Controversies in Latin American Bioethics [1st ed.] 978-3-030-17962-5;978-3-030-17963-2

Table of contents :
Front Matter ....Pages i-xii
Introduction: Why (and How) Bioethics Matters in Latin America (Martin Hevia, Eduardo Rivera-López)....Pages 1-8
Front Matter ....Pages 9-9
Anti-abortion Laws and the Ethics of Abortion (Gustavo Ortiz Millán)....Pages 11-32
Conscious Oppression: Conscientious Objection in the Sphere of Sexual and Reproductive Health (Marcelo Alegre)....Pages 33-51
The Legal Status of Surrogacy in Latin America (Martin Hevia)....Pages 53-63
Front Matter ....Pages 65-65
Revisiting Vulnerability: Its Development and Impact (Florencia Luna)....Pages 67-81
Consent and Exploitation in Bioethics: Individual Ethics and Legal Regulation (Eduardo Rivera-López)....Pages 83-95
Oneself and One’s Body: Commodification and (In)alienability (Antonio Bascuñán Rodríguez)....Pages 97-112
Front Matter ....Pages 113-113
Outsourcing Clinical Trials to Latin America: Causes and Impact (Nuria Homedes, Antonio Ugalde)....Pages 115-144
Innovative Care in Latin America: Definition, Justification and Ethical Principles (Felicitas Holzer, Ignacio Mastroleo)....Pages 145-176
Ethics in Conducting and Communicating Research: A Brazilian Perspective (Marisa Palácios, Sergio Rego)....Pages 177-199
Front Matter ....Pages 201-201
A Latin American Perspective to Agricultural Ethics (Cristian Timmermann)....Pages 203-217
A Territorial Mediation in a Triangular Affair Towards an Ecological Territorial Sovereignty (Alfonso Donoso)....Pages 219-235
Back Matter ....Pages 237-243

Citation preview

International Library of Ethics, Law, and the New Medicine 79

Eduardo Rivera-López Martin Hevia   Editors

Controversies in Latin American Bioethics

International Library of Ethics, Law, and the New Medicine Volume 79

Series Editors David N. Weisstub, Faculty of Medicine, University of Montreal, Montreal, QC, Canada Dennis R. Cooley, History, Philosophy, and Religious Studies, North Dakota State University, Fargo, ND, USA Founding Editors David N. Weisstub, Faculty of Medicine, University of Montreal, Montreal, QC, Canada Thomasine Kimbrough Kushner, Berkely, CA, USA David C. Thomasma, Dordrecht, The Netherlands

The book series International Library of Ethics, Law and the New Medicine comprises volumes with an international and interdisciplinary focus. The aim of the Series is to publish books on foundational issues in (bio) ethics, law, international health care and medicine. The volumes that have already appeared in this series address aspects of aging, mental health, AIDS, preventive medicine, bioethics and many other current topics. This Series was conceived against the background of increasing globalization and interdependency of the world’s cultures and governments, with mutual influencing occurring throughout the world in all fields, most surely in health care and its delivery. By means of this Series we aim to contribute and cooperate to meet the challenge of our time: how to aim human technology to good human ends, how to deal with changed values in the areas of religion, society, culture and the self-definition of human persons, and how to formulate a new way of thinking, a new ethic. We welcome book proposals representing the broad interest of the interdisciplinary and international focus of the series. We especially welcome proposals that address aspects of ‘new medicine’, meaning advances in research and clinical health care, with an emphasis on those interventions and alterations that force us to re-examine foundational issues.

More information about this series at http://www.springer.com/series/6224

Eduardo Rivera-López Martin Hevia

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Editors

Controversies in Latin American Bioethics

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Editors Eduardo Rivera-López Law School Universidad Torcuato Di Tella Buenos Aires, Argentina

Martin Hevia Law School Universidad Torcuato Di Tella Buenos Aires, Argentina

ISSN 1567-8008 ISSN 2351-955X (electronic) International Library of Ethics, Law, and the New Medicine ISBN 978-3-030-17962-5 ISBN 978-3-030-17963-2 (eBook) https://doi.org/10.1007/978-3-030-17963-2 © Springer Nature Switzerland AG 2019 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Switzerland AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland

Sources of the Articles

• Gustavo Ortiz Millán, “The Morality of Law, the Morality of Abortion”: The article is unpublished. He reworks and updates ideas of his book La moralidad del aborto (México: Siglo XXI, 2009). • Marcelo Alegre, “Conscious Oppression: Conscientious Objection in the Sphere of Sexual and Reproductive Health”: The Spanish version of the article has been published in Aldao, M. M., Clérico, L. and Ronconi, L. (eds.), Tratado del derecho a la salud, Buenos Aires: Abeledo Perrot, 2013. • Martin Hevia, “The Legal Status of Surrogacy Agreements and the American Convention on Human Rights”: The article is unpublished. It is based on two previous papers: Hevia, M. Liberalismo y Gestación por Sustitución. 2018. In Entre la Libertad y la Igualdad. Ensayos Críticos Sobre la Obra de Rodolfo Vázquez. México: UNAM. p. 301–311; Hevia, M. Surrogacy, Privacy, and the American Convention on Human Rights. Forthcoming 2019. Journal of Law and Biosciences. • Florencia Luna, “Revisiting the Concept of Vulnerability”: The article is unpublished. She reworks and updates her previous work on vulnerability, both in Spanish and in English: Luna, F., “La declaración de la UNESCO y la vulnerabilidad, la importancia de la metáfora de las capas,” in María Casado (ed.), Sobre la Dignidad y los Principios. Análisis de la Declaración Universal de Bioética y Derechos Humanos de la UNESCO. Ed. Civitas, Navarra 2009, pp. 255–266; Luna F., “Elucidating the Concept of Vulnerability. Layers not Labels” International Journal of Feminist Approaches of Bioethics, vol. 2, no. 1, 2009; Luna, F., & Vanderpoel, S., “Not the usual suspects: addressing layers of vulnerability” Bioethics, vol. 27, Issue 6, 2013, pp. 325–332; Luna F. “Vulnerability”, an interesting concept for public health: the case of older persons”, Public Health Ethics, Volume 7, Issue 2, 2013, pp. 180–194; Luna F., “Rubens, corsets and taxonomies: a response to Meek Lange, Rogers and Dodds” Bioethics, vol. 26, no. 6, 2015, pp. 448–450; Luna, F. “Vulnerability”, Encyclopedia of the Anthropocene, 2017, ELSEVIER INC, MA, United States; and Luna F. “Identifying and Evaluating Layers of Vulnerability. A way forward”, Developing World Bioethics 2018, pp. 1–10. v

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Sources of the Articles

• Eduardo Rivera-López, “Consent and Exploitation in Bioethics: Individual Ethics and Legal Regulation”: A previous version of the article has been published in Spanish in Revista de Bioética y Derecho, Vol. 40, 2017, pp. 7–22. • Antonio Bascuñán Rodríguez, “Oneself and the Body: Commodification and (In)alienability”: Revised version of “Sí mismo y cuerpo propio: ¿(In)disponibilidad, (in)alienabilidad, (in)comerciabilidad?,” published in: La Irrupción del Cuerpo / Oralidad: Memoria, Relatos y Textos - Actas IV y V Escuela Chile-Francia (Cátedra Michel Foucault), Santiago, 2013, pp. 79–98. • Nuria Homedes and Antonio Ugalde, “Outsourcing Clinical Trials to Latin America: Causes and Impact”: The article is unpublished. • Felicitas Holzer and Ignacio Mastroleo, “Innovation as New Non-validated Practice: Definition, Justification, Principles, and Its Context in Latin America”: The article is unpublished, but is based and incorporates parts of the following previous work: Holzer, F. S., & Mastroleo, I. (2018). Ethical Aspects of Precision Medicine: An Introduction to the Ethics and Concept of Clinical Innovation. In H.-P. Deigner & M. Kohl (Eds.), Precision Medicine (pp. 1–19). London: Academic Press-Elsevier. https://doi.org/10.1016/B978-0-12-8053645.00001-9; and Mastroleo, I., & Holzer, F. (2018). New non-validated practice: a refined definition of innovation in traditional research ethics. Submitted to Hastings Center Report on 16th March, under review. • Marisa Palácios and Sergio Rego, “Research Integrity or Ethics in the Conduct and Communication of Research? A Brazilian Perspective”: The article is unpublished. • Cristian Timmermann, “A Latin American Perspective to Agricultural Ethics”: The article is unpublished. • Alfonso Donoso, “A Territorial Mediation in a Triangular Affair. Towards an Ecological Territorial Sovereignty”: The article is unpublished.

Contents

1

Introduction: Why (and How) Bioethics Matters in Latin America . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Martin Hevia and Eduardo Rivera-López

Part I

Sexual and Reproductive Rights

2

Anti-abortion Laws and the Ethics of Abortion . . . . . . . . . . . . . . . Gustavo Ortiz Millán

3

Conscious Oppression: Conscientious Objection in the Sphere of Sexual and Reproductive Health . . . . . . . . . . . . . . . . . . . . . . . . . Marcelo Alegre

4

The Legal Status of Surrogacy in Latin America . . . . . . . . . . . . . . Martin Hevia

Part II

1

11

33 53

Vulnerability, Exploitation, and Commodification 67

5

Revisiting Vulnerability: Its Development and Impact . . . . . . . . . . Florencia Luna

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Consent and Exploitation in Bioethics: Individual Ethics and Legal Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Eduardo Rivera-López

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Oneself and One’s Body: Commodification and (In)alienability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Antonio Bascuñán Rodríguez

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Part III 8

Biomedical Research with Human Subjects

Outsourcing Clinical Trials to Latin America: Causes and Impact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115 Nuria Homedes and Antonio Ugalde

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9

Contents

Innovative Care in Latin America: Definition, Justification and Ethical Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145 Felicitas Holzer and Ignacio Mastroleo

10 Ethics in Conducting and Communicating Research: A Brazilian Perspective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177 Marisa Palácios and Sergio Rego Part IV

Agriculture and Environment

11 A Latin American Perspective to Agricultural Ethics . . . . . . . . . . . 203 Cristian Timmermann 12 A Territorial Mediation in a Triangular Affair Towards an Ecological Territorial Sovereignty . . . . . . . . . . . . . . . . . . . . . . . 219 Alfonso Donoso Author Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237 Subject Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239

Editors and Contributors

About the Editors Eduardo Rivera-López is licentiate in Philosophy (Universidad de Buenos Aires) and Ph.D. in Political Sciences (University of Mainz). He has been Alexander von Humboldt Foundation, John Simon Guggenheim Foundation, and H.L.A. Hart (Oxford) fellow. He has published books in Argentina, Spain, Germany, and México, and articles on moral philosophy and bioethics in several international journals, among others: Pacific Philosophical Quarterly, Bioethics, Journal of Applied Philosophy, Philosophy & Phenomenological Research, Journal of Value Inquiry, Law & Philosophy, Utilitas, Ratio, and Journal of Medical Ethics. He is currently full professor at the Universidad Torcuato Di Tella and researcher at the National Council of Scientific and Technological Research of Argentina. Martin Hevia is Dean and Associate Professor at the School of Law, Universidad Torcuato Di Tella. He earned his doctorate in law in 2007 at the University of Toronto, Canada and his law degree in 2001 at the Torcuato Di Tella University. Professor Hevia’s research and teaching interests include Comparative Private and Constitutional Law, Health Law and Reproductive Rights, and Legal and Political Philosophy. He is the author of Reasonableness and Responsibility: A Theory of Contract Law (2013), Derecho Privado y Filosofía Política (2011) and editor of Teoría y Crítica de la Propiedad Intelectual (2016) y Teoría y Crítica del Derecho Privado (2012). His papers have been published in international journals such as Harvard Journal of Health & Human Rights, Journal of Law & Biosciences, Texas Law Review, International Review of Intellectual Property and Competition Law, Florida Journal of International Law, Canadian Journal of Law & Jurisprudence, and International Journal of Gynecology and Obstetrics. His papers have been quoted by Argentine courts such as the National Civil and Commercial Law Chamber. He is the Vice President of the Iberoamerican Association of Law Schools.

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Contributors Marcelo Alegre JD, Universidad de Buenos Aires, JSD NYU. He is Professor of Law and Philosophy at the Universidad de Buenos Aires Law School and Global Professor at New York University Law School. His research interests and publications (books, book chapters and articles) are focused on legal theory, moral and political philosophy, human rights law, constitutional law and legal education. Antonio Bascuñán Rodríguez teaches at the Law Schools of the Universidad de Chile and the Universidad Adolfo Ibáñez in Chile. He is a lawyer and he holds postgraduate studies at the University of Munich. His research focuses on the constitutional dimensions of criminal law and the criminal regulation of bioethics. His articles have been cited by the Supreme Court of Chile and the Supreme Court of Puerto Rico. He has been a consultant to the National Congress of Chile on several issues. Alfonso Donoso is Associate Professor at the Pontificia Universidad Católica de Chile. He holds a B.A. in Philosophy (Pontificia Universidad Católica de Chile), an MLitt in Philosophy (University of St. Andrews, UK) and a Ph.D. in Politics (University of York, UK). His areas of research are environmental justice and environmental ethics, and applied ethics in general. He is currently the main researcher of the project Towards a Theory of Ecological Justice: Reciprocity and State Obligations to Nature, funded by the National Council of Scientific and Technological Research of Chile. Felicitas Holzer obtained her Master of Science degree in Interdisciplinary Studies in Biomedical Sciences from the University of Buenos Aires (UBA) in 2015, and her Master of Philosophy degree in History and Philosophy of Science from the University of Cambridge in 2016. She is a doctoral student in Philosophy at the Sorbonne (Paris IV) and the University of Buenos Aires, doctoral fellow of CONICET (National Scientific and Technical Research Council of Argentina), and junior research at the Bioethics Program of FLACSO Argentina under the supervision of Dr. Ignacio Mastroleo, Dr. Florencia Luna, and Dr. Stéphane Chauvier. Her articles and contributions have been published in Bioethics, Hastings Center Report, Journal of Medical Ethics, among other international journals of the field. Nuria Homedes MD, DrPH is Executive Director at Salud y Farmacos and Adjunct Professor at the University of Texas, School of Public Health and Adjunct Professor at Georgetown University. She has done consulting work for several international agencies (WHO, PAHO, US Agency for International Development, and Latin American governments, and was a public health specialist at the World Bank in Washington DC (1992–1997). She has published more than 100 articles and edited six books. Her research interests are US-Mexico relationships, health systems and pharmaceutical policies. She is currently coordinating an eight-country project that aims at strengthening the capacity of Latin American research ethics committees to protect subjects in clinical trials financed by the pharmaceutical industry.

Editors and Contributors

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Florencia Luna is Master of Arts in Philosophy (Columbia University) and Ph.D. in Philosophy (University of Buenos Aires). She is principal researcher at the National Council of Scientific and Technological Research (CONICET). She is head of the Area of Ethics, Rights and Public Goods at FLACSO (Facultad Latinoamericana de Ciencias Sociales) from 2012 and the Bioethics Program (FLACSO-Argentina) from 1996. She was president of the la International Association of Bioethics (IAB) 2003–2005. She obtained the John Simon Guggenheim Memorial Foundation fellowship (2006–2007). Among her books: Reproducción Asistida, Género y Derechos Humanos en Latinoamérica, San José, Costa Rica, Instituto Interamericano de Derechos Humanos (IIDH), 2008. Bioethics and Vulnerability: A Latin American View, Value Inquiry Book Series, RODOPI, Amsterdam—NY, 2006. Ensayos de Bioética: reflexiones desde el Sur, Biblioteca de ética, filosofía del derecho y política, Distribuciones Fontamara S.A., México, 2001. Ignacio Mastroleo has a Ph.D. in Philosophy from the University of Buenos Aires (2012). He is Assistant Researcher from CONICET (National Scientific and Technical Research Council of Argentina), works at the Program of Bioethics in FLACSO Argentina (Latin American Social Sciences Institute of Argentina) and is a lecturer in Ethics at the Department of Philosophy (University of Buenos Aires). He is a member of the Post-Trial Responsibility Workgroup of MRCT (Multi Regional Clinical Trials) Center of Harvard and Brigham and Women’s Hospital, United States. His articles and contributions have been published in Developing World Bioethics, Hastings Center Report, Journal of Medical Ethics, Revista de Bioética y Derecho among other international journals of the field. Gustavo Ortiz Millán is research professor at the Institute for Philosophical Research, National Autonomous University of Mexico (UNAM). He is also a member of Mexico’s National Researchers System. He has published La moralidad del aborto (Siglo XXI, 2009), Aborto, democracia y empoderamiento (Fontamara, 2014) and has edited several books. He has published papers on bioethics as well as theoretical ethics. Marisa Palácios is Medical Doctor, psychiatrist, and sanitarist. She obtained her Master in Sciences in Collective Health from Institute of Social Medicine of the University of the State of Rio de Janeiro. Doctor in Sciences degree in Engineering from Federal University of Rio de Janeiro (UFRJ). Director and associate professor of bioethics at the Center for Studies and Research in Bioethics and Applied Ethics at UFRJ. Coordinator of the Research Ethics Committee of the Institute of Studies in Collective Health of the UFRJ from 1997 to 2013. Member of the National Commission of Ethics in Research (CONEP) from 1997 to 2001, from 2007 to 2011 and consultant of CONEP in 2017 and 2018. Coordinator of the Research ethics advisory council of UFRJ from 2013 to 2017. Coordinator and professor of the graduate program in bioethics and applied ethics at UFRJ from 2010. Sergio Rego is Medical Doctor, pediatrician, and sanitarist. He obtained his Master and doctorate in Collective Health from the Institute of Social Medicine/University of the State of Rio de Janeiro. Coordinator of the Research Ethics Committee of the

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Sergio Arouca National School of Public Health of the Oswaldo Cruz Foundation (FIOCRUZ) from 2003 to 2013. Consultant of the National Commission for Research Ethics (CONEP) from 2013 to 2014. Coordinator and full professor of the graduate program in bioethics and applied ethics and public health at Fiocruz. Coordinator of the Research Integrity Commission of Fiocruz from 2012 to 2013 and since 2018. He was general editor of the Brazilian Journal of Medical Education from 1998 to 2015. Head of the Unit of Rio de Janeiro—Brazil of the International Network of the UNESCO Chair in Bioethics (Haifa). Researcher at the National Research Council (CNPq) in Brazil. Cristian Timmermann born in Chile, studied philosophy and political science at the Ludwig-Maximilian University and Wageningen University. Previously he was a post-doctoral fellow at the Ben-Gurion University of the Negev and the Universidad Nacional Autónoma de México. He is currently postdoctoral researcher at the Centro Interdisciplinario de Estudios en Bioética, Universidad de Chile. His research areas are agricultural ethics, global justice, resource governance and property theories, with regional expertise in Latin America and extensive collaborations in Mexico, Colombia, Brazil, Puerto Rico and Argentina. Antonio Ugalde received his Ph.D. from Stanford University, California. He is a professor Emeritus at the Department of Sociology, University of Texas-Austin. Dr. Ugalde has taught as a visiting professor in several US, European and Latin American universities and his editorial experience includes the US Library of Congress Handbook of Latin American Studies (1980–2012), Social Science and Medicine (1982–2006), Salud Colectiva (2007 to present), Boletín Fármacos (1997 to present), and other journals. He has been a consultant for the US Agency of International Development, WHO, and other UN Agencies. His research interests and publications are related to international migration and health, the role of international organizations on development, and health systems and pharmaceuticals. Currently, Dr. Ugalde is studying the consequences of global pharmaceutical corporations’ research and drug development on human rights.

Chapter 1

Introduction: Why (and How) Bioethics Matters in Latin America Martin Hevia and Eduardo Rivera-López

1.1 Introduction Bioethics embraces a number of ethical problems connected to medicine, biomedical research, and health law. Most of these have both a universal dimension and a more particular one. Reproductive rights, exploitation, commodification, biomedical research, and the protection of the environment, among others, are issues that can be discussed from a universal perspective. Basic human rights and values, such as life, privacy, autonomy, wellbeing, or a healthy environment, are involved in all those discussions and concern every human being, regardless of her cultural, national, or socioeconomic background. However, all these controversies have also a more specific dimension according to the particular political, social, and economic framework in which those problems arise and are dealt with. In this introduction, we would like to explain why the different topics discussed in this book are relevant to the Latin American reality and how each of the collected articles contributes to improving our understanding of these problems by connecting universal concerns with the specific issues of our region. The book is organized around four relevant topics for Latin America: (i) reproductive rights; (ii) vulnerability, exploitation, and commodification; (iii) biomedical research and innovation; and (iv) agriculture and environment.

M. Hevia (B) · E. Rivera-López Law School, Universidad Torcuato Di Tella, Buenos Aires, Argentina e-mail: [email protected] E. Rivera-López e-mail: [email protected] E. Rivera-López IIF-Conicet (National Scientific and Technical Research Council of Argentina), Buenos Aires, Argentina © Springer Nature Switzerland AG 2019 E. Rivera-López and M. Hevia (eds.), Controversies in Latin American Bioethics, International Library of Ethics, Law, and the New Medicine 79, https://doi.org/10.1007/978-3-030-17963-2_1

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1.2 Reproductive Rights Under the heading of reproductive rights we find a number of highly controversial bioethical issues. Two of them are abortion and new reproductive technologies. These are, of course, problems with a clear universal dimension, discussed in different latitudes. However, they have also some interesting specificities in Latin America. Let us consider first the abortion debate. Nowadays, the legal status of abortion varies from country to country. Some countries in the region, like Argentina, Brazil, Colombia, Mexico, and, more recently, Chile, have decriminalized abortion to some extent; in contrast, El Salvador and Nicaragua continue to be among the few countries in the world that criminalize abortion in almost every situation. In Latin America and the Caribbean, the rate of maternal mortality due to clandestine abortions is high—in 2014, for instance, it was at least 10% (Guttmacher 2018). Recently, the legal regulation of abortion has been debated in the highest courts of the region. In 2008, the Supreme Court of Mexico stated that under Mexican law, Mexico City can have a liberal approach to abortion. In turn, in 2012, the Argentine Supreme Court held that every woman has a right to abortion in case of rape. However, some lower courts have issued decisions against permissive abortion rules (Bergallo and Ramón Michel 2016). In 2018, a new project has been discussed in the Argentine Parliament to legalize abortion during the first 14 weeks of pregnancy. The project was finally rejected. Abortion is by far the bioethical issue with greatest social, economic, and cultural importance in Latin America. This is why we open the collection with an essay specifically concerned with the moral and legal status of abortion. Gustavo Ortiz Millán’s paper “Anti-Abortion Laws and the Ethics of Abortion” begins by explaining the situation of abortion in Mexico, both from the statistical point of view (number of abortions, women’s mortality rates, etc.) and with regards to its legal status. Building on this context, Ortiz Millán makes a general philosophical evaluation both of the morality and of the legalization of abortion. The analysis encompasses three different perspectives. The first one is consequentialist. Ortiz Millán brings abundant empirical evidence showing the negative consequences of the legal prohibition of abortion. Secondly, the problem is discussed from the perspective of women’s rights, and Ortiz Millán claims that restrictive abortion laws imply the violation of several rights (to privacy, autonomy, dignity, and equality). Still, one might object that all these arguments against the criminalization of abortion fail because they do not take into account the fact that abortion is a serious moral wrong in itself, insofar as it implies killing a human person. If this were true, and assuming that the right to life is the most fundamental human right, all considerations about the (negative) consequences of criminalization or about women’s rights would be displaced and become (at least largely) irrelevant. This is why Ortiz Millán finally addresses the (highly controversial) philosophical issue of the moral status of the human embryo. Ortiz Millán offers a rich analysis of the different attempts to argue that the embryo is a moral person, including that it is a person because it is a human being, or that it is a person in virtue of its potentiality. His view is that the features that make the

1 Introduction: Why (and How) Bioethics Matters in Latin America

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existence of a (human) being valuable do not emerge during the first two trimesters of pregnancy. Therefore, during that period the legal prohibition of abortion cannot be justified on moral grounds. As we mentioned above, and as Ortiz Millán points out in his article, one of the interesting developments in recent years in Latin America is that certain kinds of abortions have become legally permitted (for example, in the case of rape), and some few jurisdictions have legalized abortion in the early stage of pregnancy (like Mexico City and Uruguay). This has been done against a framework of general legal prohibition and condemnation of abortion by the Catholic Church and other religious and social groups. The contrast between the rather conservative (“pro-life”) cultural framework and this kind of (partial) legalization has resulted in many doctors and medical institutions resorting to conscientious objection in order to avoid carrying out an action they condemn based on moral or religious beliefs. The problem of conscientious objection in cases of abortion is present in developed countries as well, but the dimension of the problem is far greater in Latin America because of the aforementioned clash between increasing legalization and conservative moral and religious beliefs. In “Conscious Oppression: Conscientious Objection in the Sphere of Sexual and Reproductive Health,” Marcelo Alegre addresses this phenomenon and tries to develop precise guidelines for conscientious objection, especially in the case of legal abortion. Alegre distinguishes two traditional models of conscientious objection in the realm of medical practice: a “libertarian” model and a “conciliatory” model. The first allows physicians (and other members of medical staff) to refuse to perform the objected action. A version of this view is the “contract model,” according to which doctors and patients freely decide the terms of their relationship. In the case of abortion, this model would imply that a doctor who does not want to perform the procedure, for whatever reason, would be granted the right to object. The problem with this model (and this is also the key difference between traditional conscientious objection and conscientious objection in the realm of reproductive rights) is that in those cases in which abortion is legal, failing to perform the abortion implies a violation of the sexual and reproductive rights of the woman involved. This is why Alegre considers a second, conciliatory, model. According to this model, the professional has the right to conscientious objection but is at the same time required to refer the case to another, non-objecting, professional. This model is also problematic in Alegre’s view for several reasons, but the main point against this model is that it does not ensure satisfaction of the woman’s reproductive rights. Alegre therefore develops a third approach. This “egalitarian” model provides absolute priority to the respect of sexual and reproductive rights and emphasizes the obligations that doctors have in virtue of being part of a regulated profession that holds a legal monopoly on the provision of health services. For Alegre, conscientious objection should not be prohibited, but it should be ensured that the exercise of objection does not become an obstruction to the satisfaction of women’s rights. Besides abortion, the most controversial issue in the field of reproductive rights is assisted reproduction and, within that area, commercial (and non-commercial) surrogacy. As in the case of abortion, the legal regulation of surrogacy is not uniform in Latin America. In most of the region, the legal status of surrogacy agreements

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is uncertain: they are neither expressly prohibited nor permitted. Thus, legal uncertainty is the rule in Latin America. This means that where surrogacy agreements are celebrated, their validity is left up to judicial discretion. Courts have decided for or against surrogacy agreements: some judges may consider surrogacy agreements void because body parts and humans cannot be traded; other judges have recognized the validity of the agreements, sometimes by making reference to the principle of the best interests of the child. The uncertain legal status of surrogacy agreements may entail human rights violations for all the parties involved, such as the right to privacy of the surrogate mother and the intended parents, as well as a disregard for the best interests of children born from surrogacy. In light of this uncertainty, in his essay “The Legal Status of Surrogacy in Latin America,” Martín Hevia focuses on the legal regulation of surrogacy in the region. The starting point of the paper is a recent landmark decision on reproductive rights (Artavia Murillo v. Costa Rica) by the Inter-American Court of Human Rights, which held that a complete ban on assisted reproductive technologies interferes with the right to a private and family life. For the Court, that right includes the decision to become a parent, as well as the access to the means to realize that private decision. In light of this, Hevia argues that, prima facie, surrogacy is compatible with the Inter-American System of Human Rights. Nevertheless, given that there are no absolute rights under the American Convention on Human Rights, Hevia considers several arguments that may justify a complete or partial ban on surrogacy. His conclusion is that surrogacy ought to be allowed but that legislation must be passed to assure the protection of the rights of all parties involved.

1.3 Vulnerability, Exploitation, and Commodification According to the World Economic Forum, Latin America is the world’s most unequal region (Bárcena Ibarra and Byanyima 2016). In light of this, the second thematic node of the collection focuses on vulnerable populations and how situations of exploitative and commodifying transactions should be dealt with, both from the moral and the legal perspective. The three concepts—vulnerability, exploitation, and commodification—are closely related, though not identical. It is more likely that a vulnerable person can be exploited or be forced to commodify part of her body, but the connection is more complex. The three articles in this part face each of these concepts from different perspectives and with different purposes. The first article is Florencia Luna’s “Revisiting Vulnerability: Its Development and Impact.” The author tries to elaborate a concept of vulnerability that proves adequate to be used in regulations and guidelines, especially those concerned with biomedical trials with human subjects. In previous work, Luna had developed a conception of vulnerability in terms of “layers” instead of applying it as a label to some specific populations. She now reevaluates and defends her theory against criticism and possible shortcomings. She not only defends her view from a theoretical standpoint but also from a political perspective. In fact, her layered account has been

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incorporated in important documents regulating biomedical research, such as the 2016 CIOMS-WHO Guidelines. As suggested above, one concern with vulnerable populations is that they can easily be captured into exploitative transactions. However, the questions of when a transaction is exploitative and when it should be legally prohibited are not obvious. In “Exploitation and Bioethics. Individual Ethics and Legal Regulation,” Eduardo Rivera-López discusses a peculiar (but highly relevant) kind of exploitation: mutually beneficial exploitation. The idea that an exploitative contract can also be beneficial for the exploited party in the transaction has been famously advanced by Alan Wertheimer. Wertheimer discusses this kind of contract and concludes that it should not be illegal. The approach adopted by Rivera-López is broader. He first discusses the issue from the moral, interpersonal perspective. From this perspective, the question is whether the action performed by the exploiter (extracting an unfair benefit from the transaction) is wrong and why. Rivera-López suggests that a plausible way to conceptualize this kind of action is considering them “suberogatory:” the exploiter performs an action that is wrong but which she nonetheless has a right to perform. The second question is whether exploitative actions should be legally banned (or strongly regulated). Rivera-López’s aim here is to offer some reasons why legal prohibition can only exceptionally be justified. His idea is that, while exploitation is a morally serious wrong, legal prohibition is too easy a way out and can not only fail to prevent exploitation from existing but also harm the most vulnerable party in the transaction. Closely connected with exploitation is commodification. In fact, these are the two main sources for rejecting a transaction between free, consenting (adult) parties. In both, moreover, one of the parties is particularly vulnerable and sees the exploitative or commodifying contract as the best way to deal with her situation of social disadvantage. Antonio Bascuñán’s article “Oneself and the Body: Commodification and (In)alienability” is a critique of both European and Chilean law concerning the commodification of the human body. Bascuñán starts by distinguishing what he calls “excorporation” (transforming one’s own body or one of its parts into an external object whereby the body or its parts are alienated from oneself) from commodification (the exchange of excorporated parts of the human body for profit). His main point is that while the legal prohibition of commodification is plausible in the case of non-renewable parts of the own body (such as selling oneself as slave or selling one’s heart), it is not as plausible in the case of renewable parts (tissues, blood, etc.). Bascuñán concludes that while the argument for prohibiting any case of commodification appeals to the value of human dignity, the real, underlying arguments are consequentialist and, therefore, contingent.

1.4 Biomedical Research and Innovation Connected to exploitation and commodification is the issue of biomedical research in Latin America. The key problem here is related to the standards that should be observed with vulnerable populations by sponsors and multinational pharmaceutical

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companies. Within this issue, the three papers in this collection take on specific but especially relevant problems. In “Outsourcing Clinical Trials to Latin America: Causes and Impact,” Nuria Homedes and Antonio Ugalde discuss the history of outsourcing medical trials to the region, which has had a strong drive because of the availability of poor patients willing to enroll. In particular, the authors explain the role played by ethics committees and, more importantly, national regulatory agencies in several countries. Homedes and Ugalde show that these types of institutions have often been co-opted by pharmaceutical companies that offer rewards to physicians, clinical personnel, and other professionals involved in clinical trials. The authors claim that clinical trial regulations in Latin America are incomplete and ought to be improved so that vulnerable populations are protected. They make several proposals, including an income threshold to exclude vulnerable persons from enrolling in a clinical trial. In their article titled “The Concept of Innovation as New Non-validated Practice: Definition, Justification, Ethical Principles, and the Latin American Context,” Felicitas Holzer and Ignacio Mastroleo address the problem of clinical innovation. Broadly speaking, “clinical innovation” refers to insufficiently validated interventions used in medical practice for the benefit of an individual patient when there are no reasonable alternatives. This phenomenon has recently taken on greater importance and has become more common in Latin America due to the lack of regulation and guidelines on clinical innovation. Holzer and Mastroleo start by discussing three novel therapeutic interventions: stem cell therapies, gene editing, and Mitochondrial Replacement Technologies. Based on this discussion, they revisit the distinction between research, validated practice, and innovation with the aim of developing a new conceptual account of non-validated practices. Once this idea is clarified, the authors argue that given the dangers that new clinical interventions with an insufficient level of validation entail for individual patients, the use of new non-validated practices ought to be regulated. As Holzer and Mastroleo show, regulation should take into account the peculiarities of the Latin American context, such as the anti-scientific influence of the Catholic Church and public health demands like considering social value for future patients. The final article in this section, “Ethics in Conducting and Communicating Research. A Brazilian Perspective,” addresses the problem of conflicts of interest in biomedical research. In it, authors Marisa Palácios and Sergio Rego are concerned with the scope and magnitude of academic fraud in Latin America and particularly in Brazil, as well as the subsequent mistrust of scientific knowledge that this type of fraud foments. The article identifies several reasons why condemnable behavior takes place, ranging from a highly competitive environment that requires constant publications to non-transparent funding. Of course, scientific malpractice is a cause of fraud. However, Rego and Palacios propose that we should focus on the conditions that promote malpractice and can prevent it. Perhaps counter to a culture of management based on research results and the increasing competition for funds and prestige, they claim that research institutions should build institutional structures able to give feedback on ethical issues that arise in the different phases of research, including resource gathering, conduction of the research, and authorship (especially

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in collective papers). Rego and Palacios argue that in addition to the academic and research community other stakeholders such as the state and its three branches of power should make a commitment to research credibility by promoting and enforcing regulations that aim to avoid conflicts of interest and scientific mistrust.

1.5 Agriculture and Environment The final topic of the book aims to be highly innovative as it includes an article that combines two issues that are not connected in the standard bioethical literature but are particularly relevant for Latin America. Environmental ethics is a topic of increasing interest around the world. Given that a clean and healthy environment is a worldwide public good, the importance of facing the problem of environmental degradation does not recognize national or political borders. In fact, the problem has been mostly discussed in the North. However, Latin America, as well as other regions of the global South, struggles with specific problems connected to the environment. Latin American countries are expected to find reasonable compromises between environmental concerns, economic growth, and the satisfaction of basic needs. Agriculture is one of the key areas in which such compromise must be discussed. According to the Food and Agriculture Organization of the United Nations, in spite of widespread inequality in the region, due to a range of factors including its agricultural potential and policies, Latin America is the region that has made the most progress in reducing the percentage and total number of people suffering from hunger in the past 20 years (FAO 2018). Cristian Timmermann addresses the environmental problem from the perspective of establishing a sustainable agricultural system. In his contribution to this collection, “A Latin American Perspective on Agricultural Ethics”, he discusses a number of challenges that must be solved in order to achieve that reduction: extreme inequality, rapid urbanization, homogenization of culinary customs, and a lack of agricultural sovereignty, among others. Timmermann’s purpose is to review the issue in a largely unexplored terrain in bioethics. He advances the overarching hypothesis that a solution to the above problems can only be achieved through a longstanding South-South dialogue among affected populations. The final article in the collection, Alfonso Donoso’s “A Territorial Mediation in a Triangular Affair. Towards an Ecological Territorial Sovereignty,” explores the complex connections and tensions between the two main strands of anti-anthropocentric thought: animal rights theory and environmental ethics. Donoso illustrates this tension with a telling and dramatic example: the recent invasion of beavers in southern Patagonia (Argentina and Chile). Imported beavers have destroyed the natural forest and habitat in Tierra del Fuego. Upon a first examination, it seems that the only way of rescuing the ecosystem is by exterminating the beavers, while the only way of respecting the rights of these sentient (and highly developed) animals is by sacrificing the ecosystem. Donoso’s main purpose is to find a middle road, a compromise between environmental and animal ethics. To what extent this is possible is an open question, a fact that Donoso acknowledges; in real circumstances, we can only aspire

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to imperfect solutions. Still, it is important to create a theoretical framework that can achieve reasonable compromises, and this is the thrust of Donoso’s article. The diversity of bioethical controversies and challenges that Latin America faces is enormous. This collection aspires to offer a representative sample of that diversity, and, at the same time, demonstrate the increasing philosophical and legal sophistication that Latin American bioethics is able to achieve.

References Bárcena Ibarra, A., and W. Byanyima. 2016. Latin America is the World’s Most Unequal Region. Here’s How to Fix it, World Economic Forum. Available at: https://www.weforum.org/agenda/ 2016/01/inequality-is-getting-worse-in-latin-america-here-s-how-to-fix-it/. Bergallo, P., and A. Ramón Michel. 2016. Constitutional Developments in Latin American Abortion Law. International Journal of Gynaecology and Obstetrics 135 (2): 228–231. FAO (Food and Agriculture Organization of the United Nations Regional Office for Latin America and the Caribbean). 2018. Available at: http://www.fao.org/americas/acerca-de/en/. Guttmacher Institute, Hoja Informativa: Aborto en América Latina y el Caribe. 2018. Available at: https://www.guttmacher.org/sites/default/files/factsheet/fs-aww-lac-es.pdf.

Part I

Sexual and Reproductive Rights

Chapter 2

Anti-abortion Laws and the Ethics of Abortion Gustavo Ortiz Millán

Abstract In this paper, I begin by distinguishing between the moral evaluation of the law that criminalizes abortion and the moral evaluation of abortion itself. In the public debate on abortion, these are issues that we frequently find mixed up, and that must be analyzed separately. Regarding the moral evaluation of the law, there are at least two possible ways of assessing it: in terms of the consequences of the law and in terms of women’s rights. I argue that anti-abortion laws have negative consequences at different levels: for the women who are denied termination of their pregnancies when they do not want to go on with them, for unwanted children, and for society at large. These laws also infringe upon some of women’s most fundamental rights in a way no other law does, requiring them to sacrifice their freedom, autonomy, privacy, and future life, and putting their health and bodily integrity at risk. However, according to those with a conservative view on abortion, none of this justifies the intentional killing of an embryo, which they take as a person with a right to life. I argue that there are no good arguments in favor of considering an embryo to be a person since on all accounts, the ascription of personhood requires the presence of mental or psychological properties, which do not appear until the end of the second trimester of pregnancy. We cannot ascribe a right to life to the embryo, either. Therefore, there is no justification for all the negative consequences of anti-abortion laws and for the infringement of women’s rights. Keywords Abortion · Moral status of embryos · Reproductive rights

2.1 Introduction There are a number of moral questions we often find included in discussions about abortion that are important to set apart. Here I want to distinguish between (1) the moral evaluation of the law that criminalizes abortion and (2) the moral evaluation of G. Ortiz Millán (B) Instituto de Investigaciones Filosóficas, Universidad Nacional Autónoma de México, Mexico City, Mexico e-mail: [email protected] © Springer Nature Switzerland AG 2019 E. Rivera-López and M. Hevia (eds.), Controversies in Latin American Bioethics, International Library of Ethics, Law, and the New Medicine 79, https://doi.org/10.1007/978-3-030-17963-2_2

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abortion itself, i.e., the act of intentionally terminating a pregnancy, when a woman decides to do so. These are issues that must be analyzed independently, although it is clear that they are connected. To a large extent, the moral evaluation of laws criminalizing abortion depends on whether or not abortion is considered morally permissible. The criminalization of abortion is justified upon the argument that it is wrong to kill an innocent human being, and since human embryos are innocent human beings, it is wrong to kill human embryos; since killing an innocent human being is a crime, then killing human embryos is also crime and should be penalized. So when people claim that they are against abortion, they not only mean that women should not have an abortion since it is morally wrong: what they usually mean is that abortion must be penalized by the law since it is a crime, and that women who have abortions and the physicians who help them should go to jail—as actually happens in many countries, mostly in the developing world. In this paper, I shall analyze the laws that criminalize abortion from two different ethical perspectives: the first in terms of some of the consequences anti-abortion laws have on women who want to terminate their pregnancies, on unwanted children, and on society; and the second in terms of the rights of women. Although these two issues are usually intertwined, I want to examine them separately. These two perspectives are not incompatible when we analyze this issue since both offer us very similar conclusions about the moral evaluation of the law, in favor of the decriminalization of elective abortion (at least in the first months of pregnancy, as I shall argue). But since the moral evaluation of restrictive abortion laws depends on whether the intentional termination of a pregnancy is equivalent to murder, I shall also analyze the issue of whether we can consider a human embryo a person and, on that basis, attribute to it the right to life.1 There are different answers to the question of whether an embryo is a person but, as I shall try to show, there are no good reasons for holding that an embryo is a person—at least from a secular perspective, such as the one that should prevail in societies where there is separation of church and state. Therefore, the laws that criminalize abortion and regulations restricting access to legal abortion have no moral justification, and all the negative consequences of these laws, as well as the ways in which they infringe upon women’s acknowledged rights, are not morally justifiable.

1 Many people who favor the criminalization of abortion tend to use words indiscriminately, claiming

that ‘abortion kills babies’ or ‘abortion kills children,’ making ‘embryo’ equivalent to ‘baby’ or ‘child,’ which is incorrect—in that case we would talk about infanticide, not about abortion. This is obviously intended to elicit a stronger negative emotional response from the audience against abortion. However, we should be careful with words: a zygote (a cell formed by the fertilization of two gametes) divides through mitosis and, by the fifth day, forms a blastocyst, which after further divisions may become implanted in the uterus. Although there is no universal agreement on when the embryo begins, ‘embryo’ is the term used to refer to this organism between the fourth week (after implantation has already occurred) and the eleventh week after fertilization. At the beginning of the twelfth week the embryo is termed a ‘fetus’ (Schoenwolf et al. 2015: 3–4). Only after birth it can properly be called a ‘baby’ or a ‘child.’ Since I focus mainly on abortion during the first trimester, I will mostly use the term ‘embryo’—although, as will be apparent, my arguments can be used to justify the permissibility of abortion during the second trimester, as well.

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2.2 Some Consequences of Anti-abortion Laws Like many other legal norms, restrictive abortion laws may be evaluated in terms of the consequences they have on the welfare of individuals and the community. If we want to look at the consequences of anti-abortion laws, we should look at places where these laws are in place. I construct my argument on the case of Latin America and the Caribbean since it is a region with some of the most punitive anti-abortion laws in the world. Of 41 countries in the region, only nine have no restrictions on abortion (Barbados, Cuba, Guadalupe, Guyana, French Guyana, Martinique, Puerto Rico, Saint Martin, and Uruguay). Only 10 allow abortion in cases of rape, ten in cases of fetus malformation, and 28 if it is deemed necessary to save a woman’s life. In five countries it is completely prohibited (Dominican Republic, El Salvador, Honduras, Nicaragua, and Sint Maarten); that is, these countries make no exceptions for pregnancies that result from rape, in which there are fetal anomalies, or when the life of the woman is in danger, and they impose jail sentences on women who are found to have had an abortion.2 In El Salvador, for instance, women who have an abortion face sentences of two to eight years in prison, and health care personnel who assist them may face up to 12 years in prison. Out of fear of being legally prosecuted, doctors report women who experience complications after abortions (or even miscarriages) to the police (UNPD 2002). While some countries allow for legal abortion in cases of rape, fetal anomalies, and in order to save a woman’s life, these cases together probably cover the motives for less than 10% of abortions. There are no studies on the reasons Latin American women have abortions, but studies done in the United States show that rape accounts for 1%, fetal anomalies for 13%, and women’s health for 12%.3 Furthermore, in settings such as Latin America, where abortion is very negatively regarded and there is legal uncertainty for health care personnel, legal abortions are hard to access and are rarely officially practiced. Physicians, district prosecutors, and judges obstruct women’s access to legal abortions as much as they can, so in many cases it is virtually impossible to get one. An illustrative example is the case of Paulina Ramírez, a 13 year-old Mexican girl who was raped in 1999 by an intruder to her house and was subsequently denied a legal abortion by state health and law enforcement officials; she was forced to have the child (GIRE 2005). In some states in Mexico, there are no reported cases of legal abortions being provided, though in these places it is estimated that thousands of illegal abortions are performed (Cruz Sánchez 2014). The main purpose of anti-abortion laws is to protect the lives of unborn human beings and stop abortions from being performed. However, prohibiting abortion does not stop the practice, it merely pushes women into the dangerous world of clandestine and unsafe abortions. Women who want abortions are usually desperate, and even when they know that abortion is illegal, they are willing to put their freedom, health, and life at risk to get one. Since many of them do not have access to adequate 2 This

information comes from Lerner and Guillaume (2007) and CRR (2017). et al. (2005); see also Johnston (2016), who argues that these cases represent less than 1% of all the reasons given for having abortions in the U.S.

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and safe health services to have an abortion, they often resort to home remedies and self-induced abortions with clothes hangers, knitting needles, infusions, and concoctions, among others, that will help them expel the embryo. These women also go to midwives and doctors, usually without any official certification, who will perform an abortion in frequently unsafe conditions, which will often result in very serious medical complications, sterility, and sometimes death. According to some estimates, in Latin America, 95% of the 4.4 million abortions performed annually are unsafe (Guttmacher 2012). The World Health Organization estimates that in 2008, 12% of all maternal mortality in the region (1,100 deaths in total) was due to unsafe abortion and about one million women were hospitalized for treatment of complications from unsafe abortion (WHO 2011). In fact, although abortion laws have become more punitive in some countries of the region,4 abortion rates have not only failed to decline, they have in fact increased: in the period 1990 to 2014, there was an estimated increase of 2.1 million abortions per year in the region (Sedgh et al. 2016: 263). These data show us that restrictive abortion laws do not curb the practice since women have abortions despite penalties. These restrictions do not deter women from having abortions, but only make the procedure more complicated, increase risks, and lead to the death of mostly poor women. Abortion is unsafe when it is performed under conditions of illegality, often by poorly trained providers, resulting in medical complications and sometimes death. But under legal conditions, an abortion performed by a qualified physician is one of the safest obstetrical procedures a woman can undergo once she is pregnant. Studies done in the United States over more than a decade tell us that the risk of dying from a legal and safe abortion within the first trimester of pregnancy is 0.6 deaths per 100,000 procedures; comparatively, the risk of dying from childbirth is 8.8 deaths per 100,000 live births (Raymond and Grimes 2012; see also Khan et al. 2006).5 The experience of many countries that have decriminalized abortion has shown not only that maternal mortality due to unsafe abortion has virtually disappeared but also that there has been a reduction in the number of abortions performed each year; that is, decriminalization had positive consequences.6 In Italy, for instance, the decriminalization of abortion in 1978 led to a gradual reduction in the number of 4 In El Salvador,

abortion was legal under some limited circumstances, but in 1998 a new law made abortion illegal under any circumstance. Nicaragua prohibited any type of abortion in 2007. Many states in Mexico amended state constitutions to protect life from the moment of conception, as a reaction to Mexico City’s law reform that decriminalized elective abortion for the first trimester in 2007. In Brazil, where evangelicals are becoming more powerful political actors, members of Congress have tried to toughen penalties for women who abort (Carless 2016). 5 In Latin America, due to restrictive abortion laws, the risk of dying from abortion is 32.9 deaths per 100,000 procedures (Khan et al. 2006: 1068). In Mexico, nationwide, it is around 40 deaths per 100,000 procedures, versus 0.0 deaths per 100,000 procedures in Mexico City, where elective abortion is legal (Schiavon et al. 2015). Thanks are due to Raffaela Schiavon for sharing the results of her research. 6 I realize that framing a reduction in numbers of abortions as a positive consequence of decriminalization is quite controversial within the reproductive rights movement. There are those that believe abortions should be “safe, legal and rare” [e.g. Hillary Clinton in her 2008 campaign (On the Issues 2008)] and those who believe equating rare and good heightens the stigma around abortion.

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abortions. Overall, considering only the abortions carried out by Italian citizens, the number of abortions fell in 2016 below 60 thousand, which represents a reduction of 74.7% compared to the data for 1982 (Ministerio della Salute 2017). Sedgh and her colleagues (2007) have shown that between 1995 and 2003, rates of induced abortion declined worldwide but fell most where abortion is broadly legal. For instance, abortion rates fell most significantly, by 50%, in Eastern Europe, where contraceptive choices have broadened since the fall of socialism. Consistent with this trend, in 2016, they showed (Sedgh et al. 2016) that in the developed world—where abortion has been decriminalized since the 1960s—abortion rates have dropped by more than 40% over the past 25 years: from 46 abortions per 1,000 women in 1990–1994 to 27 in 2010–2014, whereas in the developing world, where restrictions prevail, abortion rates have remained stagnant (a non-significant 2 point decline, from 39 abortions per 1,000 women in 1990–1994 to 37 in 2010–2014). In Latin America, as already mentioned, abortion rates have increased, regardless of the recent strengthening of penalties. As Greene Foster (2016) has argued in her comments on the Sedgh’s report, part of the reason why abortion rates in the developing world are so high has to do with the fact that under restrictive conditions, contraception, sex education, and family planning services are hard to obtain. Where there are no family planning services, there tend to be more unintended pregnancies, and therefore more abortions. In contrast, in developed countries, the continued fall in abortion rates is due to increased use of modern contraception, which gives women greater control over their reproduction. The recent experience of the decriminalization of elective abortion during the first trimester in Mexico City in 2007 has shown that, contrary to conservative expectations, abortion rates have not grown; they have remained steady. The Legal Termination of Pregnancy program (ILE or Interrupción Legal del Embarazo, in Spanish) requires health care centers to provide women with post-procedure contraceptive counseling. Some of these women did not know of these methods beforehand (Van Dijk et al. 2011). As a result of this, the rate of recidivism has been low: 6.3% (GIRE 2017). Of all unsafe abortions in the world, 96% occur in developing countries (IPPF 2006). Several studies have shown that the people most affected by anti-abortion laws are women who live in poverty: nearly all the women who die or are injured in Latin America due to unsafe abortion are poor. Not surprisingly, nearly all the women who are prosecuted for abortion in the region are also poor. As many have already claimed, it is the poorest women—those who are least able to afford a minimal level of health care—who end up paying the highest price, the ones who end up sacrificing their liberty, health, and life. According to the International Planned Parenthood Federation, in Latin America (as in other developing countries), poor and rural women tend to live in contexts of gender inequality, where women have less control over their own bodies and the circumstances of sexual intercourse. Poor women have less sex education and information about contraception, and less access to family planning services, and they tend to depend on the least safe contraceptive methods. In many of these places there are stigmas surrounding single women and the use of contraception, and women have less power to negotiate contraception as

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well. There is a higher correlation between poverty and sexual violence, rape, and incest. As a consequence, the rate of unintended pregnancies is higher, as is the rate of induced abortion. These women resort to poorly qualified providers, and as a result, they are more likely than other women to experience complications from unsafe abortion, and most likely to end up in public health care centers were physicians will report them, so many of them end up being prosecuted for the crime of abortion. Laws that criminalize abortion punish these women not only for the lack of prevention they were often not even aware of but also for their lack of education, their ignorance of contraceptive methods, and, ultimately, their marginalization and lack of options—that is, the law punishes them for things they are mostly not responsible for. Paradoxically, these laws punish them for being victims of a situation the state is to a certain extent responsible for, through not having created the conditions in which women can exercise a protected and informed sexuality, not offering them safe and adequate health care services, and, in most cases, not being able to offer them alternatives to escape poverty. The negative effects do not end here. The law that penalizes abortion also has negative effects on the unwanted child and on society. If it is true that the majority of women who resort to abortion are poor, it is also true that they will not have the economic resources to raise the child properly [which coincidentally, is one of the most frequently cited reasons women give for seeking abortions (Finer et al. 2005)]. Many women seek an abortion because they are aware of this, and the option of giving a child in adoption is in many cases a harder decision for many women than having an abortion.7 Women who keep the child, even if they did not want it, are not likely to give the same care and attention that a wanted child usually receives. A number of studies indicate that these women are more likely to initiate prenatal care later and tend to be less prepared for parenthood (Brown and Eisenberg 1995). There is an increased risk of physical violence during pregnancy. They are also more likely to suffer depression during or after pregnancy than women with intended pregnancies, and are less likely to breastfeed, resulting in less healthy children. Finally, there is an increased likelihood of lower mother-child relationship quality (Kost et al. 1998 and Cheng et al. 2009). In sum, unintended pregnancies result in bad consequences for the woman and for her relationship with the child, during and after pregnancy. There are also consequences for the unwanted children. A number of correlations have been drawn between unwanted pregnancies and their effects on the mental health of the resulting children. Studies in several countries show some of the negative consequences of having been born unwanted. In a study on Bolivian unwanted children, Shapiro-Mendoza and her colleagues found that children 12–35 months (toddlers) from unwanted and mistimed pregnancies “were at about a 30% greater risk for stunting than children from intended pregnancies. Infants and toddlers with 7 It

is often said that adoption is a solution to the problem of abortion, but the disparity between the high number of abortions and the low number of adoptions in Latin America (and elsewhere) makes this option unrealistic. I have argued that adoption is not an answer to the problem of abortion, at least in the case of Mexico, in Ortiz Millán (2009).

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both parents reporting them as unwanted had an increased risk of being stunted as compared with children both of whose parents intended the pregnancy” (2005: 387). Brown and Eisenberg, working with information about unwanted pregnancies in the United States, conclude that “unwanted conception especially… is at greater risk of being born at low birthweight, of dying in its first year of life, of being abused, and of not receiving sufficient resources for healthy development” (1995: 1). Other studies have found that unwanted children are less likely to succeed in school and more likely to live in poverty and in need of public assistance (Gruber et al. 1999). Probably the most striking study done on unwanted children is the Prague Study, which for 35 years followed the psychological development of 220 children, born to women denied abortion between 1961 and 1963. Henry David, in his last analysis of the study, argued that unwanted pregnancy, operationally defined as actively rejected by the woman soon after conception, leads, in the aggregate, to a social environment conducive to slightly deviant development in childhood and increasing problems in adolescence and young adulthood, followed by more severe mental problems (up to age 35), when compared with the social and mental development of children born to women who accepted their pregnancies and did not request abortion. (David 2011: 184)

Other studies have argued that unwanted children are more likely to have delinquent and criminal behavior. Levitt and Donohue (2001) have argued that, in the United States, the reduction in unintended pregnancies due to the approval of abortion in the 1970s seems to have been the main reason behind the decline in crime observed in the 1990s. Given that the incidence of abortion in the 1970s was very high among poor women from minority groups, the total number of young people who could be involved in crime in the 1990s was lower. In states that legalized abortion before the 1973 Supreme Court decision Roe v. Wade, crime rates dropped earlier. Levitt and Donohue argue that since these unwanted children would have been born into an environment of poverty and lack of maternal love, the probability that they would have had problems of criminality or psychological or social maladjustment is greater. This is another of the negative effects of the law that criminalizes abortion. However, this study has been the subject of much criticism, and its conclusions should be taken with certain reservations (see, for instance, Foote and Goetz 2008). Nonetheless, this thesis has likewise been argued for the case of some European countries that also decriminalized abortion in the 1970s (François et al. 2014). Of course, the decriminalization of abortion should not be seen a mechanism to prevent crime; issues of crime are not going to be solved this way since they are usually caused by a number of different factors. But decriminalization of abortion may help reduce some of the social problems that create the conditions that may lead to high rates of criminality. We could go on analyzing other negative consequences of restrictive abortion laws,8 but this information is more than enough to show the many negative effects of 8 There

are economic analyses of the consequences of anti-abortion laws. Monea and Thomas (2011), for instance, estimate the annual costs of unintended pregnancies in the U.S., and how the prevention of such pregnancies could save taxpayers a significant amount of money.

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anti-abortion laws on women, the unwanted child, and on society. If we conceive of morality as a system of values and rules tending to promote, among other things, the welfare of individuals and of society as a whole, then laws criminalizing abortion do not promote that wellbeing. However, as it happens with consequentialist analyses, it may be the case that better results might come from prohibiting abortion if some of the variables were modified. The first would be that abortion laws would save the lives of unborn human persons if only these laws were properly enforced. But this argument takes for granted that the prohibition of abortion saves the lives of persons and a good part of the debate is whether embryos are persons. If they are not, then we cannot say that these laws are saving lives. As I will try to show below, there are strong reasons for believing that embryos are not persons, so these laws are not saving anybody’s life. Additionally, it might be argued that public health problems related to the practice of unsafe abortion (such as maternal morbidity and mortality) give us a reason not to abolish abortion laws, but rather to tighten them in order to deter women from seeking abortions. If unsafe abortions involve dire consequences for women’s health, they should be proscribed at all costs, and laws should be properly enforced. However, on the one hand, increasing penalties does not seem to decrease the practice of abortion, as has been shown in Latin American countries that have toughened their laws; and on the other, those who use this argument do not tell us what it means to ‘properly enforce these laws.’ Shutting down illegal abortion clinics, for instance, would most likely push abortion providers to bribe police, who usually raid these clinics, to turn a blind eye to these illegal practices (as happens in many places in Latin America), and this would contribute to police corruption. It would also increase the difficulties and dangers for women with unwanted pregnancies, pushing these women to more unsafe practices, such as home remedies and self-induced abortions, with worse consequences for their health. If by ‘properly enforced anti-abortion laws’ people mean that preventive measures ought to have been taken in order to make sure that unintended pregnancies never occurred, this would still be impossible to accomplish since many pregnancies occur due to contraceptive failures,9 or sometimes women change their minds about their pregnancies, for instance, when they get a negative reaction from their partners or families. Prevention, in any case, is always laudable. As the 1994 Cairo Conference concluded, “prevention of unwanted pregnancies must always be given the highest priority and every attempt should be made to eliminate the need for abortion” (ICDP 1994: 89). However, people who favor a prohibitionist approach to abortion usually tend to be opposed to the most effective forms of prevention, such as sex education, contraception, and family planning—unless by ‘prevention’ they mean abstinence, which seems to be an unrealistic answer to the

9 Kost et al. (2008) analyze the results of the 2002 National Survey of Family Growth and conclude

that “12.4% of all episodes of contraceptive use ended with a failure within 12 months after initiation of use.” Fertility-awareness-based methods, such as the “rhythm,” “periodic abstinence,” or “natural family planning” have the highest probability of failure (25%).

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issue of abortion. Therefore, it is not clear how a consequentialist approach could justify anti-abortion laws.10

2.3 The Moral Evaluation of Abortion Laws: Women’s Reproductive Rights There is another way to ethically evaluate anti-abortion laws that has to do with the fact that these laws infringe women’s rights. Sometimes people assert that ‘women’s rights are human rights,’ so restrictive abortion laws infringe women’s human rights. This would count for a negative evaluation of these laws. If a law infringes some of the basic rights of a good part of the population (half of it, in fact), then there are good reasons to believe that this law should not be maintained, unless there are strong reasons for keeping it in force. In the last section of this paper, I shall argue that there are no such reasons; in this section I will examine how anti-abortion laws infringe women’s rights. Women’s rights are the rights claimed for women and girls to certain goods or benefits that have traditionally been ignored, suppressed, or denied to them throughout the world. Issues usually associated with women’s rights include: the right to vote and hold public office, to work and to fair wages or equal pay, to own property, and to education, but also sexual and reproductive rights. Let me argue this in parts and examine on what basis women have human rights and what we mean when we talk about sexual and reproductive rights, so that we can see if there is a violation of these rights in the case of restrictive abortion laws. We must begin by pointing out an obvious but important point: when we speak of human rights we must distinguish between legal and moral rights. Moral rights are rights that have not necessarily been recognized by any positive legal order but which are justified in moral terms to be legal rights. They are valid claims designed to protect some vital human interests, goods, or needs that we want to be respected and protected from abuses and possible threats from the interference of other individuals, society, or the state. Human rights are moral claims that usually justify demands to change the moral and legal order within a given society. Many human rights have been accepted in different moral systems and have also been recognized as positive legal rights. However, their justification is not that they are recognized in a legal order, but that they are rights established by a moral justification. Legal rights constitute the juridical recognition of previously justified moral rights. People usually demand 10 To be sure, decriminalization by itself does not make abortion safe. Conditions of poverty and ignorance, lack of sex education, lack of access to adequate health services and contraceptive methods, among others, contribute to making abortion unsafe. To assume that decriminalizing abortion would be enough to make abortion safe is an oversimplification of the problem. India, for instance, decriminalized abortion in 1971 through the Medical Termination of Pregnancy Act, but out of 6.4 million abortions, 3.6 million (56%) are unsafe (Sedgh et al. 2007). Decriminalization has to be accompanied by public policies that contribute to making abortion safe, such as family planning programs.

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the respect of moral rights against legal systems that do not recognize them or, as Carlos Nino says, “precisely because they do not recognize them” (Nino 1989: 15, his emphasis). Human rights are universal because they belong to all individuals simply in virtue of being persons and having certain traits that we justifiably believe should be protected or promoted (values, interests, or needs that have a universal character). This universality is incompatible with thinking that human rights may be the product of some particular positive juridical order. If women have moral rights, say, to equality or to education, these are rights that any woman has by virtue of having a set of needs and interests that can be affected if those rights are not recognized, i.e. rights that all women in the world have regardless of their cultural context or the legal order under which they live. There is a set of human rights that we believe belong to everyone equally, such as the rights to life, health, autonomy, privacy, and equality, among others. These have long been established as human rights, and they are regarded as protecting some basic interests in each case. However, linked to the rights just mentioned, there is a set of rights that have been called ‘sexual and reproductive rights.’ These are specifications of some of those already established, but more abstract, rights (such as the right to life, non-discrimination, access to information, education, and the rights to autonomy and freedom to form one’s own life plan), but, at the same time, they acquire specific forms. Among the most prominent we can find: (a) the right of all couples and individuals to decide freely and responsibly the number, spacing and timing of their children; (b) the right of all to make decisions concerning reproduction free of discrimination, coercion, and violence; (c) the right to sexual and reproductive health, which includes access to health care services; (d) the right to access and information on the use of contraceptive methods, such as pills, intrauterine devices, and so on; (e) the right to access to reproductive technologies such as assisted reproduction techniques; (f) the right to information on sexuality, reproductive health, and family planning (this right includes information about the risks of contracting diseases and sexually transmitted infections); (g) the right to education on sexuality, reproductive health, and family planning; (h) the right to have an abortion in case of rape; (i) the right to have an abortion in case of fetal anomalies or in case of risk to the woman’s life; and (j) the right to have an elective abortion. This does not intend to be an exhaustive list but it gives us a good idea of what we are talking about when we discuss reproductive rights. Many people ask whether there is really a right to abortion. Sometimes people put this issue in terms of women’s right to choose regarding their own bodies and reproduction. This right is based on some other, more abstract rights, which are infringed when women are not allowed to have an abortion on demand—at least to a certain point—in their pregnancies. Among the most important ones, I want to highlight the rights to privacy, autonomy, health, and equality. In 1973, the United States Supreme Court justified the landmark Roe v. Wade decision, which decriminalized abortion on demand (during the first trimester), arguing that the criminalization of abortion violates a woman’s right to privacy: everyone has a right to be protected in their most private and intimate decisions from the interfer-

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ence of third parties, particularly from the interference of the state. One of the most intimate and private decisions someone can ever make is the one concerning his or her reproduction. The criminalization of abortion infringes the right of every woman to decide over her body and reproduction. This is the way in which the Supreme Court justified their decision: The right to privacy, whether it be founded in the Fourteenth Amendment’s concept of personal liberty and restrictions upon state action, as we feel it is, or, as the District Court determined, in the Ninth Amendment’s reservation of rights to the people, is broad enough to encompass a woman’s decision whether or not to terminate her pregnancy. The detriment that the State would impose upon the pregnant woman by denying this choice altogether is apparent. Specific and direct harm medically diagnosable even in early pregnancy may be involved. Maternity, or additional offspring, may force upon the woman a distressful life and future. Psychological harm may be imminent. Mental and physical health may be taxed by child care. There is also the distress, for all concerned, associated with the unwanted child, and there is the problem of bringing a child into a family already unable, psychologically and otherwise, to care for it. In other cases, as in this one, the additional difficulties and continuing stigma of unwed motherhood may be involved. All these are factors the woman and her responsible physician necessarily consider in consultation. (Roe v. Wade 66)

In banning abortion, states not only interfere with a woman’s personal liberty to decide on matters that concern her own life, but also force upon her a distressful life and future. This is a very heavy burden that the state imposes on an individual’s life. It should also be clear how, by infringing the right to privacy, the state also infringes a woman’s right to autonomy, that is, her right to freely decide her own life plan. An unintended pregnancy may be an obstacle to accomplish the kind of life a woman has chosen. Particularly in situations of poverty, imposing on a woman the burden of rearing a child may completely nullify her possibility of freely deciding her own life. By criminalizing abortion, the state also infringes a woman’s right to health care. This is a right to the medical care and social services necessary to achieve an adequate standard of living for the health of a woman. It is a right directly addressed to the state, which must guarantee a system of health protection for everyone: hospitals, medicines, and qualified health care personnel must be available for every individual. By prohibiting abortion, the state not only fails to offer a highly demanded service for women and renounces its responsibility of offering an essential health care service but also pushes women to seek unsafe abortions with unqualified physicians and in unsafe conditions.11 It may be contended that the state violates the right to health of women only if we assume that abortion is a health service, which is exactly what an anti-abortionist would deny; however, the problem is that by prohibiting abortion, the state pushes women to seek unsafe abortions, compromising the achievement of an adequate standard of living for the health of women. Anti-abortion laws also infringe on women’s right to equality. According to the Committee on the Elimination of Discrimination against Women (CEDAW), refusing to provide health care services that only women need is a form of discrimination 11 The

case of the US is an example of how the state has infringed upon a woman’s right to health care “legally,” since the US legally denies women this type of health care.

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against women. States have the obligation to rectify these forms of discrimination generated by their legal systems. Prohibiting abortion is, first of all, a form of sex discrimination between men and women. Restrictive abortion laws are targeted only at women because abortion is a service that only women require since only they can become pregnant (Jaggar 2009). Furthermore, the burdens of pregnancy and childrearing are overwhelmingly borne by women, and although men may participate to a certain extent in the process, restrictive abortion laws make it harder for women to avoid these burdens. In many places in Latin America, a large number of men do not take any responsibility over a woman’s pregnancy and childrearing, among other reasons because they think that women are completely responsible for contraception, though in truth they are not.12 Many single women resort to abortion because men either abandon them or do not want to bear any responsibility for the child, and these women do not want to carry out a pregnancy alone, either for reasons of honor and social rejection, or because they do not have the economic resources to raise a child on their own. Having a child severely disrupts any kind of life plan a woman may have, and the opportunities of education and employment that she might have had. Abortion laws not only increase inequalities between women and men but also increase inequalities among women, and in that way it is a double violation of women’s right to equality. As already mentioned, women in poverty are the most affected by anti-abortion laws; nearly all cases of maternal mortality or morbidity due to unsafe abortion in Latin America are among women in poverty. Women with economic resources also resort to abortion, but they have the means to find a good OB-GYN who will perform an illegal abortion, in optimal sanitary conditions and protecting women’s confidentiality. Women who do not have the economic resources to pay a good OB-GYN are the ones who are going to pay the highest price by being punished by the law. Thus, anti-abortion laws end up penalizing poor women and in that sense are unjust and discriminatory laws that accentuate existing inequalities in Latin American societies that are already far from egalitarian. These laws even help to perpetuate the poverty conditions in which poor women live by imposing on them the extra burden of raising an unwanted child in precarious circumstances. Unwanted children who will grow up in poverty and, most likely, will remain there. Restrictive abortion laws, therefore, infringe a number of women’s rights. There is no other case where the law requires an individual to sacrifice freedom, autonomy, privacy, health, equality, bodily integrity, and future life in the way criminal law does when it punishes abortion. A good legal system must recognize the autonomy of all people and minimize discrimination and inequality among members of society; thus, anti-abortion laws should not be part of such a legal system. However, those who favor the criminalization of abortion—pro-life individuals, as they call themselves—argue that there is a powerful reason that justifies these laws: they aim to protect an innocent human being’s right to life, that of the embryo. 12 Around 30% of Latin American married or in-union women of reproductive age do not use any contraceptive method, and among those who do, the dominant methods are those that are, so to speak, the responsibility of women (IUDs, pills, rhythm, implants, etc.), and less than 10% use male condoms (UN 2015). This suggests that men tend to leave contraception in the hands of women.

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Remember that the criminalization of abortion is justified on the argument that it is wrong to kill an innocent human being, and since human fetuses are innocent human beings, it is wrong to kill human fetuses; since killing an innocent human being is a crime, then killing human fetuses is also a crime and should be penalized. If abortion is the intentional killing of a human being, it is a crime. The fact that penalizing the killing of a human being has negative consequences, pro-lifers claim, does not make the killing itself any less criminal; these consequences do not justify the horror of killing an innocent human being who has a right to life—in any case, they might claim, the problem is that the law is not properly enforced, or we should look for better prevention strategies. The fact that penalizing abortion infringes women’s rights does not make abortion less of a crime, either. In fact, when it comes to rights, as John Paul II claimed, “abortion is a direct violation of the fundamental right to life of the human being” (John Paul II 1995). Those who favor criminalization tell us that a human embryo’s right to life is superior to any reproductive right of women and, as “the first of the fundamental rights” must always prevail. From the moment a sperm fertilizes an egg, they claim, we have a new human life, a person with the right to life. In this view, abortion is murder, the intentional killing of a person. If this is so, nothing can justify not penalizing it; it is never morally permissible to end the life of a person, and the law must enforce morality—or at least this particular morality. Women who intentionally try to terminate their pregnancies, and the physicians who help them, must be punished. The argument in favor of an embryo’s right to life is probably the main objection to the recognition of women’s sexual and reproductive rights (as if at the moment a sperm fertilizes an egg, all of the woman’s reproductive rights were overridden), and the main obstacle for the decriminalization of abortion. Nevertheless, there are two ways to confront this argument: (i) to acknowledge the embryo’s right to life and then balance it against women’s rights, and (ii) to question whether the embryo is a person, because if it is not, then it does not follow that we acknowledge it the right to life. Even though I want to focus on the second approach, let me say a few words about the first. This line of argumentation does not question whether the embryo or the fetus is a person but simply assumes that it has rights and that these rights are in conflict with women’s rights. For instance, Mexico’s Supreme Court, in its decision about the constitutionality of Mexico City’s 2007 reform, which decriminalized abortion on demand during the first trimester of pregnancy, acknowledged both rights. The Court did not try to solve the metaphysical issue of the embryo’s personhood. It just assumed that it had a right to life and that this right was in conflict with the acknowledged rights of women. However, the Court did not take the right to life as an absolute right, since Mexico’s Constitution takes a pluralistic account of rights and does not recognize absolute rights. Balancing the two rights, it tried to reach a compromise, deciding to give priority to women’s rights during the first trimester and to the fetus’s rights afterwards (SCJN 2008).13 13 An

alternative account of this kind of argumentative line is that of Thomson (1971). She grants, for the sake of the argument, that the fetus has a right to life and then argues that it does not trump the pregnant woman’s right to decide over her pregnancy, and that an intentional abortion is not morally impermissible.

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However, a good part of the debate about the morality of abortion goes through the discussion of the embryo’s personhood since this is taken to be the basis of its right to life. So let me analyze now the issue of the personhood of the embryo and switch from the ethics of anti-abortion laws to the ethics of abortion per se. I shall argue that there are no good arguments in favor of considering an embryo to be a person and that we also cannot ascribe it a right to life. Therefore, we shall see that there is no justification for all the negative consequences of anti-abortion laws and for the infringement on women’s rights.

2.4 The Ethics of Abortion: Are Embryos Persons? So far, my arguments have been about the ethics of anti-abortions laws, not about abortion itself, that is, not about whether the intentional termination of pregnancy is morally justifiable. The arguments have been against banning abortion, not about whether abortion is morally permissible. The distinction is important because one may believe that the law should allow abortions on demand but at the same time believe that one would never have an abortion because it is immoral. However, many people think that abortion on demand should be illegal since it is immoral, and that the law should enforce morality in this matter. Those who favor the criminalization of abortion argue that an embryo is an innocent human person and, therefore, it is morally wrong to kill it. We all may agree with this. However, not all of us agree on whether the embryo is a human person with all the rights, dignity, and value that already born human persons have. The judgments we make about the morality of abortion will depend essentially on how we conceive what a person is. Let me discard a possible answer to the question about the value of an embryo before we analyze the issue of its personhood. Some might claim that it is wrong to kill an embryo since it is a living being, and that we should respect life. However, we would still have to ask why life, in itself, is valuable. Unless there is no other qualification to this claim, people who hold this position should agree not only that we must not allow abortions, but that we must not kill animals, since they are living beings, and probably plants and other forms of life as well. It is very likely that these people would not accept these implications of their claim and would state that they are referring to human life, and not to any kind of life. And then they might add that since an embryo is a human being, it is valuable, and therefore it is wrong to kill it. To be sure, the relevant question is not whether an embryo is a human being, but what gives a human life a special kind of value. The question of whether an embryo is a human being is not the relevant one, either; if being human means being a member of the species Homo sapiens, then it is clear that embryos are members of this species. This can be determined scientifically by examining the genetic code in the cells of this organism. And from the very first moment in which an egg is fertilized by a sperm, there is a cell with the genetic code of the human species. But this does not yet explain the question of what gives a special value to a human being.

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In fact, just like a zygote, all of our cells have the genetic code of the species Homo sapiens, and yet we do not consider that each one of our cells has a special value and should not be killed. For example, by scratching our skin we kill cells; since these cells are human cells with the genetic code of the species Homo sapiens, then it would be wrong to scratch our skin. This is absurd. Having the genetic code of a species is not enough to give a cell or a set of cells the special value that we give to a human being. Furthermore, it is probably more important to notice that belonging to a particular species does not give us any special moral value. If being human means being a member of a particular species or having some genetic information, then it still has to be explained why this mere biological fact has any moral significance. Belonging to a species or having a particular genetic code, in itself, has no moral value because it is a biological fact that all living beings share. Each animal, plant, fungi, bacteria, or protozoa has a specific genetic code, but that does not give them any special moral value, either. If that is so, then it is not clear why killing a member of a species, even if it is our own, is morally wrong. Those who follow this line of argument would have to accept that the defense they make of the life of the embryo is not based on a characteristic with moral value and they have not shown why it is morally wrong to terminate a pregnancy. If anyone were to insist that it is immoral because it is not just any genetic information, but that of a human being, they would have fallen either into some kind of circular argument, which is a bad argument, or some form of speciesism, which is a form of discrimination.14 Appealing to species membership or to our genetic information does not explain why human beings have a special kind of value, which is the premise behind the idea that it is wrong to kill an embryo since it is a human being. Thinking that they have introduced a scientific concept of human beings, those who defend this view have not yet shown why the lives of human beings are valuable and should be protected. The important question here is not whether an embryo is a human being but whether it is a person. Although in everyday speech the term ‘person’ is more or less interchangeable with ‘human being,’ there are reasons for differentiating between the two. The concept of a human being, as I have claimed, is a descriptive concept that does not allow us to explain the moral value of an individual. On the other hand, the concept of personhood is important in this discussion because it refers to beings with moral value and, therefore, is the basis on which we attribute rights. The origins of the term ‘person’ go back to the ancient Romans, who defined a person as the holder of legal rights, such that women, children, and slaves were not persons in that sense. The scope of the term was extended under stoicism and Christianity—belief systems with a more egalitarian conception of personhood—to refer to human beings who possessed a rational soul, so that ‘person’ referred to bearers of moral value. Nowadays we maintain that meaning of ‘person’, and it is a normative concept that imposes certain restrictions on the way we treat whatever we claim to be a person, such as the obligation to treat it with respect. So the central question here is whether an embryo is a person.

14 For

more on this line of argumentation, see Warren (1997).

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Now, the question of whether an embryo is a person cannot be answered in terms of species membership or genetic information. Those who argue in these terms believe that by appealing to these concepts, they are introducing a scientific concept of person. But there is no such “scientific” concept, at least in the context of the natural sciences. The concept of person is not part of any explanation of why or how any natural phenomenon occurs. It is not a concept that we find, for example, in explanations in biology of why a certain phenomenon occurs at the biological level. We will not find the concept of person employed in an explanatory sense in any serious biological theory. The concept is not a scientific one because of its strong normative character; it is not merely factual or descriptive, unlike the notion of a human being. Again, to say that something is a person imposes on us certain restrictions or demands on the way we treat it. Trying to derive the concept of person from a certain genetic code or other biological properties is to fall into the so-called naturalistic fallacy, which consists of deriving normative characteristics from purely natural properties. A possible answer to the question about the personhood of the embryo—and therefore about its moral value—is that an embryo is a ‘potential person,’ that is, an entity that has the capacity to become a full-fledged person, which makes its life valuable. On the basis of our appreciation of certain actual characteristics of persons (such as consciousness, rationality, and so on), opponents of abortion claim that embryos have the potentiality of acquiring those characteristics that make us persons. If it is wrong to kill an actual person, it is also wrong to kill a potential one, an embryo. However, this argument has many problems. First, even if a human embryo has the potential of becoming an actual person, it also has the potential of not becoming anything (in fact, out of 100 fertilized eggs, 40 are lost spontaneously before implantation, without women even noticing their loss). Aristotle, who introduced the topic of potentiality in metaphysics, claimed that “[e]very potentiality is at the same time a potentiality for the opposite… Therefore that which is capable of being may both be and not be. Therefore the same thing is capable both of being and of not being” (Metaphysics 1050b 8–11). The embryo has both the potential of becoming an actual person and of not becoming anything at all. If it does not become a person, either if it is lost through miscarriage or intentional abortion, or does not have in the future the characteristics that confer value to people, then there is nothing from which to derive its moral value in the present. On the other hand, an embryo has the potential to become many different things. Embryonic cells are totipotential, that is, they have the ability to differentiate into other cell types. Through genetic engineering, they can be induced to produce all of the differentiated cells in an organism and help in the reconstruction of tissues and organs. An embryo has the potential of becoming stomach lining, muscle, blood, or epidermal tissue, among many other things. That is why embryonic cells have a high value for genetic engineering, because when implanted in different types of tissue, they can be induced to adopt the characteristics of that tissue and regenerate it. Thus, an embryo has the potential to become a person, to become nothing, and also to become a tissue of some organism.

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But why should a potential entity have the same rights that an actual entity has? As a matter of fact, in everyday life we do not think that potential entities have the same value and the same rights as actual entities: a president-elect is a potential president and does not have the same rights a president has. Moreover, we do not judge in the same way someone who destroys a sack of seeds and someone who destroys a forest. Therefore, the death of an embryo cannot be equated with the death of an actual and full-fledged person. Thus, arguing that the embryo is a potential person does not necessarily lead us to conclude that the embryo has the same moral value and the same rights as an actual person. Another argument against the idea of potential persons is based on a thought experiment: if, in an emergency, one could save either ten frozen embryos (later to be implanted) or five adult patients, most people would choose to save the patients, suggesting that they have a higher moral value, or in any case a moral value that the embryos do not have. If the embryos did have the same moral value, then we should rather choose them, just because ten is more than five. Francis Beckwith, who defends the potentiality argument, claims that we should choose the embryos, and that our intuitions are unreliable: we choose to save the patients only because the embryos do not look like people (Beckwith 2007: 169–70, quoted in Stretton 2008: 795). But if the alternative were between ten androids and the five patients, would we then save the androids since they have a human appearance, even though they are robots with no consciousness? Our intuitions are not based on appearances but on the difference in moral value between embryos and rational, self-conscious human persons. What, then, is a person? One of the most influential philosophical theories on what it means to be a person is that of P. F. Strawson. He discusses person as “the concept of a type of entity such that both predicates ascribing states of consciousness and predicates ascribing corporeal characteristics, a physical situation &c. are equally applicable to a single individual of that single type” (Strawson 1959: 101–2). That is, a person is a kind of entity to which we can attribute corporeal or physical characteristics, but also mental ones, such as consciousness. Many have criticized Strawson’s definition as too broad and have tried to restrict the semantic field of the concept by raising the threshold of what persons are, holding that they are the entities to whom we can ascribe not only consciousness, but self-consciousness, the ability to value, reason, choose, perform intentional actions, and recognize other similar individuals and interact with them. Obviously, the more we specify the mental predicates necessary for the attribution of the condition of person, the more we will restrict the set of entities we call persons—and therefore, if we set the standard too high, we risk leaving embryos aside. But, in fact, we do not need to set the standard so high in order to see that embryos do not count as persons. Daniel Dennett has argued that personhood is a kind of cluster concept defined by a list of criteria in which each individual criterion is neither necessary nor sufficient. He enumerates six conditions that can give us an idea of what it means to be a person: (1) persons are rational beings; (2) persons are beings to which states of consciousness are attributed, or to which psychological or mental or intentional predicates are ascribed; (3) whether something counts as a person depends in some

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way on an attitude taken toward it, a tance adopted with respect to it, an intentional stance; (4) the object toward which this personal stance is taken must be capable of reciprocating in some way, i.e. to be a person is to be able to recognize and treat others as persons; (5) persons must be capable of verbal communication; (6) persons are distinguishable from other entities by being conscious in some special way: there is a way in which we are conscious in which not many other species are conscious, and this is sometimes identified as self-consciousness of one sort or another (Dennett 1981: 177–8). Some of these characteristics may be debatable, but it is not my purpose to discuss them here, simply to point out that, whatever a person is, its main characteristics depend on the fact that we are able to attribute mental or psychological properties to it, minimal as they may be. The attribution of consciousness seems to be the most basic one, and this is probably the criterion we should first consider to answer the question of whether an embryo is a person. (Of course, if we set the standard higher and think that only rational beings are persons, embryos would not be persons, either.) Science may not tell us what a person is, but it does tell us when an embryo is able to develop the most basic mental characteristics. Scientific advances on embryonic neurodevelopment give us important information to establish at what stage we can say that the embryo has developed the neurophysiological basis necessary to ascribe it mental states. These studies tell us that this basis does not appear at conception, but at 22–24 weeks of pregnancy. Only then the embryo—or the fetus, at this stage—has developed the cortical plaque and cerebral cortex, which enable the emergence of conscious mental states. Only then is the fetus able to have sensations and a mental life (Mai and Ashwell 2004, and Müller and O’Rahilly 2004). During the first trimester, the development of the brain is barely in its initial stages, and the cerebral cortex and neurophysiological connections that are indispensable for attributing sensations and consciousness to the embryo have not yet developed. It would not be until the beginning of the third trimester of pregnancy that we have the minimum necessary, though not sufficient, conditions for personhood. I say “not sufficient” because we usually have a richer conception of what a person is, including some of the characteristics already mentioned in Dennett’s list, such as intentionality, rationality, capacity to reciprocate, and so on. What gives special value to the life of an embryo, then, is not that it has the genetic code of the species Homo sapiens, nor that it is a potential person, but that it has a mental life that enables it to be conscious and have experiences of the world. However, this does not happen until the end of the second trimester. Until then we do not have the minimal necessary condition for personhood or the basis for ascribing it moral value. If we cannot say that the fetus, before that time, is a person, then we can neither attribute rights, such as the right to life. Therefore, the conflict between the supposed rights of the embryo and the effective rights of the woman does not exist.15 15 There

are other answers to the question about why abortion is immoral. Don Marquis has given one of the most prominent ones. According to Marquis, abortion is immoral since it deprives an embryo or fetus of a “future like ours” (1989: 191), and this is something of value to us. However, many have objected to Marquis’s argument. Walter Sinnott-Armstrong (1999), for instance, argues

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If the intentional termination of pregnancy, at least during the first two trimesters, is not killing someone with moral value, that is, it is not killing a person and a bearer of a right to life, then it is not morally wrong. If it is not morally wrong, then there is no moral basis to justify that the law should penalize it.16 What justifies considering abortion a crime, other than its moral wrongness? But then the idea that the moral wrongness of abortion justifies all the negative consequences of the law, as well as the infringement of women’s rights, has no basis. It does not justify them.

2.5 Conclusion I have argued that anti-abortion laws have negative consequences at different levels: on the women who are denied termination of their pregnancies when they do not want to continue them, on unwanted children, and on society at large. These laws also infringe some of women’s most fundamental rights in a way no other law does, requiring them to sacrifice their freedom, autonomy, privacy, and future life, and putting their health and bodily integrity at risk. These laws also promote discrimination and inequality between men and women, as well as among women of different economic classes. All this counts for a negative moral evaluation of these laws. Their only justification is the protection of an alleged right to life of an unborn person. A human embryo, it is claimed, is a person with the same right to life as any adult person, and this is why intentionally terminating the life of an embryo is considered murder. However, as I have tried to show, there are no good arguments in favor of considering an embryo to be a person since on all accounts the ascription of personhood requires the presence of mental or psychological properties, which do not appear until the end of the second trimester of pregnancy. Those who see abortion as immoral and justify its criminalization may insist that my characterization of the value of a human embryo is not accurate and that it simplifies the matter, that human life is of supreme value, and the right to life from the moment of conception is absolute and trumps women’s rights. But since the concept of personhood is not one on which we can all agree but rather one for which there are many conceptions, it may not be possible either for whomever supports anti-abortion laws or for me to ‘prove’ whether the embryo is a person. That is what makes abortion such a controversial issue. But if neither party can prove that the embryo is a person, I do not see why the state can prove it—or at least take it for that Marquis equivocates the meaning of “loss.” It either means the privation of a future to which the embryo has a moral right or the privation of a future to which it has no moral right. If this definition were accepted, Marquis would still have to explain how an embryo has a moral right to the means of realizing its future for his argument to be sound. For a deeper analysis of Marquis’s argument, see Boonin (2002). 16 Even if human embryos are not persons and have no right to life, they should be legally protected goods, just like parks, water, historic monuments, or the environment. Human embryos are valuable and must be protected by law. This point is important because it would be the basis for punishing, for example, someone who causes an abortion to a pregnant woman against her will.

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granted when criminalizing abortion as if it were murder. All this is well captured by the words of Roger Wertheimer: “the social costs of the present abortion laws are so drastic that only the preservation of human lives could justify them. So to justify those laws the state must demonstrate that the fetus is [a person]. But if that can’t be done at all, the state can’t do it either, so the laws must be deemed an unjustifiable burden and hence an illegitimate exercise of power” (Wertheimer 1971: 94). They are, indeed, an illegitimate exercise of power through which the state imposes on its citizens a law that, if everything I have argued here is correct, is immoral. Acknowledgements Thanks are due to Jennifer Paine, Eduardo Rivera-López, Enrique Rodríguez, and to an anonymous reviewer for their many comments on an earlier version of this paper, and to Susana Lerner and Raffaela Schiavon for the information they gave me regarding their research on abortion. I am also grateful to the Dirección General de Asuntos del Personal Académico of the Universidad Nacional Autónoma de México (UNAM) for the financial support that allowed me to do this research as a visiting scholar at Duke University.

References Beckwith, F. 2007. Defending Life: A Moral and Legal Case Against Abortion Choice. New York: Cambridge University Press. Boonin, D. 2002. A Defense of Abortion. New York: Cambridge University Press. Brown, S.S., and Eisenberg, L. (eds.). 1995. The Best Intentions. Unintended Pregnancy and the Well-Being of Children and Families. Washington, DC: National Academy Press. Retrieved from https://www.nap.edu/read/4903/chapter/1. Carless, W. 2016. A New Bill Aims to Make Brazil’s Abortion Law Even Tougher. Public Radio International. Retrieved from https://www.pri.org/stories/2016-03-26/new-bill-aimsmake-brazils-abortion-law-even-tougher. Cheng, D., E.B. Schwarz, E. Douglas, and I. Horon. 2009. Unintended Pregnancy and Associated Maternal Preconception, Prenatal and Postpartum Behaviors. Contraception 79: 194–198. CRR. 2017. The World’s Abortion Laws. Center for Reproductive Rights. Available at: http:// worldabortionlaws.com/map/. Cruz Sánchez, V. 2014. Guanajuato: joderse a las mujeres más pobres y más jodidas no beneficia a ninguna nación. In Aborto, Democracia y Empoderamiento, ed. G. Ortiz Millán, 115–134. Mexico City: Fontamara-ITAM. David, H.P. 2011. Born Unwanted: Mental Health Costs and Consequences. American Journal of Orthopsychiatry 81 (2): 184–192. Dennett, D. 1981. Conditions of Personhood. In The Identities of Persons, ed. A. Rorty, 175–196. Berkeley-Los Angeles: University of California Press. Finer, L.B., L.F. Frohwirth, L.A. Dauphinee, S. Singh, and A.M. Moore. 2005. Reasons U.S. Women Have Abortions: Quantitative and Qualitative Perspectives. Perspectives on Sexual and Reproductive Health 37 (3): 110–118. Foote, C.L., and C.F. Goetz. 2008. The Impact of Legalized Abortion on Crime: Comment. The Quarterly Journal of Economics 123 (1): 407–423. François, A., R. Magni-Berton, and L. Weill. 2014. Abortion and Crime: Cross-Country Evidence from Europe. International Review of Law and Economics 40: 24–35. GIRE. 2005. Paulina. Five Years Later. Mexico City: Grupo de Información en Reproducción Elegida.

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GIRE. 2017. Perfil de las usuarias que han realizado la interrupción legal del embarazo en la Ciudad de México. Abril 2007–28 de febrero de 2017. Mexico City: Grupo de Información en Reproducción Elegida. Retrieved from: http://informe.gire.org.mx. Greene Foster, D. 2016. Unmet Need for Abortion and Woman-Centered Contraceptive Care. The Lancet 388: 216–217. Gruber, J., P. Levine, and D. Staiger. 1999. Abortion Legalization and Child Living Circumstances: Who is the “Marginal Child”? Quarterly Journal of Economics 114 (1): 263–291. Guttmacher Institute. 2012. Facts on Abortion in Latin America and the Caribbean Available at: http://www.guttmacher.org/pubs/fb_IAW.pdf. ICPD. 1994. International Conference on Population and Development. Programme of Action. New York: United Nations. Retrieved from http://www.unfpa.org/publications/internationalconference-population-and-development-programme-action#sthash.tgttDGJZ.dpuf. IPPF. 2006. Death and Denial: Unsafe Abortion and Poverty. London: International Planned Parenthood Federation. Jaggar, A. 2009. Abortion Rights and Gender Justice Worldwide: An Essay in Political Philosophy. In Abortion. Three Perspectives, ed. M. Tooley, C. Wolf-Devine, P.E. Devine, and A. Jaggar, 120–179. New York: Oxford University Press. John Paul II. 1995. Evangelium Vitae. Retrieved from http://w2.vatican.va/content/john-paul-ii/en/ encyclicals/documents/hf_jp-ii_enc_25031995_evangelium-vitae.html. Johnston, R. 2016. Reasons Given for Having Abortions in the United States. Available at: http:// www.johnstonsarchive.net/policy/abortion/abreasons.html. Khan, K.S., D. Wojdyla, L. Say, A.M. Gülmezoglu, and P.F.A. Van Look. 2006. WHO Analysis of Causes of Maternal Death: A Systematic Review. Lancet 367: 1066–1074. Kost, K., D.J. Landry, and J.E. Darroch. 1998. Predicting Maternal Behaviors During Pregnancy: Does Intention Status Matter? Family Planning Perspectives 30 (2): 79–88. Kost, K., S. Singh, B. Vaughan, J. Trussell, and A. Bankole. 2008. Estimates of Contraceptive Failure from the 2002 National Survey of Family Growth. Contraception 77 (1): 10–21. Lerner, S., and A. Guillaume. 2007. Abortion in Latin America and the Caribbean. A Review of the Literature from 1990 to 2005. Mexico-Paris: Institut de Recherche pour le DéveloppementEl Colegio de México. Retrieved from http://www.ceped.org/cdrom/avortement_ameriquelatine_ 2007/en/infos/introduction.html. Levitt, S., and J. Donohue. 2001. The Impact of Legalized Abortion on Crime. Quarterly Journal of Economics 116 (2): 379–420. Mai, J.K., and K.W.S. Ashwell. 2004. Fetal Development of the Central Nervous System. In The Human Nervous System, ed. G. Paxinos and J.K. Mai, 49–94. Amsterdam: Elsevier. Marquis, D. 1989. Why Abortion is Immoral. The Journal of Philosophy 86 (4): 183–202. Ministerio della Salute. 2017. Relazione del Ministro della Salute sulla attuazione della legge contenente norme per la tutela sociale della maternità e per l’interruzione volontaria di gravidanza (Legge 194/78). Retrieved from http://www.salute.gov.it/imgs/C_17_pubblicazioni_2686_ allegato.pdf. Monea, J., and A. Thomas. 2011. Unintended Pregnancy and Taxpayer Spending. Perspectives on Sexual and Reproductive Health 43 (2): 88–93. Müller, F., and R. O’Rahilly. 2004. Embryonic Development of the Central Nervous System. In The Human Nervous System, ed. G. Paxinos and J.K. Mai, 22–48. Amsterdam: Elsevier. Nino, C.S. 1989. Ética y derechos humanos, 2nd ed. Buenos Aires: Astrea. On the Issues. 2018. Hilary Clinton on Abortion. On the Issues. Retrieved from http://www. ontheissues.org/Celeb/Hillary_Clinton_Abortion.htm. Ortiz Millán, G. 2009. La moralidad del aborto. Mexico City: Siglo XXI. Raymond, E.G., and D.A. Grimes. 2012. The Comparative Safety of Legal Induced Abortion and Childbirth in the United States. Obstetrics and Gynecology 119 (2): 215–219. Roe v. Wade. 1973. Roe v. Wade: The 1973 Supreme Court Decision on State Abortion Laws. In The Ethics of Abortion: Pro-Life vs. Pro-Choice, 3rd ed., ed. R. M. Baird and S. E. Rosenbaum, 63–72. New York: Prometheus Books.

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Schiavon, R., E. Troncoso, and G. Polo. 2015. Abortion Hospitalizations Trends in Mexico 2000–2013: Analysis of Complicated vs. Uncomplicated Cases Using the ICD-10 Classification. Paper presented at the XXI FIGO World Congress of Gynecology and Obstetrics, Vancouver, Canada, October 4–9, 2015. Schoenwolf, G.C., S.B. Bleyl, P.R. Brauer, and P.H. Francis-West. 2015.. Larsen’s Human Embryology, 5th ed. Philadelphia: Elsevier. SCJN. 2008. Acción de inconstitucionalidad 146/2007 y su acumulada 147/2007. Mexico City: Suprema Corte de Justicia de la Nación. Available at: https://www.sitios.scjn.gob.mx/codhap/ completo/despenalizacion_abortodf. Sedgh, G., S. Henshaw, S. Singh, E. Åhman, and I.H. Shah. 2007. Induced Abortion: Estimated Rates and Trends Worldwide. Lancet 370: 1338–1345. Sedgh, G., J. Bearak, S. Singh, A. Bankole, A. Popinchalk, B. Ganatra, C. Rossier, C. Gerdts, O. Tunçalp, B. Ronald Johnson Jr, H. Bart Johnston, and L. Alkema. 2016. Abortion Incidence between 1990 and 2014: Global, Regional, and Subregional Levels and Trends. Lancet 388: 258–67. Shapiro-Mendoza, C., B.J. Selwyn, D.P. Smith, and M. Sanderson. 2005. Parental Pregnancy Intention and Early Childhood Stunting: Findings from Bolivia. International Journal of Epidemiology 34: 387–396. Sinnott-Armstrong, W. 1999. You Can’t Lose What You ain’t Never Had: A Reply to Marquis on Abortion. Philosophical Studies 96: 59–72. Strawson, P.F. 1959. Individuals. London: Routledge. Stretton, D. 2008. Critical Notice: Defending Life: A Moral and Legal Case Against Abortion Choice by Francis J. Beckwith. Journal of Medical Ethics 34 (11): 793–797. Thomson, J.J. 1971. A Defense of Abortion. Philosophy & Public Affairs 1 (1): 47–66. UN. 2015. Trends in Contraceptive Use Worldwide 2015. New York: United Nations. Retrieved from http://www.un.org/en/development/desa/population/publications/pdf/family/ trendsContraceptiveUse2015Report.pdf. UNPD. 2002. Abortion Policies: A Global Review. United Nations Population Division. Retrieved from http://www.un.org/esa/population/publications/abortion/. Van Dijk, M.G., L.G. Arellano Mendoza, A.G. Arangure Peraza, A.A. Toriz Prado, A. Krumholz, and E.A. Yam. 2011. Women’s Experiences with Legal Abortion in Mexico City: A Qualitative Study. Studies in Family Planning 42 (3): 167–174. Warren, M.A. 1997. Moral Status. Obligations to Persons and Other Living Things. New York: Oxford University Press. Wertheimer, R. 1971. Understanding the Abortion Argument. Philosophy & Public Affairs 1 (1): 67–95. WHO. 2011. Unsafe Abortion: Global and Regional Estimates of the Incidence of Unsafe Abortion and Associated Mortality in 2008, 6th ed. Geneva: World Health Organization.

Chapter 3

Conscious Oppression: Conscientious Objection in the Sphere of Sexual and Reproductive Health Marcelo Alegre

Abstract This paper advances a normative framework to understand conscientious objection in the area of sexual and reproductive health services. Here, the objection of health professionals, unlike traditional cases of objection (such as the refusal of mandatory military service), directly affects the rights of other people. For this and other reasons I detail, the permissive strategies of the model I call “libertarian” (in which the scope of objection is limitless) and the model I call “conciliatory” (in which the referral of patients to non-objecting professionals is the condition for access to the right to conscientious objection) run into serious problems. I argue in favor of a third model inspired by the ideal of equality. From this perspective, it is unlikely that conscientious objection can be acceptable for sexual and reproductive health professionals. For this to be so, the limits on its exercise would have to be much stricter than those established by the conciliatory model and, in any case, the acceptance of any objections would have to be subordinated to the prior existence of non-discriminatory, universal access to sexual and reproductive health services. Keywords Abortion · Conscientious objection · Sexual and reproductive rights · Equality

3.1 Introduction Although for centuries conscientious objection was primarily claimed by those who for religious or ethical reasons refused to join the ranks of the military, whether out of a general principle or in response to a particular violent conflict, in recent decades a significant broadening of the concept has been seen. In Thailand, for example, doctors recently refused medical attention to injured policemen suspected of having violently repressed a demonstration. In Argentina, a few public defenders M. Alegre (B) New York University School of Law, Buenos Aires, Argentina e-mail: [email protected] Universidad de Buenos Aires, Buenos Aires, Argentina © Springer Nature Switzerland AG 2019 E. Rivera-López and M. Hevia (eds.), Controversies in Latin American Bioethics, International Library of Ethics, Law, and the New Medicine 79, https://doi.org/10.1007/978-3-030-17963-2_3

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have refused for conscientious reasons to represent individuals accused of massive human rights violations. In different countries all over the world, there are doctors who refuse to perform euthanasia, schoolteachers who do not accept teaching the theory of evolution, and students who refuse to attend biology classes where living frogs are dissected. In this piece, I will focus my attention on an area in which people are making increasingly frequent claims of conscientious objections to excuse themselves from legal obligations: the field of sexual and reproductive rights, particularly the case in Argentina.1 Various providers (doctors, pharmacists, etc.) use the protection of conscientious objection in order to deny providing services such as information on contraception or legal abortion, prescribing or dispensing contraception (including emergency contraception), performing tubal ligations or vasectomies, or carrying out lawful abortions. Occasionally, some health professionals and pharmacists even refuse to provide information on alternatives to which access for patients and clients is guaranteed by legislation. Some go further yet, refusing to refer patients to doctors who do not object to performing a given service. Such cases are frequent in Argentina, although few make it to the newspaper headlines. One case that was publicized involved a mentally handicapped rape victim from the province of Entre Ríos who, despite benefiting from a court ruling in her province authorizing the interruption of her pregnancy, was not able to obtain a legal abortion because of the lack of doctors willing to perform it. The National Health Secretary was forced to have the woman transported to another province for the abortion to be carried out.2 My purpose in this paper is to advance some criteria to establish a more precise framework for conscientious objection than those currently in operation. The objection of health professionals, unlike traditional cases of objection, such as the refusal of mandatory military service, affects the rights of third parties. For this and other reasons I will mention, the permissive model I will call “libertarian” (according to which the scope of objection is limitless) and the model I will call “conciliatory” (according to which the right to conscientious objection depends on the availability of non-objecting professionals) run into serious problems. I will argue in favor of a third model inspired by the ideal of equality. From this perspective, it is doubtful that conscientious objection can be acceptable for sexual and reproductive health professionals. Should it be deemed acceptable, the limits on its exercise would have to be much stricter than those established by the conciliatory model and, in any

1 Among the works consulted for this piece, some that stand out are: Casas (2006), Dickens (2006),

White (1999), Dresser (2005), Cantor and Baum (2004), Cook (2007), Cook and Dickens (2003, 2006), Charo (2005). Regarding considerations which are relevant in the developing world, see Van Bogaert (2002). 2 “Le practicaron el aborto a la chica discapacitada de Entre Ríos que fue violada” Clarín, 24/9/2007. Cantor and Baum inform us that in Texas, a pharmacist refused to dispense emergency contraception to a rape victim who had a doctor’s prescription (Cantor and Baum 2004, note 9). Allison Grady describes the case of a married mother of four who tried to buy the morning-after pill in a pharmacy in Wisconsin. The pharmacist denied her the product and refused to return the prescription to her (Grady 2006).

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case, it would have to be subordinate to the existence of simple, non-discriminatory, universal access to sexual and reproductive health services.

3.2 Conscientious Objection, Before and After 3.2.1 Traditional Conscientious Objection Conscientious objection consists of the right not to be obligated to perform actions that contradict the deepest ethical or religious convictions of an individual.3 This right has its basis in the constitutional protections of the freedom of religion and conscience and of behavior that does not harm others (Articles 14 and 19 of the Argentine Constitution). This right is commonly exercised in various domains. In our country, the scope of conscientious objection has been debated in relative depth with regards to military service when it was still mandatory and, more recently, with regards to the legislation and regulation of sexual and reproductive health. In 1982 under the dictatorship, the (“so-called”) Supreme Court considered two cases, Ascensio4 and Lopardo,5 emitting decisions in which a restricted conception of conscientious objection was implicit. The matter in question in Ascensio was the constitutionality of the expulsion from primary school of a 10 year-old Jehovah’s Witness who had refused to recite patriotic oaths. The Court struck down the suspension on the grounds that the punishment was excessive, that there was no prior misbehavior by the child, that there had been the possibility of applying less strict sanctions, that the child was a minor and dependent on the parents, and that expulsion affected the child’s right to education under Article 14 of the Constitution. The Court did not recognize any right to objection. It simply decided that it was appropriate to apply intermediate sanctions rather than resorting to expulsion. In the Lopardo case, the matter discussed was the constitutionality of a punishment imposed upon a Jehovah’s Witness who had refused to wear military uniform (although he had shown up for his mandatory military service). Lopardo alleged that his freedom of religion and conscience were at stake. The Court ruled that freedom of religion was not absolute and that it had to be reconciled with the duty to perform military service, which was also constitutionally required. The anti-liberal worldview of the Court under the dictatorship is summed up in its affirmation that “the exercise of the freedom of conscience is bound by the reasonable requirements of just public order, of the common good of society, and of the protection of the existence and legitimate rights of the nation itself.”6 This worldview does not leave any room for conscientious objection (or, in fact, for any other individual right). 3 Singer

(1973), Rawls (1971). José H. s/Amparo, Fallos 304:1293. 5 Lopardo, Gabriel Fernando (Fallos 304:1524). 6 Fallos 304:1533. 4 Ascensio,

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After the end of the dictatorship, in 1989, a democratic Supreme Court had the opportunity to consider a case of conscientious objection.7 Gabriel Portillo had refused to appear for his mandatory military service, for which he had been sentenced in a criminal court to perform his military service with an additional year as punishment. Portillo challenged the constitutionality of the law requiring military service on the grounds that it violated the freedom of ideology and of conscience protected by Article 14 of the Constitution since his Catholic beliefs prevented him from using arms against another human being in violation, as he saw it, of the Fifth Commandment. He was willing, however, to perform any alternative service that would not imply the use of arms. The Court distanced itself (in Consideration 6) from the simplistic approach of Lopardo: “The matter cannot be resolved by merely referring to the jurisprudence establishing that all rights are relative.” In Consideration 8, the Court recognized the specific value of religious freedom and went on to extend the protection of the right of conscience to whomever “establishes a determined hierarchy of ethical values that gives special primacy to not endangering the lives of their fellow men and women” (Consideration 9). It would be a contradiction in terms, the Court continued, “to protect the right to freedom of religion as a manifestation of the right to freedom of conscience without treating the latter as something to be protected itself as well.” It added that in a democracy, the state must be “impartial with regards to the governed, even when they practice religions that the majority repudiate” (Consideration 10). Subsequently an important point is clarified: that in this case “a contradiction does not exist between rights per se … but rather between a right and a legal obligation” (Consideration 11) whose non-fulfillment “does not entail serious or imminent harm to interests protected by the State” so that it is possible to find alternatives that reconcile the duties of the objector to the State with their personal convictions. Another crucial affirmation is found in Consideration 12: “What is at stake is not the … legal scope of the religious prohibition: ‘Thou shall not kill’ … since this Court lacks the competence to interpret religious dogma.” In Consideration 13, the Court established that objections must be based on sincere beliefs that seriously conflict with the challenged obligation. In the end, the Court confirmed the sentence on appeal, only changing it so that the military service be completed “without the use of arms.” This was a conciliatory ruling. Liberal values were vindicated, but the original punishment imposed on the objector was not challenged, which is not fully consistent with the recognition that the “right of citizens to carry out their mandatory service may be done without the use of arms.” It was simply this right that Portillo wished to exercise. Why should he be punished? In Portillo, the Court established the following jurisprudential criteria regarding the reach of the right to conscientious objection: 1. Freedom of conscience is, to begin with the most obvious point, a right; as such, it cannot be subordinated (as it was in Lopardo) to simple considerations of public utility or convenience. 7 Portillo,

Alfredo s/infracción art. 44 ley 17531 (JA 1989-II-658, Fallos 312:496).

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2. The right to freedom of conscience goes further than the right to freedom of religion, encompassing ethical convictions (“a system of values not necessarily religious,” according to Portillo). 3. The objection must be sincere. 4. This right requires protection even if the objector belongs to a minority. 5. A distinction must be made between cases in which conscientious objection does not run counter to any other rights and cases where it does indeed “entail serious or imminent harm to interests protected by the state.” 6. Whenever possible, reconciling compliance of legal obligations with the convictions of the objector must be sought. In Argentine legislation, conscientious objection is accounted for in statute 24,429 establishing voluntary military service.

3.2.2 Contemporary Conscientious Objection Appeals to conscience to excuse oneself from complying with legal obligations have increased exponentially in every direction. Starting in the second half of the 1990s, the debates and regulations concerning conscientious objection have acquired increasing importance in an area where basic rights are at stake: that of the laws and regulations regarding sexual and reproductive health. These norms mandate, for example, the creation of programs for public policies on sexual and reproductive health, the liberalization of access to surgical contraception, and the supply of emergency contraception or access to legal abortions, or access to pregnancy interruption in cases where pathologies of the fetus incompatible with life (like anencephaly) are diagnosed. Within some of these norms, specific clauses regulate the differing degrees to which health professionals and other actors in the sector have the right to exercise conscientious objection. In general, the phenomenon arises when a health professional (doctor, pharmacist, etc.) objects to certain practices regulated by law, such as contraception (including emergency contraception and tubal ligation) or abortion, even in cases in which it is legally permitted. A survey carried out in Argentina in 2001 by researchers at the Center for the Study of the State and Society, (CEDES for its initials in Spanish) revealed that 50% of the health professionals surveyed believed that doctors should not perform vasectomies or tubal ligations or provide information on these services. More than 30% hold the same beliefs with respect to female contraception (Ramos et al. 2001, p. 94.). One head of obstetrics declared: “Emergency contraception is a form of abortion in my opinion, so I won’t even speak of it … that is why it shouldn’t be used and why I won’t provide information about it or let anyone else here provide the information” (Ramos et al. 2001, p. 98). Statute 25,673, which created the National Program for Responsible Parenthood and Sexual Health, protects institutional conscientious objection, albeit establishing the obligation to provide referrals in order to guarantee access to the Program’s services. Article 6 of law 26,130, which establishes the Protocol

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for Contraceptive Surgery, also recognizes and regulates the right to conscientious objection on an individual level, requiring the authorities of each health institution to make immediate replacements available to patients in these cases. National Law 26,150 on Sexual Education, which creates the National Program of Integrated Sexual Education within the National Education Ministry, however, does not consider conscientious objection. At the provincial level,8 the scope of the regulations governing conscientious objection vary from one jurisdiction to the next. The federal state and the Argentine provinces adopted different regulatory options to implement the constitutional mandate regarding the right to conscientious objection and the rights with which it might conflict (see Appendix 1). Not all of these options are equally acceptable, and some of them are even questionable due to the generality they ascribe to the right or the preference it enjoys over the fundamental rights with which it may conflict, such as the life, health, or autonomy of patients in general, and women in particular.

3.2.3 Relevant Factors for Conscientious Objection in the Context of Sexual and Reproductive Health The following considerations are, in my opinion, important in evaluating the acceptability and the limits of conscientious objection in the field of sexual and reproductive health. These factors distinguish the current application of conscientious objection from the traditional one and seek for an innovative approach that takes into account the rights that are threatened by this practice. (1) The behavior of objectors is usually motivated by reasons that challenge the morality of certain public policies. For example, the provisions of the Criminal Code allowing abortion in certain situations are denounced as unconstitutional because the objector rejects those exceptions. (2) The objection is motivated by the desire to derail public policies on sexual and reproductive health. What is sought is not merely an individual exception to a legal obligation. The coordination with which conservative institutions and the authorities of the Catholic Church promote widespread practice of conscientious objection shows that it is a matter of collective action that aims to reform laws and state decisions, and whose consequences affect the general public. (3) The actions involved affect basic interests of third parties by impeding or obstructing access to contraceptive methods, or to information on how to avoid unwanted pregnancy, or to legally permitted abortions, actions which pose risks to the lives, health, physical integrity, or autonomy of other people.9 (4) The negative impact on rights is exacerbated by the fact that one group, women in a state of poverty, is doubly affected disadvantageously. This reinforces a 8 See

Cárdenas and Tandeter (2008). right treatises, which are constitutional norms in Argentina, guarantee women’s right to “medical care without discrimination” including “family planning”.

9 Human

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dual source of structural inequality in a context in which sexual and reproductive rights are far from being fully guaranteed. For example, denying emergency contraception leads to unwanted births or to abortions, and the refusal to perform legally permitted abortions puts women’s lives or health, and their autonomy and bodily integrity, at risk. Furthermore, conscientious objection in the domain of sexual and reproductive health imposes (independently of the particular intentions of the objectors) behavioral stereotypes on women that tend to deprive them of control over their sexual and reproductive lives. (5) Sexual and reproductive health service providers are professionals. Professions act as regulated monopolies. In this sense they are different from other monopolies, which we could call irregular and whose existence is undesired. Professionals are granted exclusive access to certain practices deemed especially valuable by society. To be a professional is to be part of a monopoly; anyone who is not a professional is excluded from the practice in question (medicine, law, etc.). In exchange for this monopoly, professionals must satisfy various requirements, including formal education, accreditation, oaths, and so on. Once a privileged position is obtained, a professional does not enjoy the same level of discretion with respect to obligations as a non-professional does.10 It is not unreasonable to include among professional obligations the forfeit of the recourse to conscientious objection in the exercise of the profession when this recourse endangers values such as the lives and health of others, or the enjoyment of important constitutional and/or legal rights. (6) The circumstances of health professionals impose even more stringent restrictions on their autonomy. They have an obligation to care for their patients11 and operate in a sphere of enormous importance for the type of interests at stake. Cantor and Baum emphasize that, unlike military conscription (which is obligatory by definition), joining the health profession is entirely voluntary, and thus the recourse to conscientious objection must be treated very differently (Cantor and Baum 2004, p. 2009). This does not deny the high cost a restrictive model would impose on objectors; it simply notes that such cost is probably lower than the cost that the practice of conscientious objection imposes on others. These observations seem to support those who assert that being a health professional is incompatible with conscientious objection.12 Conscientious objection in this case is not a mere omission to act on the part of a normal person intending not to perform an action she rejects on moral grounds. The distinction between acting and failing to act is less clear in the case of health professionals. It would be a gross oversimplification to speak of merely “not acting” after having taken an oath to serve patients’ interests, after enlisting in 10 Charo

(2005, p. 2473). the United States, courts extend the duty of care to pharmacists. Hooks Super X, Inc. V. Mc Laughlin, 642 N.E. 2d 514 (Ind. 1994). 12 Savulescu (2006). A New York Times editorial agrees: “Doctors who cannot talk to patients about legally permitted care because it conflicts with their values should give up the practice of medicine.” “Editorial: Doctors Who Fail Their Patients” February 13, 2007. Cf. Asch (2006). 11 In

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the monopolistic exercise of a given activity and becoming part of the health network. The failure to act on the part of someone exercising the type of power with which health professionals are invested is morally equivalent to an action; in this case, an action of obstruction to the exercise of the right to health. (7) In Argentina, conscientious objection in the domain of sexual and reproductive health occurs in a context in which guarantees of equal access to these services without obstacles do not exist for everyone. The state does not fulfill its obligations to provide sexual education and universal access to contraception. Nor does it consistently enforce the text of the Criminal Code when abortion is legally permitted in cases of risk to the mother’s life or health or when she has been the victim of rape or is mentally handicapped.13 In these circumstances, enlarging the scope of conscientious objection is not a means to protect rights but rather to threaten them, and to perpetuate unequal conditions for impoverished women, who comprise the majority of the victims that suffer from a lack of these services. Despite the fact that national and international norms in force in Argentina provide various sexual and reproductive rights,14 the obstacles to effective enforcement of these norms are such that unrestricted, free, and universal access to the services established by law remains illusory. For example, the 2008 CELS Report on Human Rights in Argentina15 makes reference to concealment of contraceptives, impeding access to the surgical contraception regulated by law, limits on information regarding available contraceptives, purposefully and deceitfully failing to insert IUDs, and failing to replace expired contraceptives in locations that report shortages, out of negligence or for ideological reasons. Sexual and reproductive health policies are the target of legal harassment by extremist Catholic entities that make use of conservative judges to prevent delivery of emergency contraception under the auspices of the calamitous Supreme Court decision Portal de Belén.16 Perhaps the most serious case is that of legally permitted abortions. According to article 86 of the Criminal Code, abortions are not punishable in cases of danger to the life or health “of the mother,” in cases of rape, or of “affront to 13 As of June 2018, a bill establishing free abortion in the first 14 weeks of pregnancy passed in the lower chamber and is under consideration in the Senate. 14 CEDAW, Sexual Health and Responsible Procreation Act, N. 25.673, Law 26.130 regulating contraceptive surgery, Law 26.150 establishing a National Program of Sexual Education, etc. 15 CELS, 2008 HHRR Report, “El acceso al aborto permitido por la ley: un tema pendiente de la política de derechos humanos en la Argentina” by CEDES researchers Silvina Ramos, Paola Bergallo, Mariana Romero, and Jimena Arias Feijoó. 16 “Portal de Belén—Asociación Civil sin Fines de Lucro c/ Ministerio de Salud y Acción Social de la Nación s/ amparo,” CSJN, March 5, 2002 (citing a fictitious Nobel Prize and the opinions of a geneticist from a decision by the Tennessee Supreme Court, hiding the fact that said Court dismissed his opinions because of his lack of expertise in the issues discussed, and for showing a deep confusion between science and religion). Investigation by Virginia Menéndez, included in the appeals procedure before the courts of Córdoba province: “Mujeres por la vida Asoc. sin fines de lucro c. Superior Gobierno de la Provincia de Córdoba—amparo—Recurso de Apelación” file no. 1270503/36, in file with author).

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modesty [atentado al pudor] committed against a mentally deficient woman.” In these cases, access to free and safe abortion is a basic right given the crucial interests at stake (life or health of the pregnant woman, her autonomy, and her physical integrity). Many factors conspire against the effective enforcement of this right. First, we have the unjustifiably restricted interpretation of the law by many doctors and judges holding (i) that the danger must be very grave, (ii) that mental and social health are not included in the concept of health (in opposition to the definition given by the World Health Organization), and (iii) that the exception in the case of rape is only applicable in cases involving mentally handicapped women. Second, many doctors do not dare perform licit abortions because of the latent threat of being subject to criminal prosecution. Third, a limited interpretation of doctor-patient confidentiality (again in disagreement with the text of the Criminal Code and the most basic ethical rules) is prevalent, a fact that leads many doctors in public hospitals to report women seeking treatment for complications suffered in clandestine abortions. This scenario of structural impediments to access to the most basic services concerning sexual and reproductive health is correlated to the fact that clandestine abortion is the most important cause of maternal mortality.17 The analysis of the right to conscientious objection would be radically flawed without considering the context in which the practice is exercised. When this context is characterized by the systematic denial of rights to groups that suffer structural discrimination, as is the case of women and people in poverty, it may well be that the freedom of some is the oppression of others. (8) Another relevant aspect of the existing conditions is the excessive influence of religion in civic affairs. Most of the time, conscientious objectors use their objection to express religious values, such as those who are against sex outside of marriage, or against sex not oriented to reproduction, or homosexual relations, or the voluntary termination of pregnancy. The line separating the right to adhere to one’s religious convictions from an imposition of those religious values on another person is very fine. It is just as fine, coincidentally, as the line separating church from state. One risk, to take an example, is that health professionals who adhere to the Catholic religion behave as soldiers of faith, illuminated by religious documents such as the Circular Letter of 1995, “Evangelium Vitae,” by Karol Wojtyla. In that letter (paragraph 28), the Pope describes the current situation as “a dramatic shock between good and evil and between life and death” The document states that the laws authorizing abortion and euthanasia lack “authentic legal validity,” and that they are not “truly rights or morally obligatory” (p. 72); it further reads that “abortion and euthanasia are crimes that no human law can legitimate,” going on to affirm that “there is no conscientious obligation to obey them and instead a clear and serious obligation to oppose them by conscientious objection” (p. 73). 17 See the 2002 Report by the National Ministry of Health and CEDES on maternal mortality in Argentina, available at http://www.msal.gov.ar/htm/site/pdf/Resumen%20ejecutivo.pdf.

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In societies such as that of Argentina, the fact that civic life remains strongly conditioned by the impositions of the Catholic religion provides an additional reason to be extremely cautious when permitting practices that, in effect, contribute to the cultural hegemony of a religious vision. The common view is that, given the large majority of Catholics in our society, the permeation of social life by Catholic values is justified. I think, conversely, that in countries where a majority of the population subscribes to one religion, stronger protection against the influence of that religion in civic life is necessary.

3.3 Three Approaches to Conscientious Objection 3.3.1 The Libertarian and Conciliatory Models Three different models or strategies can be distinguished with regards to conscientious objection in the domain of sexual and reproductive health services. The first strategy is permissive or “libertarian.”18 In this approach, the professional has the right to avoid doing what he objects to and cannot be required to refer the patient to another professional willing to perform the objected action. Likewise, the professional is free to reproach the patient if they express their intent to use contraceptives or to have an abortion. The professional may give the patient reasons, whether ethical or religious, for their objection, and can also attempt to dissuade the patient.19 The patient may of course, as an adult, end the conversation whenever he or she wishes. This approach presents several problems. First, it presupposes equality in the relationship between the professional and the patient, something that in reality is far from the truth. (Think only of a poor woman interacting with the health system). Second, it assimilates the provision of health services to any other good or service, failing to consider the special importance of health, and sexual and reproductive health in particular. Third, it is unfair since it forces the patient to seek the service she needs indefinitely. Fourth, the privacy of patients is compromised as they are subjected to an unwanted evaluation of their behavior or personal preferences. Notice that decisions regarding sex and reproduction stem from the very core of our conscience. This being so, the price of the objector’s purity of conscience might be the desecration of the patient’s conscience. This model, however, also allows health institutions to refuse to hire objectors. The sanctity of contracts is a universal principle: the objector cannot protest if hospitals and pharmacies use the principle to freely hire employees with whatever stipulations they see fit, including the condition of not being an objector. 18 This strategy is similar to what Rebecca Dresser calls a “contract model,” in which the doctor informs the patient at the outset about the limits of her or his services (Dresser 2005, p. 9). The libertarian strategy allows even more leeway to the doctor. 19 Adrienne Asch claims that the objector “exercises his right of conscientious refusal only by honest conversation followed by referral if the patient persist in her desires” (2006, p. 11). The scope of this “conversations” remains as a valid concern.

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The second strategy is the “conciliatory” model.20 According to this approach, the objecting professional has the right to refuse to perform the service in question but is required to refer the petitioner of the service to a professional who does not object. This second strategy has problems as well. First, as many have observed, it does not deserve much respect from the perspective of the objector. If someone objects to the practice of abortion because she considers it to be the murder of an innocent and defenseless child, she will not feel comfortable with a norm allowing doctors to abstain from practicing abortions without losing their job if they are also required to tell the person seeking an abortion the name and address of someone willing to carry out such a despicable task.21 Secondly, the strategy is also rather unattractive for the person seeking the service. As it happens, some problems require immediate care (for example in the case of emergency contraception). In these cases, referral may be tantamount to denial of service. The referral model also depends on the degree of equality in the relationship between the requester of the service and the professional. The doctor-patient relationship is asymmetric for several reasons. There is an asymmetry of information obviously with regards to medical science but also in relation to other aspects of medical activity. The doctor is the one who knows about medicine but also the one who knows more about the legal aspects of healthcare. It is also to be expected that when the factors at stake are as sensitive as those related to sexual and reproductive health, patients find themselves in a position of increased vulnerability. All of these factors are exacerbated in countries where doctors are traditionally granted virtually absolute authority over patients. Conscientious objection by health professionals is not an act that occurs in a vacuum or in the context of absolute free will. It takes place in an asymmetric, nearly hierarchical relationship that sometimes involves submission. What otherwise would amount to a simple exercise of individual freedom runs the risk of constraining the freedom and dignity of the patient. The mere expression of the reasons for objection can become a lecture on personal ethics, an unasked sermon, or a humiliating intrusion into the sphere of the patient’s personal decisions.

3.3.2 A Third Approach: Conscientious Objection Through an Egalitarian Lens Current debates appear to be dominated by the controversy generated by the libertarian and conciliatory models. The weakness of each of these models can motivate the attempt to develop a third strategy based on the principle of equality. This principle implies an obligation on the part of the state to show equal respect and consideration towards the people subject to its authority. It also requires that people have equal resources for the development of their life projects. These resources should be understood in a broad sense that includes opportunities, material and symbolic 20 Cantor 21 See

and Baum defend this model (Cantor and Baum 2004, p. 2011). Dresser (2005, p. 9).

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goods, freedoms, and so on. A prominent place is occupied by health, understood integrally, and sexual and reproductive health in particular. Access to health is a basic right, in the sense argued by Henry Shue,22 inasmuch as it is comprised of a bundle of interests so crucial that they transcend the distinction between positive and negative rights, combining the most salient aspects of both categories. The key element of this approach is minimizing oppression. A democratic community must make efforts to the effect that the dignity of persons does not become vulnerable, putting their moral integrity in danger by forcing them to carry out actions they reject profoundly. If we were not willing to make these efforts, the community would oppress individuals, denying their moral equality by forcing them to choose between their profession and their conscience. But the approach casts one eye on the objector and the other on those affected by the objection. The latter also have the right not to be put in the humiliating position of having to justify their sexual and reproductive choices to another person, or to listen to an unwanted sermon, or to go from one pharmacy or hospital to the next until they finally find someone willing to provide them a service to which they have a right for legal and moral reasons. While an egalitarian society accepts that, in principle, people can excuse themselves from respecting legal responsibilities for reasons of conscience, in the case of sexual and reproductive health the following stringent limitations seem plausible: 1. Professional responsibility. Since the professional holds a privileged role, she cannot limit her obligations as easily as a non-professional. Conscientious objection must be regulated with special care and in a restrictive way in the exercise of the profession when the objection implies risks for values such as the lives and health of others or for the enjoyment of important constitutional and/or legal rights, especially when joining the profession is entirely voluntary. While prohibiting conscientious objections seems an extreme measure, it must not be forgotten that people are objecting to providing services in circumstances in which access to said services is either unavailable or highly restricted for the users. The availability of services is an important variable when assessing the recognition and implementation of the right of objectors who have a monopoly on providing health services. 2. Objection without obstruction. The need for prioritizing access as a precondition for the exercise of conscientious objection. Access to health services is a precondition for the admissibility of conscientious objection on the part of health service providers. Otherwise the freedom of the health professionals would be privileged over the right of the patients to life and health. 3. Transparency and scrutiny of objectors. Objectors’ registry. Public registries must be put in place for conscientious objectors. Public and private institutions would thus be able to organize themselves and their staff to account for the need to prevent failures in their capacity to provide services and avoid loss of time and discomfort for patients.23 The registry should be updated periodically. 22 See

Shue (1980). the Province of Santa Fe, Sexual Health Law 11888 of 2001 in its Article 4 recognizes the right to conscientious objection but mandates the government to ensure “access to the services”. 23 In

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Registration cannot be automatic and should follow the model for conscientious objection used in the military24 : every objector must present the grounds of her objection ex-ante before a panel of representatives of the medical profession and the state (in particular the anti-discrimination agencies) that will determine: a. Whether a sincere ethical or religious belief exists. b. Whether the health professional is aware of all the relevant scientific knowledge regarding the product or practice in question,25 ensuring that the objection is not motivated by a desire to ease workload or discriminatory beliefs (including prejudices or stereotyped attitudes toward women) and that the professional is not in favor of imposing ethical or religious values on others. c. Whether serious harm would be done to the moral integrity of the provider if she were forced to perform her professional duty. 4. Obligatory referral. The most desirable solution is the one that eliminates the conflict between the right to objection and the needs of patients, thus guaranteeing the health service is provided. The cost of the objection must not be transferred to the patient. Health institutions must guarantee that no patient be put in the uncomfortable position of having to confront an objector, and tolerating objection should not entail the slightest delay or restriction of access to the service. Hence it is the responsibility of the directors of health institutions to ensure that the practice is carried out by means of an effective and immediate referral, replacing the objecting staff, or a total ban on objection during medical emergencies. 5. The public health system. Another factor that justifies a limitation of the right to conscientious objection is found in the case of state employees and functionaries of every rank. The state acts through them, and for this reason denying health services in public institutions is unacceptable as it would imply a private use of state power, the quintessential definition of abuse of power. The state cannot object to or disobey its own norms, and it would be preferable for the state to require willingness to carry out all of the services that a position or role entails as a condition for occupying said position in the public health system, unless there is an available way to accommodate conflicting interests, whose impact on the quality of and access to the services would be minimal. 6. Institutional objection. An additional limitation to the scope of conscientious objection arises in the case of so-called institutional objection. Can an objector be a hospital, a school, or a pharmacy? Upon an initial appraisal, the case is problematic. Where is the conscience of these objectors? Conscientious objection is indissolubly linked to a mind belonging to a person of flesh and blood. Hospitals and pharmacies do not possess consciences and therefore cannot object. Challenging institutional objection in this way can be questioned. The decree regulating the Law creates a registry of objectors, not yet implemented. A similar norm in La Pampa was vetoed by the governor in 2007. 24 I would like to thank Bo Burt for an illuminating conversation on this point. 25 This requirement would rule out an objection to prescribing or selling the morning-after pill on the grounds of its abortive effects.

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We must attempt to understand the idea of institutional objection in good faith, and it would be unsympathetic to attribute to its defenders the idea that entities composed of people have in turn their own conscience, implying that they believe in the existence of supraindividual minds that adhere to moral and religious principles. The words “hospital” and “pharmacy” do not invoke supraindividual entities, and thus their use does not require us to contemplate ontological eccentricities, as would an entity lacking neurons but possessing conscience. These words are used as shortcuts to refer to groups of living, breathing people interacting in a coordinated manner. Hence, a defender of institutional objection could try to advance the plausibility of the institutional objection as the right of these people to object. After all, if an individual has the right to course of action X, she should not lose this right for wanting to exercise it in the company of other individuals, all of whom have the right to X as well. Nonetheless, for institutional objection understood in this way to be valid, it must meet the strict requirement that every member of the institution be an objector. I do not see how a constitutional democracy could allow hospitals and pharmacies to meet this requirement for it would imply that the institution is allowed to require being a conscientious objector of certain practices as an exclusive condition for hire. This would constitute a blatant form of workplace discrimination. Statute 25,673 and its regulatory decree, which (perhaps in violation of the Constitution) recognize institutional objection, establish the obligation of objecting institutions to guarantee services and to “refer the population to other assistance centers.” This norm at least recognizes that institutional objection cannot be given unlimited force since referral must be provided in all cases. So, is the egalitarian model really a “third” model?26 Why not simply consider it a variant of the referral model? I think the distinction is justified because of the “last resource” character of the referral requirement in the egalitarian model, and also because this model accepts as morally admissible a public policy making it incompatible to be a doctor and a conscientious objector (something unacceptable for the second model). The proposed third model deems the duty of referral a final recourse, whereas the conciliatory model starts and ends with that duty. If the reader still believes that there are only minor differences between the first two models, I cannot object as long as we all acknowledge that in some of those differences, the life or death of patients is at stake. In its 2012 “FAL” decision, which affirms a woman’s right to abortion in cases of rape, the Argentine Supreme Court seems to adopt a view quite similar to the egalitarian model. On the other hand, an adequate system must be in place to allow health personnel to exercise their right to conscientious objection without this translating into referrals (derivaciones) or delays that jeopardize care of the person seeking an abortion. To such effects, it should be required that the objection be expressed upon implementation of the protocol or at the beginning of activities in the health establishment.

26 I

am grateful to Florencia Luna for conversations on this question.

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3.4 Objection and Disobedience: Classic Boundaries and Their Problems Before concluding, I would like to consider some similarities and differences between conscientious objection and civil disobedience. The common characterizations of conscientious objection27 contain a crucial difference with respect to civil disobedience concerning the type of public commitment that these behaviors display. A person who disobeys is protesting against a norm or political decision she considers unjust, and her disobedience is an attempt to trigger the consciences and sense of justice of her fellow citizens in the hopes of reforming the norm or decision. The protest can be directed against a policy or a substantive decision, or against a lack of adequate channels for participation and debate.28 The person who disobeys is contributing to democratic deliberation by means of her behavior, combining her motives with the decision to risk her freedom or physical safety, even going as far as to force authorities to employ violence. In this way, she draws attention to the lack of justification for the policies she challenges. People who engage in civil disobedience, despite a superficial appearance of paradox, display by their conduct a profound sense of loyalty to the law and the community. Their disobedience is localized in a defined sphere and presupposes a confidence in the capacity of their fellows to modify their opinions and listen attentively to the reasons those engaging in civil disobedience present. The disobedience is not meant to overthrow the government but rather to urge it to change its course. On the other hand, the objector (according to classical definitions) does not defend an idea publicly or advocate for reform of a norm or decision. She is simply refusing to take part in a practice to which she objects. Objectors do not attempt to convince anyone; they only want others to leave them and their beliefs be, and not to force them perform actions they profoundly reject. People who disobey seek a change in the institutions or policies, while people who object seek only an exception to the norms. In principle, then, the behavior of the objector is less disruptive to public order, and the degree of impact on the interests of others is lower as well. As regards the degree of commitment to public deliberation, the difference is considerable. Let us take the case of defiance towards patriotic symbols, such as the flag, the national anthem, or official honors. An objector simply explains that her religious or ethical convictions prevent her from standing during the anthem or swearing loyalty to the flag. Someone who disobeys could be protesting the same obligation, but her refusal to show respect for the patriotic symbols will be accompanied by reasons meant to convince others. This person could, for example, allege that the norm is perfectionist, or that mandating a sentiment (such as loyalty) is contradictory and probably counterproductive. Theoretically, it is even possible that the person who disobeys has deep personal respect for the national symbols but rejects public imposition of the obligation. 27 Like 28 See

that of Rawls, for example, in Rawls (1971). Markovits (2005).

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Conscientious objection has a more constrained framework than civil disobedience because its aspirations as a vehicle for communicating ideas are much more modest. It would be reasonable to require that the greater the impact of a behavior on the rights of others, the greater the burden to provide public reasons to justify the behavior. This explains why the range of actions legitimately justifiable as conscientious objection is smaller than the range of actions legitimately justifiable as the exercise of civil disobedience. Hence we would have at one end of the spectrum actions that challenge the law but do not affect other people (in Argentina, these would be the ones protected by Article 19 of the Constitution). This group includes, for example, the refusal to show respect for patriotic symbols. Next to this would be the group of actions that obstruct state policies or produce inconveniences more or less significant for the rest of society. These are the typical cases of civil disobedience such as sit-ins, blocking roads, etc. The case of refusing to join the armed forces would belong in the first category when it is a matter of actions by isolated individuals based on religious or ethical beliefs. If the refusal to enlist is coordinated and based on dissent regarding a particular armed conflict, I would interpret the action to be an example of civil disobedience. Beyond disobedience, when the rights of others are affected, or a higher degree of violence is involved, we have actions we can qualify as rebellious. Rebellion requires a much greater justification. Unlike in the case of civil disobedience, the rebel must be prepared to challenge the legitimacy of a political regime in its entirety or prove that her actions prevent much greater harm. The extreme illegitimacy of a regime or the harm produced by oppression are what justify rebels who, for example, carry out assassination attempts against tyrants even when these endanger the safety of innocent bystanders. This table resumes what has just been discussed:

Course of action

Conscientious objection

Civil disobedience

Rebellion

Reasons

Private (ethical or religious)

Public (denunciation of very unjust norms or policies)

Public (illegitimate regime; oppression)

Motives

Does not challenge the norm or policy in question; seeks an individual exception for the objector

To appeal to the sense of justice of the community; intent to peacefully change the policy or norm in question

To overthrow the government or system; to weaken it as much as possible: to privately punish oppressors (continued)

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(continued) Course of action

Conscientious objection

Civil disobedience

Rebellion

Impact on the interests of others

None or minimal

Insignificant; does not violate basic rights

High (may endanger the lives or safety of innocent bystanders)

Examples

Refusing to show respect for national symbols; refusal to enlist in the army (when the refusal is isolated, individual, and unrelated to dissent with a particular conflict)

Blocking roads, picketing restaurants, refusing to enlist in the army (when the refusal is coordinated, includes many people, and is based on dissent regarding a specific conflict)

Acts of sabotage (setting off explosives in installations), tyrannicide

To be sure, it is difficult to translate the academic tidiness of these distinctions to the complexities of real life. Resistance to the military draft is a good example because it is not absolutely clear when it ought to be considered objection or disobedience. But while the boundaries between objection and disobedience are sometimes obscure, I do think the differences between these on the one hand and rebellion on the other are clearer. Only under a legitimate rebellion is it admissible to transgress the basic rights of other people (for example, it could be considered acceptable to endanger the life of bystanders if a bomb were the only way of killing Hitler). The actions of objectors in the domain of sexual and reproductive health threaten basic rights of other persons. Therefore, they exceed the limits both of conscientious objection and of civil disobedience.

3.5 Conclusion Conscientious objection inspires natural compassion in defenders of freedom. Our intuitive reaction is to protect minorities who sail against the current, reject some aspect of the predominant morality, refrain from following the flock, and are prepared to sacrifice themselves. The decision of the objector to oppose the power of the state when her deepest principles call for it demonstrates the value of integrity in its greatest splendor. Challenging power is proof of courage, independent thinking, and conviction. One example is the increasing number of doctors who have become conscientious objectors to the practice of feminine genital mutilation in Mali.29 That sympathetic reaction, however, dissipates when conscientious objection is used as a means to reinforce structural and systematic barriers to access to sexual and reproductive health services to which all people have a right, or when it is used to 29 MacLucas

(2007).

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impose religious or hegemonic belief systems or simply to humiliate people who are in a position of vulnerability. In these cases, the objection does not equal rebelling against power, but rather is one of the strategies of the powerful to deny the enjoyment of basic human rights to others. The objector in this case is not swimming against the current; they are part of it. Protecting the right to objection in these conditions does not necessarily represent a defense of freedom but instead a rather subtle form of subjugation. Lastly, I would like to call attention once again to the fact that the harm inflicted by objectors is of the same kind as the very harm they assert they wish to avoid. Conscientious objection does not only affect the basic rights of other people, the majority of whom are women and/or poor. Respecting the conscience of the objector can also imply an offense to the consciences of the patients. A woman who has been the victim of rape and asks for a prescription for the morning-after pill has made an ethical decision of enormous depth and importance. Erecting barriers to this decision is an insult to her conscience. A person who has decided not to have any more children without renouncing her sexuality feels that a stranger can override her conscience when she is denied access to contraceptive surgery. And the women who, in full command of their moral autonomy, seek legal abortion when their lives or health are endangered and find themselves prevented from exercising their rights cannot but feel that the system privileges the consciences of some over their own. Conscientious objection is, then, at times, conscious oppression. Acknowledgements I wish to express my thanks to Gloria Orrego for her very valuable research assistance and to Paola Bergallo for illuminating discussions. This work was supported by the Centro de Estudios de Estado y Sociedad and was developed during my stay at Yale Law School during February–March 2009. I thank Owen Fiss, Bo Burt, George Priest, Daniel Markovits, Reva Siegel, Robert Post, and Bradley Hayes for the warmest winter for me and my family.

References Asch, Adrienne. 2006. Two Cheers for Conscience Exceptions, 11–12. Hastings Center Report, November–December 2006. Cantor, Julie, and Ken Baum. 2004. The Limits of Conscientious Objection—May Pharmacists Refuse to Fill Prescriptions for Emergency Contraception? The New England Journal of Medicine 351: 2008–2012. Cárdenas, Edurne, and Tandeter Leah. 2008. Derechos sexuales y reproductivos en Argentina, Conders. Available at http://argentina.unfpa.org/sites/default/files/pub-pdf/Conders_ DSR-Legislacion-y-Jurisprudencia-en-Argentina.pdf. Casas, Lidia. 2006. La objeción de conciencia en salud sexual y reproductiva. Una ilustración a partir del caso chileno. In Más Allá del Derecho, L. Cabal y C. Motta (Comps.), Red Alas, Siglo del Hombre. Charo, R. Alta. 2005. The Celestial Fire of Conscience—Refusing to Deliver Medical Care. The New England Journal of Medicine 352 (24): 2471–2474. Cook, Rebecca. 2007. Accommodating Women’s Differences Under the Women’s AntiDiscrimination Convention. Emory Law Journal 56 (1): 1040–1091.

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Cook, Rebecca, and Bernard M. Dickens. 2003. Human Rights Dynamics of Abortion Law Reform. Human Rights Quarterly 25: 1–59. Cook, Rebecca, and Bernard M. Dickens. 2006. The Growing Abuse of Conscientious Objection. Virtual Mentor, Mayo 8: 337–340. Dickens, Bernard M. 2006. Conscientious Objection: A Shield or a Sword? In First Do No Harm. Law Ethics and Healthcare, ed. Sheila A.M. McLean, 337–351. Dresser, Rebecca. 2005. Professionals, Conformity, and Conscience, 9–10. Hastings Center Report, November–December 2005. Grady, Allison. 2006. Legal Protection for Conscientious Objection by Health Professionals. Virtual Mentor 8 (5): 327–331. MacLucas, S. 2007. Conscientious Objection to Female Genital Mutilation in Mali. Peacework 375, May 2007. Markovits, D. 2005. Democratic Disobedience. Yale Law Journal. Ramos, S., M. Gogna, M. Petracci, M. Romero, and D. Szulic. 2001. Los médicos frente a la anticoncepción y el aborto ¿Una transición ideológica? CEDES. Rawls, John. 1971. A Theory of Justice. Cambridge, Mass: Belknap Press of Harvard University Press. Savulescu, J. 2006. Conscientious Objection in Medicine. British Medical Journal 332: 294–297. Shue, H. 1980. Basic Rights. Princeton. Singer, Peter. 1973. Democracy and Disobedience. Oxford: Clarendon Press. Van Bogaert, Louis-Jacques. 2002. The Limits of Conscientious Objection in the Developing World. Developing World Bioethics 2 (2): 131–143. White, Katherine A. 1999. Crisis of Conscience: Reconciling Religious Health Care, Providers’ Beliefs and Patient Rights. Stanford Law Review 51 (6): 1703–1749.

Chapter 4

The Legal Status of Surrogacy in Latin America Martin Hevia

Abstract Under the Inter-American Human Rights System, individuals have a right to access reproductive technologies. This is so in virtue of the 2012 Inter-American Court of Human Rights landmark reproductive rights decision in Artavia Murillo v. Costa Rica, in which the Court held that a complete ban on reproductive technologies, and assisted reproductive technologies in particular, interferes with the right to a private and family life, which includes the decision to become a parent, as well the option and access to the means to materialize that private decision. In spite of the Artavia Murillo ruling, the legal status of surrogacy agreements in State Parties to the American Convention on Human Rights is uncertain. This paper examines whether surrogacy is compatible with the Inter-American System of Human Rights. It focuses on three types of potential objections to the legalization of surrogacy: “corruption arguments,” that is, the idea that surrogacy corrupts maternity; “child welfare concerns,” that is, the idea that surrogacy should not be allowed because of its effects on resulting children; and the potential exploitation of surrogates. The author of this article concludes that these objections are not convincing but that the American Convention on Human Rights requires regulatory schemes that protect the rights of surrogates, intending parents, and children. Keywords Surrogacy · Inter-American human rights system · Reproductive rights

4.1 Introduction Surrogacy is a practice whereby a woman intentionally becomes pregnant and carries and gives birth to a child for another person or persons, the intending parent(s). The legal status of surrogacy varies across countries and regions. In Continental Europe, This paper is based on two previous papers on surrogacy in Latin America (Hevia 2018; Hevia forthcoming 2018). M. Hevia (B) Law School, Universidad Torcuato Di Tella, Buenos Aires, Argentina e-mail: [email protected] © Springer Nature Switzerland AG 2019 E. Rivera-López and M. Hevia (eds.), Controversies in Latin American Bioethics, International Library of Ethics, Law, and the New Medicine 79, https://doi.org/10.1007/978-3-030-17963-2_4

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for instance, some countries—France, Germany, Italy, Spain, and Switzerland—completely ban it because it is taken to be immoral. Some Anglo-Saxon countries like Australia, Canada, and the United Kingdom only allow for gestational, altruistic surrogacy—whereby a fertilized egg is implanted in the surrogate, who does not receive payment. In turn, in the United States, some states allow for both altruistic and commercial surrogacy. This paper is about the legal status of surrogacy in Latin America, which is not uniform. As in the US, the fact that Mexico is a federal state allows for different regulations by state. For instance, the states of Coahuila, Querétaro, and Tabasco allow for both altruistic and commercial surrogacy. In Brazil, two resolutions allowing for altruistic surrogacy were passed in 2010 and 2015, respectively. Uruguay also allows only for altruistic surrogacy. In most of the region, surrogacy is neither expressly allowed nor prohibited, that is, its legal status is uncertain. In practice, then, the validity of surrogacy agreements is usually left to judicial discretion. Some courts recognize the validity of surrogacy agreements (Defensor del Pueblo de la Ciudad 2017). In contrast, other courts may consider commercial surrogacy agreements void because of the immorality of the transactional object: human beings cannot have commercial value. Moreover, to make the landscape even more complex, many courts deny parenthood on the basis of the mater certa est principle, a legal principle that recognizes motherhood on the basis of the biological fact of pregnancy, leading to a presumption that the mother of a child is the woman who gave birth to the child (Lamm 2013a). Nevertheless, this denial does not mean that intending parents will never be recognized as legal parents. After a long and complex legal process, they may adopt the child born from surrogacy (Lamm 2013a, b; Tecú and Lamm 2013). Now, all Latin American countries have ratified international human rights treaties that recognize the rights to autonomy, privacy, and health. These treaties have been interpreted to protect reproductive rights and the right to family planning. While the Inter-American system has yet to address the legal status of surrogacy, the InterAmerican Court of Human Rights (IACtHR) decision in the 2012 Artavia Murillo v. Costa Rica case held that a complete ban on assisted reproductive technologies interferes with the right to a private and family life, which includes the decision to become a parent, as well as access to the means to materialize that private decision (Murillo 2012).1 In its judgment, the Court established that private choices belong to the important sphere of individual existence and identity in which state discretion should be curtailed (Murillo 2012: ¶ 74) and that the “decision of the couples […] to have biological children is within the most intimate sphere of their private and family life” (Murillo 2012: ¶ 76). More specifically, the Court established that “the way in which couples arrive at that decision is part of a person’s autonomy and identity, both as an individual and as a partner” and that such decision “is therefore protected under Article 11 of the American Convention” (Murillo 2012: ¶ 288). In light of this, 1 Article

11(1) of the American Convention on Human Rights establishes that each person has a right to respect for his/her honor and recognition of his/her dignity. In addition, article 11(2) states that “[n]o one may be the object of arbitrary or abusive interference with his private life, his family, his home, or his correspondence, or of unlawful attacks on his honor or reputation.” Article 11(3), in turn, establishes that this right must be protected by law.

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it may be argued that surrogacy agreements are an exercise of the right to privacy recognized by the American Convention on Human Rights (ACHR). In spite of these arguments for allowing surrogacy, it must be borne in mind that under the international human rights system, there are no absolute rights: other rights may collide with the right to privacy and freedom from discrimination. Under Article 16.2 of the ACHR, these restrictions ought to be established by law and are necessary to protect public health or morals or the rights and freedoms of others (Banfi Vique et al. 2011). Thus, the following sections discuss potential objections to surrogacy. The paper is organized as follows. In Sects. 4.2–4.4, I examine objections to surrogacy that, if correct, may justify restrictions on the practice. Section 4.2 explores what I call “corruption arguments,” that is, the idea that surrogacy corrupts maternity. In Sect. 4.3, I discuss “child welfare concerns,” the idea that surrogacy should not be allowed because of its effects on resulting children. In Sect. 4.4, I consider whether surrogacy ought to be banned because of the potential exploitation of surrogates. I show that although this objection is not convincing, surrogacy may be regulated in different ways. I then discuss three regulatory approaches: the contractual economic, the expectations, and the anti-stigmatization approaches. Section 4.5 offers a short summary and conclusion.

4.2 Corruption Arguments Let me start by discussing the “essentialist thesis,” which states that there is something about reproductive work that makes it special, that is, different from other types of physical jobs and activities (Satz 2013). Reproductive work involves restrictions on a woman’s behavior during the nine months of pregnancy. These restrictions are not present in other types of jobs. In addition, in “traditional surrogacy” cases—where the woman contributes her ovule—surrogacy has a genetic component absent in other types of jobs. In this line, Carole Pateman has argued that the reproductive work of women is more “integral” to their identity than other productive capacities that women and men have. An example of this position is found in the Warnock report, which establishes that “it is inconsistent with human dignity that a woman uses her uterus to earn a benefit” (Warnock et al. 1984). These arguments are objectionable for several reasons. For example, as Debra Satz explains very well, “[h]ow do we decide what are the attributes or capacities of women that are essential to their identity and which are not? In other words, why should we consider sexuality as something more binding to being than friendship, family, religion, nationality or work?” (Satz 2013) In addition, other jobs can also entail important restrictions, such as the prohibition to work for other people when the employment contract includes an exclusivity clause. Finally, as Satz explains, perhaps the underlying aim of the prohibition on selling reproductive capacity is, ultimately, an attempt to control female sexuality (Satz 2013). A second argument against surrogacy is that it corrupts motherhood, understood as the relationship and connections between mothers and their children (Satz 2013).

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This is a perfectionist argument: maternal bonds and their corresponding lifestyle reflect ideals of virtuosity that legal and political institutions ought to promote. Seen in its best light, this objection could be based on some form of communitarianism, which criticizes the universalist and “atomistic” claims of liberalism: it deprives us of contextual ties such as our families or religions that define our identity as persons (Trebilcock 1993: 155). Therefore, political and legal institutions must promote social and community values, which build our identity (Bell 2001). First, it is not clear why surrogacy denigrates motherhood. As a matter of fact, intending parents develop bonds that may certainly be as deep as those developed between biological parents and their children. Second, the above argument presupposes that motherhood is, as a life plan, more valuable than, say, the life plan of women who become pregnant but do want to raise children. It may still be objected that by not supporting ideals of virtue, liberals are not neutral on this point because they end up imposing their own account of the good life: an autonomous life (Duff 1993). This objection, however, fails because liberals do not deny that communal values are important. As Rawls explains, communal values can flourish in the context of different types of voluntary associations like family life, churches, sports club, and so on (Rawls 1993). However, the rights and duties of individuals, their identity before the law, do not depend on those individuals’ accepting or rejecting certain conceptions of the good. In a liberal society, people can change their conception of the good, or their political or religious affiliation, but this does not affect their public or legal identity as free people; their basic rights and duties are not affected (Rawls 1993).

4.3 Commodification and Child Welfare Concerns The second objection to surrogacy focuses on its potential effect on children. Susan Moller Okin, for example, has argued that surrogacy contracts do not take into account the best interests of children (Satz 2013). This concern is not exclusive to surrogacy but is common to various areas of law. Thus, the Convention on the Rights of the Child provides in its Preamble that “children have the right to special care and assistance” and recognizes in Article 3 that “[i]n all measures concerning children who take public or private social welfare institutions, courts, administrative authorities or legislative bodies, a primary consideration that will be addressed will be the best interests of the child” (Convention on the Rights of the Child 1989). There are two different objections to surrogacy relating to children. The first is the commodification objection, a concern that applies to commercial surrogacy; children cannot be objects of market transactions. The second objection regards child welfare concerns. I will discuss each in turn. With regards to commodification, as Satz explains, intending parents are not the owners of children born from surrogacy. These children are not expendable objects. Parents cannot sell them nor destroy them as they may do with other objects (Satz 2013; Hevia and Vacaflor 2013). Children born from surrogacy are not slaves. Intend-

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ing parents are subject to the same laws and human rights responsibilities that bind a biological or adoptive parent (Satz 2013). It may be objected there are no relevant differences between commercial surrogacy and directly buying and selling children because the buyer would also be subject to the same laws and human rights responsibilities as intending parents in surrogacy agreements. However, there is a conceptual distinction between surrogacy and buying and selling children. In surrogacy, the object of the agreement is not a child per se, but the provision of a certain service, to wit, surrogacy. In contrast, in a buying and selling contract, the object of the agreement is the thing to be delivered to the buyer, to wit, the child. Richard Posner develops a similar view (Posner 1989). Let me now address the child welfare concern objection, which applies to both altruist and commercial surrogacy. The best interests principle has been invoked against surrogacy in different ways. First, it has been discussed in scenarios in which surrogacy is forbidden but a child is born from surrogacy, and the issue faced by legislators or by courts is whether the resulting child should remain with her intentional parents, with the surrogate, or with someone else. The case law of the European Court of Human Rights has focused on this issue (Lamm and Rubaja 2016). Second, it has also been argued that, where possible, children should always remain with their biological parents. However, as we know, it is not obvious that children will always be better off under the care of their biological parents. This is not the case, for example, when those parents treat their children violently. Finally, child welfare concerns are invoked as a reason for completely banning surrogacy. The objection is that given the potential personal costs for children born from surrogacy, it should be banned. Glenn Cohen proposed an argument against this view. He claims that banning surrogacy would not actually be in the best interests of children born from surrogacy: So long as a child will not be provided a “life not worth living,” the child cannot be said to be harmed when its counterfactual was not existing, or by having a different child (genetically speaking) substituted for it. Thus, any intervention that will alter whether, with whom, or even when individuals reproduce cannot be justified by concern for protecting the resulting child’s welfare unless the child would have a life not worth living absent the intervention. (Cohen 2012)

Cohen applies the famous “non-identity problem,” first developed by Parfit (1987), to show that the transposition of the best interests of the child principle to the regulation of surrogacy “is rhetorically attractive but deeply intellectually problematic” because, had surrogacy not been used, the child would not exist (Cohen 2012). In sum, counter to what Moller Okin argues, it is not true that surrogacy necessarily ignores the best interests of children.

4.4 Surrogacy, Inequality, and Exploitation The concern regarding gender inequality takes two forms. First, surrogacy may entail the exploitation of vulnerable women, who may accept surrogacy agreements because of their disadvantaged socioeconomic position. Second, by commodifying

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women’s reproductive capacities, surrogacy could reinforce the structural exploitation of women, that is, it could reinforce gender inequality between men and women. Let me address each of these concerns separately. There is no doubt that commercial surrogacy agreements may be concluded in scenarios where women accept contractual conditions they would not accept if they were not in a “state of necessity.” Nevertheless, even in developing countries there are situations in which consent will not be vitiated by necessity. As Pamela Laufer-Ukeles explains, the context in which the transaction takes place is critical (Laufer-Ukeles 2013: 1245–47). Furthermore, many women may want to exercise their autonomy by entering surrogacy agreements. Thus, a universal prohibition would not be sensitive to the context in which each transaction takes place. Of course, if surrogacy is allowed, the law should take measures to avoid or minimize the potential exploitation of women, such as what Laufer-Ukeles dubs “exploitation avoiding” measures. With regards to structural exploitation, it should be noted that, paradoxically, banning surrogacy may reinforce gender stereotypes: it may, in fact, strengthen—rather than combat—social norms about the role of women in society, including the “Good Mother/Bad Mother” stigma (Abrams 2015). According to this conceptualization, sexist societies disapprove of “bad mothers,” understood as women who reject the inevitability of biological maternal bonds. These women are depicted as selfish individuals who abandon their children and give priority to their careers and other personal concerns over motherhood, childbearing, and the welfare of their children. This is the same type of stereotyping suffered by women who choose to have an abortion. In contrast, the “good mother” fulfills the expectation of becoming a child-bearer whose priority is motherhood. Bad mothers are socially stigmatized and are subject to social stereotyping. Thus, banning surrogacy will not contribute to gender equality. This conclusion may be taken to mean that given the general liberal commitment to freedom to contract, surrogacy should be seen in the same way as most contracts, where specific performance or damages are the rule when the debtor fails to comply. If that were the case, the usual debtor defenses in contracts would apply, such as the unconscionability doctrine, violence, and fraud. Thus, for example, unconscionability would prevent the intending parents from taking advantage of the surrogate to obtain an excessively disproportionate advantage, say, by paying a low price. However, as Michael Trebilcock explains, surrogacy presents challenges, such as the situation of those born from surrogacy, that entail risks that would be better avoided. For example, when cases become notorious those born by surrogacy often become involuntarily famous, which may cause them psychological damage (Baby 1988; Trebilcock 1993: 54). This means that surrogacy requires specific regulation. Although liberals usually disagree with regulations of freedom of contract, they would accept that surrogacy ought to be somehow regulated because of the potential externalities involved in surrogacy agreements. Against this backdrop, in order to address the issue of potential exploitation, let me consider three regulatory approaches: the “contractual-economic” view, the “anti-stigmatization” approach, and the “expectations” perspective. For each, I shall discuss how regulation should or should not be formulated.

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i. The “Contractual-Economic” Approach Many would argue that from an economic perspective, in the absence of a contractual defense as Richard Posner has suggested, surrogacy contracts should be strictly enforceable (Posner 1989; Epstein 1995; Pelzman 2018). However, this view is not unanimous among economic analysts of law (Brining 1995). As I mentioned earlier, Trebilcock does not share that view and proposes regulation that grants the surrogate the right to decide whether she would like to keep the resulting child until up to one month after the delivery. In commercial surrogacy, given that intending parents would lose their right to specific performance, that is, to the handing over of the resulting child, the risk of non-compliance would be discounted from the price that would be paid if that right were not to exist. In addition, in order to avoid potential opportunistic behavior of the surrogate, all parties would have the opportunity to strike a bargain over the exact time when payment would take place (Trebilcock 1993: 54). In addition, intending parents would not be allowed to repent and exit the surrogacy agreement because that would leave the surrogate at the mercy or good will of the intending parent(s). Suppose that a few months after they the intending parents had entered into an agreement with a gestational mother, the intending mother became pregnant and, thus, the couple would like to get out of the surrogacy agreement (Trebilcock 1993: 54). ii. The Anti-Stigmatization Approach According to this approach, regulators ought to be careful about the potential stigmatizing dimensions of surrogacy regulations. Take the cooling-off period after the birth of the resulting child that I mentioned in the previous section. Besides the economic justification proposed by Trebilcock, it can also be justified from a libertarianpaternalistic perspective (Thaler and Sunstein 2008). In that view, economic analysts of law have been wrong in assuming that human beings are rational individuals, that is, “econs”; rather, we are humans, which means that more often than not, based on the many biases we have, we make wrong decisions that econs would not make. In light of that, in this view, the law can take paternalistic measures that aim to help us improve our decision-making processes. The cooling-off period proposed by Trebilcock would be an example of this type of measure because it would provide the surrogate the opportunity to rethink whether she actually wants to give up the child she gave birth to. Now, from the anti-stigmatization approach, this libertarianpaternalistic justification assumes that surrogates are irrational because “a rational woman would not voluntarily disrupt the connection between pregnancy and maternity” (Abrams 2015).2 Moreover, because surrogates are irrational, the law can assume that they are more likely to experience regret. And, as Paula Abrams explains, “[t]he State should not be a participant in the process of shaming women for their reproductive decisions; such actions deny women moral agency. Law instead should be a means for contesting stigma associated with gendered stereotypes, particularly those stereotypes that undermine reproductive decision making” (Abrams 2015, 188).3 2 Id. 3 Abrams,

supra note 50, at 188.

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Counter to this view, it may be objected that cooling-off periods do not aim to stigmatize women or assume their irrationality; rather, they are based on the uniqueness of the experience of pregnancy, which explain why many surrogates may find it difficult to separate from the child. The next section discusses the “expectations approach,” which aims to conciliate both perspectives. iii. The “Expectations” Approach Laufer-Ukeles proposes regulating surrogacy in a way that is respectful of the intimacy developed among the parties to the surrogacy agreement. We usually refer to the special intimate bond developed between the surrogate and the child. We also need to consider the intimate bond between the surrogate and the intending parents because the surrogate may expect that the birth of the child will not mean the end of these intimate connections. Thus, regulation ought to protect surrogates from emotional harm, support intending parents, and address the popular view that surrogacy threatens human dignity (Laufer-Ukeles 2013: 1283). In light of these concerns, Laufer-Ukeles proposes “autonomy-promoting” and “exploitation-avoiding” measures. She does so against the backdrop of a relational autonomy theoretical framework, according to which autonomy is a capacity that can be fostered or undermined through personal relationships and societal structures. This view exceeds the limits of boundaries between individuals.4 As we shall see, the distinction between “autonomy-promoting” and “exploitation-avoiding” measures is illuminating, but its actual reflection in the law may be problematic. Let me begin with autonomy-promoting measures. For Laufer-Ukeles, in order to honor the intimate connections between the surrogate and the child, as well as the connection between the surrogate and the intending parents, a good example of this type of measure would be a recognition of a right of the surrogate to ongoing visitations in the event she has difficulty separating from the child (Laufer-Ukeles 2013: 1254–1255).5 Now, this right may entail too much intrusion on the privacy of the intending parents. It would also lead to the conclusion that only intimate, close individuals may engage in surrogacy agreements, which means that those who would not want to develop intimate connections should not be allowed to enter surrogacy agreements. Another case of autonomy-promoting regulations is a policy of allowing only for gestational surrogacy, which is based on the empirical assumption that because of their genetic link to the child, traditional surrogates find difficulties in separating from the child. In turn, Laufer-Ukeles proposes “exploitation-avoiding” measures that would include a “fair price” in commercial surrogacy and psychological evaluations and informative counseling before surrogacy agreements are concluded. Consider the fair price measure, which has also been proposed by other scholars. As Sharon Bassan explains, [i]t is hard to determine what is considered a fair price. A minimum price might reduce exploitive conditions towards the supplier by giving them better payment for their work. 4 For 5 Id.,

a general theory of relational autonomy, see Nedelsky (2011). at 1254–1255.

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However, it might raise objections on the part of infertile patients incapable of paying higher amounts. These people would not be able to recourse to the market to fulfill their right to reproduce. A possible suggestion may be to set a minimum price, or to determine that suppliers get no less than 50% of the value of the transaction. (Bassan 2016: 342)

However, the final suggestion in fair price proposal does not take into account evidence of how price caps lead to shortages. That would mean that, in practice, many potential surrogates will not want to become so because of the price cap, which would make it more difficult for intending parents to find surrogates (unless they found someone with whom they have a prior special connection). A further exploitation-avoiding measure could be the requirement, established in the law of some jurisdictions, that gestational women have been pregnant before (Laufer-Ukeles 2013: 1259–65). From a liberal point of view, this may be unacceptable because some women may prefer to be surrogates before raising a child of their own. It may be true that the probability that women who are already parents will keep the resulting child is low. But that is a contingent, empirical argument based on a merely probabilistic assumption, that on its own cannot justify this restriction. With regards to prior psychological counseling, again, it may stigmatize women by assuming that their decision to engage in surrogacy is irrational. At this stage, let me use the autonomy-promoting and exploitation-avoiding measures distinction to propose ways of regulating surrogacy that would take into account the above discussions. I propose that the law should include ex-ante judicial intervention. This requirement would help avoid the surrogate being unfairly taken advantage of. In commercial surrogacy, that would include analyzing the price paid. Courts would also verify her informed consent. The number of surrogacy agreements per jurisdiction is not massive (at least not as massive as consumer contracts) and the legal takes of the agreement are so important that ex-ante intervention would be justified. In addition, independent legal counseling ought to also be required: just as under the law of the State of California in the United States, it should be mandatory for surrogates and intending parents to have independent legal counseling about the legal implications of the agreement. This would avoid conflicts of interests between the interests of surrogates and intentional parents.

4.5 Conclusion In this paper, I have claimed that a complete ban on surrogacy would be incompatible with the American Convention on Human Rights because it is incompatible with the right to autonomy and privacy. I argued that although there are clearly no absolute rights under the Convention, the objections against surrogacy are not convincing. I suggested that this does not mean that surrogacy ought not to be regulated; the ACHR requires regulatory schemes that protect the rights of surrogates, intending parents, and children. Of course, there is still much to be discussed about the scope of regulation. Moreover, scientific and technological breakthroughs will surely confront

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the legal and the scientific community, legislators, and society with new, complex, and challenging questions about surrogacy and other reproductive techniques.

References Abrams, P. 2015. The bad mother: stigma, abortion and surrogacy. J Law Med Ethics 43: 179. Baby, M. 1988. 109 N.J. 396, 537 A.2d 1227. Banfi Vique, A., O. Cabrera, F. Gómez-Lugo, and M. Hevia. 2011. The Politics of Reproductive Health Rights in Uruguay: Why the Presidential Veto to the Right to Abortion is Illegitimat. J Health Law 12: 192. Bassan, S. 2016. Shared Responsibility Regulation Model for Cross-Border Reproductive Transactions. Mich J Int’l L 37: 299–342. Bell, D. 2001. Communitarianism. In: The Stanford Encyclopedia of Philosophy, ed Edgar N. Zalta. Available at http://plato.stanford.edu/entries/communitarianism/. Last visited May 5, 2018. Brining, M.F. 1995. A Maternalistic Approach to Surrogacy: Comment on Richard Epstein’s Surrogacy: The Case for Full Contractual Enforcement. Virginia Law Review 81: 2377. Cohen, G. 2012. Response: Rethinking Sperm-Donor Anonymity: Of Changed Selves, Nonidentity, and One-Night Stands. Geo L J. 100: 431–435. Convention on the Rights of the Child, November 20, 1989, 1577 U.N.T.S. 3, art. 3. Defensor del Pueblo de la Ciudad Autónoma de Buenos Aires y Otros c. GCBA y Otros s/amparo, judgment of 4-08-2017 (Argentine Appellate Chamber for Administrative Law and Taxation, 2017). Duff, R.A. 1993. Choice, Character, and Criminal Liability. Law and Philosophy 12: 345–381. Epstein, R. 1995. Surrogacy: The Case for Full Contractual Enforcement. Virginia Law Review 81: 2305. Hevia, M. 2018. Liberalismo y Gestación por Sustitución. In Entre la Libertad y la Igualdad. Ensayos Críticos Sobre la Obra de Rodolfo Vázquez, 301–311. México: UNAM. Hevia, M. 2018. Surrogacy, Privacy, and the American Convention on Human Rights. Forthcoming. Journal of Law and Biosciences 5: 375. Hevia, M., and C.H. Vacaflor. 2013. From Recognition to Regulation: The Legal Status of In Vitro Fertilization and the American Convention on Human Rights. Florida Journal of Intonational Law 25: 453. Lamm, E. Argentina. 2013a. In International Surrogacy Arrangements: Legal Regulation at the International Level, ed. K. Trimmings and P. Beaumont, 5–24. Oxford: Hart Publishing. Lamm, E. Venezuela. 2013b. In International Surrogacy Arrangements: Legal Regulation at the International Level, ed. K. Trimmings and P. Beaumont, 397. Oxford: Hart Publishing. Lamm, E., and N. Rubaja. 2016. Parámetros Jurisprudenciales en los Casos de Gestación por Sustitución Internacional. Los Lineamientos del Tribunal Europeo de Derechos Humanos y sus Repercusiones en el Contexto Global. Revista de Bioética y Derecho 37: 149–156. Laufer-Ukeles, P. 2013. Mothering for Money: Regulating Commercial Intimacy. Indiana Law of Journal 88: 1123. Murillo, A. et al. 2012. Inter-American Court of Human Rights (In Vitro Fertilization) v. Costa Rica; November 28, 2012 CDH-12.361/177. Nedelsky, J. 2011. Law’s Relations: A Relational Theory of Self, Autonomy, and Law. Oxford: Oxford University Press. Parfit, D. 1987. Reasons and Persons, 359. Oxford: Oxford University Press. Pelzman, J. 2018. Womb for Rent: Gestational Surrogacy Contracts—A New Path for Outsourcing Service Contracts. Available at https://www2.gwu.edu/~iiep/assets/docs/papers/Pelzman_ IIEPWP2010-30.pdf. Last visited Jan 16, 2018.

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Posner, R.A. 1989. The Ethics and Economics of Enforcing Contracts of Surrogate Motherhood. Journal of Contemporary Health Law and Policy 5: 21. Rawls, J. 1993. Political Liberalism, 139–140, 217. New York: Columbia University Press. Satz, D. 2013. Por Qué Ciertas Cosas No Deberían Estar a la Venta. Los Límites Morales de los Mercados: Los Mercados en la Reproducción Femenina 13 Revista Argentina de Teoría Jurídica. http://www.utdt.edu/download.php?fname=_135092683913866300.pdf. Last visited May 5, 2018. Tecú, J., and E. Guatemala Lamm. 2013. In International Surrogacy Arrangements: Legal Regulation at the International Level, ed. K. Trimmings and P. Beaumont, 167. Oxford: Hart Publishing. Thaler, R.H., and C. Sunstein. 2008. Nudge: Improving Decisions About Health, Wealth, and Happiness. New Haven: Yale University Press. Trebilcock, M. 1993. Paternalism in The Limits of Freedom of Contract, 155. Cambridge: Harvard University Press. United Nations Convention on the Rights of the Child. Warnock, M. et al. 1984. Report of the Committee of Inquiry into Human Fertilisation and Embriology. London. Her Majesty’s Stationery Office.

Part II

Vulnerability, Exploitation, and Commodification

Chapter 5

Revisiting Vulnerability: Its Development and Impact Florencia Luna

Abstract The concept of vulnerability has been hotly debated in research ethics literature. Some critics considered it a useless concept. In 2009—against some of those criticisms—I defended the importance of understanding this concept in terms of layers instead of applying it as a label given to certain subpopulations. In this paper, I present some of the limits of this analysis and I also explore the similarities and differences this approach has when compared to using a taxonomy as another answer on how to assess vulnerability. I present the notion of cascade vulnerability and underscore the dispositional character of layers and their relevance to identify and evaluate layers of vulnerability. Finally, I show how this layered account has been incorporated in important documents such as the new 2016 CIOMS-WHO Guidelines. Keywords Vulnerability · Biomedical research · CIOMS guidelines

5.1 Introduction The concept of vulnerability has been widely used in research ethics and public health ethics. However, it is a slippery notion. In this article, I introduce my view of the concept of vulnerability. I first explain why the traditional approach to vulnerability is incorrect and present some of the criticisms to that approach. As an answer to these concerns, I introduce the metaphor of layers (Sect. 5.2). Then, I describe the impact of the layered view of vulnerability in academic research ethics and in recent guidelines (Sect. 5.3). In Sects. 5.4, 5.5 and 6, I present my current ideas regarding a possible way of going further and working with layers of vulnerabilities. To that end, I introduce the notion of ‘cascade-vulnerability’ and underscore the dispositional character of layers and the relevance of the stimulus condition (Sect. 5.7). I include F. Luna (B) FLACSO/CONICET (Scientific and Technical Research Council of Argentina), Buenos Aires, Argentina e-mail: [email protected] © Springer Nature Switzerland AG 2019 E. Rivera-López and M. Hevia (eds.), Controversies in Latin American Bioethics, International Library of Ethics, Law, and the New Medicine 79, https://doi.org/10.1007/978-3-030-17963-2_5

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both distinctions in a two-step process of analysis that can contribute to the work of researchers, research ethics committees (RECs), and policy designers in the case of public health (Sect. 5.8). Finally (Sect. 5.9), I offer an example showing my proposal at work.

5.2 Labels and the Initial Versions of Codes “Vulnerability” and “vulnerable groups” are concepts that have been widely used in research ethics theory. The notion of “vulnerable groups” can be traced back to the Belmont Report in 1979. The term appears in research ethics codes to describe certain kinds of populations considered to be worthy of special protection. However, there were some critical conceptualizations of this concept, such as that of Kipnis (2001); but these alternative views were not incorporated into international ethical guidelines or into regular use of the concept of vulnerability.1 If we go back to the formulation of research ethics codes, we can see that the Belmont Report sets up the framework. Vulnerable subpopulations appear in the section that examines the selection of research subjects. The Report lists racial or ethnic minorities, the economically disadvantaged, the very sick, and persons confined to institutions and states that they may continually be sought as research subjects, owing to their ready availability in settings where research is conducted. Given their dependent status and their frequently compromised capacity for free consent, they should be protected against the danger of being involved in research solely for administrative convenience, or because they are easy to manipulate as a result of their illness or socioeconomic condition. (Belmont Report 1979, B.3.)

Another landmark document in research ethics is the Declaration of Helsinki. However, in the original version of this Declaration (before 2000), there is no reference to vulnerability or vulnerable populations. In the 2000 version, article 8 (World Medical Association 2000) does refer to vulnerable populations, mentioning some of the groups previously considered in the Belmont Report and the 1982 CIOMS Guidelines. Yet the strategy is the same as in Belmont Report: the Declaration of Helsinki only lists groups of people, going no further. However, as this is a short guideline, the absence of further comments or clarifications may be accepted. In the 1982 version of the International Guidelines for Biomedical Research Involving Human Subjects CIOMS-WHO (CIOMS Guidelines), vulnerability appears as an important issue. It is mentioned in the Background Note, as well as in the commentary of several guidelines, and appears explicitly in Guideline 10. This guideline identifies three groups of vulnerable populations: (1) those with limited capacity or freedom to consent (such as children, persons with mental or behavioural disorders, and prisoners); (2) junior or subordinate members of a hierarchical group (medical or nursing students, subordinate hospital or laboratory personnel, members of the armed forces or police); and (3) other groups or classes such as residents 1 There

was also a thorough conceptualization of this notion in analytic ethics by Goodin (1985).

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of nursing homes, people receiving benefits or social assistance, other poor people and the unemployed, patients in emergency rooms, some ethnic and racial minority groups, homeless persons, nomads, refugees, and patients with incurable diseases. In this guideline, there is clearly an effort to identify vulnerable persons and groups. The CIOMS Guidelines goes back to exactly the same analysis made by the Belmont Report. CIOMS does so in more detail but it essentially repeats what was established in the previous document. This guideline lists groups of persons that should be considered vulnerable. In sum, this is the analysis that can be found in the prevailing codes or ethical documents for almost two decades (Luna 2009a: 123–124). The only ethical code that tried to provide a general idea of, or definition for, vulnerability was the CIOMS Guidelines in their 2002 version (I will consider the 2016 version of CIOMS separately in Sect. 5.5). The first paragraph of the commentary on Guideline 13 states that “[v]ulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. More formally, they may have insufficient power, intelligence, education, resources, strength or other needed attributes to protect their own interests” (CIOMS-WHO 2002: 64). Hence, the main criterion identified was the lack of power. The document tries to provide the rationale behind the enumeration of groups of people, but the main purpose of identifying subpopulations remains (Luna 2009a: 124). During this first period, what we can see is the tendency to treat vulnerability as a label attached to a particular subpopulation. Labelling fixes the content and, once this is done, it cannot be easily changed. It frequently tends to overprotection and leads to a rigid view of the problem and an easy stereotyping of these persons and populations. I call this approach ‘the metaphor of labels.’2 When vulnerability is used as a fixed label attributed to a particular subpopulation, it suggests a simplistic answer to a complicated problem. Research situations are often very complex and influenced by context, and this kind of analysis overlooks this fact.

5.3 Criticisms of the Traditional Concept In 2004, Carole Levine, Ruth Faden, Christine Grady, Dale Hammerschmidt, Lisa Eckenwiler, and Jeremy Sugarman criticized this concept (Levine et al. 2004). These authors published an article in the American Journal of Bioethics that had a strong impact among bioethics scholars. In what follows, I introduce some of the problems raised by these authors. I do not follow their exact presentation but try to offer a conceptual rearrangement that includes my own views. a. The Meaninglessness Argument Levine et al. state that so many categories of people are now considered vulnerable under the 2002 CIOMS approach that virtually all potential human subjects are included. They quote regulations, CIOMS 2002 and other documents, and then 2 For

further discussion on this notion, see Luna (2009a).

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explain: “Under one or another of these rubrics, nearly everyone is vulnerable, especially since the benefits of research can never be guaranteed in advance […]. If everyone is vulnerable, then the concept becomes too nebulous to be meaningful” (Levine et al. 2004: 46 [my emphasis]). If this is the case, the concept is not relevant. This strong criticism denies the utility of the concept. b. The Existential Approach Argument The existential approach offers a related reasoning. The problem, it states, is confusing vulnerability in research with the “ontological vulnerability” depicted by continental philosophers. The existential approach claims that everyone is vulnerable, fragile, and finite. It expresses an overall view about the human condition, appealing mainly to continental philosophical perspectives. Onora O’Neill illustrates this view, saying, Human beings begin by being persistently vulnerable in ways typical of the whole species: they have a long and helpless infancy and childhood; they acquire even the most essential physical and social capacities and capabilities with others’ support; they depend on longterm social and emotional interaction with others; their lives depend on making stable and productive use of the man-made world […]. (O’Neill 1996: 192)3

On this account, vulnerability is a universal human feature, an ontological condition. c. The Stereotypes and Labels Argument A further argument against the idea of vulnerable individuals or populations as a category is that it “stereotypes whole categories of individuals, without distinguishing between individuals in the group who indeed might have special characteristics that need to be taken into account and those who do not.” (Levine et al. 2004: 47). d. The Overpopulation Argument One of the arguments developed by Levine et al. is that while the drafters of the Belmont Report and other early US documents (for example, the US Code of Federal regulation or guidelines of the Office of Human Research Protection [OHRP]) “were reacting to a series of specific historical events, and groups of research subjects, the recent history of the use of vulnerability is more expansive, particularly in the international context” (Levine et al. 2004: 45). The concern of these bioethicists seems to be that the concept of vulnerability can become too broad.4 They seem to fear a growing overpopulation of “new vulnerable groups,” especially in developing countries, where such groups of research subjects (the unemployed, ethnic groups, etc.) may be prevalent. Under these circumstances, the concept of vulnerability becomes a laxly used label, under which any individual can be classified as vulnerable in the research setting. 3 This

view can be found in the works of continental philosophers like Ricoeur (2007) or Lévinas (1972). Other analyses have recently tried to capture this idea. See (Rogers et al. 2012; Lange et al. 2013a, b). 4 They criticize the CIOMS Guidelines, Zion et al (2000), Ruth Macklin, and Kenneth Kipnis, among others.

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5.4 Throwing the Baby Out with the Bathwater! The above are some of the plausible criticisms of the subpopulation approach. Levine et al. are right when they ask for a non-vacuous concept of vulnerability. They rightly point out that we need a more meaningful concept. However, the fear of an overpopulation of vulnerable groups along with the denial of the importance of this concept is problematic. This strategy seems to throw the baby out with the bathwater, rejecting the concept of vulnerability altogether instead of accepting the challenge of thinking about ‘new’ vulnerabilities arising from socioeconomic conditions. Ignoring vulnerability by rejecting the existence of ‘problematic’ aspects of some populations could prove cynical. It is far more comfortable to deny the idea of vulnerability than to acknowledge it and conscientiously provide safeguards to avoid harmful consequences. If we revisit the above arguments, we can see that the danger of the existential and essentialist interpretation of vulnerability is naturalizing vulnerability: if everyone is equally and essentially vulnerable, no one is specifically vulnerable. And, while it is true that everyone is exposed to suffering, deterioration, and death, this is not the relevant point. When reviewing and conducting research with human subjects or when designing public health policies, the relevant point is that participants or persons express their fragility in multiple ways in response to particular circumstances, and they express this fragility in different degrees and combinations. Some persons or groups experience specific situations of vulnerability, and it is these specific forms of vulnerability that must be addressed by offering not only protection and safeguards but also the possibility of empowerment. Instead, if everyone is equally and essentially vulnerable, no one needs any kind of special protection. This is exactly what critics of the traditional account of vulnerability are aiming at. They seek to annul the normative force of this concept. As we have seen, Levine et al. say: “If everyone is vulnerable, then the concept becomes too nebulous to be meaningful” (Levine et al. 2004: 46, my emphasis). For this reason, the overly broad use of vulnerability is dangerous. In contrast, it seems more accurate to think that the universal dimension of human vulnerability functions merely as a background condition, and the contextual or relational features of the concept of vulnerability are the important features. If we consider the stereotype and label argument, we should point out once again that critics are correct when they call attention to this problem. Stereotyping implies attaching a label to someone that cannot easily be removed. It fixes content that is difficult to change. Moreover, this kind of analysis makes two problematic assumptions. First, it assumes a default standard for a paradigmatic research subject (a mature, moderately well-educated, clear thinking, self-supporting person). Second, it assumes the possibility of identifying vulnerabilities in subpopulations in opposition to the paradigm or as a failure of it.5 This model is based on an idealization and simplification of research subjects. Ideal subjects do not exist, and no two people are exactly alike. Furthermore, a person or group of persons may experience different 5 For

further discussion, see Luna (2009a).

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kinds of vulnerabilities, and this complexity can remain imperceptible if we identify just one group of persons as vulnerable. In sum, Levine et al. are right in some of their criticisms; the traditional subpopulation approach and the existentialist approach do pose problems. However, this does not mean we have to drop the concept of vulnerability altogether.

5.5 The Layer Metaphor We face two relevant questions: first, how should the concept of vulnerability be understood? And second, how should it be used? In a 2009 article (Luna 2009b) I distinguish between these two questions.6 The first concerns the conceptual and theoretical problems of the concept of vulnerability itself. The second belongs to the practical-ethical sphere, in which we can examine the need for protection of certain persons and the relevance and usefulness of using the concept of vulnerability in the evaluation of protocols or in research ethics. For the sake of clarity, I will refer to these questions as the conceptual and practical spheres of analysis, respectively. The criticisms and objections by Levine et al. mainly target the first sphere of analysis (i.e. that it is a vacuous concept, etc.) by rejecting its relevance in the practical sphere. However, I believe the concept is still very relevant from a practical point of view.7 In my view, the criticisms presented in the previous section are related to a mistaken understanding of the concept of vulnerability. In order to face those criticisms, we need a deeper analysis. A critical issue is the intended function of the concept. Is it a label? Can it be conceived as a category without connection to the environment, as Levine et al. criticize? I propose that the concept of vulnerability be examined through the concept of layers.8 The metaphor of a layer refers to how the concept functions. It suggests that there may be multiple and different strata that can be removed one by one. These layers may overlap: some of them may be related to problems of informed consent, others to violations of human rights, or to social circumstances. I accept different definitions of vulnerability to provide its content because I distinguish between the functioning of the concept and its content. Definitions of vulnerability such as the one proposed by Hurst (2008) or by Zion et al. (2000) and accounts such as those proposed by Kenneth Kipnis (2003)9 can provide a plausible content of vulnerability and are compatible with my proposal. 6 This

section is based in Luna (2009b). In this article, I use the terms “political-ethical” sphere and “theoretical-ethical” sphere, literally translated. The article was written in Spanish and the denomination in that language fits better than its translation into English. In this article, I am using another translation of the terms but I maintain the same distinction. 7 Although these are two different spheres of discussion, they are closely related. Thus if we cannot offer an adequate answer to the conceptual sphere we will not be able to defend its practical relevance. 8 See Luna (2009a). 9 I accept Kipnis’s account as an open list of categories but not as a fixed taxonomy (see my upcoming article on this issue).

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My metaphor of layers applies to the functioning of the concept. Once we accept this different way of understanding how the concept functions, we do not face “a solid and unique vulnerability” that exhausts the category anymore. There might be different vulnerabilities, different layers operating at the same time. For example, we can say that being a woman does not, in itself, imply that a person is vulnerable. But a woman living in a country that does not recognize reproductive rights acquires a layer of vulnerability (a layer that a woman living in a country that does respect such rights does not necessarily face). In turn, an educated and wealthy woman in that same country can overcome some of the consequences of the lack of recognition of reproductive rights. On the contrary, a poor woman living in such a country acquires another layer of vulnerability (for example, it is possible that she will not have access to emergency contraceptives and hence be more susceptible to unwanted pregnancies). Moreover, an illiterate poor woman in a country intolerant to reproductive rights acquires still a further layer of vulnerability. And if she is a migrant and does not have proper papers, or she is a member of an indigenous group, she will acquire additional layers of vulnerabilities. She will suffer from all these overlapping layers.10 The way of understanding vulnerability is relational. It concerns the relationship between a person or group of persons and the circumstances or the context. Thus, it is closely related to the particular situation under analysis. It is not a category or a label we can mechanically apply. If the situation changes, the person may no longer be considered vulnerable. For example, a French working woman of reproductive age with middle-to-low income may not be vulnerable in a research protocol if she unwillingly becomes pregnant (because in her country, if she wants to, she can get an abortion at the public hospital), whereas if she is in El Salvador (where legal abortion is not allowed under any circumstance), the same French woman in the same protocol may acquire a layer of vulnerability. She does not become vulnerable simpliciter. The layered approach ‘unpacks’ the concept of vulnerability and shows how the concept functions. This analysis can be used both in research ethics and in public health ethics.11

5.6 Impact of the Layered Proposal The layered approach has impacted academic bioethics (Durocher et al. 2016) and bioethics regulations. At the academic level, Ruth Macklin has considered the layered approach, together with the analysis proposed by Hurst (2008), in her effort to develop a theory of vulnerability that can be applied to broader social contexts, such as women in developing countries (Macklin 2012). Macklin argues that Hurst’s notion of “a claim to special protection” is interesting but too narrow. It cannot account for 10 For

further examples, see Luna (2009a).

11 For example, in Luna (2014), I show the different layers of vulnerability that elderly persons may

experience and how these complex situations can be tackled by policy makers.

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circumstances in which culture, custom, tradition, and laws make women unable to protect themselves. According to Macklin, Hurst’s proposal only applies to research and clinical care, but public health cannot be easily included (Macklin 2012). Hurst’s analysis has thus been ‘re-interpreted’ by Ruth Macklin, who considers that my approach can complement Hurst’s theory by providing a contextual and relational aspect to this definition. I do agree with Macklin’s proposal as I believe my account can complement other definitions or analyses of vulnerability. In a different vein, an application of the idea of layers is found in an article by Den Hollander et al. (2016). They consider the case of a pregnant woman. Such a person, they argue, cannot be considered vulnerable per se. However, when they consider the situation of pregnant women facing the decision to participate in clinical trials in Ghana, they identify different layers of vulnerability. Factors such as the lack of familiarity with modern scientific concepts, the wide power difference between the patient and the provider, and therapeutic misconceptions, among other issues, can render these women vulnerable. The authors argue that the identification of context-specific factors can facilitate research design adaptation and completion in a culturally competent way. The layered approach has had a still stronger impact on ethical guidelines. This is highly relevant because a proper understanding of the concept of vulnerability can be used to defend guidelines or codes from the criticisms we have seen above, and can also serve as a more suitable criterion for research ethics committees. The second paragraph of the Commentary to Guideline 15 in the current version of the CIOMS guidelines states: A traditional approach to vulnerability in research has been to label entire classes of individuals as vulnerable. The account of vulnerability in this Guideline seeks to avoid considering members of entire classes of individuals as vulnerable. However, it is useful to look at the specific characteristics that may render individuals vulnerable, as this can aid in identifying the special protections needed for persons who may have an increased likelihood of being wronged or of incurring additional harm as participants in research. Different characteristics may also co-exist, making some individuals more vulnerable than others. This is highly dependent on the context. For example, persons who are illiterate, marginalized by virtue of their social status or behaviour, or living in an authoritarian environment, may have multiple factors that make them vulnerable. (CIOMS-WHO 2016 [my emphasis])

This document modifies the position adopted in its 2002 version of the Guidelines. This is the first time a research ethics guideline has moved away from the traditional approach to the concept of vulnerability. It abandons the traditional scheme and circumvents the subpopulation approach. Even if the CIOMS guidelines do not use the word ‘layer,’ the metaphor is embedded in this conceptual analysis. CIOMS uses the words ‘characteristics and factors,’ but these play the role of ‘layers.’ The document states that multiple factors can render a person vulnerable and that different characteristics can coexist. It also overcomes the vague indication regarding protection and suggests a strategy whereby research ethics committees consider specific characteristics that can help to identify special protections.12 Moreover, the 2016 version of 12 I

have elsewhere suggested this as a method to be considered by research ethics committees. See Luna (2009a: 129–131).

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CIOMS was presented with an article published in JAMA by its Chair and Scientific Secretary (van Delden and van der Graaf 2016). In this article, the authors explain some of the changes introduced and challenges faced, and mention a change in global perspectives about the inclusion of potentially vulnerable groups as a reason to revise this document. They also quote Hurst’s article (2008) and Luna and Vanderpoel’s article (2013), where the layered approach is explained and exemplified. The authors explain: In the 2002 version, certain groups, such as children and incompetent individuals, were explicitly labeled as vulnerable. However, a group approach to vulnerability may no longer be appropriate because it may have led to the routine exclusion of certain groups from research and hence has exacerbated knowledge gaps. Moreover, a group approach could also lead to under protection because it does not address different ways in which people can be vulnerable, for example, an illiterate woman in a low-resource setting participating in a study on domestic violence. (van Delden and van der Graaf 2016 [my emphasis])13

Again, the layered approach to vulnerability prevails, and it seems that this new way of considering vulnerability can be fruitfully incorporated. Feminist thinkers, such as Rogers, Mackenzie, and Dodds, have also accepted my theoretical account. However, as we will see, they were critical of the way in which it could be applied. They endorsed a relational approach to autonomy and a layered account of vulnerability (Rogers et al. 2012). Their proposal integrates different dimensions of this concept: the universal-ontological condition plus the contingent and context specificity of many kinds of vulnerabilities, as well as their origin in social and political structures (rather than in biological forces). The authors aim to reconcile vulnerability with autonomy. Thus, in some specific situations, vulnerability must be addressed by offering not only protection and safeguards but also the possibility of empowerment. For these authors, not only should harm be minimized but empowerment and autonomy should also be supported. They accept the layered approach to vulnerability but want to go beyond it: “We also outline a taxonomy of different kinds of sources of vulnerability which we think is helpful in further specifying the layered approach to vulnerability advocated by Luna (2009a)” (Rogers et al. 2012: 19). In another article, in which they incorporate the considerations of another bioethicist (Margaret Meek Lange), they accept my account but continue building on a more practical approach. They say: What is needed is an approach that, first of all captures Luna’s insight that vulnerable research participants inhabit a context generated by the coming together of layers of vulnerability. The approach should make progress towards naming and classifying the layers while remaining sensitive to their possible interactions. Last, such account should identify vulnerabilityrelated duties. (Lange et al. 2013a, b: 336)

They propose a taxonomy as an answer, in which different sources of vulnerability are differentiated: inherent, situational, and pathogenic. In reference to my layers approach, Lange et al. contend that, “[u]nlike Luna’s, our approach gives concrete, 13 I

left the original footnotes in the text (6 and 7) as they refer to one article of my authorship and the other to Hurst’s (2008) article.

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general guidance to researchers and research ethics committees […]” (Lange et al. 2013a, b: 337). Thus, while they hold a positive view of my theoretical approach, they also want to move forward and propose a taxonomy of sources of vulnerability.14 As I show in the next section, I do agree that it is a challenge to elaborate practical criteria to apply the concept in concrete situations. However, I do not agree that a taxonomy is a solution.15

5.7 Identifying Relevant Features16 As we have seen, my analysis of vulnerability has been welcomed by renowned bioethicists, and an important guideline has endorsed the idea. However, the practical challenge still remains: providing further analysis that enables us to apply the concept. To this end, in recent years I have been reworking the concept of vulnerability and developing a complementary approach in answer to the challenges mentioned in the previous section. I believe the specifications can be determined in a simple and useful way in order to establish a middle ground between layers on one side and taxonomies on the other. I believe this will be useful for researchers and research ethics committees. Two basic features of layers may help not only to specify but also to prioritize layers of vulnerabilities. The first feature has to do with an important contribution made by Rogers et al. (2012). These authors speak of a pathogenic source of vulnerability. In presenting their taxonomy, they say: Some responses (to vulnerability) may exacerbate existing vulnerabilities or generate new vulnerabilities. We refer to these as pathogenic vulnerabilities. There are a variety of sources of pathogenic vulnerability. Pathogenic vulnerability may be generated by morally dysfunctional interpersonal and social relationships characterized by disrespect, prejudice or abuse or by socio-political situations characterized by oppression, domination, repression, injustice, persecution or political violence. For example, people with cognitive disabilities, who are occurrently vulnerable due to their care needs, are susceptible to pathogenic forms of vulnerability, such as sexual abuse by their carers. (Rogers el al. 2012: 25 [my emphasis])

The key issue in this characterization is the fact that there is a potential to “exacerbate existing vulnerabilities or generate new vulnerabilities.” In my view, what the pathogenic source shows is a replication or consecutive deployment of harmful effects: a cascade effect. Consequently, I believe the term “pathogenic” is misleading because it likens this kind of vulnerability to disease and pathology. Additionally, its origin may not necessarily be related to dysfunctional interpersonal or social relationships.17 The notion of a pathogenic source can be useful, though it 14 Specific

details are beyond the scope of this article. See Luna (2015). Luna (2015), I provide some of the reasons I do not think taxonomies are a good strategy. 16 This section is based on Luna (2018). 17 For example, I explain that the lack of an early diagnosis in the case of rare diseases can be considered a cascade vulnerability as it may impact in reproductive decisions, in future treatments, etc. See Luna (2018). 15 In

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should be formulated in a broader way. I propose we name these layers of vulnerability cascade-vulnerability and that we stress the devastating power these layers exert. The second feature I would like to stress is the dispositional nature of layers of vulnerability. Being vulnerable or suffering from a layer of vulnerability reveals that a person might be mistreated/abused/exploited under certain circumstances. A classic example of a disposition is the property of being soluble. Sugar has the disposition to solubility. That is, it dissolves if placed in water. So, the disposition is latent until a specific stimulus condition triggers it. In the case of layers of vulnerability, if that stimulus condition does not obtain, a certain layer of vulnerability will never be actualized. In the case of a lump of sugar, the stimulus condition will be the event of introducing it into water. Similarly, just as we have identified the stimulus condition to make the lump of sugar soluble, we should identify the stimulus conditions that trigger a particular layer of vulnerability.

5.8 The Two-Step Procedure: A Guide for Evaluation At this point, I would like to introduce the two-step procedure to work with layers of vulnerability. The first step consists of identifying different layers of vulnerability (related to physical problems, consent, dependency, exploitation, socioeconomic situations, etc.), cascade layers, and stimulus conditions. In the first step we should identify: (1) The content of layers, that is, different existing layers of vulnerability (we can use different definitions of vulnerability (Zion et al. 2000; CIOMS 2002; Hurst 2008), as well as other strategies such as the characteristics that Kipnis proposes (2001)). (2) The stimulus conditions, that is, the triggers of layers and the likelihood that they become manifest. (3) Cascade vulnerabilities, that is, layers that have a “cascade effect”. In a second step, we can evaluate how to rank these different layers. The previous identification of layers and their stimulus conditions will guide our evaluation. We should assess harms and risks involved in the different layers (from physical to psychosocial, dependent, or abusive patterns). We should begin with the most harmful layers and move down to the less damaging ones. As we may have several layers, we should begin by evaluating whether cascade layers exist. Cascade layers are frequently the most harmful. We should balance the possibility of their occurrence and judge how harmful these layers are. How should we do this? We should consider the dispositional structure of layers of vulnerability and assess what stimulus conditions can trigger them (their presence and probability of developing). If the stimulus conditions are highly probable, they should take priority. Once we have identified and ranked the different layers of vulnerability, the remaining question is what we should do with them. I propose three obligations.

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Our first obligation will be: avoid exacerbating layers of vulnerability. Thus, our first obligation is to not worsen the actual situation of vulnerability the person or group is facing (be this with a protocol intervention or a public policy). We will then have to consider whether we are able to eradicate layers of vulnerability. Finally, the third obligation will be to minimize layers. If layers cannot be eradicated, we should try to minimize them. These obligations can be expressed as protections or safeguards but also as empowerment and the generation of autonomy. I believe the two-step procedure and these three basic obligations can guide the deliberative thinking of researchers, research ethics committees, and policy makers in the evaluation and design of protocols and policy regulations. It allows them to rank layers, to evaluate which takes priority, and to take actions. See table: PROCESS OF PRIORITIZATION

OBLIGATIONS

(FROM MORE TO LESS HARMFUL)

-

CASCADE VULNERABILITY

-AVOID

EXARCERBATING

LAYERS

-

VERY HARMFUL -ERADICATE LAYERS

-

VERY PROBABLE -MINIMIZE LAYERS

HOW? THROUGH THEIR STIMULUS

THROUGH

CONDITIONS

STRATEGIES:

DIFFERENT PROTECTIONS,

SAFEGUARDS, EMPOWERMENT.

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5.9 How It Works: An Example In this final section, I provide an example that shows how these concepts work. Let us consider a drug research project conducted with poor women in countries where abortion is illegal.18 In this case, the possibility of pregnancy functions as a cascadevulnerability. As I have argued elsewhere,19 in the same situation, a woman enjoying a high socioeconomic position will also acquire a layer of vulnerability. There is moral harm when she has to undergo an illegal abortion (even if it is a safe process and she can afford it). However, wealthy women will not suffer a cascade effect of vulnerability, while this can well be the case of the women with scarce resources. In the situation of poor women, we can easily imagine the anguish of an undesired pregnancy in the middle of a biomedical research project testing new drugs, and the fear that the tested drug may have a teratogenic effect on the fetus’s development (note that teratogenic effects frequently occur in the first trimester). If the woman continues with the pregnancy because she has no other option, the baby may be born with neurological or other serious defects, creating multiple problems for her and her family. If she opts for an illegal and unsafe abortion, other harmful consequences might arise: future sterility, morbidity, and even death. Thus, we should identify whether there are stimulus conditions that may actualize this cascade vulnerability and assess how probable they are. If stimulus conditions are highly probable, this layer should be prioritized (because not only is it very harmful with a cascade feature, but it is also quite probable). This is the case, for example, when women are poor and lack socioeconomic resources such as a formal education, and also lack sexual education and access to contraception. If the REC considers the research highly relevant for these women and their community and it meets other ethical conditions20 but its members are worried about this cascade layer of vulnerability and its stimulus conditions, they should consider how not to trigger this cascade layer. They should assess whether they can eradicate or eliminate such a dispositional layer. If they cannot, they should examine strategies to minimize its occurrence. Regarding the possibility of eradication, we should acknowledge that without safe policies to end pregnancies, the possibility of having an unwanted pregnancy will always exist despite special steps to avoid it. We should also understand that researchers or RECs cannot themselves change the law. Therefore, inadequate sexual education, lack of contraception, and lack of emergency contraception are some of the stimulus conditions that can give rise to this cascade layer of vulnerability. As was suggested, it may be quite difficult for RECs’ members and researchers to eradicate this layer; yet they should be able to minimize it. They ought to consider different strategies, including effective protective measures or safeguards and empowerment for the women in question. For example, a first set of necessary actions to achieve minimization includes: explaining and educating about methods to avoid unwanted pregnancies, or providing education on the use 18 This

case was presented in Luna (2018). Luna (2009a). 20 See CIOMS (2016) regarding pregnant women and research (Guideline 19). 19 See

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of contraception and access to it (explaining that it is better to use a double method and offer two birth control methods, as well as the possibility of emergency contraception). The RECs cannot eradicate that layer of vulnerability, but by requiring researchers to implement the first set of protections mentioned, they can minimize it. However, if a REC thinks these strategies do not suffice (because the drug needs more research before giving it to women that may not be able to have an abortion, or because women will not be able to comply because of their partners’ refusal or because it may lead to intra-family violence, etc.), the REC should either (1) reject the protocol, or (2) choose not to recruit these kinds of women into the study and set clear conditions for the participation of other women. RECs should carefully evaluate layers and establish what kinds of provisions and safeguards should be in place for each layer.

5.10 Conclusion The traditional approach to vulnerability has shown itself to be problematic. Not only does it imply a lack of flexibility but also reinforces a stereotyping effect. In practice, it frequently leads to overprotection. The metaphor of layers I propose shows how the concept can function in a more flexible way and offers a possible response to the existent theoretical challenges. The practical-ethical analysis I have recently suggested provides a new answer to complement my previous proposal. This two-step process of analysis may be helpful to RECs, researchers, and policy makers.

References Belmont Report. 1979. The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. U.S. Government Printing Office. Council for International Organizations for Medical Sciences (CIOMS) and World Health Organization (WHO). 2002. International ethical guidelines for biomedical research involving human subjects, 2nd ed, Geneva: CIOMS. Council for International Organizations for Medical Sciences (CIOMS) in collaboration with World Health Organization (WHO). 2016. International Ethical Guidelines for Health- Related Research involving Humans, 3rd ed. Geneva: CIOMS. Den Hollander, G., J. Browne, D. Arhinful, R. Van der Graaf, and K. Klipstein-Grobusch. 2016. Power Difference and Risk Perception: Mapping Vulnerability within the Decision Process of Pregnant Women Towards Clinical Trial Participation in an Urban Middle-Income Setting. Developing World Bioethics. https://doi.org/10.1111/dewb.12132. Durocher E., R. Chung, C. Rochon, and M. Hunt. 2016. Understanding and Addressing Vulnerability Following the 2010 Haiti Earthquake: Applying a Feminist lens to Examine Perspectives of Haitian and Expatriate Heath Care Providers and Decision-Makers. Journal of Human Rights Practice 1 (20). Goodin, R.E. 1985. Protecting the Vulnerable. Chicago: University of Chicago Press.

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Hurst, S. 2008. Vulnerability in Research and Health Care; Describing the elephant in the room? Bioethics, vol. 22: 4. Kipnis, K. 2001. Vulnerability in Research Subjects: A Bioethical Taxonomy. In Ethical and Policy Issues in Research Involving Human Research Participants. Bethesda. National Bioethics Advisory Commission. G1-G12 (p. G4). Kipnis, K. 2003. Seven Vulnerabilities in the Pediatric Research Subject. Theoretical Medicine and Bioethics 2003 (24): 107–120. Lange, M., W. Rogers, and S. Dodds. 2013. Vulnerability in Research Ethics: A Way Forward. Bioethics 27 (6): 333–340. Lévinas, E. 1972. L´humanisme de l´autre homme. Montpellier-France: Fata Morgana. Levine, C., R. Faden, C. Grady, D. Hammerschmidt, L. Eckenwiler, and J. Sugarman. 2004. Consortium to Examine Clinical Research Ethics 2004. The Limitations of “Vulnerability” as a Protection for Human Research Participants. American Journal of Bioethics 4 (3): 44–49. Luna, F. 2009a. Elucidating the Concept of Vulnerability. Layers not Labels. International Journal of Feminist Approaches of Bioethics 2 (1): 121–139. Luna, F. 2009b. La declaración de la UNESCO y la vulnerabilidad, la importancia de la metáfora de las capas. In Sobre la Dignidad y los Principios. Análisis de la Declaración Universal de Bioética y Derechos Humanos de la UNESCO, ed. Casado M. 255–266, Ed. Civitas, Navarra. Luna, F. 2014. ‘Vulnerability’, an interesting concept for public health: the case of older persons. Public Health Ethics 7 (2): 180–194. Luna, F. 2015. Rubens, corsets and taxonomies: A response to Meek Lange, Rogers and Dodds. Bioethics 26 (6): 448–450. Luna, F. 2018. Identifying and Evaluating Layers of Vulnerability. A Way Forward. Developing World Bioethics: 1–10. Luna, F., and S. Vanderpoel. 2013. Not the usual suspects: Addressing layers of vulnerability. Bioethics 27 (6): 325–332. Macklin, R. 2012. A Global Ethics Approach to Vulnerability. International Journal of Feminist Approaches of Bioethics 5 (2): 64–81. O’Neill, O. 1996. Towards justice and virtue. Cambridge: Cambridge University Press. Ricoeur, P. 2007. ‘Autonomy and vulnerability’ in Reflections on the just. Chicago: University of Chicago Press. Rogers, W., C. Mackenzie, and S. Dodds. 2012. Why bioethics needs a concept of vulnerability? International Journal of Feminist Approaches to Bioethics 5 (2): 11–38. van Delden, J., and R. van der Graaf. 2016. Revised CIOMS International Ethical Guidelines for Health Related Research Involving Humans, JAMA (6 December). https://doi.org/10.1001/jama. 2016.18977. World Medical Association. Declaration of Helsinki. 2000. Adopted by the 52nd WMA General Assembly. Edinburgh, Scotland. Zion, D., L. Gillam, and B. Loff. 2000. The Declaration of Helsinki, CIOMS and the ethics of research on vulnerable populations. Nature Medicine 6: 613–617.

Chapter 6

Consent and Exploitation in Bioethics: Individual Ethics and Legal Regulation Eduardo Rivera-López

Abstract In this paper, I discuss exploitative transactions in bioethics. Examples of this kind of transactions allegedly include, among others, commercial surrogacy, organ selling, and research with human subjects in developing countries. The most problematic kind of exploitation is what Allan Wertheimer calls “mutually advantageous exploitation:” the weak party’s (W’s) consent for the transaction is an effective and rational consent. Moreover, W does not suffer any harm by the transaction; on the contrary, the transaction benefits W. My aim in this paper is twofold. From the perspective of individual ethics, I offer a model to understand the nature of the wrongfulness of the strong party’s action. And from the perspective of legal ethics, I suggest some reasons to believe that the prohibition of beneficial exploitative contracts is problematic and can only be justified in very exceptional cases. Keywords Exploitation · Mutual benefit · Legal status of exploitative transactions

6.1 Introduction A recurring problem in bioethics, and in applied ethics more generally, is that of exploitative contracts or transactions: transactions in which a strong party (S) benefits 1 unfairly or takes undue advantage over a weak or vulnerable one (W). We may 1 I always refer to what Alan Wertheimer calls “transactional exploitation,” that is, when exploitation occurs in a contract or transaction between two (or more) parties. I leave aside what he calls “structural exploitation,” which depends on the existence of a set of rules and institutions that unduly harm a class of individuals (workers, women, etc.) in a systematic way. Such a concept of macro-exploitation is referred to by the Marxist tradition (see Wertheimer and Zwolinski 2017). For a similar distinction between Marxist and non-Marxist exploitation, see Hawkins (2008, pp. 44–49).

E. Rivera-López (B) Law School, Universidad Torcuato Di Tella, Buenos Aires, Argentina e-mail: [email protected] IIF-CONICET (National Scientific and Technical Research Council of Argentina), Buenos Aires, Argentina © Springer Nature Switzerland AG 2019 E. Rivera-López and M. Hevia (eds.), Controversies in Latin American Bioethics, International Library of Ethics, Law, and the New Medicine 79, https://doi.org/10.1007/978-3-030-17963-2_6

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recognize two main variables in the analysis of exploitive transactions. The first concerns whether the transaction is really voluntary for W (assuming that it is always voluntary for S). In some cases, we speak of exploitation in part because W’s consent is not valid (as, for example, when S deceives W or W is not entirely competent). The second variable concerns whether the transaction harms or benefits W (assuming it always benefits S). In some cases, we say that the transaction is exploitative in part because W would be better off without such a transaction.2 The most problematic case within this scenario seems to be that of beneficial or “mutually advantageous” exploitation.3 In beneficial exploitation (which should actually be called “voluntary beneficial exploitation”), each of the above variables assumes a value favorable to W. First, W’s consent to the transaction is effective and rational. Secondly, W does not suffer any harm from the transaction; on the contrary, compared to not performing the transaction, performing it is beneficial to W. Possible examples of beneficial exploitation are found in at least three areas of bioethics: 1. Biomedical research with human subjects in Third World countries: a person with HIV who lacks access to both specific treatment and to basic health services enters a research protocol to develop a drug for HIV in conditions that are different from the conditions in which the same research would be carried out in rich countries. Specifically, a placebo for the control group will be used, whereas in developed countries, the standard is to use the best available treatment for the control group. The person agrees to participate, because, given her situation, this is the best option to treat her disease and receive basic health care.4 2. Organ selling: a person in extreme poverty decides to sell a kidney for transplantation, as this is the best way to help her own subsistence or that of her family.5

2 For

this classification and, in general, for a careful conceptual analysis of the concept of exploitation, see Wertheimer (1996, 2008, pp. 68–85). 3 The last expression is used by Wertheimer (2017). 4 The example is based on two known cases of research. The first took place in several African countries and the Dominican Republic between 1994 and 1997 to find a medically more efficient and cheaper way to avoid maternal-fetal transmission of HIV. The second was proposed to test a new drug for acute respiratory distress syndrome called Surfaxin in Bolivia in 2000. In this last case, it was also proposed to carry out the research using a placebo, although other effective drugs existed (Hawkins and Emanuel 2008, pp. 1–3; 58–61). 5 The case is quite realistic. Despite the existing prohibition worldwide, selling kidneys for transplantation is a reality in countries like Pakistan, India, China, Egypt, Turkey and the Philippines. In Pakistan alone, it is reported that about two thousand kidney transplants are performed each year to patients from Europe or North America with this methodology (Kelly 2013, p. 1320). Still, this practice should be distinguished from trafficking persons in order to coercively obtain organs for transplantation. I will not go into the question of whether this kind of traffic exists or its magnitude. In any case, I do not refer to it in this paper.

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3. Commercial surrogacy: a woman decides to gestate a baby in exchange for money as the best option available to her, under the conditions of vulnerability in which she is living, to help her own subsistence or that of her family.6 In all three cases, a frequent argument to reject the legal permissibility of these transactions (although not the only one, especially in the latter two cases) is that it is exploitative. However, in all three cases, contracts are arguably, in the given context, beneficial to W (the research subject, the organ seller, the surrogate), and at least in many cases W’s consent is sufficiently rational and, therefore, valid (or at least as valid as in many other transactions we are prepared to accept). Assuming that these transactions are exploitative and, therefore, unfair to W, we have to address at least two issues. First, we should determine the moral status of the actions involved, namely the action of the exploiter (S) to offer and contract in exploitative terms, and the action of W to accept those terms. This is important because even if we assume that a transaction is exploitative and, therefore, unfair towards W, it is not exactly clear why it is unfair, why it is not simply a voluntary and mutually beneficial transaction. Second, we should determine what the legal system should say about this kind of transaction, in the sense of allowing or prohibiting it. In this paper I will not focus on the concept of exploitation or on developing a model to explain why exploitative transactions are unfair. Rather, I assume that contracts showing a very large disparity of burdens and benefits, in which, moreover, one of the parties (W) would suffer a very serious harm or risk of harm if she rejected the transaction, are exploitative. My goal is more modest. First, I would like to present a model for thinking about the nature of the moral wrongness that we assign to S’s behavior of contracting with W in exploitative terms (Sect. 2). Second, and assuming that this behavior is, in a sense to be defined, morally wrong, I argue that a legal prohibition of this type of exploitative behavior is problematic and can only be justified in very exceptional cases (Sect. 3).7

6.2 Exploitation and Private Action At the level of interpersonal morality, we are naturally inclined to think that S does something wrong by contracting with W in exploitative terms. However, it is not obvious what the nature of such wrongness is, and the reason why the behavior is wrong. My purpose is to offer some suggestions to answer the first question. I do not

6 Unlike the case of the sale of kidneys, commercial surrogacy takes place (even legally) in both rich

and poor countries. There is the phenomenon of “reproductive tourism” since the costs of surrogacy are much lower in developing countries, but poor women in the United States also accept this type of transaction since it is legal in some states. For an overview of both phenomena, see Voskoboynik (2016). 7 A very similar position has been defended by Wertheimer, at least in terms of public decision. My purpose is to provide different arguments that go in the same direction.

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offer an argument to justify my proposal except in the sense of offering reasons to think that it accords well with intuitions we have about other similar cases. In order to evaluate S’s behavior of carrying out an exploitative transaction, the interesting case is one in which S is able to contract in non-exploitative terms in a manner that is not morally over-demanding. This is important because there could be occasions on which S might argue that he contracted in these terms because he had no alternative, or because contracting in more favorable conditions for W would be too demanding (for example, because it would involve excessive sacrifice). These cases are controversial and there would certainly be gray cases. However, at least in clear cases of a lack of alternatives or of over-demandingness, it would be difficult to argue that S’s behavior is morally wrong, even if we still think that the contract is exploitative and therefore unfair. My focus will be exclusively on those (clear) cases in which, while contracting on more equitable terms has some cost for S, it is not impossible for him to do so, nor are there independent reasons to consider that contracting on more equitable terms cannot be demanded of S. Even in these cases, we may ask why S must comply with the requirements of the more equitable terms when the exploitative conditions are beneficial for W and W voluntarily accepts. There are two kinds of exploitative transactions (two kinds of situations in which exploitative transactions can be carried out) that might be thought to deserve partially different approaches. First, there are situations in which W agrees to contract in exploitative terms due to failures of background distributive justice. I use the term ‘failures of background distributive justice’ (or ‘background injustice’) to refer to certain general distributional patterns in a society that violate acceptable criteria of distributive justice and are a necessary condition for W to decide to make the transaction. In these cases, it is plausible to claim that in a sufficiently fair counterfactual situation, W would not have agreed to the terms of the transaction (since the transaction would no longer be beneficial) or would only be willing if non-exploitative terms were offered. On the other hand, we can imagine cases in which W contracts because of reasons different from those generated by background injustice. There may be situations in which W’s weakness or vulnerability is due to W’s own negligence, bad luck, or to other factors for which other members of society are not responsible. We can take the example of instances of price gouging: after a natural catastrophe, and given the unavoidable shortage of drinkable water, the few water sellers charge astronomical prices for water. Here, too, when people buy water at those astronomical prices, they make a perfectly rational and beneficial decision for themselves, given the circumstances. Situations of this type might arise in bioethics. A person may have lost all of his or her livelihood due to bad luck or self-neglect and be ‘forced’ to undergo unfavorable research, sell a kidney, or gestate a baby for money. And it may very well be that any of these decisions, in their circumstances, are fully rational, voluntary, and beneficial. Whether the justice or injustice of the background conditions affects the moral status of S’s offer (as exploitative) is not clear. When there is such injustice, S takes advantage of a background circumstance that is not morally neutral, whereas when

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there is not, S takes advantage of a background circumstance that is itself neutral (in the sense that no one is responsible for that situation except, perhaps, W). Such a difference might impinge on our evaluation to some extent, although, as far as I can see, this depends on the concrete circumstances and is therefore highly contingent. For example, it may happen that S is so powerful that he is in some way a participant in, or responsible for, the background injustice that makes the exploitative transaction possible. But it may also be the case that S only takes advantage of a situation for which he is not responsible. If, in a given case, conditions of background injustice are a necessary condition for the existence of the exploitative transactions (because they would not have been taken place in more equitable conditions) but S is not responsible for their existence and is rather only an opportunist who takes advantage of that situation, it is not clear that the fact that the unjust circumstances make W accept the conditions is relevant to evaluating S’s action. Certainly, one might think that when S contracts with W in conditions of background injustice, there is an aspect that is different in comparison to cases in which there is no such injustice, namely the fact that S is, in some way, complicit in the situation of injustice. By taking advantage of these conditions to maximize his own benefit, S validates and, even if perhaps minimally, contributes to the perpetuation of those conditions (Malmqvist 2017). Still, I do not think this is the essential aspect of S’s wrongness. We need a more general argument covering all cases and explaining why, regardless of the reasons why W accepts the exploitative transaction (social injustice, bad luck, or even her own fault), there is something objectionable in S’s attitude of making the transaction in those terms. Let us then ignore why W accepts the transaction in exploitative terms. Whatever the cause, we have the strong intuition that there is something problematic in S’s contracting with W under those terms (even if the transaction benefits W and her acceptance is fully voluntary). The problematic feature of S’s action seems to lie in the fact that it reveals a tension between two intuitions. On the one hand, we have the intuition that S takes advantage of and abuses W and, therefore, does something wrong; on the other hand, we also have the intuition that, even so, we should not (at least not in all cases) prevent the transaction from occurring because that would be detrimental to W. The model I would like to propose to conceptualize this tension is to classify S’s behavior as a ‘suberogatory’ act.8 Suberogatory acts have two opposite properties. On the one hand, there are actions that are morally permissible, or that the agent has a moral right to carry out. On the other hand, these are bad, objectionable actions that the agent should not perform. Our moral discourse needs this concept to adequately classify a large number of ordinary behaviors. Here some possible examples: • Assuming one is entitled to (or has the freedom to) freely choose friends, a person selects her friends with a racial criterion (Hurd 1999, p. 6). • Assuming lawyers have freedom to accept and refuse clients, a lawyer accepts clients who pursue aberrant or grossly unfair or immoral goals (Rivera-López 2015). 8 On

this concept, see Driver (1992) and Hurd (1999).

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• Assuming a moral right to abortion without restrictions, a woman undergoes numerous abortions for trivial reasons (Driver 1992). • Assuming we have a right to be compensated for the harms we suffer, a person exacts compensation for trivial injuries (Hurd 1999, p. 6). • Assuming receiving favors does not imply any duty to reciprocate, a person never reciprocates for the favors she receives (Driver 1992, p. 289).9 The cases are diverse and cannot always be conceptualized in the same way. But in all of them the person performs an action that is not right, but that, somehow, we cannot prohibit her from doing. One way to conceptualize this tension is in terms of “abuse of rights” (Schauer 1981), or of “a right to do wrong” (Waldron 1993). The person has a moral protection (a right) to perform acts that we nevertheless consider wrong, unfair, or impermissible. Another way of understanding suberogatory acts is to distinguish between the concepts of ‘ought to do X’ and ‘has an obligation to do X.’ A suberogatory act would be an act that a person should not perform, but which, however, is not prohibited (Driver 1992, p. 291). The discussion about the best way to conceptualize this kind of actions exceeds the purpose of this paper. I will opt, somewhat dogmatically, for the first alternative: a suberogatory action is one that the agent has the right to perform, but, nevertheless, should not perform.10 When I say that the agent has a right to perform a suberogatory act, I do not mean that the agent has (or we think she should have) a legal right to perform that action (this will be the issue in the next section). I mean the agent has a moral right. The idea is that a moral right held by an agent A is a set of (moral) reasons that other agents have about how to treat A. For example, A’s right to perform an act X is the set of reasons that the rest of the individuals have in relation to A’s doing X. Those reasons may simply consist of reasons not to (try) to prevent A from doing X (in that case, A would have a negative right to do X), or (in the cases of positive rights) to help A in some way to do X. The central point is that the fact that A has a right to X does not say anything about A’s (moral) reasons to do X, but about those of others (Waldron 1993, p. 71). This makes A’s having the right to do X and A’s having moral reasons against doing X compatible. Let me show how this conceptual scheme works with the following example of beneficial exploitation discussed by Pogge (2008, pp. 108–109). A filmmaker wants to film a real shipwreck (including how the castaways are drowned). He waits for the occurrence of a real shipwreck (for which no one will come to the rescue) and, once he has detected it, offers the castaways a chance to toss a coin: if it comes up heads, he will rescue them; if tails, he will let them die and film them while drowning. This is a case of beneficial exploitation: in the absence of alternatives, it is perfectly rational for the castaways to accept the contract (they gain a 50% chance of survival). However, we see the filmmaker’s offer as miserable: he is taking advantage of the need of others for his own benefit. 9I

do not intend for all of these examples to be convincing; only some are. For other examples, see Waldron (1993, p. 63–64). 10 I follow Waldron (1993) on this.

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How should we conceptualize the filmmaker’s offer? There is a clear and plausible sense according to which we can say that the filmmaker has a moral right to contract in these terms. Suppose that the castaways have no positive right to be saved by the filmmaker. Therefore, the failure to save them does not violate a right they possess. In fact, the filmmaker might have been unaware of the shipwreck and dedicated his energies to filming the local fauna, in which case we would not say he violates a (positive) right of the castaways to be rescued (by the filmmaker). However, once he has detected them, failing to save them, while being able to do so at a non-excessive cost, is objectionable. In this case, giving them a 50% chance of being saved would be suberogatory: something that the filmmaker has moral reasons not to do but that he has the right to do, insofar as nobody would have moral reasons to prevent the filmmaker from offering the deal. The nature of the wrongdoing involved depends on the nature of the reasons militating against making the transaction. Heidi Hurd opts for a justification based on a virtue theory: the obligation not to perform suberogatory actions would be an “aretaic duty” (Hurd 1999, pp. 19–24). Another alternative is to think that there are imperfect duties to help or to benefit that are triggered in certain circumstances. These duties are moral reasons to prevent or minimize damages, or to promote or maximize social benefits. However, they are not correlated with positive rights held by others (the recipients of those duties). As I have said, I offer no theory that explains why suberogatory actions are wrong, nor do I want to choose one of the existing theories. I only aim to show that this way of understanding exploitative behaviors is in line with the way we understand other behaviors within our moral framework. A future task could be to develop a theory explaining the nature of all suberogatory behaviors, but that is beyond the purpose of this paper. Let us see how this way of conceiving exploitative actions (as suberogatory actions) works in each of the three bioethical examples I have mentioned. In the first case, let us recall, a research subject from a poor country voluntarily consents to participate under exploitative terms because (although the conditions are abusive) she will foreseeably benefit by participating. To the extent that we assume that the pharmaceutical company (the sponsor) could have conducted the research under the same conditions as in developed countries and that to do so is not over-demanding for independent reasons, we can say that offering different (exploitative) conditions to participants from poor countries is wrong. The company should offer all research subjects the same conditions (in our example, using the best available therapy for the control group, rather than a placebo). In this sense, the members of the company who have taken the decision to contract in exploitative terms may be the target of moral criticism or blame (provided there are no excusing or attenuating circumstances). However, this is consistent with claiming that the prospective research subject does not have a right to participate in a given research protocol. The sponsor could perfectly (for morally neutral reasons) not carry out such research and would not be violating the right of that potential participant. Recruiting research subjects under worse conditions than those applied in developed countries is, in this sense, suberogatory: the company has the right to do so, but it is morally objectionable.

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The cases of the organ sale for transplantation and of commercial surrogacy are similar, although some differences are worth noting. An important difference between these two cases, on the one hand, and the cases of the filmmaker and of biomedical research, on the other, might be that in the latter there is a possible scenario of a nonexploitative transaction: the filmmaker (we assume) could simply save the castaways (giving up filming how they actually drown), and the sponsor could conduct the research with the same standards as in developed countries. On the other hand, it seems that in cases of organ sale and commercial surrogacy, there is no possible scenario in which the transaction could be carried out in a non-exploitative way. For example, there is no amount of money in exchange for a kidney or a gestation that would make the transaction acceptable. Although in the case of biomedical research the background social injustice is involved in the transaction, there is a natural element, the existence of the disease, which is determinant in the acceptance by the research subject. And in the case of the filmmaker, that natural element is the only relevant one (being in a shipwreck). On the other hand, in the other two examples, it would seem that the background injustice is what explains the acceptance of the kidney sale or of the commercial surrogacy. Therefore, in the circumstances of the context, there is nothing that the kidney buyer or the genetic parents can do to make the transaction non-exploitative. In these cases, the only scenario in which S does not exploit W is the one in which S does not offer the deal. Paradoxically, this, in principle, damages W. This interpretation, however, is not the only one possible. The idea that there cannot be a non-exploitative transaction in the cases of organ sale and commercial surrogacy may, perhaps, be misinterpreting the principles involved. In these cases, other arguments, related to the use of one’s own body and its eventual ‘commodification,’ are at work, and those arguments are not present in the examples of the filmmaker and research. One might maintain that these other arguments make us think that there can be no ‘fair price’ in this type of contract. If we leave aside Kantian considerations connected to the commodification of one’s own body, it may be possible to think of a non-exploitative sale of a kidney or surrogacy. If this is so, then these examples are quite close to the other two, and the analysis would be similar. In summary, S’s action to enter into a mutually beneficial and voluntary exploitative contract is, on the one hand, an action that S is entitled to carry out. The reason for this is that S does not have a duty to contract with W in the first place, and W does not have a right that S contract with her, so it would be striking if S did not have the right to contract with W in terms that benefit W. On the other hand, S’s action is nonetheless wrong, in the sense that S should not contract with W under these terms and, unless there is some excuse, we can blame S for doing so. A good person, once he is in the situation of contracting with someone in a vulnerable position, does not exploit his greater power to extract the greatest benefit, but seeks to do so on equitable terms. As I have reiterated, this is not an argument as to why S’s action is wrong. It is simply a plausible way of thinking that is consistent with our intuitions regarding a wide range of behaviors in which we feel a moral tension between having moral reasons not to prevent an action and believing that that action is wrong.

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6.3 Exploitation and Public Power Let us take for granted that, from the point of view of individual morality, S’s action of contracting with W in exploitative terms is suberogatory. S has a moral right to do so, but doing so is morally wrong. What follows from this for the question of whether such action should be legally permissible, or whether a legal right should be granted to carry it out? From our previous conclusion it does not follow that such a right has to be granted. Even if we accept that S has a (prima facie) moral right to contract in exploitative terms, there could be other reasons overcoming that right and enabling the state to forbid such kind of contracts. In many cases of suberogatory actions, we do not think the state should coercively interfere with and prohibit those actions (for example, in the case of the person who selects friends with racist criteria, or the person who never returns favors, among others). In some other cases, there are even independent reasons to ensure that people can perform that kind of actions by granting a legal right to perform them. For example, in the case of the Nazi editor or the lawyer who defends abject causes, there are independent reasons for granting that these people have a right to publish Mein Kampf or to defend aberrant causes, even if we may legitimately blame them. In the first case, we have reasons based on freedom of expression; in the second, the reasons are grounded on the right of defense (Rivera-López 2006). But there may also be cases in which the state has reasons not to allow this type of behavior. Exploitation might be one of them. Let me first specify more clearly what I mean by not allowing or by prohibiting exploitative behaviors. I mean not allowing the transaction exactly in the terms the parties want to contract. A regulation allowing transactions only if they are not exploitative (for example, only allowing biomedical research in the same conditions as in developed countries) is, in my sense, a prohibition, since it does not allow the transaction, such as the parties want to realize it. In any case, it is important to note that S always has the (legal) right of not contracting at all with W (in the above examples, not performing the research in the poor country, not buying a kidney, not contracting with a surrogate woman). From the point of view of the possible justification of a legal prohibition or regulation, the most interesting case is the one in which W’s motivation to contract with S is explained by the background conditions of injustice. I leave aside, therefore, those possible cases in which W’s vulnerability is due to morally neutral reasons (luck, natural catastrophes, or self-neglect). One of the most promising strategies for answering the question of whether exploitative transactions should be legally permissible is based on the idea that this depends on what contributes to the realization of an ideal (non-exploitative) state of affairs.11 In this direction, Wertheimer mentions (but does not defend) the “strategic argument.”12 According to this argument, it might be that prohibiting exploitative 11 This is obviously not the only possible strategy. I assume without argument that other strategies, such as paternalism, are less plausible. 12 Wertheimer (2008, p. 81, 1996, pp. 300–305).

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transactions creates an incentive for strong parties to contract on more equitable terms. This can happen, for example, when there is a prisoner’s dilemma among potential weak parties. Everyone has an incentive to make exploitative contracts because it benefits them individually; but, if all could agree to reject those terms, the strong parties would have to agree to more equitable terms. For example, if developing countries could agree to refuse to allow pharmaceutical companies to conduct research with human subjects under conditions that would not be acceptable in developed countries, then those companies would perhaps be willing to do so under the same conditions as in developed countries. Athanasiou et al. (2015) argue in the same direction. According to these authors, when W accepts an exploitative offer, it reveals her willingness to contract in those terms, which encourages potential S’s to continue with their exploitative contracting policies. A prohibition on making such offers would avoid W’s problem of revealing her willingness to accept and thus create incentives for S to make fairer offers (pp. 443–444). Whether this type of argument is plausible depends on contingent facts. There may be cases in which it is true that prohibiting exploitative transactions generates sufficient incentives to avoid exploitation in the future and others in which it does not. However, even in cases in which it is true that the prohibition contributes to that goal, it is clear that the contribution of each individual instance of prohibition is only marginal, and the temporal distance between the concrete prohibition and the goal to be obtained (non-exploitation) can be large. In any case, it is clear that such a contribution will hardly benefit the specific weak party (W), who, in a specific instance, is prevented from contracting in exploitative terms. For example, in the case of research involving human subjects in developing countries, a prohibition on (or international agreement not to allow) research protocols below the standards observed in developed countries will hardly result in those individuals, who would otherwise enter in those protocols in exploitative terms, benefiting by the prohibition. At most, the benefit of a restrictive policy would be enjoyed by other potential participants in the future. This raises the problem of the transition to a more just state of affairs. During the transition, persons will be prevented from entering into contracts that benefit them. This poses a dilemma, rightly identified by Margaret Radin in her seminal article on commodification:13 if we allow exploitation, oppression of the weak is increased and reinforced, whereas if we forbid exploitation, the worse off will be still worse off than otherwise. While it is possible that this dilemma can only be successfully faced on a caseby-case basis, let me suggest some comments that, in my view, make it particularly difficult to think that the balance may tilt in favor of prohibition. First, the discussion on exploitation seems to be focused excessively on the question of whether S, the exploiter, has the right to contract with W in exploitative terms. The right of W, the exploited, does not receive the same attention. And it may be argued that, regardless of the valuable goal of a society (or of the international community) to improve its standards of social justice, it is not morally permissible 13 Radin

(1987, p. 1917).

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to use W as a means to achieve that goal. W, after all, is also a right-holder and she explicitly expresses her genuine willingness to make a contract that benefits her. She is not the one who performs a wrong action (suberogatory or otherwise), since she is not taking advantage of any other person. Her right to enter the transaction, therefore, is difficult to remove or displace with a consequentialist argument. The second reason of why it is difficult to justify the legal prohibition of beneficial exploitative transactions refers to the moral authority to make such a prohibition. The argument is similar to what Glenn Cohen has called the “hypocrisy argument”.14 This argument is directed against the paternalistic claim that prohibiting exploitative transactions protects the exploited person (W). If the transaction is the best alternative available to W, pretending that the prohibition protects W is certainly hypocritical. The idea that I want to suggest here, however, is somewhat different. When the state (or the international community) prohibits a transaction in order to create incentives to the effect that future transactions not be exploitative, the best justification is not that the prohibition protects the actual exploited persons. The state is aware that they will be harmed. To the extent that the state is (at least politically) responsible for the background social injustice, the question is whether it has the moral authority to prohibit individuals from performing behaviors that do not directly harm others and that are beneficial to themselves. One might argue that the state has a justification to prohibit exploitative transactions only when it is plausible to think that doing so is the only way to get closer to a situation of background justice in which the transaction would be unnecessary or not exploitative. That would be a justification by necessity, involving the violation of a right in order to obtain a future benefit. However, such justification would only be plausible in extreme cases where there is no other alternative to achieve higher levels of justice. Typically, states have a huge variety of possible policies to improve labor conditions and justice in general, without it being necessary to prohibit the weakest members of society from improving their own situation by contracting with others (even if in exploitative terms). The intention of governments to improve standards of fairness in transactions is understandable, and one strategy for this may include (as one of its components) prohibiting or restricting exploitative contracts. I do not want to exclude the possibility that a strategy of this kind can be justified in some cases. But I do want to stress that such a strategy is difficult to justify, at least in many cases, firstly because vulnerable people have a right, which cannot easily be sacrificed in the pursuit of a social goal, and secondly because the government lacks the moral authority to impose such a sacrifice.

14 Cohen (2013, p. 279). Cohen refers to Radin (1987, p. 1910), and Rivera Lopez (2006, pp. 44–48).

The hypocrisy argument has been defended also more recently in Stone (2013). Using an argument similar to the one I develop here, Stone objects to Shiffrin’s argument (in 2000), according to which the state cannot recognize exploitative contracts, not for paternalistic reasons, but for self-referential ones.

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6.4 Conclusion The case of mutually beneficial transactions that are nonetheless grossly unfair and, therefore, deemed as exploitative is a philosophically puzzling but highly relevant issue for bioethics. I have offered three examples where such transactions may take place and tried to understand them both from the perspective of interpersonal morality and of their legal permissibility. The underlying idea was that exploitative actions occupy an intermediate space in our moral framework. They are not harmful. They are not instances of rights-violations. However, there are moral reasons not to perform them. I did not try to answer the question about the content of those reasons. My (more modest) aim has been to show that there is conceptual space to understand exploitative actions. The morally hybrid nature of exploitative actions has consequences when we ask about the moral reasons to allow or prohibit them legally. In a broadly liberal society, free and voluntary actions that are not harmful to others are usually not prohibited; and exploitative transactions are free and beneficial for both parties. Still, many think they should not be allowed, and most legal orders prohibit them or incorporate severe restrictions on them. I have focused on one argument that has been provided for those restrictions: the strategic argument. The idea is that prohibition creates the right incentives to the strong parties in those transactions to act in a fairer way in the future. Setting aside the empirical basis of this argument, I have provided two reasons to be skeptical, and to think that, apart from exceptional cases, the proper role of government should be to prevent the creation of situations in which being exploited is the best option, rather than the banning of exploitative transactions.

References Athanasiou, Efthymios, Alex John London, and Kevin Zollman. 2015. Dignity and the Value of Rejecting Offers Profitable but Insulting. Mind 124 (494): 409–448. Cohen. 2013. Transplant Tourism: The Ethics and Regulation of International Markets for Organs. Journal of Law, Medicine, and Ethics 41 (2013): 269–285. Driver, Julia. 1992. The Suberogatory. Australasian Journal of Philosophy 70 (3): 286–295. Hawkins, Jennifer. 2008. Research Ethics, Developing Countries, and Exploitation: A Primer. In Hawkins/Emanuel 2008, 21–54. Hurd, Heidi. 1999. Duties Beyond the Call of Duty. In Altruism and Supererogation, ed. Sharon Byrd, Joachim Hruschka, and Jan C. Joerden, 3–39. Berlin: Dunker & Humblot. Kelly, Emily. 2013. International Organ Trafficking Crisis. Solutions Addressing the Heart of the Matter. Boston College International & Comparative Law Review 36 (2): 1317–1349. Malmqvist, Erik. 2017. Better to Exploit than to Neglect? International Clinical Research and the Non-Worseness Claim. Journal of Applied Philosophy 34 (4): 474–488. Pogge, Thomas 2008. Testing Drugs on the Poor Our Abroad. In Exploitation and Developing Countries. The Ethics of Clinical Research, eds. Hawkins, Jennifer, and Ezekiel J. Emanuel, 105–14. Princeton: Princeton University Press (2008). Radin, Margaret Jane. 1987. Market-Inalienability. Harvard Law Review 100 (8): 1849–1937.

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Rivera-Lopez, Eduardo. 2006. Organ Sales and Moral Distress. Journal of Applied Philosophy 23 (1): 41–52. Rivera-Lopez, Eduardo. 2015. Is it Morally Wrong to Defend Unjust Causes as a Lawyer? Journal of Applied Philosophy 32 (2): 177–189. Schauer, Frederick. 1981. Can be Abused Rights? The Philosophical Quarterly 31 (124): 225–230. Shiffrin, Seana. 2000. Paternalism, Unconscionability Doctrine and Accomodation. Philosophy & Public Affairs 29 (3): 205–250. Stone, Rebecca. 2013. Unconscionability, Exploitation, and Hypocrisy. The Journal of Political Philosophy 22 (1): 27–47. Voskoboynik, Katherine. 2016. Clipping the Stork’s Wings: Commercial Surrogacy Regulation and Its Impact on Fertility Tourism. Indiana International & Comparative Law Review 26 (2): 336–382. Waldron, Jeremy. 1993. The Right to Do Wrong. In Liberal Rights. Collected Papers 1981–1991, ed. J. Waldron, 63-87. Cambridge: Cambridge University Press (Originally in Ethics, vol. 92, no. 1, 21–39, 1981). Wertheimer, Alan. 1996. Exploitation. Princeton: Princeton University Press. Wertheimer, Alan. 2008. Exploitation in Clinical Research.In Exploitation and Developing Countries. The Ethics of Clinical Research, eds. Hawkins, Jennifer, and Ezekiel J. Emanuel, 63–104. Princeton: Princeton University Press (2008). Wertheimer, Alan and Matt Zwolinski. 2017. Exploitation. The Stanford Encyclopedia of Philosophy (Summer 2015 Edition), ed. Edward N. Zalta. https://plato.stanford.edu/cgi-bin/encyclopedia/ archinfo.cgi?entry=exploitation&archive=sum2017. Hawkins, Jennifer, and Ezekiel J. Emanuel. (eds.). (2008). Exploitation and Developing Countries. The Ethics of Clinical Research. Princeton: Princeton University Press.

Chapter 7

Oneself and One’s Body: Commodification and (In)alienability Antonio Bascuñán Rodríguez

Abstract In this paper, I discuss the moral justification for the commodification of the human body. I address this issue by first engaging with legal and bioethical documents and declarations. I explain that existing restrictions are not based on a respect for human dignity and deontological considerations, but on utilitarian grounds. In contrast to both European and Chilean law, I propose a limited sphere for the commodification of the body consistent with the principle of autonomy. Keywords Commodification · Body parts · Excorporation

7.1 Introduction One basic question in the theory of justice regards the type of significant normative relationships that can be established by people over their living bodies, based on a deliberate alteration of the states of affairs regarding one of two basic categories: one’s body and the external world. The modern theory of justice certainly starts from an understanding of the relationship between oneself and one’s body, asserting that the latter is inviolable and can be used freely. On that premise, it focuses its attention on significant normative relations that can be established with regard to the use of one’s body (work) and the possession of the elements belonging to the world outside oneself (ownership). It crosses the border delimited by that distinction when the question is posed about the legitimacy of transforming one’s own body or one of its parts into external world through an action whereby the body or part is alienated from oneself. I will hereafter stipulatively call this transformation by alienation “excorporation.” Of course, excorporation is not the only form of action made possible by bioscience and biotechnology that entails a risk of reification of (parts of) a living human body. A similar problem is found in the genetic programming of descendancy and A. Bascuñán Rodríguez (B) Adolfo Ibáñez University, University of Chile, Santiago, Chile e-mail: [email protected] © Springer Nature Switzerland AG 2019 E. Rivera-López and M. Hevia (eds.), Controversies in Latin American Bioethics, International Library of Ethics, Law, and the New Medicine 79, https://doi.org/10.1007/978-3-030-17963-2_7

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in the enhancement of physiological capacities or anatomical structures of the body through chemical or cybernetic redefinition. The way in which those actions may cause reification is certainly different. Genetic programming alters the symmetry of our responsibility for our personal fate as free beings, while the chemical-cybernetic enhancement of our capacities or structures erodes the foundation for our reciprocal assessment of personal merit. Nonetheless, all these cases have in common the fact that they create a novel possibility of altering and manipulating, through the advances of science and technology, what seemed until now to be natural and unchangeable presuppositions of the condition of a person and his identity. From the viewpoint of the theory of justice, the moral difficulties posed by excorporation lie, in my view, at an intermediate point between the comparatively greater moral difficulties posed by genetic manipulation—because the latter directly concerns others—and the comparatively smaller moral difficulties posed by the technological enhancement of our capacities, which is, by definition, prima facie instrumentally desirable. The reason why I will focus exclusively on excorporation is its connection to the possibility of a consented exchange between one person who removes a part of his or her body from him or herself and another person who takes advantage of it. Imperative altruism is the dominant moral principle in this kind exchange in Europe and in Chile, i.e. considering the exchange to be morally valuable if, and only if, it takes place as a donation, while it is considered morally unacceptable in all other cases. I will hereafter call this second part of the principle of imperative altruism—the prohibition of any form of exchange of parts of the human body for consideration—the principle of the uncommodifiability or prohibition of commodification.1 The relationship between the concepts of excorporation and commodification is obvious: excorporation is, as a general rule, a necessary step prior to the commodification of the body of a living human being or of any of its parts when the intention is to ensure displacement of its possession. The use of these two stipulative terms should be seen as a way of immunizing the outset of the debate from contextual misunderstandings. The words “availability,” “alienability,” and “merchantability” are frequently used by legal experts and are therefore presumably greatly contextualized. The use of the stipulative terms “excorporation” and “commodification” lets us put the role of that contextual meaning temporarily on hold, leading to an initial representation of the problem in as abstract a manner as possible, neutral to those contexts. The problem is whether the uncommodifiability of the human body and its parts is correct as principle of justice. Note that the principle of imperative altruism does not prohibit excorporation or the transfer of an excorporated part of the body. On the contrary, the normative system to which the principle belongs encourages excorporation and its transfer when it is subordinate to an altruistic purpose. Removing parts of the body from oneself or doing so entirely upon death for essentially charitable ends—for transplant, research, or another therapeutic application—is considered to be a morally laudable act. What 1 The

term “commodification” is a newly coined word in English, not yet fully coined in Spanish as “comodificación.” Commodification is the conversion of one object or state of things into a commodity, something negotiable on the market for a price.

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is forbidden is the commodification of body parts, that is, excorporation for profit. The question I am interested in posing in relation to this principle refers to the moral justification for that prohibition. I proceed as follows to discuss this question. First, I explain the moral question through an examination of the texts that declare or set down bioethical principles (Sect. 7.2). Second, I explain my position by identifying two spheres of problems that, in my view, should organize the debate about restricting the exercise of individual freedom consistent with the principle of respect for autonomy (Sect. 7.3). Finally (Sect. 7.4), I propose a reduced scope of commodifiability, which has not been recognized by European or Chilean law, and I claim that this lack of recognition is based on utilitarian considerations and not on an alleged principle of respect for human dignity.

7.2 Bioethical Principles in Legal Documents The fifth guiding principle of the World Health Organization (WHO) on the transplant of cells, tissues, and human organs states: Cells, tissues and organs should only be donated freely, without any monetary payment or other reward of monetary value. Purchasing, or offering to purchase, cells, tissues or organs for transplantation, or their sale by living persons or by the next of kin for deceased persons, should be banned.2

Article 21 of the European Convention on Human Rights and Biomedicine establishes a prohibition on profiting with the human body in the following terms: “The human body and its parts shall not, as such, give rise to financial gain.”3 If the first provision is used as basis for a generalization and if that generalization is made to match with the idea that the second provision is literally an absolute prohibition, the principle of the uncommodifiability of the human body and its parts is obtained. Parallel to the principle of the uncommodifiability of the human body, these texts assert the basic principle that the autonomy of an individual is inviolable and requires the person’s consent for any intervention to his body, including for therapeutic ends. Article 5 of the European Convention on Human Rights and Biomedicine stipulates the following general rule: An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. The person concerned may freely withdraw consent at any time.4

2 http://www.who.int/transplantation/Guiding_PrinciplesTransplantation_WHA63.22en.pdf. 3 http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm. 4 Loc.

cit., supra note 4.

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Article 5 of the Universal Declaration on Bioethics and Human Rights of UNESCO, enacted in 2005, sets out the principle of respect for autonomy and specifies, in Article 6, the following conditions regarding consent: 1. Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice. 2. Scientific research should only be carried out with the prior, free, express and informed consent of the person concerned. The information should be adequate, provided in a comprehensible form and should include modalities for withdrawal of consent. Consent may be withdrawn by the person concerned at any time and for any reason without any disadvantage or prejudice.5 The interplay of both principles leads to the conclusion that the relevant regulatory system recognizes a qualified bioethical autonomy. In exercise of this autonomy, the person can legitimately consent to interventions to his body. That means that he can legitimately waive the inviolability of his body or, in other words, can validly cancel the prohibition against others intervening onto his own body. But in exercise of that autonomy, one cannot irrevocably waive that inviolability nor can one waive it for profit. It is, consequently, a right of autonomy that cannot be conceived in terms of the model of autonomy comprised by the combination of the right of ownership and contractual freedom.6 Unseizability and non-expropriability are the correlates of uncommodifiability: an absolute prohibition of the state or a third party arrogating power over (part of) the body of an individual, either as a consequence of the breach of duties (seizability) or as economic compensation for that arrogation (expropriability).7 Of course, this is 5 http://portal.unesco.org/en/ev.php-URL_ID=31058&URL_DO=DO_TOPIC&URL_SECTION=

201.html. his well-known article, Harris (1996, p. 55) characterizes the inviolability that is common to both the qualified autonomy model and the contractual and proprietary model of autonomy as (i) “mere ownership” as opposed to the total powers of transmission of the exclusive rights of use and control, which constitute (ii) full-blooded ownership (p. 59). The core of Harris’s argument holds that recognizing “mere ownership,” understood as not being owned by another, does not lead to the recognition of “full-blooded ownership,” understood as being the owner of oneself. However, it does not follow from this that the idea of establishing rights of ownership to parts of one’s own body after they have been separated from that body is morally unacceptable. Similarly, it should be noted, in regard to Harris’s argument, that the statement that no one owns living human bodies does not follow from the fact that full-blooded ownership is not inferable from mere ownership. 7 The correlation between expropriability and commodifiability has been explored by Cecile Fabre in Fabre (2006). Her provocative theory, which justifies the expropriability of the human cadaver and, in qualified cases, of parts of a living human body under a principle of solidarity, leads her to recognize, in compensation, a margin of commodifiability of both the cadaver and parts of the living body (see p. 126 s.). The difference between the expropriability of ownership (“mere” or “full”) and inexpropriability of qualified autonomy is not noted by Harris (1996) nor in the classical study in Spanish by Garzón Valdés (1999, p. 216). Following Garzón Valdés, see De Lora (2003, p. 141 s). The work by Cecile Fabre is also important because it questions the rationale for the 6 In

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nothing new. Recognizing a personal right of autonomy, generally understood to be a component of the right to privacy, is characterized precisely by those three features: it is not considered to be compatible with an irrevocable waiver of exercise thereof; it is not understood to be compatible with transactions for valuable consideration; nor it is understood to be expropriable or subject to a coercive utilization in favor of another. Protection of the most intimate sphere of action, expressive of personality and part of one’s own identity and of the legal status of a person, takes place under this paradigm of qualified autonomy, untranslatable to the terms of ownership and contract. Of course, there are many differences in comparative law in relation to the legal treatment of contracts that deal with parts of the body (gametes, blood, tissues, and organs) or actions within this intimate sphere (surrogate motherhood, sexual favors, production of pornography, exhibition of private life in the press, nuptial or divorce agreements). Nonetheless, the principle of qualified autonomy is central to treating the intervention by third parties in one’s own body. The right of the patient to reject or interrupt medical treatment, the right of a spouse to refuse sexual contact and to dissolve the bond of marriage, as well as the right of women to interrupt a pregnancy at a reasonable time, are materializations of this moral principle, extended in modern Western law, at least in legal systems of the Northern Hemisphere. If the prohibition on expropriation has a relevant analytical connection to the prohibition on commodification, this is one powerful reason to make a distinction between qualified autonomy and contractual and proprietarized autonomy.8 This statement does not alone justify its application to the results of actions of excorporation. Whenever the action of exercising autonomy, or the outcome thereof, continue to be an expression of personality, it is understood that they are protected by that qualified autonomy. But that is no longer the case regarding excorporation, where the part separated from the body (or from the dead body) has been alienated from a live person by a voluntary act and has thus been assigned by that person to the outside world. Those objects, even if they are, according to his will, things—since principle of imperative altruism. She brings to light that this principle fails because it considers actions that are required by a duty of solidarity as supererogatory, and also because it absolutely forbids behaviors made for a personal interest, which the principle of solidarity does not impose as a duty. The first failure is the aspect that matters to that author; the second failure is the subject of analysis here. 8 A woman’s right to interrupt a pregnancy is currently recognized by Chilean law only in exceptional cases: danger to the woman’s life, the unviability of the child once born, or pregnancy resulting from rape (until 1989, Chilean law only authorized abortion for “therapeutic purposes”; between 1989 and 2017, Chilean law forbade any conduct intended to cause an abortion). Moreover, only as of recently is the right of spouses to dissolve a marriage recognized in Chile (2004), as well as the right of a patient to reject therapeutic treatment (2012); nonetheless, the law prevents exercise of the first of those rights and leaves the validity of exercising the second uncertain when there is a risk of death or a serious side effect to health. This demonstrates that the strong prohibition against commodifiability characterizing Chilean law is not due to a principle of qualified autonomy, but rather constitutes a case of legal moralism. The alliance between that moralism and the capitalism characteristic of the neoconservative position is a relevant fact for a liberal defense of the rights of autonomy; for that reason, it is important to examine the connection between non-expropriability and uncommodifiability.

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they are no longer constituent parts of his person—continue to be uncommodifiable for him. Despite the manifestation of will to terminate the condition expressing his personality, the person could only continue to exercise a qualified autonomy or perform an altruistic act of disposal regarding those objects, but he can never establish ownership in order to exercise contractual freedom for profit. The famous dictum by Kant, found in his Lectures on Ethics, that it is impossible to own oneself because of the need to distinguish between owner (person) and property (thing), and the impossibility of possessing both qualities simultaneously, is not pertinent in the case of excorporation.9 The question here is not why we cannot conceive personal autonomy as ownership of oneself, but rather why a person, in exercise of their personal autonomy, cannot, by an act of excorporation, redefine the organic presuppositions of their body identity in order to submit the excorporated object to the model of instrumental autonomy. Believing that the answer to the first question assumes the answer to the second implies depriving a person of a considerable margin of power to define his or her personal identity.10

7.3 Excorporation and Commodifiability Margaret Jane Radin has identified two opposing answers to this question.11 One answer comes from the Marxist trench; the other is the super-Benthamite clause. From the Marxist perspective, all actions taken under the model of private property and contractual freedom are alienated as their conception of freedom is linked to materializing a principle of universal uncommodifiability. For this reason, Marxists argue that all social institutions representing an exception to commodifiability are precious. Any restriction on commodifiability will be one more victory against capitalist alienation. For the Super-Benthamite clause, which, on the contrary, makes universal commodifiability the key to realizing freedom, exceptions are justified by reasonable conjectures about potential market failures. If those conjectures were removed, there would be no moral constraint on applying the rules of commodifiability entirely to the human body in whole or in part, dead or alive. Between one extreme and the other, Margaret Jane Radin prefers a pluralistic option justified by considerations that are rather strategic: endorsing Marx’s utopia, she opts for a transition via an evolutionary, instead of revolutionary, path. For that reason, her strategy is not to passively wait for the opportunity to implement revolu9 Immanuel

Kant, Ethica, p. 386 (in the standard edition by the German Academy of the Sciences of Moral Philosophy by Georg Ludwig Collins). 10 For this reason, arguing the legitimacy (of at least a range) of commodification of the human body does not imply assuming a dualistic (Cartesian) conception of the relationships between subject (mind, soul) and body, as mistakenly assumed by much of the literature (above all, Campbell 2009, p. 4 s.). The existence of an incorporeal subject holding ownership rights to a unique body does not need to be affirmed to recognize the power of “an incorporated self” to redefine the organic conditions of a person’s existence or survival. 11 Radin (1987 and 1989).

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tionary ideas but rather to aim for a coexistence of the principle of uncommodifiability with that of commodifiability, even in the market environment, which may lead to the predominance of uncommodifiability. Her strategy is to colonize, via the design of market inalienabilities, a non-commercial meaning of the action in the sphere of anonymous, mutually obligatory transactions. Accepting the coexistence of both principles seems reasonable, but from a perspective opposite to that of Margaret Radin. This position is not utopian but rather shares the classical liberal idea that realizing freedom via commodification and realizing freedom via uncommodifiability create a basic, and therefore irresolvable, tension in the modern concept of justice, such as the tension between the rights of individual autonomy and the rights of participation in the exercise of collective autonomy.12 For that reason, it should be considered that the purpose of the theory of justice is not to resolve or overcome that tension but rather to manage it. According to Margaret Jane Radin, the traditional form of management by liberalism has consisted thus far of building walls or—following Walzer’s well-known metaphor—to distinguish spheres. In her opinion, this implies granting an unrestricted legitimacy to the logic of commodifiability in a vast sphere of action, and she is not willing to make that concession. She defends a superior conception of autonomy, even in the market environment, through the design of inalienabilities. The position I prefer to defend in the field of bioethical problems is precisely the opposite, namely not conceding here a total exclusion of the logic of commodifiability. From the bioethical perspective, the defense of individual autonomy requires a plausible normative design granting a margin of commodifiability via excorporation, even for those who do not share the super-Benthamite radicality. From Radin’s viewpoint, this position would suffer from that tendency to validate the pure arbitrariness that infects everyone who adheres to the negative conception of freedom. From the point of view I am defending, Radin suffers from that distrust of diversity that infects everyone who rejects the negative conception of freedom. Roger Brownsword has coined the expression “bioethical triangle” to identify three competing ethical perspectives that give shape to the discourse on bioethics and, in that capacity, underlie the provisions in the most conspicuous regulatory texts, both hard and soft: the utilitarian perspective, which encourages the maximization of wellbeing; the perspective of human rights, which prioritizes the respect for individual autonomy; and the perspective that he calls the “dignitarian alliance.”13 The axiom of this latter perspective is that no action may affect human dignity, regardless of the benefits it may generate and regardless of the consent of those participating in that action who bear its consequences. It is described as an “alliance” by Brownsword because it is reached through the adoption of different ethical theories or religious 12 The statement that the recognition of a space of inalienable freedom is a distinctive note of liberalism as opposed to libertarianism has been widely defended by Freeman (2001). This is a principle shared by classical liberalism, as John Tomasi has carefully pointed out (2012, pp. 48 and 69). Nevertheless, from a Rawlsian perspective, Jon Quong has clearly noted the anti-perfectionist potential of the commodified conception of freedom (2011). In general, on the commodified conception of freedom of Nozick and Steiner, see Flikschuh (2007). 13 See Brownsword (2009, p. 93); also Brownsword (2003, p. 15).

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perspectives. The alliance is formed, inter alia, by Kantians, Aristotelian or Hegelian communitarianists, Roman Catholics, Marxists and, of course, Margaret Jane Radin. In other to justify the uncommodifiability of the human body, there are several reasons that are pertinent to a discussion between the utilitarian perspective and the human rights perspective. The most important of these reasons is that the creation of a market for parts of the human body or human cadavers would inevitably lead to an asymmetrical distribution among potential buyers and potential sellers based on their wealth or poverty, respectively. According to this argument, the risk of asymmetric exploitation is too great. This argument is prevalent in other contexts of bioethical debate, particularly that of legal authorization of euthanasia. This is not surprising, as unrestricted commodification would obviously involve assisted suicide and consented homicide. There is abundant literature on these reasons, both confirming and rejecting them. An examination of that literature is not only interesting but also urgent in light of the evidence available on the existence of black markets for human cells, tissues and organs, which obviously generates the feared resulting abuses.14 But that is not the focus of my interest. What I am interested in here is confronting the objection of principle,15 that is, the thesis that any concession to the commodifiability of the human body constitutes an intolerable impact on human dignity. The core of the problem lies in the contrast between human dignity and individual autonomy; or, to be more precise, in the invocation of human dignity, not to justify the recognition of the manifested will of the individual, regardless of its content, but rather to qualify the content of that will as unworthy of recognition.16 This idea of dignity restricting freedom can be argued for in any of the wide variety of alternative theories belonging to the alliance, ranging from considering divine revelation to be the criterion for recognizing what violates human dignity, to emphasizing the contrast between the person’s will, characterized by the presence of second-order volitions (a robust deliberation), and the pure discretionary whim, understood as a mere first-order volition (a desire). Instead of facing the overwhelming task of elaborating a taxonomy of that alliance, I will address the question by subjecting it to two tests: (i) the displacement test; and (ii) the enslavement test.

14 For

a view of the whole, see Wikinson (2003), especially p. 101 s., and also the different contributions to Steinmann (2009). 15 The distinction between the argument of avoiding abuse and the argument of principle comes from the distinction by Michael Sandel between the arguments on coercion and the arguments on corruption as classes of anti-commodification arguments; see Sandel (2003). 16 The dual consideration of human dignity as a justification for recognizing freedom and as a justification for restraining freedom, and the identification of the progressive preponderance of the second consideration in the discourse on bioethics, comes from the work by Brownsword (2009 and 2003) together with Byeleveld (1998) and Brownsword and Byeleveld (2001).

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(i) The displacement test17 consists of distinguishing between appealing to dignity to justify forbidding all excorporation or to justify forbidding only excorporations aiming to transfer to another person the powers of use or disposal of (all or) part of the body, whether it be considered (part of) the power over one’s body or over ownership of one’s body. The first alternative is easily recognizable when dignity is invoked to restrict any type of intervention in one’s own body that will extinguish or diminish one’s capacities because it is considered to be an attack against bodily health or integrity. In this case, it involves theories of dignity that intend to justify the coercive imposition of duties towards oneself.18 The magnitude of the discrepancies between a position of this kind and bioethical utilitarian and human rights perspectives turns the discussion into a debate about the more general assumptions of moral theory. On the other hand, to the extent that the second alternative consists of a restriction of modes of treatment, the duty that it asserts can be defined as a prohibition directed primarily towards whomever acts in order to gain a benefit, for himself or for a third person, from the displacement. In other words, it is no longer a duty towards oneself and acquires the nature of a duty of justice, i.e. toward another. This sort of otherness brings the consideration of dignity closer to the harm principle. The difference survives, of course, to the extent that the principle volenti non fit iniuria is excluded: the undignifying treatment of another cannot be validly agreed to by that person. That is the problematic residue. It is interesting to note that this argument cannot then be classified as paternalism or perfectionism as it admits the efficacy of the volenti in all interactions of assisted self-harm or consented harm, provided that they do not imply displacement. (ii) The test of the slavery contract consists of admitting that a case of undignifying treatment can be identified that, even from a human rights perspective, cannot be legitimized by the consent of the person who is the subject of that treatment. That case is becoming a slave under a freely agreed contract. Suppose that, unlike in the super-Benthamite clause, contractual slavery is rejected as an institution for being unconditionally incompatible with the principle of respect for personal autonomy and that, therefore, we reject that the right of personal autonomy encompasses the freedom to agree irrevocably to be enslaved to another. This would imply that there is a case of inalienability and uncommodifiability of the 17 Here I use the word “displacement” (from the German Verschiebung) in the same way that criminal law doctrine treats crimes against instrumental interests. Unlike attacks against life and bodily integrity, which are paradigmatically crimes of diminishment, i.e., pure damage to the victim, in attacks against property, a systematic distinction arises between crimes of diminishment and crimes of displacement, that is, damage to the victim with a correlative benefit to another. These latter are the most important crimes: theft, robbery, extortion, fraud. The displacement test shows that a moral difference is made between pure self-diminishment (or even pure consented-by-other diminishment) and diminishment that is correlative to an increase for another. 18 The consideration that these duties are a legitimately enforceable is inherent to Catholic moral theology (Thomas Aquinus, Summa Theologiae II-II, q. 64 a. 5). The consideration of moral duties to oneself asserted by Kant to be non-enforceable, yet legally relevant, standards of behavior (for example, to invalidate consent to hetero-diminishment) also characterizes an argument in German criminal law doctrine (Maatsch 2001).

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use of the human body that seems to be common to the human rights perspective, the dignitarian alliance and at least some of the variants of the utilitarian theory.19 The displacement test paves the way for the super-Benthamite clause. To the extent that the prohibition against affecting dignity involves ways of treating others to the benefit of someone other than that person, it is always possible to argue that qualifying the treatment as undignifying in fact abridges (or even conceals) the utilitarian reasons justifying that prohibition. Yet the second test puts the clause in question. To the extent that a prohibition of treatment is considered a categorical imperative, regardless of the condition of consent, a realm of obligatory exercise of autonomy is recognized, which is precisely what a theory of dignity asserts. The displacement test is important not just because it helps to classify theories from the viewpoint of a greater proximity to a fundamental moral principle of respect for autonomy. Explaining the violation of the respect for human dignity on the basis of the treatment that the person who excorporates part of his body is caused to suffer by the person interested in appropriating it makes the inappropriateness of attempting to provide a temporary solution to the problem more evident. This is because the commodification subsequent to the excorporation could no longer, by definition, imply a risk of reification of the person. When excorporation takes place in a context defined by the anticipation of displacement of the excorporated object, its reification takes effect ex ante, by definition. This does not mean that all rules on ownership and contractual freedom must take effect, by definition, prior to the act of excorporation but rather that the meaning of reification can affect the person. Obviously, this temporal projection is what makes Kant’s argument against the ownership right over oneself plausible. The importance of the slavery test is that it brings to light the congruence between the recognition of autonomy and the compulsory requirement to exercise autonomy that justifies excluding the irrevocable relinquishment of its exercise ex nunc from the universe of acts covered by its exercise. This sense of alienability of the condition of being a free man is easily transferrable to the meaning of inalienability of the right to life and to bodily integrity; in that capacity, it constitutes a limit on the commodifiability of the human body, making promises of self-harm unenforceable by coercion, with or without displacement after the harm. On the basis of that premise, the scope of the controversy runs in two directions. First, the question arises as to whether the prohibition on an irrevocable relinquishment of the right extends to the act of disposal with de facto irrevocable effects. That extension is not possible regarding the status of free man, because the alteration of that status is not a de facto effect but rather a normative one. Yet, in the case of suicide and excorporation by one’s own hand or by consenting to irreparable by-other harm, it is possible. The difference 19 The classical place of the liberal perspective

is the passage on the slave in Chap. 5 of On Liberty, by John Stuart Mill: “The principle of freedom cannot require that he [i.e., who sells himself as a slave] should be free not to be free. It is not freedom, to be allowed to alienate his freedom” (Mill 2009, pp. 102–104). Please note that what is unacceptable is not the de facto condition of being a slave—which, as long as it rests on actual and essentially revocable intent, is not a problem for Mill—but rather the irrevocable relinquishment of the condition of being a free man.

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between normative effects and de facto effects seems crucial to the prohibition of the irrevocable relinquishment precisely because its meaning is associated with the ‘de facto’ possibility of reversing the irrevocably agreed-upon situation. For that reason, its generalization is doubtful. The second scenario of the controversy around the slavery test refers to the scope of its understanding as a condition of autonomy and not as justified paternalism, as Margaret Radin argued against Joel Feinberg.20 The question in this scenario consists of identifying the consequences to the conception of autonomy because its recognition requires an inter-subjectively recognized range of exercise. Can we infer the plausibility of the positive concept of freedom defended by Radin and, generally, by the members of the dignitarian alliance from this requirement? That concept maintains a connection so robust between the authenticity of will and normative ethics that it inevitably ends up making the moral correction of the action the only proof of freedom. There is, of course, an abyss between the minimum obligation of being free by permanently exercising a discretionary will, such as that defended by Mill, and the thesis that one is only free when moral obligations are fulfilled. That abyss is called freedom.

7.4 The Scope of Commodifiability Hegel’s well-known justification for the alienability of personal labor is intended to shed light on a relationship that we assume between “interiority” and “totality” when we distinguish the corporeal personality from things that can be owned. Hegel theorizes that a total commitment of corporeal capacity is required to affect personality.21 Regardless of the merit to be attributed to that justification of appropriation of another’s work, the passage shows that our subject/object, person/thing, internal/external distinctions are not in a unilateral relationship with the autonomy/ownership distinction that would permit descriptive judgments that are both independent from it and relevant to it. Applying a distinction between person and thing to the context of excorporation reveals such an interdependence. It is obvious that the distinction between a living human organism and the environment is not inconsistent with the existence of processes for the exchange of components of both: inhalation and ingestion are processes for the incorporation of things to the body; exhalation and excretion are processes of excorporation. The healthy survival of the organism requires that these 20 Feinberg

(1971). is well known that §§65, 66, and 67 of the Grundlinien begin by asserting the inalienability of whatever is by nature interior to the subject, consequently comprising his person, and they end up asserting the alienability of part of the time and product of personal activity, thereby dissolving the interior/exterior distinction into the total/partial distinction (G. W. F. Hegel, Grundlinien der Philosophie des Rechts, oder Naturrecht und Staatswissenschaft in Grundrisse, in: Georg Wilhelm Friedrich Hegel’s Werke, Vollständige Ausgabe, Tome VIII, Berlin: Duncker und Humblot, 1833, pp. 105–108). 21 It

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processes take place. It is therefore evident that the internal/external distinction does not precede the normative categories of person and thing, but rather is predicated on the basis of those categories. One can object that these examples encompass components of the living body that do not belong to its cellular structure, while the principle of uncommodifiability restricts its scope to cells, tissues, and organs of the human body. But going from one category to another is easy. Cellular composition of the excorporated object does not alone make excorporation, and the eventual commodification, problematic according to the existing normative categories of person and thing. Cutting one’s hair and nails, exfoliating skin, and menstruating form a class of actions or processes that manifestly excorporate components of the cellular structure but do not raise questions about those categories. Of course, it does not follow from the fact that cut hair is unequivocally a commodifiable thing that all excorporation is legitimately commodifiable. However, it does allow an argument by analogy of a range of excorporating actions that do not compromise personality, which meet three conditions: the action is taken regarding (i) a part (ii) that is naturally renewable (iii) of a living body. The range thus defined encompasses three main categories of objects based on the circumstances of their excorporation.22 First, there are objects of excorporation that are more or less habitual in the organism: depositions, urine, milk, menstrual discharge, and cells exfoliated from the epidermis. Second, there are objects of sporadic excorporation resulting from actions or the occurrence of states of things considered to be valuable, or at least not denigrating: the placenta, the amniotic sac, and the umbilical cord because of birth, and blood and tissues discarded after surgery. Finally, there are objects of excorporation obtained by a deliberate intervention in one’s own body for that sole purpose: blood, cells, and tissues or organs that are removed. There is a difference between the objects in the first two categories and those in this latter. In first two categories, excorporation occurs by disposal of the body or as an indirect effect of human action on the body from which the alienated object is taken for a therapeutic purpose. The objects in the third category are excorporated deliberately by human action that is taken for that purpose. This difference gives the anticipation of the displacement, in the sense of treatment of whomever excorporates, an intensity in this context that it cannot have in the previous contexts. This is why treating these objects as commodifiable is more problematic than the treatment of the objects in the first two categories. In the literature on the commodifiability of the human body, the Hegelian argument on partiality is well known, namely that the commodification of a part of the body does not compromise personality.23 The weakness of the argument lies in its disregard for the criteria by which we identify a person in reference to his body. The person 22 I leave pre-implant zygotes and embryos, stem cells, and even gametes out of this analysis. The question of whether or not to equate them to a general rule on renewable parts of the human body is in itself a morally controversial question. I also leave out interests other than the establishment of ownership over the excorporated object, such as privacy of information and the rights to control the use or fate of cells and tissues that might be compulsively exercised in respect of the possessor thereof after assignment or that, if harmed, could result in obligations to compensate the possessor. 23 See Campbell (2009, p. 15 s).

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is not the non-physical soul nor the Kantian noumenal subject but rather a living corporeal being. For that reason, a part of the body can compromise personality, but not so its temporary use. The weakness of the argument disappears if we require, as has been done here, that excorporation be performed regarding a renewable part of the body. The attribute comprising the identity of the person is not its immutability or identity in the sense of ‘sameness.’ Personal identity is ‘ipseity:’ its attribution is not incompatible with change.24 This is obviously predictable of a living organism: its components are constantly renewed within the boundaries defined by its membranes. Saying that personality is compromised in the permanence of a renewable component of the body is the same as fixing the personal identity in a photograph. The commodifiability of renewable parts of the human body, i.e., taking them as objects that can be excorporated for displacement for consideration, is permitted by the law of the United States of America25 It is not, however, in Chile or in Europe. In Chile, the rules in Book IX of the Sanitary Code apply the same principle of imperative altruism defined in the law on organ transplant to the transplantation of tissues or parts of the body of a living person.26 In Europe, Directive 2004/23/EC of the European Parliament and Council on procurement and distribution of human cells and tissues, issued March 31, 2004, prohibits across the board the commodification of parts of a living body, parts of a dead body, or the entire dead body by excorporation if that biological material is procured for third parties for therapeutic purposes. The distinction between excorporation done for therapeutic purposes and excorporation done for other purposes—the directive only covers the former—can be explained in terms of the purpose of establishing standards of quality and safety for human cells and tissues to be used in a human body in order to guarantee a high level of protection of human health (Article 1). However, in application of Article 12, the principle of uncommodifiability takes effect in its regard: the thing can be abandoned at the discretion of another, but that abandonment must be performed for free. Why this difference? Why does Europe not extend the logic of hair to cells and tissues? One possibility to explain the difference in treatment is the therapeutic use of the parts. Remark 18 of Directive 2004/23/EC understands it in this way: “As a matter of principle, tissue and cell application programs should be founded on the philosophy of voluntary and unpaid donation, anonymity of both donor and recipient, altruism of the donor and solidarity between the donor and recipient.”27 This would appear 24 For a distinction between selfhood and ipseity based on the question of permanence of the former over time, see Ricoeur (1996 p. 109 s). 25 See Rao (2000) and Hardcastle (2007, especially p. 63 s). 26 The reason dates back to the text on the joint regulation of both procedures in that book introduced by Law 18,173 of 1982. The transplant procedure is currently regulated by Law 19,451 of 1996, as subsequently amended. Article 17 of the Regulations to Book IX of the Sanitary Code exempts from its provisions “The donations of sperm, eggs, blood, bone marrow, bones, skin, skin appendages as well as any product of conception that is not born alive” in order to not subject them to formalities. The principle of imperative altruism contained in article 145 of the Sanitary Code is fully applicable to them. 27 Official Journal of the European Union L 102/48 for April 7, 2004.

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to be reinforced by the fact that Directive 2004/23/EC excludes from its scope of application the procurement of cells and tissues for research for purposes other than their application to the human body, such as in vitro research or on animal models. But this is a false appearance for three reasons. First of all, it is evident that the aforementioned exclusion from the scope of the Directive is due primarily to another reason: the irrelevance of the primordial goals of quality and safety with a view toward protecting the health of the recipients of those cells, tissues, and their derivatives. It is so obvious that this is the fundamental reason that the Directive alternatively includes in its scope of application the procurement of cells and tissues for industrial production. More important than that contextual consideration is that, as a matter of principle, despite its categorical imperative rhetoric, it cannot hide the fact that it is a choice of a regulatory model of altruism that simply replicates the option adopted by Directive 2002/98/EC on the procurement of blood. That Directive recognizes more humbly and honestly in its paragraph 20 that: “Modern blood transfusion practice has been founded on the principles of voluntary donor services, anonymity of both donor and recipient, benevolence of the donor and absence of profit on the part of the establishments involved in blood transfusion services.”28 This was the model of altruism, famously defended by Richard Titmuss in 1970 for the organization of the English blood procurement system. Although it is true that Titmuss wielded arguments suitable for dignitarian alliance, which since then has been used by that alliance (the presumption in Directive 2004/23/EC shows his influence in its construction), the fact is that the bulk of his arguments were rather consequentialist, both economically and sociologically, that is, they were not arguments of principle. For that reason, in the framework of Tittmus’ conception, the question of whether to organize a free system or a paid system of blood procurement is strictly a matter of public policy, not a question that can be immediately answered on the basis of the principle of respect for human dignity.29 Thirdly, the relationship between donor and recipient may be mediatized in such a way by intermediate processes, in many cases manifestly based on the commodification of blood and its components, the cells and the tissues procured, that the very idea of a solidary bond loses meaning. The most obvious case is that of an investigation like that of Moore vs. Regents of the University of California (1990),30 in which a patent worth millions of dollars was granted for a cellular lineage of spleen cells procured from a patient suffering from spleen cancer. Of course, the question of the status of the research may be equivocal under Directive 2004/23/EC because of its public health priorities. Yet the alternative solution created by the Directive is also unacceptable: if the case is covered by the Directive, Moore must be properly informed but cannot obtain any benefit from transferring biological materials; and if it is not covered, the only true thing in his regard is that the duty of information ordered by article 18 does not apply. The Directive does not preclude that the subse28 Official

Journal of the European Union L 33/30 for February 8, 2003. a critical analysis of the arguments by Tittmus, see Skýora (2009, p. 13 s). 30 51 Cal. 3d 120, 793 P.2d 479; 271 Cal. Rptr. 146. 29 For

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quent manufacturing of the biological materials commodifies them. If that happens, the recipient of that manufactured material does not pay for an incorporation service, but rather makes a direct purchase of a thing that he incorporates. In this context of ensuing commodification, there are no reasons of principle to require altruism by the source. Of course, there are other kinds of reasons. One must assure the flow of blood, cells, and tissues into the system, and commodification at the source might create transaction costs that will block that flow. This is an important argument, without a doubt, but it is an argument on maximizing general wellbeing, i.e. the antithesis of the argument of principle on which the regulation is supposedly based. In summary, the conception of the excorporation of blood, cells, and tissues as an imperatively altruistic act uses a rhetoric inherent to the dignitarian alliance to conceal the true reasons for denying the immediate alienability and commodifiability of the part of the body excorporated. Those are all utilitarian reasons. An examination of the conclusiveness of those reasons is blocked by the dignity rhetoric. That is the precise function of invoking the argument on dignity: to dogmatically inhibit critical thought. Acknowledgements I thank the Academic Committee of the Chile-France Michel Foucault Chair for its authorization to include this article, which is a revised version of “Sí mismo y cuerpo propio: ¿(In)disponibilidad, (in)alienabilidad, (in)comerciabilidad?,” published in: La Irrupción del Cuerpo/Oralidad: Memoria, Relatos y Textos - Actas IV y V Escuela Chile-Francia (Cátedra Michel Foucault), Santiago, 2013, pp. 79–98.

References Brownsword, Roger. 2003. Bioethics Today, Bioethics Tomorrow: Stem Cell Research and the ‘Dignitarian Alliance’. University of Notre Dame Journal of Law, Ethics and Public Policy 17: 15. Brownsword, Roger. 2009. Property in Human Tissue: Triangulating the Issue. In ed. Michael Steinmann, et al., 93. Brownsword, Roger, and Deryck Byeleveld. 2001. Human Dignity in Bioethics and Biolaw. Oxford: Oxford University Press. Byeleveld, Deryck. 1998. Human Dignity, Human Rights and Human Genetics. The Modern Law Review 61: 661. Campbell, Alastair V. 2009. The Body in Bioethics. Londres y Nueva York: Routledge. De Lora, Pablo. 2003. Entre el vivir y el morir. México: Fontamara. Fabre, Cecile. 2006. Whose Body is Anyway?. Oxford: Oxford University Press. Feinberg, Joel. 1971. Legal Paternalism. Canadian Journal of Philosophy 1: 105. Flikschuh, Katrin. 2007. Freedom—Contemporary Liberal Perspectives. Cambridge, UK: Polity Press. Freeman, Samuel. 2001. Illiberal Libertarians: Why Libertarianism Is Not a Liberal View. Philosophy & Public Affairs 30: 105–151. Garzón Valdés, Ernesto. 1999. Algunas consideraciones éticas sobre el trasplante de órganos. In Bioética y Derecho. Fundamentos y Problemas Actuales, Rodolfo Vásquez (comp.), 216. México: ITAM-Fondo de Cultura Económica. Hardcastle, Rohan. 2007. Law and the Human Body. Oxford y Portland: Hart Publishing. Harris, J.W. 1996. Who Owns my Body? Oxford Journal of Legal Studies 16: 55.

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Maatsch, Asmus. 2001. Selbstverfügung als intrapersonaler Rechtspflichtvertoß. Berlin: Dunker & Humblot. Mill, John Stuart. 2009 [1989]. On Liberty. In ed. Stefan Collini. Cambridge: Cambridge University Press. Quong, Jon. 2011. Left-Libertarianism: Rawlsian not Luck Egalitarian. Journal of Political Philosophy 19: 64–89. Radin, Margaret Jane. 1987. Market Inalienability. Harvard Law Review 100: 1849. Radin, Margaret Jane. 1989. Justice and the Market Domain. In Markets and Justice, ed. John W. Chapman and J. Roland Pennock, 165. Nueva York y Londres: New York University Press. Rao, Radhika. 2000. Property, Privacy and the Human Body. Boston University Law Review 80: 359. Ricoeur, Paul. 1996. Sí mismo como otro. México: Siglo XXI Editores. Sandel, Michael. 2003. Note: The Price of Everything, the Value of Nothing: Reframing the Commodification Debate. Harvard Law Review 117: 689. Skýora, Peter. 2009. Altruism in Medical Donations Reconsidered: The Reciprocity Approach. In ed. Steinman, et al. supra, 13. Steinmann, Michael, Peter Sýkpra, Urban Wiesing. 2009. Altruism Reconsidered. Farnharm/Burlignton: Ashgate. Tomasi, John. 2012. Free Market Fairness. Princeton and Oxford: Princeton University Press. Wilkinson, Stephen. 2003. Bodies for Sale. Nueva York: Routledge.

Part III

Biomedical Research with Human Subjects

Chapter 8

Outsourcing Clinical Trials to Latin America: Causes and Impact Nuria Homedes and Antonio Ugalde

Abstract The article reviews the international clinical research projects that were conducted in Latin America prior to the surge in the globalization of clinical trials. It also explains the late interest of the pharmaceutical industry in outsourcing clinical trials in the region, and shows the institutional and regulatory adaptations that countries had to implement to accommodate those interests. The need for implementing the trials in accordance with protocol at appropriately equipped research sites and by qualified researchers, and in compliance with internationally accepted ethical standards is also discussed. Based on these discussions, the article analyzes whether clinical trials in Latin America have actually resulted in tangible benefits for its population. Keywords Clinical trials · Outsourcing · Regulatory agencies

8.1 Introduction The outsourcing of clinical trials to Latin America began to accelerate in the decade of the 90s, a very late start compared to the swift process of globalization of other industries after the signing in 1947 of the General Agreement on Tariffs and Trade (GATT). The manufacturing industries were interested in the abundant labor and low wages found in developing nations. However, the pharmaceutical industry is capital intensive, and it has been suggested that outsourcing clinical trials, the most labor-intensive component of drug development, did not compensate for the risk of exposing industrial secrets in locations where they could not be securely guarded.

N. Homedes (B) Salud y Farmacos, El Paso, TX, USA e-mail: [email protected] A. Ugalde Department of Sociology, University of Texas-Austin, Austin, USA e-mail: [email protected] © Springer Nature Switzerland AG 2019 E. Rivera-López and M. Hevia (eds.), Controversies in Latin American Bioethics, International Library of Ethics, Law, and the New Medicine 79, https://doi.org/10.1007/978-3-030-17963-2_8

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In this chapter we review the international clinical research projects that were conducted in Latin America prior to the surge in the globalization of clinical trials, explain the late interest of the pharmaceutical industry in outsourcing clinical trials in the region, and show the institutional and regulatory adaptations that countries had to implement to accommodate those interests. We also examine the success of these noble initiatives. We discuss the need for implementing the trials in accordance with protocol at appropriately equipped research sites and by qualified researchers, and in compliance with internationally accepted ethical standards. In response to these needs, many governments in the region created national regulatory pharmaceutical agencies, which issued regulations and norms to safeguard the implementation of clinical trials in Latin America. Finally, we analyze the forces that maintain the desire to implement clinical trials in Latin America and question if this policy results in tangible benefits for its population.

8.2 The History of Outsourcing Clinical Interventions to Latin America: The Early Years 1945–1990 There are no comprehensive records of the clinical intervention projects conducted in Latin America and sponsored by foreign entities prior to the late 1990s. According to available information, there were a few clinical interventions, and most failed to benefit the population involved. One of the first interventions was discovered by chance by Susan M. Reverby, a historian at Wellesley College—and took place between 1946 and 1948 in Guatemala. The intervention was funded by the United States government and carried out by its Public Health Services (PHS). Funds were transferred to Guatemala by the Pan American Sanitary Bureau that in 1949 was integrated into the United Nations as the Pan American Health Organization. The following paragraph hints at why the information of this trial remained hidden in the archives of the University of Pittsburgh where Dr. Cutler, the project director, had taught and stored the archives of the Guatemalan experiment since 1968. Cutler and the other physicians chose men in the Guatemala National Penitentiary, then in an army barracks, and men and women in the National Mental Health Hospital for a total of 696 subjects. Permissions were gained from the authorities but not individuals, not an uncommon practice at the time, and supplies were offered to the institutions in exchange for access. The doctors used prostitutes with the disease [syphilis] to pass it to the prisoners (since sexual visits were allowed by law in Guatemalan prisons) and then did direct inoculations made from syphilis bacteria poured onto the men’s penises or on forearms and faces that were slightly abraded when the “normal exposure” produced little disease, or in a few cases through spinal punctures. Unlike in Alabama [the Tuskegee syphilis experiment that Cutler directed a few years later], the subjects were then given penicillin after they contracted the illness. However, whether everyone was then cured is not clear and not everyone received what was even then considered adequate treatment. (Reverby 2011: 2)

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During the sixties and seventies a few clinical trials were implemented in Costa Rica. In 1962, the Louisiana State University signed a contract with the Costa Rica Ministry of Health creating the International Center for Medical Research and Training (ICMRT) that was financed by the United States National Institutes of Health (NIH) (Ugalde and Homedes 2014a). Some four years later, due to restrictions imposed by the United States Senate on the use of NIH funds in international programs, the Institutes withdrew from the ICMRT, and the Louisiana State University continued carrying out vaccine clinical trials with funding from international pharmaceutical companies. Merck-Sharp-Dohme ended up contributing 79% of the ICMRT budget (Trejos 1986). Trejos, from the National University of Costa Rica, mentioned that Dr. Víctor Villarejos, director of ICMRT, informed him that the Institute was implementing vaccine trials in other Central American countries including El Salvador, Honduras and Nicaragua, all very poor countries (Trejos 1977), but we have not been able to find any additional information about these trials. In Costa Rica, in 1968 and 1969, the ICMRT recruited 15,766 children, or almost 1% of the entire population, to be vaccinated against measles and rubella or a combination of mumps-measles or measles-smallpox, all provided by Merck-Sharp-Dohme (Trejos 1986). In 1974 and 1975, 34,000 participants including children were to be enrolled in clinical trials of two formulations of three different strains of the influenza virus with adult-only vaccines also provided by Merck-Sharp-Dohme. The clinical trials were not authorized by the Ministry of Health, and children were enrolled without parental consent. One of the vaccines had been tested on a small number of adults in Great Britain and although it was commercialized, it was quickly withdrawn from the market due to “inconvenient” reactions. The pharmaceutical company then imported 25,000 vaccine dosages from Great Britain for the Costa Rican trials. The National University of Costa Rica carried out a study involving a statically significant sample of the vaccinated children and found that 70% had suffered local or systemic reactions. After reviewing these results, the Ministry of Health stopped the trials and asked ICMRT to never again conduct clinical trials without prior approval. By then, 20,000 children had been vaccinated (Trejos 1986). In those days Costa Rica was a poor country, and the children for the trials were chosen from rural populations and marginal neighborhoods in San Jose, the capital. In 1976, the ICMRT submitted several protocols of vaccine trials to the Ministry of Health for approval, but they were rejected on the consideration that they did not address the country’s health needs. Nevertheless, that same year, the Ministry did approve two vaccine trials, one for measles and another for the respiratory syncytial virus that affects children during the cold months in temperate countries, a condition that hardly applies to Costa Rica. The lowest temperature throughout the year in San Jose (elevation 3.753 ft) is never less than 58 °F and seldom less than 60; and the highest is always above 80, while the lowlands of Costa Rica are considered tropical. The measles vaccines used in the approved trial had expired seven years earlier, a fact unknown to the Ministry and the syncytial vaccine was given to a higher number of children than the Ministry had approved. The two vaccines were tested in poor neighborhoods. In the case of the syncytial vaccine, all children were recruited from

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three public day care centers for poor children and parental written permissions were not requested before enrollment (Trejos 1986). The same year, the Costa Rican Children’s Foundation (El Patronato Nacional de la Infancia) at the request of the mothers of the vaccinated children and a public health civil organization petitioned the Ministerio Público (Public Ministry) to evaluate whether ethical violations had occurred during the trials. The Ministry’s function is to protect citizens and, when appropriate, it files criminal cases, which in this case it did the following year. However, the courts could not sanction the ICMRT because clinical trial violations were not included in the Costa Rican legislation, and the Ministry of Health was not authorized to penalize the pharmaceutical corporations. In 1977, the National Assembly appointed a Commission of Special Affairs to investigate the allegations. The Commission confirmed the claims: the ICMRT had conducted clinical trials without the authorization of the Ministry of Health, used vaccines that had expired seven years earlier, and children had participated in the trials without parental permission. The National Assembly approved a bill amending the General Health Law by adding articles incorporating the values enshrined in the Declaration of Helsinki (Asamblea Legislativa, de Costa Rica 1976). The President of the country, in accordance with the recommendation of the Ministry of Health, vetoed the bill (Ministerio de Salud 1976). It was not until 2010 that, in response to a citizen’s request to the Supreme Court to review human rights violations during clinical trials, the Court forbade the implementation of any new trial until the National Assembly approved a bill regulating clinical research. Finally, the Assembly after four years of bitter debate among political parties approved a bill that was subsequently signed by the President (Asamblea Legislativa 2014). As of today, Costa Rica is the only Latin American country with a law that regulates clinical trials. Presidential decrees, resolutions, and regulations are used by the rest of the countries, and history shows that these legal instruments are easily modified according to the swings of the political pendulum. At times the regulations are improved but they also may be weakened. The case of Costa Rica, a country with a stable democracy, an active civil society, a working judicial system and steady economic growth, provides a glimpse of the power of the global pharmaceutical corporations, which were able to obstruct the approval of a law to regulate clinical trials for 38 years. Contrary to the situation in Costa Rica, we have found very little information about clinical interventions that were sponsored by foreign entities, and conducted during this first period in Argentina, Brazil, Chile, Colombia, Mexico and Peru, and today these are the countries where 90% of all clinical trials are conducted in the region. Freitas et al. wrote that in Brazil, the global pharmaceutical corporations did not express interest in the implementation of clinical research until the mid-1980s, a date that coincides with the end of the military dictatorship. European and United States investigators then began to invite leading hospitals and research centers to participate in clinical trials (Freitas et al. 2014). In Argentina, the 1964 Medicines Law (No. 16.463) declares that drugs must show their efficacy and safety through controlled clinical trials. Although clinical trials were conducted in the 1980s, in the absence of a registry, it is impossible to

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know how many were conducted during that period. The Argentinean Regulatory Agency, ANMAT, was created in 1992 but it did not register the trials retrospectively (Mondino 2003). In the case of Mexico, we have not identified any public information about clinical trials, their quality and/or related ethical concerns, prior to 1990. We know that in 1987 there was no clinical trial registry. Article 10 of the Regulation of the General Act Related to Health Research requires that in order to: “… Coordinate and Promote Scientific Development and Technology… the Ministry [of Health] will publish formal rules for institutions where research will take place, and for the registration and monitoring of projects.” (De la Madrid 1987). Mexico did not participate significantly in clinical trials, and in 1992 Mexico did not have an auditing system: “…the majority of clinical drug tests in Mexico come from abroad, not many Mexican investigators collaborate closely with pharmaceutical companies… Mexico itself has no formal government system for the auditing of trials” (Castellanos and Chiprut 2002).

8.3 The Growing Interest in Outsourcing Clinical Trials to Latin America in the 1990s The innovative pharmaceutical industry aims at maximizing its profits by expanding the period of market monopoly for its innovative products, and one of the strategies is to shorten the duration of clinical trials by expediting recruitment. Recruiting clinical trial volunteers in high income countries had become increasingly difficult and was delaying the completion of clinical trials. It is within this context that the pharmaceutical industry developed an interest in recruiting patients in middle and low income countries that could fulfill certain conditions. These included: fast recruitment and high retention of enrolled volunteers; respect for intellectual property rights; reliable research sites and qualified researchers capable of implementing clinical trials in accordance with the International Conference of Harmonization, and good clinical practices (ICH-GCP); assurance that the clinical trials would be approved by a research ethics committee, as required by ICH-GCP; and the existence of a regulatory agency that would guarantee that all the above conditions were being met.

8.3.1 Fast Recruitment and Retention of Clinical Research Volunteers Several factors facilitate the speedy recruitment of research volunteers in Latin America where the population is largely urbanized and there are very large hospitals in major cities. Many patients can be recruited in a relatively low number of research sites requiring a relatively low number of principal investigators. The concentration of clinical research infrastructure in a few sites also simplifies the logistics involved

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in the clinical trial implementation process from regulatory approval to contracting and training of personnel and then monitoring of the clinical trials. And it guarantees the availability of eligible clinical trial participants. While, the second part of the twentieth century witnessed profound sociodemographic changes in the entire world, Latin America experienced massive ruralto-urban migration earlier than in other third world countries. Millions left impoverished rural villages and moved to shanty towns and favelas in major urban centers looking for jobs and a better life. Latin America was transformed from a rural to an urban society (45% rural in 1955 to 74% urban in 1995), and at the same time experienced a population explosion (from 87 million to 355 in the same years). Urban infrastructure was slowly built to service the rapidly expanding number of urban dwellers. In the health sector, colonial hospitals were refurbished and new ones built. By the 1990s, a substantial number of large hospitals offered high quality medical care and could serve as research sites. Contrasting with the level of infrastructure, the public sector did not offer a steady supply of pharmaceuticals. According to the Pan American Health Organization (2016) up to 60% of the pharmaceutical expenditures are out of pocket and low-income families purchase remedies in flea markets. Therefore, poor urbanities could be easily recruited into clinical trials to access treatment. Moreover, having been unexposed to prior treatments, the participation of those naïve patients offers methodological advantages to clinical trial sponsors. In recent years, concerns have been raised about the mismatch between the characteristics of the clinical trial participants, who tend to be male adults with few or no comorbidities, and the population who are more likely to consume the new pharmaceuticals, which includes patients of both sexes, children, pregnant women and people with other concomitant health problems. Major regulatory agencies are incentivizing the implementation of clinical trials in children and pregnant women, and in addition to having a larger pool of children in middle and low-income countries, mothers in high income nations are likely to be more reluctant to enroll their children in a clinical trial than their counterparts in less economically developed nations. In addition, for a constellation of reasons that are beyond the scope of this chapter, it has been documented that the retention rates of clinical trial participants in lowand middle-income countries is double that in high income countries (Kline 2001). Retention rates are a critical component in the timely conclusion of clinical trials.

8.3.2 Respect for Intellectual Property Rights The industry has always placed as its highest priority maintaining the secrecy of all documentation related to the development of new drugs. Clinical trials are the last stage of a lengthy development process and must be carried out outside of the organization’s buildings. Sensitive documents are exposed to outside workers in hospitals, universities, Contract Research Organizations (CROs), and research sites. The pharmaceutical companies file multiple patents, at times hundreds—to protect

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every aspect of the drug development process. Before outsourcing clinical trials, an essential part of drug development, the companies want assurances that their commercial secrets will be well kept during implementation of the trials, which necessarily involves many professionals in third world countries. These fears began disappearing, albeit slowly, as the world powers continued to build the legal infrastructure for global businesses. The first step was the creation of the World Intellectual Patent Organization (WIPO) in 1967. Several years later, a lengthy process of discussions and drafts resulted in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which was finally signed in 1994. The Agreement set down minimum standards for the regulation of intellectual property by national governments and established that compliance with the agreement would be monitored and enforced by the World Trade Organization (WTO). The WTO took over the functions of the GATT in 1995.

8.3.3 Assurance that the Clinical Trial Will Be Implemented by Qualified Researchers in Accordance to ICH-GCP To ensure that clinical trial data collected around the world complied with the ethical and scientific standards required by the regulatory agencies of high income countries, it was important to develop Good Clinical Practice Guidelines. The first GCP guidelines were issued by the World Health Organization in 1995 (World Health Organization 1995). Subsequently, in 1996, the International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) issued its own set of GCP Guidelines (International Conference of Harmonization 1996). The ICH was founded by the regulatory agencies and industry associations of the United States, Europe and Japan in 1990, and its aim was to simplify the process of registering pharmaceutical products in high income countries. However, the outsourcing of clinical trials to low and middle-income countries expanded the need to comply with those requirements to all countries where clinical trial participants were being recruited, and compliance with ICH-GCP took precedence over compliance with the WHO-GCP. The Pan American Health Organization has played a key role in expanding compliance with ICH-GCP in the region, and in March 2005 the Good Clinical Practice: Document for the Americas was officially adopted during the IV Pan American Conference on Drug Regulatory Harmonization (Pan American Health Organization 2005). It is worth noting, that ICH-GCP have often been criticized for multiple reasons, including that they were not the result of in-depth research but of an informal consensus among a handful of actors with very little input from regulatory agencies and experts from low and middle- income countries, for failing to take into account the challenges faced by low and middle income country researchers (Ravinetto 2017) and for weakening ethical standards (Kaur and Choy 2014).

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The legal status and composition of ICH has been evolving and in 2015 it became the International Council of Harmonization and earned the status of international association under Swiss law (http://www.ich.org/about/history.html). During that same year, a new set of ICH-GCP guidelines was issued, but as previously, their main focus is on the improved use of technology and quality systems, ignoring other aspects that could have strengthened the protection of human research subjects. Issues such as pertinence of the research for the communities in which it is conducted, ensuring the availability and affordability of the new products in the countries where tested, issues of informed consent—specially the informed consent of minors, the role of communities and patients’ associations, biobanking, and data sharing were not addressed (Ravinetto 2017).

8.3.4 Research Ethics Committees According to ICH-GCP all clinical trials have to be approved by a Research Ethics Committee (REC). Human experimentation requires clear delineations of what is ethically permissible and what is not, and there are issues that remain ethically debatable. Some of the most obvious include the issue of placebo controls, patient autonomy, and informed consent (Young 2009; Lau et al. 2003). In these grey zones, the industry is free to choose the side more advantageous for its commercial interests and society needs to establish mechanisms to protect human research subjects. All pharmaceutical companies have always affirmed (it could not be otherwise) that their clinical trials follow strictly all universally accepted ethical principles. But while they feel comfortable sponsoring placebo-controlled clinical trials, many ethicists consider them unacceptable. In Mexico, for example, researchers consider that placebo-controlled trials do not even raise ethical problems: “… more than 70% of clinical trials in Mexico are conducted in government-backed hospitals and public institutions. Placebo-controlled trials are necessary for accurate determination of drug efficacy and safety, are routine” (Castellanos and Chiprut 2002). In Colombia, Careño Duñas analyzed 242 placebo-controlled studies and found that 49 (20.2%) did not fulfill ethical criteria (Careño Duñas 2014). As mentioned earlier, the early period of clinical interventions sponsored by foreign entities and implemented in Latin America were plagued with behaviors that today would be unanimously characterized as highly unethical. When the pharmaceutical industry began to outsource the recruitment of research volunteers to many countries and cultures, it had to establish a system to ensure that it could continue to proclaim their exemplary ethical behavior. It was well known, that some of the countries where they intended to recruit research volunteers had weak legal systems or authoritarian or military regimes that were not overly concerned with ethics. In addition, health bureaucracies in third world countries may tolerate sloppy research and errors, and data manipulation can easily be covered up. The convenient and practical way to resolve this issue was to require that all clinical trial protocols be approved by a research ethics committee (REC) or an

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Institutional Review Board, as they are known in the United States. The RECs would be responsible for analyzing whether the research protocols complied with ethical principles, monitoring the implementation of the trials, and verifying that the research participants had freely participated in the trial and had signed a consent form prior to enrollment. This would allow pharmaceutical companies to be more credible when affirming that the clinical trial had strictly adhered to all ethical principles and the RECs could confirm it.

8.3.5 The Regulatory Agencies The profit margins of the innovative pharmaceutical corporations result from selling their new expensive medicines in wealthy nations. However, for the new products to reach the market they need to be authorized by the corresponding pharmaceutical regulatory agency. To that effect, the regulatory agencies review copious amounts of information, including the results of the clinical trials, regardless of the geographical location in which patients had been recruited. The innovative pharmaceutical corporations need to be sure that when they present the data collected in third world countries, the regulatory agencies of the wealthy nations will know that, among other things, the research sites and relevant clinical trials had been inspected, that the principal investigators and their teams had the required technical qualifications, that all adverse events were properly identified, that the criteria to include or exclude subjects were adhered to, that the diagnostic equipment was properly calibrated and clinical tests properly done, and data had not manipulated. In short, that the protocols had been strictly followed. In Latin America, all regulatory agencies were established after 1990. The relatively few clinical trials that were executed prior to their establishment fell under the responsibility of the ministries of health, and there were few clinical research regulations. The pharmaceutical corporations realized that if clinical trials were to be outsourced and the results accepted as valid, it would be necessary to have regulatory agencies in the host countries of the region. Within a period of 12 years, all countries, which together implement about 90% of clinical trials, created regulatory agencies: Peru (DIGEMID/OGGIT 1990/2003), Colombia (INVIMA 1991), Argentina (ANMAT 1992), Costa Rica (CONIS first 1998 recreated in 2003), Brazil (ANVISA 1999), Mexico (COFEPRIS 2001), and Chile (ANAMED 2002).

8.3.6 Other Logistical Advantages According to documents from the pharmaceutical industry, Latin America offers additional advantages for the outsourcing of clinical trials. Having reversed climatic seasons allows for the recruitment of patients all year around for clinical trials related

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to seasonal health problems. The use of two common languages, simplifies the need to translate protocols and regulatory documents. Excellent communication systems, the development of fast commercial flights, industrial exchanges, easy international communication, and the growth of commerce all increased significantly the relations between wealthy nations and Latin America. Other aspects that Latin America offers to clinical trial sponsors are a growing pharmaceutical market. Population growth, higher life expectancy and the increasing purchasing power of the middle classes forecast a growth in the sales of expensive new drugs. The changing shape of the population pyramid and the resulting increase in the aging population would increase the demand for treatment of chronic diseases. Looking toward the future, the industry could see a market of 550 million people in the early twenty-first century, with perhaps a third covered by social security and a slowly growing percentage by public health programs that could pay for the drugs. On the other hand, outsourcing trials to many countries also had drawbacks. Companies had to maintain a small headquarters in each country even if except for vaccines trials that tend to recruit several thousand subjects, there were only a few clinical trials and a few subjects per trial. Working in foreign countries with diverse cultures and bureaucratic organizational systems is a challenge for any organization. In the case of clinical trials, both the number and complexity of the tasks is challenging. Maintaining offices in ten, twenty or more countries is difficult and could turn into an expensive nightmare. Fortunately for the pharmaceutical companies, a solution arrived at the needed moment. Its name: the contract research organization or CRO. From the beginning of the 1980s, the growth of CROs has been monumental in number and size. The first ones, Quintiles and Parexel, were created in 1982, PPD in 1985, Covance in 1996 and many more later. Some CROs have evolved into multibillion dollar global enterprises. In 2016, all CROs had a combined revenue of almost US$28 billion and in the last few years a few CROs have developed strategic partnerships with global pharmaceutical corporations, including Eli Lilly, Takeda, Sanofi, Pfizer, and Bristol-Myers-Squib (ISR Reports c. 2017). One CROs’ analyst wrote in 2010: The other area that promises further growth is the expansion of large scale clinical research into new areas of the globe. Since the 1990s, pharma companies and CROs have set up trials in Latin America, Eastern Europe, where high-quality infrastructure and well trained doctors left over from communism provided an attractive prospect, India, with its enormous population and English-speaking medical staff, and China. (Walsh 2010)

For example, Molina Salazar et al. (2016) explain that in Colombia there are two main sources of clinical research funding: one is the national government and the “other, the contracted research generally sponsored by the large multinational corporations that they themselves manage or is carried out by contract research organizations or CRO. The latter is very important since they are responsible for bringing foreign currency to the country.” Local CROs have been created in some Latin American countries and at times perform services for the global CROs. Despite the important roles that CROs play in clinical trials their ethical behavior while performing their multiple tasks has not been independently evaluated (Agostini Balfinot et al. 2011).

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CROs may be responsible for a variety of tasks, and more than one CRO might be involved in a clinical trial. Some of the tasks outsourced to CROs include the import and export of products that require special transportation conditions, ensuring that trials adhere to the ever-changing regulations and dispositions of the several ministries, navigating through the bureaucracy maze to obtain a variety of permits and approvals, monitoring the performance of the trial, dealing with clinical labs and the uniform calibration of diagnostic instruments, and managing contracts with principal investigators and their teams. Some prepare research protocols, write the consent form and obtain the informed consent, monitor the implementation of the trials, serve as the middle man between the national regulatory agencies and the pharma industries, analyze the data collected from international sites, and obtain the approvals of the RECs.

8.4 RECs and Regulatory Agencies: What Purpose Do They Serve? The answer to this question depends on who the respondent is. The industry, would categorically respond that both, the RECs and the regulatory agencies, have been very useful. They have resolved critical issues for them. Today it is impossible, anywhere in the world, to begin a clinical trial without the approval of a REC and the authorization of the national regulatory agency. However, there are fundamental questions about what the REC’s seal of ethical approval and the supervision of the agencies means for the research participants and the quality of the data gathered (Homedes and Ugalde 2014, 2017). A few examples follow.

8.4.1 The RECs Are Unable to Assure that the Implementation of Clinical Trials Are Implemented According Universally Accepted Ethical Principles According to clinical trial regulations, RECs are mandated to review the protocol of the trials and see that it does not violate universally approved ethical principles. RECs are also responsible for monitoring the implementation of the trials and reporting any violation of these principles. Research shows that RECs have failed to perform these obligations. (1) We saw that during the first clinical trials implemented in the region, the subjects of experimentation were the poor. There is overwhelming agreement that this continues to be the case. Latin American participants are recruited from low income groups (Amorin et al. 2018; Ávila Vázquez 2007; Berne Decla-

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ration 2013; Cerdán et al. 2014; Freitas and Shlemper 2014; Homedes and Ugalde 2012; Meneguin et al. 2010; Minaya Martínez 2014; Minaya et al. 2017; Mondino 2003; Schlemper Junior 2007; Ugalde and Homedes 2014b; Zavala and Alfaro-Mantilla 2011) some of which might be functional illiterates, and most are health illiterates; as a result, subjects often sign the informed consent without reading it or, more commonly, without understanding it (Homedes and Ugalde 2014). It has been documented in all Latin American countries, and practically in all low and middle income countries, that RECs rarely, if ever, verify that the subjects understand the form they have signed, are aware of the risks they take, know the rights and obligations that ensue from participating in a clinical trial, for example the right to be covered by an insurance policy, and the obligation to strictly adhere to the physician’s recommendations. REC members are satisfied if the forms are timely signed and dated (Ibid). At the prestigious National Cancer Institute in Mexico City, researchers found that subjects thought that the informed-consent form was a requirement for admission to the hospital. While conducting a focus group, researchers asked clinical trial participants about the purpose of the consent form and the answer was: “it does not matter to us what it is for, they told us to sign it and that was enough…” (Cerdán et al. 2014: 245). (2) Many subjects of clinical experimentation do not know that they are part of an experiment. The industry does not use the word experiment, their preference is to use study, program, project or research (Minaya et al. 2017). Some official documents reinforce the use of these words. Thus, the Mexican National Commission of Bioethics, in a model of an informed consent form uses the word investigation (Comisión Nacional de Bioética 2016). (3) Subjects are poor and eager to participate because they cannot purchase the needed medications or purchasing the available treatment would represent a severe economic burden. (4) Subjects are not aware that they may not receive the experimental drug, or that they can be randomly assigned to the control group. In other words, they agree to participate without knowing the conditions or under false premises (Minaya et al. 2017). How Latin American participants would react if they became aware that there is a 50% possibility of not receiving any treatment or the best available treatment is unknown, but in the United Kingdom it was found that 76.8% cancer patients were not willing to participate in a randomly assigned placebo-controlled trial (Fallowfield et al. 1998). It is not easy to obtain data about the number of on-going or completed placebocontrolled trials in Latin America, but in Costa Rica, 93 trials were registered between 2005 and 2009, of which 41 had placebo in the title (Ugalde and Homedes 2014a); and in Guatemala, 28% of the trials conducted until 2007 used placebos (López Dávila 2008). Even in Brazil, where the Federal Council of Medicine banned the participation of doctors in studies using placebos for diseases with effective treatments in 2008, the proportion of Phase III placebo-controlled studies during 2003–2007, and 2009–2013 was similar with an average of 42.6, and 44.2%, respectively (Rubenich et al. 2015).

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(5) Often, research sponsors do not protect participants or their families with an insurance policy to compensate them in the event of death, sickness or disability related to their participation in the trial, and if they do, the difficulties in obtaining fair recompense might be unsurmountable. In the COMPAS trial, which will be discussed later, the promoter refused to accept the responsibility for the death of 12 babies but decided to pay compensation. A payment by the insurance company would have implied that the product tested was unsafe and had caused the deaths or did not exercise due diligence. (6) It is well recognized that Latin American RECs do not have adequate resources to monitor the implementation of clinical trials, and consequently they cannot determine if ethical violations occur (Homedes and Ugalde 2015a). (7) REC members rarely have the expertise to understand complex protocols, understand advanced statistical theory, have the necessary clinical knowledge to evaluate the design of clinical trials that target a broad array of diseases and to assess whether the potential benefits of participating in the trial compensate for the risks incurred (Ugalde and Homedes 2015). (8) Frequently, research participants are induced to participate in a trial by their treating physicians, whom they trust, but are unaware that the physician receives compensation per patient enrolled and ignores the conflicts of interest generated by the payment. (9) In most Latin American RECs, protocols are approved by a handful of persons. In Mexico, for instance, RECs only need to have five members and prior to 2012 three persons sufficed. The RECs must reach a decision by consensus, but if only three persons are present an approval can be made even if one person is in disagreement but willing to go along. As a result, in Mexico a protocol can be approved by two persons (Comisión Nacional de Bioética 2016). Even if RECs were to have more members, nine or twelve, three or four members could still approve a protocol.

8.4.1.1

The Express Approval

The industry complains that RECs take too much time in deciding about the fate of a clinical trial protocol, perhaps one month or longer. With the encouragement of the Food and Drug Administration of the United States, a new business has been created: the independent REC, a label that is meant to indicate that they are not linked to a research site; but that is deceiving because all RECs must be independent. In our view it would be best to refer to them as commercial RECs. A commercial REC is a business or a foundation that reviews protocols in exchange for a payment. Some CROs have organized their own RECs. The commercial RECs know that the industry or the CROs want fast protocol approvals, with minimal changes; and they are aware that failure to satisfy these demands means that the client will find another commercial REC that will. This bumping from one REC to another until the protocol is approved is known in Colombia as the ‘carrusel’ (merry-go-around).

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The conflicts of interest of the commercial RECs are obvious (Gonorazky 2008). In Argentina, a foundation was created in 1994 for the exclusive purpose of reviewing protocols. Five years later it began to offer courses related to clinical trials. This foundation and another commercial REC review about sixty percent of all protocols in Argentina. In Peru, one commercial REC reviews 40% of all protocols implemented in the country and the number of commercial RECs is growing in Mexico. Only the legislation of Brazil precludes the establishment of commercial RECs, but under the influence of the pharmaceutical industry, its legislation is under review (Palacios and Rego 2015). RECs are not fulfilling key responsibilities entrusted to them and consequently they are unlikely to be protecting human research participants. Therefore, we need to ask: what purpose do they serve? A possible answer is that, perhaps unintentionally, the RECs are providing the pharmaceutical companies with an alibi. When accused of violating ethical principles, the industry can answer that their experiments “were approved and monitored by one or several RECs.” If such is the case, they have become the antithesis of what they were created for.

8.4.2 The Regulatory Agencies: Have They Been Co-opted? As mentioned earlier, the Latin American regulatory agencies were created within a span of 12 years. Their establishment coincided with the outsourcing of clinical trials, and from their inception one of their essential functions was to approve the regulations of clinical trials and oversee all the activities related to their implementation. Pharmaceutical industries would only invest in testing new drugs in countries with regulatory agencies capable of implementing these functions. The regulatory agencies are complex organizations. The size and organizational chart of the Latin American agencies varies. Below, we present some examples of how they have managed some clinical trial issues.

8.4.2.1

Argentina. The National Administration of Medicines, Food and Medical Technology (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica ANMAT)

ANMAT was created in 1992. Probably the best in the region, it is responsible for the authorization, registration, standardization, supervision, and control of products used in medicines, for the registration of clinical trial protocols, and for inspecting clinical trials. ANMAT houses the National Drug Institute, which in addition to being responsible for ensuring adherence to good manufacturing practices in the production of medications, also evaluates preclinical information. ANMAT, after confirming that principal investigators violated its regulations, imposed small sanctions, which have not been significant enough to deter further infractions. The first time that ANMAT imposed a relatively sizeable administrative

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fine to a global corporation (GlaxoSmithKline) for gross violations was in 2009, during the implementation of the COMPAS trial, which was testing a pneumococcal vaccine already approved and commercialized in Europe. The trial was also taking place in Colombia and Panama. In Argentina, children were recruited in very poor urban neighborhoods; and Santiago del Estero, one of the provinces where the vaccine was tested, was the poorest in the country. The trial aimed at recruiting 17,000 children in Argentina. The death of 12 participants caused a public outburst of complaints, and ANMAT sent the Chief of Inspections and two medical inspectors to the research sites. To have a better understanding of the local communities, two sociologists were asked to join the inspectors in the provinces of San Juan and Mendoza. The following are some of the regulatory and ethical violations found by ANMAT (Ugalde and Homedes 2014b): • Non-compliance with the study inclusion criteria. The vaccine had been administered to children with a history of acute respiratory infections; in several cases children had more than one hospitalization, rendering them more susceptible to pneumococcal infection; • In case of illiterate parents, the informed consent was not obtained in the presence of two witnesses; • Legal representation for signing the consent form was not established, neither at the beginning nor during the implementation of the trial; • The documentation about the study participants was inaccurate; for example, their age and perinatal birth record were absent, and this information was necessary to evaluate whether the babies met the inclusion criteria; • There was no strategy to exclude from the study babies who were carriers of HIV or had sickle cell disease or a history of splenectomy, since there are no reports that the appropriate tests were done to detect these conditions (Ugalde and Homedes 2014b). • Parents were unaware that only half of the babies were given the pneumococcal vaccine and the other half another vaccine. • According to local health workers at the public Hospital of Santiago del Estero, the conditions of the hospital and the number of clinical workers were not appropriate for the implementation of the clinical trial. The need to allocate hospital workers to the trial resulted in leaving other patients unattended, a limitation that should have been detected by the REC that approved the protocol. Many violations and abuses were also reported by several investigative reporters (Calvo 2007; Federico 2008; Seeger 2008). The deaths may not have been caused by the vaccine but by other violations related to the implementation of the trial, such as violating the inclusion or exclusion criteria. The fine for GlaxoSmithKline was US$97,500, and for the principal investigator and the co-investigator US$76,000 each, tiny amounts considering the cost of a trial and that researchers received compensation of US$350 per child and by this time more than 13,000 had been recruited. GlaxoSmithKline appealed the fine but the Supreme

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Court of the Province of Cordoba (where CEDPAP, the CRO that was implementing the trial, was headquartered) dismissed the appeal (Ugalde and Homedes 2013). A few months later, the Director of ANMAT was removed from his office without any public explanation. The improvements that he was trying to introduce in an agency that for many years had been in receivership because of corruption and inefficiencies lost a director who was trying to make changes and rein in the industry. The most likely reason for this unexpected removal by Argentina’s President was to respond to a request of the global pharmaceutical corporations through CAEMe (Cámara Argentina de Especialidades Medicinales), its lobby organization, which represents and protects the interests of about 50 global pharmaceutical corporations in Argentina. CAEMe had previously attacked ANMAT’s Director for reforms that had been unwelcomed by its clients and accused him of forcing the corporations to find other countries for their trials (Cámara Argentina de Especialidades Médicas 2010). In Cordoba, the president of the CRO responsible for implementing the trial was also the principal investigator, who was also the chair of pediatrics at Cordoba’s municipal hospital. He had previously been forbidden from conducting trials in the city due to administrative and ethical violations (including the use of hospital resources for clinical trial participants without reimbursing the hospital). However, the provincial governor of Cordoba, the second most important province of Argentina, allowed him to implement clinical trials in the provincial hospitals. The secrecy that surrounds many aspects of the design and implementation of clinical trials prevents us from reaching definitive conclusions, but cases like this one and the ones that follow suggest that in many Latin American nations the global pharmaceutical corporations, or Big PhARMA, as they are called in the United States, influence the highest political powers. In this case, the death of babies opened the Pandora box. Otherwise the many ethical and legal violations that occurred during the implementation of COMPAS would have remained unknown.

8.4.2.2

Colombia. Instituto Nacional de Vigilancia de Medicamento, INVIMA (National Institute of Drug Vigilance)

The Colombian case illustrates how pharmaceutical innovative corporations may influence the appointments and removal of those who occupy high positions and can affect the regulations of clinical trials. In Colombia, President Juan Manuel Santos announced that a well-recognized pharmacist—known for her critical views of the innovative pharmaceutical industry—would be the future director of INVIMA, the pharmaceutical regulatory agency of the country. A few weeks later, the President retracted the appointment without providing any explanations. Groups that try to protect the interests of citizens claimed that the pharmaceutical corporations were behind the retraction (López Linares 2010). Instead, the pharmacist received an appointment at the Ministry of Health. As in Argentina, Colombia has a well-organized and funded association of foreign pharmaceutical companies, AFIDRO, which lobbies for the interests of the industry. It was well known that the initial appointee had ethical

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positions that if implemented would have harmed the commercial interests of the innovative pharmaceutical industry.

8.4.2.3

Peru. Oficina General de Investigación y Transferencia Tecnológica (OGITT). General Office of Research and Technology Transfer

Not too long ago, in Peru an inspector of clinical trials was appointed director of OGITT, an office that is part of the National Institute of Health (Instituto Nacional de Salud or INS in Spanish) and that regulates and oversees clinical trials. The director, who we will call Dr. Blanco, a civil service employee, decided to leave the directorship two years after his appointment. This is the story. In Peru, like in many other countries civil service workers cannot be expelled from their jobs unless they commit a crime. They are protected from the political swings that are common in some countries. During his previous post as inspector, Dr. Blanco had seen many ethical and regulatory violations and was actively trying to protect human research participants and improve the quality of clinical trials. OGITT had developed one of the most ambitious programs to inspect clinical trials in the region. Throughout the years, before receiving the directorship appointment, Dr. Blanco had identified violations that could compromise the quality of trial data such as inadequate storage and management of biological specimens, failures to notify of adverse effects and unjustified deviations from the protocols, to mention a few. These violations transgressed ethical principles (see Table 8.1). However, OGITT did not have the right to impose sanctions. The inspectors let the pharmaceutical company or CRO know the results of the inspections and the responses were always very similar: the problem will be corrected. After Dr. Blanco’s appointment as director of the OGITT, he insisted before the leadership of the INS that in order to ensure adherence to clinical trial protocols and ethical standards, it was imperative to develop a system that would allow them to fine pharmaceutical firms, CROs and/or principal investigators who misbehaved. Dr. Blanco prepared a draft regulation, including descriptions of violations and the corresponding fines, which the INS director kept in his office without taking any action. Neither the INS or the Ministry of Health was interested in changing the status quo. Dr. Blanco decided to take a bold decision and began to interview clinical trial participants about their experience. The principal investigators were incensed and claimed that the confidentiality of the subjects had been violated. After consulting with the Ministry of Justice and the ombudsman, Dr. Blanco was pleased to confirm that the agency that oversees clinical trials had the right to talk to anybody involved in a trial. But the criticisms from the INS director and the Minister of Health intensified. It was difficult to work in such environment and Dr. Blanco resigned and returned to his previous post as inspector of clinical trials. Dr. Blanco decided to publish a paper with the results of the interviews with clinical trial participants in an international clinical ethics journal exposing the multiple ethical

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Table 8.1 Ethical violations found in 80 of 91 clinical trials in Peru (2006) Observed violations

n

In the process of obtaining informed consent the language used does not correspond to the level of understanding of participants, and the adequate comprehension of the informed consent is not verified

22 (16.7)

%

Omitting information in the consent form

17 (12.9)

Participants are not informed about medical insurance and compensation in the event of adverse events

13 (9.9)

Not guaranteeing contraception in men and women in their reproductive years

10 (7.6)

The product under research and other items which are part of the clinical trials are not provided without payment

10 (7.6)

Failure to provide the number of participants in Peru

9 (6.8)

Information for contacts in case the participant has questions is not adequately provided

8 (6.1)

The participant is not provided information about the medical care that will be offered if pregnancy occurs

4 (3.0)

The director of the institution where the clinical trial takes place is also the principal investigator of the clinical trial

3 (3.0)

After the completion of the clinical trial, follow-up medical care of the participant is not assured

3 (3.0)

Compensation for additional expenses such as transport was not included

2 (1.5)

Informed consent documents are missing date, stamps and signatures; The informed consent does not explain that participants may withdraw from the study; Alternative treatments are not discussed; The informed consent was not administered

1 (0.76)

Source Adjusted from Minaya-Martínez and Sandoval (2008)

violations he had uncovered, without divulging any information that could identify the informants. The article was accepted, but the Minister of Health was greatly upset and initiated an internal hearing accusing Dr. Blanco of violating the confidentiality of the subjects and the internal norms of the Institute. Such charges, if confirmed, would have been sufficient to expel Dr. Blanco from the civil service. The hearing process became an unpleasant Inquisition ordeal. Dr. Blanco was forbidden from accepting foreign requests for lecturing. Only the fortuitous change of the Minister of Health enabled the former director of OGITT to avert the undesirable results of the hearing; however, Dr. Blanco and the co-author of the article were transferred to a different unit of the INS. In Peru, in 2007, a principal investigator, who was responsible for the highest number of clinical trials being conducted in the country, was appointed Minister of Health. Within a year of his appointment he had changed the clinical trial regulations, which had been approved only a few months before he became Minister of Health and had been considered by international experts as exemplary. The new regulations

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favored the interests of the industry. After less than two years, the Minister resigned and returned to his former, better-paid job as principal investigator of twenty plus trials. During his tenure as Minister, he halted the clinical trial inspections, probably because of the number of violations detected at his research sites. The Peruvian case teaches us how the industry finds ways to maintain the secrecy around the implementation of clinical trials. Also, that when regulatory nomrs are unwelcomed by the industry, Big Pharma succeeds at changing them.

8.5 The Forces that Sustain the Outsourcing of Clinical Trials to Latin America Migration studies commonly refer to push and pull factors; those that cause migrants to leave their communities and those that attract them to the new destination. These factors complement each other and enhance the understanding of the migration process: I leave because I cannot find a paid job, I attract migrants because I can offer jobs. This approach has not been used in explaining the outsourcing of clinical trials. Pull and push factors change with the passing of time and can even be reversed. We have already explained an important push factor: high income countries cannot recruit enough participants, either because they do not have sufficient patients for the numerous trials that pharmaceutical companies want to execute or because patients are not willing to enroll. The most important pull factor is the availability of many poor patients in low- and middle-income countries who are willing to participate and can be easily recruited. Lower costs have also been mentioned as a pull factor. In fact, their cost might be somewhat lower in low and middle-income countries, but since neither the host countries nor the industry have revealed the actual costs of the clinical trials, the magnitude of the savings is difficult to assess. Some have said that implementing foreign clinical trials might lead the public sector of the host country to incur tangible and intangible costs, and the estimated costs for the industry, calculated by groups funded by the industry, have been overestimated. Keeping this information secret allows the pharmaceutical industry to justify the astronomic prices of new drugs. Until we have reliable information about the costs of clinical trials, it will not be possible to judge if lower costs are a pull factor for outsourcing trials to Latin America. When foreign pharmaceutical corporations are criticized for outsourcing clinical trials and using the Latin American poor as guinea pigs, the critics do not consider other pull factors (or insourcing). There are many local persons, not necessarily those poor who participate as subjects of experimentation—although some do benefit—who want clinical trials to be implemented in Latin America. The Latin American principal investigators are physicians whose income from clinical trials is many times that of other physicians in their countries and they receive many additional fringe benefits. The industry may reward them with trips for lecturing at professional meetings, domestically or abroad, with all expenses paid and very little

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work, since most presentations are prepared by the companies (Homedes and Ugalde 2014; Ugalde and Homedes 2015). Non-monetary rewards include the professional prestige earned by these presentations, publications in high-impact journals, and continued participation in clinical trials. In addition, they may receive invitations to become board members of international and national professional societies and prestigious committees. Occasionally, as we have seen in Peru, principal investigators receive political appointments. In Costa Rica, two principal investigators also became Ministers of Health. From these positions of professional dominance or political power, principal investigators are among the most powerful voices promoting the insourcing of clinical trials. They all want more trials. In Latin American countries, few principal investigators reach these powerful positions, but they are sufficient to dampen the efforts of civil organizations and/or other physicians who demand an end to using poor citizens as guinea pigs. Clinical trials also employ additional physicians, clinical personnel, and other professionals, but even more important are the businesses directly contracted by the pharmaceutical corporations, like the CROs or the commercial RECs. Hospitals, some very prestigious institutions, and universities, frequently internationally renowned, receive large grants to execute clinical trials. Hospitals receive modern clinical equipment. All these interests are powerful lobbying forces for insourcing clinical trials. When other voices opposed to clinical trials demand changes to the current regulations, all those with vested interests are ready to raise a commanding response to neutralize the opponents and request more insourcing.

8.5.1 Articulating the Insourcing Voices: The Case of Argentina Insourcing demands are articulated via national ministries, frequently the Ministries of Finance or Economy or of Science and Technologies. The position of the Ministries of Health is not the same in all countries and may change according to the views held by the minister. In countries that house an association of innovative pharmaceutical industries, that association coordinates the efforts to protect the implementation of clinical trials and the interest of those who benefit from insourcing. The Secretary of Interior Commerce of the Argentinean Ministry of Economy and Public Finance gave the following reasons to justify the insourcing of clinical trials through a Resolution (República de Argentina 2011): they are a source of foreign currency; they create jobs; and they help to create national [research] projects. But to the informed reader, these reasons are insignificant when considering that Argentina is the third largest world exporter of beef, produces 22% of the world supply of soybeans, has the fourth largest world reserves of lithium, and produces about 450,000 cars per year, 85% of which are exported to Brazil. It is obvious that the insourcing of clinical trials can contribute very little to Argentina’s need for foreign currency. Similarly, clinical trials contribute very little to scientific research

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in Argentina. Practically all the clinical trial protocols are prepared by scientists who work outside of Latin America, and because the data belong to the sponsor and are collected in multiple countries, the results are also analyzed by scientists outside of Argentina. The principal investigators are better characterized as managers (Ugalde and Homedes 2015). Fallas López describes clinical trials investigators with these words: “Health professionals who become researchers… do not make any significant contribution but extract significant economic benefits… those involved in … [clinical trials] are mere recruiters interested less in the progress of health sciences than in the growth of their bank accounts…” (Fallas López 2006). In Argentina, according to CAEMe, the number of persons that in 2011 were employed in clinical trials was about 7,800, and the same year the tourist sector employed over one million. The influence that CAEMe has in coordinating the insourcing voices can be seen by contrasting the similarity of the Resolution of the Secretary of Interior Commerce with the article published by CAEMe one year earlier (Cámara Argentina de Especialidades Médicas 2010; República Argentina Boletín Oficial 2011).

8.6 Discussion and Conclusions 8.6.1 Poverty and Clinical Trials Participation As has been discussed, the availability of many poor and naïve patients willing to enroll in clinical trials provided a strong impulse for outsourcing clinical trials to Latin America. Poor patients seeking treatment are told by their attending physician—who receives a payment per patient enrolled—that given their medical and socio-economic conditions their best option is to enroll in a clinical trial. Most clinical trial participants in Latin America and other third world regions, have a pleasant experience when they participate in clinical trials. They feel more valued and better treated than in overcrowded and understaffed public health care centers and hospitals. What remains unknown is how they would react if told that due to the design of the trial, according to a random distribution—a concept that they do not understand, they did not receive any drugs, but instead were administered a placebo—a term unknown to them—or were given a comparator—which was not the best available treatment, and as a result their health might have worsened. Equally unknown is how they would react if told, as will be seen below, that only a very small percentage of the drugs tested are approved by the regulatory agencies, and even fewer are judged to be more safe and effective than existing treatments. Clinical trial regulations in Latin America have not established the income threshold to classify a person as vulnerable and exclude him/her from enrolling in a clinical trial. To estimate the income of poor persons is technically difficult.1 Household loca1 If

household income were to be used to determine poverty, demographers would undoubtedly point to the problems to be encountered, probably many insurmountable. There are other variables

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tion would be the easiest if not the most precise measure to determine the poverty level of any given person, and would serve to significantly reduce the number of poor currently being recruited. To this end, residents in the rural areas of poor provinces and in city neighborhoods known to house low income persons, temporary workers or unemployed should be considered ineligible to participate in clinical trials. RECs could identify and map these poor neighborhoods and let recruiters know that residents in those areas are to be excluded. When verifying that the consent forms are appropriately signed and dated, the RECs and the regulatory agencies should verify that none of the participants reside in the poor neighborhoods that ought to be excluded. For those recruited by media advertisements, the place of residency should be used to establish his/her level of vulnerability and if he or she can participate in the trial. RECs and regulatory agencies ought to be concerned with the future financial availability and affordability of the product about to be tested, if eventually it were to be marketed. Latin American subjects of experimentation and their communities should have access to the medicines they helped bring to market. Countries should establish affordability thresholds of the drugs tested and only approve the testing of drugs that would be affordable for the public sector.2 At present, many drugs that were tested in Latin America are only affordable to the very small percentage of the super wealthy (Homedes and Ugalde 2015b).

8.6.2 Do We Need so Many Trials? Since, or perhaps due, to the outsourcing of trials, the number of trials has increased exponentially in recent years. In 2013, the International Clinical Trials Registry Platform database contained data on 186,523 interventional clinical trials. The annual

or combinations that could be used, such as occupation, household location, functional literacy, or level of formal education. 2 Some might consider that the price of a product cannot be determined before the development process is completed. Consequently, a pharmaceutical company could not determine the price of an innovative drug before the clinical trials are concluded and the data analyzed. Contrary to this affirmation, it is possible for the pharmaceutical industry to estimate closely the cost of a clinical trial using the number of patients to be recruited, the number of sites, and the locations of the sites. Estimates of costs of trials are prepared when the pharmaceutical company contracts with a CRO to implement the trial. Additionally, some CEOs have admitted that the price of a new drug is not related to the cost of research and development but to the price the buyer will be willing to pay. In many countries the buyer is the government, and in the United States also health insurance companies and pharmacy benefits managers. This is the reason why the price of the same drug is different in each country, and the differences can be extremely large. That the price is not related to cost is also confirmed when the industry justifies high prices based on savings obtained in comparison to costs of alternative treatments; if a patient’s health deteriorates, the industry argues, medical costs are greater than the cost of the drug.

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number of registered clinical trials increased from 3,294 in 2004 to 23,384 in 2013 (Viergever and Li 2015). The industry needs to explain the reasons why this increase has occurred. The hypothesis that more research, including more clinical trials, leads to truly breakthrough drugs is not supported by data. The number of truly innovative therapies commercialized in the last years is extremely low. A pharmaceutical industry lobby group with analysts at BioMedTracker and Amplion analyzed 7,455 drug development programs implemented between 2006 and 2015, and found that the probability of success of the tested product was 63% in phase I trials, 31% in Phase II, 58% in Phase III, and 85% during the regulatory review process, which translates into an overall success rate of 9.6%. However, “When the analysis focused on new molecular entities to assess only the most innovative therapies, the overall success rate was 6.2%” (Mullard 2016). This is considerably lower than the conventional 10% that is given for drugs that make it from phase I to approval. The above figures (9.6%) are used by the industry to show the difficulty and high costs of bringing one product to the market and to justify the very high prices of new drugs (Homedes and Ugalde 2014). According to independent pharmaceutical experts the number of truly innovative medicines that reach the market is even smaller (Prescrire 2017). For the drugs tested in Latin America that were approved by the FDA in 2011 and 2012, 15 independent pharmacology bulletins from 11 wealthy nations found that of the 26 drugs that they had reviewed, 21 did not add any therapeutic advantage over those already in the market. According to Prescrire, the five drugs that added value offered advantages to certain subgroups of patients with an uncertain cost/benefit ratio. All were unaffordable except for few superrich, who very rarely are the subjects of experimentation (Homedes and Ugalde 2016). Several reasons explain so many failures. A contributing factor is that few preclinical trials are published. The FDA does not require the publication of pre-clinical trials (Federico et al. 2014), and it is believed that if published, some products would not be tested in humans. Access to such information would be extremely useful because it would allow researchers to learn and avoid making the same mistakes, but in competitive markets sharing research information is evaded and is a possible explanation for the high number of Phase I trials that fail. Patents also play a role. Until the decade of the 1980s, only a few countries patented pharmaceuticals, and those who did, issued process and not product patents. For example, France, Italy, Japan and Switzerland excluded the patentability of medicines until the late 1970s and Spain and Portugal until 1992. A few years later, coinciding with the surge in outsourcing, product patents became a necessity not to promote discoveries but to obtain market exclusivity. Medicines started to be protected from competition by multiple patents, sometimes hundreds, covering the product, every part of the process, instructions for usage and even the color and shape of the pill. Having obtained the patents, the industry starts the clinical trials—the clinical development phase—and it is of utmost importance to be the first to reach the market, in order to enjoy a longer period of marker exclusivity and monopoly prices. As mentioned, outsourcing is a strategy to expeditiously recruit the poor in third world

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countries, but it is also possible that pressures to expedite the trials and data analysis lower the quality of the research. Poor attention to the results of pre-clinical studies, poor research designs and implementation might explain why so few products that begin phase I do not finish successfully phase III. The additional costs of conducting trials for drugs that do not reach the market can be absorbed. Selling a handful of product under monopoly conditions allows the company to establish the price the market will bear.

8.6.3 Is There a Connection Between Outsourcing and the Beginning of the End of Big Pharma? The newly appointed Director-General of the World Health Organization, Dr Tedros Adhanom Ghebreyesus, underscores that access to needed medicines is a human right: Health is a fundamental and universal human right. No one should get sick or die just because they are poor or because they cannot access the services or technologies they need. And access to health technologies—vaccines, diagnostics, medicines, medical devices and assistive technologies—is a key pillar of universal health coverage. (World Health Organization 2018)

Big Pharma, without taking into account that access to needed drugs is a fundamental human right, approaches drug research and development according to economic principles that are based on want rather than on need. The differences between an economy based on want and not on need have been explained by Weiss et al. (1998). In the case of pharmaceuticals, the need is there, and the industry for economic gain successfully created and prioritized the want. Today the want for drugs has increased, and paradoxically at the same time the drug needs of people suffering from 6000+ rare diseases and of the millions affected by neglected diseases both go unattended. The reason: those drugs do not generate the funds needed to continue expanding the economy of want. The research and development of new drugs prioritizes the created want over the need, without regarding the added therapeutic value that an innovative drug is supposed to offer. Today’s example of opioids is a clear and tragic example of this shift and its consequences. An industry based on promoting excess want requires significant amounts of funds to convince customers that they want the product. Generating want of therapeutic drugs includes the creation of diseases (Payer 1992; Drug Watch 2012), and large investments in advertising. The industry has been spending more money in advertising than in research and development (Swanson 2015; Sarich 2016; Robbins 2016). It is estimated that “… in 2015, out of the top 100 pharmaceutical companies by sales, 64 spent twice as much on M&A than on R&D, 58 spent three times, 43 spent five times as much and 27 spent 10 times the amount” (Institute for Health and Socio-Economic Policy 2016). Direct marketing of prescription drugs to consumers is only allowed in the United States and New Zealand, but indirect marketing has

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been very successful in these two countries and everywhere. Physicians, scientific journals, health foundations, organizations that assist patients, the media, and today social media, have been used successfully by Big Pharma to promote unneeded drugs. We have arrived at the utterly absurd situation that physicians and pharmacists are beginning to be trained in de-medicalizing or de-prescribing their patients. Until now, the pharmaceutical industry has been successful in keeping therapeutic drugs as want products. There is something very wrong with an industry that spends enormous amounts of money to produce only a handful of truly needed products while disregarding many other unresolved health needs, and in the process deceives thousands of poor people by asking them to enroll in clinical trials of doubtful value and unpredictable risks. According to Ioannidis, a leading researcher of evidencebased medicine at Stanford University, in his article “Why most clinical research is not useful,” offers a well-supported argument of why this is the case and concludes by saying: “Most clinical research… fails to be useful not because of its findings but because of its design” (Ioannidis 2016). Criticism of the shift in the R&D activities of the innovative pharmaceutical industry had been voiced before. In the decade of the 1990s, Vagelos a former chairman of Merck & Company and well recognized pharmaceutical industry leader, commenting on the Vioxx disaster said: “This industry delivered miracles, and now they are throwing it all away… they just don’t get it” (Harris 2004). Cañás et al. (2005) explain the failure of Vioxx (rofecoxib), a nonsteroidal anti-inflammatory drug (NSAID). The protocol of one clinical trial had been prepared by the marketing department. The FDA took into consideration the results of this trial to approve rofecoxib, unaware that the data had been manipulated. It took thousands of sick patients and deaths before the FDA removed Vioxx from the market. The reason for the disaster: to bring the product to the market ahead of Pfizer’s NSAID competitor Celebrex with hundreds of millions of dollars at stake. Criticisms were extended to the rest of the innovative industry. Kelly, president of Pfizer’s American drug division lamented that the polls were comparing the drug industry with tobacco companies. In his words: “We find quite incredible that we could be equated with an industry that kills people as opposed to cure them” (Harris 2004). He seemed to be unaware that increasing the want of medicines, making needed drugs unaffordable, and disregarding the development of medicines for rare and neglected diseases also kills daily many thousands (Stevens 2004). According to a recent study of the Centers for Disease Control and Prevention of the United States (2018): “From 1999 to 2017, almost 218,000 people died in the United States from overdoses related to prescription opioids. Overdose deaths involving prescription opioids were five times higher in 2017 than in 1999.” The critical views have increased, and the responses of the industry only seem to satisfy itself. At present there are a number of initiatives seeking new models of development and production of innovative drugs (Love and Hubbard 2007; Love 2012). Big Pharma’s future role will depend on its ability to acknowledge and adjust to the principle that access to needed drugs is a fundamental and universal human right.

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References Agostini Balfinot, R.A., D. Bhagianadh, C.B. Duca de Freitas, et al. 2011. Putting Contract Research Organisations on the Radar. An Exploratory Study on the Outsourcing of Clinical Trials by Pharmaceutical Companies to Contract Research Organizations in Not-Traditional Trial Regions. Amsterdam: Somo, Salud y Fármacos and Centre for Studies in Ethics and Rights. Amorin, K.P.C., V. Garrafa, A.D. De Melo, et al. 2018. Participantes de ensaios clinicos em oncologia: perfil e aspectos envolvidos nas suas decisoes. Trabalho, Educação e Saúde, Rio de Janeiro 16 (3): 1381–1402. Asamblea Legislativa de Costa Rica. 1976. Proyecto de Reforma a los Artículos 64, 65, 66 y 67 de la Ley General de Salud (Bill to Reform Project of Articles 64, 65, 66, 67 of the General Health Act). Expediente 7530, April 12. San José: Archives of the Legislative Assembly. Asamblea Legislativa. República de Costa Rica. 2014. Ley Reguladora de Investigación biomédica N0 9234 (Regulatory Act of Biomedical Research), April 22. http://www.pgrweb.go.cr/ scij/Busqueda/Normativa/Normas/nrm_texto_completo.aspx?param1=NRTC&nValor1=1& nValor2=77070&nValor3=96424&strTipM=TC. Accessed 26 Feb 2018. Ávila Vázquez, M. 2007. Globalización e identidades médicas en los ensayos clínicos. Salud Colectiva 3 (3): 235–245. Berne Declaration (ed.). 2013. Clinical Trials in Argentina: Pharmaceutical Companies Exploit Flaws in the Regulatory System. Lausanne/Zurich: Berne Declaration, September. Calvo, P. 2007. Santiago: cuestionan la captación de niños para ensayos de vacunas (Santiago: It is Questioned the Enrollment of Children in Vaccine Trials). Clarín, December 23. Cámara Argentina de Especialidades Médicas. 2010. Ensayos clínicos. La industria sin chimeneas (Clinical Trials. The Industry Without Chimneys). CAEM 1 (1): 32–39. Cañás, M., A. Ugalde, J. Orchuela, and N. Homedes. 2005. Las secuelas del Rofecoxib (The Fallout of Rofecoxib). Salud y Fármacos 8 (2): 58–70. http://www.saludyfarmacos.org/boletin-farmacos/ boletines/abr2005/investigaciones042005C/. Accessed 28 Feb 2018. Careño Duñas, J.A. 2014. Cumplimiento de las condiciones éticas relacionadas con el uso de placebos en los estudios de experimentación en Colombia (Fulfilling the Ethical Condition to Use Placebo En Experimental Studies in Colombia). Bioética 14 (2): 128–137. http://www.scielo.org. co/scielo.php?pid=S1657-47022014000200011&script=sci_abstract&tlng=es. Accessed 23 Feb 2018. Castellanos, M.A., and R. Chiprut. 2002. Clinical Research in Mexico: An Overview. Applied Clinical Trials, June 1, 2002. http://www.appliedclinicaltrialsonline.com/clinical-research-mexicooverview. Accessed 22 Feb 2018. Centers for Disease Control and Prevention. 2018. Opioid Overdose. https://www.cdc.gov/ drugoverdose/data/prescribing.html. Accessed 2 Jan 2019. Cerdán, A., A. González-Arreola, and E. Verástegui. 2014. Who Decides? Informed Consent for Cancer Patients in Mexico. In Clinical Trials in Latin America: Where Ethics and Business Clash, ed. N. Homedes and A. Ugalde, 237–249. New York: Springer. Comisión Nacional de Bioética. 2016. guía nacional para la integración y el funcionamiento de los comités de ética de investigación. Mexico, D.F. http://www.conbioetica-mexico.salud.gob.mx/ descargas/pdf/registrocomites/Guia_CEI_paginada_con_forros.pdf. Accessed 19 Feb 2018. De la Madrid, M. 1987. Reglamento de la Ley General de Salud en Materia de Investigación para la Salud (Regulation of the General Act related to Health Research), Diario Oficial, January 6. Drug Watch. 2012. Disease Mongering and Drug Marketing. January 22 (last modified 2017). https://www.drugwatch.com/2012/01/22/disease-mongering-and-drug-marketing/. Accessed 28 Feb 2018. Fallas López, L.A. 2006. El péndulo maniqueo de la investigación clínica en Costa Rica (The Manichean Pendulum of the Clinical Research in Costa Rica). Diálogos 7 (1): 157–207. https:// revistas.ucr.ac.cr/index.php/dialogos/article/view/6188/21325. Accessed 25 Feb 2018.

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Fallowfield, L.J.V., C. Jenkins, C. Brennan, et al. 1998. Attitudes of Patients to Randomised Clinical Trials of Cancer Therapy. European Journal of Cancer 34 (10): 1554–1559. https://www.ncbi. nlm.nih.gov/pubmed/9893627. Accessed 23 Feb 2018. Federico, M. 2008. Se investiga si 12 bebés murieron por un experimento (It is Investigated the Possible Connection Between the Cause of Death of 12 Babies and Their Participation in a Clinical Trial). Crítica de la Argentina, July 10. Federico C.A., B. Carlisle, J. Kimmelman, D.A. Fergusson. 2014. Late, Never or Non-existent: The Inaccessibility of Preclinical Evidence for New Drugs. British Journal of Pharmacology 171 (18): 4247–4254. http://dx.doi.org/10.1111/bph.12771. https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC4241091/. Accessed 26 Feb 2018. Freitas C.B.D., and B.R. Shlemper Junior. 2014a. Progress and Challenges of Clinical Research with New Medications in Brazil. In Clinical Trials in Latin America. Where Ethics and Business Clash, ed. N. Homedes and A. Ugalde, 151–172. Freitas, C.B.D., W.S. Hossne, and S. Dutra. 2014b. Brazil: The System for the Protection of Voluntary Participants in Research. In Clinical Trials in Latin America: Where Ethics and Business Clash, ed. N. Homedes and A. Ugalde, 131–149. New York: Springer. Gonorazky, S.E. 2008. Comités de ética independientes para la investigación clínica en Argentina. Evaluación y sistema para garantizar su independencia (Independent Ethics Committees for Clinical Research. Evaluation and a System to Guarantee Independence). Medicina (Argentina) 68: 113–119. Harris, G. 2004. Drug Makers Seek to Mend Their Fractured Image. New York Times, July 8, pg C1. http://www.nytimes.com/2004/07/08/business/drug-makers-seek-to-mend-theirfractured-image.html. Accessed 28 Feb 2018. Homedes, N., and A. Ugalde. 2012. El cáncer de cérvix y el desarrollo de vacunas para el control del VPH en Guanacaste, Costa Rica, en Homedes N. y Ugalde A., Ética y ensayos clínicos en América Latina, Lugar Editorial, Buenos Aires, 293–348. Homedes, N., and A. Ugalde. 2014. Globalization and Clinical Research in Latin America. In Clinical Trials in Latin America: Where Ethics and Business Clash, ed. N. Homedes and A. Ugalde, 55–78. New York: Springer. Homedes, N., and A. Ugalde. 2015a. The Evaluation of Complex Clinical Trial Protocols: Resource Available to Research Ethics Committees and the Use of Clinical Trial Registries—A Case Study. Journal of Medical Ethics 41: 464–469. Homedes, N., and A. Ugalde. 2015b. Availability and Affordability of New Medicines in Latin American Countries Where Pivotal Trials Were Conducted. Bulletin of the World Health Organization 93: 674–683. http://www.who.int/bulletin/volumes/93/10/14-151290.pdf. Accessed 27 Feb 2018. Homedes, N., and A. Ugalde. 2016. Health and Ethical Consequences of Outsourcing Pivotal Clinical Trials to Latin America: A Cross-Sectional Study. PLOS One, June. http://dx.doi.org/ 10.1371/journal.pone.0157756. Accessed 26 Feb 2018. Homedes, N., and A. Ugalde. 2017. Latin American Research Ethics Committees: Whose Interest Do They Serve? In The Future of Research Ethics Committees in Europe: Creating the Way to Innovation, ed. European Network Research Ethics Committee and ANCEI, 75–82. Barcelona: CEDRO. ISBN:978-84-16732-76-0. Institute for Health and Socio-Economic Policy. 2016. The R&D Smokescreen. The Prioritization of Marketing & Sales in the Pharmaceutical Industry, October 20. https://nurses.3cdn.net/ e74ab9a3e937fe5646_afm6bh0u9.pdf. Accessed 2 Jan 2019. International Conference of Harmonization. 1996. ICH Tripartite Guideline for Good Clinical Practices E6 (R1). June 10. Ioannidis J.P.A. 2016. Why Most Clinical Research Is Not Useful. PLOS Medicine, June. https://doi.org/10.1371/journal.pmed.1002049, http://journals.plos.org/plosmedicine/article?id= 10.1371/journal.pmed.1002049. Accessed 27 Feb 2018.

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ISR Reports. c. 2017. Infographic: A History of Clinical Development Outsourcing. https://www. outsourcedpharma.com/doc/a-history-of-clinical-development-outsourcing-0001. Accessed 17 Feb 2018. Kaur, S., and C.Y. Choy. 2014. Ethical Considerations in Clinical Trials: A Critique of the ICH-GCP Guideline. Developing World Bioeth 14: 20–28. https://doi.org/10.1111/dewb.12004. Kline, D. 2001. Clinical Trials in Latin America. DataEdge. http://www.fast-track.com/pdfs/ ClinicalTrialsLatinAmerica.pdf. No longer available. Cited in Clinical Trials in Latin America: Where Ethics and Business Clash, ed. H. Homedes and A. Ugalde, 73. 2014. New York: Springer. Lau, J.T., J. Mao, and J. Woo. 2003. Ethical Issues Related to the Use of Placebo in Clinical Trials. Hong Kong Medical Journal 9 (3): 192–198. López Dávila, L.M. 2008. Retos y posibilidades de los ensayos clínicos controlados por los pacientes. Slide Presentation Slide 17. First Costa Rica Congress of Bioethics, Faculty of Medical Sciences, Universidad de San Carlos, Guatemala, no date circa 2008. http://www.eventos.bvsalud.org/agendas/BVS-COR/public/documents/Javier_ bonfil_retos_oportunidades_ensayos_clinicos_EC_Costa_Rica-145546.pdf. Accessed 18 Feb 2018. López Linares, R. 2010. Carta de AIS LAC al Presidente de la República de Colombia (Letter from AIS-LAC to the President of the Republic of Colombia). 6 de enero de 2010. Love, J.P. 2012. The De-linkage of R&D Cost and Drug Prices Through the Prize Fund for HIV/AIDS Will Cost Less, Expand Access, Accelerate and Improve Innovation, and Replace an Incentive System that is Expensive, Inefficient and Unsustainable. Testimony of James Packard Love. Hearing of the United States Senate, Committee on Health, Education, Labor and Pensions, Subcommittee on Primary Health and Agency on The High Cost of High Prices for HIV/AIDS Drugs and the Prize Fund Alternative, May 15. Washington DC. https://www.help.senate.gov/ imo/media/doc/Love.pdf. Accessed 8 May 2018. Love, J., and R. Hubbard. 2007. The Big Idea: Prizes to Simulate R&D for New Medicines. KEI Research Paper 1. http://www.keionline.org/misc-docs/bigidea-prizes.pdf. Accessed 8 May 2018. Meneguin, S., A. Zoboli, R. Domingues, M. Nobre, and L. César. 2010. Entendimento do termo de consentimento por pacientes partícipes em pesquisas com fármaco na cardiologia. Arquivos Brasileiros de Cardiologia 94 (1): 4–9. Minaya, G., D. Fuentes, A. Ugalde, and N. Homedes. 2017. A Missing Piece in Clinical Trial Inspections in Latin America: Interviews with Research Subjects in Peru. Journal of Empirical Research on Human Research Ethics 12 (4): 232–245. Minaya Martínez, G.E. 2014. Los usuarios de hospitales públicos que son incluidos en ensayos clínicos: el conocimiento sobre sus derechos y obligaciones, Tesis de Master en Salud Pública, Fiocruz, Programa de Extensión, Lima. Minaya-Martínez, G., and R. Díaz Sandoval. 2008. Capacidad de evaluación de los ensayos clínicos por los comités de ética (Competency of Ethics Committees to Evaluate Clinical Trials). Revista de la Sociedad Peruana de Medicina Interna 21 (4): 153–165. Ministerio de Salud, República de Costa Rica. 1976. Veto. Comunicación del Presidente de la República Daniel Oduber y el del Ministro de Salud de Salud Herman Weinstock (Veto. Communication of Daniel Oduber, President of the Republic and Herman Weinstock, Minister of Health). San José: Presidential House. Molina Salazar, D.I., S.M. Botero, and G.C. Giraldo. 2016. Investigación clínica y ensayos clínicos. ¿En qué vamos? (Clinical Research and Clinical Trials. How Are We Going?). Acta Médica Colombiana 41: 3. Digital Supplement July–September. https://www.researchgate.net/ publication/311066058_Investigacion_clinica_y_ensayos_clinicos_En_que_vamos. Accessed 23 Feb 2018. Mondino E. 2003. Informe especial sobre ética en la experimentación con humanos y el deber del estado nacional (Special Report About Ethics in Experimentation in Humans and the Duty of the Nation). Defensoría del Pueblo de la Nación, Buenos Aires. http://www.unal.edu.co/bioetica/ documentos/cd_ei_sh_a1_inf_ex_sh_arg_05.pdf. Accessed 27 Feb 2018.

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Mullard, A. 2016. Parsing Clinical Success Rates. Nature Reviews Drug Discovery 15: 447. https:// doi.org/10.1038/nrd.2016.136. Palacios, M., and S. Rego. 2015. The Bill Submitted to the Brazilian Senate for Ethical Regulations of Clinical Research is Contrary to the Interests of Research Subjects. Ca de Saude Publica 31 (8): 1–3. http://www.scielo.br/scielo.php?pid=S0102-311X2015000801583&script= sci_arttext&tlng=en. Accessed 23 Feb 2018. Pan American Health Organization. 2005. Good Clinical Practice: Document for the Americas. Washington D.C. http://apps.who.int/medicinedocs/documents/s22153en/s22153en.pdf. Accessed 27 Feb 2018. Pan American Health Organization. 2016. Main Health Problems and Challenges. Inequities and Barriers in Health Systems. Access to Essential Medicines and Other Health Technologies. In Health of the Americas. http://www.paho.org/salud-en-las-americas-2017/?p=59. Payer, L. 1992. Disease-Mongers: How Doctors, Drug Companies, and Insurers Are Making You Feel Sick. New York: Wiley. Prescrire. 2017. Real Innovation. Prescrire International 26 (182): 115. Ravinetto, R. 2017. The Revision of the ICH Good Clinical Practice Guidelines: A Missed Opportunity. Indian Journal of Medical Ethics 2 (4): 255–259. http://doi.org/10.20529/IJME.2017.057, http://ijme.in/wp-content/uploads/2017/05/20170523_the_revision.pdf. Accessed 27 Feb 2018. República de Argentina. 2011. Boletín Oficial de la República Argentina. N. 32.072, 9–10, January 18. Reverby, S.M. 2011. ‘Normal Exposure’ and Inoculation Syphilis: A PHS ‘Tuskegee’ Doctor in Guatemala, 1946-48. Journal of Policy History 23 (1): 6–28. http://academics.wellesley.edu/ WomenSt/Synopsis%20Reverby%20%27Normal%20Exposure%27.pdf. Accessed 28 Feb 2018. Robbins, R. 2016. Drug Makers Now Spend $5 Billion a Year on Advertising. Here’s What that Buys. Statenews, 9. https://www.statnews.com/2016/03/09/drug-industry-advertising/. Rubenich, G.B., S.T. Heck, F. Hellmann, B.R. Schlemper Junior. 2015. El uso de placebo en ensayos clínicos de fase II en Brasil. Salud Colectiva 11 (1): 99–114. Sarich, C. 2016. Pharma Companies Spend 19x More on Marketing than Research, and Returns are Dropping. Natural Society, December 21. http://naturalsociety.com/research-development-newdrugs-not-paying-off-6321/. Schlemper Junior, B.R. 2007. Acceso às drogas na pesquisa clínica. Revista Bioética 15 (2): 248–266. Seeger, M. 2008. Faltan morir 13.986 bebés. Argentina de espaldas a una aberración (Still 19,983 Babies to Die. Argentina Avoids Confronting an Outrage) Agencia Efe, August 14. Stevens, P. 2004. Diseases of Poverty and the 10/90 Gap Health Projects. London: International Policy Network. http://www.who.int/intellectualproperty/submissions/InternationalPolicyNetwork. pdf. Accessed 28 Feb 2018. Swanson, A. 2015. Big pharmaceutical companies are spending far more on marketing than research. The Washington Post, February 11. https://www.washingtonpost.com/news/wonk/wp/ 2015/02/11/bigpharmaceutical-companies-are-spending-far-more-on-marketing-than-research/ ?utm_term=.2536525d0be3. Trejos, A. 1977. Las actividades del ICMRT in Costa Rica. Ejemplo de cómo los intereses comerciales pervierten la investigación científica (Activities of ICMRT in Costa Rica. Example of How Commercial Interest Distort Scientific Research). Unpublished document, available upon request. Trejos, A. 1986. Los procedimientos no éticos del LSU-ICMRT, Semanario Universitario 754, November 28–December 4. Ugalde, A., and N. Homedes. 2013. The Contribution of High-Impact Journals to Science: The Case of the Lancet. Salud Colectiva 9 (1): 5–10. http://revistas.unla.edu.ar/saludcolectiva/article/view/ 196/pdf_73. Accessed 28 Feb 2018. Available in Spanish at http://www.scielo.org.ar/scielo.php? script=sci_arttext&pid=S1851-82652013000100001.

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Ugalde, A., and N. Homedes. 2014a. A Small Country for Big Pharma: Costa Rica. In Clinical Trials in Latin America: Where Ethics and Business Clash, ed. N. Homedes and A. Ugalde, 173–194. New York: Springer. Ugalde, A., and N. Homedes. 2014b. The Regulatory Framework and Case Studies from Argentina. In Clinical Trials in Latin America: Where Ethics and Business Clash, ed. N. Homedes and A. Ugalde, 79–113. New York: Springer. Ugalde, A., and N. Homedes. 2015. La contribución de los investigadores/administradores fieles a la ética y calidad de los ensayos clínicos en América Latina (The Impact of Researchers Loyal to Big Pharma on the Ethics and Quality of Clinical Trials in Latin America). Salud Colectiva 11 (1): 67–86. http://www.scielo.org.ar/scielo.php?script=sci_arttext&pid=S185182652015000100006&lng=es&nrm=iso&tlng=es. Accessed 24 Feb 2018. Viergever, R.F., and K. Li. 2015. Trends in Global Clinical Trial Registration: An Analysis of Numbers of Registered Clinical Trials in Different Parts of the World from 2004 to 2013. British Medical Journal Open 5 (9): e008932. https://doi.org/10.1136/bmjopen-2015-008932. http:// bmjopen.bmj.com/content/5/9/e008932. Accessed 25 Feb 2018. Walsh, R. 2010. A History of: Contract Research Organisations (CROs). Pharmaforum, November, 10 2010. https://pharmaphorum.com/views-and-analysis/a_history_of_contract_research_ organisations_cros/. Accessed 13 Feb 2018. Weiss, F., E. Denters, and P. de Waart (eds.). 1998. International Economy Law with a Human Face. The Hague: Kluver Law International. World Health Organization. 1995. Guidelines for Good Clinical Practices for Trials on Pharmaceutical Products. Technical Report Series No 850, Annex 3. Geneva. World Health Organization. 2018. WHO-WIPO-WTO Technical Symposium on Sustainable Development Goals: Innovative Technologies to Promote Healthy Lives and Well-Being, February 26. Geneva: World Health Organization. http://www.who.int/dg/speeches/2018/tehnicalsymposium-sdgs/en/. Accessed 28 Feb 2018. Young, R. 2009. Informed Consent and Patient Autonomy. In A Companion to Bioethics, ed. H. Kushe and P. Singer, 530–540. New Jersey: Wiley-Blackwell. Zavala, S., and J. Alfaro-Mantilla. 2011. Ética e investigación. Revista Peruana de Medicina Experimental y Salud Pública 28 (4): 664–669.

Chapter 9

Innovative Care in Latin America: Definition, Justification and Ethical Principles Felicitas Holzer and Ignacio Mastroleo

Abstract The term “innovation” or “innovative care” has recently gained attention in the context of the use of novel and not yet fully validated medical interventions and technologies. Most notably, there have been various incidences of medical activities insufficiently validated for its regular use in healthcare that fall into this category, such as stem cell treatments, genome sequencing for diagnostic purposes, or novel reproductive technologies. Latin American countries are among the places where new and non-validated medical activities take place, notably due to a lack of clear regulations and the poor support of authorities of existent legal and ethical guidelines, which is driven by “hidden battles” on the moral status of certain interventions. The increasing importance of innovative care underlines the importance of developing a general framework for these practices. Therefore, the present chapter scrutinizes this nascent field of inquiry in Latin America and offers a conceptual framework for innovation as well as its ethical justification. As we will argue, an important use of the term “innovation” or “innovative care” is best interpreted as “new non-validated practice” and not as a research activity. Then, we will defend that responsible innovation understood as responsible new non-validated practice is ethically permissible and poses an acceptable medical option if done in exceptional circumstances—where no reasonable alternatives can be provided to an individual patient—and following special ethical principles. Finally, we focus on the peculiarities and specific difficulties the concept of new non-validated practice poses to the Latin American context. We will conclude the chapter by some remarks and recommendations we draw from our analysis for individual patients, doctors, and societies in Latin America. F. Holzer (B) Sorbonne University Paris, Paris, France e-mail: [email protected] University of Buenos Aires, Buenos Aires, Argentina F. Holzer · I. Mastroleo CONICET (National Scientific and Technical Research Council of Argentina), Buenos Aires, Argentina e-mail: [email protected] FLACSO Argentina, Buenos Aires, Argentina © Springer Nature Switzerland AG 2019 E. Rivera-López and M. Hevia (eds.), Controversies in Latin American Bioethics, International Library of Ethics, Law, and the New Medicine 79, https://doi.org/10.1007/978-3-030-17963-2_9

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Keywords Responsible innovation · New non-validated practice · Research and practice distinction in the Belmont report · New health technologies in Latin America · Stem cell therapies

9.1 Introduction This chapter introduces our original conceptual framework of new non-validated practice (Holzer and Mastroleo 2018; Mastroleo and Holzer 2018) to give a precise definition of one important meaning of the term “innovation” or “innovative care”. In the current literature of innovative care frameworks, the paradigmatic case of an ethical and successful new, but insufficiently validated medical intervention has been the application of a stem cell treatment in an umbilical cord blood transplant outside sound clinical trials in the late 1980s to save the life of Mathew Farrow, a 5-yearold child with Fanconi’s anemia (Sugarman 2012; Taylor 2010). This treatment has paved the way for valuable clinical procedures, nowadays validated and established in clinical routine. However, recent incidences of an unsuccessful insufficiently regulated and, most probably, unethical use of innovative care point to the substantive risks associated with new and unproven interventions outside sound research. For instance, the case of Jim Gass—that will be discussed in more detail in the next section—provoked an outcry in international media. Jim Gass had previously undergone several stem cell therapies at clinics in Mexico, China and Argentina, paying tens of thousands of dollars each time for injections in an attempt to recover from a stroke. Eventually, Gass developed a tumor in his lower spinal column, a mass that was made up of abnormal, primitive cells that were growing aggressively. Here, we argue that the same complex situation could be recognized in other cases of new and insufficiently validated clinical interventions, such as genome editing and mitochondrial replacement techniques. Successful and ethical cases of innovation illustrate the potential benefits of innovative clinical interventions and are the basis of defending this pathway for patients without a validated medical alternative. However, unfortunate and irresponsible cases also show that allowing for the unrestricted use of new and insufficiently proven interventions may have untoward consequences for both individuals and society. Consequently, new non-validated practice needs to be treated with caution because neither research nor practice regulations protect patients that undergo innovative care. Moreover, Latin American countries are among the places where an increased application of new and non-validated medical activities can be observed, notably due to a lack of clear regulations and poor support of authorities of existent legal and ethical guidelines (Rosemann et al. 2018; Chan and Medina-Arellano 2016). Therefore, we will first of all outline in this chapter, and in particular Sect. 2, exemplary cases that have taken place in Latin America, and more specifically in Mexico and Argentina. Here, we will discuss three potential novel therapeutic biomedical interventions, namely, stem cell therapies, gene editing, and Mitochondrial Replacement

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Technologies (MRTs), as well as a novel and yet non-validated diagnostic tool, that is, genome sequencing for patients with rare diseases. Section 3 is dedicated to a comprehensive analysis of what the current literature in research ethics calls “innovation” (Taylor 2010; Sugarman 2012; London 2006) and what we define as “new non-validated practice” in our conceptual framework (Holzer and Mastroleo 2018; Mastroleo and Holzer 2018). In Sect. 4, we will address epistemic and ethical concerns related to our neutral conceptual framework of innovation as new non-validated practice. In particular, we will argue that the health needs of seriously ill patients with no reasonable medical alternatives ethically justify and occasionally even demand the application of new non-validated practices outside clinical trials or other sound research activities. However, we will also point to the danger that new clinical interventions with an insufficient level of validation for individual patients may “crowd out” sound clinical research or other forms of research. Thus, there may be good ethical and epistemic reasons to regulate the use of new non-validated practice regarding the impact clinical decision may have on future patients and society. In Sect. 5, we then identify and outline commonly defended ethical principles that govern the use of responsible new non-validated practices, which has been so far described as “responsible innovation” in the literature (Sugarman 2012; ISSCR 2016). The work of the principles is to distinguish between responsible or irresponsible cases of innovative care but only as a logical third step after neutrally defining what is innovation within our conceptual framework (Sect. 3) and giving a justification that is an ethically permissible activity (Sect. 4). In the last Sect. 6, our conclusion, we finally bring together the outlined cases of applied new non-validated practices in Latin America and our conceptual analysis of the other sections. Here, we will mainly focus on the peculiarities and specific difficulties the category of new non-validated practice poses to the Latin American context, such as e.g. the strong influence on law and regulations by the Catholic Church. We will conclude the chapter by some remarks and recommendations we draw from our analysis for individual patients, doctors, and societies in Latin America.

9.2 Exemplary Cases of Innovation and Its Context in Latin America Before developing a formal definition of innovation as “new non-validated practice” in the clinical context, we want to outline four exemplary cases. Even though we cannot provide detailed case studies, we want to capture the major intuitions that will be furthermore developed in our conceptual framework. We decide to introduce different cases that cover responsible, irresponsible, successful and failed innovative care. This already hints at our further goal to provide a “neutral” framework of innovation, independent of its outcomes and responsible conduction.

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We argue that new non-validated practice comprises therapeutic, preventive, and diagnostic interventions. Nevertheless, we will only discuss three potential novel therapeutic biomedical interventions, namely, stem cell therapies, gene editing, and Mitochondrial Replacement Technologies (MRTs), as well as a novel and yet nonvalidated diagnostic tool, and more precisely, genome sequencing for patients with rare diseases. Here, we will focus on case examples that took place in the Latin American context, most notably in Argentina and Mexico. After looking into the cases, we will have a better idea about the context in which these take place. As we will further outline, there are at least two specific contextual characteristics with respect to the use of new non-validated practice in these countries. First, the regulatory landscape that is often vague and, second, the influence by the Catholic Church on the deliberation regarding the application of new biomedical technologies, especially in the field of embryonic stem cell research and reproductive technologies. Following Luna and Salles (2010), we may advance the hypothesis that both characteristics regarding the Latin American context are deeply connected, as ‘unsolved’ metaphysical conceptions and doctrines have been impeding a clear public position in the form of clear-cut regulations.1

9.2.1 Stem Cell Therapeutic Interventions Stem cell treatments are on the rise not only in Latin America, but also all over the world. Innovative stem cell therapies, such as the first successful bone marrow transplantation in the 1990s initiated this global trend (Sugarman 2012). However, there are current concerns about cases, as the following one: According to Kolata (2016), Jim Gass’s problems began on May 10, 2009, when he woke up with a terrible headache. “He tried to get out of bed and fell to the floor, unable to move. He’d had a stroke. Two years later, he was able to walk only with a leg brace and a cane”. After that, Jim Gass had several stem cell therapies at clinics in Mexico, China and Argentina, paying tens of thousands of dollars each time for injections to recover from a stroke he had in 2009. The total cost including travel expenses reached 300.000 US dollars. Eventually, Jim Gass developed a tumor in his lower spinal column. The following tests have shown that the tumor mass was made up of abnormal, primitive cells that were growing aggressively (Kolata 2016). In Argentina, Gass received interventions made from his own stem cells at a private clinic.2 In México, he received an injection of fetal cells shipped from Russia (Kolata 2016). As Kolata describes Mr. Gass’s current condition:

1 As Luna and Salles argue “[…] legislative silence regarding stem cell research may not necessarily

be a manifestation of a legal/moral disconnection, but rather a survival strategy for navigating the long and heated battle on the moral status of the embryo and the kind of treatment it deserves” (Luna and Salles 2010, p. 120). 2 Jim Gass, personal communication 30th June 2016.

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After the stroke, Mr. Gass lived independently although his left arm was useless and his left leg weak. Now, however, with the foreign body in his spine, he is paralyzed from the neck down, except for his right arm. He needs a hoist to move from his bed to a wheelchair, and his doctors do not know how to stop the tumor from growing. (Kolata 2016)

The case of Jim Gass provoked an outcry in international media that illustrated a growing concern about the number of stem cell tourists worldwide. The New York Times article reports that there is an increasing trend of clinics in countries with low regulation standards for stem cell therapies, including Latin American countries, such as Argentina and Mexico. Promises are often made to treat and cure patients’ diseases, such as muscular dystrophy, Alzheimer’s, Parkinson’s, or spinal cord injuries as well as strokes by injecting patients with stem cells.

9.2.2 Genome Editing Therapeutic Interventions New “genome editing” techniques, most notably the CRISPR/Cas system have provoked a huge interest in this research area. “Gene” or “genome editing” technologies are molecular complexes that can achieve a specific targeted modification of the DNA sequence. CRISPR/Cas, ZFNs and TALENs are editing systems that are nowadays applied, investigated, and widely discussed (Chan and Medina-Arellano 2016; Rasmussen 2015). The possibilities of applying these new techniques include among others the combination of genome editing and stem cell science for a new generation of somatic gene therapies. According to Chan and Medina-Arellano (2016), the therapeutic potential of CRISPR/Cas is likely to stimulate demand from patient groups to use these techniques in cases of health conditions where no effective treatment is available. The possibility of germ line genetic modification and its associated ethical concerns, such as the creation of genetically modified human embryos, has however overshadowed the debate about potentially new, but yet untested therapeutic interventions. This again supports the hypothesis that there exist “hidden battles” between scientists and the Catholic Church regarding the debate on the moral status of the embryo, which affects the initiation of regulatory and juridical processes for certain interventions (Luna and Salles 2010). Shedding more light on the regulatory, economic, scientific, and social landscape for the use, research, and implementation of new technologies in the biomedical field, Chan and Medina-Arellano (2016) investigate the case of Mexico. They show e.g. that genome editing technologies have raised debates on conflicting arguments that have heavily influenced the regulations of such technologies. These interest comprise international trade, economic development, compliance with international governance, food security, and environmental and biosafety concerns. In particular, gene editing regarding agriculture and the environment has triggered and exacerbated such conflicts around the Law on Biosafety. However, human generic modifications in ‘human beings’ are not considered ‘organisms’ in the sense of the Law on Biosafety (Chan and Medina-Arellano 2016; Ley de Bioseguridad de Organismos Genéticamente Modificados 2005, Article 3),

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which takes out from the jurisdiction the human genome, stem cell cultures, and the modification of human germ cells. These issues fall under the General Health Act and international treaties and regulatory frameworks, such as the guidelines by the International Society for Stem Cell Research (ISSCR 2016). Yet, regulatory frameworks rarely address the clinical application of stem cell derived products, including cells that have undergone gene editing. In practice, experimental therapies with stem cells or stem cell derived products are easily available and commercialised. Loopholes in the regulatory system permit scientists to avoid regulation by switching terms for activities. Thus, although commercialisation of tissues and cells themselves is prohibited, there are ways to sell the procedure, isolation, processing of the cells, which creates a market in practice (Chan and Medina-Arellano 2016: 431). This leaves potential patients exposed to physical and financial burdens and risks when undergoing stem cell-based therapies, as demonstrated in problematic cases, such as the one of Jim Gass. Applying these lessons for the regulation of past new forms of biotechnological innovation and in particular stem cell treatments, Chan and MedinaArellano (2016) conclude that the application of gene editing technologies could face similar problems in the future. So far, international regulations have been a patchwork regarding different countries and the scientific fields involved. In Mexico in particular, laws are vague and broad, which makes a juridical case by case analysis of the implementations of new biomedical technologies difficult. Especially with regard to innovative experimental therapies for desperate patients with no alternatives, countries with low regulatory burdens seem attractive. Medical tourisms and international marketing show that the problem of regulating yet unproven treatments has an impact on an international level. Providers have shown to make use of regulatory differences in different countries.

9.2.3 Mitochondrial Replacement Techniques In 2016, the first baby was born to a Jordanian couple after a mitochondrial replacement technique (MRT, specifically maternal spindle transfer). The mitochondrial replacement procedure happened in Mexico where scientists from the U.S. carried out the procedure. Dr. John Zhang who is leading the scientific group is the founder and medical director of the New Hope Fertility Clinic in New York City. The couple has consulted his clinic after two of their children had died from Leigh’s syndrome, a neuro-metabolic disorder that affects the central nervous system (Palacios-González and Medina-Arellano 2017a, b). Mitochondrial DNA diseases occur when mitochondria with deleterious DNA mutations exist and energy is insufficiently supplied to somatic cells (see PalaciosGonzález and Medina-Arellano 2017a: 6). These deleterious mutations can be inherited or acquired during life and affect all (homoplasmy) or only some (heteroplasmy) mitochondrial genomes. Women with homoplasmic deleterious mutations will always pass this condition across the whole mitochondrial genome to their biological children and those with heteroplasmic mutations will pass a mixture of healthy

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and unhealthy mitochondria. However, the severity of Mitochondrial DNA disease depends on the type of mutation and the number of mitochondria affected. MRTs offer a technology to these women to reproduce a healthy biological child. Thus, in all cases in which women wish to reproduce and the mitochondrial DNA disease is severe, MRTs pose a new and not yet fully validated intervention for women without other alternatives. MRTs basically comprise two main techniques. In the so called “pronuclear transfer” (PNT), two zygotes are created (see Palacios-González and Medina-Arellano 2017a: 8–9). One is created with the intending parents’ gametes (or the intending mother’s egg and a donor’s sperm). The second is created with an egg that has been donated from a woman without mitochondrial DNA disease and the intending father’s (or donor’s) sperm. After fertilization, the nuclear material of the egg and sperm are enclosed in different membranes (pronuclei) and removed from both zygotes during the first 24 h. The pronuclei of the donor’s nuclear material and the enucleated cell with the intending mother’s oocyte are discarded. The intending parent’s pronuclei are transferred to the enucleated zygote of the donor’s egg. In this way, the healthy donor’s mitochondria and the nuclear material of the intending parents are combined. Another procedure is the “maternal spindle transfer” (MST) where oocytes are obtained from the intending mother and a healthy donor. The chromosomes of both oocytes during cell division are removed and the donor’s chromosomes and the intending mother’s enucleated oocyte are discarded. Then, the intending mother’s chromosomes are transferred to the donor’s enucleated oocyte and the new egg with healthy mitochondria is fertilized in vitro. MRTs have been only legal in the UK since 2015. In the U.S., the National Academy of Sciences panel also recommended accepting MRTs in certain limitations, but the Congress blocked the novel techniques for prevention of maternal transmissions of mitochondrial DNA diseases, meaning that the FDA was hindered to consider these techniques in certain exceptional circumstances (Palacios-González and Medina-Arellano 2017a, b). Due to these regulatory issues, Dr. Zhang and colleagues decided to carry out the procedure in Mexico. To do this, he opened two branches of his fertility clinic in the State of Mexico City and in the city of Guadalajara in the state of Jalisco. According to public statements and the abstract of a conference paper for the American Society for Reproductive Medicine 2016 Scientific Congress in 2016, Dr. Zhang (2016) claimed that he performed the MRT procedure in Mexico because “there are no rules”, where he most likely referred to the rather ‘loose’ regulations in Mexico. In fact, even though there are laws regulating reproductive technologies, they are fairly loose and moreover, do neither explicitly allow nor forbid MRT. The legality of performing the procedure in Mexico has been, however, questioned by Palacios-González and Medina-Arellano (2017). They claim that a revised reading of the legal framework applied to the discussed case would not have permitted MRT under the regulations of the General Health Law on Health Research. According to this article 56 (Ley general de Salud en Materia de Investigación para la Salud 1987), research on assisted fertilization is only permitted when

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it solves sterility problems that cannot be solved otherwise. However, the woman was fertile at the point in time when Dr. Zhang performed the procedure.3

9.2.4 Genome Sequencing as Diagnostic Tools for Individual Patients Examples of using new and unproven interventions outside sound clinical research activities are not limited to therapeutic procedures, such as the above-mentioned exemplary cases of stem cell therapies, gene editing, or MRTs. They also include diagnostic interventions. Genome sequencing technologies, including whole genome and whole exome sequencing, for patients with rare diseases is a recent exemplary case of a new insufficiently validated diagnostic intervention used outside sound clinical research activities. Patients who suffer from rare diseases often face long and burdensome diagnostic procedures over several decades. Decoding the genetic causes of disease is crucial in order to target potential therapies for rare diseases. In Argentina, diagnostic procedures for rare diseases are preformed and established as ‘research activity’ under the ethical principles for research (CIOMS-WHO 2016) and regulatory system of the Argentine Health Authority ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología) (ANMAT 2010; MSAL 2011). Decreasing costs for sequencing technologies has paved the way for extended research and diagnostic applications of these technologies. For instance, Córdoba et al. (2018) report a diagnostic yield regarding rare mutations in patients with unknown neurological disorders of around 40% in a cohort of 40 patients that have undergone whole genome and exome sequencing methods (Córdoba et al. 2018; see Kaufmann 2013; see Kaufmann and Turjanski 2015). Previous studies had revealed a diagnostic rate of about 30% in neuro-genetic disorders regarding results of large series that have included other medical conditions as well (Córdoba et al. 2018). Due to the lack of national guidelines, Argentine geneticists base the report of findings to patients most notably on the recommendations by the National Bioethics Advisory Commission (NBAC 2001) and the American College of Medical Genetics (Committee on Bioethics 2013), despite their contradictory instructions. Still, it remains questionable whether the application of sequencing technologies for yet nonvalidated interventions should be labelled ‘research’. In particular, in cases where the

3 This is Palacios-Gonzalez’ and Medina-Arellano’s reading of the general Health Act., which might

be also, in our opinion, interpreted differently. The original text is the following: “La investigación sobre fertilización asistida sólo será admisible cuando se aplique a la solución de problemas de esterilidad que no se puedan resolver de otra manera, respetándose el punto de vista moral, cultural y social de la pareja, aun si éste difiere con el de investigador.” [“The research on assisted fertilization will only be admissible when applied to the solution of sterility problems that cannot be solved in another way, while respecting the moral, cultural and social point of view of the couple, even if this differs from the point of view of the researcher.”] (Article 56, Ley general de Salud en Materia de Investigación para la Salud 1987, translated).

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main aim is not to contribute to general knowledge but to improve (not yet entirely validated) diagnostic tools for individual patients.

9.2.5 Context in Latin America: The Hidden Battle Hypothesis, Effective Regulation and the Influence of the Catholic Church In this section, we would like to briefly highlight a peculiarity of the Latin American regulatory landscape and more precisely focus on the power of conservative voices most notably represented and put forward by the Catholic Church. Here we discuss the situation in Argentina, which can be, however, applied to other countries in Latin America. As an exemplary case, Luna and Salles (2010) dwell on the influence of the Catholic Church on the regulations of regenerative medicine, such as (embryonic) stem cell research in Argentina. They refer to an article by Shawn Harmon (2008) who had previously tried to contextualize the discussion on regulatory attempts for stem cell research in Argentina. According to him, the country has already taken many positive steps to build up its stem cell research capacity and has considerably advanced in the field. Based on that, he is interested in the translation of country-specific moral values held by Argentines into their legislation and regulatory guidelines. According to the Luna and Salles (2010), the influence of the Church should not be underestimated. For instance, the document of Donum Vitae (Congregation for the Doctrine of the Faith 1987) clearly states that an embryo, from its first moment of its existence, demands morality and respect to the human being, as well as its spiritual totality. In a dogmatic but common interpretation of the text, there is no objective that could overrule the moral prohibition to destroy an embryo. Moreover, the Vatican’s Instructions Dignitas Personae, launched in 2008, holds that an embryo possesses ‘the dignity proper to the person’ and ‘unconditional respect’ is owed to ‘every human being at every moment of his or her existence’ (Congregation for the Doctrine of the Faith 1987). This has major implications, also for the recommendation for the use of embryonic stem cells: …the use of embryonic stem cells or differentiated cells derived from them – even when these are provided by other researchers through the destruction of embryos or when such cells are commercially available – presents serious problems from the standpoint of cooperation in evil and scandal. (Declaration on the Production and the Scientific and Therapeutic use of Human Embryonic Stem Cells 2000)

Harmon (2008) points to the juridical ‘silence’ on the status of embryos, which may implicitly permit research with embryonic stem cells. However, Luna and Salles (2010) argue that there is also a more conservative reading of existing law, namely that personhood can be attributed to an embryo, especially in the context of assisted reproductive technologies and reproductive health in general. Previously, conservative voices and lobbying in Argentina had lead to legal demands, such as the demand

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to have a lawyer acting as a legal guardian for cryo-preserver embryos at court (Luna and Salles 2010: 125). In Argentina, more than 80% of the people call themselves Catholic. Historically speaking, Luna and Salles (2010) claim that the Church influenced on the nation and citizens through its institutions and its presence in education and charity. This shaped the views on sexual rights and sexuality in general, meaning that legislation often followed the Church’s view despite legislative changes regarding LGBT rights and assisted reproductive technologies (Luna 2018). Generally speaking, the Catholic Church is still one of the main stakeholders involved through their value schemes in the development of the regulatory landscapes for new and yet insufficiently proven biomedical interventions and technologies. According to the Luna and Salles (2010), the growing importance of liberalism during the twentieth century did not stop the Catholic groups from proliferating and promoting Christian values. However, today’s influence of the Church on the behaviour of individuals is not as easy to analyze. For instance, women widely use birth control methods and a considerable number of women have undergone abortion illegally until its recent legalization. Finally, one can increasingly hear voices that support stem cell research as a promising new opportunity for the country to achieve international recognition. But apart from the debate in which scientific interests and religious concerns clash, Luna and Salles (2010) consider women an underrepresented group in the debate in which feminist interests and concerns are frequently ignored.

9.3 Definition: What Is Innovation as New Non-validated Practice? In a previous work, we defended that the term “innovation” in the context of clinical medicine (Brierley and Larcher 2009; London 2006; Mastroianni 2006; Sugarman 2012; Taylor 2010) is best interpreted as “new non-validated practice”, a term we define as the first or recent use of an intervention that introduces a significant change, with an insufficient level of safety or efficacy for regular healthcare, and with the main aim to benefit patients (Mastroleo and Holzer 2018). An important characteristic of our definition is that we frame innovation in morally neutral terms. This eventually separates the normative evaluation, i.e. ethical principles and justification of innovation from the activity itself, which allows for a reasonable disagreement about the scope of responsible innovation and leaves the “description” or “category” of the activity intact (Lipworth et al. 2018; Mastroleo and Holzer 2018). In this section, we outline the arguments and results of this previous work to offer a sound explication of “new non-validated practice”. More specifically, we revisit the distinction between research, validated practice and innovation made in the Belmont Report, as well as in Levine’s definition of “non-validated practice”. This preliminary conceptual analysis builds the basis to develop our conceptual

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framework of our definition of “innovation” as “new non-validated practice”. Here, we depart from Levine’s definition and argue that innovation is characterized by three features and not two, namely, novelty (new), validation (non-validated) and the intention to benefit individual patients (practice). Moreover, to avoid confusions, we introduce a taxonomy of four categories for interventions that logically follows from our definition.

9.3.1 Traditional Research Ethics Distinction Between Research, Validated Practice and Innovation (Non-validated Practice) In order to address the concept of “non-validated practice”, we would like to start by referring to the distinction in traditional research ethics between research, validated practice and non-validated practice. Following this distinction, non-validated practice is neither research nor validated medical practice. According to Beauchamp and Saghai’s (2012) interpretation of the Belmont report, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (hereinafter National Commission) has established two classes of complex activities labeled “research” and “practice” as categories for medical interventions that are “logically distinguishable” (Beauchamp and Saghai 2012: 55) from each other (although they may coexist).4 The first distinction the Belmont Report introduces is between research and what we here will call validated practice. This distinction has practical consequences because it draws a clear line between activities that should undergo review for the protection of research participants (“research”) and activities that do not need this special consideration (“validated practice”). On the one hand, the Commission introduces “practice” we identify as “validated practice” for individual patients, and gives the following definition: [F]or the most part, the term [validated] “practice” refers to interventions where: (P1) the purpose of an intervention is “to provide diagnosis, preventive treatment, or therapy”; (P2) the intervention is “designed solely to enhance the well-being of an individual patient or client” (though benefit to other persons is sometimes the goal); (P3) the intervention has “a reasonable expectation of success”. (National Commission 1978, as quoted in Beauchamp and Saghai 2012, p. 52, edited)

4 As

Beauchamp and Saghai state Belmont Report “did not conclude that research and practice cannot be “carried on together when research is designed to evaluate the safety and efficacy of a therapy” [4, p. 4]. It affirmed that they can be so integrated. The segregation thesis is merely that research interventions are logically distinguishable from practice interventions. Belmont claimed no more than that an activity involving both research and practice components must be reviewed as research even if its primary goal is improving treatment for patients” (Beauchamp and Saghai 2012: 55). To understand how research and practice may coexist, see the concept of a component analysis developed by Weijer (2000), Weijer and Miller (2004).

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On the other hand, the National Commission defines research as follows: To qualify as research two conditions are central. The first is not a necessary condition for all forms of research, but the second is a necessary condition: (R1) there is (in pertinent research methods) a formal protocol-controlled design to test a hypothesis; (R2) there is an organized design “to develop or contribute to generalizable [scientific] knowledge”. (National Commission 1978, as quoted in Beauchamp and Saghai 2012, p. 52).

The National Commission recommends that if an activity has an organized design “to develop or contribute to generalizable [scientific] knowledge”, it should undergo a research review to protect human subjects, irrespective of the fact that the intervention or procedure is also intended to provide direct health benefits to the individual patient-subject (Levine 2008, p. 217). This is a precautionary measure to prevent researchers from taking advantage of a loophole in the oversight system by applying investigational interventions under the label of “practice” to avoid the review process (Beauchamp and Saghai 2012, p. 43). In turn, an activity designed to enhance the well-being of an individual patient should be considered “practice”.5 However, despite the distinction between research and practice through the establishment of two logical, although non-mutually exclusive, domains, the National Commission already gives credit to interventions labeled as “innovation” that we identify as “non-validated practice”, as follows: When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is “experimental” in the sense of new, untested or different does not automatically place it in the category of research. (National Commission 1979, edited)6 5 Belmont Report present a narrow and a wide definition of practice. Practice in a narrow sense refers

to “the most part” of interventions “designed solely to enhance well-being of individual patients”. However, the Belmont Report also defines the practice condition (P2) in a wider sense as “an intervention designed to enhance the well-being of a particular individual or groups of individuals” (National Commission 1979, note 1). This wide sense captures what Levine (1979) calls “practice for the benefits of others.” That is, interventions designed only to enhance the well-being of others (e.g., blood donation and organ transplant) and interventions designed to enhance the well-being of an individual and others (e.g., vaccination) (Levine 1979, p. 22; National Commission 1979, note 1). The role of other persons as an essential part of the interventions complicates the assessment of the benefit-harm profile of an intervention because there is a need to evaluate the potential harms to other persons who are involved in the intervention. Nevertheless, these interventions should be considered practice, as they have the intention or main aim of enhancing the well-being of individual patients. According to Beauchamp and Saghai “The point of these qualifications was to reassure readers that activities designed to benefit others do not threaten the research-practice distinction the Commission had developed […] Commissioners thought they had done enough for purposes of public policy by distinguishing research from practice, whatever those various forms of practice might turn out to be on a closer inspection of the scope of practice” (Beauchamp and Saghai 2012: 54). 6 The unedited complete quotation of the paragraph on innovation in Belmont Report is the following “When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is ‘experimental’, in the sense of new, untested or different, does not automatically place it in the category of research. Radically new procedures of this description should, however, be made the object of formal research at an early stage in order to determine whether they are safe and effective. Thus, it is the responsibility of medical practice committees, for example, to insist that a major innovation be incorporated into a formal research project.” (National Commission 1978).

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As stated in the Belmont Report, “innovation” is understood as departing significantly from standard accepted practice. However, innovation does not, in itself, constitute research. Hence, the Belmont Report does not introduce a third category for innovation, but considers it as some sort of medical practice because it is designed to benefit the individual patient, as stated above in (P2). This has important practical consequences because considering an innovative intervention as a clinical practice implies that the intervention underlies the general regulations of medical practice and not those of clinical research (Mastroianni 2006). Nevertheless, since the innovative intervention does not show sufficient evidence, it cannot be considered validated medical practice, and hence does not fulfill the standard interpretation of condition (P3). In our previous work we identify innovation in the traditional research ethics paradigm (Holzer and Mastroleo 2018; Mastroleo and Holzer 2018) as non-validated practice (Levine 1979, 2008). We believe that this interpretation of the National Commission’s work is useful because it integrates and connects a recent trend in the research ethics literature that has often adopted this specific meaning of innovation (Brierley and Larcher 2009; London 2006; Mastroianni 2006; Sugarman 2012; Taylor 2010).

9.3.2 Levine’s Definition of Non-validated Practice As presented in the previous section, the Belmont Report states that “practice” refers to diagnostic, preventive, or therapeutic interventions designed to enhance the wellbeing of an individual with reasonable expectations of success. In contrast, “research” is designed to test hypotheses and permit conclusions that generate generalizable knowledge, irrespective of the use of interventions or procedures intended to provide direct health benefit for the individual patient-subject.7 However, Levine points out that there is one particular subclass of “medical practice” which he describes as “non-validated practices”. Here, he notices that the National Commission refers to non-validated practice in various ways and in different documents by using terms such as “innovative therapies” or “experimental design”. In a following step, he argues that the best designation of these terms is “non-validated practice”, defining it as follows: Nonvalidated practices. A class of procedures performed by physicians conforms to the definition of ‘practice’ to the extent that these procedures are [P2] ‘designed solely to enhance the well-being of an individual patient or client.’ However, [not P3] they may not have been tested sufficiently often or sufficiently well to meet the standard of having ‘a reasonable expectation of success’. (Levine 1979: 22, edited).

7 However,

Levine already argues that there are plenty of medical practices including, for example, public health practices or practices for the benefits of others that overlap with the aims of research. In turn, research also takes into consideration the well-being of a research subject to some extent (Levine 2008).

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Comparing this definition with the Belmont Report’s definition of validated practice presented above, we note that non-validated practice meets the first two conditions, namely the purpose and scope of interventions (P1) and the design to benefit an individual (P2). However, the definition does not comply with the third condition of ‘reasonable expectations of success’ (not P3) due to a lack of sufficient evidence of the intervention. Hence, medical practice can be classified as validated or nonvalidated practice. This is in line with the reality of medical practice where not all interventions used to enhance the well-being of patients are sufficiently validated. Consequently, the term “practice” in traditional research ethics refers to a complex activity whose main aim is to enhance an individual patient’s well-being. This implies the level of evidence of the intervention used is not a sufficient condition to determine the type of activity, research or practice. Rather, the defining condition is given by the main aim or intention of the activity. In Levine’s more colloquial terms, “it depends upon what you’re intending to do” (Levine 2004) whether something is framed as research or practice.

9.3.3 Innovative Care as New Non-validated Practice In the previous sections, we have introduced and clarified the definitions of research, validated practice and non-validated practice. Moreover, we started this section with a neutral definition of new non-validated practice as the first or recent use of interventions that introduce a significant change, with an insufficient level of safety or efficacy for regular healthcare, and with the main aim to benefit patients (Mastroleo and Holzer 2018). Our definition of new non-validated practice is narrower than Levine’s definition of non-validated practice and distinguishes practice between two definitional attributes, validation and novelty (and not only validation, as Levine proposes). Below, we introduce our own classification of practice (with slight modifications regarding our framework in Holzer and Mastroleo 2018) based on these two definitional attributes: As we argued in Holzer and Mastroleo (2018), we think that it is of great importance to add the distinction between new and long-standing non-validated practice because both categories imply different real-world problems. By definition, both subtypes of non-validated practice lack a sufficient level of evidence regarding safety or efficacy for regular healthcare use from the point of view of a sound scientific standard. Since new non-validated interventions—or “innovation” as it is referred in the Belmont Report—introduce a significant change, they can be and have been easily confused with research (National Commission 1978; Taylor 2010). This problem has never concerned long-standing non-validated practices.8 8 Gracia (2013), one of the most influential scholars in Latin American bioethics (Álvarez-Díaz 2012,

p. 18), has developed an alternative classification of practice that captures a similar distinction in a different way. This gives us independent support to the idea that rethinking the classifications of practice might be a useful effort.

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In our recent work (Holzer and Mastroleo 2018; Mastroleo and Holzer 2018), we also analyze the three core elements of our definition of new non-validated practice: novelty (“first or recent use of interventions that introduce a significant change”), validation (“use of interventions with an insufficient level of safety or efficacy for regular healthcare”) and practice (“use of interventions with the main aim to benefit patients”). After outlining some general remarks about our definition, we would like to present the results of our previous conceptual analysis.

9.3.3.1

General Remarks on Our Conceptual Framework

First, it is useful to distinguish between normative and descriptive concepts in research ethics and to note explicitly that traditional definitions of practice and research—and our definition of new non-validated practice in particular—are normative definitions in the sense that they propose certain conditions to be sufficient to assign an intervention to a certain class of interventions. This categorization determines whether a medical activity ought to be called validated practice, non-validated practice, or research, independently of whether these categories are in fact being used in practice. The traditional research ethics distinction between validated practice, nonvalidated practice (innovation), and research is owed to the debate on the conceptual boundaries of practice and research (Levine 2004). As Beauchamp and Saghai (2012) explicitly state, the National Commission realized that not all accepted practices used in regular healthcare were scientifically sound and validated. After more than 40 years, this is still the case regarding the current practice of some interventions, as for instance, episiotomy, the surgical enlargement of the vaginal orifice by an incision of the perineum to increase the diameter of the vaginal outlet to facilitate the baby’s birth. According to the literature, almost 90% of primiparous women had an episiotomy (Althabe et al. 2002). This would make routine episiotomy an accepted practice in Latin America (Graham et al. 2005). However, current sound scientific evidence shows restrictive episiotomy is better than routine episiotomy, generating less overall trauma, less suturing and fewer complications (Carroli and Mignini 2009). Thus, routine episiotomy has been for a long time an accepted, but yet non-validated practice, that is, an intervention introduced and maintained with insufficient evidence regarding safety and efficacy for its regular use in healthcare according to our current sound scientific knowledge. Therefore, it is useful to distinguish between successful and failed instances of new non-validated practice (outcome), as well as between responsible and irresponsible instances of new non-validated practice (responsibility). Importantly, the category of innovation itself is morally neutral, meaning that it is independent of the outcomes and the compliance with the principles of responsible innovation. With respect to the latter, responsibility, we believe the definition and concept of innovation should be morally neutral to avoid superficial or even flawed justifications and ethical principles, and to allow for reasonable disagreement about what constitutes responsible innovative care (Lipworth et al. 2018; Mastroleo and Holzer 2018).

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Regarding the outcome, our framework departs from London (2006) who considers “improvement” a definitional attribute of “innovation” and distinguishes between “genuine” (successful) and failed innovation. We believe that it is more fruitful to adopt an outcome-neutral definition of innovation, because the ethics of “new nonvalidated practice” considers the reasonableness and the intention of agents, which cannot be reduced to the success or failure of an intervention. Indeed, a failed new non-validated practice may be also a genuine and responsible new non-validated practice if it follows the appropriate ethical principles. That way, the success or failure of an intervention is distinct from the evaluation of the conditions of its responsible use. This is analogous to the responsible evaluation of the benefit-harm profile of an intervention, as the benefit-harm profiles pose a judgment ex ante (foreseeable or not foreseeable) instead of ex post (realized or not realized). We argue that the core concern of defining innovation as new non-validated practice is the aim of an activity, namely to enhance the well-being of patients or the intention to use that intervention to end or alleviate current suffering of a patient. Neither realized success, nor failure, poses a necessary condition for the responsible use of new non-validated practice. As we will show in Sect. 5, responsible new nonvalidated practice is assessed not by its success or failure, but by the ethical principles of responsible new non-validated practice.

9.3.3.2

Novelty

We stipulate that the attribute “novelty” or “new” refers to the recent or first use of an intervention that introduces a significant change in practice. Furthermore, we use the term “long-standing” in Table 9.1 as the logical opposite to “new” in the sense that we refer to the recent or first use of an intervention that introduces a significant change. Here, it is useful to analyze the term “significant change” and differentiate it from “mere variation” or non-significant change (ACOG 2015, p. 5; London 2006, p. 31) to avoid the inclusion of meaningless changes in practice under the label of “new” practice. This would be important in view of the principles for responsible new nonvalidated practice, in particular to allow effective regulation and practicality. In most cases, changing the color of surgery gloves from blue to indigo would probably not be considered a significant change. However, a change from latex to nitrile gloves could be a significant change, and hence a new non-validated practice, given that latex allergies are a concern in certain circumstances. More formally, the criterion to distinguish between significant change and mere variation is that a change is significant if it entails a relevant modification in the benefit-harm profile of the intervention, given a specified context (London 2006, p. 31).

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Table 9.1 Medical practice characterized by validation and novelty Validation

Novelty New practice

Long-standing practice

Non-validated practice

New non-validated practice (innovation/innovative care) Examples: Jim Gass’ stem cell interventions, genome editing therapeutic interventions, Zhang’s mitochondrial replacement techniques, genomic sequencing diagnosis for rare diseases (Sect. 2)

Long-standing non-validated validated practice Example: routine episiotomy for vaginal birth (Carroli and Mignini 2009)

Validated practice

New validated practice Example: Imatinib for chronic myeloid leukemia after FDA approval (Druker 2009)

Long-standing validated practice Example: Aspirin for headaches

9.3.3.3

Validation

Due to reasons of stipulating with the scope of this chapter, we cannot dwell on what Beauchamp and Saghai call the “epistemic problem” in the clinical context, which refers to the conditions under which medical interventions are sufficiently validated. However, following Beauchamp and Saghai (2012: 49–50), we can note the following three points. First, a significant number of insufficiently validated interventions in medical practice fall short of the validation standards set by randomized clinical trials. Second, not all members of the scientific community accept the view that the validation of an intervention is obtained solely by randomized clinical trials (RCTs). Thus, there is a strong disagreement among researchers regarding the different methods or research activities of validation at stake. In fact, “RCTs have never monopolized medical knowledge production” (Bothwell et al. 2016). Moreover, there seem to be good arguments not to consider randomized clinical trials as a universal gold standard, but rather to adopt a case-by-case approach applying different research methods and methodologies to untested and new interventions when necessary (Cartwright 2007; Diaz and Neuhauser 2005). Third, the fact that an intervention is accepted in practice does not necessary provide a reason to believe that the safety and efficacy of that intervention are supported by sufficient evidence (e.g. routine episiotomy for vaginal birth). Thus, instead of offering an epistemically unwavering account for the evidence of an unproven intervention, we interpret the Belmont Report’s criterion (P3) of “reasonable expectations of success” as an epistemic standard relative to a specified body of information and a specified range of reasons. As we will argue, a certain level of evidence may not be sufficient to call a medical activity validated practice. However, the level of evidence may be enough to consider the activity as “new non-validated practice”.

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In the case of new non-validated interventions, the limited clinical and/or preclinical evidence of effectiveness and safety may not amount to the full validation of an intervention relative to the appropriate epistemic standard. In these circumstances, physicians have good reasons to restrict the use of a new non-validated intervention (e.g. cord blood transplant) to few individual patients. This means the intervention should not immediately applied at a population level (i.e. all children with Fanconi’s anemia) in regular healthcare due to lacking “reasonable expectations of success”. However, even if the probabilities of success are low or uncertain regarding the use in regular healthcare of a new non-validated practice, it may still show a minimum level of evidence to be a reasonable option in a limited number of cases in which patients do not have medical alternatives or what we call “exceptional circumstances”. That is the case because even if an intervention has not been tested sufficiently often or sufficiently well, this does not imply that the intervention has no evidence at all (Levine 1979: 22). Thus, it seems reasonable to distinguish between (i) a minimum level of evidence necessary to be a reasonable option for individual patients in exceptional circumstances and (ii) the criterion of “reasonable expectations of success” as it is used in Belmont Report and Levine’s definition of non-validated practice, which we associated with validated practices relative to an appropriate epistemic standard for use in regular healthcare of general population. Nevertheless, even if an intervention lacks sufficient evidence to reach the appropriate standard of validated medical practice for regular healthcare, to be scientifically sound an intervention has to reach a minimum level of evidence to be a reasonable option even in exceptional circumstances. Furthermore, without a minimum level of evidence in support of the efficacy and safety of an intervention, it would be futile or irrational for physicians to prescribe and for individuals to undergo the intervention as a last chance. This explains why the ISCCR Guidelines for stem cell research and clinical translation demand for clinical innovation a sound scientific rationale and justification given the lack of alternatives for the patient (scientific validity) (ISCCR 2016, recommendation 3.4).

9.3.3.4

Intention

Finally, perhaps the most important component of our definition of clinical innovation is that new and non-validated interventions are used as medical practice. This means that the intention or main aim of innovation is (P2) the “well-being of the patient” and not (R2) the generation of or contribution to “generalizable [scientific] knowledge” as in clinical research (National Commission 1979; Levine 1979). There are important real-world implications of defining new non-validated practice as a type of medical practice related to intentionality, benefit-harm evaluation and responsibility. First, our definition of “new non-validated practice” does not state that new non-validated interventions fall into a “grey zone” between research and practice (King and churchill 2008). Following the traditional definition of Levine and the Belmont Report, we define new non-validated practice as part of medical practice and not as research. Thus, clinical innovation refers to the use of an intervention that

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falls under medical practice, understanding “practice” as a practical context were physicians apply preventive, therapeutical or diagnostic means with the main aim of benefiting patients. The “grey zone” is overcome by the agents response to the basic question “what you’re intending to do” (Levine 2004). Following the basic intuition of traditional research ethics, our framework explicitly highlights that the intention of an intervention is something to be considered to determine its responsibility regime and its ethical permissibility. Second, one important aspect of defining new non-validated practice as an activity with the main aim to benefit individual patients concerns the benefit-harm analysis. Interventions considered as new non-validated practice should be subject to a benefitharm profile evaluation according to the standards of medical practice, not research (Levine 1979: 22). According to Weijer and Miller (2004) and as stated by King and Churchill (2008), the benefit-harm analysis in clinical research is considerably distinct from the evaluation in medical practice. While therapeutic risks as well as non-therapeutic risks (that are not directly associated with therapeutic procedures) occur in the context of clinical research, all risks directly relate to the individual in the case of medical practice. In the case of research, non-therapeutic risks that occur in the context of non-therapeutic procedures and that are unrelated to the intended improvement of a patients’ well-being procedures are balanced with potential therapeutic benefits to the research subjects, and ought to be in reasonable relation to the knowledge gain and social benefit to society (Weijer and Miller 2004; Emanuel et al. 2000). Hence, benefits to society are an additional factor in the assessment of research and the threshold for potential benefits to individuals might be considerably lower than in the case of medical practice (King and Churchill 2008). When we apply the aforementioned considerations on the risk-benefit analysis to the concept of new non-validated practice, we argue that the ethical evaluation of a benefit-harm profile should be in accordance with the ethical evaluation of medical practice. If a new non-validated intervention is the only reasonable intervention for diseases with potentially life-threatening or strongly life-impairing characteristics primarily designed to enhance the well-being of patients, high risks can be reasonably accepted. Nevertheless, risks that occur in the setting of clinical innovation ought to be in accordance with general guiding frameworks about risks. For instance, King and Churchill (2008) explain that there are some risks that can never be justified, and all significant risks of serious harms must have unassailable justification. Risks of harm should always be minimized.

9.4 Justification: What Is the Ethical Justification of Innovation as New Non-validated Practice? In the previous section we defined new non-validated practice as the use of new, interventions that are insufficiently validated for regular healthcare, but show a sufficient minimum of evidence to be considered reasonable, and aim to benefit individual

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participants in exceptional circumstances. In this section, our aim is to offer an ethical justification for new non-validate practice. This justification is intended to prove the ethical permissibility of new non-validated practice—at least within the limits of exceptional circumstances—in order to attenuate debunkers who sustain that insufficiently validated interventions should only be accessed by the means and under the regulations of research. Emanuel’s reformulation of the principle for the use unproven interventions in the Declaration of Helsinki of the WMA (2013, paragraph 37) can be construed as an objection to the traditional definition of non-validated practice in general and our definition of new non-validated practice in particular: 6. Research of Unproven, “Last Ditch” Treatments: In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention to promote the patient’s health or well-being, but only if it is undertaken as a research study designed to evaluate its safety and efficacy. Repeated uses of an unproven intervention can only be justified as part of a research study that fulfils all the protections in this Declaration. (Emanuel 2013, supplementary appendix)

One possible interpretation of Emanuel’s reformulation of the non-validated practice principle is that it eliminates the traditional tripartite distinction in research ethics of validated practice, non-validated practice, and research. Only validated practice and research are ethically permissible categories. Non-validated practice is ethically forbidden, even for “last ditch” treatments, such as interventions used for the benefit of patients with unmet health needs and no reasonable alternatives. Emanuel’s reformulation of the principle for the use of unproven interventions is an intellectual exercise and has never been incorporated into the Declaration of Helsinki. One limitation of this exercise is that Emanuel’s principle has no justification in itself. Why should insufficiently validated interventions only be undertaken in the context of a research study? One plausible reason to justify his principle is the shared concern in the literature that the unrestricted facilitation of new non-validated practice outside sound scientific research may endanger the generation of generalizable scientific knowledge, which could entail negative consequences for public health (ACOG Committee on Ethics 2015; Little and Wickremsinhe 2017; Rosemann et al. 2018). We have called this concern “epistemic crowding out of sound research” in our previous work (Mastroleo and Holzer 2018). It is commonly argued that unrestricted new non-validated practices can lead to less recruitment of patients in research trials, especially when patients have the incentive to receive their preferred intervention in one hundred percent of the cases (rather than, for example, having only a fifty percent chance of receiving it in randomized controlled trials) (ACOG Committee on Ethics 2015, pp. 3–4; Daniels and Sabin 1997). Unregulated promotion and advertising may foster this tendency even more (ACOG Committee on Ethics 2015, pp. 3–4). If sound scientific evidence to validate interventions for the regular healthcare use could not be attained outside multi-phase randomized controlled trials or other sound scientific research designs, it would be reasonable to accept and limit new

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non-validated practice. This is precisely the case when we foresee that the uncoordinated and unlimited aggregation of the individual use of new non-validated practice seriously risks a “crowding out” of sound scientific research with untoward consequences for public health, as the recent discussion on the “right to try legislation” exemplifies (Dresser 2016; Joffe and Lynch 2018). Hence, we believe that potential epistemic crowding out effects are important enough to regulate and limit what is usually referred to as “innovation” or “new non-validated practice” (regarding our particular interpretation of it). However, this concern is not enough to ethically forbid non-validated practice, as Emanuel’s principle states. Social expediency should not be confused with what is ethically appropriate. Here, we hold the plausible position that epistemic crowding out of sound research is not a necessary consequence of new non-validated practice. For instance, ethics frameworks, such as the ISSCR guidelines (2016, recommendation 3.4), address this issue by stating that new non-validated practice must remain the exceptional case to avoid undermining public trust, exploiting patients’ hope and delaying sound research. New non-validated interventions should be used in a very small number of patients outside of research with an obligation to move to sound research in a timely manner after experience with, at most, a few patients. This latter obligation is described in the literature as the “commitment to contribute to generalizable knowledge” (ISSCR 2016; Sugarman 2012). In turn, this ethical requirement can be seen as a form of bridging the gap between practice (intention to enhance patients’ well-being) and research (intention to contribute to generalizable knowledge). Moreover, the ethical requirement of the “commitment to contribute to generalizable knowledge” is also present in the traditional view in research ethics. Both, the Belmont Report and the Declaration of Helsinki, acknowledge this rationale as one of the core ethical requirements of the responsible use of new non-validated practice.9 However, as the literature shows, there are contextual obstacles to support this ethical requirement in real-world situations, such as the lack of research infrastructures in new fields of medicine, the lack of specific oversight structures for new non-validated practice, the prohibition of national research funding in certain clinical areas (e.g. embryo research), etc. (ACOG 2015, pp. 4–5; Rosemann et al. 2018; Taylor 2010). Hence, crowding out of sound research is not generated by one single use of a new non-validated intervention in isolation, but by the repeated use of new non-validated interventions in an unregulated context.

9 “[…]

[Unproven] intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available” (WMA 2013, para. 37), and “Radically new procedures of this description should, however, be made the object of formal research at an early stage in order to determine whether they are safe and effective. Thus, it is the responsibility of medical practice committees, for example, to insist that a major innovation be incorporated into a formal research project” (National Commission 1978).

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9.5 Regulation: What Are the Basic Ethical Principles of Responsible Innovation as New Non-validated Practice? In the previous section we defended the permissibility of new no-validated practice in exceptional situations against the objection of “epistemic crowding out”. Now, we are going to specify the principles of “responsible innovation” understood as “new non-validated practice”. As we have argued in the analysis of the definition of new non-validated practice, the principles of this complex activity set the standards for evaluating the conduct of responsible agents. We will put forward in the last section that this set of principles is useful to distinguish between serious and responsible doctors from dishonest and unscrupulous ones. The Declaration of Helsinki in 2000 (WMA 2000, paragraph 30) states that given the patient gives informed consent, physicians must be free in choice to apply unproven or new preventive, diagnostic and therapeutic measures if they are considered potentially life-saving, re-establish health or alleviating suffering for patients without reasonable alternatives. This principle has already been acknowledged in the first version of the declaration (WMA 1964) under the section “clinical research combined with professional care”. Here, the Declaration states that “[I]n the treatment of the sick person the doctor must be free to use a new therapeutic measure if in his judgment it offers hope of saving life, re-establishing health, or alleviating suffering” (WMA 1964, paragraph 1, Sect. 2). This applies to all cases in which proven preventive, diagnostic and therapeutic methods do not exist, are rare or not acceptable. It also includes conditions for the compassionate use of drugs. For instance, a physician may decide that it is reasonable to offer an individual patient an unproven intervention outside clinical trials when she is not eligible for a research study. Likewise, physicians may conclude that an individual patient can profit from new non-validated interventions, such as those ones that occur in the context of individualized diagnostics and therapies, and which cannot be currently tested under a rigid and methodologically sound clinical trial. Importantly, next to assigning responsibilities to physicians, the Declaration of Helsinki gives credit to individual patients’ health conditions that go along with substantial suffering. Thus, the application of potentially risky innovative interventions is not justified if the patient has no substantial health need to undergo the new and unproven intervention. This use of non-validated interventions in medical practice has sometimes been identified with the category of “therapeutic research” (Levine 1979). However, Levine has systematically criticized “therapeutic research” as a conceptually problematic category (Levine 1979: 23, 1999, 2008) and states that “non-validated practice” replaces this category in the most developed reports of the National Commission (Levine 1979: 23). The ethical principle in the Declaration of Helsinki (WMA 2000, paragraph 30) for the use of “last-ditch” unproven interventions, applied after a careful assessment by physicians seeking expert advice, has remained with minor changes in the revised versions of the Declaration in 2008 (WMA 2008, paragraph 35) and in 2013

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(WMA 2013, paragraph 37). Following the latest version, this has been labeled as the paragraph for the appropriate use of “unproven interventions in clinical practice”. Regarding this account, innovation as new non validated practice must respect certain conditions to be considered as a responsible activity: 37. In the treatment of [1] an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, [2, 3] after seeking expert advice, [4] with informed consent from the patient or a legally authorised representative, may use an unproven intervention if [5] in the physician’s judgment it offers hope of saving life, re-establishing health or alleviating suffering. [6] This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. [7] In all cases, new information must be recorded and, where appropriate, made publicly available. (WMA 2013, paragraph 37, edited).

The Declaration of Helsinki reveals certain core principles that are also recognized by the ISSCR (2016, recommendation 3.4.1). The principle of “provision of innovative care” guides physicians when using new non-validated practice, which ought to comply with the following ethical requirements: 1. 2. 3. 4. 5. 6. 7.

Exhausting circumstances and limited number of patients, Scientific validity, Independent review, Informed consent, Priority of patient well-being, Commitment to contribute to generalizable knowledge through research, Publication of results.

Some of the principles show similar labels compared to the ones commonly referred to in research ethics (e.g. scientific validity, independent review, informed consent, e.g.). However, their content and application may differ substantially from research since these are principles of non-validated practice intended to benefit patients. So we should be careful when evaluating new non-validated practice without mistaking it for research, as pointed out by Taylor (2010). This list of ethical requirements provides an initial ethical framework to balance the aim to attain generalizable knowledge through research with the aim to attend the needs of patients with no reasonable alternatives. Moreover, recognizing appropriate limits to new non-validated practice strengthens our argument that new and insufficiently validated interventions should not always be subject to research, which goes hand in hand with restrictive regulations, precisely in cases in which patients lack reasonable medical alternatives. We call this argument the “argument of lacking reasonable alternatives”. This argument sustains that physicians can and sometimes should use unproven interventions in exceptional situations within the context of medical practice. As stated by Sugarman (2012), the lack of reasonable medical alternatives for an individual goes along with a changed evaluation of the risk-benefit profile of an unproven intervention. The mere fact that individuals cannot access any alternative treatment can make even a low expectation of success of the unproven therapy ex ante a rational and acceptable choice for them, given that the intervention reaches a

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minimum threshold of sound evidence. Surely, we should point to the responsibilities physician have in this context. The evaluation of the reasonability and acceptability of an unproven intervention is part of a cautious balancing and judging process by the physician. It might be ethically wrong for a physician to make a patient undergo a non-validated intervention outside the context of clinical research in the case of available clinical trials or validated medical alternatives.

9.6 Conclusion: What Is the Importance of Responsible Innovation as New Non-validated Practice in Latin America? So far, this chapter presented a conceptual framework of “new non-validated practice” to interpret the meaning of the terms “innovation” and “innovative care” within the larger category of medical practice, and not research. We intended to support our approach by arguing that this classification is necessary from an epistemic and ethical stance. In particular, it is ethically necessary and reasonable to consider new non-validated practice as medical practice and not as research in order to align it with the urgent health needs of patients with no reasonable medical alternatives. If our previous arguments are sound, new non-validated practice in the appropriate circumstances has the potential to benefit individual patients and society. Hence, we should be cautious about treating new non-validated practice as an inferior kind of activity in comparison with research. As Taylor reminds us: That innovative therapy can be, and continues to be, so positively transformative in the right circumstances, ought to make us cautious, I think, about treating it as a presumptively flawed and inferior activity that requires the corrective guidance of the research paradigm. Each is legitimate in a certain sphere; each has different goals; and, as I shall argue, each has distinct oversight needs. (Taylor 2010: 286)

This position would most probably have a substantive impact on the norms and practices of regulating new non-validated interventions in the clinical context. In this last section, we want to put emphasis on the importance to develop a valid concept of innovation as new non-validated practice in the light of new emerging therapies and diagnostics and its regulations and applications in the Latin American context. All of the scientific and social promises that originate from significant changes in treatments and diagnostic tools, such as the presented cases of stem cell interventions, gene editing, mitochondrial transfer technologies, or genome sequencing, nourish hope within research. This discussion goes along with the hope to find solutions for patients with yet lacking alternatives for their health conditions, but should take into account its potential benefits as well as its risks. In our view, our case examples clearly fall under the neutral concept of new non-validated practice due to their novelty, their insufficient validation, and their alleged main aim to foster an individual patient’s well-being. However, as we will argue, not all cases of nonvalidated practice are cases of responsible innovation. Now, let us have a look at the

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potential impact and use of our framework for individual patients, ethics committees, and Latin American societies.

9.6.1 Recommendations for Doctors, Individual Patients and Surrogates In our view, innovation as new non-validated practice is a reasonable possibility given to patients with no or no reasonable medical alternatives, when applied within the limits of responsible innovation, as outlined in the previous section. One important concern by individual patients is to distinguish between responsible doctors and scientists from pretenders, charlatans, and dishonest health professionals in general. Scientific assessment of new interventions may be out of reach for most patients. This asymmetric situation regarding the level of epistemic knowledge is analogous to other asymmetric epistemic situations in our everyday lives, such as the legal context. One possibility for patients or their representatives would be to appoint their trusted doctors to function as advisors, as we usually do with trusted lawyers to guide us through legal transactions. However, although a sound epistemic evaluation of new scientific interventions may be out of reach to most of us, the ethical character of institutions and doctors may be yet accessible. Principles of “responsible innovation” understood as new nonvalidated practice can be used to do a prudential evaluation of a particular doctor who offers a new non-validated intervention in a particular institution. Our practical hypothesis is that when an agent complies with the ethical principles of responsible treatment, she is more likely to be committed to scientifically sound actives than to charlatanry. In this regard, patients or their surrogates may be indeed capable to notice whether a praised intervention is rather futile or scientifically sound and in line with the promise to enhance their individual well-being. For instance, one good proxy for responsible innovation is the publication of results in the scientific literature. Although this is not always the case, once doctors have already published results of previous uses of a new non-validated practice in well-known peer-reviewed scientific journals, it seems more likely that these interventions are scientifically sound and its overall use responsible. As Jim Gass recalls, when he asked for evidence regarding his treatments, the treating physicians could not provide reliable scientific information about the treatment’s evidence, but anecdotes and testimonies of patients getting “dramatically better” (Kolata 2016). As Mr. Gass notes, the websites of the respective clinics often provided data that had previously been published in vanity journals. When asked by Kolata (2016) what he would like others to learn from his experience, Mr. Gass said “don’t trust anecdotes”. As the case of Jim Gass shows, we can generally notice that only some of the Latin American examples we choose follow what we call responsible new non-validated practice. This claim is supported by various authors, most notably by Rosemann (2013) and Palacios-González and Medina-Arellano (2017a, b) who lament that

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vague regulations and loop holes in health law allow scientists to apply innovative therapies to patients outside the limits of responsible innovation as new non-validated practice. New non-validated practice can indeed be conducted under the false pretenses of beneficial purposes even though the intervention may lack transparency or a minimum level of sound evidence and scientific validity (see Rosemann 2013). These concerns and lessons from stem cell tourism can be transferred to other contexts of new non-validated practices (Charo 2016). As the case of Jim Gass further shows, a reasonable analysis of benefits, risks, scientific validity, and the prospect of the applied stem cell therapies—as e.g. demanded by the ISSCR guidelines (2016)—has not been done within the limits of a sound external evaluation procedure. Also, it remains unclear whether Jim Gass’ health need and desperate health state were reasons urgent enough to undergo unproven stem cell therapies. In other words, we may wonder if his therapies could ever be considered legitimate in the sense that he had no reasonable medical alternatives and the suffering was strong enough to justify the application of non-validated interventions outside a sound research activity. Most probably, one may suspect that the involved physicians were attracted by the prospect to apply their novel therapies with no regulatory hurdles and clinics in countries with few regulations may have speculated to gain advantage from these so-called stem cell tourists. As shown by anecdotal evidence, negligence or complicity of political authorities cannot be ruled out. However, following the principles of responsible innovation as new non-validated practice offers a good way to assure that doctors and scientists do not take advantage of the desperate situation of patients to test innovative interventions, but act in the interest of the patient to enhance or re-establish her well-being. Hence, these principles may offer a useful tool to educate doctors and scientists regarding their professional ethos and integrity.

9.6.2 Recommendations for Ethics Committees In the light of our analysis, we think that ethics committees can make use of our framework of new non-validated practice to deliberate on how to categorize and link different activities to different medical contexts (validated practice, non-validated practice and research). Generally speaking, we believe that a public deliberation would show respect for patients and fosters public trust. Also, scientists’ or doctors’ behavior could be evaluated more easily by following the principles of “responsible innovation” (ISSCR 2016; Sugarman 2012) as new non-validated practice. We furthermore think that it is very important to put emphasis on the fact that ethics committees need to address new non-validated interventions outside clinical trials or other research activities in a sufficient and responsible way. These considerations go along with Taylor’s (2010) notion of the different real-world contexts of standard care, clinical innovation and research or analogously, with the standard distinction between validated practice, non-validated practice and research. According to Taylor, these contexts are not opposed, but interact in many and different biomedical fields.

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Innovative therapy [that is new non-validated practice] develops in diverse ways. […] With this model, innovative therapies are suggested by understanding where current therapies fail, and combining that knowledge with hypotheses about how changes in somewhat-known compounds might affect their action on other diseases. (Taylor 2010: 287, edited)

As Taylor explains, research and “innovative therapy” (interpreted here as new non-validated practice) are always somewhat interrelated practices that occur in different medical fields. Most notably, the fields of new therapies and diagnostics in biomedicine make the category of “innovation” even more salient. As we have previously shown, undergoing new and insufficiently tested interventions outside clinical trials or other sound research activities can be ethically justified in cases in which individuals lack reasonable medical alternatives or when appropriate trials cannot be made available.

9.6.3 Recommendations for Society Society as a whole can use the principles of responsible innovation to revise current regulations and shape new ones specifically targeted to new non-validated practices whose use does not fall under a sound research activity. Still, there are innovative diagnostics uses, such as genome sequencing for rare diseases, that clearly relate to the aim to foster a patient’s well-being, but are regulated by the standards of research. Also, as argued by Palacios-González and Medina-Arellano (2017a), reproductive technologies, such as MRTs may be forbidden depending on the specific reading of Mexico’s Health Law that addresses research. However, in our view, it would be especially useful to address the ethical and epistemic peculiarities of new nonvalidated practice in separate laws and regulations. As we have argued, the category itself implies a different ethical analysis compared to sound research and validated practice. In this regard, our framework and the principles for the responsible implementation of non-validated practice are very important to guide the public discussion and the deliberative process. Regarding this deliberative process, there are several issues at stake that societies have to face and to balance carefully. First, there is the obvious demand by individual patients to act as autonomous and rational agents in their interest to foster their health within the limits of “responsible innovation” understood as new non-validated practice. Outside these limits, the application of innovative interventions would not be ethical, and in most cases, not even rational for the individual. Second, public health demands, however, that those new and non-validated interventions have to be tested in a way that they yield social value for future patients. This means that new and yet unproven interventions must undergo the most rigorous epistemic testing for which randomized controlled trials still serve as a gold standard in many cases. The Belmont Report (1979), the Declaration of Helsinki (2013, paragraph 37) and the ISSCR guidelines (2016) incorporate this rationale by stating that the application of innovative interventions in particular cases with therapeutic, preventive, or diagnostic purposes must be made object of formal research—after

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the exceptional use as medical practice for an individual patient—to further attain a sound epistemic evaluation of the intervention. If regulatory frameworks ignore this guiding principle, there is the danger of an ‘epistemic crowding out’ effect that hinders social value for society to the benefit of individuals with urgent health needs who access the interventions outside clinical trials or other sound research activity. Even patients who want to access new non-validated practice, such as expanded access programs (also called “compassionate use”), could benefit from sound statistical analyses of such interventions in sound research (Joffe and Lynch 2018). Here, we also want to point to the potentially important role of drug regulatory agencies to balance interests of individual patients, future patients, scientists, health professionals, and companies (Joffe and Lynch 2018). Third, as argued mostly by scientists (see Luna and Salles 2010), offering a fruitful environment for the application of research and new non-validated practice, especially in the field of stem cell therapies, gene editing, and novel reproductive technology, can have very positive scientific and economic effects in Latin American countries. According to Harmon and Laurie (2008), Argentine scientists look at stem cell research as a promising new opportunity for the country to achieve international recognition and serve as a regional leader (see also Luna and Salles 2010). However, society must be cautious and not let dubious and profit-driven clinics benefit from regulatory loopholes and desperate medical tourists. Therefore, guidelines and regulations have to be developed and/or improved to prevent such dubious cases and to ensure a responsible application of new biomedical interventions. Last, there remains the big question about conservative views on innovative methods and technologies in the biomedical field, especially as far as embryonic stem cell interventions are concerned. Here, we do not argue that society would need to ban the Catholic Church or other religious groups from public deliberation—if they respect the principles of reasonable democratic argumentation—as they represent a valuable and common view among citizens and offers important ‘social capital’ for society (Habermas and Ratzinger 2008). Nevertheless, Latin American societies should allow a reasonable pluralism concerning comprehensive doctrines and public opinions on new and yet unproven biomedical technologies. In particular, rights of less powerful individuals, groups and underrepresented voices, and patients ought to have a secure and protected place in the public debate. Acknowledgements We are extremely grateful to an anonymous reviewer, Florencia Luna, Eduardo Rivera López, Diana Salmún, and the members of the Work in Progress (WIP) Seminar of FLACSO Bioethics Program for valuable comments and suggestions. Financial Support This publication has been made possible thanks to financial support by CONICET (National Scientific and Technical Research Council of Argentina), the German DAAD, the Biothera foundation, as well as the Brocher foundation.

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References ACOG Committee on Ethics. 2015. ACOG Committee Opinion No. 352: Innovative Practice: Ethical Guidelines. Obstetrics and Gynecology 108(6): 1589–1595. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT). 2010. Disposición 6677/2010 “Régimen de Buena Práctica Clínica para Estudios de Farmacología Clínica”. http://www.anmat.gov.ar/comunicados/dispo_6677-10.pdf. Althabe, F., J.M. Belizán, and E. Bergel. 2002. Episiotomy Rates in Primiparous Women in Latin America: Hospital Based Descriptive Study. BMJ 324 (7343): 945–946. Álvarez-Díaz, J.A. 2012. Latin American Bioethics or Bioethics in Latin America? Revista Latinoamericana de Bioética 12 (1): 10–27. Beauchamp, T.L., and Y. Saghai. 2012. The Historical Foundations of the Research-Practice Distinction in Bioethics. Theoretical Medicine and Bioethics 33 (1): 45–56. https://doi.org/10.1007/ s11017-011-9207-8. Bothwell, L.E., A.G. Jeremy, S.H. Podolsky, and D.S. Jones. 2016. Assessing the gold standard—lessons from the History of RCTs. New England Journal of Medical 374 (22): 2175–2181. https://doi.org/10.1056/NEJMms1604593 Brierley, J., and V. Larcher. 2009. Compassionate and Innovative Treatments in Children: A Proposal for an Ethical Framework. Archives of Disease in Childhood 94 (9): 651–654. https://doi.org/10. 1136/adc.2008.155317. Cámara de Diputados del H. Congreso de la Unión, Reglamento de la ley general de salud en materia de investigación para la salud. 1987. Accessible at http://www.hcg.udg.mx/PAGs/Sec_ Transparencia/PDFs_Transparencia/II_D_RF_3.pdf. Accessed 02 Apr 2018. Carroli, G., and L. Mignini. 2009. Episiotomy for Vaginal Birth. In Cochrane Database of Systematic Reviews. Wiley. Retrieved from http://onlinelibrary.wiley.com/doi/10.1002/14651858. CD000081.pub2/abstract. Cartwright, N. 2007. Are RCTs the Gold Standard? Biosocieties. 1: 11–20. Chan, S., and M.M. Arellano. 2016. Genome Editing and International Regulatory Challenges: Lessons From Mexico. Ethics, Medicine and Public Health 2 (3): 426–434. Charo, R.A. 2016. On the Road (to a Cure?)—Stem-Cell Tourism and Lessons for Gene Editing. The New England Journal of Medicine 374 (10): 901–903. https://doi.org/10.1056/NEJMp1600891. Committee on Bioethics. 2013. Committee on Genetics, and the American College of Medical Genetics and Genomics Social, Ethical, and Legal Issues Committee: Ethical and Policy Issues in Genetic Testing and Screening of Children. Pediatrics 131(3): 620–622. Congregation for the Doctrine of the Faith. 1987. Donum Vitae. Rome: The Vatican. Congregation for the Doctrine of the Faith 2008. Dignitas Personae. Rome: The Vatican. Available at http://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_ 20081208_dignitas-personae_en.html. Accessed 02 Apr 2018. Córdoba, M., S.A. Rodriguez-Quiroga, P.A. Vega, V. Salinas, J. Perez-Maturo, H. Amartino, and M.A. Kauffman et al. 2018. Whole Exome Sequencing in Neurogenetic Odysseys: An Effective, Cost- and Time-Saving Diagnostic Approach. PLOS ONE 13(2): e0191228. https://doi.org/10. 1371/journal.pone.0191228. Daniels, N., and J. Sabin. 1997. Limits to Health Care: Fair Procedures, Democratic Deliberation, and the Legitimacy Problem for Insurers. Philosophy & Public Affairs 26 (4): 303–350. https:// doi.org/10.1111/j.1088-4963.1997.tb00082.x. Diaz, M., and D. Neuhauser. 2005. Pasteur and Parachutes: When Statistical Process Control is Better than a Randomized Controlled Trial. BMJ Quality & Safety 14 (2): 140–143. Dresser, R. 2016. Terminally Ill Patients and the ‘Right to Try’ Experimental Drugs. In Silent Partners: Human Subjects and Research Ethics. New York: Oxford University Press. Druker, B.J. 2009. Perspectives on the Development of Imatinib and the Future of Cancer Research. Nature Medicine 15 (10): 1149–1152. https://doi.org/10.1038/nm1009-1149 Emanuel, E.J., D. Wendler, and C. Grady. 2000. What makes clinical research ethical? Jama 283 (20): 2701–2711.

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Emanuel, E.J. 2013. Reconsidering the Declaration of Helsinki. The Lancet 381 (9877): 1532–1533. https://doi.org/10.1016/S0140-6736(13)60970-8. Gracia, D. 2013. Práctica clínica e investigación clínica. In Luces y sombras en la investigación clínica, ed. R. Dal-Ré, X. Carné, and D. Gracia, 39–55. Madrid: Triacastela. Graham, I.D., G. Carroli, C. Davies, and J.M. Medves. 2005. Episiotomy Rates Around the World: An Update. Birth 32 (3): 219–223. Habermas, Jürgen, and Joseph Ratzinger. 2008. Dialektik der Säkularisierung. Blätter für deutsche und internationale Politik 4(2008): 33–46. Harmon, S.H. 2008. Emerging Technologies and Developing Countries: Stem Cell Research Regulation and Argentina. Developing World Bioethics 8 (2): 138–150. Harmon, S., and G. Laurie. 2008. The Regulation of Human Tissue and Regenerative Medicine in Argentina: Making Experience Work. Arts and Humanities Research Council, Policy Brief 4. Buenos Aires: Ministry of Science, Technology and Productive Innovation. Holzer, F.S., and I.D. Mastroleo. 2018. Ethical Aspects of Precision Medicine: An Introduction to the Ethics and Concept of Clinical Innovation. In Precision Medicine: Tools and Quantitative Approaches, ed. H.-P. Deigner and M. Kohl (Eds.), 1–19. London: Academic Press-Elsevier. https://doi.org/10.1016/B978-0-12-805364-5.00001-9. International Society for Stem Cell Research (ISSCR). (2016, May 12). Guidelines for Stem Cell Research and Clinical Translation. Retrieved from http://www.isscr.org/docs/default-source/ guidelines/isscr-guidelines-for-stem-cell-research-and-clinical-translation.pdf?sfvrsn=2. Joffe, S., and H.F. Lynch. 2018. Federal Right-to-Try Legislation—Threatening the FDA’s Public Health Mission. New England Journal of Medicine 378 (8): 695–697. https://doi.org/10.1056/ NEJMp1714054. Kaufmann, M. 2013. Jaque a las enfermedades mitocondriales. http://www.conicet.gov.ar/jaque-alas-enfermedades-mitocondriales/. Kaufmann, M., and A. Turjanski. 2015. Científicos argentinos hallan un gen clave relacionado al autismo. http://www.clarin.com/sociedad/Cientificos-argentinos-hallan-relacionado-autismo_0_ 1334867289.html. King, N.M.P., and L.R. Churchill. 2008. Assessing and Comparing Potential Benefits and Risks of Harm. In The Oxford Handbook of Clinical Research Ethics, ed. Emanuel et al, 514–526. Kolata, G. (2016). A Cautionary Tale for ‘Stem Cell Tourism’. New York Times Article published 22 June 2016. Available at https://www.nytimes.com/2016/06/23/health/a-cautionary-tale-of-stemcell-tourism.html?_r=1. Accessed 17 Apr 2017. Levine, R.J. 1979. Clarifying the Concepts of Research Ethics. Hastings Center Report 9 (3): 21–26. Levine, R.J. 1999. The Need to Revise the Declaration of Helsinki. The New England Journal of Medicine 341 (7): 531–534. https://doi.org/10.1056/NEJM199908123410713. Levine, R.J. 2004, May 14. Robert Levine. Oral History of the Belmont Report and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Retrieved from https://www.hhs.gov/ohrp/education-and-outreach/luminaries-lectureseries/belmont-report-25th-anniversary-interview-rlevine/index.html. Levine, R.J. 2008. The Nature, Scope, and Justification of Clinical Research. In The Oxford Textbook of Clinical Research Ethics, ed. E.J. Emanuel, C. Grady, R.A. Crouch, R.K. Lie, F. Miller, and D. Wendler, 211–221. Oxford University Press. Ley de Bioseguridad de Organismus Genéticamente Modificados. 2005. Article 3, XX. Accessible at https://mexico.justia.com/federales/leyes/ley-de-bioseguridad-de-organismos-geneticamentemodificados/titulo-primero/capitulo-i/. Accessed 02 Apr 2018. Little, M.O., and M.N. Wickremsinhe. 2017. Research with Pregnant Women: A Call to Action. Reproductive Health 14 (3): 156. https://doi.org/10.1186/s12978-017-0419-x. Lipworth, W., C. Stewart, and I. Kerridge. 2018. The Need for Beneficence and Prudence in Clinical Innovation with Autologous Stem Cells. Perspectives in Biology and Medicine 61 (1): 90–105. https://doi.org/10.1353/pbm.2018.0029.

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London, A.J. 2006. Cutting Surgical Practice at the Joints: Individuating and Assessing Surgical Procedures. In Ethical Guidelines for Innovative Surgery, ed. A.M. Rietsma and J.D. Moreno, 19–52. Hagerstown, MD: University Publishing Group. Luna, F., and A. Salles. 2010. On Moral Incoherence and Hidden Battles: Stem Cell Research in Argentina. Developing World Bioethics 10 (3): 120–128. Luna, F. 2018. From the Middle Ages to the 21st Century. Abortion, Assisted Reproduction Technologies and LGBT Rights in Argentina. Canadian Journal of Bioethics/Revue Canadienne de Bioéthique 1 (2): 26–36. Mastroianni, A. 2006. Liability, Regulation and Policy in Surgical Innovation: The Cutting Edge of Research and Therapy. Health Matrix: The Journal of Law-Medicine 16 (2): 351. Mastroleo, I., and F. Holzer. (2018). New Non-validated Practice: A Refined Definition of Innovation in Traditional Research Ethics. Manuscript under review. Buenos Aires. Ministerio de Salud Argentina (MSAL). 2011. Resolución 1480/2011. Guía para Investigaciones con Seres Humanos. http://www.uba.ar/archivos_secyt/image/Resolucion1480-11%20Naci% C3%B3n.pdf. National Bioethics Advisory Commission (NBAC) (2001). Ethical and Policy Issues in Research Involving Human Participants. Report and Recommendations of the National Bioethics Advisory Commission. https://bioethicsarchive.georgetown.edu/nbac/human/overvol1.pdf. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission). (1978). The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. US Government Printing Office. National Commission. 1979. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington DC, US Government Printing Office. Palacios-González, C., and M.D.J. Medina-Arellano. 2017a. Mitochondrial Replacement Techniques and Mexico’s Rule of Law: On the Legality of the First Maternal Spindle Transfer Case. Journal of Law and the Biosciences 4 (1): 50–69. Palacios-González, C., and M.D.J. Medina-Arellano (2017b). Author’s Response to Peer Commentaries: Mexico’s rule of law and MRTs. Journal of Law and the Biosciences. Pontifical Academy for Life. 2000. The Declaration on the Production and the Scientific and Therapeutic use of Human Embryonic Stem Cells. Rome: The Vatican. Rassmussen. (2015). “Moratorium” on Use and Asilomar Conference. Chichester: Wiley. Rosemann, A. 2013. Medical Innovation and National Experimental Pluralism: Insights from clinical Stem Cell Research and Applications in China. The London School of Economics and Political Sciences BioSocieties 8 (1): 58–74. Rosemann, A., G. Bortz, and F. Vasen. 2018. Regulatory Developments for Non-hematopoietic Stem Cell Therapeutics: Perspectives from the EU, the USA, Japan, China, India, Argentina and Brazil. In A Roadmap to Non-hematopoietic Stem Cell-based Therapeutics: From the Bench to the Clinic, ed. X.D. Chen. Amsterdam: Elsevier Academic Press. Sugarman, J. 2012. Questions Concerning the Clinical Translation of Cell-Based Interventions under an Innovation Pathway. The Journal of Law, Medicine & Ethics 40 (4): 945–950. https:// doi.org/10.1111/j.1748-720X.2012.00723.x. Taylor, P.L. 2010. Overseeing Innovative Therapy without Mistaking It for Research: A FunctionBased Model Based on Old Truths, New Capacities, and Lessons from Stem Cells. The Journal of Law, Medicine & Ethics 38 (2): 286–302. https://doi.org/10.1111/j.1748-720X.2010.00489.x. Weijer, C. 2000. The Ethical Analysis of Risk. The Journal of Law, Medicine & Ethics 28 (4): 344–361. https://doi.org/10.1111/j.1748-720X.2000.tb00686.x. Weijer, C., and P.B. Miller. 2004. When are research risks reasonable in relation to anticipated benefits? Nature medicine 10 (6): 570. World Health Organization, & Council for International Organizations of Medical Sciences. 2016. International Ethical Guidelines for Health-Related Research Involving Humans. Geneva: Council for International Organizations of Medical Sciences. World Medical Association. (1964). Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Available at https://www.

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google.de/url?sa=t&rct=j&q=&esrc=s&source=web&cd=4&cad=rja&uact=8&ved= 0ahUKEwj7vpWgl6rTAhWBxpAKHafgCSUQFgg6MAM&url=http%3A%2F%2Fwww. upenn.edu%2Fregulatoryaffairs%2FDocuments%2FDeclaration_Helsinki.doc&usg= AFQjCNGnUd3ulQnn3wlJ46kX9YUfsQH6MA Accessed April 17 2017. World Medical Association (WMA). 2013, October 19. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. Retrieved from http://www.wma.net/en/ 30publications/10policies/b3/index.html. Zhang, J., et al. 2016. First Live Birth Using Human Oocytes Reconstituted by Spindle Nuclear Transfer for Mitochondrial DNA Mutation Causing Leigh Syndrome. Fertility and Sterility’s 106: e375–e376.

Chapter 10

Ethics in Conducting and Communicating Research: A Brazilian Perspective Marisa Palácios and Sergio Rego

Abstract The purpose of this article is to discuss some ethical aspects arising in the conducting and communication of medical research in the Brazilian context, and to propose actions that can control or mitigate some reprehensible behaviors. We present some typical cases that have populated the pages of scientific journals and the press, showing academic fraud and setting society in conflict with scientists, who now need to demonstrate their trustworthiness. How can we consider the development of science if what is disclosed on the topic can be manufactured or made up; that is to say, if this content is not reliable? Several responses can be found today. For example, some publishers are imposing new guidelines for research funding agencies or research institutions to engage in mechanisms to prevent fraud and promote good research practices. The goal of these measures is to ensure that research results being funded or produced under their auspices are reliable. In this article, we make an incursion into the process of production of technological knowledge—through the stages of financing, production itself, and dissemination—in an effort to identify the factors that can lead to misconduct. In the investment stage, the socioeconomic and political context is important in evaluating what should be researched, and with what goals. We discuss aspects such as coloniality and investment in ST&I, among others. Our conclusion is that the discussion on research integrity must go beyond aspects related to the researcher’s personal and professional ethics.

M. Palácios (B) Center of Bioethics and Applied Ethics of the Federal University of Rio de Janeiro, Rio de Janeiro, Brazil e-mail: [email protected] S. Rego Department of Social Sciences, National School of Public Health Sergio Arouca of the Oswaldo Cruz Foundation, and National Council for Scientific and Technological Development (CNPq), Rio de Janeiro, Brazil e-mail: [email protected] © Springer Nature Switzerland AG 2019 E. Rivera-López and M. Hevia (eds.), Controversies in Latin American Bioethics, International Library of Ethics, Law, and the New Medicine 79, https://doi.org/10.1007/978-3-030-17963-2_10

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10.1 Introduction Significant global development in the areas of science and technology and the consolidation of a culture of human rights are considered to be two remarkable features of the last century, at least in the West. The International Declaration of Human Rights and its corresponding code in the field of human research—the Nuremberg Code—express the valorization of this culture of rights. Subsequently, in 2005, UNESCO adopted its Universal Declaration on Bioethics and Human Rights. Particularly in the last quarter of the last century, there was widespread debate on the creation of standards regarding what is reasonable in research involving human beings, under what circumstances and in what manner, and with what consequences for participants. Nevertheless, such consolidation does not mean that the relevant ambiguities, uncertainties, and conflicts have ceased to exist or have been agreed upon and dealt with. On the contrary, the complexity of the interests involved and the implications of the results and conclusions in the real world have also led to an ethical discussion regarding the dissemination of research findings. From 1964 to 1987, Brazil experienced a period of political repression. During those years of military dictatorship, both individual and collective human rights were severely restricted. It was only after the promulgation of the new Brazilian Constitution in 1988 that real concern for human rights found a means of expression in the form of regulations. Not by chance, it was in 1988 that the first attempt was made to achieve the ethical normalization of research using human beings in Brazil. Although the field of health has dominated the landscape of discussions on research ethics, the debate on the ethicality of conducting and publishing research has been extended to include other scientific fields. The basic premise is this: society must be able to rely on the integrity of all phases of scientific research, from design to publication. As with precautions taken to ensure respect for ethical principles when conducting research, it is also necessary for the scientific community and society to agree on precautions related to the dissemination of results. The goal of this article is to discuss some ethical aspects related to conducting and communicating research, regardless of the area of knowledge in which it is grounded, and to propose actions that can control or mitigate those activities considered to be unacceptable. Our analysis takes into account the sociopolitical and economic context in Brazil, a country on the fringe of mainstream politics in which capitalism has developed sluggishly and dependently. We begin with some paradigmatic cases that were reported in scientific magazines and by the general media, all of which contain instances of academic fraud and scientists confronted by society. Trustworthiness is the keyword that rises above all others. How can scientific development proceed when published material can be fabricated or forged—that is, when that material is untrustworthy?

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10.2 Some Elements that Characterize the Scope and Magnitude of the Problem First and foremost, it is necessary to make clear that the phenomenon of academic fraud (scientific malpractice) is not an event that occurs only in periphery countries, on the fringe of mainstream science, or in less-esteemed academic institutions. Fang et al. (2012) published an article titled Proceedings of National Academy of Science of the United States of America, stating that fraud is a worldwide issue in scientific publishing. Another important fact to note is that it is highly likely that malpractice is not a recent phenomenon. Greater access to scientific works has been made possible by the Internet and open access publications, and therefore a more substantial number of fraudulent publications has been observed. The improvement of Internet search mechanisms, in conjunction with the appearance of specialized software, is another factor that has allowed for better detection of possible plagiarism. In 1977, for example, Umberto Eco published a book titled Como si scrive in a tesi de laurea?, in which he makes an ironic and provocative comment to the book’s intended audience. He pointed out that his book was not targeted at those obligated to write a thesis. He suggested that they pay someone to write their thesis for them, or copy an unpublished thesis from another city (Eco 1977). This was a joke, but not an impossibility. In the 1980s, the US Congress’s concern about malpractice in scientific research led to the creation of the 1989 Office of Research Integrity (ORI). This office was established under the purview of the Ministry of Public Health and Social Welfare (ORI 2018a). The ORI’s work has been decisive in the worldwide dissemination of concern regarding scientific integrity. Its online portal, for example, provides a unique service whereby it fully divulges cases of malpractice identified in research financed by the US government. We shall provide some examples below. In 2007, an investigation by the University of Oslo found that Jon Subdø had engaged in fraud, and the researcher voluntarily agreed not to compete in any calls for research proposals by the US government. He also pledged not to work as a counselor, assigned instructor, or reviser to any entity related to the US government. Subdø engaged in malpractice when he forged and fabricated data in reports used in an application for a call for research proposals. He was the author of 14 retracted articles (Grieneisen and Zhang 2012). Those who commit fraud are subject to an administrative penalty or even criminal punishment (Reich 2011). The most common penalty is retraction, which represents a significant level of embarrassment for the researcher. In these cases, information about the retraction appears in place of the article in the journal, as well as in bibliographical databases where the article was indexed. The administrative penalty applied by the National Institutes of Health, for example, includes banning the researcher from receiving public funding for a specific period of time. Grieneisen and Zhang (2012) considered the frequency of these cases in order to measure the impact of this phenomenon on the credibility of science. They

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consulted 42 sources of data, including bibliographical databases, publishing houses’ web pages, and a collection of journals not linked to publishing houses or search portals. The authors found 4,232 retraction notices, and 14% of these notifications did not contain any justification. Misconduct in research was the reason for 20% of the retractions. In this study, behavior considered as misconduct in research included the following activities: fraud, understood as the falsification or manipulation of data; the intentional bias of the design in favor of a particular result; and not obtaining the approval of an ethics committee (e.g., an institutional review board). Misconduct in publication accounted for 47% of the retractions and included cases of plagiarism, multiple publications, self-plagiarism, and authorship cases involving the omission or gifting of authorship. Another point of interest that the article raised is the recurrence of fraudulent behavior by individuals. They note that a single author might have committed fraud up to 88 times and identified nine authors with more than 20 retractions, as well as 13 authors with 391 retractions (representing 54% of all frauds). Grieneisen and Zhang conclude that ethical issues in the conduct or publication of research results are present in all countries and areas of knowledge, a trend that began to intensify in the 1980s and grew exponentially in the first decade of this century. Martinson et al. (2005) published in Nature the results of research on 3,247 scientists, in which 33% of those surveyed admitted to having committed at least some form of misconduct as listed by the authors. The study drew attention to the fact that there are various types of misconduct, including forms that go beyond plagiarism, falsification, and fabrication. Thus, the authors describe activities such as changing the design, methodology, or results of a study due to pressure from funders, or revealing details of the method or results in the publication or proposal. One theme that has been discussed regarding the assessment of possible misconduct involves pertinence: for example, whether the publishing of certain research results could reveal techniques and technologies that enable biological weaponry. An excellent example of this situation is the case of the study carried out on the avian flu virus H5N1, which included a sequence of induced mutations in a laboratory by the German researcher Ron Fouchier. The result was a mutant virus that could be transmitted orally without any direct contact. The case underwent extensive analysis because it is the type of research whose results could be used for bioterrorism (Schnirring 2012). While a key issue is fraud in conducting or communicating research, determining the ethical adequacy of the proposal (based on the method and techniques used) is also an open issue in cases such as the H5N1 virus research and other studies associated with human enhancement, with or without the intent of a dual purpose of results. By dual purpose, we mean that the product of the study could serve either the intended purpose of the research, or another application. An example of this could be military research (studies that aim to create a super soldier or explore the possibility of exterminating certain communities or population groups) or commercial expansion (a medicine to treat memory loss that could serve to enhance any memory). From another angle, a drug that is initially used to “erase” memories that have triggered a post-traumatic disorder could be used for more sinister applications by the military.

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A study developed by Almeida et al. (2015) involved a sample of university students attending higher education courses and colleges in Portugal. A total of 11,000 students from 252 courses and 127 institutions participated, and 69% of these individuals believed that academic fraud is the norm or occurs on a regular basis at their institutions. While there are no studies to date in Brazil that quantify this problem, the rate of misconduct is likely to be similar here. In fact, ethics in human research has received much attention in Brazil since 1986 with the creation of a national structure, the CEP/Conep (Research Ethics Committee/National Commission on Research Ethics) system of the National Health Council. However, a truly systematized discussion on the ethics of the dissemination of science only first occurred in Brazil in 2010, as we will see below. First, however, an observation: the discussion of ethics in research, as well as the systems created to control abuses since WWII with the existence of the crimes perpetrated by Nazi doctors, have developed out of the discussion on integrity in research. From an academic point of view, research ethics has been developed in research institutions based on the Belmont Report (originally issued in 1978), which established basic principles anchored in respect for participants, beneficence, and justice. The central focus was the abuse of participants and the need for prior evaluation and approval of research projects by a multi-professional ethics committee, with a preventive intent. The integrity of research related to publication did not come within the scope of these ethics committees. Strictly speaking, even the discussion of whether research similar to the H5N1 study mentioned above is ethically justified did not enter the concerns of a CEP. In fact, this type of research does not require CEP approval at all since it does not involve human participants. This observation is necessary because there are some topics related to research ethics that exceed the purview of those involved in the control systems for research involving humans. Thus, we seek to connect ethics to the conducting and publication of research.

10.3 The Academic Integrity Movement Worldwide and in Brazil The movements for integrity and ethics in human research have taken parallel paths. Publishers organized themselves into associations, primarily aimed at standardizing medical publishing in both Europe and the United States, and first became concerned about ethical issues in the 1970s. The first movement to control fraud occurred among the editors of medical journals, and the International Committee of Medical Journals Editors was created in 1978. In the 1980s, cases of academic fraud intensified, and these editors’ main concerns focused on issues related to authorship and acknowledgments, redundant publications, retraction, freedom and integrity, and conflicts of interest (HUTH 2004). In 1997, a group of editors held their first meeting to specifically address ethics in publishing, leading to the establishment of the Committee on Publication Ethics (COPE) in 2000.

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Reactions to fraud have been widespread and varied in different parts of the world. International conferences on research integrity are one example of attempts to generate a discussion about fraud and other types of scientific misconduct and impropriety worldwide. In 2007, the first Research Integrity World Conference was held in Lisbon, organized by the European Science Foundation (ESF) and the ORI (ESF 2007). It was then that a more systematic international movement to discuss the issue of research integrity began to define its first policies for scientific communication. The second world conference was held in Singapore in 2010 and established, in its Singapore Declaration, some globally applied basic principles and responsibilities related to integrity and responsible conduct in research (2nd World Conference on Research Integrity 2010). In its preamble, the Declaration states that “the values and benefits from research essentially depend on its integrity. Although there are differences among countries and disciplines in the form by which research is organized and conducted, there are also common principles and professional responsibilities which are vital to its their integrity no matter where it takes place.” This declaration highlights several issues: authorship, the responsibility of researchers regarding research reliability, and data sharing, among others. Emphasis was also placed on the responsibility of researchers to advise the appropriate authorities whenever they identified improper practices that could be categorized as misconduct. The third Research Integrity World Conference was held in Canada in 2013. The Montreal Declaration (3rd World Conference on Research Integrity 2013) reinforced the responsibilities of researchers expressed in the Singapore Declaration while also adding sections on special responsibilities in situations of scientific collaborations. The integrity of research was stated as a general obligation of the parties involved, and the trustworthiness of all parties was included as an aim and shared objective. The Declaration also emphasized researchers’ responsibility to establish and manage collaboration. This includes free and adequate communication, clear and recognized agreements, compliance with laws, policies, and regulations, the fair distribution of costs and benefits, transparency, the redistribution of resources and monitoring, and responsibilities related to the results of collaborative research. The fourth Research Integrity World Conference (4th World Conference on Research Integrity 2015) was held in Rio de Janeiro, Brazil in 2015 and placed the country at the center of debates on the prevailing issue of ethics. Hence, Brazilian researchers (in particular those who work in the field of Bioethics and Practical Ethics) were invited to participate in both the theoretical formulation and the design of initiatives to enable intensification of public trust in research. Brazil has gained a reputation for its efforts to develop integrity in research, both academically and in practice, through institutional initiatives. Prior to the 4th World Conference on Research Integrity, researchers in the country had already held four conferences—the Brazilian Meetings on Research Integrity, Science and Publication Ethics (BRISPE)—in Rio de Janeiro, twice in Sao Paulo, in Porto Alegre, and in Goiania. The first and second BRISPE conferences were organized by some of the leading Brazilian centers for scientific research: the Federal University of Rio de Janeiro, the University of Sao Paulo, the Pontifical Catholic University of Rio Grande do Sul, and the Osvaldo Cruz Foundation. These initiatives were motivated by a new

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world reality in which cases of plagiarism, falsification, or the fabrication of research results were becoming more and more common, with the consequent result of the public’s discrediting of science (BRISPE II 2010a). The second BRISPE conference (2010b) resulted in a declaration addressed predominantly to institutions to promote educational events on responsible conduct and scientific integrity. This declaration also shared international initiatives such as the Singapore Declaration and the COPE guidelines, which seek to ensure ethics in scientific publications (COPE 2018a, b). The third conference, BRISPE III, was held in Sao Paulo and focused primarily on the discussion of ethics in publications; BRISPE IV was held in the State of Goias and addressed a discussion beyond the main Brazilian centers of research (which are located in southeastern Brazil). The Code of Good Practice in Research from the Research Support Foundation of the State of Sao Paulo (FAPESP for its initials in Portuguese 2014) and the guidelines for research integrity of the National Council for Scientific and Technological Development (formerly CNPq) (CNPq 2012) were also included in this statement. The FAPESP code contains guidelines for good practice, while also determining procedures that should be followed to investigate each case of suspected noncompliance with these norms. FAPESP releases its investigation results, making all of its procedures public. This publication is essential to ensuring transparency in all of its actions and contributes to promoting a culture of integrity, although the organization’s report is still associated with a fear of punishment. The FAPESP code affirms that “They [research bodies] are primarily responsible for promoting the conduct of good practice among the researchers and students associated with them as well as prevention, investigation, and punishment of scientific misconduct which occur within their scope” (FAPESP 2014: p. 35). This singular focus in the FAPESP code is especially relevant not only because it emphasizes the morality of the agent who carries out research but also because it appropriately extends liability to the research institution. The institution should seek to ensure that it provides optimal conditions for scientific research to be carried out, and that it acts as a guardian of ethical values. One of FAPESP’s efforts in partnership with the Latin American and Caribbean Center on Health Sciences Information (BIREME/OPAS/OMS) in 1998 also merits mention in any discussion seeking to summarize the means of scientific diffusion in the Brazilian and Latin American landscape: the creation of SciELO (Scientific Electronic Library Online). SciELO is not merely an online library with open access; it is an index that establishes editing parameters for periodicals to continuously enhance the quality of researchers wishing to submit articles to them. Today, SciELO is supported by organizations that supply funding, such as CNPq and the FapUnifesp (a supporting foundation of the Federal University of Sao Paulo). The system’s indexing has rapidly grown to represent a criterion whose quality is widely recognized. Having begun with only 10 periodicals, today SciELO covers 14 Latin American countries and South Africa, with each country publishing a collection of national journals. It can also be found in two theme-oriented multinational collections. Together, these countries index around 1,000 periodical titles in which more than 40,000 articles are published annually (Packer and Meneghini 2014: 16). Currently, it is being developed in Paraguay and plays a central role in promoting Latin American scientific

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production. SciELO also offers a series of books (the result of partnerships with 14 university presses that, as of January 12, 2017, were available from http://books. scielo.org/), of which there have already been 77,888,523 downloads. There are a total of 908 titles available, including 608 open access books. A total of 8,071 book chapters are available for free. It should be noted that discussions around integrity usually occur separately from debates on ethics in research involving humans and bioethics. While integrity in research refers to the morality of the scientist (the agent), ethics in research and bioethics developed from criticism of the model of professional ethics by prioritizing situated action. This will be examined in the following section.

10.4 Professional Ethics and Practical Ethics The two points of view presented in this article, professional ethics and practical ethics (an umbrella under which research ethics and bioethics are situated), should not be mutually exclusive. In the first area, focus lies primarily on the agent, while the second focuses largely on the actions and their determining factors. We will examine these two perspectives below. Ethics in conducting research and scientific publication has usually been understood in terms of the professional ethics of scientists. Thus, this field is inscribed in an array of actions/behaviors/attitudes that result in decisions based on the understanding of professional duties. Scientists must follow specific principles in order to act ethically; the scientific community recognizes these principles, and they are accepted by society in general as being correct. Thus, scientists’ actions are motivated by the understanding that ethicality is a duty that must be followed. Within this theoretical paradigm, there has been a discussion about the creation of a code of ethics for scientists. In this moment of the universalization of knowledge, it makes sense to have an agreement on global standards of conduct. More specifically, what is considered plagiarism in one region should equally be plagiarism worldwide. The concept of data fabrication and falsification ought to be the same around the world. The commitment to honesty and scientific rigor must be understood as a critical imperative that cannot be ignored without incurring in the possibility of sanctions, whether by one’s peers or by the state. Many articles have examined this theme and seek to more precisely define what is considered fraud in each field. While there is no universal code of ethics for scientists, the defense of public trust in science is a growing concern, and it is a permanent topic on the agenda of both national and international associations of scientists. In this theoretical approach in terms of professional ethics (in the case of editors), what is expected is a self-regulated code (COPE could be a key guide in this process) that can guarantee to the public the trustworthiness and dependability of published results. Professional codes are becoming more common with the regulation of research activities. The Helsinki Declaration, for example, is an attempt to establish professional self-regulation via the World Medical Association.

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This referential focus on the morality of the agent turns the focus of the discussion to research integrity, and almost exclusively to the individual sphere of the researcher, searching for culprits in order to apportion blame. The adoption of practical ethics as a referential establishes a shift in the focus of the analysis, moving from the agent to the agent’s actions on a case-by-case basis. This requires us to think about the ethicality of human activities in their context. So let us begin to examine what it would be like to consider situated action.

10.5 Is It Enough to Establish Guides of Good Practice? So far, we have commented on the dimension of the problem related to conducting and publishing research, as well as some international and local initiatives and what has been done to address the issue. Our discussion thus far begs the question: Could we solve the problem by proposing of a guide of good practice? For us to think about ethics regarding both conducting and publishing research, we need to bear in mind the context in which research develops: the very process of producing scientific knowledge. In this process, there are three different moments that we will refer to as financing, research, and communication. The financing phase involves either the private sector (the industrial complex) or the state, or both. On the one hand, the benefits of the diversification of production attract companies and encourage them to invest in research; on the other, the interests of the state in maintaining and expanding its power also forces it to supply funding, according to its strategic interests, which may also be related to its industrial parks. Therefore, the state and private industry are the main investors in the development of research. The research phase is carried out in research institutions, whether they are connected to the state or the private sector, or both. This phase includes universities and independent research centers seeking sponsorship. In general, they bid in a public notice or possess direct contracts with companies, which subtly determine what to research and how, capturing and redistributing their resources. Data from the Ministry of Science Technology, Innovation and Communication (Brasil 2012) indicate that Brazil’s public investment in research and development is meager compared to that of other countries at the same level of development. Furthermore, investment levels are below the government’s proposed goals, and it has remained this way for the past 10 years. However, the majority of research funding comes from the state (in 2010, state investments totaled 0.66% of GDP and private investments only reached 0.56%). In comparison, investment in research and development in South Korea equals 2.68% of its GDP, and the average among OECD countries is 2.3%. The National Strategy of Science Technology and Innovation states that for 2012–2015, Brazil’s investment contribution totaled 2% of its GDP. Data from the British government indicate that the most substantial investments in research and development came from the biotechnological and pharmaceutical sectors (from 2009). Of those companies that spend the most on research and development, five of the top ten are in the biotechnological and pharmaceutical sectors, two

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are in the automobile industry, and three are from the telecommunications/computing sector (Brasil 2012). It is not surprising, therefore, that research in the field of biomedicine raises concerns about the establishment of trust. The industrial sector, which is currently expanding (that is, it has more available capital and resources) and finding investors and research centers keen for resources, forms the perfect breeding ground for an agreement that excludes the general public. Whether or not the deals are spurious, they are viewed with distrust by the community and can have an impact on consumption. Research should be communicated and made public. It is at this moment that other elements come into play. Journals and publishing companies have their own interests and compete for resources for maintenance and expansion. These resources come from sponsorship or the sale of space to those who wish to publish (the authors), regardless of whether the journals have restricted circulation or an open access option. Understanding that the ethical issues in research cannot be limited to the individual attributes of those involved, such as virtue or a sense of duty, it is therefore necessary to consider where the research is developed, especially economically speaking, and its implications for other fields. The public’s trust in research depends less on a system that punishes fraudsters and more on a system that enables a research setting that is unaffected by the pressure of the secondary interests of scientists/researchers. Returning to the title of this section, how do we devise good practices without considering the significant economic interests in favorable results, as these will affect profits and/or the power of investors? While we highlight the case of medications, which is the most studied, the same must be applied to all and any research that may have an industrial application. Founded in a systemic view of the regulation of ethics in research, we also propose a need to consider the integrity of the research, as it will be affected by conflicts of interests. In the following section, we will use the process of testing and commercialization of new medications as a model for analysis. This model is the most studied because of its immediate consequences in the lives of individuals, regardless of whether they are directly involved in research or simply consume the medications when they become available in pharmacies. It is central to note that what we present as a conflict of interests is not restricted to the health field, as it also affects situations in all areas of knowledge.

10.6 Conflict of Interest Dennis F. Thompson (1993: 573) affirms that “a conflict of interest is a set of conditions in which the professional judgment concerning a primary interest (such as patient’s welfare or the validity of the research) tends to be unduly influenced by a secondary interest (such as financial gains).” Thus, examining the conditions under which a secondary interest can influence a primary interest takes us from the scope of the exclusivity of the agent’s morality to a perspective of collective responsibility. It forces us to propose optimal conditions for research to be conducted free of fraud,

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and to better protect its participants. To weigh such conditions and establish those that promote the development of research with the highest ethical standards, we must take into consideration the context in which research takes place: the three phases presented above. We defend the idea that our focus must be broadened to include the process of knowledge production within the perspective of a capitalist mode of production and the valorization of the market in the area of health, understanding industrial production as the motor of the sector. Taking the production of drugs as a model, we will find a conflict of interest in every stage: • • • •

New product research Clinical research Process of gaining approval of regulatory bodies Advertising and marketing

Conflicts of interest appear at all points during the research process and scientific communication, pari passu with fraud. Researchers, authors, editors, research institutions, regulatory bodies, and the proponents of policies have interests that are not entirely apparent but may influence their judgment on what is published. A conflict of interest may originate from a secondary source: personal reasons or commercial, political, academic, or financial interests. The latter may include a job offer, funds for research, shared propriety, the payment of lectures and trips, consulting, or the support of companies to hire personnel. What is essential in Thompson’s definition (1993) is that the central focus is not on the individual; environmental influences are valorized to a higher degree than the personal integrity of the researcher. Hence, the focus should not be on the individual caught in a conflict of interest but on the conditions under which such a conflict occurs. The importance of conflicts of interest in the production and divulgence of scientific knowledge has been highlighted by several authors in recent decades. For example: The philosophy of science is not independent of the way research is organized. Can scientists produce objective knowledge in a world where their research is increasingly directed towards making money or meeting social needs? (Ziman 1996) One obvious concern is that these ties will bias research, both the kind of work that is done and the way it is reported. Researchers might undertake studies by whether they can get industry funding, not whether the studies are scientifically important. That would mean more research on drugs and devices and less designed to gain insights into the causes and mechanisms of disease. It would also skew research toward finding slight differences between drugs because those differences can be exploited for marketing. Of even greater concern is the possibility that financial ties may influence the outcome of research studies. (Angell 2000)

Roseman et al. (2012) published an analysis of some reviews from Cochrane, and revealed that most of the 151 reviews examined did not contain information about any conflicts of interest. Thus, in that case, the declaration of conflict as an instrument to enable the reader to be critical and consider his/her belief in the study results are lost when information is to be given by the review. Because the review is the most significant reference of credibility used worldwide to signify types of

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treatment and to generate reliable information about the efficacy and security of a drug, the readers might underestimate the influence of the conflicts of interest. Deyo (2004), in turn, revealed conflicts of interest in the assessment process of products by the Food and Drug Administration (FDA) and discussed how the strategies to control these conflicts had not been effective despite federal legislation on this matter. Returning to the points previously mentioned, there are a number of relevant issues to highlight concerning the research of new products: (1) The participation of the industry in the induction of research introduces market logic; that is, financial resources will go towards the development of products that can ensure the greatest return on investment; (2) the Legal Framework for Science and Innovation in Brazil (Brasil 2018) provides incentives for innovation, which is not a problem if we consider the small businesses that form around universities in an incubator format and grow on their own. For that, the financial system should be autonomous from the university and its vocation, with independent funding. Support could come from the state or be provided via incentives for businesses. From this perspective, the autonomy of the university to decide where to invest should be absolute. In most universities, we find so-called innovation side by side with the allocation of talents and scarce state resources in research according to big industry interests. A frequent argument states that only multinationals have the necessary conditions to operate in the pharmaceutical market, but this is not entirely accurate. If Brazil invested in developing its biodiversity and traditional knowledge in clinical research and provided some protection to national industry, the country would be perfectly able to produce a menu of alternative therapies, as defended by Carvalho et al. (2011). This is especially true if we think in an integrated manner about the competencies we develop in our universities, such as machinery, production technology, and physicochemical and biological investigation. In clinical research, we can identify those conflicts of interest that negatively affect the ethicality of research, from the design stage to the publication of the results. Many times, as Chalmers et al. (2014) indicated, the design of clinical research to test medication does not address whether the drug will be useful for the intended population. The justification is based on how the drug will bring more benefits to the industry or even improve its position in the market. The conducting of research associated with ruthless competition for resources and prestige in the academic world, with soft regulation as always arises when the laissez-faire principle is a guiding value of a policy that involves economic interests, can lead researchers to commit fraud (fabrication or forging) in terms of the results. A publication is the reflection of research conducted and is the crowning moment of the knowledge production process—recognition of the work that has been done. However, for researchers all over the world today, publication represents the currency with which they wish to be paid. Publication represents more power: the more publications a researcher has, the more power he or she has. This is what makes the quest for power part of the marketing game, and the inventions of each individual or group can be used to obtain more productivity. It is evident that at this level the only interest is in the product/article to be published, with little attention paid to content or ethical aspects. Chalmers et al. (2014) highlight the waste of resources and time related to the quality

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of published research when investments largely go towards publishing a high number of papers. Considering now the approval of regulatory bodies (with the FDA as an example), we find that all discussions in the chambers of technical specialists are carried out by experts with connections to US universities linked to big industry. Warde (2001) published in the Le Monde diplomatique that Novartis (a Swiss pharmaceutical company) held two of the five positions on a research committee at the University of California in Berkeley under a commercial agreement between the two. The potential of influence of secondary interests on researchers’ judgment varies from insignificant to high, and not all relationships represent a real conflict of interest. The potential for the effects of conflicts of interest can exist independently, whether or not the individual believes that the relationship affects his or her scientific judgment. Furthermore, conflicts of interest can arise for other reasons, including personal relationships, academic competition, and intellectual passion. The problem is, as Angell (2000) asks: How can we trust the results of studies that were funded by those with interests in the results? Controlling the problem by the disclosure of a conflict of interest in published research results has a limited power to produce an effect; thus, it is up to the readers themselves to decide to what extent they should believe what they are reading. Furthermore, it is common for some authors to declare that there is no conflict merely because they cannot see one. A more effective option to control for conflicts of interest is the elaboration of a code of ethics by corporations, funding agencies for research such as CNPq and FAPESP, or editors and publishers such as the guidelines of COPE. However, these initiatives are still self-regulatory, and self-regulation is of little value when powerful economic interests are at play. Another alternative is to develop a managing policy in research centers to ensure the credibility of research carried out in the institution and the university’s autonomy. This approach seems to be the most efficient alternative because it is selfregulatory, but also multi-professional and transparent, therefore increasing the possibility of obtaining positive results. The primary focus of institutional intervention to ensure confidence in research results is the management of conflicts of interests. This requires investments in transparency and in the thorough and independent evaluation of the conditions under which research is conducted. Thus, if we consider the “publish or perish” catchphrase, especially in a periphery country, Brazilian scientists will be particularly vulnerable. This is the direction indicated by the code developed by FAPESP and the recommendations from international conferences. From an international perspective, decisions have been made in favor of the first option, which is to ensure that the financial relationships between individual researchers and the industry are transparent. Policies requiring the disclosure of any conflicts of interest, already implemented by the most relevant scientific publishers, are gaining increased traction. In Australia in 2007, the Australian Competition Tribunal placed disclosure requirements on Medicines Australia (which represents the discovery-driven pharmaceutical industry in Australia), a code of conduct for the relationship between the professionals and the industry. Thus, Medicines Australia now publishes its biannual reports with information about the financial allocations

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made directly to professionals or through educational activities (Medicines Australia 2018). Legislators from the United States approved a law in 2009 that seeks to guarantee greater transparency in the relationship between pharmaceutical companies, medical devices, and doctors. This law was included in the Patient Protection and Affordable Care Act, aka Obamacare, and the Physician Payments Sunshine Act of 2009 (USA 2009). The Sunshine Act states that all transactions worth more than US$10 must be registered, and when annual individual value reaches US$100, even transactions for less US$10 must be disclosed (Page 2017). It is clear that considerable emphasis is being placed on small transactions; this generates an enormous database, which hardly leads to efficient control of existing interests. In its original conception, the purpose of the Sunshine Act (as proposed by Republican Senator Chuck Grassley of Iowa) was to support patients in their choice of doctors. Its current form does not seem to reflect the original intent. Many discussions have been diverted to the “free meals” that are paid for by pharmaceutical representatives. Without a doubt, this emphasis favors those who do not want to discuss conflicts of interest. The fundamental issue is that the techniques used in advertising and marketing influence individual choices, and the use of these techniques together with economic power can generate abuse and distortions in commercial practices. We do not believe that the influence of modern advertising techniques or the grants or small gifts bestowed on the decision-maker should be an important element in a decision. When someone decides which drug will be prescribed, which prosthesis should be implanted, or which life support should be used, he or she should not be under the influence of powerful propaganda. We do not intend to discuss whether a doctor is influenced by a US$20 lunch, which she could pay for himself, but rather how these marketing actions are structured to affect decisions and their efficacy. Professionals like legislators, policy makers, public officials, editors, and experts in ethics have little awareness about the influence of secondary interests in doctors’ and health professionals’ decision processes. Herein lies the primary problem. Doctors and other health professionals (e.g. dentists, physiotherapists) have good intentions. In fact, we believe that they have the best of intentions, but this is not enough. A study published at the beginning of this century by Steinman et al. (2001) on resident doctors clarifies some aspects of this phenomenon. The researchers asked doctors whether the gifts and support that they received from the pharmaceutical industry affected what they prescribed. The majority (61%) declared that they were not influenced and only 1% considered themselves to be very influenced. We do not view these results with judgment but instead as evidence of how difficult it is for each of us to perceive a conflict of interest when we are involved, therefore reinforcing the necessity of actions that are not merely based on norms and codes. To make this “banalization” of the gifts and support given to health professionals more evident, we propose an analogy: if we ask a person whether they consider it acceptable for a politician or public official to receive gifts or a reward of any kind from companies that have an interest in decisions upon which he or she exerts influence, very few will consider this practice acceptable. However, in the case of

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health professionals, this view is rarely observed. Free samples, free lunches, allinclusive trips to conferences, or bonuses are considered the norm and even justifiable. If conflicts of interest are a worldwide problem, they are also a problem in Brazil, but for a different and highly complex reason. It is related to the point of view from which we began our discussion: Brazil is a periphery country with sluggish capitalist development and economic relations dependent on central nations. Nonetheless, this view would not be complete without mentioning a very specific perspective of old colonial relations involving countries with very little economic development, which are still associated with the colonial model imposed by core countries. We have discussed this perspective in an earlier article, and it is connected to the definition of coloniality: Coloniality was initially described by Quijano (1988) and can be understood as something that transcends colonialism per se (that is to say, towards the end of the colonial relationship) and is configured to maintain the relationships of subordination in the inter-state capitalist system (Fiori 2007). The model of colonization meant not only economic but also cultural dominance. As Assis (2014) pointed out: the structuring of hierarchies of race and gender, and ways of appropriating natural resources, can be seen as contemporaneous to establishing an international division of work and territories, marked by asymmetrical relationships between central and peripheral economies. From the point of view of coloniality, the old colonial hierarchies, which were grouped as Europeans versus non-Europeans, remained entrenched and attached to the international division of work. (Assis 2014, p 614, author’s translation) In this perspective, the national economic elites do not antagonize foreign interests since their dependence articulates them. (Rego and Palácios 2016: 68, author’s translation)

This situation makes researchers and physicians even more vulnerable in the battle for economic power represented by the actions of the pharmaceutical industry. Living with salaries that are significantly below those of their core country peers and with little perceived chance of improvement, they can become even more vulnerable to the pressures and rewards that a strong relationship with the pharmaceutical industry can promote.

10.7 Initiatives in Rio de Janeiro, Brazil The committee on research integrity at Oswaldo Cruz Foundation (Fiocruz) was created in February 2012 with the aim of stimulating the development of a culture of scientific integrity and promoting working conditions that enable integrity. The committee’s actions can include the development of research and its publication, as well as teaching and establishing methodology. Its goal is to establish clear rules to fight plagiarism (and other types of fraud) and encourage the value of research integrity among those working for or considering working for Fiocruz. Its main priorities are educational: promoting and defining values and coherent procedures at the end of the research process and, whenever possible, conducting proper legal investigation of problems that might arise.

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In June 2013, the Federal University of Rio de Janeiro created the Research Ethics Advisory Council. This forum is the consequence of a movement that united professors and researchers concerned about ethics within the university. It was connected to the idea of building a structure based upon university expertise to offer institutional feedback on ethical issues related to all phases of the research process: setting up the study, gathering resources, conducting the actual research, the relationships among the individuals involved, the context of the research, communication with the public, and the consequences for all parties involved and the environment. This council was subdivided into sub-chambers to address specific matters such as research with humans, the use of animals in research and teaching, biodiversity and related traditional matters, biosecurity, and the university-businesses relationship.

10.8 Conclusion: Our Proposal As we have seen, weak research integrity impacts the credibility of the field of science. The initiatives resulting from international and national discussions have had some effect in the sense that they have expanded the areas of knowledge involved in the scientific production of research ethics. Thus, two main models can be presented to understand and mitigate the problems of integrity. In the first, the focus is on the moral agent. The integrity of the agent is in question, and possible mitigating policies involve education, security, and punishment. In the second model we propose, the focus is on controlling the settings—the conditions that promote malpractice and can prevent it. In this sense, conflicts of interest are a highly productive lens through which to consider research integrity, even more so if we take into consideration the influence of coloniality. The scientific community must actively face those conflicts of interest that many times are not even perceived. Considering the still deep-rooted culture of subordination that exists in periphery countries, even among researchers with vast experience who are sometimes part of an international project, strong secondary interests can blind Brazilian researchers. For evidence we need look no further than the debates during the 1990s about US participation in research that involved the vertical transmission of HIV in developing countries as reported by Lurie and Wolfe (Lurie and Wolfe 1997). The authors revealed that 15 trials were developed with a placebo group, in violation with the World Medical Association’s code of ethics involving research with humans. All the studies were conducted with the participation of local researchers who were subordinate to the requirements of the core country. If we think about integrity and responsible conduct in research from the perspective of conflicts of interest, we broaden the field of vision to include conditions in which an individual can be negatively influenced and commit minor or serious misconduct. Expanding that scope, we can more accurately not only identify the origin of the misconduct but also reflect on the unethical behaviors and their consequences for all those affected. It is also necessary to consider (1) the context in which the research is carried out, (2) the factors that interfere with conducting research, and, (3) explicitly, the primacy of respect for human beings.

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We reject the idea that there is only one way of conducting research and that an individual person or a certain factor holds the key to what is ethical. It is a reflection that should permeate all human activities, particularly the professional activities that affect the lives of other humans. This means that it is necessary for researchers involved in any research to reflect on the best way of conducting it. They should hold the utmost respect for those affected and consider any alternative actions that could enable better human development, whether they involve in the relationship between the teams that share the research or its effects. Furthermore, research is a social activity implanted in an institutional context. Thus, once the action is institutional, responsibility for the consequences of the researchers’ actions is shared. Reflection and shared decision-making in research teams do not occur without institutional involvement. This implies, therefore, that constant consideration of the actions of all those who directly engage in research should be transformed into an institutionalized activity (with the creation of space and time for reflection on the practice). It is clear that this proposal runs counter to management based on research results and the increasing intensification of work because of competition for funds and prestige. In particular, public institutions must make their activities transparent and justify their actions. By doing so, those who reflect on better ways to conduct research and make it public cease to be the only ones involved directly in the research; it also includes the institution and society as a whole. Via legislation (of which the Sunshine Act is an example), society plays a role in the assessment of how reliable research results are when the secondary interests of the main actors come into play. In the area of health, Brazil, as a society, has had some success in controlling the actions of the state. The Brazilian Constitution of 1988 established the creation of a deliberative council within the scope of the Ministry of Health, called the National Health Council. Its function is to formulate policies and monitor their implementation. The composition of this council is equal, with 50% of its members being representatives of the population that uses the national health system and 50% representing government, health professionals, educational institutions, and research institutions that provide private health services. While this form of equal representation is reproduced in some of its committees, this is not the case for the National Commission for Research Ethics (CONEP), which is responsible for formulating national guidelines for research ethics (although a number of the above institutions are represented). Similarly, the 50/50 proportion is not reproduced in research ethics committees. The principle that guides the presence of research participant representatives in research ethics committees, always in a deeply disadvantageous proportion, needs to be reconsidered so that the voice and ideas of those not responsible for conducting or promoting research can be considered. To paraphrase Georges Clemenceau, who said “War is too important to be left to the generals” (as quoted by Barone 2002), it is our view that care and research are too critical to be left only to the researchers and their funders. Control by the civil society and public transparency of research into new medicines seem to be fundamental for the protection of the population. One question that must be answered is how to prevent the pharmaceutical industry from financing and conducting studies that will provide evidence of the safety and efficacy of its product.

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One has to think about which design should be most appropriate to evaluate the safety and efficacy of a particular drug. Why not achieve this through a public announcement so that universities or research centers can make their proposals? Why not capture the resources of the industry to carry out this type of research, in which society, represented by a council, can deliberate on the choice of research designs and groups of researchers transparently and independently? This would mean that an equal representation of all facets of society, such as in the National Health Council of Brazil, would determine the design and teams for at least one study of the efficacy and safety of any device for use in human health, before approval by the system of health surveillance. We do recognize the real possibility of malicious researchers who deliberately falsify or fabricate search results. Of course this is possible, and most of their peers and society will regard this action as reprehensible. However, even in the case of intentional malpractice, we need to consider how the environment contributes to condemnable behavior. The field of research is highly competitive. Researchers’ academic achievements in general lead to the accumulation of prestige, and this leads to the need to obtain new resources and facilitate the dissemination of results. The sociologist Robert Merton described this phenomenon in 1968 as the Matthew Effect (Merton 1968). It is necessary for research centers, universities, and research agencies to be attentive to and combat the deleterious effects of competition. As it is reasonable to assume that there will always be competition, the institutional environment must seek to control it in some way and to instead promote cooperation (Singer 2000). The open science movement is considered one alternative that seeks democratization in access to science and an increase in the public transparency of its development (this includes open science data). This international movement dates back to the middle of the last century and is still seen as a challenge by scientific institutions and researchers in general. The idea that the data produced are the “property” of the researcher, considered to be fundamental input in the academic dispute, is still very relevant in the research environment. However, a document released by the OECD and adopted in January 2004 represented an essential step in this direction in bringing together signatories seeking to facilitate digital access to publicly funded research data. However, there is still a long way to go with many questions on how to operationalize open science, especially considering the inequalities between core countries and those with delayed development, even when those inequalities are not acknowledged. Regardless of whether institutions in periphery countries recognize coloniality, its effects are unequivocal. Thus, additional protection mechanisms must be created to safeguard the scientific development of periphery countries against the economic power of core countries. There is no doubt that with this awareness and its present place in the international division of scientific work, it is necessary to further promote its importance (Freire 1987). Fiocruz, for example, is engaged in the politics of open science and has adopted its principles as an institutional policy that demands such a commitment from its researchers, journals, and publishers since 2014 (Fiocruz 2014).

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When a relationship with foreign researchers or institutions subjugates national interests, this must be appropriately denounced to protect national interests and national researchers. Consider, for example, the case of research and publications related to the Zika virus outbreak. According to the WHO, the Zika virus spread to more than 50 countries and territories between January 2007 and March 2016. In a scientometric study, Singh (2016) identified 467 Scopus-indexed articles on the Zika virus published since the year 2000, and the authors of these articles mostly originated from the United States, followed by the United Kingdom, the Netherlands, Germany, Switzerland, and France. It should be noted that none of those countries affected by the outbreak were positioned among the top six countries to publish on the epidemic. Is it not time for institutions and countries to commit to protecting their national researchers? Is not time to discuss again the meaning of international cooperation? Another issue that merits consideration relates to the financing of research carried out in countries on the periphery of capitalism, like Brazil. Despite the fact that we have a system of funding and support for research by the Brazilian state (the system of Foundations for Research Support and the National Research Council [CNPq] and the Financier of Studies and Projects [FINEP]), the total investment in research and scientific innovation is insufficient (especially when compared with core countries) to adequately ensure competitive scientific and technological development in Brazil. Although in 2003 and 2004 Brazil expanded its National Agenda for Priorities (Brasil 2015), the limits and possibilities of research still suffer from severe restrictions because of the scarcity of resources made available for this purpose. In the last 2 years, however, the situation has become even worse. The current Brazilian government (which took office in August 2016 after the previous president’s impeachment, a poignant demonstration of the country’s subservience to international interests) dramatically reduced funding for the sector; in 2018, budgetary resources for science and technology represented less than one third of the 2010 budget (Escobar 2017). If research were determined solely by the interests of international private lenders (the drug industry, for example), it is clear that studies would only be of interest to those agents and not meet the legitimate interests of the country. Individuals affected by so-called “neglected diseases” do not represent a consumer market for the pharmaceutical industry because they are diseases associated with poverty. Brazil must develop a robust ethical evaluation system for research. However, the country’s subordination to international interests continues to be reflected in recurrent proposals to reduce ethical requirements on research carried out here (e.g., the draft law proposed by the Chamber of Deputies to end the Brazilian system of ethical evaluation, limiting it to a mere bureaucratic instance). If we consider the financing phase mentioned above, there is consensus that it is inappropriate to let profits exclusively determine what research should be supported. Potential benefits should be the main criterion when considering the allocation of research funding. If it is not, will there be an argument justifying the death of people with rare diseases because of a lack of research funding? Shouldn’t universities be impervious to this type of funding constraint and actually demand different consideration? Would it not be ethically worthwhile for research institutions to be committed

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to respecting individuals and the choice of better actions that promote human development? Universities must make very clear to their researchers, staff in general, students, and also society their commitment to respect and support the values of research ethics, which are in the best interests of the community and the country. In conclusion, we have reviewed two ways of thinking about the questions involved in the theme of integrity and responsible conduct in research. While it is essential to emphasize the responsibility of the researcher, this is not enough. Thus, the institution must become involved in order to systematically and efficiently contribute to research so that studies occur in an ethical environment. This environment must be critical and continually improved by the community. It is clear that when we think about research institutions, we cannot ignore the fact that this involvement should be democratic and transparent, with decisions based on arguments considered valid by society, bearing in mind the primary interests of those involved with research as a social activity. In this chapter we have attempted to broaden the horizon of the discussion on research ethics. Not only should the research institution be involved, but also those involved in the three phases of knowledge production: society as a whole, the state, and its three branches of government. There is, for example, the need to more strictly regulate the actions of advertising companies as well as the marketing directed at health professionals. Advertising should be entirely banned from the educational environment (Palácios et al. 2008). It cannot become the norm for investors to influence production at research institutions just because they provide funding, whether directly or indirectly. By itself, the disclosure of financial connections is insufficient to control the damage that may result from any conflicts of interest inherent in the situation. Thus, we assert that the strategies presented here, connected to both professional ethics and practical ethics, should be implemented. This problem must be addressed in all its complexity and with multiple approaches. All stakeholders should be invited to the discussion on research ethics and the best alternatives regarding relevant issues, no matter whether they stem from research and publication or regulatory bodies, considering all those affected and their contexts. These are actions at the center of interest in our society, constituting the development of technical and scientific processes. Therefore, we are all invited to engage in this discussion. Acknowledgements We thank Katie Stallard, LLB, from Edanz Group for editing a draft of this manuscript.

References II Brazilian Meeting on Research Integrity, Science and Publication Ethics (BRISPE). 2010a. II Brazilian Meeting on Research Integrity, Science, and Publication Ethics, Rio de Janeiro. Available http://www.iibrispe.coppe.ufrj.br. Accessed January 11, 2018. II Brazilian Meeting on Research Integrity, Science and Publication Ethics (BRISPE). 2010b. Joint Statement of the II Brazilian Meeting on Research Integrity, Science and Publication Ethics (II BRISPE), Rio de Janeiro. Available http://www.iibrispe.coppe.ufrj.br/images/IIBRISPE/ JoinStatement/JointStatementonResearchIntegrity_IIBRISPE_2012_English.pdf. Accessed January 11, 2018.

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2nd World Conference on Research Integrity. 2010. Singapore Statement on Research Integrity. http://www.singaporestatement.org/statement.html. Accessed on January 17, 2018. 3rd World Conference on Research Integrity. 2013. Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations. Available http://www.researchintegrity.org/ Statements/Montreal%20Statement%20English.pdf. Accessed January 11, 2018. 4th World Conference on Research Integrity. 2015. Research Rewards and Integrity: Improving Systems to Promote Responsible Conduct. Available http://www.wcri2015.org/index.php. Accessed January 11, 2018. Almeida, F., A. Seixas, P. Gama, and P. Peixoto. 2015. A fraude académica no Ensino Superior em Portugal: um estudo sobre a ética dos alunos Portugueses [Academic Fraud in Higher Education in Portugal: A Study on the Ethics of Portuguese Students]. Coimbra: Editora da Universidade de Coimbra. Available http://hdl.handle.net/10316.2/38480. Accessed mai 19, 2017. [in Portuguese]. Angell, M. 2000. Is Academic Medicine for Sale? New England Journal of Medicine 342 (20): 1516–1518. Assis, W.F.T. 2014. Do colonialismo à colonialidade: expropriação territorial na periferia do capitalismo [From Colonialism to Coloniality: Land Expropriation on the Periphery of Capitalism]. Salvador: Caderno CRH, v. 27, n. 72, 613–627, set./dez. [in Portuguese]. Associação Brasileira de Editores Científicos (ABEC). 2018. Available: https://www.abecbrasil. org.br/. [in Portuguese]. Barone, M. 2002. War is Too Important to be Left to the Generals. The Weekly Standard June 10, 2002. Available at https://www.weeklystandard.com/michael-barone/war-is-too-important-tobe-left-to-the-generals. Brasil. 2012. Em Discussão. Revista de audiência pública do senado federal ano 3, no. 12, setembro de 2012 “Investimento em pesquisa e desenvolvimento, ciência, tecnologia e inovação no Brasil” [In Discussion. Public Hearing Magazine of the Federal Senate 3(12); September 2012 “Investment in research and development, science, technology and innovation in Brazil”]. http:// www.senado.gov.br/NOTICIAS/JORNAL/EMDISCUSSAO/inovacao/ciencia-tecnologia-einovacao-no-brasil.aspx. Accessed on January 17, 2018. [in Portuguese]. Brasil. 2015. Ministério da Saúde. Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Ciência e Tecnologia. Agenda nacional de prioridades de pesquisa em saúde/Ministério da Saúde, Secretaria de Ciência, Tecnologia e Insumos Estratégicos, Departamento de Ciência e Tecnologia [National Agenda for Health Research Priorities/Ministry of Health, Secretariat for Science, Technology and Strategic Inputs, Department of Science and Technology], 2 ed, 4. reimpr, 68 p. Brasília: Editora do Ministério da Saúde. [in Portuguese]. Brasil. 2018. Lei Nº 13.243, de 11 de janeiro de 2016. Available at http://www.planalto.gov.br/ ccivil_03/_ato2015-2018/2016/lei/l13243.htm. Accessed on June 11, 2018. [in Portuguese]. Carvalho, A.C.B., J.P.S. Perfeito, L.V.C. Silva, L.S. Ramalho, R.F.O. Marques, and D. Silveira. 2011. Regulation of Herbal Medicines in Brazil: Advances and Perspectives. Brazilian Journal of Pharmaceutical Sciences 47 (3). Chalmers, I., M.B. Bracken, B. Djulbegovic, S. Garattini, J. Grant, A.M. Gülmezoglu, D.W. Howells, J.P.A. Ioannidis, and S. Oliver. 2014. How to Increase Value and Reduce Waste When Research Priorities are Set. The Lancet 383 (9912): 156–165. Available at http://www.sciencedirect.com/ science/journal/01406736/383/9912 or https://doi.org/10.1016/S0140-6736(13)62229-1. Committee on Publication Ethics (COPE). 2018a. History. Available at https://publicationethics. org/about/history. Accessed May 29, 2018. Committee on Publication Ethics (COPE). 2018b. Guidelines. Available https://publicationethics. org/resources/guidelines. Accessed January 11, 2018. Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq). 2012. Diretrizes sobre Integridade em Pesquisa [Guidelines on Research Integrity]. Available at http://cnpq.br/ diretrizes. Accessed January 11, 2018. [in Portuguese]. Council of Science Editors (CSE). 2012. White Paper on Promoting Integrity in Scientific Journal Publications, 2012 Update (approved by the CSE Board of Directors on March 30, 2012). Available at https://www.councilscienceeditors.org/wp-content/uploads/entire_whitepaper.pdf.

198

M. Palácios and S. Rego

Council of Science Editors. 2018. History of CSE. Available https://www.councilscienceeditors. org/about/history-of-cse/. Accessed January 11, 2018. Deyo, R.A. 2004. Gaps, Tensions, and Conflicts in the FDA Approval Process: Implications for Clinical Practice. The Journal of the American Board of Family Practice 17: 142–149. Available at http://www.jabfm.org/content/17/2/142.full.pdf+html. Accessed January 10, 2018. Eco, U. 1977. Como si scrive ina tesi de laurea?. Milano: Editore Bompiani. [in Italian]. Escobar, H. 2017. Orçamento de ciência e tecnologia pode encolher ainda mais em 2018 [Science and Technology Budget May Shrink Even Further in 2018]. Caderno Ciência, Jornal O Estado de São Paulo, 11 Julho 2017. DIsponível em http://ciencia.estadao.com.br/blogs/herton-escobar/ orcamento-de-ciencia-e-tecnologia-pode-encolher-ainda-mais-em-2018/. Accessed May 30, 2018. [in Portuguese]. European Science Foundation. 2007. ESF-ORI First World Conference on Research Integrity: Fostering Responsible Research. ESF, Archives. http://archives.esf.org/index.php?id=4479. Accessed on January 17, 2018. Fang, F.C., R.G. Steen, and A. Casadevall. 2012. Misconduct Accounts for the Majority of Retracted Scientific Publications. Proceedings of the National Academy of Sciences 109 (42): 17028–17033. Fiori, J.L. 2007. O poder global e a nova geopolítica das nações [The Global Power and the New Geopolitics of Nations]. São Paulo: Boitempo Editorial. [in Portuguese]. Freire, P. 1987. Pedagogia do oprimido [Pedagogy of the Oppressed] 17ª. Ed. Rio de Janeiro: Paz e Terra. [in Portuguese]. Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP). 2014. Código de Boas Práticas Científicas [Code of Good Scientific Practice]. Available http://www.fapesp.br/boaspraticas/ FAPESP-Codigo_de_Boas_Praticas_Cientificas_2014.pdf. Accessed January 11, 2018. [in Portuguese]. Fundação Oswaldo Cruz (FIOCRUZ). 2014. Acesso aberto [Open Access]. Available at https:// portal.fiocruz.br/acessoaberto. Accessed on May 30, 2018. [in Portuguese]. Grieneisen, M.L., and M. Zhang. 2012. A Comprehensive Survey of Retracted Articles from the Scholarly Literature. PLoS ONE 7 (10): e44118. https://doi.org/10.1371/journal.pone.0044118). International Committee of Medical Journal Editors (ICMJE). 2017. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals Updated December 2017. Available at http://www.icmje.org/icmje-recommendations.pdf. Accessed on January 15, 2018. John Willey Best and Sons, Ltda Practice Guidelines on Publishing Ethics A Publisher’s Perspective, 2nd ed. Available https://authorservices.wiley.com/asset/Ethics_Guidelines_7.06.17.pdf. Accessed on January 11, 2018. Lurie, P., and S.M. Wolfe. 1997. Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries. The New England Journal of Medicine 337 (12): 853–856. Martinson, B.C., M.S. Anderson, and R. De-Vries. 2005. Scientists Behaving Badly. Nature 435: 737–738. Medicines Australia. 2018. Educational Event Reports. Medicines Australia 2009 Educational Event Reports. Available: https://medicinesaustralia.com.au/code-of-conduct/transparency-reporting/ previous-transparency-reports/educational-event-reports/. Accessed on January 17, 2018. Merton, R.K. 1968. The Matthew Effect in Science. Science 159 (3810): 56–63. N Engl J Med 1993; 329: 573–576 August 19, 1993 https://doi.org/10.1056/nejm199308193290812. Available at http://www.nejm.org/doi/full/10.1056/NEJM199308193290812. Accessed on January 17, 2018. OECD. 2004. Declaration on Access to Research Data from Public Funding. Science, Technology, and Innovation for the 21st Century. Meeting of the OECD Committee for Scientific and Technological Policy at Ministerial Level, 29–30 January 2004—Final Communique. Available at: http://www.oecd.org/science/sci-tech/sciencetechnologyandinnovationforthe21stcentury meetingoftheoecdcommitteeforscientificandtechnologicalpolicyatministeriallevel2930january2004-finalcommunique.htm.

10 Ethics in Conducting and Communicating Research …

199

Office of Research Integrity (ORI). 2018a. Historical Background. https://ori.hhs.gov/historicalbackground. Accessed January 11, 2018. Office of Research Integrity (ORI). 2018b. Case Summary: Sudbo, Jon. https://ori.hhs.gov/content/ case-summary-sudbo-jon. Accessed January 08, 2018. Office of Research Integrity (ORI). 2018c. Case Summary—Eric T. Poehlman. Available at http:// ori.hhs.gov/poehlman_notice. Accessed January 11, 2018. Packer, A.L., and R. Meneghini. 2014. O SciELO aos 15 anos: raison d’être, avanços e desafios para o futuro [The SciELO to 15 years raison d’être, Progress and Challenges for the Future], 15–18. In: A.L. Packer, N. Cop, A. Luccisano, et al., orgs. SciELO - 15 Anos de Acesso Aberto: um estudo analítico sobre Acesso Aberto e comunicação científica [SciELO - 15 Years of Open Access: An Analytical Study on Open Access and Scientific Communication]. Paris: UNESCO, 2014, 188 p. ISBN 978-92-3701-237-6. Available from: http://dx.doi.org/10.7476/ 9789237012376. [in Portuguese]. Page, L. 2017. Sunshine Act: Are Doctors Still Enjoying Free Lunches From Drug Reps? Medscape, November 21, 2017. Available at https://www.medscape.com/viewarticle/885792_2. Accessed on January 17, 2018. Palácios, M., Rego, S., Lino, M.H. 2008. Promoção e propaganda de medicamentos em ambientes de ensino: elementos para o debate [Promotion and Drug Advertising in Teaching Environments: Elements for Debate]. Interface (Botucatu) 27 (12). http://dx.doi.org/10.1590/S141432832008000400018. Accessed on January 17, 2018. [in Portuguese]. Quijano, A. 1988. Colonialidad del poder, y conocimiento cultura en América Latina [Coloniality of Power, Knowledge and Culture in Latin America] (Análisis). Ecuador Debate. Descentralización: entre lo global y lo local, Quito, n. 4, 227–238, ago. [in Spanish]. Rego, S., and M. Palácios. 2016. Ética e democracia em tempos de crise [Ethics and Democracy in Times of Crisis]. Saúde em Debate. Rio de Janeiro, v. 40, n. especial, 63–72, DEZ 2016. [in portuguese]. Reich, E.S. 2011. Biologist Spared Jail for Grant Fraud. Nature 474 (552): 2018. https://doi.org/ 10.1038/474552aAccessonJan17. Roseman, M., E.H. Turner, J. Lexchin, J.C. Coyne, L.A. Bero, and B.T. Thombs. 2012. Reporting of Conflicts of Interest from Drug Trials in Cochrane Reviews: Cross Sectional Study. BMJ 345: e5155. https://doi.org/10.1136/bmj.e5155. Published 21 August 2012. Schnirring, L. 2012. Mutações H5N1, outros detalhes revelados na reunião H5N1 [H5N1 Mutations, Other Details Revealed in the H5N1 Meeting]. University of Minnesota, CIDRAP. Available www.cidrap.umn.edu/news-perspective/2012/04/h5n1-mutations-other-details-unveiled-h5n1meeting. Accessed on January 17, 2018. [in Portuguese]. Singer, P. 2000. A Darwinian Left: Politics, Evolution, and Cooperation. Yale University Press. Singh, N. 2016. Scientometric Analysis of Research on Zika Virus. Virusdisease 27 (3): 303–306. https://doi.org/10.1007/s13337-016-0339-3. Steinman, M.A., M.G. Shlipak, and S.J. McPhee. 2001. Of Principles and Pens: Attitudes and Practices of Medicine Housestaff Toward Pharmaceutical Industry Promotions. The American Journal of Medicine 110: 551–557. http://dx.doi.org/10.1016/S0002-9343(01)00660-X. Accessed on January 17, 2018. Thompson, D.F. 1993. Understanding Financial Conflicts of Interest. New England Journal of Medicine 329 (8): 573–576. USA. 2009. Physician Payments Sunshine Act of 2009. Available at https://www.congress.gov/ bill/111th-congress/senate-bill/301/text. Accessed on January 17, 2018. Warde, I.A. 2001. Casamento Por Dinheiro À Moda Liberal: A Universidade Norte-Americana Sugada Pelos Mercadores [Marriage for Money to Liberal Fashion: The American University Sucked Those Merchants]. Le Monde diplomatique [Portuguese]. March, 2001. disponível em http:// ibrahimwarde.com/articles/casamento-por-dinheiro-%C3%A0-moda-liberal-universidadenorte-americana-sugada-pelos-mercadores. Accessed on January 17, 2018. [in Portuguese]. Ziman, J. 1996. Is Science Losing Its Objectivity? Nature 382: 751–754. https://doi.org/10.1038/ 382751a0. Accessed on January 17, 2018.

Part IV

Agriculture and Environment

Chapter 11

A Latin American Perspective to Agricultural Ethics Cristian Timmermann

Abstract The mixture of political, social, cultural, and economic environments in Latin America, together with the enormous diversity in climates, natural habitats, and biological resources the continent offers, make the ethical assessment of agricultural policies extremely difficult. Yet the experience gained while addressing the contemporary challenges the region faces, such as rapid urbanization, loss of culinary and crop diversity, extreme inequality, disappearing farming styles, water and land grabs, malnutrition, and the restoration of the rule of law and social peace, can be of great value to other regions in similar latitudes, development processes, and social situations. This chapter will provide a brief overview of these challenges from the perspective of a continent that is exposed to the consequences of extreme inequality in multiple dimensions and conclude by arguing for the need to have a continuous South–South dialogue on the challenges of establishing socially and environmentally sustainable food systems. Keywords Food ethics · Extreme inequality · Food production · Land use · Rural development · Agrobiodiversity

11.1 Introduction Latin America is a highly diverse region. In terms of natural environments, we find both the driest desert—the Atacama Desert—and the most biodiverse area in the world: the Amazon rainforest. While the region boasts two major centers of origin, safeguarding an enormous variety of vital landraces for humanity (Kloppenburg 2005), it also maintains some of the largest monocultures of genetically modified soy fields in the world (Arancibia 2013). Culturally, this region in the Americas and C. Timmermann (B) Centro Interdisciplinario de Estudios en Bioética, Universidad de Chile, Diagonal Paraguay 265 - of. 806, Santiago, Chile e-mail: [email protected] Instituto de Estudios Internacionales, Universidad de Chile, Av. Condell 249, Santiago, Chile © Springer Nature Switzerland AG 2019 E. Rivera-López and M. Hevia (eds.), Controversies in Latin American Bioethics, International Library of Ethics, Law, and the New Medicine 79, https://doi.org/10.1007/978-3-030-17963-2_11

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Caribbean consists by definition of the countries and dependencies where Romance languages are predominantly spoken (Lolas 2014b). Yet especially in the countryside, this apparent homogeneity is vastly enriched by an enormous number of indigenous languages and regional dialects. The area embraces traditional, mixed, and fused cultural heritages from indigenous communities, colonizing nations, decedents of slaves, and multiple immigration waves. Politically, the region unfortunately shares a long history of abuse of power, disregard for human rights, discrimination, corruption, foreign intervention, and military coups, making it crucial to build trustworthiness in political institutions as the number of disappeared, tortured, enslaved, raped, and murdered people reaches several thousands in most Latin American countries. Socially, we find mixed progress. A few countries in the region stand out for already having elected women as heads of state and for having above world average female political representation (Rein Venegas 2013), yet at the same time the region also holds some of the most alarming rates of violence against women in the world (Bott et al. 2012). As far as the representation of indigenous peoples goes, we find similarly diverging images. Although an indigenous president took in Mexico already office in 1858, only a very small number of persons who have identified themselves as members of indigenous communities have been elected as heads of state since. Discrimination and human rights violations against indigenous peoples and people of Sub-Saharan descent is still rampant. The region has had little success in reducing its very high rates of violence and homicides. In terms of urbanization, we find here a number of the largest cities in the Western Hemisphere and also some of the least populated areas of the world. Economically, we encounter a wide spectrum of development stages. Latin America is characterized by having extreme inequality both within and between countries. While Chile and Argentina are listed among the countries with a very high human development, Haiti remains the only country ranked as having “low human development” in the Americas (Jahan 2016). The differences in income and infrastructure are not only tremendous between rural and urban areas, but even within the same cities. Regarding food production, as a region Latin America and the Caribbean produce sufficient food to feed their entire population. Unfortunately, despite major advances in addressing the right to food, poverty still makes food inaccessible for the 37 million people (6.1% of the population) who suffer from hunger (FAO 2018). The problems of poverty are further aggravated by the level of extreme inequality in the region, which, together with those in Southern Africa, are the highest in the world (Jahan 2016). Extreme inequality also hinders diverse participation and adequate political representation (Di Castro 2010) and facilitates exploitation, corruption, and unfair competition, with disastrous effects for rural people and the environment. Improving continuous access to adequate food therefore demands solutions of a political nature. These realities bring about a number of problems and opportunities for addressing social justice and protecting the environment. In this article, I can only focus on a few of the most notorious challenges for the region and their ethical issues: the problem of extreme inequality and the struggle for food sovereignty (Sect. 11.2); the pursuit of agroecology and the problem of coexistence in agriculture (Sect. 11.3); the challenges of securing adequate food (Sect. 11.4); the mission of maintaining

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diversity (Sect. 11.5); and the need to make food systems more resilient (Sect. 11.6). As a conclusion (Sect. 11.7), I defend the necessity and benefits of a South–South dialogue.

11.2 Food Sovereignty and Extreme Inequality A series of trends have triggered great discontent among food producers and consumers on how agricultural policies and trade agreements are being created and on how the law is being enforced. People are particularly worried about large-scale land-grabbing, a lack of consultation on agricultural and food policies, the violation of land workers’ rights, the loss of heritage varieties, and insufficient space for alternative food production methods (Baquedano Jer and Larraín 2015). Farmers’ organizations in Latin America have been particularly strong in organizing themselves and raising their voice. A major movement pursued by these farmers is the fight for food sovereignty (Altieri and Toledo 2011). The concept of food sovereignty consists of a series of demands, in seeking a right to produce food, to participate in the design of agricultural policies, to end systematic violence in rural areas, to empower farmers (especially female and indigenous farmers), to improve rural infrastructure, and to provide fairer access to land, water, loans, and technical assistance (Nyéléni Forum for Food Sovereignty 2007; Via Campesina 1996). To realize food sovereignty, a series of reforms must be implemented, some of which will encounter fierce opposition, as is the case of the redistribution of resources and the democratization of decision-making mechanisms (Barkin and Lemus 2016). With regards to the redistribution of resources, it is self-evident that food cannot be grown without land and water. Yet especially under extreme inequality, these two resources are being seized at grand scale, threatening the existence of smallholders. Water is becoming increasingly scarce not only because of increasing demand for it, but also due to lower precipitation rates caused by climate change (McMichael 2017). Land-grabbing must be broadly understood to identify the different factors that contribute to the reduction in the number of farms (Giraldo 2018). One form of landgrabbing is the large-scale acquisition of land and waters for investment purposes and as foreign reserves. A second form of land-grabbing is changing the use of the land, particularly to move from food production for the local population to the production of export cash crops, most alarmingly the cultivation of soy for animal feed and crops for biofuels. According to 2014–2015 numbers, 52% of land under cultivation in Argentina was used to grow soy, of which 96% was exported (Leguizamón 2016). Here we should also consider the effects that the production of drugs and the war against them is having on the region. The cultivation of coca, cannabis, and poppies demands vast areas of land, water, and labor. The criminalization of drug production brings the destruction of these cultivars and pushes drug cartels to take new lands for their production, usually expelling, tormenting, or even murdering non-complying farmers. In 2014, the cultivation of coca bushes alone occupied a total 132,000 ha in Bolivia, Colombia, and Peru, while the same year 110,000 ha were eradicated

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(United Nations Office on Drugs and Crime 2016, Annexe V). As a comparison, to visualize the magnitude of such areas, the cultivation of 141,000 ha of vineyards make Chile one of largest wine producers of the world, providing legally protected jobs and paying taxes (ODEPA 2018). The rural population often feels that they are not sufficiently and adequately consulted on agricultural policies (Carro-Ripalda et al. 2015). Food sovereignty advocates claim that agricultural policies mostly favor large landowners and multinational corporations, and that such policies need to be redesigned so that they also benefit smallholders. This would require a right to protect local markets and prohibit the use of particular technologies, especially genetic modification (Nyéléni Forum for Food Sovereignty 2007). A special concern is how these technologies end up putting farmers in a position of dependency, with debt as a common consequence, ultimately obliging farmers to sell their land and labor. Inadequate agricultural policies have caused a number of Latin American countries that once had a strong tradition of being food-exporting countries to become net food-importing countries over the last decades (Lara Cortés 2001). In 2012 Mexico, for example, had to import approximately 30% of maize, 58% of wheat, and 82% of rice to cover domestic needs (Escalona-Aguilar et al. 2015). Food sovereignty raises important ethical questions. While the right to selfdetermination may at first seem something one should welcome from an ethical perspective, there are some special considerations about ethical responsibility that need to be attended when environmental resources are in play (Villarroel 2013; Lecaros Urzúa 2013). The resources needed to grow food, particularly water and land, are in limited supply. Moreover, food is a basic human need. Current population size, together with existing land distribution arrangements, make it impossible to be unconcerned about how land is cultivated. People who are not involved in food production have a strong interest in food production systems functioning efficiently and cost-effectively. There is huge political pressure to make food cheap (Patel and Moore 2017). A number of organizations and food activists are also demanding more sustainable farming systems in the interest of conserving the environment and not jeopardizing future food production capabilities (McIntyre et al. 2009). These three societal interests—access to affordable and adequate food, environmental sustainability, and the maintenance of future food production capacities—must be balanced with whatever diverging interest food producers may have. To defend their interests, farmers’ organizations that seek political support will have to advocate for education campaigns to teach the population at large about the true social and environmental costs of food production (Timmermann et al. 2018). There is increasing awareness that food production is a sector in which workers are exploited in large numbers and with great intensity (Raynolds 2014). Many are also suffering from the health consequences of agrochemicals. Farmers have first-hand experience with the environmental and health impact of conventional agriculture; it would be unwise and unjust to ignore their testimony. To improve agricultural practices for people and the environment, two leading agricultural ethicists, Thompson (2015) and Korthals (2004), have defended the use of a deliberative approach to improve ethical decision-making. Inspired by the work

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of Jürgen Habermas, the principal idea of this kind of approach is to organize meetings with key stakeholders, representing the interests and opinion of experts, consumer groups, farmers, retailers, and environmental organizations, to discuss the concerns and demands of all affected groups, identify priorities, and come to a consensus. Since most the urban population has lost its connection to food production venues (Thompson 2015), it is becoming increasingly important for such public deliberations to be linked to education campaigns that improve people’s food literacy. Food producers, on the other hand, will have to commit to learning about the nature of problems of collective action, the shared benefits of environmental regulations, the concept of the human right to adequate food, and basic ecological principles. This knowledge is crucial to ensuring that dialogues between experts, consumers, and food producers are built on an adequate understanding of social and environmental needs and challenges. In the Latin American context, it is particularly important to include any affected indigenous communities in such discussions and make sure that discussion forums do not perpetuate historical injustices (Barkin and Lemus 2016). Action needs to be taken against discrimination, and training programs must be established to empower indigenous leaders and historically underrepresented groups so that they can take part in such discussions as peers of equal standing.

11.3 Agroecology and the Coexistence of Different Farming Styles A farming system that includes an enormous intellectual and biological contribution from Latin American farmers is agroecology (Altieri and Nicholls 2017). As a principled based approach to agriculture, agroecology seeks to substitute external inputs with locally produced inputs, prevent nutrient run-off, and embed food production units into the larger social and ecological environment (Gómez Echeverri et al. 2017). There are numerous non-ecological advantages of this farming system. By working with biodiversity, this system allows for wider nutritional diversity among farm workers, thus reducing malnutrition (Altieri 2003). The diversification of crops also distributes work more evenly throughout the year as these farms have multiple harvesting periods. Agroecology can thus offer better year-round employment, improving work quality and reducing the need of a migrating workforce (Timmermann and Félix 2015b). Moreover, a considerable amount of agroecological principles are built upon traditional ecological knowledge, which has been tested over a prolonged period of time (Tittonell et al. 2016). By building on the knowledge of indigenous peoples, agroecology facilitates the recognition of their intellectual standing and contributions (Waldmueller 2015). Many plants, animals, and insects that provide crucial ecosystem services to agroecological farms are vulnerable to agrochemicals used in conventional agriculture. Moreover, farmers who use organic agriculture methods are only able to sell their produce in specialized markets at a premium rate when their harvests have not been

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contaminated by residues (especially from genetically modified crops) from nearby conventional farms (Robaey 2016). To allow for the coexistence of both farming systems, regulations must be in place to avoid contamination and maintain the delivery of ecological services. Coexistence in agricultural practices and ways of life calls for a series of ethical questions. What is the value of providing room for multiple methods of working the land? Should we support this coexistence even if agricultural land could be used more efficiently? As the efficiency of agroecological farming practices is continuously called into question (Tittonell 2014), defending diversity among farming systems becomes much stronger if we also spell out the different social and ecological benefits of this diversity. One of the strongest advantages of having diverse production systems is that this variety widens the possibilities for participation. About a third of the world’s population are smallholders, which makes the development of farming systems that function with local resources and local know-how a necessity to foster inclusion, assure food entitlement, and improve welfare. Another approach to defending coexistence in agriculture is to identify any agricultural practice that directly jeopardizes the livelihood of other farmers as a form of harm. Unfortunately, while a non-harm principle is widely accepted, the implications of such a principle are all but clearly defined. Among the most widely accepted forms of harm are spills of agrochemicals in above-normal use concentration, caused for example by leakage or accidents. Yet in practice, especially when the negative effects of such agrochemicals are felt in distant locations or with a significant delay of time, there is a decline in taking responsibility and holding parties accountable. It is even more debatable to interpret the reduction of opportunities as a form of harm; for example, when a farm is invaded by pollen from genetically modified organisms from neighboring farms and thereby loses the option of exporting a product to a country with a zero-tolerance policy against traces from genetically modified organisms. Ethics comes into play by assisting in the identification of different notions of harm, in spelling out the importance of reaching a consensus, and in insisting along policy-makers on the need for regulations.

11.4 Adequate Food Trade agreements, which have established an economic environment that strongly favors large-scale farms and retailers of processed foods, are having disastrous consequences for adequate nutrition. A radical example is Mexico, with a skyrocketing increase in the rates of obesity and malnutrition after the North American Free Trade Agreement (NAFTA) came to force in 1994 (Loría and Salas 2014). In a number of cases, these obesity rates were justified by claiming that the local population had a genetic tendency for obesity, ignoring the fact that such a development is recent and unprecedented (García-Deister and López-Beltrán 2015). However, when analyzing the problem of obesity and malnutrition, we should not forget the various factors that influence people’s eating behaviors. As justified as the

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accusations regarding the inadequacy of trade policies may be, these do not fully explain recent changes in eating behaviors. To understand the causes of obesity and malnutrition, we must look at both individual and social factors; only then can we design effective public policies (Lolas 2014a). Here a number of additional causes can be listed. Extremely low wages, something that to be fair has even been condemned by wealthy trading partners, not only oblige the poorer population to feed themselves with cheap calories but has invited government policies that press farmers to produce food at low costs, often at the cost of workers’ rights and the environment. Another factor is the combination of poor education, weak regulations, and deceiving advertisement, which increase the demand for processed food, especially in cases where traditional nutritious recipes are forgotten. The mix between excessive weekly working hours, as we see in Mexico and Chile, and living in large urban agglomerations with poor transportation infrastructure and unsustainable driving habits leaves people with insufficient time to regularly procure food in local markets and to prepare meals that fulfill their physiological needs and social traditions. In terms of overall food security, despite the fact that significant improvements have been made, climate change, crop failure, slow emergency relief programs, and urban poverty are still responsible for a considerable amount of hunger and malnutrition. The eradication of hunger and malnutrition, as major sources of suffering and impediments for human flourishing, are among the most urgent global tasks. Reducing hunger in the present not only saves massive future human suffering, but also economic costs, which are considerable. In Guatemala, for example, the costs of hunger are calculated to be approximately 11.4% of its GDP (Vivero-Pol and Ramírez 2009). It has been estimated that the costs of eliminating hunger are at least ten times smaller than the cost existing hunger causes (idem). From an ethical perspective, the priority of fighting hunger is widely defended (Thompson 2010). As a source of suffering, utilitarianism strongly condemns hunger. As a policy recommendation, such reasoning demands that any international agreement only be signed if it also improves the situation of the least advantaged. The right to food is a human right and is defended by most rights-based approaches. Here we should keep in mind that the human right to food not only covers absence of hunger but also a right to adequate food (De Schutter 2011). To do justice to the element of ‘adequacy’ within food politics, people must have a voice in decision-making and real freedom to choose. It is clear that without a serious commitment to reducing current levels of poverty, the full scope of such a right remains impossible to fulfill (Dieterlen 2003). Regarding food adequacy, ethics can be a supportive tool to reveal misplaced incentives. Private profit-seeking activities, such as the selling of highly processed foodstuffs with excessive amounts of salty, sweet, or fatty ingredients to trick the consumer’s senses (Pollan 2008), can lead to huge profits while inflicting massive costs on public welfare, including individual suffering and public health expenses. Here we can observe a hidden tragedy of commons problem: while the benefits of aggressively selling such foods are fully grasped by private companies, the costs of the corresponding changes in diets are paid by the public at large. Once this outcome is identified as parasitic, proper regulation can be placed to internalize the cost of these

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business practices, create adequate food labeling, or even prohibit certain industry practices altogether.

11.5 Seed and Culinary Diversity Latin America is home to two of the five major global centers of crop origin, contributing to a radical change in the world’s food consumption, through the propagation of maize from the Mexican and Central American highlands and potato from the region in and around Southern Peru (Kloppenburg 2005). These two centers, together with later cultural exchanges, have made the region a culinary and agrobiodiversity hotspot. The cultural heritage handed down from our pre-Columbian ancestors, colonizing nations, and African descendants have led to a huge diversity of culinary and agricultural traditions. This heritage has been further expanded with contributions from more recent immigration waves coming mostly from Europe, East Asia, and the middle East. This cultural heritage enriches peoples’ lives. Partly due to the long-lasting discrimination of indigenous diets (Vargas-Domínguez 2018), the region holds a number of under-explored alternatives for sustainable food consumption. The recent popularization of quinoa from its Andean homeland to the world’s slow food tables is a well-known example. The region also maintains European traditions that have been falling into disuse on the continent. It also holds a number of potentially sustainable protein alternatives for the future, as we can observe with the still widely consumed edible insects, such as chapulines and maguey worms, which were identified by Mexican indigenous peoples (Ramos-Elorduy 2009). Unfortunately, the stewardship and conservation of this heritage involves massive costs. Landraces holding unique varieties that are crucial for future breeding must be conserved, requiring the establishment and enforcement of policies that prohibit changes in land use and hinder the introduction of invasive varieties and species. This involves both actual and opportunity costs. Traditional knowledge must be documented, and involvement with traditional practices must be encouraged to avoid the loss of tacit knowledge. Many regions have established special fairs and commemoration weeks in order to popularize local culinary heritage and seed varieties. However, government policies should take care to avoid rapid popularization leading to unsustainable exploitation, thereby endangering the livelihood of the communities that have stewarded these resources and sometimes even driving these resources near extinction. An important ethical question is how this diversity should be treated. While some communities see this heritage as a gift to humankind, a common heritage, others feel that there are sacred elements that should stay within the community. There is also widespread discontent with the commodification of this heritage, especially when outsiders are the ones profiting from it, as this is perceived as a form of biopiracy (cf. Madrazo Lajous 2011). It is crucial to come to a common agreement on how these resources should be governed, as this would not only help to specify rights but also

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responsibilities, especially regarding conservation and sustainable use (Timmermann and Robaey 2016). The current situation in which countries rich in biodiversity absorb the majority of the costs of maintaining and developing their traditional landraces and also lose business opportunities caused by halting land use changes, from which ultimately the whole of humanity benefits, is neither fair nor sustainable. A more equitable division of costs is needed since much of this tradition and resources are treated and embraced as a common heritage.

11.6 Building Resilient Food Systems: Climatic and Social Challenges Disruption of the systems we rely upon is inevitable (Kolers 2016). As food is a basic need, increasing the resilience of food systems becomes an issue of social justice, especially since in a region of extreme inequality, price shocks due to scarcity or temporary unavailability will be suffered far more intensely by the poor (Tendall et al. 2015). Two factors make the region particularly vulnerable: extreme weather events and the exponential concentration of people in the major cities. Historically, the region is prone to natural disasters, as it harbors one of the most active earthquakes regions in the world along the Pacific coast and the Antilles and is vulnerable to weather-related events such as floods, droughts, and, in the Caribbean and Northern Pacific coast of the region, also hurricanes and tropical cyclones. The likelihood of extreme weather events will increase considerably in the future due to climate change. We have reached a point at which human survival already depends upon our undertaking major climate change adaptation strategies due to the ongoing lack of action to halt carbon emissions (McMichael 2017). One of the clearest and most recent examples of the need to adapt food production to extreme weather events is the case of hurricane Irma, which impacted Puerto Rico in September 2017. The hurricane left 3.4 million people without power, water, or fresh food. The destruction of costal infrastructure and large-scale power cuts, together with the island’s strong reliance of imported food, created a national food emergency. This extreme vulnerability is the result of irresponsible and exploitative public policies that are not suited to an island with natural disasters. It has become clear that these regions need to reclaim food sovereignty (Félix and Holt-Giménez 2017). Regions that have redesigned food production on the basis of agroecological principles, and thus reduced their current dependency on imports of food and agricultural inputs, have improved their resilience regarding extreme weather events and price increases, as studies from Nicaragua (Holt-Giménez 2002) and Cuba (Rosset et al. 2011) show. Biodiverse farms are more resilient after extreme weather events and capture far greater amounts of carbon (Altieri et al. 2015), thus helping to adapt to climate change while contributing to its mitigation (Timmermann and Félix 2015a). As an issue of justice, we ought to keep in mind that the failure to adapt food production to climate change is most strongly paid by the poor, in many cases with

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hunger. Justice demands that the burdens of climate change be distributed fairly, and the current situation in which the poor—usually people with a far lower carbon footprint—end up paying the highest price in terms of well-being (or with their lives) is clearly ethically unacceptable (Loewe 2013). The vulnerability created by climate change adds one more argument in favor of redesigning food systems in view of increased resilience. As the region will have to undertake massive efforts to adapt food production to climate change, it is crucial that good relations be maintained to exchange knowledge, data, and innovation. Latin American countries will have to work on common agendas so that they exert pressure as a group to avoid absorbing the full cost of this agricultural transition and advocate for mitigation efforts. Besides the environmental risks factors the region faces, we can increasingly observe a risk factor stemming from another facet: the social sphere. Latin America is home to some of the largest cities in the Western Hemisphere, which makes the population particularly vulnerable to fluctuations in food supply and prices. Massive agglomerations such as Mexico City, Sao Paulo, Buenos Aires, and Rio de Janeiro, among many others in the region, bring major challenges for food security and sustainability. With their much greater purchasing power, these large urban centers absorb crucial resources needed for food production: water, land, labor, and food needed for land workers (Delgado Ramos 2013). Agricultural workers, especially those practicing ecological methods, also have an important role as natural resource stewards and providers of ecological services. Agricultural land hosts a number of species, captures carbon, and filtrates air. Moreover, rural inhabitants also act as stewards of environmental resources, hindering or slowing down unsustainable exploitation (Rozzi 2012). These ecological services are rarely remunerated, despite the fact that urban populations are dependent on them. It has become clear that the current urban-rural relationship is neither fair nor sustainable and that a new arrangement must be found. Logistical challenges favor solutions that foresee an increase in food production within cities in the form of farm towers, allotments, and roof farms (Rydin et al. 2012). If properly designed, such urban food production systems could capture carbon, make use of rainwater and some types of wastewater, recycle nutrients from food waste, and reduce food miles, making cities both more sustainable and more resilient. Stimulating urban food production also demands social innovations, and here ethics comes into play. For many urban dwellers, growing food is not a cost-effective way of using their labor and sometimes even resources. We require arguments based on ideas of justice to motivate people to undertake their own share of urban food production as a contribution towards reducing the environmental footprint of the food they consume (Di Paola 2014) and increase the resilience of food systems. As a first justice-based argument to become involved in urban agriculture we can list the importance of doing one’s share in increasing the resilience of urban food systems. The stability of political and economic institutions depends on the maintenance of a civil order. Food insecurity is a major destabilizing factor (Holt-Giménez et al. 2010). We thus also draw benefits from stable food supply systems even if we personally are not likely to suffer from food insecurity. In this sense, food security is a public good, and like most public goods its establishment requires our individual contribu-

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tions. Justice thus demands that we not free-ride but rather do our part to increase the system’s resilience. The second justice-based argument appeals to the idea of offsetting our environmental footprint. Urban agriculture is in this sense an attractive offsetting strategy as it is highly visible and thus may lead to multiple replications. Lastly, to make a system resilient we must learn from past mistakes as a society and identify weak points in the systems we rely upon. Here, knowledge sharing and acquisition become crucial (Tendall et al. 2015). This demands regional cooperation and building local research and development capacities. It requires willingness to cooperate, and for this it is fundamental that past injustices be acknowledged and that peoples work towards building new types of constructive relationships and exploring new opportunities for cooperation.

11.7 Conclusion: Horizontal Knowledge Transfers: A Dialogue Among Peoples Living in the Same Latitudes Countries in the Global South have a poor record of exchanging scientific ideas. In particular, there is very little scientific exchange between Africa and Latin America (Mazloumian et al. 2013). A scientific dialogue on social, ecological, and agricultural issues is strongly needed as the countries of the Global South are facing very similar challenges and opportunities. Climate change will have a far worse effect on food security in the countries within the tropics, creating a strong need to make tropical agriculture more resilient to climate change and extreme weather events (Altieri and Koohafkan 2008). Rapid urbanization is becoming a social and environmental challenge in most countries of the Global South (Rydin et al. 2012). These countries will have to learn how to tackle extreme inequalities and their negative effects on social justice and the environment. While the region faces a number of similar struggles, it also offers many new opportunities. The population is young and open to new ideas. Many nations have not previously had a substantial knowledge exchange, providing an ideal ground for developing new ideas in cognitively diverse relationships. Ecologically, the Global South offers enormous potential to explore permacultures since in large parts of the region the absence of harsh winters allows for the cultivation of many different crops throughout the year. The similarity of many of the challenges faced by the Global South allows countries in the region to pool intellectual and financial resources to develop common technological and social innovations (Camacho 2008). The different regions should not, however, depend on intermediaries for such exchanges. Their own necessities and enthusiasm should be sufficient to come up with common research and cooperation agendas. It is crucial that knowledge developed in these regions be used and expanded, which requires the establishment of alternative research networks better suited to incorporate traditional knowledge and provide solutions for the challenges of sustainable development and the optimal use

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of local resources (Olivé 2004; Gupta 2006; Kelbessa 2015). The success of these efforts will depend on how historic and present injustices are addressed, and on how confident the Global South becomes in re-establishing and recognizing these independent and parallel knowledge systems and cultures, without falling in the conceptual and methodological “traps” that failed to recognize the value of this diversity (Escobar 1998; Álvarez and Coolsaet 2018). Such a dialogue may allow us to truly incorporate the desire and need of living in harmony with the natural environment into developing agendas to achieve a so-called ecodevelopment that many communities and countries of the Global South strive for (Max-Neef 1992; Gudynas 2011; Leff 2013). Long-term sustainability demands a transformation of food systems to include the conservation and restoration of natural habitats as a central policy goal by encouraging production methods that seek a symbiotic relationship between nature and people, reduce dependency on externally produced inputs and exploitative social and environmental arrangements, are resilient to environmental changes and social pressures, and provide adequate food to both rural and urban populations. Acknowledgements This work is supported by a postdoctoral fellowship (FONDECYT/CONICYT No. 3170068). I am thankful to Georges Félix and Eduardo Rivera-López for helpful comments.

References Altieri, Miguel A. 2003. Dimensiones éticas de la crítica agroecológica a la biotecnología agrícola. Acta Bioethica 9 (1): 47–61. Altieri, Miguel A., and Parviz Koohafkan. 2008. Enduring Farms: Climate Change, Smallholders and Traditional Farming Communities. Penang: Third World Network. Altieri, Miguel A., and Victor Manuel Toledo. 2011. The Agroecological Revolution in Latin America: Rescuing Nature, Ensuring Food Sovereignty and Empowering Peasants. Journal of Peasant Studies 38 (3): 587–612. Altieri, Miguel A., Clara I. Nicholls, Alejandro Henao, and Marcos A. Lana. 2015. Agroecology and the Design of Climate Change-Resilient Farming Systems. Agronomy for Sustainable Development 1–22. Altieri, Miguel A., and Clara I. Nicholls. 2017. Agroecology: A Brief Account of Its Origins and Currents of Thought in Latin America. Agroecology and Sustainable Food Systems 41 (3–4): 231–237. Álvarez, Lina, and Brendan Coolsaet. 2018. Decolonizing Environmental Justice Studies: A Latin American Perspective. Capitalism Nature Socialism. https://doi.org/10.1080/10455752.2018. 1558272. Arancibia, Florencia. 2013. Challenging the Bioeconomy: The Dynamics of Collective Action in Argentina. Technology in Society 35 (2): 79–92. Baquedano Jer, Sandra, and Sara Larraín. 2015. The Seeds of Liberation in Latin America. In Seed Sovereignty, Food Security, ed. Vandana Shiva, 333–344. New Delhi: Women Unlimited. Barkin, David, and Blanca Lemus. 2016. Local Solutions for Environmental Justice. In Environmental Governance in Latin America, 257–286. London: Palgrave Macmillan.

11 A Latin American Perspective to Agricultural Ethics

215

Bott, Sarah, Alessandra Guedes, Mary M. Goodwin, and Jennifer Adams Mendoza. 2012. Violence Against Women in Latin America and the Caribbean: A Comparative Analysis of PopulationBased Data from 12 Countries. Washington, DC: Pan American Health Organization. Camacho, Luis. 2008. Agriculture Intensification from the Perspective of Development Ethics. In The Ethics of Intensification, ed. Paul B. Thompson, 97–110. Dordrecht: Springer. Carro-Ripalda, Susana, Marta Astier, and Patricia Artía. 2015. An Analysis of the GM Crop Debate in Mexico. In Governing Agricultural Sustainability: Global Lessons from GM Crops, ed. Phil Macnaghten and Susana Carro-Ripalda, 33–73. Oxon: Routlegde. De Schutter, Olivier. 2011. The Right to an Adequate Diet: The Agriculture-Food-Health Nexus, Report Presented at the 19th Session of the United Nations Human Rights Council (A/HRC/19/59). Geneva: United Nations. Di Castro, Elisabetta. 2010. Desigualdad, exclusión y justicia global. Isegoría (43): 459–478. Di Paola, Marcello. 2014. Climate Change: Who Does What, Why, and How. In Canned Heat: Ethics and Politics of Global Climate Change, ed. Marcello Di Paola and Gianfranco Pellegrino, 144–159. New Delhi: Routledge. Dieterlen, Paulette. 2003. La pobreza: un estudio filosófico. México, DF: Fondo de Cultura Económica. Echeverri, Gómez, Luis Fernando, Leonardo Ríos Osorio, and María Luisa Eschenhagen Durán. 2017. Propuesta de unos principios generales para la ciencia de la agroecología: una reflexión. Revista Lasallista de Investigación 14 (2): 212–219. Escalona-Aguilar, Miguel Ángel, María Teresa Leal-Ascencio, María del Rosario Pineda-López, Edgar Eduardo Ruíz-Cervantes, and Lázaro Rafael Sánchez-Velásquez. 2015. El papel de la universidad pública en la soberanía alimentaria. Revista mexicana de investigación educativa 20 (67): 1215–1231. Escobar, Arturo. 1998. Whose Knowledge, Whose Nature? Biodiversity, Conservation, and the Political Ecology of Social Movements. Journal of Political Ecology 5 (1): 53–82. FAO. 2018. Food and Nutrition Security in Latin America and the Caribbean. FAO, accessed January 4, 2018. http://www.fao.org/americas/perspectivas/seguridad-alimentaria/en/. Félix, Georges F., and Eric Holt-Giménez. 2017. Hurricane María: An Agroecological Turning Point for Puerto Rico? Food First Backgrounder 23 (4). García-Deister, Vivette, and Carlos López-Beltrán. 2015. País de gordos/país de muertos: Obesity, Death and Nation in Biomedical and Forensic Genetics in Mexico. Social Studies of Science 45 (6): 797–815. Giraldo, Omar Felipe. 2018. Ecología política de la agricultura. Agroecología y posdesarrollo. San Cristobal de las Casas: El Colegio de la Frontera Sur. Gudynas, Eduardo. 2011. Buen Vivir: Today’s Tomorrow. Development 54 (4): 441–447. Gupta, Anil K. 2006. From Sink to Source: The Honey Bee Network Documents Indigenous Knowledge and Innovations in India. Innovations (summer): 49–66. Holt-Giménez, Eric. 2002. Measuring Farmers’ Agroecological Resistance After Hurricane Mitch in Nicaragua: A Case Study in Participatory, Sustainable Land Management Impact Monitoring. Agriculture, Ecosystems & Environment 93 (1–3): 87–105. Holt-Giménez, Eric, Raj Patel, and Annie Shattuck. 2010. Rebeliones alimentarias: crisis y hambre de justicia. Barcelona: El Viejo Topo. Jahan, Selim. 2016. Human Development Report 2016: Human Development for Everyone. New York: United Nations Development Programme. Kelbessa, Workineh. 2015. African Environmental Ethics, Indigenous Knowledge, and Environmental Challenges. Environmental Ethics 37 (4): 387–410. Kloppenburg, Jack. 2005. First the Seed: The Political Economy of Plant Biotechnology, 2nd ed. Madison: University of Wisconsin Press. Kolers, Avery. 2016. Resilience as a Political Ideal. Ethics, Policy & Environment 19 (1): 91–107. Korthals, Michiel. 2004. Before Dinner: Philosophy and Ethics of Food. Dordrecht: Springer. Lara Cortés, Claudio. 2001. Moral de mercado versus seguridad alimentaria: una aproximación desde la ética del bien común. Acta Bioethica 7 (2): 233–248.

216

C. Timmermann

Leff, Enrique. 2013. La geopolítica de la biodiversidad y el desarrollo sustentable: Economización del mundo, racionalidad ambiental y reapropiación social de la naturaleza. Cuaderno Interdisciplinar de Desarrollo Sostenible 10: 185–209. Leguizamón, Amalia. 2016. Disappearing Nature? Agribusiness, Biotechnology and Distance in Argentine Soybean Production. The Journal of Peasant Studies 43 (2): 313–330. Loewe, Daniel. 2013. El calentamiento global y la asignación de los costes de las políticas medioambientales. Dilemata 13: 69–92. Lolas, Fernando. 2014a. Ética y conducta alimentaria: la obesidad y sus desafíos. O Mundo da Saúde 38 (3): 349–354. Lolas, Fernando. 2014b. Latin American Perspectives. In Handbook of Global Bioethics, ed. Henk ten Have and Bert Gordijn, 311–325. Dordrecht: Springer. Loría, Eduardo, and Emmanuel Salas. 2014. Sobrepeso e integración económica en México. Economía Informa 389: 3–18. Madrazo Lajous, Alejandro. 2011. Biocolonialismo. In Propiedad intelectual. Fundamento y crítica, ed. Martín Hevía and Facundo M. Rojo, 199–260. Bogotá: Universidad del Externado. Max-Neef, Manfred. 1992. Development and Human Needs. In Real-Life Economics: Understanding Wealth Creation, ed. Paul Ekins and Manfred Max-Neef, 197–214. London: Routledge. Mazloumian, Amin, Dirk Helbing, Sergi Lozano, Robert P. Light, and Katy Börner. 2013. Global Multi-Level Analysis of the ‘Scientific Food Web’. Science Reports 3 (1167). https://doi.org/10. 1038/srep01167. McIntyre, Beverly D., Hans R. Herren, Judi Wakhungu, and Robert T. Watson. 2009. International Assessment of Agricultural Knowledge, Science and Technology for Development (IAASTD): Synthesis Report with Executive Summary: A Synthesis of the Global and Sub-Global IAASTD Reports. Washington, DC: Island Press. McMichael, Anthony. 2017. Climate Change and the Health of Nations: Famines, Fevers, and the Fate of Populations. Oxford: Oxford University Press. Nyéléni Forum for Food Sovereignty. 2007. Declaration of Nyéléni. Sélingue: Nyéléni Forum for Food Sovereignty. ODEPA. 2018. Vinos. Accessed April 9, 2018. http://www.odepa.gob.cl/rubros/vinos-y-alcoholes. Olivé, León. 2004. La exclusión del conocimiento como violencia intercultural. Polylog. Foro para la filosofía intercultural 5. Patel, Raj, and Jason W. Moore. 2017. A History of the World in Seven Cheap Things: A Guide to Capitalism, Nature, and the Future of the Planet. Oakland: University of California Press. Pollan, Michael. 2008. In Defense of Food: An Eater’s Manifesto. New York: Penguin. Ramos, Delgado, and Gian Carlo. 2013. Cambio climático y la alimentación de las ciudades. Investigación Ambiental Ciencia Y Política Pública 5 (1): 76–93. Ramos-Elorduy, Julieta. 2009. Anthropo-Entomophagy: Cultures, Evolution and Sustainability. Entomological Research 39 (5): 271–288. Raynolds, Laura T. 2014. Fairtrade, Certification, and Labor: Global and Local Tensions in Improving Conditions for Agricultural Workers. Agriculture and Human Values 31 (3): 499–511. https:// doi.org/10.1007/s10460-014-9506-6. Rein Venegas, Tatiana. 2013. Participación política de las mujeres: Aspectos de confluencia entre la ética y los derechos humanos. Acta Bioethica 19 (2): 219–228. Robaey, Zoë. 2016. Gone with the Wind: Conceiving of Moral Responsibility in the Case of GMO Contamination. Science and Engineering Ethics 22 (3): 889–906. Rosset, Peter Michael, Braulio Machin Sosa, Adilén María Roque Jaime, and Dana Rocío Ávila Lozano. 2011. The Campesino-to-Campesino Agroecology Movement of ANAP in Cuba: Social Process Methodology in the Construction of Sustainable Peasant Agriculture and Food Sovereignty. The Journal of Peasant Studies 38 (1): 161–191. Rozzi, Ricardo. 2012. Biocultural Ethics: Recovering the Vital Links Between the Inhabitants, Their Habits, and Habitats. Environmental Ethics 34 (1): 27–50. Rydin, Yvonne, Ana Bleahu, Michael Davies, Julio D. Dávila, Sharon Friel, Giovanni De Grandis, Nora Groce, Pedro C. Hallal, Ian Hamilton, and Philippa Howden-Chapman. 2012. Shaping

11 A Latin American Perspective to Agricultural Ethics

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Cities for Health: Complexity and the Planning of Urban Environments in the 21st Century. The Lancet 379 (9831): 2079–2108. Tendall, D.M., Jonas Joerin, P. Birgit Kopainsky, Aimee Shreck Edwards, Q.B. Le, Pius Kruetli, Michelle Grant, and Johan Six. 2015. Food System Resilience: Defining the Concept. Global Food Security 6: 17–23. Thompson, Paul B. 2010. Food Aid and the Famine Relief Argument (Brief Return). Journal of Agricultural and Environmental Ethics 23 (3): 209–227. Thompson, Paul B. 2015. From Field to Fork: Food Ethics for Everyone. New York: Oxford University Press. Timmermann, Cristian, and Georges F. Félix. 2015a. Adapting Food Production to Climate Change: An Inclusive Approach. In Climate Change and Human Rights: The 2015 Paris Conference and the Task of Protecting People on a Warming Planet, ed. Marcello Di Paola and Daanika Kamal. Durham: Global Policy. Timmermann, Cristian, and Georges F. Félix. 2015b. Agroecology as a Vehicle for Contributive Justice. Agriculture and Human Values 32 (3): 523–538. Timmermann, Cristian, and Zoë Robaey. 2016. Agrobiodiversity Under Different Property Regimes. Journal of Agricultural and Environmental Ethics 29 (2): 285–303. https://doi.org/10.1007/ s10806-016-9602-2. Timmermann, Cristian, Georges F. Félix, and Pablo Tittonell. 2018. Food Sovereignty and Consumer Sovereignty: Two Antagonistic Goals? Agroecology and Sustainable Food Systems 42 (3): 274–298. https://doi.org/10.1080/21683565.2017.1359807. Tittonell, Pablo. 2014. Ecological Intensification of Agriculture—Sustainable by Nature. Current Opinion in Environmental Sustainability 8: 53–61. Tittonell, Pablo, Laurens Klerkx, Frederic Baudron, Georges F. Félix, Andrea Ruggia, Dirk van Apeldoorn, Santiago Dogliotti, Paul Mapfumo, and Walter A.H. Rossing. 2016. Ecological Intensification: Local Innovation to Address Global Challenges. Sustainable Agriculture Reviews 19: 1–34. United Nations Office on Drugs and Crime. 2016. World Drug Report 2016. New York: United Nations. Urzúa Lecaros, and Juan Alberto. 2013. La ética medio ambiental: Principios y valores para una ciudadanía responsable en la sociedad global. Acta Bioethica 19 (2): 177–188. Vargas-Domínguez, Joel. 2018. De la Historia de los Alimentos a la Historia de la Nutrición: Reflexiones sobre América Latina en la Primera Mitad del Siglo XX. Revista Perfiles Económicos 6: 137–171. Via Campesina. 1996. The Right to Produce and Access Land. Rome: Via Campesina. Villarroel, Raúl. 2013. Ética del desarrollo, democracia deliberativa y ciudadanía ambiental: El desafío global de la sustentabilidad. Acta Bioethica 19 (2): 189–198. Vivero-Pol, José Luis, and Pablo Ramírez. 2009. Hambre, derechos humanos y la consolidación del Estado en América Latina. In Derecho a la Alimentación, Políticas Públicas e Instituciones contra el Hambre, ed. José Luis Vivero-Pol and Ximena Erazo, 41–75. Santiago: Ediciones LOM. Waldmueller, Johannes M. 2015. Agriculture, Knowledge and the ‘Colonial Matrix of Power’: Approaching Sustainabilities from the Global South. Journal of Global Ethics 11 (3): 294–302.

Chapter 12

A Territorial Mediation in a Triangular Affair Towards an Ecological Territorial Sovereignty Alfonso Donoso

Abstract I revisit the divide between environmental and animal ethics and explore the role that territory—a recently theorized subject in political theory—could play in this dispute. Specifically, I contend that a concept of state territory and territorial rights informed by values shared by environmental and animal ethics would greatly strengthen the case of non-anthropocentric ethics against the pervasive form of anthropocentrism that shapes current state policies and institutions. I propose what I dub an ecological account of territorial sovereignty and contend that a state’s territorial rights are, significantly, a function of its commitment to respecting the value of non-human organisms inhabiting the geographical area over which it claims these rights. I argue that respecting the natural world entails a commitment to the development of state policies and practices that are in line with some central tenets of animal ethics and, at the same time, requires embracing a kind of holistic moral standpoint that conforms to a plausible version of environmental ethics. If successful, my proposal will show how the dispute between animal and environmental ethics could be softened if viewed through the lens of territorial rights, and contribute to an articulation of territorial rights and sovereignty that is sensitive to the environmental challenges we face today. Keywords Animal rights · Environmental ethics · Territorial rights

12.1 Introduction It is spring, but in Ushuaia it is snowing. Supposedly, here, in Tierra del Fuego National Park, there should be a forest dense with more than a hundred-year-old lenga trees. But in this place, it looks like a bomb exploded. Some of the trees died standing, others are nothing but a mutilated trunk only inches high, while the rest seems to have drowned in the stagnant 1 water. (Sousa 2016) 1 My

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A. Donoso (B) Instituto de Ciencia Política, Pontificia Universidad Católica de Chile, Santiago, Chile e-mail: [email protected] © Springer Nature Switzerland AG 2019 E. Rivera-López and M. Hevia (eds.), Controversies in Latin American Bioethics, International Library of Ethics, Law, and the New Medicine 79, https://doi.org/10.1007/978-3-030-17963-2_12

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This apocalyptic image is a description of the consequences of the voracious behavior of the beaver in Argentinean and Chilean Patagonia. Since their arrival in the region, beavers have quickly multiplied from only 50 individuals in 1946 to a current estimated population of over 100,000. Imported from Canada to Argentina with the idea to developing a fur industry, this rodent endemic to North America has transformed the southern territory of both Chile and Argentina. Beavers have changed the direction of rivers, swamped immense patches of native forest, and radically disturbed the habitat of the flora and fauna of this region of the American continent. Voices like the one that opens this article have multiplied, and state and international institutions have joined the environmentalist community to respond to the consequences of the beavers’ behavior. The state response has been the standard one: extermination. Chile and Argentina have promoted intensive hunting of the animal, implemented the practice of paying for each beaver’s tail presented to the authorities, and trained people to become expert exterminators of beavers through the use of traps that smash their heads. The case of the beavers in Patagonia provides a good illustration of a now longstanding controversy between two kinds of non-anthropocentric ethics, namely environmental and animal ethics. Almost 40 years ago, in “Animal Liberation: A Triangular Affair”, J. Baird Callicot (Callicot 1980) pointed to a radical split between those who argue for the liberation and/or rights of animals, on the one hand, and those who are concerned with the environment and its value, on the other. This view rapidly became influential, and soon after the publication of Callicot’s paper, Mark Sagoff noted that “The policies environmentalists recommend are informed by the concepts of population biology, not the concepts of animal equality”, as is the case with animal ethics (Sagoff 1984: 301). Due to this deep strife between animal and environmental ethics, Sagoff ended up denying that “the sermons [of animal ethics against cruelty to animals] have anything to do with environmentalism or provide a basis for an environmental ethic” (Sagoff 1984). A motivation for this article is the conviction that this deep divide between environmental ethics (EE) and animal ethics (AE) is a regrettable state of affairs. It portrays our concern for nature as a terrain of internal dispute that distracts us from the real job of opposing the strongly anthropocentric view that guides environmental policies almost everywhere.2 Keeping this in mind, a premise in my argument is that to effectively confront strong anthropocentrism—a view that denies non-instrumental value to the natural world—we need to be pragmatic and give serious attention to the question of the limits that the state and its policies should have with respect to nature. It is in this sphere of exercise of political power that we can find more effective ways to transform how we relate to the natural world. Fortunately, despite appearances, joining forces to oppose strong anthropocentrism should not be an impossible task for either EE or AE. Although they differ in important respects (for example, the former is holistic and the latter is individualistic) 2 As Callicot himself later recognized, “From a practical point of view, it would be far wiser to make

common cause against a common enemy – the destructive forces at work ravaging the nonhuman world – than to continue squabbling among ourselves” (Callicot 1992: 249).

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both views are non-anthropocentric ethics to the extent that they expand the world of the intrinsically valuable beyond the human species to then deny the strongly anthropocentric thesis “that the differences between species provides grounds for thinking that humans are superior to the members of other species” (Sterba 1994: 230).3 In this sense, EE and AE share a common place in the spectrum of moral theory. Also, both understand that the moral status of (at least parts of) the natural world is at odds with various features of strong anthropocentrism, including the view that nature has merely the value of a resource to be used and exploited for the satisfaction of humans’ desires and needs.4 Furthermore, these two non-anthropocentric ethics share similar convictions about the moral problems that current state practices—or practices allowed by state legislation—entail with regard to animal suffering and the destruction and spoiling of the environment: EE does not deny the moral importance of animals’ welfare while AE, insofar as it is required for animals’ wellbeing, deeply cares about the environment and its ecosystems. In light of current worldwide and pressing environmental challenges, it is urgent that we highlight these commonalities to find strategies that, rather than separating our various understandings of the natural world, bring them together to act more effectively against strong anthropocentrism and its consequences.5 In what follows, I adopt this pragmatic approach and consider a different and under-explored perspective of analysis of the state’s relationship with the natural world. By putting pressure on the conventional conception of state territorial sovereignty, I confront strong anthropocentrism and propose a more adequate relationship between the state and non-human nature.6 As I will argue, the implications that this proposal would have for environmental state policies should be welcomed by both EE and AE. 3 The

key point in Sterba’s account is that “we have no nonquestion-begging grounds for regarding the members of any living species as superior to the members of any other” (Sterba 1994: 229). 4 I borrow the concept of a strongly anthropocentric ethics from Brian Norton, who says that a “value theory is strongly anthropocentric if all value countenanced by it is explained by reference to satisfaction of felt preferences of human individuals” and defines a felt preference as “any desire or need of a human individual that can at least temporarily be sated by some specifiable experience of that individual” (Norton 1984). 5 For methodological reasons, throughout this paper I use AE and EE as a roughly unified set of nonanthropocentric ethics. The truth is that under AE and EE fall a large number of theories with different emphases and features. Some of them are less individualistic, others weakly anthropocentric, some are consequentialist, others deontologist, and so on. Be this as it may, in general terms the divide between environmental holistic and animal individualistic ethics holds and well represents two horns of the triangular affair that Callicot considered in his seminal paper. 6 This conciliatory motivation is nothing new and has been shared by others in the past. After the publication of Callicot’s and Sagoff’s influential papers, there have been various attempts, including one by Callicot himself, to bring together EE and AE (see Callicot 1992). To illustrate, Dale Jamieson has adopted a common-ground-strategy and contended that “however one traces the history of the environmental movement, it is clear that it comes out of a tradition that expresses strong concern for animal suffering and autonomy”, while also noting that that is no coincidence that “Peter Singer’s first article on animal liberation appeared less than three years after the first Earth Day” (Jamieson 1998).

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The article is organized as follows. In the next section, I introduce and criticize the conventional concept of territorial rights to then, in Sect. 12.3, defend what I call an ecological version of territorial sovereignty. I argue that in light of the pressing environmental problems we currently face, this proposal not only represents a more adequate conception of territorial sovereignty but also aligns the common moral motivations of environmental and animal ethics towards a more effective pursuit of their shared moral goals. Section 12.4 provides conclusions. My proposal will show how the dispute between animal and environmental ethics could be softened if viewed through the lens of territorial rights and contribute to an articulation of territorial rights and sovereignty that is sensitive to our urgent environmental challenges.

12.2 Natural Resources, Property, and Territorial Rights A fairly recent development in political theory, the literature on territorial rights has already provided a substantive amount of theories, concepts, and analysis. In this section, I do not want to offer yet another theory of territorial rights but rather to point to a problematic element of such theories. To begin with some clarifications about the meaning of territory and territorial rights, let us consider David Miller’s helpful characterization of a territory as a geographical space defined by a certain kind of relationship between that space, the people who inhabit it, and the political structures that govern these people in that geographical space (Miller 2012). This relationship is normed by territorial rights, which are a category of rights claimed by the relevant agent, which, for present purposes, I simply assume to be the state.7 These are rights that define a state territorial sovereignty (see Simmons 2001: 302), so that the state is sovereign if it possesses reasonably extensive and exclusive (but not necessarily absolute) rights over a citizenry and territory. Importantly, these rights entitle the state to both internal control and external independence. In this article, I am interested in a specific subset of these rights over the territory, namely over natural resources. Miller defines the right over natural resources as “the right to control and use the resources that are available in the territory. If the territory contains extractable mineral resources, for example, those resources are at the state’s disposal to make use of as it sees fit” (Miller 2012: 253). Furthermore, in a recent important contribution to this matter, Chris Armstrong has offered an extensive and detailed account of the object of the right over natural resources. Reflecting on the German word Rohstoff, he defines natural resources as 7 Two

things need to be clarified regarding this assumption. First, it should not be assumed that my position is a version of territorial rights statism since I accept that not only states can have territorial rights, even though this is not evident in the current analysis. Second, a justification for this assumption is that I am trying to address the tension between EE and AE in particular and the natural world in general within existing constraints, especially those determined by the way in which the international community is organized. In this sense, the conclusions reached in this article are valid for a world organized like ours.

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raw materials we are confronted with in coming into existence in the world, with which we can potentially support our various (and competing) human projects. The trees of the forest, the water of the rivers and oceans, and the mineral and petrochemical wealth lying under the soil and the seas are familiar enough examples. But we can also include the air we breathe, wild (uncultivated) plants and animals and the energy contained in wind, waves, sunlight. So too can we include the land itself. (Armstrong 2017: 11)

Thus, according to this conventional view on natural resources, the key unifying factors of these various “raw materials” is that we can use them and control them to advance our human projects and that none of us is responsible for creating them. A right over natural resources is then the right of the state to use and control any of these materials and organisms for the advancement of the projects of the members of its political community. The importance of these ‘raw materials’ for the argument I am developing here is that, with different emphases, they are the focus of EE’s and AE’s value-claims and, therefore, they fall directly under their normative scrutiny. What I shall argue is that the normative framework of EE and AE puts pressure on how territorial right theory conceives of this aspect of territorial sovereignty and, in so doing, these ethical standpoints demand a re-elaboration of the way in which we should understand natural resources and, consequently, state territorial sovereignty. This move helps us articulate an environmental approach that is sensitive to the diverse axiological standpoints of both EE and AE, thereby allowing us to present a more unified normative position regarding the non-human natural world. Though the topic is generally left unconsidered, some theorists have recently touched on the challenges that non-anthropocentric ethics represent for theories of territorial rights (Mancilla 2014; Kolers 2018; Armstrong 2017). Chris Armstrong offers a particularly acute articulation of this issue: “a large moral question looms in the background, which is the question of the constraints humans ought to place on their use of natural resources not in light of each other’s claims, but in light of the claims of other species or of ‘nature’ in general” (Armstrong 2017). This question points to the core of a large number of environmentally conscious ethical theories according to which what we ought to do is not always or necessarily derived from what advances human interests or from the claims that humans may legitimately make. Armstrong is thus accepting as a possibility what EE and AE take to be a fact, namely “that morality requires constraints on our use of resources above and beyond the demands imposed by a theory of distributive justice” (Armstrong 2017: 20). In the end, he asserts, “We might then envisage a division of labour whereby a moral theory determined which benefits people might permissibly derive from animals, say (and we could imagine a range of answers to that question), and a theory of distributive justice determined how those permissible benefits should be allocated between people now or in the future” (Armstrong 2017: 20).8 I believe Armstrong’s reflection is on the right track, and the analysis that follows is concerned with the 8 An

alternative that Armstrong does not mention is the inclusion of non-humans as subjects in our theories of distributive justice. Like most justice theorists, he simply assumes that non-humans cannot be recipients of duties of justice.

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first and most fundamental horn of the full account of territorial rights justice that Armstrong envisages. To begin, note that among the organisms covered by the conventional right over natural resources—i.e., those raw materials that we can use and control to advance our human projects, and that have not been created by us—are basically all and each of the beings that AE values non-instrumentally, plausibly including terrestrial animals, fish, birds, amphibians, and insects. Furthermore, this conventional right also includes the constituent elements of the biotic community and ecosystems that EE envisions as a fundamental source of value, including forests, rivers, oceans, the land and its minerals, the atmosphere, and so on. The difficulty with this conventional view is that in the end it leaves unconstrained the activity of the state over the natural world. The concept of ‘natural resources’ expresses a lack of environmental consciousness in conventional territorial rights theory that uncritically adopts the language of international law and economics and uses it for its own purposes.9 The outcome is symptomatic of a conventional modern view of the natural world, according to which, in the words of Immanuel Kant, animals, not to mention other non-sentient organisms, are not to be regarded “as fellow creatures, but as means and instruments to be used at will for the attainment of whatever ends [humans] pleased” (Kant 1991: 225). The concept of natural resources shows that the non-human natural world is conceived of simply as something given, separate from humanity, and ready to be used and instrumentalized at the sole disposal of the state for the benefit of the members of its political community. Connected to this understanding of the natural world is the usual link between natural resources and property rights over these resources, an influential line of thought since the work of early modern philosophers, such as Grotius, Hobbes, Locke, and Pufendorf. This view has also been encouraged by modern international law, which permits the appropriation or ownership of the natural world and recognizes a state’s jurisdictional right to determine whether, how, and by whom these raw materials are held as property within the territory. In light of this common view of natural resources, a brief consideration of the concept of property is then a helpful way to further enlighten the tension between AE’s and EE’s values and the conventional understanding of the right over natural resources. It is usually maintained that to hold something as property is to have a particular standing vis-à-vis the standing of other agents regarding the object of property. Thus, my right to property over X generally entails your duty not to use X without permission, as well as my liberty to use X as I wish insofar as this does not infringe on my duties towards you and others (see, for example, Honoré 1961 and Waldron 1988, Chap. 2). This understanding, however, must be complemented by the fact that property entails a particular standing not only in relation to other persons, but also in relation to what is held as property. This relationship is what I call a property relationship. 9 International Law uses as a standard the language of natural resources, by which it means something

to be used for the benefit of the nations and its people. See the General Assembly resolution 1803 (XVII) of 14 December 1962, “Permanent sovereignty over natural resources.”

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A property relationship involves, as a matter of necessity, strong discretionary powers on part of the property holder as to how to deal with what is under her property. If you hold X as your property, then X is in a significant sense at your disposal. This understanding of property does not deny that property relationships may adopt different forms depending on the peculiarities of the property scheme under which they take place. Such variability of conceptions between different property schemes—the precise incidents of a specific scheme of property rights—is not my concern. Instead, it is an aspect of the concept of property that is of interest here, namely the discretionary powers that the property holder has over what she holds as property.10 If through its jurisdictional right the state defines the relationship between right-holders within its territory and the natural world as a property relationship—something that international law maintains through the principle of permanent sovereignty over natural resources—then such a relationship must exhibit, or more strongly, it must be defined by, this form of discretionary power over what is held as property. As I now proceed to explain, from the point of view of EE and AE, this makes the concept of property rights over natural resources seriously problematic. From the perspective of an enquiry into the concept of property, it is not an adequate defense of a property relationship between A and B to state that although A holds B as property, A does not have absolute discretion over B, such that B cannot be rightfully destroyed or harmed by A. Instead, what we look for is a justificatory ground for the discretion entailed in the property relationship between A and B. In this respect, let me state, non-controversially, that in some forms of relationships between A and B (among which I shall include our relationship with at least some parts of the natural world) such grounds are unavailable. The most obvious illustration occurs in the property relationship between a master and her slave. Such a relationship cannot be justified even if it is clearly determined that the former is not entitled to kill or maim the latter and even if the master only pursues the slave’s interests. What this shows is that the concept of property entails a kind of relationship that is not adequate or legitimate in all circumstances (for example, in a relationship between moral agents). This is the case because there are entities whose value cannot be rightly represented when submitted to the form of power entailed in property relationships. Thus, my claim is that when the property relationship of A over B is unable to express the value of B, we should then maintain that a property relationship between A and B is illegitimate and should not be accepted. Let us now come back to our main matter of concern: does a property relationship—entailed by the conventional understanding of the rights over natural resources—express value-claims to which EE and AE are committed? To answer this question, it may be useful to consider the response provided by a theory of justice specifically concerned with the question of property and natural resources. Inspired by the work of Hugo Grotius, Mathias Risse has argued that the earth and 10 This

borrows and adapts what Waldron says about private property. Thus, I understand that property “is a concept of which many different conceptions are possible, and that in each society the detailed incidents of ownership amount to a particular concrete conception of this abstract concept” (Waldron 1988, p. 31).

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its resources are possessed in common by all humans and has maintained that even though the satisfaction of human needs matters, and matters more than any environmental concern (see Risse 2012, p. 114), the value of nature (the earth and its natural resources) can perfectly be integrated in his account of global justice in a legislative stage. Thus, Risse gives an answer in the affirmative to the question of whether property relationships can express the value of nature. From the point of view of the values EE and AE give to the natural world, this conclusion is problematic for at least two reasons. First, it leaves the determination of this value to the contingencies and flows of processes of actual legislative deliberation. It is up to the will of those in power (or of those loud enough to make their voices heard) to determine the value of the earth and its resources and, ultimately, to determine the incidents of the property right held by humans over the earth. In the end, this political contingency in the definition of the value of nature is the result of an incomplete understanding of what a property relationship entails or, worse, the outcome of a simply speciesist or chauvinist understanding of the natural world.11 If a fundamental motivation in a theory of rights over natural resources is to establish just terms between persons, appealing to property relationships may appear to be the right strategy. Unfortunately, this can only be done at quite a high cost for our understanding of nature and its value.12 Linked to this concern is a second one. Once the state permits property relationships between humankind and the earth, we are left with a very limited normative space to incorporate environmental values. This incapacity, again, is due to the very nature of the concept of property that is unable to capture and respect the rightful value of the natural world. By allowing the proprietor discretionary powers over nature, the concept of property simply denies the possibility that the natural world may be valued for its own sake. This valuation is precisely what is at the core of any form of non-anthropocentric ethics, including EE and AE.13 In a nutshell, property relationships cannot coherently extend to cover intrinsically valuable subjects, which is why human beings cannot be held as property without, at the same time, being disrespected. When a property relationship extends in such a manner—which in the case of EE and AE entails extending property relationships to the natural world—the outcome is illegitimate and unjust.

11 As it is well known, the term speciesism came into common use in animal ethics thanks to Peter Singer’s Animal Liberation. It can aptly be defined as “a failure, in attitude or practice, to accord any nonhuman being equal consideration and respect” (Dunayer 2004: 5). 12 It may be argued that accounts that defend the intrinsic value of nature are precisely the type of ethical systems that theorists like Risse leave aside because they are too extreme (the worry being that the value of the earth and its resources might outweigh the value of humankind) and, therefore, my objection fails. I think my critic’s retort can be dispatched. To argue that X has intrinsic value is not to argue that X has a greater value vis-à-vis the value of Y. To claim otherwise is to confuse the intrinsic value of something with its degree of value. The relative value of X with respect to Y is a question different from the intrinsic value of X or Y. 13 See, for example, Agar (2001), Baxter (1996), Regan (1985).

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12.3 Towards Ecological Territorial Sovereignty As an alternative to the reductive and instrumental view of the natural world of the conventional view of territorial rights, I suggest an ecological form of territorial sovereignty that coheres with EE’s and AE’s views of (at least parts of) nature as being intrinsically valuable.14 In an ecological account of territorial rights, the state has a right to administer in trust the natural world existing in the territory, as opposed to having full jurisdiction or having property rights over it. This means that the state does not have exclusive and discretionary entitlements over parts of nature, as it is the case in property relationships over the same bits of the world. If the territory contains, for example, forests, non-human animals, and fresh water, these elements of the natural world are under the state’s authority, but conditionally. This conception of territorial rights recognizes the sovereignty right of the state over a politically defined geographic space but does not reduce the object of this right, as is the case in a strongly anthropocentric view, to mere resources for exploitation or for the satisfaction of humans’ preferences. Instead, it explicitly recognizes limits on the entitlements of the state over the natural world and, thereby, imposes obligations on the state and the ways it relates to the natural world within its territory. The idea is that the territorial sovereignty of the state partly but substantively depends on the fulfillment of, or less demandingly, the genuine attempt to satisfy, certain ongoing obligations related to the good of the non-human natural world. Although not focused on the same kind of questions, Lea Ypi’s recent theory of territorial rights advances a conditional view of rights over territory with a normative structure of the sort I am suggesting here. She says that “states are only permitted to exercise territorial rights. Their citizens’ acquisition and exclusive control of such territories is provisional and conditional upon their contribution to the full realization of the principle of right” (Ypi 2012: 4). Putting aside the most technical aspects of her Kantian account, what matters for ecological territorial sovereignty is that in addition to other obligations it may have to satisfy in order to uphold its full sovereign status, the state must respect the natural world that exists in its territory. According to my view, a state’s claims to the natural parts existing in a certain territory are justified and legitimized only to the extent that the state is committed to respecting their moral standing. To see more fully the implications of this perspective, and to see the progress it can make in reducing the tension between EE and AE, we should consider the nature of the constraints that ecological territorial sovereignty imposes upon state’s policies and practices. Upon a first appraisal, it may be thought that the precise details of these restrictions will depend on the specific ethical theory one may adopt regarding the non-human natural world. For example, an animal welfarist would probably fix the 14 I must clarify that my use of the word ‘ecological’ in the term ‘ecological territorial sovereignty’ should not be understood as if I was necessarily and primarily adhering to ecocentrist or holist environmental ethics. In effect, I am not. As will become clearer later in the text, without denying that collectives can have value, my position sits better with axiological individualism than with any form of holism.

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limits of state action in the sentience and wellbeing of animals, while an animal rights theorist would establish those limits in the area of protection defined by the rights of animals. In turn, environmental ethicists may conclude that the sustainability of ecosystems is the mark of the legitimate exercise of the state’s territorial rights, thus imposing restrictions on a state’s policies and practices that interfere with that good. If this is the case, is ecological territorial sovereignty really avoiding the split between environmental and animal ethics? If the limits that ecological territorial rights impose on the state depend on the kind of ethical theory we adopt, how could this possibly help us to eliminate or at least soften the controversy between environmental and animal ethics? These questions seem to suggest that we have not really ameliorated the controversy between EE and AE but simply translated their dispute to a different place. Consider again the case of the beavers in Patagonia: the restrictions ecological justice would impose upon the state policies may be different, if not contrary to one another, depending on whether I endorse EE or AE. If my considered belief is that the good of the lenga forests in the south of Chile and the entire ecosystem they contain are the primary source of the restrictions imposed upon the state, it may then be permitted for the state to cull beavers through the means it may have available. On the other hand, if my convictions lean towards the wellbeing of sentient animals, then it seems that the state should forbid interventions in Patagonia that may likely harm the beavers, like those implemented by Chilean and Argentinean authorities. To respond to this crucial challenge, we must recall that the proposed amendment of the right of the state over the natural world within its territory is ultimately an intervention on the extension of the sovereignty of the state.15 By re-defining the object over which the state can exercise its territorial rights, ecological territorial sovereignty also redefines the extension of state sovereignty. As I shall now explain, this is key to understanding the way in which an ecological account of territorial rights can fulfill the task regarding EE and AE. Territorial sovereignty has both a domestic and an international face, which are deeply connected to each other. In Hohfeldian terms, territorial rights give the state a privilege to act over its territory, including humans, non-humans, and geographical borders limiting the territory. Yet this entitlement is not limitless: there are constraints that restrict legitimate state action within its territory. The scope of this privilege to control is largely defined by the sphere within which the state can act without violating the rights of those who are controlled by the sovereignty of the state. For example, even though the French state is entitled, through its sovereignty, to create, exercise, and amend labor law, it cannot impose forced labor, say, on those living in Brittany so the rest of France can be better off. In other words, the domestic dimension of sovereignty is constrained by moral considerations related, for example, to the sphere of protected freedoms that individual rights grant to the citizens of the community. 15 A

limitation on state sovereignty should not be seen as a particularly surprising proposal. The concept of absolute sovereignty is not recognized in international law, and the ways in which the idea of a limited sovereignty is defined evolve over time. What I am proposing here can be aptly seen as another step in the evolution of the constrains imposed on state sovereignty.

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The international dimension of territorial sovereignty, in turn, is defined by a right to noninterference. This is a claim of one state against others that they not interfere with its internal affairs, that is, with the exercise of the rights that constitute the domestic dimension of the sovereignty of the state. As is the case with the domestic dimension of territorial sovereignty, this right to independence from others, although quite extensive, is not absolute. The sphere of legitimate action of the state in my proposal is defined by the exercise of an ecological version of the harm principle.16 A consequence of this conception of territorial rights is that under certain circumstances (those defined by the harm principle) it is permissible to infringe on the right to noninterference entailed in the territorial sovereignty of the state. The fundamental premise of these two dimensions of territorial sovereignty is that the exercise of state power is legitimate only if constrained by certain moral demands. An ecological account of territorial sovereignty expands the constraints imposed on the traditional ideal of sovereignty, influential accounts of which focus on the demands of justice or the respect of human rights, to include recognition of the moral standing of the natural world and the respect that this recognition gives rise to. Thus, as a complement to the thought that, say, the exercise of political power is morally justified “only if it meets a minimal standard of justice, understood as the protection of basic human rights” (Buchanan 2004: 234), ecological territorial sovereignty adds the respect owed to the natural world to the conditions of legitimate exercise of state powers. Let us, then, return once more to the original challenge and ask whether ecological territorial sovereignty softens the split between environmental and animal ethics and thus helps us reduce the controversy between them. The key to answering this question is the idea that ecological territorial sovereignty entails a systemic view of the natural world that allows for a virtuous combination of the environmental values of EE and AE.17 The domestic face of state territorial sovereignty is limited by an obligation to recognize and respect the value of animals, expressed in our concern for their rights and/or wellbeing. Depending on the moral 16 An

early expression of this idea is found in Oppenheim 1912: “A State, in spite of its territorial supremacy, is not allowed to alter the natural conditions of its own territory to the disadvantage of the natural conditions of the territory of a neighbouring State” (Oppenheim 1912: 220). This is the principle of sic utere tuo ut alienum non laedas (you should use your property in such a way as not to cause injury to your neighbours). The first application in international law of a version of this principle goes back to 1941 with the Trial Smelter case between Canada and the U.S. There it was established that “no state has the right to use or permit the use of its territory in such a manner as to cause injury by fumes in or to the territory of another or the properties or persons therein, when the case is of serious consequence and the injury is established by clear and convincing evidence” (35 AJIL (1941) 716, as cited in Bernie et al. 2009, p. 144). This principle is later established in Principle 21 of the 1972 Stockholm Declaration on Human Environment: “States have, in accordance with the Charter of the United Nations and the principles of international law, the sovereign right to exploit their own resources pursuant to their own environmental policies, and the responsibility to ensure that activities within their jurisdiction or control do not cause damage to the environment of other States or of areas beyond the limits of national jurisdiction” (my emphasis). 17 Again, my use of the word ‘system’ here should not be confused with a form of environmental holism. Rather, the point I am trying to make is that the fate of individuals and natural wholes are intermingled. Whether they have the same normative weight or moral status is a separate question.

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standing adopted, this obligation may require not violating the rights of individual right-holders in the territory or promoting the wellbeing of those individuals. Insofar as non-human animals are recognized as having non-instrumental value, the territorial sovereignty of the state is limited by the respect and recognition owed to these animals. In other words, under this view, the state has the privilege (it is entitled) to control non-human animals within its territory to the extent that it does not act in ways that contravene or transgress their own good. At the very least, the regulations imposed upon state action should be concerned with the protection and assistance of non-human animals’ basic needs, which include physical and psychological protection and assistance, access to shelter, and an appropriate habitat.18 The external face of territorial sovereignty, in turn, gives the state protection against the interference of other states. This is a pro tanto right of noninterference according to which no state has the right to interfere with the internal sovereign affairs of another state, unless the latter, as a result of its own actions, harms others beyond its borders.19 When such is the case, the state fails to satisfy a condition of full territorial sovereignty and undermines its own right to noninterference, weakening its territorial sovereignty. This last dimension of territorial sovereignty is especially relevant for EE. Since ecosystems are a complex of interactions and relations between members of the biotic community and also between them and other abiotic components, the territorial sovereignty of the state is conditional on the fact that state domestic practices and policies do not harm the ecosystems of other regions of the planet.20 This, in turn, depends on specific state actions and policies of respect towards the ecological community existing within the limits of the territorial state. All this is the case because ecosystems are not politically defined: they trespass political boundaries and extend through and over geographical areas irrespective of state limits. This means that if the state is to avoid harming other states—and thus, if the state is to maintain its full territorial sovereignty—it will necessarily have to exercise its territorial rights in ways that do not have a negative impact on the sustainability of the ecosystems that, although they may be part of its own territory, extend well beyond it. A good example of this complex interaction is the impact that extensive animal farming has on the ecosystems of the planet. It is by now common knowledge that industrial animal farming is not only a wrong committed against the individual animals that suffer the consequences of humans’ addiction to meat and dairy foods, but also a wrong against the environment and its ecosystems. According to FAO’s report Livestock’s Long Shadow, livestock production is the largest anthropogenic 18 Although I cannot develop this further, note that I am suggesting that negative obligations towards the non-human natural world entail some positive elements. 19 This is not to deny (nor affirm) that a state is protected from interference from others when it violates the rights of those within its territory. Although I recognise the force of international law doctrine in this matter, in this paper I leave this question open. However, as I will argue below, the idea of ecological territorial sovereignty allows for an extensive articulation of the idea of harm which, perhaps, solves the question of interference for violations of rights within the territory of the state. 20 For the classical definition and analysis of ecosystems see Tansley (1935) and Odum (1953).

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user of land in the planet, occupying 70% of all agricultural land and 30% of the land surface of the earth. Furthermore, the livestock industry is a key factor in deforestation. In the Amazon, for example, nearly 70% of deforested land is used for pasture, and the total deforested extension in the Brazilian Amazonia has grown from 15.2 million hectares in 1978 to 60.3 million hectares in 2001 (Margulis 2004: 6). Also, the animal industry is responsible for approximately 18% of greenhouse emissions, accounting for 37% of anthropogenic emissions of methane, and for almost twothirds of anthropogenic emissions of ammonia, which contributes substantively to acid rain and the acidification of ecosystems (see FAO 2006: xxi). From the point of view of ecological territorial sovereignty, state policies regarding animal farming are not just detrimental to its internal authority because of the wrongs inherent to this industry; also, given the impacts it has on ecosystems beyond its territorial limits through the emission of CO2 and other greenhouse gases, the acidification of ecosystems, and so on, it has consequences regarding the external dimension of its own sovereignty. You cannot harm the natural world of your own territory without, at the same time, harming the natural world of other distant territories. What about the case of the beavers in Patagonia? How would ecological territorial sovereignty address a case such as this in the southern part of Chile and Argentina? It is clear that in line with the domestic face of ecological territorial sovereignty, the state would not be allowed to violently exterminate the beavers from the southern region of Chile and Argentina: the negative impact that the beavers are having in that ecosystem is no reason to deny what AE affirms, that is, the beavers’ moral standing and the respect owed to them in virtue of this standing. This, however, does not mean that we should turn a blind eye to the consequences of the presence of the beavers in Argentinean and Chilean Patagonia. From the perspective of ecological territorial sovereignty, this would be unsatisfactory since in that case no consideration would be given to the reasons EE offers for the value of the natural world. Thus, in line with the international dimension of ecological territorial sovereignty, my proposal requires that the state redress the wrong committed some seventy years ago when it imported, or allowed the importation of, beavers into the region. Even though the precise nature of these actions of redress go well beyond the scope of this paper (they are to be provided by science and not normative theorizing), what it is clear is that without violating the rights of non-human animals, the state must respond to EE’s concerns by bearing the costs of moving towards a more stable and sustainable ecosystem.21 It is only then that it can satisfy the requirements of ecological territorial sovereignty and, thereby, maintain its full territorial rights. In a nutshell, the legitimacy of state territorial sovereignty depends on a systemic view of the natural world that requires that state actions and policies within its territory be consistent or at least tend towards the stability and sustainability of transnational ecosystems. In other words, an ecological conception of territorial sovereignty 21 A palatable alternative for AE in this case might be the implementation of an extensive neutering

program of beavers in the region. Morally speaking, whether this is a plausible alternative will depend on a plurality of complex considerations, for example, on the weight of the beavers’ interest in breeding vis-à-vis the interests they have in a continued existence.

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requires from the state a particular—ecological—relationship with ecosystems and biotic communities that are not merely confined to its territorial boundaries. I am aware that ultimately this attempt to soften the tensions between EE and AE is a form of compromise that may seem to impose a heavier burden upon the environmentalists than on those concerned with animal ethics. Be this as it may, this is a fair compromise requiring effective action on both fronts—the individualistic front of AE and the holistic one of EE—in order for the state to maintain its full sovereignty rights. Morality is hardly clean and neat, and in non-ideal circumstances, like the ones that characterize the situation of the beavers in Patagonia, an outcome where each part gives and takes is the best we can aspire to.

12.4 Conclusion Taken together, the internal and external face of territorial sovereignty helps us define an ecological account of territorial rights. As I have argued, with respect to the question of the natural world, this amended version of territorial sovereignty avoids the flaws of other conventional accounts of territory by incorporating core values of EE and AE in a unified normative structure. In the face of serious current social and environmental crisis, this proposal should count positively: on the one hand, it imposes upon the state substantive obligations to respect the natural world within its territory; on the other, to the extent that satisfying this requirement is a condition of its full territorial sovereignty, the state should have a substantive interest in satisfying the demands of ecological territorial sovereignty. By focusing on territorial sovereignty, I have aimed to present the central claims of EE and AE in a unified normative structure. I believe this is important. The most urgent battles of non-anthropocentric ethics should not take place within the field. On the contrary, the recognition and respect owed to the natural world requires that our moral theories, even through the compromise of some of their claims, work together towards a sustained and radical review of how we understand the state, its institutions, and the way in which they relate to the non-human natural world. An ecological account of territorial sovereignty is a first step in that direction. Of course, many aspects of this proposal must still be developed and assessed and, by way of conclusion, I would like to mention two of them. The first has to do with the institutions that an ecological account of territory would require to evaluate the action of states towards the natural world. A comprehensive account of ecological justice would have to consider this issue in much more detail. Simply as an illustration of what might be needed, let us think of a global environmental institution. This institution would be in charge of monitoring and assessing state policies and practices based on available scientific information and providing public and widely available reports on states’ policies with regard to the non-human natural world. This institution would work as an important source of ecological information for the states, helping to coordinate international collective action relevant to pursue the good of nature in its various forms and, in the end, as an instance of institutional representation of

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the interest of the natural world.22 Furthermore, analogous to the role of the UN and some NGOs with regards to, for example, exposing those states which violate human rights, the judgments of this global environmental institution would work as one of the pillars of the recognition of state sovereignty in the international community.23 A second important issue concerns the burdens that ecological territorial sovereignty would impose over the state. This turns out to be an especially important matter when the demands of ecological territorial sovereignty impact more heavily on disadvantaged countries. These are important and difficult questions on global distributive justice that would be raised by a proposal like this: who should be responsible for the actions required by the idea of respect for nature? How should we distribute the burdens of this responsibility in the international community? How much heavier should the load on advantaged countries be compared to the load on disadvantaged ones? An answer to these questions would really require a full book and, for the moment, I can only anticipate some directions in that analysis. Although ideally each state should be responsible for the burdens that ecological territorial sovereignty may require, current circumstances impede such a distribution of responsibilities. The fact is that the disadvantaged circumstances of many states are the result of global injustices permitted and even promoted by developed states. In turn, these disadvantages often force states to over-exploit and spoil the natural world within its territory. In these circumstances, to impose burdens on the disadvantaged similar to those imposed on advantaged states would be unjust. From an ecological justice perspective, the solution here cannot be to allow the disadvantaged to continue its business as usual, nor can it be to permit the advantaged to carry on with unjust practices. Thus, while the disadvantaged may have to redesign their strategies of subsistence and development, a substantive duty of redress would have to fall upon the advantaged states. The resources generated by the satisfaction of this duty would be allocated in such a way as to facilitate the redesign of the development strategies of the disadvantaged countries and redress for the ecological losses that over-exploitation may have produced within the territory of the state.24

22 I

have developed this idea in Donoso (2017). this point the skeptic will surely complain that in a world like ours, such an institution could never exist. In our world, the objection goes, the interests of the strongest take the lead, independently of the impact of the satisfaction of these interests on other people, let alone on non-humans. I think this complaint is overstated. There have been appeals from countries from all over the world—not just from those more vulnerable to environmental injustices—to create a U.N. Environmental Organization, an institution that in many regards resembles the global environmental institution my proposal requires. Furthermore, there are currently existing international institutions, such as the International Criminal Court and the Inter-American Court of Human Rights, that decades ago were considered a chimera and that today fulfill an important role in setting rightful limits on the sovereignty of states, whether these states are powerful or not. All this is to say that even though a global environmental institution will probably not come into existence within a very short time, it is certainly a grounded aspiration. 24 As I have stated above, this is a complex topic that requires a book-length treatment, and here I have only suggested a couple of lines of analysis. For a more complete view on the matter see Armstrong (2017), especially Chap. 10. 23 At

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Although these and other central elements have not been developed here, this article should be seen as a first step towards a fully-fledged account of ecological territorial sovereignty. I have offered some basic elements of this account hoping that by rethinking the contours of legitimate political action of the state, EE and EA can join forces towards their common objectives regarding the natural world. A central source of change in our relationship with the natural world depends on how we conceive of and model the state and its institutions. Acknowledgements I would like to thank Eduardo Rivera Lopez and also Alejandra Mancilla, Juan Pablo Mañalich, and Olof Page for their comments and suggestions, as well as all the participants in the workshop “Justice and Non-Humans” that took place in the Institute of Political Science at the P. Universidad Católica de Chile in June 2018, where a section of this article was presented. This work is part of a Fondecyt project Nº 11160170, and the author would like to thank Fondecyt for its financial support.

References Agar, N. 2001. Life’ s Intrinsic Value. New York: Columbia University Press. Armstrong, C. 2017. Justice and Natural Resources. Oxford: Oxford University Press. Baxter, B. 1996. Ecocentrism and Persons. Environmental Values 5 (3): 205–219. Bernie, P., A. Boyle, and C. Redgwell. 2009. International Law and the Environment. USA: Oxford University Press. Buchanan, A. 2004. Justice, Legitimacy, and Self-Determination: Moral Foundations for International Law. Oxford: Oxford University Press. Callicot, J.B. 1980. Animal Liberation: A Triangular Affair. Environmental Ethics 2: 311–338. Callicot, J.B. 1992. Animal Liberation and Environmental Ethics: Back Together Again. In The Animal Rights/Environmental Ethics Debate: The Environmental Perspective, ed. E. Hargrove. Albany: State University of New York Press. Donoso, A. 2017. Representing Non-human Interests. Environmental Values 26 (5): 607–628. https://doi.org/10.3197/096327117X15002190708137. Dunayer, J. 2004. Speciesism. Ryce Publisher. FAO. 2006. Livestock’s Long Shadow: Environmental Issues and Options. Rome: Food and Agriculture Organization of the United Nations. Honoré, A.M. 1961. Ownership. In Oxford Essays in Jurisprudence, ed. A.G. Guest. Oxford: Oxford University Press. Jamieson, D. 1998. Animal Liberation is an Environmental Ethics. Environmental Values 7: 41–57. Kant, I. 1991. Conjectures on the Beginnings of Human History. In Kant’s Political Writings, 2nd ed, ed. Hans Reiss, 221–234. Cambridge: Cambridge University Press. Kolers, A. 2018. Zoopolis or Ecopolis? Unpublished manuscript. Mancilla, A. 2014. Review Article: The environmental Turn in Territorial Rights. Critical Review of International Social and Political Philosophy 19 (2): 221–241. https://doi.org/10.1080/13698230. 2013.868981. Margulis, S. 2004. Causes of Deforestation of the Brazilian Amazon. World Bank Working Paper 22. Miller, D. 2012. Territorial Rights: Concept and Justification. Political Studies 60 (2): 252–268. https://doi.org/10.1111/j.1467-9248.2011.00911.x. Norton, B.G. 1984. Environmental Ethics and Weak Anthropocentrism. Environmental Ethics 6 (2): 131–148. https://doi.org/10.5840/enviroethics19846233. Odum, E. 1953. Fundamentals of Ecology. Philadelphia: W. B. Saunders Company.

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Oppenheim, L.F.L. 1912. The Future of International Law. London, Oxford: At the Clarendon Press. Regan, T. 1985. The Case for Animal Rights. In In Defense of Animals, ed. P. Singer, 13–26. New York: Basil Blackwell. Risse, M. 2012. On Global Justice. Princeton: Princeton University Press. https://doi.org/10.1515/ 9781400845507. Sagoff, M. 1984. Animal Liberation and Environmental Ethics: Bad Marriage, Quick Divorce. Philosophy & Public Policy Quarterly 4 (2): 6. https://doi.org/10.13021/g8pppq.41984.1177. Simmons, A.J. 2001. On the Territorial Rights of States. Nous 35 (s1): 300–326. https://doi.org/10. 1111/0029-4624.35.s1.12. Sousa, G. 2016. Los castores del Sur están fuera de control y por primera vez buscarán erradicarlos. Clarín 20/10/2016. Retrieved from https://www.clarin.com/sociedad/castores-sur-primerabuscaran-erradicarlos_0_By5w3uryx.html. Sterba, J.P. 1994. Reconciling Anthropocentric and Nonanthropocentric Environmental Ethics. Environmental Values 229–244. Tansley, A. 1935. The Use and Abuse of Vegetational Concepts and Terms. Ecology 16 (3): 284–307. Waldron, J. 1988. The Right to Private Property. Oxford: Clarendon Press. Ypi, L. (2012). A Permissive Theory of Territorial Rights. European Journal of Philosophy. http:// doi.org/10.1111/j.1468-0378.2011.00506.x.

Author Index

A Alegre, Marcelo, 33

O Ortiz Millán, Gustavo, 11

B Bascuñán Rodríguez, Antonio, 97

P Palácios, Marisa, 177

D Donoso, Alfonso, 219

R Rego, Sergio, 177 Rivera-López, Eduardo, 1, 83

H Hevia, Martín, 1, 53 Holzer, Felicitas, 145 Homedes, Nuria, 115 L Luna, Florencia, 67

T Timmermann, Cristian, 203 U Ugalde, Antonio, 115

M Mastroleo, Ignacio, 145

© Springer Nature Switzerland AG 2019 E. Rivera-López and M. Hevia (eds.), Controversies in Latin American Bioethics, International Library of Ethics, Law, and the New Medicine 79, https://doi.org/10.1007/978-3-030-17963-2

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Subject Index

A Abortion criminalization of, 2, 12, 14, 17, 20–23 illegal, 13, 18, 22, 79 unsafe, 13–16, 18, 21, 22, 79 Abuse of right, 88 Academic fraud, 6, 177, 178, 181 Academic integrity movement, 181 Accepted practice, see validated practice Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), 119, 123, 128–130, 152 Advertising research, 138, 164, 187, 190, 196 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), 121 Agricultural practices, 206, 208 Agricultural workers, 212 Agriculture, 1, 7, 149, 204, 206–208, 212, 213 Agrobiodiversity, 210 Agrochemicals, 206–208 Agroecology, 204, 207 Altruism, 98, 101, 109–111 Amazon, 203, 231 American College of Obstetricians and Gynecologists Committee on Ethics (ACOG Committee on Ethics), 164 American convention on human rights, 53–55, 61 American health organization, 116, 120, 121 American society for reproductive medicine, 151 Anecdotes, 169 Animal ethics, 7, 219, 220, 222, 226, 228, 229, 232

Animal liberation, 220, 221, 226 Animal rights, 7, 219, 228 Anthropocentric thesis, 221 Anthropocentrism, 219–221 Anti-abortion laws, 2, 11–13, 17–19, 21, 22, 24, 29 Argentina, 2, 7, 33, 34, 37, 40, 42, 48, 118, 123, 128–130, 134, 135, 146, 148, 149, 152–154, 172, 204, 205, 220, 231 Argentine Food and Drug Authority (ANMAT) (Administración Nacional de Medicamentos, Alimentos y Tecnología ANMAT), Argentina, 119, 123, 128, 129, 130, 152 Argument of lacking reasonable alternatives, 167 Artavia Murillo, 4, 53, 54 Assisted reproduction, 3, 20 Australia, 54, 189, 190 Autonomy, 1, 2, 11, 20–22, 29, 38, 39, 41, 50, 54, 58, 60, 61, 75, 78, 97, 99–107, 122, 188, 221 B Background injustice, 86, 87, 90 Beavers, 7, 220, 228, 231, 232 Belmont Report, 68, 154–158, 161, 162, 165, 171, 181 Big Pharma, 130, 133, 138, 139 Bioethical principles, 99 Bioethical triangle, 103 Bioethics, 1, 5, 7, 8, 69, 70, 73, 76, 83, 84, 86, 89, 94, 99, 100, 103–105, 126, 152, 158, 172, 178, 182, 184 Biomedical research, 5, 6, 68, 79, 84, 91

© Springer Nature Switzerland AG 2019 E. Rivera-López and M. Hevia (eds.), Controversies in Latin American Bioethics, International Library of Ethics, Law, and the New Medicine 79, https://doi.org/10.1007/978-3-030-17963-2

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240 Biotic community, 224, 230, 232 Blood procurement of, 110 Body parts, 4, 99, 109 Bolivia, 16, 84, 205 Boundaries of practice and research, see distinction between research and practice Brazil, 2, 6, 14, 54, 118, 123, 126, 128, 134, 177, 178, 181–183, 185, 188, 189, 191–195, 231 Brazilian Constitution, 193 C Catholic Church, 3, 6, 147–149, 153, 172 Center for the Study of the State and Society (CEDES), the, 37 Children, 4, 11, 12, 16, 17, 20, 22, 25, 29, 50, 53–58, 61, 68, 75, 117, 118, 120, 129, 150, 162 Chile, 98, 101, 109, 118, 123, 204, 206, 209, 220, 228, 231 CIOMS guidelines, 68, 69, 74 Civil disobedience, 47–49 Climate change, 205, 209, 211–213 Clinical research, 115, 116, 118, 119, 123, 124, 139, 147, 152, 157, 162, 163, 166, 168, 187, 188 Clinical research combined with professional care, see innovation Clinical trials, 6, 74, 115–137, 139, 146, 147, 161, 166, 168, 170, 172 outsourcing of, 115, 123, 133 Code of Good Practice in Research, 183 Collaborative research, 182 Colombia, 2, 118, 122–124, 129, 130, 205 Coloniality, 177, 191, 192, 194 Committee on the Elimination of Discrimination Against Women (CEDAW), 21, 40 Commodifiability, 98–109, 111 Commodification, 1, 4, 5, 56, 90, 92, 97–99, 101–104, 106, 108, 109, 111, 210 Communicating research, 177, 178 Conflict of interest, 186, 187, 189, 190 Conscientious objection, 3, 33–50 conciliatory model, 3, 33, 34, 42, 43, 46 egalitarian model, 3, 46 libertarian model, 3, 42 Consent, 58, 61, 68, 72, 77, 83, 84, 89, 98–100, 103, 105, 106, 117, 122, 123, 125, 126, 129, 132, 136, 164, 166, 167 Contractual approach, 59 Corruption, 18, 53, 55, 104, 130, 204

Subject Index Costa Rica, 4, 53, 54, 117, 118, 123, 126 CRISPR/Cas, 149 Crowding out of sound research, 164, 165 Culinary diversity, 210 D Declaration of Helsinki, 68, 164, 166, 167, 171 Delaying sound research, see crowding out of sound research Deontologism, 97, 221 Dignitarian alliance, 103, 106, 107, 110, 111 Dignitas personae, 153 Dignity, 2, 5, 24, 43, 44, 54, 55, 60, 97, 103–107, 110, 111, 153 Discrimination, 20–22, 25, 38, 41, 45, 46, 55, 204, 207 Displacement test, 104–106 Distinction between research and practice, see distinction between research, validated practice and innovation Distinction between research, validated practice and innovation (Distinction between research, validated practice and non-validate practice), 6, 154, 155 Distinction between research, validated practice and non-validate practice, 155 Distributive justice, 86, 223, 233 Donum Vitae, 153 Drug criminalization of, 205 E Ecodevelopment, 214 Ecosystem, 7, 207, 221, 224, 228, 230–232 El Salvador, 2, 13, 14, 73 Embryo (human), 2, 12, 23–26, 29, 149 Embryonic stem cells, 148, 153, 172 Environment, 1, 6, 7, 17, 29, 74, 103, 107, 131, 149, 172, 192, 194, 196, 203, 204, 206–209, 213, 214, 220, 221, 229, 230 Environmental ethics, 7, 219, 220, 222, 227–229 Environmental risks, 212 Episiotomy, 159, 161 Epistemic crowding out, see crowding out of sound research Epistemic problem, see validation Equality, 2, 20–22, 33, 34, 42–44, 58, 220 Ethical guidelines, 68, 74, 145, 146 European Convention on Human Rights and Biomedicine, 99 Evangelium Vitae, 41 Excorporation, 5, 97–99, 101–103, 105–109, 111

Subject Index Existential approach argument, 70 Expectations, 15, 55, 58, 60, 155, 157, 158, 161, 162, 167 Experimental design, see innovation Experimental drugs, 126 Exploitation, see patients hope beneficial, 5, 83, 84, 88 Exploitative transaction, 5, 83, 85–87, 90–94 F Fair price, 60, 61, 90 Fanconi’s anemia, 146, 162 Farmers, 205–209 Farming styles, 203 Feminist argument, 154 Food, 7, 127, 128, 149, 188, 203–214, 230 Food adequacy, 209 Food and Agriculture Organization (FAO), 7, 204, 230, 231 Food and Drug Administration (FDA), 127, 137, 139, 151, 161, 188, 189 United States, 127 Food diversity, 205 Food ethics, 7, 206, 209, 212 Food insecurity, 212 Food production, 204–207, 211, 212 Food security, 149, 209, 212 Food sovereignty, 204–206, 211 Food systems, 203, 205, 211, 212, 214 Fraud (in research), 179, 180, 186–188, 191 Freedom of religion, 35, 36 Futile practice, see validation G Gene (genome) editing, 146, 149, 150, 161 General Health Law on Health Research (Ley general de Salud en Materia de Investigación para la Salud), Mexico, 151, 152 Genome sequencing technologies, 152 Global South, 7, 213, 214 Gold standard, see randomized clinical trials (RCTs) Greenhouse gases, 231 Grey zone between research and practice, see innovation; distinction between research and practice H Harm principle, 229 Health workers, 129 HIV, 84, 129, 192

241 Hohfeldian rights, 228 Homo sapiens, 24, 25, 27 Hope, 45, 165–168 Human body, 5, 97–100, 102, 104, 106, 108–110 Human rights, 1, 4, 19, 20, 34, 40, 50, 53–55, 57, 61, 72, 99, 100, 103–106, 118, 178, 204, 229, 233 Hypocrisy argument, 93 I Indigenous peoples, 204, 210 Inequality, 7, 15, 22, 29, 39, 57, 58, 203–205, 211 Informed consent, 61, 72, 99, 100, 122, 125, 126, 129, 132, 164, 166, 167 Innovation, 1, 5, 6, 145–147, 150, 154–163, 165–171, 185, 188, 195, 212, 213 definition as non-validated practice, 157, 158, 162, 164 definition as new non-validated practice, see practice responsible, 145, 147, 154, 159, 166, 168–171 Innovative care, see innovation Innovative practice, see innovation Innvoative therapies, see innovation Intellectual property, 119–121 Intention, 93, 98, 155, 156, 160, 162, 163, 165, 190 See also main aim Inter-American Human Rights System, 53 International Planned Parenthood Federation, 15 International Society for Stem Cell Research (ISSCR), 150 K Kant, 102, 105, 106, 224 Kantian account, 227 L Land, 203, 205, 206, 208, 210–212, 223, 224, 231 land and water, 205 cultivation of, 205 use of, 205 Last ditch treatments, see innovation Latin America, 1–8, 13–16, 18, 22, 53, 54, 115, 116, 118–120, 122–128, 130, 133–137, 145–148, 153, 158, 159, 169, 172, 183, 203–207, 210, 212, 213 Legal status, 2–4, 53, 54, 101

242 LGBT rights, 154 Long-standing practice, see practice M Main aim, 156, 158 See also intention Malnutrition, 203, 207–209 Malpractice, 6, 179, 192, 194 Manipulation of data, 180 Maternal Spindle Transfer (MST), see Mitochondrial Replacement Technologies Meaningless argument, 69 Medical tourism, 150 Mere variation, see innovation Mexico, 2, 3, 13–16, 23, 54, 118, 119, 122, 123, 126–128, 146, 148–151, 171, 204, 206, 208, 209, 212 Military dictatorship, 118, 178 Misconduct in research, 180 Mitochondrial Replacement Technique (MRT), 146, 150, 161 Mitochondrial Replacement Technologies (MRTs), 148 Montreal Declaration, 182 Moral status of embryos, 2, 11, 148, 149 Moral value, 25–29, 153 Motherhood, 21, 54–56, 58, 101 Mutual benefit, 84, 85, 90, 94 N National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission), 155 Natural resources, 191, 222–226 New non-validated practice, 6, 145–148, 154, 155, 158–165, 167–172 New product research, 187 Nicaragua, 2, 13, 14, 117, 211 Non-anthropocentric ethics, 219–221, 223, 226, 232 Non-validated practice, 6, 145–148, 154–172 See also nonvalidated practices Nuremberg Code, 178 O Organ selling, 83, 84 Oswaldo Cruz Foundation (Fiocruz), 191 Outsourcing, 6, 115, 116, 119, 121, 123, 124, 128, 133, 135–138 Overpopulation argument, 70

Subject Index P Pan American Health Organization, 116, 120, 121 Patagonia, 7, 220, 228, 231, 232 Patents, 120, 137 Paternalism, 91, 105, 107 Patients, 3, 6, 27, 33, 34, 38, 39, 42–46, 50, 61, 69, 119, 120, 122, 123, 126, 129, 133, 135–137, 139, 145–150, 152–156, 158–160, 162–172, 190 Patient’s hope, see hope Perfectionism, 105 Person potential, 26–28 Personhood, 11, 23–29, 153 Peru, 118, 123, 128, 131, 132, 134, 205, 210 Pharmaceutical companies, 6, 92, 119, 120, 122–124, 128, 130, 133, 138, 190 Pharmaceutical corporations, 118, 123, 124, 130, 133, 134 Pharmaceutical industry, 115, 116, 119, 123, 128, 130, 131, 133, 136, 137, 139, 189, 191, 193 Physicians, 3, 6, 12, 13, 21, 23, 116, 127, 133, 134, 139, 157, 162, 163, 166, 167, 169, 170, 191 Placebo, 84, 89, 122, 126, 135, 192 Poverty, 15–17, 19, 21, 22, 38, 41, 84, 14, 135, 136, 195, 204, 209 Practical ethics, 184, 185, 196 Practice accepted practice, 156, 157, 159 standard practice, 156 validated practice, 6, 154, 155, 158, 159, 161, 164, 170 non-validated practice, 6, 145–148, 154–172 2D classification: new validated practice, 161 new non-validated practice, see innovation long-standing validated practice, 161 long-standing non-validated practice, 158 Prague Study, 17 Pregnancy, 2, 3, 11, 12, 15–17, 21–25, 28, 29, 34, 37, 38, 40, 41, 54, 55, 59, 60, 79, 101, 132 Privacy, 1, 2, 4, 11, 20–22, 29, 42, 44, 55, 60, 61, 101, 108 Private action, 85 Professional ethics, 177, 181, 184 Pronuclear Transfer (PNT), see Mitochondrial Replacement Technologies

Subject Index Property right to, 224 Protocols, 72, 78, 92, 117, 122–125, 127, 128, 131, 135 Public health, 6, 16, 18, 45, 55, 67, 68, 71, 73, 74, 110, 116, 118, 124, 135, 157, 164, 165, 171, 179, 209 Public power (and exploitation), 91 Public trust, 165, 170, 182, 184 Q Qualified bioethical autonomy, 100 R Randomized Clinical Trials (RCTs), 161 Rationality, 26, 28 Reasonable expectation of success, 155 Rebellion, 48, 49 Recruitment of volunteers, 119, 122 Redistribution of resources, 182, 205 Regular healthcare, see validated practice Regulatory agencies, 6, 119–121, 123, 125, 128, 130, 135, 136, 172 Religious beliefs, 3, 45 Reproductive rights, 1–4, 14, 19, 20, 23, 34, 40, 53, 54, 73 Research Ethics Advisory Council (Federal University of Rio de Janeiro), 192 Research ethics committee, 68, 74, 76, 78, 119, 122, 193 Right to do wrong, 88 Right to try, see innovation Routine episiotomy, see episiotomy Rural population, 117, 206 S Scientific community, see validation Seeds, 27, 210 Sexual and reproductive health services, 33, 35, 42 Sexual and reproductive rights, 3, 19, 20, 34, 40 Sexual violence, 16 Significant change, see innovation Singapore Declaration, 182, 183 Slavery contract, 105 Social justice, 92, 204, 211, 213 Speciesism, 25, 226 Standard practice, see validated practice Stem cell therapy, 6, 146, 148, 152, 172 Stereotypes and labels argument, 70

243 Strategic argument, 94 Suberogatory acts, 87–89, 91 Sunshine Act, 190 Surrogacy, 3, 4, 53–62, 83, 85, 90 commercial, 54, 56–61, 83, 85, 90 T Taking advantage, see patients hope Territorial rights, 219, 222–224, 227–232 Territorial sovereignty, 7, 219, 222, 223, 227–234 Theory of justice, 97, 98, 103 Therapeutic research, see innovation Trade policy, 209 Transparency, 44, 170, 182, 183, 189, 190, 193, 194 Two-step procedure, 77 U Umbilical cord blood transplant, 146 United States, 13, 14, 17, 20, 39, 54, 61, 85, 109, 117, 121, 123, 127, 130, 136, 138, 139, 179, 181, 190, 195 Universal Declaration on Bioethics and Human Rights of UNESCO, 100, 178 Unproven interventions in clinical practice, see innovation Utilitarianism, 209 V Vaccine, 117, 118, 124, 129, 138 Vaccine trials, 117 Validated practice, see practice Validation, 6, 147, 155, 158, 159, 161, 162, 168 Vulnerability, 1, 4, 43, 50, 67–80, 85, 86, 91, 136, 211, 212 layers of, 67, 73–75, 77, 78 Vulnerable populations, 4–6, 68 W Welfare, 13, 18, 53, 55–58, 179, 186, 208, 209, 221 Women’s rights, 2, 3, 11, 19–24, 29, 38 World Health Organization (WHO), 14, 41, 67, 99, 121, 138, 195 World Intellectual Patent Organization (WIPO), 121 World Trade Organization (WTO), 121