42, 359 nn. 125–126, 377 n. 15, 379 n. 20, 381 n. 26, 382 n. 29, 427 n. 10 Article 6  29 nn. 31–35, 30 nn. 36–40, 31 nn. 41–42, 34 n. 57, 36 n. 66, 37 n. 75, 41 n. 86, 69 nn. 99, 101, 70 n. 107, 108 n. 95, 153 n. 22,

157 n. 47, 158 n. 54, 161 nn. 72–74, 78, 162 nn. 84–85, 89, 169 n. 126, 189 n. 15, 193 n. 36, 202 n. 79, 234 n. 66, 250 n. 16, 251 n. 19, 254 n. 33, 277 n. 33, 320 n. 94, 357 nn. 121–122, 358 n. 124, 364 n. 133, 379 n. 19, 426 n. 9, 428 n. 13, 443 n. 65, 470 n. 47, 500 n. 126 Article 7  36 n. 67, 54 n. 9, 255 n. 39, 256 nn. 43, 48, 259 n. 64, 262 n. 74, 269 n. 2, 277 n. 36, 321 nn. 96–97, 378 n. 17, 441 n. 56 Article 8  13, 44 n. 114, 47 n. 127, 48 n. 135, 100 nn. 60–61, 108 n. 96, 109 n. 99, 118 n. 142, 125–126, 129–132, 134, 137, 146–147, 157 n. 48, 158 n. 53, 159 n. 63, 170 n. 133, 295 n. 2, 307 n. 47, 323 n. 108, 364 n. 136, 365 nn. 138, 142, 390 n. 6, 413, 415 n. 67, 417, 420 nn. 82, 85, 498 n. 122, 499 n. 123 Article 9  34 n. 53, 195, 263, 290 n. 94 Article 10  34 n. 54, 42, 96 n. 41, 173 n. 149, 177 n. 181, 182 n. 196, 255 n. 40, 260 n. 66, 263 n. 80, 374 n. 7, 381 n. 27, 391 n. 7, 417 n. 74, 418 n. 77, 489 n. 92 Article 11  172 n. 147, 255 n. 41, 391 n. 8, 417 n. 75, 419 n. 81, 496 n. 116 Article 12  10 n. 38, 41 nn. 89–92, 94, 53 n. 4, 73 n. 121, 99 n. 55, 110 n. 104, 223 nn. 24, 29, 234 nn. 68–69, 256 nn. 44–45, 257 n. 55, 317 nn. 84–85, 360 n. 127, 364 n. 135, 379 nn. 21, 23, 494 n. 108, 500 n. 127 Article 13  168 n. 120, 277 n. 35, 473 n. 56 Article 14  9 n. 32, 74 n. 125, 104 nn. 74–75, 161 n. 77, 254 n. 34, 323 n. 107, 469 nn. 41–44, 470 n. 46, 471 n. 48, 475 n. 61 Article 15  32 n. 45, 34–35, 41 n. 96, 164 n. 99, 171 n. 141, 251 n. 18, 431 n. 17, 434 n. 31, 439 n. 49, 441, 444, 448 n. 73, 471 n. 49 Article 16  34 n. 58, 41 n. 95, 42 nn. 97–99, 255 n. 38, 261 n. 72, 290 n. 93, 292 n. 100, 317 n. 86, 320 n. 95, 431 n. 17, 434 n. 32, 439 n. 50, 441–442 Article 17  34, 37–38, 46 n. 121, 104 nn. 76–77, 171 n. 142, 196 nn. 51–52, 197 nn. 56–57, 203 n. 87, 204 nn. 88–90, 213 n. 136, 250 n. 15, 253 nn. 25–26, 261 n. 71, 267 n. 96, 279 nn. 46, 50–51, 291 n. 97, 292 n. 99, 362 n. 130, 383 nn. 31–32, 434 n. 33, 439 n. 51, 442, 476 n. 62, 477 nn. 65–66, 478 n. 67, 483 nn. 78, 81

540   Index Article 18  34–36, 42 n. 100, 53 n. 3, 72 n. 113, 425, 431 n. 17, 432 n. 24, 433, 437 n. 41, 445 n. 68, 488 n. 90, 494 n. 109, 495 nn. 110, 112, 500 n. 128 Article 19  10 n. 36, 34 n. 59, 118 nn. 144–145, 493 n. 103, 494 n. 105 Article 20  10 n. 37, 35 n. 60, 119 n. 146, 374 n. 8, 384 n. 33, 385 n. 36, 391 n. 9, 420 nn. 83–84, 494 nn. 104, 106 Article 21  234 n. 70, 472 n. 54, 473 n. 55 Article 22  11 n. 39, 34 n. 55, 503 n. 135 Article 23  202 n. 80, 385 n. 37, 503 n. 136 Article 24  196 n. 48, 500 n. 129 Article 26  50 nn. 142–144, 249 n. 10, 495 n. 114 Article 27  487 n. 89 Article 28  454 n. 9 Article 29  210 Article 30  9 n. 32, 224 n. 32, 439 n. 48, 449 n. 74, 487 n. 87 Article 31  249 n. 10, 495 nn. 111, 113 Namibia  220 n. 11, 225–226 National coordination  168 n. 121, 182 Natural ingredients  372–373, 375–377, 384, 386 Natural resources  23, 53, 65, 78–79, 150, 157, 160, 162–165, 189, 192–193, 195, 221, 230–231, 233, 237–239, 277, 289, 301–302, 312–313, 326, 339, 341, 349, 352, 391–392, 487 n. 89, 512 New Zealand  14 n. 42, 65 n. 75, 295–298, 315, 319–320, 322, 326–329 North American Agreement on Environmental Cooperation  297 Norway  295–299, 304, 309–310, 320, 322, 328–329 Obligation of result  160–161 of means  161 Panama  16, 331, 333, 336, 349–350, 355–360, 364 Pandemic  43, 45, 124–126, 128 n. 16, 138, 146–147 Pandemic Influenza Preparedness  13, 45, 125, 128 n. 16, 136 n. 41, 138 n. 47, 139 n. 54, 140 n. 67, 141 n. 69, 142 nn. 72–73 Partnership Agreement between the members of the African, Caribbean and Pacific Group of States of the one part, and the European Community and its Member States, of the other part  202 Patent disclosure  210

Pathogen (Pathogenic material)  123, 127, 132–133, 510 Peru  16, 96 n. 40, 114 n. 119, 232 n. 63, 261, 262 n. 73, 297 n. 6, 331, 333, 334 n. 7, 335 n. 11, 351–352, 355, 356 n. 120, 357–362, 364–365, 379 n. 22 Pharmaceuticals  125, 135, 137, 147, 344, 376–377, 380 Philippines  297 n. 6, 331, 399 Plant genetic resources  13, 27, 43, 48, 83, 85, 88–90, 94, 97 n. 47, 99, 102–103, 105, 109–110, 112 n. 112, 113 n. 114, 115 n. 127, 116, 178 n. 185, 182, 189 n. 18, 206, 219, 259 n. 62, 263, 288, 337 n. 16, 352, 364, 396 n. 24, 402–404, 411–412, 416, 435 n. 36, 485, 509 Portugal  287, 292 Prior informed consent  see Consent (prior informed) Private sector  1, 2 n. 8, 10, 12, 15, 50, 91, 142–143, 232 n. 63, 236 n. 83, 243–244, 310, 312, 345, 387, 410, 453, 474, 481, 507, 513, 516 Protocol on Environmental Protection to the Antarctic Treaty  62 n. 53 Protocol to the African Charter on Human and Peoples’ Rights on the Establishment of an African Court on Human and Peoples’ Rights  60 n. 42 Public domain  5, 48, 95, 105 n. 79, 114, 161, 200, 259–260, 262, 289–290, 321, 344, 349, 401–402, 414–416, 419–420 Public health  13, 45, 125–127, 129–130, 133–137, 141 n. 68, 142 n. 71, 144, 147–148, 196 Recognition of foreign judgments  17, 36, 72, 423–424, 426, 430, 445–446, 449, 494 n. 109 Research and development  8, 23, 28–29, 31, 86–87, 91, 123–125, 129, 136, 146, 153–156, 160, 163, 187–188, 250–251, 284, 300, 302–303, 309–310, 323, 329, 356, 366, 373, 375–378, 380, 383, 385, 387, 414–416, 477 n. 66 collaboration  139, 346 Researching State  14, 153, 157–159, 161, 163–166, 170–172, 510 Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade  206 n. 100 Rwanda  486 n. 85 Saint Lucia  333 Samples  6, 8, 24, 124, 138–139, 147, 154, 164, 180, 195, 339–340, 348, 354, 362,

Index   541 389, 393–394, 396 n. 24, 399, 403, 408, 409 n. 55, 454 n. 8, 480 San  2 n. 7, 217, 220, 224–228, 236, 238 n. 91, 262, 511 Scientific research freedom of . . .  157, 159, 175 commons  17, 390–395, 398, 400–407, 409, 411, 414, 416–420, 513 Seabed  154 n. 31, 155 n. 36, 160 n. 68, 172 n. 146, 174–175, 490 Seychelles  220 n. 11, 486 n. 85 Singapore  296 South Africa  166 n. 110, 208, 220 n. 11, 225–226, 230 n. 51, 231, 233 n. 64, 235 n. 77, 240, 241 n. 99, 244 n. 109, 262, 297 n. 6, 414, 454 n. 7 Sovereignty over natural resources  79, 189, 195 Spain  15, 166 n. 110, 269–280, 281 n. 54, 282–293, 297, 512 Specialised ABS instrument  102, 110, 125–126, 136, 143 Straits  158–159 Switzerland  296–297, 307–308, 322, 328–329, 431 n. 16 Transboundary Cooperation  17, 172, 378, 391, 395, 419, 496 Technology transfer  139, 164, 275, 287, 339, 342, 346, 353, 371, 385 n. 38, 386, 503 Territorial sea  154, 158–159, 160 n. 68, 161, 164, 172–173, 289 Trade and environment  185, 190, 211 n. 129, 212 Treaty establishing the European Community  273 n. 16 Treaty on European Union (TEU)  276 n. 26

Treaty on the Functioning of the European Union (TFEU)  273 n. 14 Uganda  220 n. 11 UN Convention on the Law of the Sea  3 n. 12, 490 UN Convention to Combat Desertification in Countries Experiencing Serious Drought and/or Desertification, Particularly in Africa  490 n. 97 UN Framework Convention on Climate Change  73 Union for Ethical BioTrade (UEBT)  119, 123 n. 3, 332 n. 4, 371 n. *, 373 United Kingdom  134 n. 37, 138 United Nations  66, 149 n. *, 150, 155 nn. 34, 36, 174 n. 154, 179 n. 187, 180 n. 188, 296 United States of America  xxxv Uruguay  399 Vaccine  45, 123–124, 125 n. 10, 135–136, 138–141, 142 n. 72, 143 Venezuela  7 n. 26, 16, 297 n. 6, 331, 333, 353–356, 358, 360 Vienna Convention on the Law of Treaties  103, 153 n. 10, 152 n. 17, 191, 252 Vietnam  132 Virus  124, 128, 132, 138 World Health Organisation  13, 43, 124, 135, 178 n. 185, 253 n. 24 World Trade Organisation  43, 91, 185, 219, 251, 292, 297 WTO Agreement on Technical Barriers to Trade  197 WTO Agreement on Trade-Related Aspects of Intellectual Property Rights  91, 200, 219