Ethical Dilemmas in Assisted Reproductive Technologies 9783110240214, 9783110240207

Table of contents :
Preface
Author index
1 The foundations and application of medical ethics
1.1 Introduction
1.2 Historical background
1.3 General ethical theories and principles
1.4 Modern medical ethics
1.5 Conclusion
2 Legislation for assisted reproductive technologies
2.1 Introduction
2.2 Legislation and regulations
2.3 Legislative motivations
2.4 Evidence-based legal policy
2.5 The focus of legislation
2.6 Human rights
3 Reproductive rights as an integral part of women’s rights
3.1 Introduction
3.2 Granting women equal rights: the origin of discrimination
3.2.1 Cornerstones of women’s rights
3.2.1.1 Dignity, body integrity, and freedom from violence
3.2.1.2 Equality and empowerment
3.2.1.3 Full, unconditional access to health care services
3.2.2 A right to treat infertility
4 Right to reproduce
4.1 Socioeconomic issues
4.2 Religious issues
4.3 Legal and historical aspects
4.4 Moral aspects
4.5 ART-related aspects
5 Informed consent for treatment of fertility
5.1 Introduction
5.2 The right to experience parenthood and its standing
5.3 The informed-consent doctrine
5.3.1 The doctrine and its nature
5.3.2 Application of the doctrine to fertility treatments
5.4 Mutual consent of spouses
5.4.1 Joint process
5.4.2 The good of the child and consideration of parental capability
5.5 Validity of the consent
5.5.1 Effect of the initial consent
5.5.2 Withdrawal of patient consent
5.5.3 Physician’s withdrawal of consent
5.5.4 Consent after death
5.5 Conclusion
6 Specific ethical and legal aspects of ART practice in eastern European countries
6.1 Introduction
6.2 Situation in eastern European countries
6.2.1 Number of centers
6.2.2 Legal regulation of ART
6.2.3 Coverage or reimbursement of ART
6.2.4 Marital status in ART
6.2.5 The number of transferred embryos in ART
6.2.6 Cryopreservation
6.2.7 Posthumous ART
6.2.8 Gamete donation
6.2.9 Anonymity
6.2.10 Micromanipulation
6.2.11 In vitro maturation of oocytes
6.2.12 Welfare of the child
6.2.13 Multifetal-pregnancy reduction
6.2.14 Preimplantation genetic diagnosis
6.2.15 Surrogacy
6.2.16 Research on the embryo
6.2.18 Gamete intrafallopian transfer
6.2.19 The moral status of the embryo
6.3 Conclusions
7 Sperm donation and sperm-bank management
7.1 Introduction
7.2 Limiting the number of donor offspring
7.2.1 United States
7.2.2 United Kingdom
7.3 Minimizing the risk of infection and genetic complications from sperm donors
7.4 Age requirements for sperm donors
7.5 Anonymity versus nonanonymity of sperm donors
7.5.1 Anonymous sperm donation
7.5.2 Nonanonymous sperm donation
7.6 Sperm-donor compensation
7.7 Informed consent and counseling
7.8 Conclusions
8 Oocyte donation: medical and legal perspectives
8.1 Introduction: Indications for egg donation
8.2 Preparation of donor and recipient
8.3 Outcome determining factors
8.4 Obstetric and perinatal outcomes
8.5 Ethical aspects
8.6 Legislation
8.6.1 The new Israeli legislation
8.7 Summary
9 Egg donation: ethical considerations and regulatory context
9.1 Introduction
9.2 The regulatory context
9.3 Donating eggs
9.3.1 Informed consent
9.3.2 Meeting demand: remuneration and other programs
9.3.2.1 Financial compensation
9.3.2.2 Egg-sharing programs
9.3.3 Other obligations
9.4 Use of donated eggs
9.4.1 Informed consent
9.4.2 Nontraditional patients and access to donated eggs
9.4.3 Age
9.5 Donor identity and disclosure
9.6 Conclusions
10 Medical, ethical, and legal aspects of fetal reduction
10.1 History
10.2 Ethical issues
10.2.1 Moral compromise
10.3 Legal issues
10.3.1 Recommendations
10.4 Summary
10.5 Acknowledgments
11 Fertility treatments in human immunodeficiency virus (HIV) infected patients
11.1 Introduction
11.2 HIV and the male genital tract
11.3 HIV and the female genital tract
11.4 Assisted reproductive technologies in HIV-positive patients
11.5 Semen processing
11.6 Viral testing of spermatozoa
11.7 Success rates
11.8 Summary
12 Pregnancies in perimenopause and beyond
12.1 Medical aspects and considerations
12.1.1 Fertility fecundity and abortions
12.1.2 Pregnancy-associated physiological changes
12.1.3 Obstetrical and intrapartum complications
12.1.4 Maternal mortality
12.1.5 Neonatal outcome
12.2 Oocyte-donation programs
12.3 Ethical aspects
12.3.1 The issue of choice
12.3.2 The welfare of the child
12.4 Coping with the medical risks
12.5 Legislation, regulation, and religion aspects
12.6 Summary
13 Legal control of surrogacy – international perspectives
13.1 Introduction
13.2 Surrogacy – definition
13.3 Surrogacy – history
13.4 Legal control of surrogacy – international perspectives
13.4.1 Prohibition of Surrogacy by legislation
13.4.2 Counties – surrogacy no prohibited by law
13.4.3 Surrogacy in China
13.4.4 Non commercial surrogacy
13.4.5 Greece Law
13.4.6 South Africa
13.5 Commercial surrogacy
13.5.1 Former Countries of the Soviet Union
13.5.2 India
13.5.3 Surrogacy in USA
13.5.4 Surrogacy in Russia
13.6 Russian Public Opinion
13.7 Surrogacy in Islamic Countries
13.8 Cross-border Surrogacy
13.9 Conclusions
14 Preimplantation genetic diagnosis in assisted reproduction: medical, ethical, and legal aspects
14.1 Introduction
14.2 Biopsy methods for preimplantation genetic diagnosis
14.2.1 Polar-body biopsy
14.2.2 Embryo biopsy
14.3 Chromosomal aneuploidies in preimplantation development
14.4 Chromosomal rearrangements
14.5 Impact of PGD on IVF outcome
14.6 Conclusion
15 Preimplantation genetic diagnosis of late-onset diseases
15.1 Introduction
15.2 Embryo selection
15.3 Huntington’s disease
15.4 Cardiovascular disorders
15.5 Alzheimer’s disease
15.6 Genetic testing for cancer
15.7 Breast cancer
15.8 Genetic counseling
15.9 Conclusion
16 Bioethics of human embryonic stem cells and cloning for stem cells: an Israeli perspective
16.1 The scientific and medical aspects
16.2 Ethical issues related to human embryo stem cells
16.2.1 Pluralism of moral views on the preimplantation embryo
16.2.2 Potentiality of human preimplantation embryo
16.2.3 Personal status of the embryo
16.2.4 Therapeutic aims of human ES cells
16.2.5 Pluralism of decisions on human ES cell production and research in various countries
16.2.6 A case study: ethical regulations on human ES cell research in Israel
16.3 Ethical views on cloning to obtain autologous ES cells
16.3.1 Bioethical arguments
16.3.2 National and international resolutions
16.3.3 Case study: regulations in Israel regarding cloning for ES cells
17 The future of human embryonic stem cell research: medical, legal, and ethical perspectives
17.1 Introduction: Human embryonic stem cell research
17.2 The first possible clinical applications of cells differentiated from hESC
17.3 Challenges in clinical treatment using hESC-derived cells
17.3.1 Microbial contamination
17.3.2 GMP and EU tissues and cells directive
17.3.3 Immunogenicity
17.3.4 Tumorigenicity
17.4 iPS cells versus hESC
17.5 Legal and ethical aspects of hESC research
17.6 Conclusions
18 Preservation of fertility in children with cancer: medical, ethical, and legal aspects
18.1 Introduction
18.2 Population at risk
18.3 Medical and surgical options for fertility preservation
18.4 The ethical propriety of fertility-preservation options
18.5 Autonomy, justice, and treating pediatric patients
18.6 Ethical and legal issues with unused tissue and gametes
18.7 Posthumous reproduction
18.8 Conclusion
19 Fertility preservation for cancer patients: a review of current options and their advantages and disadvantages
19.1 Introduction
19.2 Cancer and fertility preservation
19.3 Current options for fertility preservation
19.4 Medical options: GnRH agonists
19.5 Surgical options: ovarian transposition and cryopreservation of ovarian cortical tissue
19.5.1 Ovarian transposition
19.5.2 Cryopreservation of ovarian cortical tissue
19.6 ART: in vitro fertilization and in vitro maturation
19.6.1 Embryo and oocyte cryopreservation after ovarian stimulation
19.6.1.1 Embryo cryopreservation
19.6.1.2 Oocyte cryopreservation
19.6.2 Embryo and oocyte cryopreservation without prior ovarian Stimulation
19.6.3 IVM embryo cryopreservation
19.6.4 IVM-oocyte vitrification
19.6.5 Fertility preservation: the McGill experience
19.7 Conclusion
20 Sexual orientation and use of assisted reproductive technology: social and psychological issues
20.1 Introduction
20.2 A note about terminology
20.3 Routes to parenthood among nonheterosexual adults
20.4 Legal issues surrounding sexual orientation and family formation
20.5 Sexual orientation and incidence of parenthood
20.6 Sexual orientation and plans for parenthood
20.7 Studies of sexual orientation and plans for parenthood
20.8 Outcomes for children of lesbians and gay men
20.9 Relationships with peers
20.10 Child behavior problems
20.11 Gender development
20.12 Conclusions and future directions
20.13 Assisted reproduction among nonheterosexual adults
20.14 Barriers to ART use by nonheterosexual adults
20.15 Donor-insemination decisions
20.16 Recommendations for clinical practice
20.17 Conclusion
21 Access to fertility treatment by lesbian couples
21.1 Introduction
21.2 Legal changes
21.3 Assisted reproduction
21.4 Being a lesbian and a mother
21.5 Donor anonymity
21.6 Ethical assessment
21.7 A Child with two mothers
22 ART practice and tourism
22.1 Introduction
22.2 Background and methods
22.3 Major findings
22.3.1 The United Arab Emirates
22.3.1.1 Reproductive travel to the UAE
22.3.1.2 Reproductive travel from the UAE
22.3.1.3 Reproductive travel to and from the UAE
22.3.2 The East Coast of the United States
22.4 Conclusion
23 A savior child conceived by PGD/HLA: medical and ethical aspects
23.1 Introduction
23.2 Medical indications and social acceptance of PGD
23.2.1 Chromosomal abnormalities
23.2.2 Monogenic diseases
23.2.3 Adult-onset diseases and cancer-predisposing genes
23.2.4 Creating a “savior child”
23.3 Other possible applications of PGD: savior embryos, gender selection, and designer babies
23.3.1 Savior embryos
23.3.2 Gender selection
23.3.3 Designer babies
23.4 Legislation and professional guidelines for the uses of PGD/HLA
23.5 Ethical considerations
23.5.1 Embryo wastage
23.5.2 Moral status of the human embryo
23.5.3 Harm of embryo biopsy
23.5.4 The condition of absolute medical necessity
23.5.5 PGD SC and family ethics
23.5.6 Well-being of the savior child
23.5.7 PGD, parental interests and public access
24 Posthumous reproduction: ethical and legal perspectives
24.1 Introduction
24.2 The source
24.2.1 What counts as consent?
24.2.2 Coercion
24.2.3 Minors as sources
24.3 Requesters of retrieval
24.4 Reproductive partners
24.5 Children
24.6 Summary
25 Human reproductive cloning: ethical perspectives
25.1 Introduction
25.2 The potential value of HRC
25.3 Ethical concerns with HRC
25.4 HRC and the value of our unique genetic make-up
25.5 Conclusion
26 ART practice – religious views
26.1 Introduction
26.2 The Jewish law
26.2.1 Torah
26.2.2 The Mishnah
26.2.3 The Talmud
26.2.4 Post-Talmudic codes
26.2.5 Responsa
26.2.6 Orthodox Judaism
26.2.7 Reform Judaism
26.2.8 Conservative
26.3 Christian denominations
26.3.1 Roman Catholic Church
26.3.2 Anglican Church
26.3.3 The Protestant Church
26.3.4 Eastern Orthodox Church
26.4 Hinduism
26.5 Buddhism
27 A Catholic ethical perspective on human reproductive technology
27.1 Catholic position on respect for the human embryo
27.1.1 Biblical perspective
27.1.2 Christian tradition
27.1.3 Embryo defined
27.1.4 Catholic Christian teaching
27.1.5 A person from conception
27.1.6 Ethics and destructive research on human embryos
27.1.7 Morality and personalized natural law
27.1.8 Secular ethics and the human embryo
27.1.9 Challenge to find ethical alternatives
27.2 Catholic ethics, marriage, and reproductive technology
27.2.1 Catholic Christian position on children of the marriage union
27.2.2 Assisted insemination
27.2.3 Rights of children and natural parents
27.2.4 Donor gametes
27.2.5 Surrogacy
27.2.6 Access to ART by single women and lesbians
27.2.7 Human reproductive cloning
27.3 Conclusion
28 Islamic laws and reproduction
28.1 Islamic laws
28.2 Reproduction in Islam
28.3 ART and Islam
28.4 Islam and various ART practices
28.5 Surrogacy
28.6 Multifetal pregnancy reduction
28.7 Pregnancy in postmenopause
28.8 Sex selection
28.9 Cryopreservation
28.10 Embryo implantation following husband’s death
28.11 Embryo research
28.12 Gene therapy
28.13 Cloning
28.14 ART practices in different Muslim countries
29 Jewish law (halakha) and reproduction
29.1 Introduction
29.2 Homosexuality
29.3 Lesbianism
29.4 Evaluation of the infertile couple
29.5 The laws of niddah
29.6 Infertility treatment
29.7 The beginning of human life
29.8 Artificial insemination by husband
29.9 Artificial insemination by donor
29.10 Oocyte donation
29.11 Surrogacy
29.11.1 Legalizing surrogacy in Israel
29.11.2 The state-appointed permission committee
29.11.2.1 Guidelines set by the committee for surrogacy
29.11.2.2 Expenses
29.11.2.3 Legal status of the newborn
29.11.2.4 Surrogate mother’s withdrawal from the agreement
29.11.2.5 Legal rights of the surrogate mother
29.11.2.6 Enforcement of the law
29.11.2.7 Right to privacy
29.11.2.8 Illegal financing
29.11.2.9 Legal adoption
29.12 Fetal reduction
29.13 Gender preselection
29.14 Cryopreservation
29.15 Posthumous reproduction
29.16 Cloning
29.17 Preembryo research
30 Commercialized assisted reproduction
30.1 Position of reproductive treatment in the economy
30.2 Commercialization of assisted reproduction
30.3 Divergent national policies toward reproductive treatment
30.4 International economic integration and assisted reproduction
30.5 Absence of effective restrictions on reproductive tourism
30.6 Natural barriers to reproductive tourism
30.7 Intellectual property and assisted reproduction
30.8 Doing business in the reproductive industry
30.9 Assisted reproduction in united Europe
30.9.1 Case study: German patients in Czech centers
31 The intersection between economic and ethical aspects of ART
31.1 Introduction
31.2 A framework for economic and ethical aspects of ART
31.3 Distributive justice and funding of ART
31.3.1 International differences in funding
31.3.2 Provision of ART in developing countries
31.3.3 Morally challenging funding decisions
31.4 The cost of ART treatment
31.4.1 Treatment costs
31.4.2 The costs of multiple births
31.4.3 Valuing ART treatment from an economic perspective
31.5 The affordability of ART treatment and its implications
31.5.1 Affordability and utilization
31.5.2 Affordability and clinical practice
31.5.2.1 It makes economic as well as clinical sense to reduce multiple-births
31.6 Conclusion

Citation preview

Ethical Dilemmas in Assisted Reproductive Technologies Edited by Joseph G. Schenker

Ethical Dilemmas in Assisted Reproductive Technologies Edited by Joseph G. Schenker

DE GRUYTER

Editor Joseph G. Schenker MD, FRCOG, FACOG (Hon) Department of Obstetrics and Gynecology Hebrew University-Hadassah Medical Center Jerusalem, Israel ISBN 978-3-11-024020-7 e-ISBN 978-3-11-024021-4 Library of Congress Cataloging-in-Publication Data Ethical dilemmas in assisted reproductive technologies / edited by Joseph G. Schenker. p. ; cm. Includes bibliographical references. ISBN 978-3-11-024020-7 (alk. paper) 1. Human reproductive technology—Moral and ethical aspects. I. Schenker, Joseph G. [DNLM: 1. Reproductive Techniques, Assisted—ethics. 2. Bioethical Issues. 3. Women's Rights. WQ 208] RG133.5.E8394 2011 176—dc22

2011002651

Bibliographic information published by the Deutsche Nationalbibliothek The Deutsche Nationalbibliothek lists this publication in the Deutsche Nationalbibliografie; detailed bibliographic data are available in the Internet at http://dnb.d-nb.de. © 2011 Walter de Gruyter GmbH & Co. KG, Berlin/Boston. The publisher, together with the authors and editors, has taken great pains to ensure that all information presented in this work (programs, applications, amounts, dosages, etc.) reflects the standard of knowledge at the time of publication. Despite careful manuscript preparation and proof correction, errors can nevertheless occur. Authors, editors and publisher disclaim all responsibility and for any errors or omissions or liability for the results obtained from use of the information, or parts thereof, contained in this work. The citation of registered names, trade names, trademarks, etc. in this work does not imply, even in the absence of a specific statement, that such names are exempt from laws and regulations protecting trademarks etc. and therefore free for general use. Cover image: iStockphoto/Thinkstock Typesetting: Apex CoVantage Printing: Hubert & Co. GmbH & Co. KG, Göttingen Printed on acid-free paper Printed in Germany www.degruyter.com

Contents

Preface Author index

xvii xxi

1 The foundations and application of medical ethics ................................................. 1 Avraham Steinberg 1.1 1.2 1.3 1.4 1.5

Introduction.................................................................................................... 1 Historical background .................................................................................... 1 General ethical theories and principles........................................................... 2 Modern medical ethics ................................................................................... 8 Conclusion ................................................................................................... 13

2 Legislation for assisted reproductive technologies ................................................ 15 Bernard M. Dickens 2.1 Introduction.................................................................................................. 15 2.2 Legislation and regulations ........................................................................... 16 2.3 Legislative motivations.................................................................................. 18 2.4 Evidence-based legal policy ......................................................................... 20 2.5 The focus of legislation ................................................................................. 22 2.6 Human rights................................................................................................ 25

3 Reproductive rights as an integral part of women’s rights .................................... 29 Giuseppe Benagiano, Sabina Carrara, and Valentina Filippi 3.1 3.2

Introduction.................................................................................................. 29 Granting women equal rights: the origin of discrimination ........................... 30 3.2.1 Cornerstones of women’s rights ......................................................... 32 3.2.1.1 Dignity, body integrity, and freedom from violence ............. 32 3.2.1.2 Equality and empowerment ................................................ 34 3.2.1.3 Full, unconditional access to health care services ............... 35 3.2.2 A right to treat infertility .................................................................... 36

4 Right to reproduce ............................................................................................... 43 Harpreet Kaur and Kamini A. Rao 4.1 Socioeconomic issues................................................................................... 43 4.2 Religious issues ............................................................................................ 45 4.3 Legal and historical aspects .......................................................................... 45 4.4 Moral aspects ............................................................................................... 48 4.5 ART-related aspects....................................................................................... 49

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5 Informed consent for treatment of fertility .......................................................... 53 Yosi Green 5.1 Introduction.................................................................................................. 53 5.2 The right to experience parenthood and its standing ..................................... 54 5.3 The informed-consent doctrine ..................................................................... 55 5.3.1 The doctrine and its nature ................................................................ 55 5.3.2 Application of the doctrine to fertility treatments ......................................................................................... 55 5.4 Mutual consent of spouses............................................................................ 56 5.4.1 Joint process ..................................................................................... 56 5.4.2 The good of the child and consideration of parental capability ............................................................................ 57 5.5 Validity of the consent .................................................................................. 58 5.5.1 Effect of the initial consent ................................................................ 58 5.5.2 Withdrawal of patient consent........................................................... 59 5.5.3 Physician’s withdrawal of consent ..................................................... 59 5.5.4 Consent after death ........................................................................... 60 5.5 Conclusion ................................................................................................... 60

6 Specific ethical and legal aspects of ART practice in eastern European countries .............................................................................. 63 Jiri Dostál 6.1 6.2

6.3

Introduction.................................................................................................. 63 Situation in eastern European countries ........................................................ 63 6.2.1 Number of centers ............................................................................ 63 6.2.2 Legal regulation of ART ..................................................................... 64 6.2.3 Coverage or reimbursement of ART ................................................... 65 6.2.4 Marital status in ART ......................................................................... 66 6.2.5 The number of transferred embryos in ART ........................................ 67 6.2.6 Cryopreservation ............................................................................... 68 6.2.7 Posthumous ART ............................................................................... 70 6.2.8 Gamete donation .............................................................................. 71 6.2.9 Anonymity ........................................................................................ 72 6.2.10 Micromanipulation ......................................................................... 73 6.2.11 In vitro maturation of oocytes ......................................................... 74 6.2.12 Welfare of the child ........................................................................ 75 6.2.13 Multifetal-pregnancy reduction ....................................................... 76 6.2.14 Preimplantation genetic diagnosis ................................................... 77 6.2.15 Surrogacy ........................................................................................ 78 6.2.16 Research on the embryo.................................................................. 79 6.2.18 Gamete intrafallopian transfer ......................................................... 81 6.2.19 The moral status of the embryo........................................................ 81 Conclusions.................................................................................................. 82

Contents

冷

vii

7 Sperm donation and sperm-bank management .................................................... 87 Dan Gong and Zheng Li 7.1 7.2

7.3 7.4 7.5

7.6 7.7 7.8

Introduction.................................................................................................. 87 Limiting the number of donor offspring......................................................... 88 7.2.1 United States..................................................................................... 88 7.2.2 United Kingdom ............................................................................... 88 Minimizing the risk of infection and genetic complications from sperm donors ....................................................................................... 89 Age requirements for sperm donors .............................................................. 89 Anonymity versus nonanonymity of sperm donors ........................................ 90 7.5.1 Anonymous sperm donation ............................................................. 90 7.5.2 Nonanonymous sperm donation ....................................................... 91 Sperm-donor compensation.......................................................................... 92 Informed consent and counseling ................................................................. 93 Conclusions.................................................................................................. 93

8 Oocyte donation: medical and legal perspectives ................................................ 95 Sarit Avraham and Daniel S. Seidman 8.1 8.2 8.3 8.4 8.5 8.6 8.7

Introduction: Indications for egg donation .................................................... 95 Preparation of donor and recipient ............................................................... 96 Outcome determining factors ....................................................................... 98 Obstetric and perinatal outcomes ................................................................. 98 Ethical aspects .............................................................................................. 99 Legislation .................................................................................................. 101 8.6.1 The new Israeli legislation ............................................................... 104 Summary .................................................................................................... 107

9 Egg donation: ethical considerations and regulatory context ....................................................................................... 111 Anna C. Mastroianni and Luigi Mastroianni Jr. 9.1 Introduction................................................................................................ 111 9.2 The regulatory context ................................................................................ 111 9.3 Donating eggs ............................................................................................ 112 9.3.1 Informed consent ............................................................................ 112 9.3.2 Meeting demand: remuneration and other programs ....................... 113 9.3.2.1 Financial compensation .................................................... 113 9.3.2.2 Egg-sharing programs ....................................................... 114 9.3.3 Other obligations ............................................................................ 115 9.4 Use of donated eggs ................................................................................... 115 9.4.1 Informed consent ............................................................................ 115 9.4.2 Nontraditional patients and access to donated eggs ........................ 115 9.4.3 Age ................................................................................................. 116 9.5 Donor identity and disclosure..................................................................... 116 9.6 Conclusions................................................................................................ 118

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10 Medical, ethical, and legal aspects of fetal reduction .................................................................................................. 121 Mark I. Evans and David W. Britt 10.1 10.2

History.................................................................................................... 121 Ethical issues .......................................................................................... 123 10.2.1 Moral compromise .................................................................... 127 10.3 Legal issues............................................................................................. 128 10.3.1 Recommendations ..................................................................... 128 10.4 Summary ................................................................................................ 129 10.5 Acknowledgments .................................................................................. 129

11 Fertility treatments in human immunodeficiency virus (HIV) infected patients ............................................................................ 131 Karen Olshtain-Pops and Shlomo Maayan 11.1 Introduction ........................................................................................... 131 11.2 HIV and the male genital tract ................................................................ 132 11.3 HIV and the female genital tract ............................................................. 133 11.4 Assisted reproductive technologies in HIV-positive patients .................... 133 11.5 Semen processing................................................................................... 134 11.6 Viral testing of spermatozoa .................................................................... 135 11.7 Success rates .......................................................................................... 135 11.8 Summary ................................................................................................ 135

12 Pregnancies in perimenopause and beyond ...................................................... 139 Yoel Shufaro and Joseph G. Schenker 12.1

12.2 12.3

12.4 12.5 12.6

Medical aspects and considerations ....................................................... 139 12.1.1 Fertility fecundity and abortions ................................................ 139 12.1.2 Pregnancy-associated physiological changes ............................. 140 12.1.3 Obstetrical and intrapartum complications ................................ 140 12.1.4 Maternal mortality..................................................................... 141 12.1.5 Neonatal outcome .................................................................... 141 Oocyte-donation programs ..................................................................... 141 Ethical aspects ........................................................................................ 142 12.3.1 The issue of choice.................................................................... 142 12.3.2 The welfare of the child............................................................. 143 Coping with the medical risks ................................................................ 143 Legislation, regulation, and religion aspects ........................................... 144 Summary ................................................................................................ 145

13 Legal control of surrogacy – international perspectives.................................... 149 K. Svitnev 13.1 13.2

Introduction ........................................................................................... 149 Surrogacy –definition ............................................................................. 149

Contents

13.3 13.4

13.5

13.6 13.7 13.8 13.9

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Surrogacy –history .................................................................................. 149 Legal control of surrogacy – international perspectives ........................................................................................... 150 13.4.1 Prohibition of Surrogacy by legislation ...................................... 150 13.4.2 Counties – surrogacy no prohibited by law ............................... 151 13.4.3 Surrogacy in China ................................................................... 152 13.4.4 Non commercial surrogacy ....................................................... 152 13.4.5 Greece Law .............................................................................. 152 13.4.6 South Africa .............................................................................. 153 Commercial surrogacy ........................................................................... 153 13.5.1 Former Countries of the Soviet Union ....................................... 153 13.5.2 India ......................................................................................... 154 13.5.3 Surrogacy in USA...................................................................... 154 13.5.4 Surrogacy in Russia ................................................................... 155 Russian Public Opinion .......................................................................... 158 Surrogacy in Islamic Countries ............................................................... 158 Cross-border Surrogacy .......................................................................... 159 Conclusions ........................................................................................... 161

14 Preimplantation genetic diagnosis in assisted reproduction: medical, ethical, and legal aspects ................................................................... 165 Anver Kuliev 14.1 14.2

14.3 14.4 14.5 14.6

Introduction ........................................................................................... 165 Biopsy methods for preimplantation genetic diagnosis ........................... 166 14.2.1 Polar-body biopsy ..................................................................... 166 14.2.2 Embryo biopsy .......................................................................... 167 Chromosomal aneuploidies in preimplantation development................................................................. 167 Chromosomal rearrangements ................................................................ 169 Impact of PGD on IVF outcome ............................................................. 170 Conclusion ............................................................................................. 172

15 Preimplantation genetic diagnosis of late-onset diseases .................................. 175 Zoltán Papp, Tibor Várkonyi, and Valéria Váradi 15.1 15.2 15.3 15.4 15.5 15.6 15.7 15.8 15.9

Introduction ........................................................................................... 175 Embryo selection .................................................................................... 177 Huntington’s disease .............................................................................. 178 Cardiovascular disorders ........................................................................ 180 Alzheimer’s disease ................................................................................ 181 Genetic testing for cancer....................................................................... 181 Breast cancer.......................................................................................... 182 Genetic counseling ................................................................................ 185 Conclusion ............................................................................................ 185

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16 Bioethics of human embryonic stem cells and cloning for stem cells: an Israeli perspective ................................................................. 189 Michel Revel 16.1 The scientific and medical aspects .......................................................... 189 16.2 Ethical issues related to human embryo stem cells.................................. 190 16.2.1 Pluralism of moral views on the preimplantation embryo.......... 190 16.2.2 Potentiality of human preimplantation embryo ......................... 191 16.2.3 Personal status of the embryo .................................................... 191 16.2.4 Therapeutic aims of human ES cells .......................................... 192 16.2.5 Pluralism of decisions on human ES cell production and research in various countries..................................................... 192 16.2.6 A case study: ethical regulations on human ES cell research in Israel ....................................................................... 194 16.3 Ethical views on cloning to obtain autologous ES cells ........................... 195 16.3.1 Bioethical arguments ................................................................ 195 16.3.2 National and international resolutions ...................................... 196 16.3.3 Case study: regulations in Israel regarding cloning for ES cells ................................................................................. 197

17 The future of human embryonic stem cell research: medical, legal, and ethical perspectives............................................................ 201 Outi Hovatta and Kenny A. Rodriguez-Wallberg 17.1 Introduction: Human embryonic stem cell research................................ 201 17.2 The first possible clinical applications of cells differentiated from hESC .............................................................................................. 201 17.3 Challenges in clinical treatment using hESC-derived cells ...................... 202 17.3.1 Microbial contamination .......................................................... 202 17.3.2 GMP and EU tissues and cells directive .................................... 202 17.3.3 Immunogenicity........................................................................ 203 17.3.4 Tumorigenicity .......................................................................... 203 17.4 iPS cells versus hESC .............................................................................. 204 17.5 Legal and ethical aspects of hESC research ............................................. 204 17.6 Conclusions ........................................................................................... 206

18 Preservation of fertility in children with cancer: medical, ethical, and legal aspects.................................................................................. 209 Ginny Ryan 18.1 Introduction ........................................................................................... 209 18.2 Population at risk ................................................................................... 210 18.3 Medical and surgical options for fertility preservation............................. 211 18.4 The ethical propriety of fertility-preservation options .............................. 212 18.5 Autonomy, justice, and treating pediatric patients ................................... 214 18.6 Ethical and legal issues with unused tissue and gametes ......................... 214

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Posthumous reproduction ....................................................................... 215 Conclusion ............................................................................................. 216

19 Fertility preservation for cancer patients: a review of current options and their advantages and disadvantages.................................. 219 Shauna Reinblatt, Barnis Ata, Einat Shalom-Paz, Seang Lin Tan, and Hananel Holzer 19.1 19.2 19.3 19.4 19.5

Introduction ........................................................................................... 219 Cancer and fertility preservation ............................................................. 219 Current options for fertility preservation ................................................. 220 Medical options: GnRH agonists ............................................................ 220 Surgical options: ovarian transposition and cryopreservation of ovarian cortical tissue ......................................................................... 221 19.5.1 Ovarian transposition ................................................................ 221 19.5.2 Cryopreservation of ovarian cortical tissue ................................. 222 19.6 ART: in vitro fertilization and in vitro maturation .................................... 223 19.6.1 Embryo and oocyte cryopreservation after ovarian stimulation.................................................................... 223 19.6.1.1 Embryo cryopreservation .......................................... 223 19.6.1.2 Oocyte cryopreservation ........................................... 224 19.6.2 Embryo and oocyte cryopreservation without prior ovarian Stimulation................................................................................ 225 19.6.3 IVM embryo cryopreservation ................................................... 226 19.6.4 IVM-oocyte vitrifi cation............................................................ 226 19.6.5 Fertility preservation: the McGill experience ............................. 227 19.7 Conclusion ............................................................................................ 227

20 Sexual orientation and use of assisted reproductive technology: social and psychological issues......................................................................... 233 Rachel G. Riskind 20.1 20.2 20.3 20.4 20.5 20.6 20.7 20.8 20.9 20.10 20.11 20.12 20.13 20.14

Introduction.......................................................................................... 233 A note about terminology ..................................................................... 233 Routes to parenthood among nonheterosexual adults ........................... 234 Legal issues surrounding sexual orientation and family formation ......... 234 Sexual orientation and incidence of parenthood ................................... 235 Sexual orientation and plans for parenthood......................................... 235 Studies of sexual orientation and plans for parenthood ......................... 236 Outcomes for children of lesbians and gay men ................................... 237 Relationships with peers ....................................................................... 237 Child behavior problems ...................................................................... 238 Gender development............................................................................ 238 Conclusions and future directions ........................................................ 239 Assisted reproduction among nonheterosexual adults ........................... 239 Barriers to ART use by nonheterosexual adults ..................................... 239

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20.15 20.16 20.17

Donor-insemination decisions .............................................................. 241 Recommendations for clinical practice................................................. 242 Conclusion ........................................................................................... 243

21 Access to fertility treatment by lesbian couples................................................ 245 Simón Marina, Fernando Marina, and David Marina 21.1 21.2 21.3 21.4 21.5 21.6 21.7

Introduction.......................................................................................... 245 Legal changes ....................................................................................... 246 Assisted reproduction ........................................................................... 249 Being a lesbian and a mother ............................................................... 250 Donor anonymity ................................................................................. 250 Ethical assessment ................................................................................ 252 A Child with two mothers ..................................................................... 254

22 ART practice and tourism ................................................................................. 257 Marcia C. Inhorn and Pasquale Patrizio 22.1 22.2 22.3

22.4

Introduction.......................................................................................... 257 Background and methods ..................................................................... 258 Major findings ...................................................................................... 259 22.3.1 The United Arab Emirates ........................................................ 261 22.3.1.1 Reproductive travel to the UAE .............................. 261 22.3.1.2 Reproductive travel from the UAE .......................... 262 22.3.1.3 Reproductive travel to and from the UAE ............... 263 22.3.2 The East Coast of the United States ......................................... 263 Conclusion ........................................................................................... 265

23 A savior child conceived by PGD/HLA: medical and ethical aspects ........................................................................................... 269 Edwin C. Hui 23.1 23.2

Introduction ........................................................................................... 269 Medical indications and social acceptance of PGD ................................ 269 23.2.1 Chromosomal abnormalities ..................................................... 269 23.2.2 Monogenic diseases.................................................................. 270 23.2.3 Adult-onset diseases and cancer-predisposing genes ................. 270 23.2.4 Creating a “savior child” ........................................................... 271 23.3 Other possible applications of PGD: savior embryos, gender selection, and designer babies .................................................... 272 23.3.1 Savior embryos ......................................................................... 272 23.3.2 Gender selection ...................................................................... 273 23.3.3 Designer babies ........................................................................ 273 23.4 Legislation and professional guidelines for the uses of PGD/HLA ........................................................................................... 274 23.5 Ethical considerations............................................................................. 274

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23.5.1 23.5.2 23.5.3 23.5.4 23.5.5 23.5.6 23.5.7

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Embryo wastage ........................................................................ 275 Moral status of the human embryo ............................................ 275 Harm of embryo biopsy ............................................................ 277 The condition of absolute medical necessity ............................. 277 PGD SC and family ethics......................................................... 279 Well-being of the savior child ................................................... 281 PGD, parental interests and public access................................. 283

24 Posthumous reproduction: ethical and legal perspectives ................................ 289 Bethany Spielman 24.1 Introduction ........................................................................................... 289 24.2 The source .............................................................................................. 290 24.2.1 What counts as consent? .......................................................... 290 24.2.2 Coercion .................................................................................. 291 24.2.3 Minors as sources ..................................................................... 292 24.3 Requesters of retrieval ............................................................................ 293 24.4 Reproductive partners ............................................................................ 294 24.5 Children ................................................................................................. 295 24.6 Summary ................................................................................................ 295

25 Human reproductive cloning: ethical perspectives ........................................... 297 David A. Jensen 25.1 Introduction ........................................................................................... 297 25.2 The potential value of HRC ..................................................................... 297 25.3 Ethical concerns with HRC ..................................................................... 301 25.4 HRC and the value of our unique genetic make-up ................................ 306 25.5 Conclusion ............................................................................................. 307

26 ART practice – religious views .......................................................................... 309 Joseph G. Schenker 26.1 Introduction............................................................................................ 309 26.2 The Jewish law ....................................................................................... 310 26.2.1 Torah......................................................................................... 310 26.2.2 The Mishnah ............................................................................. 311 26.2.3 The Talmud ............................................................................... 311 26.2.4 Post-Talmudic codes ................................................................. 311 26.2.5 Responsa .................................................................................. 311 26.2.6 Orthodox Judaism ..................................................................... 312 26.2.7 Reform Judaism......................................................................... 312 26.2.8 Conservative ............................................................................. 313 26.3 Christian denominations......................................................................... 314 26.3.1 Roman Catholic Church............................................................ 314 26.3.2 Anglican Church ....................................................................... 315

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26.3.3 The Protestant Church ............................................................... 316 26.3.4 Eastern Orthodox Church.......................................................... 316 26.4 Hinduism ............................................................................................... 317 26.5 Buddhism ............................................................................................... 318 27 A Catholic ethical perspective on human reproductive technology ................................................................................... 321 Norman Ford 27.1

Catholic position on respect for the human embryo ............................... 321 27.1.1 Biblical perspective................................................................... 321 27.1.2 Christian tradition ..................................................................... 321 27.1.3 Embryo defined......................................................................... 322 27.1.4 Catholic Christian teaching ....................................................... 322 27.1.5 A person from conception......................................................... 324 27.1.6 Ethics and destructive research on human embryos ................................................................... 324 27.1.7 Morality and personalized natural law ...................................... 325 27.1.8 Secular ethics and the human embryo ...................................... 326 27.1.9 Challenge to find ethical alternatives ........................................ 327 27.2 Catholic ethics, marriage, and reproductive technology ......................... 327 27.2.1 Catholic Christian position on children of the marriage union ............................................................... 327 27.2.2 Assisted insemination................................................................ 328 27.2.3 Rights of children and natural parents ....................................... 329 27.2.4 Donor gametes ......................................................................... 329 27.2.5 Surrogacy.................................................................................. 329 27.2.6 Access to ART by single women and lesbians ........................... 330 27.2.7 Human reproductive cloning .................................................... 330 27.3 Conclusion ............................................................................................. 330 28 Islamic laws and reproduction ......................................................................... 333 Gamal I. Serour 28.1 28.2 28.3 28.4 28.5 28.6 28.7 28.8 28.9 28.10 28.11 28.12

Islamic laws.......................................................................................... 333 Reproduction in Islam .......................................................................... 333 ART and Islam ...................................................................................... 334 Islam and various ART practices ........................................................... 335 Surrogacy ............................................................................................. 335 Multifetal pregnancy reduction ............................................................. 335 Pregnancy in postmenopause ............................................................... 335 Sex selection ........................................................................................ 336 Cryopreservation .................................................................................. 337 Embryo implantation following husband’s death................................... 337 Embryo research ................................................................................... 338 Gene therapy ....................................................................................... 338

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28.13 Cloning ................................................................................................ 339 28.14 ART practices in different Muslim countries.......................................... 339

29 Jewish law (halakha) and reproduction ............................................................ 343 Joseph G. Schenker 29.1 29.2 29.3 29.4 29.5 29.6 29.7 29.8 29.9 29.10 29.11

29.12 29.13 29.14 29.15 29.16 29.17

Introduction.......................................................................................... 343 Homosexuality ..................................................................................... 344 Lesbianism ........................................................................................... 344 Evaluation of the infertile couple .......................................................... 345 The laws of niddah ............................................................................... 345 Infertility treatment ............................................................................... 346 The beginning of human life ................................................................. 348 Artificial insemination by husband........................................................ 350 Artificial insemination by donor............................................................ 350 Oocyte donation .................................................................................. 351 Surrogacy ............................................................................................. 352 29.11.1 Legalizing surrogacy in Israel ................................................ 353 29.11.2 The state-appointed permission committee ........................... 353 29.11.2.1 Guidelines set by the committee for surrogacy ..................................................... 353 29.11.2.2 Expenses ........................................................... 354 29.11.2.3 Legal status of the newborn ............................... 354 29.11.2.4 Surrogate mother’s withdrawal from the agreement ........................................... 354 29.11.2.5 Legal rights of the surrogate mother ................... 355 29.11.2.6 Enforcement of the law ...................................... 355 29.11.2.7 Right to privacy ................................................. 355 29.11.2.8 Illegal financing ................................................. 355 29.11.2.9 Legal adoption .................................................. 355 Fetal reduction ..................................................................................... 356 Gender preselection ............................................................................. 357 Cryopreservation .................................................................................. 357 Posthumous reproduction ..................................................................... 358 Cloning ................................................................................................ 359 Preembryo research .............................................................................. 360

30 Commercialized assisted reproduction ............................................................. 363 Filip Krˇepelka 30.1 Position of reproductive treatment in the economy .................................... 363 30.2 Commercialization of assisted reproduction .............................................. 363 30.3 Divergent national policies toward reproductive treatment ........................ 363 30.4 International economic integration and assisted reproduction.................... 364 30.5 Absence of effective restrictions on reproductive tourism ........................... 365

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30.6 Natural barriers to reproductive tourism .................................................... 365 30.7 Intellectual property and assisted reproduction .......................................... 366 30.8 Doing business in the reproductive industry .............................................. 366 30.9 Assisted reproduction in united Europe ...................................................... 367 30.9.1 Case study: German patients in Czech centers ................................ 368

31 The intersection between economic and ethical aspects of ART ....................... 371 Georgina M. Chambers 31.1 Introduction ........................................................................................... 371 31.2 A framework for economic and ethical aspects of ART ........................... 372 31.3 Distributive justice and funding of ART .................................................. 373 31.3.1 International differences in funding........................................... 373 31.3.2 Provision of ART in developing countries .................................. 376 31.3.3 Morally challenging funding decisions ...................................... 377 31.4 The cost of ART treatment ....................................................................... 377 31.4.1 Treatment costs ......................................................................... 377 31.4.2 The costs of multiple births ....................................................... 378 31.4.3 Valuing ART treatment from an economic perspective............... 380 31.5 The affordability of ART treatment and its implications ........................... 381 31.5.1 Affordability and utilization ...................................................... 381 31.5.2 Affordability and clinical practice ............................................. 384 31.5.2.1 It makes economic as well as clinical sense to reduce multiple-births .......................................................... 385 31.6 Conclusion ............................................................................................. 386

Preface

Medical ethics have undergone many and significant changes from antiquity to our era. In fact, it continues to change and to reshape constantly both in theory and in practice. The role of medical ethics in individual patient-physician relationships as well as in public matters is growing along with the major and rapid changes in health and life sciences. It is very important for caregivers and health care policymakers as well as for the public at large to be sensitive to ethical dilemmas and ethical debates and solutions. It is equally important for ethicists to be sensitive to public input and concerns. This mutual awareness and sensitivity will bring about better solutions to troublesome ethical dilemmas in modern medicine. Infertility has been a major medical and social preoccupation since the dawn of human existence. There are many stories of women in the Bible who struggle with infertility and the pain of not having children. The Bible not only shares the stories of these "barren women" but also offers hope and comfort during these times. Though infertility is as much a male problem as it is a female problem, people throughout history have attempted to place the blame solely on the woman's womb. At present millennium infertility affects millions people worldwide. Most of those who suffer from infertility live in developing countries where infertility services in general and assisted reproductive technology (ART) is not available. Infertility is a source of social and psychological suffering for both men and women and can place great pressures on the relationship of the couple. For a woman in developed countries the struggle with infertility can be an enormous psychological and emotional burden. The low status of women in developing countries where womanhood is defined through motherhood reproduction is a social issue, controlled by family and religious customs, and not merely a personal choice. A stigma of being childless puts pressure on the couple to have children, and for many infertile couples, infertility is a life crisis. It may translate into very serious consequences, such as divorce, husbands taking second wives, difficulties with in-laws, domestic violence and economic abandonment. Scientific advances in the field of human reproduction and genetics, the two areas of medicine that deal with infertility, have brought encouraging results. Couples who wouldn't have known the joy of being biological parents are now bringing home healthy offspring and in some cases, multiple babies, The right to procreate has been considered to be the basic human right as was pronounced in 1948, by the United Nations Universal Declaration of Human Rights “that men and women of full age, without limits due to age, race, nationality, or religion, have the right to form a family.” Similar statements were several times reconfirmed by different international declaration and Acts during the last half century. The right to reproduce has gained importance in the modern era owing to technical advances in assisted reproduction.

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ART (assisted reproductive technology) was originally developed for women with tubal factor infertility. During the last three decades there have been major advances in the development of improved drugs, individualized protocols for ovarian stimulation, the introduction of advanced laboratory techniques such as those involving embryo culturing methods, intracytoplasmic sperm injection, and enhanced egg/embryo freezing through vitrification. These have expanded the indications for IVF so that today it has become a first line of treatment for a variety of causes of infertility. It is now estimated that 5 million infants have been born worldwide following ART treatment. In many countries ART children now account for 2–4% of all children born. Preimplantation genetic diagnosis (PGD) is becoming an established tool in assisted reproduction for avoiding the transfer of the embryos with chromosomal abnormalities, which contributes significantly to implantation failure and pregnancy loss. PGD may avoid distress and increase the chance of a successful pregnancy. It also avoids the ethical dilemma of abortion if the fetus is found to have a lethal or profound disorder. The use of PGD is now being extended to include gene mutations that increase the risk of late-onset disorders such as breast and ovarian cancer. The extension of PGD raises practical ethical issues involving relative burdens, duty of care, freedom of choice, distributive justice. To date, successful results based on pregnancy rates have been obtained with cryopreserved spermatozoa, embryos, oocytes and ovarian tissue In cases of severe male infertility, such as non-obstructive azoospermia after testicular sperm retrieval, no sperm confirmed, and some male genetic diseases, the use of donor sperm is often the only approach for infertile couples to father children. As demand for sperm banks and sperm bank services continues to rise, health and ethical considerations on behalf of the sperm donor, the sperm recipient, and donor offspring remain critical issues to consider. The original aim of embryo cryopreservation was to reduce the number of embryos transferred in order to limit the well documented risk of multiple gestations. It was proved that cryopreservation of embryos offers practical, financial and social benefits. Human oocyte cryopreservation is potentially an alternative solution to the ethical legal or religious problems arising from embryo storage. Human ovarian tissue banking is proposed as a method of preserving female fertility especially in cancer patients of reproductive age. It offers the potential of restoring normal ovarian function and natural fertility. Delayed age of childbearing is increasing in industrialized nations and is related to deferment of marriage and postponement of pregnancy in marriage, as well as frequent occurrence of divorce and remarriage. More women in their late 30s to early 40s are now seeking their first pregnancy. Oocyte donation is a common form of third-party reproduction, associated with significant success rates. It gives older couples an opportunity to bear children, almost regardless of the maternal age. Oocyte donation raises a number of ethical issues, not only for donors and recipients but also for reproductive medicine professionals, offspring, and society in general. This raises the question of whether certain limits should be imposed in applying the method in older women. Since the introduction of IVF, advances in assisted reproduction technologies have resulted in the creation of family types that would not otherwise have existed. With IVF using the father's spermatozoa and the mothers oocyte, the child is genetically related to both parents, whereas children conceived by donor insemination are genetically

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related to the mother but not the father, and children conceived using donated oocytes are genetically related to the father but not the mother. When both egg and spermatozoa are donated, the child is not genetically related to either parent. This latter group of children is similar to adopted children in that they are genetically unrelated to both parents. In the case of surrogacy, the child may be genetically related to neither one or both parents, depending on the use of a donated egg and/or spermatozoa. Despite the changes that have occurred in society during the past few years the most widely accepted structure of the family remains that comprising two heterosexual married parents who are genetically related to their children. Families that have resulted through assisted reproduction, although continuously increasing in number, may differ from the normal, either because of a non-genetic relationship of one or both parents with the offspring. Surrogacy enables gay couples who desire to be parents.A growing number of single heterosexual women, lesbian women and gay men are opting for assisted reproduction. Non-heterosexual adults who want to become parents may have to overcome legal, social, and /or financial barriers to achieve this goal. Gay and lesbians endorsed the value of parenthood just as strongly as did their heterosexual peers, despite being less likely to express parenting intentions and desires. The right to reproduce is not recognized for homosexual couples in most countries. IVF contributed to the development of human embryonic stem cell lines. From the first derivations of permanent human embryonic stem cell lines, a huge amount of new information regarding early human development, use of pluripotent stem cells in regenerative medicine, and pharmaceutical and toxicity testing has followed. Ethical debates have surrounded the development of human embryonic stem cell research. The ethical position of individual societies and countries on obtaining stem cells from supernumerary embryos, there by ending their capacity to develop, derives from considerations on the moral status of preimplantation embryos, status that is itself contingent on cultural, religious, or philosophical considerations on the beginning of human life. Human reproductive for the sake of producing a child that will, in principle, grow into adulthood as a normal member of society is to be distinguished from therapeutic cloning and cloning with research aims. United Nations Declaration on Human Cloning calling for the ban of all forms of Human Cloning contrary to human dignity, was adopted Ethical issues raised by ART have been found to be so profound that several countries have created national commissions to propose legal regulatory discipline. In the present situation at this time the methods of legal regulation of ART may be divided into three categories: 1. Legal regulation under the law – a set of rules passed in the legislative process and containing penalties for nonobservance. 2. Legal regulation under various guidelines. 3. Without legal regulation. In most cases, the treatments by ART are invasive and performed solely on the woman. The medical achievements that make it possible to conceive, other than naturally, via donation of gametes, surrogacy and even posthumously, mandate a different approach to fertility-treatment consent than that required for other medical treatments. This is so due to certain unique characteristics of fertility treatments: the aim of fertility treatment and the measure of its success is the creation of a live newborn infant. Hence, the good of the future child should be considered, as should the patients’ capability to undertake parental responsibility.

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The developments in reproductive medicine raise new ethical questions for different religions that do not always have clear answers. It is important to those who practice reproductive techniques to learn about different religious perspectives related to reproductive-health problems. Religious groups are active in influencing the public with bioethical positions, and this is particularly evident with issues concerning procreation, abortion, and infertility therapy. Religious leaders in some countries still exert a powerful influence on the development and practice of reproductive technology. The attitude toward ART varies among different Christian Dominations. The Vatican statement on assisted reproduction is very clear; ART is not acceptable. The Catholic Church argues that IVF involves disregard for human life and separates human procreation from sexual intercourse. There are basic principles in Jewish Law – Halakha, that with certain restrictions favor ART. First and foremost is the commandment in The Bible "Be fruitful and multiply". Judaism allows the practice of all techniques of assisted reproduction when the sperm originates from the husband. The primary sources of Sharia have affirmed the importance of marriage, family formation, and procreation, as indicated in several verses of the Koran Today, the guidelines – fatwa that are followed by most Sunni Muslims are as follows: If assisted reproduction is indicated in a married couple as a necessary line of treatment, it is permitted within the validity of a marriage contract with no mixing of genes, but if the marriage contract has come to an end because of divorce or death of the husband, ART cannot be performed on the female partner, even when using sperm cells from her former husband. Shia guidelines, via fatwa, are even more liberal, have opened the way to a third-party donation. This fatwa allows third-party participation, including egg donation, sperm donation, embryo donation, and surrogacy. The book offers expert reviews and valuable scientific articles on a wide variety of controversial topics about the ethical dilemmas in ART. It presents a unique collection of 31 chapters by contributors from different countries, from a wide range of disciplines which include physicians applying assisted reproductive technologies for infertile patients, ethicists, lawyers, theologians and sociologists. The contributing authors were chosen for recognized international authority in their respective areas and for their ability to transmit information in a manner that is lucid and interesting. I sincerely hope that the readers of this book will find in it sufficient new information regarding ethical, legal and religious innovative approaches for ART practice. I want to thank each and every author for the tremendous time and energy spent in writing manuscripts for this book Joseph G Schenker

Author index

Barnis Ata, MD Department of Obstetrics and Gynecology McGill University Montreal, Canada [email protected] Sarit Avraham, MD Department of Obstetrics and Gynecology Tel Aviv University Tel Aviv, Israel [email protected] Giuseppe Benagiano, MD Department of Obstetrics, Gynecology, and Urology Sapienza, University of Rome Rome, Italy [email protected] David W. Britt Comprehensive Genetics Fetal Medicine Foundation of America New York, USA [email protected] Georgina M. Chambers, PhD Perinatal and Reproductive Epidemiology Research Unit University of New South Wales Randwick, Australia [email protected] Sabina Carrara Department of Obstetrics, Gynecology, and Urology Sapienza, University of Rome Rome, Italy Bernard M. Dickens, PhD, LLD Faculty of Law University of Toronto Ontario, Canada [email protected]

Jiri Dostál, PhD Centrum Assisted Reproduction Brno, Czech Republic [email protected] Mark I. Evans, MD Comprehensive Genetics Fetal Medicine Foundation of America and Mt. Sinai School of Medicine New York, USA [email protected] Valentina Filippi Department of Obstetrics, Gynecology, and Urology Sapienza, University of Rome Rome, Italy Rev. Dr. Norman Ford SDB Catholic Theological College Melbourne, Australia [email protected] Dan Gong Harvard College Harvard University Cambridge, Massachusetts, USA [email protected] Hananel Holzer, MD Department of Obstetrics and Gynecology McGill University Montreal, Canada [email protected] Outi Hovatta, PhD Karolinska Institute and Karolinska University Hospital Huddinge Stockholm, Sweden [email protected] Edwin C. Hui, PhD Li Ka Shing Faculty of Medicine University of Hong Kong Hong Kong, China [email protected]

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Marcia C. Inhorn, PhD Department of Obstetrics and Gynecology and of Anthropology Yale University New Haven, Connecticut, USA [email protected] David A. Jensen, PhD Department of Philosophy Brigham Young University Provo, Utah, USA davidj@byu Harpreet Kaur, DOG Bangalore Assisted Conception Centre Bangalore, India [email protected] Filip Krˇepelka, PhD Masarykova Univerzita Brno, Czech Republic fi[email protected] Anver Kuliev, MD, PhD Reproductive Genetics Institute Chicago, Illinois, USA [email protected] Zheng Li MD, PhD Renji Hospital Shanghai Jiao Tong University School of Medicine Shanghai, China [email protected] Anna C. Mastroianni, PhD School of Law and Institute for Public Health Genetics University of Washington Seattle, Washington, USA [email protected]

David Marina, MD Instituto de Reproducción CEFER Barcelona, Spain [email protected] Fernando Marina, MD Instituto de Reproducción CEFER Barcelona, Spain [email protected] Simón Marina, MD Instituto de Reproducción CEFER Barcelona, Spain [email protected] Karen Olshtain-Pops, MD HIV Unit Hadassah Medical Center Jerusalem, Israel [email protected] Zoltán Papp, MD Department of Obstetrics and Gynecology Semmelweis University Budapest, Hungary [email protected] Pasquale Patrizio, MD, MBE, HCLD Yale Fertility Center Yale University New Haven, Connecticut, USA [email protected] Kamini A. Rao, MD Bangalore Assisted Conception Centre Bangalore, India [email protected]

Luigi Mastroianni Jr. MD†

Shauna Reinblatt, MD Department of Obstetrics and Gynecology McGill University Montreal, Canada

Shlomo Maayan, MD HIV Unit Hadassah Medical Center Jerusalem, Israel [email protected]

Michel Revel, PhD Weizmann Institute of Science Department of Molecular Genetics Rehovot, Israel [email protected]

Author index

Rachel G. Riskind, PhD Department of Psychology University of Virginia Charlottesville, Virginia, USA [email protected] Kenny A. Rodriguez-Wallberg, PhD Karolinska Institute and Karolinska University Hospital Huddinge Stockholm, Sweden Ginny Ryan, MD, MA Division of Reproductive Endocrinology and Infertility Carver College of Medicine University of Iowa Iowa City, Iowa, USA [email protected] Joseph G. Schenker, MD, FRCOG, FACOG Department of Obstetrics and Gynecology Hebrew University Hadassah Medical Center Jerusalem, Israel [email protected] Daniel S. Seidman, MD, MCSc Sackler School of Medicine Tel-Aviv University Tel-Aviv, Israel [email protected]

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Bethany Spielman, PhD, JD Department of Medical Humanities and Health Law Southern Illinois University Carbondale, Illinois, USA [email protected] Avraham Steinberg, MD Medical Ethics Unit Shaare Zedek Medical Center Jerusalem, Israel [email protected] K. Svitnev Rosjurconsulting Reproductive Law and Ethics Research Centre Moscow, Russia [email protected] Seang Lin Tan, MD Department of Obstetrics and Gynecology McGill University Montreal, Canada [email protected] Valéria Váradi, MD Department of Obstetrics and Gynecology Semmelweis University Budapest, Hungary valeria [email protected]

Gamal I. Serour, MD, PhD International Islamic Center for Population Studies and Research Al Azhar University Cairo, Egypt [email protected]

Tibor Várkonyi, MD Department of Obstetrics and Gynecology Semmelweis University Budapest, Hungary [email protected]

Einat Shalom-Paz, MD Department of Obstetrics and Gynecology McGill University Montreal, Canada

Yosi Green, PhD Netanya College School of Law Netanya, Israel [email protected]

Yoel Shufaro, MD Department of Obstetrics and Gynecology Hebrew University Hadassah Medical Center Jerusalem, Israel [email protected]

1 The foundations and application of medical ethics Avraham Steinberg 1.1 Introduction Ethics is the branch of philosophy that deals with moral aspects of human behavior.1 Medical ethics, in the narrow historical sense, refers to a group of guidelines, such as the Oath of Hippocrates, generally written by physicians, about the physician’s ideal relationship to peers and to patients. Medical ethics, in the modern sense, refers to the application of general and fundamental ethical principles to clinical practice situations, including medical research. Individuals from various disciplines may author these principles. In recent years, the term has been modified to biomedical ethics, which includes ethical principles relating to all branches of knowledge about life and health. Thus, fields not directly related to the practice of physicians, such as nursing, pharmacy, genetics, social work, psychology, physiotherapy, occupational therapy, speech therapy, and the like, are included. In addition, bioethics addresses issues of medical administration, medical economics, industrial medicine, epidemiology, legal medicine, and treatment of animals, as well as environmental issues.

1.2 Historical background Since the beginning of human history, concern for medical ethics has been expressed in the form of laws, decrees, assumptions, and oaths prepared for or by physicians. Among the oldest of these are the Babylonian Code of Hammurabi (approximately 1750 BCE), Egyptian papyri, Indian and Chinese writings, and the works early Greek writers, most notably Hippocrates (460–377 BCE). Early medical ethical codes were written by individuals or by small groups of people, usually physicians. The Oath of Hippocrates is considered historically to be the first such code written in an organized and logical way that describes the proper relationships between physician and patient. During the Middle Ages, other medical codes were written. In more recent times, Thomas Percival’s writings, disseminated in 1803, represent one of the first ethical codes in the United States and the Western world (Chapman 1979). Beginning in the second half of the 19th century, medical organizations began writing codes of medical ethics: • The first ethics code of the American Medical Association (AMA) was published in 1847 (Baker 1997). This was the first ethical code of a professional organization that outlined the rights of patients and caregivers. Over the years, many revisions and additions to this original code have been made. The latest edition of the AMA Code of Medical Ethics (www.ama-assn.org, June 2001) contains four parts, which include general principles, opinions on specific issues, and special reports. The AMA established the Council on Ethical and Judicial Affairs to advise it on legal and ethical issues and to prepare position papers on these issues for the AMA.

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• The British Medical Association published its first code of Medical Conduct of Physicians in 1858. The code has subsequently undergone numerous changes. • The World Health Organization issued the Declaration of Geneva in 1948, the first worldwide medical ethical code, which is modeled after the Oath of Hippocrates. • Many other medical organizations throughout the world, including those in Israel, have issued medical ethical codes. Modern medical ethics as a separate field began to develop in the 1950s. One of the major innovations of modern Western medical ethics involves the physician-patient relationship, with a dramatic change from paternalism to autonomy and its resultant requirement for informing the patient, obtaining informed consent, and relating to the patient as an active partner in decision making.

1.3 General ethical theories and principles The study of ethical theories provides a logical framework for the understanding of the ethical dimensions of human conduct and helps one recognize ethical dilemmas and provides tools for their resolution. Ethics examines and measures human conduct. Accepted practices of human conduct in a given country are termed normative behavior. Ethical standards are used to evaluate and ensure the appropriateness and desirability of such practices. A value usually denotes the good and the beneficial in ethics, the truth in cognition, and the holy in religion. A value is not determined objectively. It is not a scientific term and cannot be scientifically defined. Therefore, science is neutral with respect to most bioethical values. A value represents a subjective assessment and may be measured by what a person is willing to sacrifice for it and not by what it gives to him. Ethical dilemmas are created only in relation to human beings, within the framework of relations between one human being and another. They arise when two or more alternative actions, each of which is inherently good, yield conflicting outcomes. Alternately, an action that benefits one person may cause harm to another. In such situations, one must find the ethical justification for each course of action and have a system of prioritization to select the most appropriate one. Ethics asks what should be done, not what one ordinarily does and not what one could do. The two central questions in ethical theories follow: • What is the good for which we strive or should strive, and what is the evil that we would like to or must avoid? • What is the proper or desired course of action, and what is the inappropriate or forbidden course of action? Some people believe the two questions are interrelated and debate which comes first and which the corollary is. Others totally separate the two questions. Sometimes, the dilemma is factual, and not one of values. In such cases, debates and discussions may result from imprecise knowledge about the facts related to the dilemma either due to lack of actual information or to lack of clarity or understanding of positions and views about the issues. Often, mere clarification of the facts may

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resolve the ethical question. Good ethics starts with the correct facts. A decision is inherently unethical if it is based on erroneous or incomplete data. Therefore, the first step in adjudicating a concrete medical ethical issue is to gather the pertinent facts. Proper clarification of the facts often avoids futile ethical debates. Sometimes, debates result from differences in the fundamental positions of the people involved. Even in such cases, a clear and precise presentation of the various positions may achieve mutual respect, precision of ethical focus, and sometimes even resolution of the ethical dilemma, even if a consensus is not reached. Ethical dilemmas would not exist if ethical principles were like parallel lines that never intersect. However, in reality, values do not function in that way. Rather, they go in different directions and involve situations where values conflict with each other. Then, one must choose between good and bad values or between values of greater or lesser utility. Sometimes, resolution of an ethical problem is easy, with a single, course of action all parties agreed on. At other times, the resolution is a compromise between opposing interests, with no one totally satisfied. Theoretically, ethics should decide between good and bad, between proper and improper, between correct and incorrect. But a proverb says, “A wise person is not the one who knows how to choose good from bad, but he who chooses the lesser of two evils.” Ethical acts can be evaluated on four planes: • the desire, intent, or motivation • the ethical principle, theory, or value • the method • the consequences Various ethical teachings emphasize one or more of these planes, and some utilize all four. At times, one needs to consider specific circumstances, which may be temporary or changing, or one needs to find a middle path between opposing and contradictory values. Ethics differs from precise science in several ways: • One cannot readily subject ethical questions to controlled experimentation and study, and one cannot separate purely ethical considerations from personalsubjective influences also affected by cultural and historical backgrounds. Since ethical decisions are influenced by historical, philosophical, sociocultural, and religious attitudes, each with strong subjective components, there are few universal objective truths. The most widely used terms in ethics are good or bad, proper or improper, and correct or incorrect. In contrast, in the physical and natural sciences, we arrive at specific conclusions based on objective observations or experiments with minimal human biases. Therefore, the terms used in science are true and false. • Science arrives at conclusions, whereas ethics provides decisions or recommendations. A conclusion is the obligatory acceptance of the facts, whereas a decision or recommendation is a voluntary choice among various options. Furthermore, a scientific conclusion is based on the past (i.e., on previous studies that lead to present conclusions). Ethics, on the other hand, is future oriented: A present choice is based on a future desire, intent, or consequence. Thus, the word cause is a scientific term

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that explains a current situation based on earlier data, whereas the words reason and argument are value terms that attempt to justify current action based on desires or motives. • If an error is discovered in scientific knowledge, the scientist can correct it by explaining the facts differently without being required to change personal conduct. By contrast, if an error is discovered in a value judgment or in ethical conduct, repentance and a change in the person’s behavior is required. In science, only success of the effort is considered significant, whereas in ethics, the effort itself in trying to resolve the dilemma is considered worthwhile. Many scholars in ethics and religion believe that the attainment of perfection should not be the ultimate goal. Rather, the goal should be the effort to gain perfection, since its actual attainment is all but an impossibility for a human being. This is also true from a religious point of view – it is erroneous to believe that a person is obligated to recognize the truth; rather, one must seek the truth, since absolute truth is only with God. Ethics also differs from laws and religion in that the latter two provide definitive and absolute rulings. By contrast, ethics in general does not decide absolutely, but rather focuses and clarifies questions and issues and presents options and alternatives for dilemma resolution. There have always existed various ethical schools of thought, with significant differences between them. They differ in the principal justifications and validity of the various ethical theories as well as in the terminologies, the specific principles and rules, the relative relationship between them, and their practical application. One of the basic ethical questions is the source and validity of values. Ancient Greek philosophers debated this issue. Plato and the stoics argued that the validity of moral cognition is absolute and objective and that universal ethical laws and principles apply to all people in all places and at all times. By contrast, the Sophist and Skeptic philosophers argued that one cannot prove or justify a universal ethical law or value, and they believed that ethical principles are relative, and dependent on the place, the time, and the circumstances. An intermediate view was that of Pythagoras and his followers, who said that certain values and norms exist for certain populations but may vary in different cultures and be influenced by external circumstances. These basic differences of opinion remain even in modern times. Some philosophers view most or even all values merely as subjective recommendations that differ from society to society and from era to era and, according to the circumstances, even from person to person. This view is based on the observation that various actions are perceived differently by various societies and various people. According to this view, ethical values are not innate but must be acquired and hence are influenced by forces that determine various types of behavior. Some philosophers define the source of ethics to be one’s emotions; an action is ethical if it makes one feel content and good, and unethical if it evokes a feeling of disgust and revulsion. Others, such as David Hume, Baruch Spinoza, and Lana Stermac, espouse the view that an action is ethical if it produces joy, and unethical if it leads to sadness. According to these views, emotions and social habits are the sources for the validity of ethics. By contrast, some philosophers recognize absolute and universal values that change neither according to external needs and circumstances nor from society to society or from era to era. The source of these values is either factual-empiric, intuitive, or

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metaphysical-religious. This view is based on the thesis that certain values and conduct are universally accepted as ethical or unethical in all societies and in all eras. This view also asserts that relativism is unfounded, unjust, and empties ethics of any real content, since it changes with differing temporal circumstances and conditions. (The main proponent of this view is Immanuel Kant.) Two basic theories exist today in the fundamental approach to normative ethics. The utilitarian (or consequential or teleologic) theory measures the value of an action by its consequences: An appropriate or good action is one that brings the most beneficial results for the most people. This view, in its classic sense, opines that the goal of ethics is to bring the most good to the most people so that ethical principles are used as vehicles to attain the highest or ultimate good. Ethics thus has a specific goal, and each action is taken to achieve that goal. There is obviously great variability in deciding what is the ultimate good toward which attainment one is to strive. Some view a specific individual goal as the ultimate good (= a monistic view; the main proponents of this view are Epicurus, Spinoza, and Friedrich Nietzsche), be it happiness (the main proponents of this view are Aristotle, Socrates, and the Greek Stoics, and in modern times John Stuart Mill), self-fulfillment (proposed by Georg Wilhelm Friedrich Hegel and F. H. Bradley), or pleasure (= hedonism). Thus, the individual’s own opinion is decisive and any action that gives that person benefit is by definition ethical and good. Others believe that the good should be a general one for society and not just for the individual. Thus, an action is ethical if it brings great pleasure to the largest possible number of people. (The main proponents of this view are Hume and Jeremy Bentham.) Some view the attainment of physical pleasure to be the ultimate good, whereas others consider mental pleasure and benefit to be the crowning ethical consideration. By contrast, some philosophers argue that there is no single purpose that is the sole good; rather, several goals should be sought (= a pluralistic view, espoused by Richard D. Mohr). Examples of good goals are love, health, happiness, friendship, and beauty, each one of which is an ultimate good in itself. Therefore, ethical acts need to be assessed on the basis of the greatest progress that they produce toward the conglomerate of these values and not just on the pleasure and avoidance of suffering achieved. A third utilitarian view is that the best goal is to promote individual preferences toward the fulfillment of personal desires and ambitions; the main goal is the realization of what the individual or the group view as good for them, within specific conditions and time frameworks. Utilitarianism has been strongly criticized for many reasons, including the following: • It is based on the ability to measure the good consequences and compare between various goods. How can one, however, measure individual ethical units of goods such as pleasure, happiness, love, etc.? • In many concrete situations, it is very difficult to weigh the expected benefit if varying and conflicting actions are taking place. • It is impossible to prove with certainty that a single value is the ultimate good for which one should strive. The choice of pleasure as the ultimate good is open to debate, just as is the choice of any other simple value.

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• Utilitarianism lacks ethical consistency in decision making because it changes with different expected outcomes. • It can easily lead to unjust social actions in that actions that benefit the majority of people may create serious harm to the remaining minority. In a utilitarian system, who decides what should be the best outcome, and how does one decide? The subgroup that views individual preferences as the ultimate good resolves this question but produces a much more difficult issue, in that often other peoples’ desires and preferences are ignored. Thus, utilitarianism can undermine the whole ethical foundation of universal applicability. The main theoretical objection to utilitarianism is its premise that ethical acts themselves have no intrinsic value because their ethical validity is based on their outcomes or consequences. Thus, the goal justifies the means. Hence, some acts can be ethically wrong but are justified because their outcome produces the desired benefit as defined above. The second theory of ethics, the deontological (deos, in Greek, means obligation), states that an act is considered ethically proper and good if it fulfills the basic requirements of ethical principles and values of intrinsic validity, without regard to the expected or anticipated consequences. The main proponent of the deontological theory of ethics in its extreme form is Immanuel Kant (1724–1804) (Kant 1964). According to his theory, there exist ethical values that dictate actions categorically without compromise. The source of ethics is logical, universal, and unchanging – irrespective of time or place. The ultimate good is for decisions to be made based on one’s intent to act ethically, and not on the result or outcome of that act. Only good intentions are good, without reservation. Kant’s thesis is that one must act ethically because of the autonomy of one’s will and not because of pressure, inclination or external forces of any kind (= heteronomy). The philosophic basis of this theory of ethics is that the ethical value of an act flows from an obligation, and the latter is the fulfillment of one’s autonomous will established by the laws of understanding and wisdom. According to Kant, ethical behavior is required of all people of understanding. It is not learned by experience but is established a priori by that understanding. Therefore, ethical law is objective and absolute and nothing can restrict it or attach conditions to it. One of Kant’s fundamental rules is the general formula, whereby a person must always act in a way that everyone else should act similarly. The deontological theory of ethics has also been strongly criticized for several reasons: • Pragmatically, it is difficult to determine who decides on absolute values and how they are implemented. • The extreme view of this theory, which completely ignores the goals and consequences of actions, cannot be applied practically, because the absolutism often leads to impossible situations in daily living and may produce great harm. • The deontological theory provides no mechanism to decide between two or more universal-absolute values when they are in conflict with each other. Situations frequently arise requiring a choice between two absolute values. There is no way, in Kant’s approach, to apply his general principles to such specific situations.

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A number of neo-Kantian theories developed trying to resolve the above difficulties. For example, some writers combine deontology with utilitarianism (the main proponent of this view is W. D. Ross (1939) and require one to pay attention to absolute and universal values which every decent human being should follow (= prima facie obligation). If, however, they conflict with equal or even stronger ethical imperatives in certain situations, the latter may have to be adopted and the universal values set aside. Another attempt at resolving the difficulties with the Kantian approach is to emphasize the principles of honesty, equality, and social justice. In this view, ethical principles are those that all people would agree should they be evaluated freely and independently of the actual social situation, were they to examine them from an original position (Rawls 1971). In their view, social justice is the highest ethical value, and different characteristics of individual people are ignored. Because every well-defined ethical theory has its problems, either in relation to its characteristics or in relation to its practical application, some writers speak of relativistic or situational ethics that are determined by the situation, the time, the place, the culture, etc. Thus, according to this approach, there are no universal principles applicable at all times, in all places, and for all situations. Rather, each situation is decided according to the appropriate culture, time, place, and circumstances. This view can undermine the basis of ethics and morality and leads to ethical anarchy. It is not helpful in resolving ethical questions in a consistent manner. In recent years, several fundamental ethical principles have been formulated and widely adopted as the basis for ethical discussion in medicine:2 Autonomy is defined as a fundamental principle based on the worldview that every person has an intrinsic value. One may not restrict nor negate the free wishes of an individual with respect to his own body. One must facilitate any desired action acceptable to a person’s own judgment and in accordance with her own choice. The granting of autonomy requires that we recognize and accept the free choice of each person even if that choice seems inappropriate or foolish or even dangerous. A precondition for autonomy is complete freedom of the individual from outside control or pressure. Any action that derives from external control which interferes with one’s expression of autonomy is termed heteronomy. By definition, proper, full autonomy cannot be exercised by the very young, the mentally retarded, or the psychotic. Also, autonomy is not to be respected if such a choice is likely to harm others. Many ethicists view autonomy as the most important ethical principle, one that supersedes all others (Engelhardt 1986). In recent years, the tendency is to decide more and more medical ethical and legal dilemmas according to this principle. Other ethicists view autonomy as only one of several important ethical principles (Pellegrino and Thomas 1988). This view is based on the recognition that one should not totally abandon other ethical principles regarding a physician’s obligations toward patients. Some writers even consider it “tyrannical” to view autonomy as the most important value with dominance over all others (Glick 1997), and believe that such a practice might lead to public ethical anarchy (Steinberg 1994). One should also recognize that the Western world’s espousal of autonomy is not universally accepted in all societies and cultures. Therefore, some writers state that unrestricted autonomy is culturally dependent (Glick 1997). Autonomy is not only the privilege of the patient. It is universally agreed that the physician’s autonomy, too, must be respected. A physician may refuse a patient’s request for a therapy that has no scientific or rational basis, especially if it may be harmful to the patient.

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Also, a physician may refuse to implement a patient’s decision for a certain treatment if it conflicts with the physician’s conscience, for whatever reason. In such situations, the physician has the right not to treat the patient and to transfer such care to another physician. Nonmaleficence (= primum non nocere) is defined as the obligation not to harm others and to remove and prevent potential harm (Frankena 1973). Thus, one must not only prevent intentional harm but must also be appropriately cautious not to cause harm. Health care workers must be properly trained so that they not inflict harm because of lack of knowledge or lack of appropriate skills. This concept of nonmaleficence is applied to the relationship between physician and patient based on the phrase “Above all, do no harm.” Some writers state that nowadays, nonmaleficence should be redefined as the principle of striving not to do harm, by balancing the benefit against the harm of any specific action. However, this ethical principle of not doing harm should not be absolute and cannot be applied fully in all diagnostic and therapeutic interventions (Brewin 1994; Gillon 1985). The cause for this change in the definition of nonmaleficence relates to the major changes in the practice of medicine today as compared to that practiced in antiquity. Beneficence is defined as the moral obligation to do good for others, and to help them in an active way. Ethically, it is not enough to avoid doing harm; one must actively do good to others. Obviously, there are limits to the requirement that one act to help others at all times. These vary with the degree of need, the ease and ability with which the help can be rendered, and the nature of the relationship between the individual needing help and the one able to provide it. Justice is the granting and fulfillment of legitimate rights of others, and injustice is the denial of these rights. Justice requires the division of rights and assets in an equitable and appropriate manner, but no less so the fair distribution of duties and burdens. In the simplistic sense, justice means “equality.” However, in daily life, many variables cause unequal division of obligations and rights. Therefore, several ethical theories and techniques have been developed for distributive justice, taking into consideration needs, rights, contributions to society, and other factors. Different theories of justice place greater priority on different factors: Marxism emphasizes economic needs, while liberalism emphasizes social needs. The differences in views and emphases make it difficult to attain ideal justice, since equality in one aspect may bring inequality in another and, hence, injustice. Rights – Beginning in the 19th century, individual rights became a cornerstone in political, legal, and social thinking. Some believe that people have absolute moral rights unrelated to changing social conditions. These include natural universal rights such as the right to life, liberty, and privacy. Others believe that rights flow from societal consensus, customs, and laws and therefore are relative and may change according to the circumstances.

1.4 Modern medical ethics Modern medical ethics is based on concepts derived from various disciplines, including the biomedical sciences, the behavioral sciences, philosophy, religion, and law. Modern medical ethics is essentially a form of applied ethics, which seeks to clarify ethical questions that characterize the practice of medicine and to justify and weigh the various

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practical options and considerations. Thus, medical ethics is the application of general ethical principles to ethical issues. The application of such an ethic is not specific to medicine but also relates to economy, law, journalism, and their like. In the past, only a few individuals, mostly physicians, devoted themselves to medical ethics. Beginning in the second half of the 20th century, the field underwent explosive expansion and experts from numerous disciplines entered the field. The rapid advances in medical diagnosis and treatment and the introduction of new technologies have produced numerous new ethical dilemmas, resulting in the maturation of medical ethics as a specialty in its own right. Research institutes of medical ethics have been established. Medical ethics is now part of the curriculum in schools of the health professions at all levels. The medical-ethics literature has proliferated, and numerous books and journals have been devoted entirely to the subject. Nearly all medical periodicals devote considerable space to ethical topics. For example, at the end of 1997, Medline had 3,400 citations on bioethics (Wadman 1997). The general public is also vitally interested in this subject, and public lectures, newspaper articles, legal discussions, and legislation on medical ethical issues are numerous. In the United States, medical ethics has emerged as a new profession. Medical ethicists generally have specialized in one or more of the fields such as philosophy, ethics, law, religion, and medicine, and serve as advisers in hospitals to physicians, patients, and their families. They attempt to resolve difficult ethical questions posed to them by the medical team or by patients and their families. According to recent studies, most of the medical staff found ethical consultation and advice to be valuable, but only half of patients or families found it to be valuable (McClung, Kamer, and DeLuca 1996; Orr, Morton, and deLeon 1996). A number of reasons are responsible for the enormous recent interest in medical ethics: • Significant technological and scientific advances and changes in clinical medicine and research have produced totally new ethical dilemmas and exacerbated old ones. • The change in philosophy from paternalism to autonomy in the physician-patient relationship has removed from the physician the monopoly on decision making. • The involvement of additional caregivers (various medical specialists and a variety of health professionals, students, administrators, and investigators), each with their own cultural and social value systems, have increased and sharpened ethical debates and discussions. • The involvement of society at large (through the mass communication media, courts, and legislators) has created the necessity to redefine the societal parameters of the physician-patient and physician-societal relationships. • Broad social changes throughout the world have damaged the image of the unique nobility of the physician. This change has been enhanced by the commercialization of medical services and the greater sense of consumer criticism. Moreover, in recent years, physicians have come to view medicine more in terms of their careers, honor, self-fulfillment, and income. There is a call nowadays to return to the historic principles of the medical profession, which differs from most other professions. Medicine, this opinion holds, should be viewed as service to the sick and the needy, with humility, honesty, empathy, intellectual integrity, and effacement of self-interest as guiding factors.

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A number of significant socioethical changes have occurred in the portrayal by society of medical practice and the medical profession. In the past, it was thought that all illnesses had a limited number of causes, with only minor variations between people. Thus, a holistic view of people was prevalent. The limited armamentarium of diagnostic testing and therapeutic interventions enhanced close communication between the physician and the patient because a detailed history and physical examination were virtually the physician’s only diagnostic tools. Scientific knowledge of medicine was limited, and the art of medicine was emphasized. By contrast, modern medicine has traced disease causation to a multitude of processes in individual organs, tissues, or even cells. The diagnostic and therapeutic approaches focus primarily on the illness and less so on the patient, changing the physician-patient relationship dramatically. Since most diagnostic tests and many therapeutic interventions are performed in specialized laboratories and treatment centers, there is far less need for communication and interaction between the patient and the physician. Science and technology are glorified at the expense of humanism, and this is reflected in medical education. A 1984 study reported that only 3% of American medical students had majored in humanistic subjects in their premedical education (Warren 1984). Classically, medicine had been identified with the humanities. Nowadays, young physicians choose careers in narrow subspecialty areas with emphasis on clinical or basic research. This approach has led to a reduction of empathy for the sick person and loss of the individual human concern (Glick 1981). This trend began to reverse itself in the 1980s and 1990s. Public pressure and the profound realization of the purposes of medicine and its roles resulted in attempts to balance the technological and scientific advances with the humanistic and ethical approach to medical practice. Medical ethics attempts to help resolve some of these issues. Economic issues engendered as a result of the high cost of modern medical care have created new dilemmas that require resolution, both on individual and societal levels. Economic pressures have added a new dimension to the physician-patient relationship. The physician’s responsibility to a patient often conflicts with responsibility to the physician’s employer or insurance companies or the government. The physician must skillfully and ethically balance these ethical conflicts (Welch and Fisher 1992). However, in practice, the influence of medical ethics in the United States on the formation of public policy or even the education of scientists and physicians has not been very great. Some critics regard modern medical ethical discussions as excessively academic and theoretical and insufficiently forceful. Furthermore, governmental, political, and economic considerations often influence the appointment and financing of medical ethics task forces or commissions, leading to biased results (Wadman 1997). If ethics is to have a major impact on society, there needs to be greater motivation on the part of society and intensive education toward appropriate ethical conduct and concern for one’s fellow human beings. Medicine is not an exact science. It deals with people and not objects. Therefore, its scientific and humanistic components must be combined. Better and more knowledge per se does not necessarily lead to better medical care, since the subjective feelings of the patient, which are based on personal, social, cultural, and economic value systems, must also be considered. Therefore, clinical and research medicine need to combine technical knowledge and advances with human feelings, as well as ethics and social

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justice. Only optimal synthesis of these two elements can educate ideal physicians who can “serve mankind with respect, honor, and dignity.”3 Many areas in medicine do not involve pure science but are built on interpersonal relationships, feelings, morality, and appropriate psychosocial conditions. If medicine’s function was only to cure illness, it would be a pure science without any relationship to morality or justice. However, since medicine’s goal is to cure people of their illnesses, it has major humanistic and ethical components. The basic concept of medial ethics is that the physician has a moral (and at times legal) obligation to act for the patient’s good, using the most up-to-date information. The question is how to establish that good, who defines it, and what are the components thereof. One of the most important areas of discussion in ethics is the doctor-patient relationship, which is portrayed in one of several ways: Paternalism is an approach in which the physician chooses the treatment for the patient because the physician’s professional knowledge, experience, and objectivity best qualify him or her to judge the ideal treatment for the patient. This attitude assumes that the physician and the patient have a common interest but that the doctor is better equipped for the necessary decision making, with minimal or no patient involvement. A number of significant criticisms of paternalism are as follows: • It impinges on the basic rights of patients to decide for themselves what should be done with their bodies. • Many decisions are not purely medical, but involve personal and cultural aspects in which the physician has no particular expertise. Such decisions require the patient’s input. • Many diagnostic and therapeutic decisions involve ethics. For example, the decision as to whether or not to abort a fetus with Down’s syndrome is not a medical one but an ethical, legal, and religious one. Similarly, the decision whether to attempt to resuscitate a terminally ill patient is an ethical rather than a purely medical one. Autonomy means that only patients know what is best for them and that only they have the right to decide. In order to do so, patients need to receive from physicians all the appropriate information about their condition to permit the patient to make an informed decision. A physician’s values, and his or her professional knowledge and experience, play no role in the final decision. Traditionally, the physician’s role was viewed as giving orders to nurses and to patients. In the atmosphere of autonomy, physicians must use a different language, incorporating advice, recommendation, position, etc. The main criticism of pure autonomy is the relegation of the physician to the role of a technical consultant, with little influence on the patient’s decision, which is often based on a lack of full understanding of the patient’s condition. Such a decision may cause unnecessary and avoidable harm to the patient. A compromise or middle position between paternalism and autonomy is one in which the physician provides the patient with the relevant information, the physician and patient discuss the medical and ethical issues, and they then arrive at a joint decision. This approach preserves the patient’s autonomy on the one hand, and the physician’s obligation to advise the patient about the best decision on the other hand. This is considered to be the best system, permitting responsible decisions according to the

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relevant individual circumstances while preserving the obligations and rights of both patient and physician (Emanuel and Emanuel 1992). Beginning in the 1950s in the United States, paternalism largely began to give way in favor of autonomy throughout most of the Western world. But now there is a renewed questioning of whether the pendulum has not swung too far in favor of untrammeled autonomy and individualism. Various suggestions have been put forward to create joint frameworks for the physician and patient while establishing criteria for joint decision making, sharing of responsibilities, mutual respect, and mutual trust (Balint and Shelton 1996; Pellegrino and Thomas 1988). Much of the literature in modern medical ethics has emerged from the Englishspeaking countries. These views and conclusions do not always reflect the views in other Western countries, and may conflict even more with those in Eastern European cultures and Asian and African countries. These differences are to be expected when one considers the sociocultural differences between various societies. Generally, scientific progress in technology and in knowledge precedes discussions and debates about the ethical, religious, and legal aspects of that progress. The recent extraordinarily rapid pace of advances in knowledge, science, and technology have made it even more difficult for the ethical, legal, and religious analysis of these issues to keep pace with the scientific advances. There is a need now to change this approach so that ethical, religious, legal, and social implications of innovative scientific and technological measures will be anticipated and acted on in advance rather than post-factum. The identification and characterization of a medical ethical dilemma is not always obvious. The goals of medical ethics include the analysis of the relative merits of alternative actions in medical ethical dilemmas. Definite and absolute decisions are not always attainable or implementable. Therefore, medical ethics is satisfied with decisions defining the relationship between what is desirable and what is practical or in the choice of the lesser of two evils. Medical ethics is generally pluralistic and multidisciplinary in its approach. Its main function is to identify and characterize the component elements of a given medical situation and to provide an analytic process for assessing and applying the relevant values and principles of ethics. In general, modern medical ethics does not see its function as providing definitive ethical directives in every case. In this respect, ethics differs from law, which establishes specific guidelines, whereas ethics provides pluralistic approaches and clarification and precision of understanding of the ethical aspects of medical questions. The place of legislation in regard to medical ethics is debated. Some writers would like to see major involvement of the law in medical ethical issues and thereby to set ethical norms for society. This view assumes that the legal system is capable of coping with the varied ethical dilemmas created by the rapid advances in medicine. By contrast, others argue that legislators and judges should be involved minimally only as a last resort in ethical conflicts. The legislative process is by its very nature conservative and slow moving and therefore ill suited to deal with the dynamic changes occurring in medicine and the dilemmas thereby engendered. A common alternative in a pluralistic democratic society is dealing with medicalethical issues by multidisciplinary ethics committees, which analyze issues and recommend policy or guidelines. There is also considerable utility in the creation of national

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nonpolitical commissions to study new issues in medical ethics and to recommend policies and procedures and, if necessary, legislation.

1.5 Conclusion Medical ethics has undergone many and significant changes from antiquity to our era. In fact, it continues to change and to reshape constantly both in theory and in practice. The role of medical ethics in individual patient-physician relationships as well as in public matters is growing along with the major and rapid changes in health and life sciences. It is very important for health care policymakers as well as for the public at large to be sensitive to ethical dilemmas and ethical debates and solutions. It is equally important for ethicists to be sensitive to public input and concerns. This mutual awareness and sensitivity will bring about better solutions to troublesome ethical dilemmas in modern medicine.

Notes 1. The Greek word ethike means “habit, action, character.” 2. For an in-depth discussion, see Beauchamp and Childress (1994) and Gillon (1994). 3. From the Code of Ethics of the American Medical Association (see www.ama-assn.org).

References Baker, R. Crisis, ethics, and the American Medical Association 1847 and 1997. JAMA. 1997;278:163. Balint J, Shelton W. Regaining the initiative: Forging a new model of the patient-physician relationship. JAMA. 1996;275:887. Brewin T. The ethics of complementary medicine. Lancet. 1994;344:1487. Chapman CB. Contemporary biomedical ethics. N Engl J Med. 1979;301:630. Emanuel JJ, Emanuel LL. Four models of the physician-patient relationship. JAMA. 1992;267:2221. Engelhardt HT. The Foundations of Bioethics. New York: Oxford University Press; 1986. Frankena WK. Ethics. 2nd ed. Englewood Cliffs, NJ; 1973. Gillon R. “Primum non nocere” and the principle of non-maleficence. BMJ. 1985;291:130. Gillon R, ed. Principles of Health Care Ethics. New York: John Wiley and Sons; 1994. Glick SM. Humanistic medicine in a modern age. N Engl J Med. 1981;304:1036. Glick SM. Unlimited human autonomy: A cultural bias? N Engl J Med. 1997;336:954. Kant I. Groundwork of the Metaphysic Morals (Paton HJ, transl.). New York: Harper Collins; 1964. McClung JA, Kamer RS, DeLuca M. Evaluation of a medical ethics consultation service: Opinions of patients and health care providers. Am J Med. 1996;100:456. Orr RD, Morton R, deLeon DM. Evaluation of an ethics consultation service: Patient and family perspective. Am J Med. 1996;101:135. Pellegrino ED, Thomas DC. For the Patient’s Good. New York; 1988. Rawls J. A Theory of Justice. Cambridge; 1971.

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Ross WD. The Foundations of Ethics. Oxford: Clarendon; 1939. Steinberg A. A Jewish perspective on the four principles. In: Gillon R, ed. Principles of Health Care Ethics. Chichester, UK: John Wiley and Sons; 1994:65ff. Wadman M. Business booms for guides to biology’s moral maze. Nature. 1997;389:658. Warren K. The humanities in medical education. Ann Inter Med. 1984;101:697. Welch HG, Fisher ES. Let’s make a deal – Negotiating a settlement between physicians and society. N Engl J Med. 1992;327:1312.

2 Legislation for assisted reproductive technologies Bernard M. Dickens 2.1 Introduction Until the latter decades of the 20th century, the focus of medical interventions in human reproduction was on fertility control, particularly by developments in contraception. Studies of means to control fertility indicated means to preserve and promote fertility, but studies of means to overcome infertility by laboratory (in vitro) initiatives lay in the area of animal husbandry, pedigree enhancement of animal herds, and livestock marketing. With assistance from veterinarians, however, specialists in human reproductive biology came to pioneer developments, first in human artificial insemination and then in other assisted reproductive technologies (ARTs), and in 1978 the world’s first authenticated in vitro fertilization (IVF) baby, Louise Brown, was born in England. The advancement and refinement of ARTs added an important dimension to human reproduction, both qualitatively in furnishing improved means to overcome infertility and subfertility and in time quantitatively as increasing numbers of families, particularly in more economically advanced countries, were founded by resort to ARTs. Medical means to control fertility, protect fertility, and overcome infertility were brought together in the 1990s under the concept of reproductive health. This unifying vision took shape in the late 1980s within the World Health Organization (Fathalla 1988), and received international impetus in 1994 when the concept was adopted, in an expanded form, in the Programme of Action developed at the United Nations International Conference on Population and Development (ICPD), held in Cairo. The concept was further endorsed the following year, when the UN International Conference on Women, which met in Beijing, underscored that, whatever the source of infertility, the physical burdens of overcoming it fall primarily on women. The full definition, elaborating on health as described in the first paragraph of the WHO Constitution, provides that [R]eproductive health is a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity, in all matters relating to the reproductive system and to its functions and processes. Reproductive health therefore implies that people are able to have a satisfying and safe sex life and that they have the capability to reproduce and the freedom to decide if, when, and how often to do so. Implicit in this last condition are the right of men and women to be informed and to have access to safe, effective, affordable, and acceptable methods of family planning of their choice, as well as other methods of their choice for regulation of fertility which are not against the law, and the right of access to appropriate healthcare services that will enable women to go safely through pregnancy and childbirth and provide couples with the best chance of having a healthy infant. The historical emphasis in family planning has been on its negative aspects of birth control and avoidance of unwanted pregnancy, but the expression clearly includes planning to have a family, despite reproductive barriers due to infertility. This is consistent

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with a key human rights principle of the modern, post-1945, world, embodied in Article 16(1) of the 1948 Universal Declaration of Human Rights – namely, “the right to marry and to found a family.” Paragraph (3) of the same article adds that “[t]he family is the natural and fundamental group unit of society and is entitled to protection by society and the State.” Against this background, many countries now accept the legitimacy of reproductive health as a concept well rooted in human rights (Cook, Dickens, and Fathalla 2003), and propose laws to accommodate ARTs. Nevertheless, some conservative religious institutions oppose the idea of human rather than divine control of childbearing. The Roman Catholic church, in particular, employing the unique privilege of the Holy See (representing one religious denomination) to enjoy UN membership, was active at the UN meetings in 1994 in Cairo and 1995 in Beijing in opposing acceptance of the concept of reproductive health. At the latter meeting, it proposed what some perceive as an “unholy alliance” with reactionary Islamic countries to block recognition of the concept (Hulme 2009). Countries under Roman Catholic influence tend to accommodate ARTs restrictively; for instance, a challenge was mounted before the Inter-American Commission on Human Rights against Costa Rica’s legal prohibition of IVF. Costa Rica’s approach to ARTs marks an extreme and exceptional end of the spectrum of legal responses. A more accommodating approach to lawmaking is found in many countries of western Europe, where laws are inspired by principles of consumer protection and promotion of progress in responsible employment of reproductive medical technologies. The further end of the spectrum may be in the United States, where the American Society for Reproductive Medicine (ASRM), the American Fertility Association, and, for instance, the American Congress (or College) of Obstetricians and Gynecologists, which adopted certification requirements of the American Board of Obstetrics and Gynecology, set professional standards of practice. However, governmental agencies do not exert direct legal controls, although central reporting of outcomes of interventions is required. This absence of legal control allows a de facto tariff of payments for ovum donors, exceeding the voluntary guidelines set by the ASRM, with higher rates, for instance, for athletic graduate students. It also permitted an IVF practitioner to treat an unmarried mother of six children by transferring six embryos, two of which divided, to result in birth of octuplets in January 2009. In that case, the California Medical Board subsequently took disciplinary action against the practitioner.

2.2 Legislation and regulations Designing laws to manage applications of the assisted reproductive technologies poses challenges as the ARTs evolve and different implications become apparent regarding how they are or may be applied. An increasing number of countries and legal jurisdictions within countries have therefore decided that ARTs should not be governed by their general laws. All of these were designed for other purposes, and come to be applied to ARTs incidentally or by default. Countries and jurisdictions within countries (hereafter referred to simply as “countries”) are increasingly turning to purpose-made laws (McLean 1992). The incentive to make laws specifically to govern ARTs arises because, in the absence of such laws, countries’ general laws tend to leave confusion. In codified legal systems,

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where codes of civil law and/or criminal law define the scope of particular provisions, it may not be clear under which provisions, if any, the ARTs may fall. In customary or Common law systems, where precedents are expected to be followed, it may not be clear under which body of precedent, such as regarding contracts, delicts or torts, family law, and, for instance, medical professional law, the ARTs are best approached. Lawmakers may therefore decide, as many in particularly economically developed countries have, that ART practice should be brought under the control of specifically created laws. In Europe as of early 2010, only Ireland and Poland have not enacted ART legislation; the former adopted professional guidelines endorsed by its health ministry (Brown 2010). An important legal and administrative distinction exists between legislation and regulations. Legislation is enacted by politically empowered legislatures, either as independent acts or as provisions that fit within existing codes of law. Enactments often follow political debate among members of legislatures, who among themselves may urge different preferences but decide according to their legislatures’ rules, often by majority vote. Enactments resolve issues of politically contested principle, but this legislation may provide for technical matters that are not, or are less, politically controversial to be dealt with by regulations. These are sometimes described as delegated legislation. Legislatures empower a division or officer of the executive branch of government to make subordinate law through regulations that give effect to the purposes the legislature approved in enacting the originating legislation. A ministry or minister, for instance, may be given the power under particular legislation to pronounce and apply administrative regulations that detail what must be done to achieve the purposes of the legislation. Legislative power is often very wide, but it may be limited by provisions of a country’s written constitution, and, when countries have accepted the jurisdiction of courts or commissions under international treaties, such as on trade or human rights, such supranational agencies may declare national legislated enactments to be in violation. For instance in April 2009, the Constitutional Court of Italy ruled that some provisions of Italy’s restrictive ART law, compelling uterine transfer of grossly abnormal embryos, were unlawful for violation of women’s constitutionally protected right to health. Similarly, as observed above, complaints have been brought before the Inter-American Commission on Human Rights against Costa Rica’s proposal to introduce comparably restrictive ART legislation, alleging violation of the country’s commitments accepted under the American Convention on Human Rights. Regulations are limited to the purposes intended by the legislation that empowers executive agencies or officers to make them. Regulations that are outside powers (ultra vires) are void. They may be successfully challenged for overreaching, or for being improperly developed, such as by not following due process. They may also be judicially voided for being unreasonable – that is, unsupported by the evidence claimed to justify them. The common advantage of regulations, however, is their flexibility. They can usually be introduced, amended, and revoked quickly by executive agencies empowered to make them in response to sudden developments, without having to pass through the often time-consuming political process of legislative debate and approval. As against this, however, some regulations are made subject to approval by a legislative chamber or committee, in order to preserve a measure of legislative control and accountability.

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2.3 Legislative motivations Much legislation and many regulations are reactive to events, and especially perceived crises. They are intended to preserve desirable conditions that new events appear to endanger, and/or to terminate, control, or prevent undesirable conditions. The world’s first authenticated IVF birth in 1978 was widely welcomed as providing relief for infertile couples, but the ARTs were subsequently presented to many policymakers and lawmakers primarily through sensationalized journalistic descriptions and speculation drawn from lurid or bizarre scenarios threatening to the social and moral order (Corea 1985). Religious institutions have been alarmed by such perceived threats, especially the Roman Catholic church, which speaks with unusual clarity among religious faiths through a single head. This church historically has been heavily invested in seeking to exercise moral control over human conception and in prescribing strict limits under which people may enjoy what the concept of reproductive health describes as “a satisfying and safe sex life,” which the church prohibits its ordained clergymen and nuns to experience. The ARTs also arose in a climate of rising feminist sensitivities, which were inflamed by the perception of men’s new medical techniques to condition women, by unproven or risk-laden manipulations, into motherhood (MacKinnon 1987). Under the impetus of religious outrage against the specter of ARTs, or of feminist distrust of them (Overall 1987), and sometimes of their coincidence despite doctrinal incompatibilities between advocates of conservative religion and of women’s liberation, governments in many countries established committees, often headed by women, to recommend legal control of ARTs. For instance in the United Kingdom, the 1984 report of the committee headed by Dame Mary Warnock (Her Majesty’s Stationery Office 1984) resulted in enactment of the 1990 Human Fertilisation and Embryology Act, and in Canada, the Royal Commission on Reproductive Technologies, headed by Dr. Patricia Baird (Royal Commission on New Reproductive Technologies 1993), led to enactment of the Assisted Human Reproduction Act in 2004. Most if not all Australian states set up similar inquiries in the 1980s, as did countries in western Europe and beyond, resulting in diversely different proposals for legislative and regulatory reform (McLean 1992). The goal to enact laws that both conform to moral principles and work well in practice, inducing public confidence and widespread compliance among principal stakeholders, is frequently frustrated. Laws based on moral visions may prove ineffective or dysfunctional in practice, and laws that operate to good effect in practice may require and justify compromise or refinement of moral values. The balance between good medicine, law, and ethics may be challenging to achieve (Cook 2003). The risk of incompatibility of principles and practice is most clearly illustrated in regard to abortion, which is sometimes introduced in consideration of ARTs that involve planned or anticipated wastage of human embryos. Countries in Latin America, South Asia, Southeastern Asia, and Sub-Saharan Africa that have retained repressively restrictive colonial abortion laws have the highest rates of maternal and related infant mortality due to the high incidence of unsafe abortion. In contrast, countries that, under accommodating laws, maintain abortion-related mortality at close to invisible levels suffer the unrestrained condemnation of particularly the Roman Catholic and Christian evangelical churches, and are challenged by religious institutions’ support of political strategizing to implement barriers to access to the procedure. That is, the laws based on strong moral condemnation of abortion channel its practice toward the most harmful

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procedures, and laws that accommodate safe abortion practices are condemned as violating morality. The motivations of most modern legislation and regulations regarding ARTs are compassionately to relieve the frustration experienced by reproductively impaired patients, through provision of laws that accommodate their access to safe ART services, while paying due respect to embryonic human life. It is recognized that the goal of these technologies to assist reproductively impaired patients is for them to have children, and the legal principle of seeking the best interests of such children is often invoked. Many ART laws conspicuously fail in this regard, however, because, while they address quality control of ART practitioners and facilities and pursue strategies to reduce harms from the risks of their irresponsible employment, they do not address the implications of their effects in family or parentage law. That is, their focus is on the technical control of ART practice, but they fail to address how children born through, for instance, gamete and/or embryo donation, surrogate gestation, and ovarian or testicular transplantation fit comfortably within the legally recognized families of their caregiver/social parents. Family law founded on the principle that genetic lineage constitutes parenthood often prove dysfunctional, confusing, and harmful to children when ARTs separate genetic parenthood from social and psychological parenthood. This arises, for instance, when sperm, ova, and/or embryo donation facilitates the desire of infertile couples to found families of their own. The motivation to enact laws governing ARTs that respect countries’ religious and cultural traditions and customs can present particular challenges. Because of the importance of genetic lineage in the Islamic world, for instance, IVF may be accommodated, but only without sperm, ovum, or embryo donation (Serour and Dickens 2001). Similarly in countries whose governments adhere to Roman Catholicism, the issue of abortion has cast a shadow over ARTs, particularly where Catholic fundamentalism prevails. Under this influence, abortion-derived perceptions extend beyond pregnancy to protection not only of fetuses but also of zygotes, unimplanted embryos in vivo, and the same existing in vitro. For instance, courts in Argentina, Chile, Ecuador, and Peru have interpreted constitutional protection of human life “from conception” to prohibit postcoital emergency contraception (even in the case of rape) on the grounds that a zygote may form and be prevented from development and implantation in utero. This has implications, of course, for IVF practice, in which it is often foreseeable that embryos will be created that will not be transferred, for instance due to success of earlier transfers, or that will prove unsuitable for transfer. The chance of surplus embryos remaining may be reduced by intracytoplasmic sperm injection (ICSI) and single-embryo transfer. ICSI has become more common in modern IVF clinics, and single-embryo transfer has also become strongly recommended to reduce the hazards of multiple pregnancy to women, fetuses, and born children, and also to minimize the impact of multiple pregnancies on the financial resources of health care systems (British Fertility Society and Association of Clinical Embryologists 2008). These techniques partly address concerns about nontransfer of embryos but will not placate the pervasive hostility of the Roman Catholic church to ARTs. Poland has successful IVF clinics, which patients from the United Kingdom, for instance, resort to, but its politicians have struggled with the type of legislation, respectful of religious values, under which it should be accessible. Conservative legislators approve IVF only for legally married couples and without embryo preservation, while the

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leader of its parliamentary bioethics commission proposed allowing access to unmarried couples and permission for embryo freezing. The Roman Catholic church establishment there has echoed the Vatican’s opposition to artificial conception. In a country in which positions on abortion have ended political careers and administrations, the legislative pathway to appropriate legislation seems unclear and hazardous. An option may be legislation by referendum or popular plebiscite, conducted under fair conditions. A referendum was held in Italy on its restrictive ART law, but it was held on a popular vacation weekend, and with a requirement of at least a 50%-plusone voter turnout of the electorate. An estimated 80% of voters cast ballots for legal reform, but the church succeeded in advocating a low turnout in order to prevent the anticipated pro-reform outcome.

2.4 Evidence-based legal policy The equivalent of evidence-based medicine is evidence-based social or legal policy. The two have been successfully brought together in enlightened law on ARTs. An instance is in the United Kingdom, where the Human Fertilisation and Embryology Authority (HFEA) licenses and monitors clinics that offer IVF and donor insemination, maintains vigilance of the favorable and undesirable effects of evolving clinical practices and research initiatives, educates and consults with the public on policy options, provides public information on treatment and research, and is transparent in its decision making. False steps in approving or in disapproving practices generally become recognized, and remedied. The HFEA produces a Code of Practice, the eighth edition of which, published in 2009, runs to 254 pages, guiding practitioners and patients on relevant law, regulations, and good clinical practice. Controversies have arisen, of course, and opposition remains in predictable areas, but public confidence in responsible management of ARTs has been high. This has been built on the composition and caliber of the authority’s membership, in which 21 people ensure HFEA independence, scientific awareness, accountability to stakeholders, and interest-group and lay representation. Indeed, public confidence has been sufficiently high to allow innovation, for instance in grounds for preimplantation genetic diagnosis (PGD) of embryos, and to accommodate pioneering in embryonic stem cell research on surplus embryos from IVF. The public has generally accepted HFEA provisions on the deliberate creation of embryos for such research, despite Article 18(2) of the Council of Europe’s Convention on Human Rights and Biomedicine, which provides that “[t]he creation of human embryos for research purposes is prohibited”; the United Kingdom has declined to accept this provision. In contrast to the pragmatic, nondoctrinaire approach in the United Kingdom is the morally rigid approach taken in Italy, in apparent overreaction to the criticism of uncontrolled experimentation and innovation typified perhaps by the provocative practice of Dr. Severino Antinori, such as inducing pregnancy in a woman who gave birth at 63 years of age. In Italy, as in several other countries where the Roman Catholic church exerts a strong influence, lawmaking is liable to be captured by religion. As a party to the European Convention on Human Rights, Italy could not lawfully prohibit ARTs, because human rights to found a family, to privacy against excessive state intrusion, and, for instance, to the benefits of scientific progress are central values. Italian law allows

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ARTs very restrictively, however, through repressive provisions introduced in 2004. For instance, the law allows no more than three embryos to be created in a treatment cycle, and prohibitions against embryo wastage and cryopreservation require every embryo created in vitro to be transferred to the woman’s uterus. Gamete donation and surrogate gestation are similarly prohibited. The ban on embryo preservation requires women to receive hormonal ovarian stimulation before each cycle of treatment, adding to their health burden and perhaps their expenses. Improvement in the success of freezing and later thawing of ova may in time make preservation of gametes a viable alternative to preservation of embryos, relieving the burden on women of laws following the Italian model. However, this model requires transferring to a woman’s uterus an embryo created in vitro that is grossly abnormal. This practice is unethical and in many countries would be considered professional malpractice, since it is dangerous to the woman’s health. In April 2009, the Constitutional Court of Italy modified the ART law in light of this evidence, ruling that an embryo could be transferred only if doing so would not endanger the woman’s health. One effect of restrictions in legislation and regulations on ARTs is that couples cross national borders to obtain the services they want in other countries (Blyth and Farrand 2005). For example, Italian couples escape their national restrictions and British couples escape unavailability of gametes due to such causes as legal requirements ending donor anonymity. Few national health care systems fund resorting to ARTs adequately, which therefore tends to recruit patients who can afford to pay their costs. Many such patients can also afford the costs of seeking services by traveling abroad. Depending on their destination, they may find services that are unavailable in their own countries or restricted to certain populations, such as in married partnerships, and/or may pay less for medical and related services than would be required in their own countries. Furthermore, some infertile or subfertile couples who are less affluent may be willing to make considerable financial and related sacrifices in the hope of having the families they want – including, for instance, taking second mortgages on their homes. Just, evidence-based laws would attempt to facilitate the ability of disadvantaged citizens to enjoy the same access to care as advantaged citizens enjoy by going abroad. Legislation and regulations rarely seem to address cross-border services, although Turkey has proposed to make it unlawful for Turkish nationals to employ ARTs abroad for purposes unlawful in Turkey, thereby leveling social equality downward. Patients naturally tend to travel to where services they want are lawfully accessible. For instance, patients prohibited in their own countries from attracting gamete donors by payment tend to travel to countries where payment is allowed, and the same applies to surrogate gestation. Aided by the Internet, individuals seeking donation of gametes or surrogate services and those prepared to provide them may be able to identify each other, across national borders, or within them even when financial terms of their collaboration are unlawful. For instance, when the HFEA, in the United Kingdom, refused consent for PGD to create embryos to be born as savior siblings, able to provide genetically suitable bone marrow or stem cells derived from umbilical cord blood for transplantation into existing sick children of families, the parents traveled to the United States for the services, with an encouraging outcome. This evidence persuaded the HFEA to relax its rules on acceptable PGD to allow for its availability in the United Kingdom, subject to the agency’s approval.

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A case of ideology prevailing over evidence, resulting in enactment of unjustified legislation, arose in Canada’s Assisted Human Reproduction Act of 2004. Section 5(1) (e) criminalizes any procedure, provision, prescription, or administration “that would ensure or increase the probability that an embryo will be of a particular sex, or that would identify the sex of an in vitro embryo, except to prevent, diagnose, or treat a sexlinked disorder or disease.” The Royal Commission on New Reproductive Technologies had produced evidence that Canadians generally have no preference for children of one sex as opposed to the other, and that a belief in a pro-male bias is unfounded (Royal Commission on New Reproductive Technologies 1993). Evidence in several countries, such as Canada, Germany, and the United States, shows that most couples have no interest in sex selection of their children, though a few who have one child or have two or more children of the same sex might prefer their last child to be of the other. Evidence of sex selection of male children in India and China, producing a serious sex imbalance in their societies, is contrasted with an interest in such technologies elsewhere only for family balancing (having a family with few children but one that includes both sexes). Nevertheless, for ideological reasons supporting sexual nondiscrimination, the commission recommended criminalization of sex selection by use of ARTs, while recognizing that “the use of sex selective insemination by couples to have a child of the sex they do not already have is not necessarily sex-discriminatory” (Royal Commission on New Reproductive Technologies 1993, 911), and producing evidence that Canadians’ minimal interest in sex selection is in fact for this purpose. While repressive laws tend to make ARTs inaccessible within a given country, sometimes driving residents abroad, lax laws and/or enforcement of laws may compromise quality of services. Applicants for treatment may be inadequately assessed or counseled, for instance, and donors of gametes, embryos, and/or surrogate gestation services may be inadequately screened on genetic, lifestyle, and other relevant grounds. A persuasive case can be made that evidence of ART practice be legally monitored by professionally equipped agencies to ensure safety, efficacy, and integrity of service provision. An equally persuasive case can be made for legislative and/or regulatory provisions that maintain equilibrium between services that protect the interests of recipients of care, the children they intend to have, and equitable access in society to conveniently available ART facilities. Evidence that legislation and/or regulations are failing to satisfy these criteria should compel their reform.

2.5 The focus of legislation Globally, few government-funded health programs cover the costs of ARTs, although some governments contribute to expenses to a greater or, usually, lesser extent. A social inequality in many countries is that resort to ARTs tends to appear as so-called luxury medicine, although couples in need may make sacrifices to gain access. These characteristics tend to make ARTs a source of potential profiteering by private clinics in some countries and of exploitation of perhaps unrealistically hopeful, eager patients. As measures of quality control of services and consumer protection, some laws have therefore introduced licensing conditions for both public and private facilities that offer ART services and for the qualifications and specialized training of personnel, such as embryologists.

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In addition to identifying the equipment that clinics are required to possess, laws may also identify equipment they are not allowed to employ. In countries where embryo cryopreservation is prohibited, for instance, possession or use of equipment for that purpose may constitute a license infraction and a wider offense, although freezing facilities are usually allowed for storing gametes. Consistent with prohibition of embryo preservation, laws may provide, as in Italy, that no more than a low number of embryos may be created in each cycle of treatment. Since severely defective embryos cannot ethically be transferred, however, laws must accommodate the natural disintegration of such embryos. A tendency may develop, on grounds of avoiding or reducing the harms to mothers and children of multiple births, of limiting ART to single embryo transfer (Dickens and Cook 2008). While this approach constitutes good medical care, particularly for younger women, countries may compel this limit to save costs to public health services of coping with the harmful medical and financial consequences of multiple pregnancies and births. In March 2010, for instance, Turkey introduced regulations stipulating that women in their first cycle of IVF can have only single embryos transferred and that women over 35 can have a maximum of two on their second cycle. The same maximum applies to women under 35 on their third or subsequent cycle of treatment. It has been seen that, while legislation in few countries addresses residents’ access to ART services outside their jurisdiction, Turkey has prohibited Turkish nationals from seeking ART services outside the country. The phenomenon of cross-border acquisition of ART services is now widespread and as a matter of practice difficult to contain. The legal question it affects is whether a country can bind its nationals by its legislation and regulations when they are outside the country. The countries in the English Common law tradition usually apply their laws on the basis of territoriality, leaving nationals free to do lawfully outside their territorial jurisdiction what is criminal within. In the case of Diane Blood, for instance, the English courts acknowledged that, under European Community law, nationals may, while in other member states, lawfully avail themselves of ARTs not permitted under UK law. Countries in the Civil law tradition of continental Europe, meanwhile, have come to apply their criminal legislation on the principle of nationality. Accordingly, their nationals remain bound by their law regarding what they do lawfully in other countries. Under this principle, Turkey’s prohibition of Turkish nationals obtaining ART services outside the country that are prohibited within is valid, although the prohibition may be problematic in Turkey’s application to join the European Community. An advantage of regulating nationals’ lawful resort to ARTs outside a country that is prohibited within arises when the financial costs of treating difficult pregnancies and deliveries, such as those of twins, triplets, and other multiple births, are carried by mothers’ national publicly funded health care services (McKelvey et al. 2009). This factor may direct more legislatures to consider residents’ employment of cross-border ART services. Related to this concern are provisions in many laws that limit to whom services may be delivered. Some laws do not allow reproductive services to unmarried women, including women in same-sex relationships. Others, designed to limit postmenopausal pregnancies, have age restrictions on women’s access to services. They may also set time limits on preservation of gametes and/or embryos, such as not beyond the female partner’s 55th birthday. Evidence indicates that sperm can result in births of healthy children 10 or more years after donation, and embryos may also be safely transferred after

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several years in cryopreservation. Techniques are being similarly developed to preserve viability of ova in storage, reducing the rate of loss in thawing. The background issue, however, is whether legislatures consider late-age motherhood to be in the best interests of their children (Fisher and Sommerville 1998). Further legislated or regulated provisions may address applicant patients’ suitability as parents on more individual grounds, such as mental stability. The nature, expertise, and timing of assessments may be critical to their fairness, however, since applicants for fertility treatments may be anxious and unduly self-absorbed when under critical scrutiny, leaving them unable to do justice to the composure or balance they would show as parents. More reliable guidance may exist if applicants have histories of alcoholism or drug addiction, or records of criminal behavior or of child abuse or neglect. Some laws directly or indirectly address applicants’ income levels, reflecting a concern with their ability to support children at above the poverty level. It is widely recognized that, in practice, ARTs tend to be employed by more affluent applicants, whose material means to bring up children are not open to reasonable doubt. It is also known, however, that others may be financially stretched to meet ART costs, and that their means to provide children with adequate homes and upbringing are legitimate concerns. Legislation that requires consideration of financial means of applicants to become adoptive parents may be projected onto ART applicants, although it may be more equitable to compare them to natural parents, whose suitability does not fall under general legislative scrutiny. Adoption criteria themselves may be unduly demanding, as enacted or as applied by administering agencies, and questionable under antidiscrimination laws concerning social, cultural, racial, or comparable biases. As some laws have come to accept adoption by single people and same-sex couples, however, they have allowed ART parenthood in the same circumstances. The United Kingdom offers interesting illustrations of legislatures and legal systems becoming more comfortable with and accommodating of ARTs as they become more familiar with their application. The initial Human Fertilisation and Embryology Act of 1990 required attention to future children’s welfare by providers of ART services ensuring that a child’s need for a father was met. When the Act was amended and updated in 2008, however, experience in society of successful upbringing of children by single mothers and lesbian couples, conceived naturally and by medical assistance, or acquired through adoption, as well as operation of human rights provisions regarding nondiscrimination on grounds of marital status and sexual orientation, was considered to justify withdrawal of this legislated requirement. Similarly, experience of successful surrogate-motherhood arrangements has inspired courts to approve the legal regularization of children in the families to which they were given on birth, despite the financial limits under the 1990 legislation being applied very generously, if not obviously exceeded (Blyth and Potter 2003). Several legislated enactments regarding ARTs prohibit means of sex selection unless related to sex-linked genetic disorders, and govern embryo research unrelated to diagnosing causes of infertility, genetic transmission of disorders, and/or, for instance, spontaneous malformations. They similarly prohibit cloning, although some distinguish reproductive cloning from therapeutic cloning, the latter being differently regulated in the context of regenerative medicine and tissue engineering. A matter often considered more suitable for regulations is how many times sperm donors may donate, and how

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donation rates may be monitored when, for instance, a donor may visit different clinics. Similarly, details of acceptable levels of reimbursement of gamete donors’ and surrogate mothers’ expenses are considered administrative rather than substantive matters, although some legislatures have spent time addressing permissible payments.

2.6 Human rights The United Nations’ Universal Declaration of Human Rights is often perceived to have ushered in the modern era of human rights, but the 1948 document was described as a declaration because it claimed only to declare human rights that were already recognized in national and international laws. Human rights are traceable, for instance, to before the Declaration of the Rights of Man and of the Citizen, published in 1789 in postrevolutionary France. The title, in English, uses man largely in the generic sense meaning humanity and itself declares rights existing before 1789, particularly in English and American precedents. These, like the rights declared in 1948, had been grossly violated in the immediately preceding years by oppressive agencies of government. Countries today look for sources of their responsibilities to observe human rights to their own legislation, often expressed in constitutional and similarly elevated legal documents, and their international commitments, but countries measure other countries’ observance primarily by reference to international human rights treaties (Clayton and Tomlinson 2009). Some countries’ laws give direct internal effect to international human rights treaties they have ratified, such as in Germany, but other countries’ internal laws do not incorporate such treaties unless they have been legislated into national law, such as in the United Kingdom’s Human Rights Act of 1998, which incorporates the European Convention on Human Rights into UK domestic law. Countries as such are the subjects of international law, described historically as the law of nations, but subordinate units of sovereign nations, such as states or provinces, or even municipalities, may adopt international treaties as part of their local law. For instance, the Brazilian State of São Paulo and in the United States the City of San Francisco each adopted the 1979 Convention on the Elimination of All Forms of Discrimination against Women. A contrast, however, is that Brazil as a country has ratified that convention, whereas the United States has signed but not ratified it. For international purposes, therefore, São Paulo, like every other state in Brazil, is bound by the convention, and its breach would render Brazil internationally liable, whereas neither San Francisco nor the United States bears direct international responsibility for violation. Article 16(1) of the Universal Declaration of Human Rights recognizes that “[m]en and women of full age ... have the right to marry and to found a family.” This provision was significant in light of practices of nonconsensual sterilization of mentally handicapped people and, for instance, members of minority populations, in both militarily oppressed and other countries, and may be invoked today in support of ARTs. A legally contentious point is whether the expression can be read disjunctively, so that the right to found a family is not linked to marriage, or is conjunctive, making the right to found a family dependent on prior marriage. Different interpretations are applied by countries that limit ARTs to married couples and by those that do not. Legal force was given to the declaration by a series of international human rights treaties. Parties to the International Covenant on Economic, Social, and Cultural Rights

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(CESCR), for instance, through Article 10(1), recognize that “[t]he widest possible protection and assistance should be accorded to the family ... particularly for its establishment.” Including this provision in a legally binding treaty raises the concern, however, of the nature of the right it creates. Human rights are commonly divisible into positive rights and negative rights. Positive rights accepted by countries require that individual holders of such rights be provided with resources to protect and promote their rights. Individuals’ right to life, for instance, requires governmental assurance of deterrent laws against the deliberate or negligent taking of life, means to enforce the laws by protective and preventive services, and careful procedural safeguards where capital punishment is not outlawed. Negative rights, in contrast, require state nonintervention in means individuals may employ, by their own resources and initiatives, to give effect to their rights. Negative rights are often described simply as rights to be left alone and not be subject to governmental intervention or legal prohibition. It is a matter for national and international debate whether particular human rights are positive or negative rights, although the majority are often considered only negative. The right to reproductive health, for instance, is usually understood to require fertile people’s entitlement to access to contraceptive means, but not governmental responsibilities to undertake their supply. Similarly, although some countries contribute to the costs of ARTs, many do not, and are not thereby considered in breach of infertile individuals’ human rights. However, legislated prohibitions or undue limitations on individuals and couples availing themselves of ART services can be claimed to violate the negative rights to found a family and to reproductive health. By Article 12(1) of the CESCR, parties “recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.” The WHO describes health as a state of physical, mental, and social well-being, to which successful ARTs clearly contribute, but Article 12 requires parties to the covenant to take steps to achieve, for instance, only reduction in the stillbirth rate and “conditions which would assure to all medical service and medical attention in the event of sickness.” Infertility may be due to sickness, but is not necessarily a sickness in itself, and while ARTs may overcome infertility, they do not cure most of its causes. However, the World Medical Association’s Statement on ARTs, adopted by its General Assembly in October 2006, observes at paragraph 6 that “inability to become a parent without medical intervention is not always regarded as an illness.... It is, however, a significant cause of major psychological illness and its treatment is clearly medical.” ART treatment is clearly justified as medical service and medical attention assisting achievement of the goal of reproductive health, and its prohibition or undue obstruction is a human rights violation. Other human rights of resort to ARTs are found in both general and regional international treaties, such as the entitlement to protection of the family and to protection of private and family life. These rights to be left alone exist in, for instance, the European Convention on Human Rights (Article 8) and the American Convention on Human Rights (Article 11(2)). Reinforcing such rights are those to freedom of conscience and religion, which include freedom to be reasonably unbound by religious doctrines to which one does not adhere, rights to the benefits of scientific progress, and rights to dignity and relief from cruel or unusual treatment. The American convention is subtitled the “Pact of San José, Costa Rica,” but Costa Rica, due to its prohibition of IVF, has itself to defend claims, brought before the Inter-American Commission on Human Rights, of

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violation of rights to found and raise a family, enjoy private and family life, and be free from discrimination on grounds of reproductive disability. This last claim reflects potential liability countries bear for breach of the UN Convention on the Rights of Persons with Disabilities, which came into legal force on May 3, 2008. This statement describes disability as including any long-term physical or mental impairment that may hinder full participation in society on an equal basis with others. It defines discrimination on the basis of disability as “any distinction, exclusion, or restriction on the basis of disability which has the purpose or effect of impairing or nullifying the recognition, enjoyment, or exercise, on an equal basis with others, of all human rights and fundamental freedoms.” The concept includes reproductive disability in the form of infertility and subfertility that makes individuals’ opportunities to have their genetic offspring dependent on any of the ARTs. The convention requires parties to provide reasonable accommodation of means to overcome disabilities. Laws or practices that parties introduce or tolerate that unduly limit infertile or subfertile individuals’ access to ARTs would constitute discrimination, in violation of such individuals’ human right to reproductive health. The convention therefore prohibits legislation and regulations that impose undue limits on infertile individuals’ resort to ARTs.

References Blyth E, Potter C. Paying for it?: surrogacy, market forces, and assisted conception. In: Cook R, Sclater SD, Kaganas F. Surrogate Motherhood: International Perspectives. Oxford: Hart; 2003;227–242. Blyth E, Farrand A. Reproductive tourism: a price worth paying for reproductive autonomy? Crit Soc Pol. 2005;25(1):91–114. British Fertility Society and Association of Clinical Embryologists. Elective single embryo transfer: guidelines for practice. Hum Fertil. 2008;11(3):1–16. Brown S. Poles apart. Focus on Reproduction (European Society for Human Reproduction and Embryology Newsletter), January 2010:31–34. Clayton R, Tomlinson H. The Law of Human Rights. 2nd ed. Oxford: Oxford University Press; 2009. Cook RJ, Dickens BM, Fathalla MF. Reproductive Health and Human Rights: Integrating Medicine, Ethics, and Law. Oxford: Oxford University Press; 2003. Corea G. The Mother Machine: Reproductive Technology, from Artificial Insemination to Artificial Wombs. New York: Harper & Row; 1985. Dickens BM, Cook RJ. Multiple pregnancy: legal and ethical issues. Int J Gynecol Obstet. 2008;103:270–274. Fathalla MF. Promotion of research in human reproduction. Hum Reprod. 1988;3:7–10. Fisher F, Sommerville A. To everything there is a season: are there medical grounds for refusing fertility treatment to older women? In: Harris J, Holmes S, eds. The Future of Human Reproduction: Ethics, Choice, and Regulation. Oxford: Clarendon Press; 1998: 203–220. Her Majesty’s Stationery Office. Report of the [Warnock] Committee of Inquiry into Human Fertilisation and Embryology. London: Her Majesty’s Stationery Office, Cmnd. 9314; 1984. Hulme D. Reproductive Health and the Millennium Development Goals: Politics, Ethics, Evidence, and an “Unholy Alliance” [working paper 105]. Manchester: University of Manchester Brodes World Poverty Institute; 2009. MacKinnon C. Feminism Unmodified: Discourses on Life and Law. Cambridge, MA: Harvard University Press; 1987.

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McKelvey A, David A, Shenfield F, Jauniaux E. The impact of cross-border reproductive care or “fertility tourism” on NHS maternity services. Brit J Obstet Gynecol. 2009; 116:1520–1523. McLean SAM, ed. Law Reform and Human Reproduction. Aldershot, UK: Dartmouth; 1992. Overall C. Ethics and Human Reproduction: A Feminist Analysis. Boston: Allen & Unwin; 1987. Royal Commission on New Reproductive Technologies. Final report: proceed with care. Ottawa: Minister of Government Services; 1993. Serour GI, Dickens BM. Assisted reproduction developments in the Islamic world. Int J Gynecol Obstet. 2001;74:187–193.

3 Reproductive rights as an integral part of women’s rights Giuseppe Benagiano, Sabina Carrara, and Valentina Filippi 3.1 Introduction The United Nations has been criticized as lacking effectiveness, efficacy, and incisiveness. Although there are reasons such a criticism may be warranted, this does not and cannot mean that the UN has not had an important role in fostering a number of major causes. An example of the irreplaceable role the organization can play is, without doubt, the Universal Declaration of Human Rights, adopted and proclaimed by the UN General Assembly on December 10, 1948 (United Nations General Assembly 1948). After 48 member states voted in favor, 0 voted against, and 8 (the Byelorussian Soviet Socialist Republic, Czechoslovakia, Poland, Saudi Arabia, South Africa, the Ukrainian Soviet Socialist Republic, the Union of Soviet Socialist Republics, and Yugoslavia) abstained, the General Assembly called on all member countries to publicize the text and “to cause it to be disseminated, displayed, read, and expounded principally in schools and other educational institutions, without distinction based on the political status of countries or territories.” It is interesting to note that from the early days, when there were some 60 countries in the UN, compared to the almost 200 today, the opposition came from countries where human rights were obviously denied to certain groups. Some 30 years later, in 1979, the UN adopted the Convention on the Elimination of All Forms of Discrimination Against Women, addressing for the first time the specific issue of gender discrimination (United Nations 1979). This was followed, in 1993, by the Declaration on the Elimination of Violence Against Women (United Nations General Assembly 1993), defined as “any act of gender-based violence that results in, or is likely to result in, physical, sexual, or psychological harm or suffering to women, including threats of such acts, coercion, or arbitrary deprivation of liberty, whether occurring in public or in private life.” Thus, the International Conference on Human Rights established that the rights of girls and women are an inalienable and indivisible part of human rights, to be protected not only in courts, prisons, and other areas of public life but also in the privacy of the home. The final step in the march of the UN toward women’s rights was the approval in Cairo, at the International Conference on Population and Development, of the concept of reproductive health (later renamed sexual and reproductive health), which contains a number of reproductive rights. The final document (“Summary of the Programme of Action”) approved in Cairo in Chapter VII, under the title “Reproductive Rights and Reproductive Health,” enunciates a number of reproductive rights: the right of men and women to be informed and to have access to safe, effective, affordable and acceptable methods of family planning of their choice, as well as other methods of their choice for regulation of fertility, which are not against the law, and the right of access to health care services that will enable women to go safely through pregnancy and childbirth.... Reproductive rights embrace certain human rights that

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are already recognized in national laws, international human rights documents, and other relevant UN consensus documents. These rights rest on the recognition of the basic right of all couples and individuals to decide freely and responsibly the number, spacing, and timing of their children and to have the information and means to do so, and the right to attain the highest standard of sexual and reproductive health. They also include the right of all to make decisions concerning reproduction free of discrimination, coercion, and violence. Full attention should be given to promoting mutually respectful and equitable gender relations and particularly to meeting the educational and service needs of adolescents to enable them to deal in a positive and responsible way with their sexuality. (United Nations 1995) Assisted reproduction technology (ART) and, more specifically, in vitro fertilization (IVF) in its many forms, is not specifically mentioned, and for good reasons: In 1994, the procedure was still available only in selected centers and in a limited number of countries, and it would have made no sense to mandate that couples must have access to ART. Today, however, the situation is rapidly changing, and we would not be surprised if, in a not too distant future, a right to affordable access to ART would be added to reproductive rights. Given the present situation, this chapter will address women’s rights within the broader context of women’s health, especially because, for physicians in general and for gynecologists in particular, the important issues are access to health care and freedom from violence. At the same time, health and rights cannot be seen only through the lens of reproduction and the old Latin aphorism Tota mulier in utero (“The entire woman coincides with her uterus”) must be simply abolished: A woman is not a womb; a woman has a womb. Being a woman has special implications for health that go beyond her reproductive system and function. Finally, we must never forget that the health of a woman is also not determined by her biology only; it is determined by the social context of their lives; it can be promoted or undermined by personal behavior – not only that of women but also of others toward them; and it can be improved with the establishment of dedicated health services (Fathalla 2008).

3.2 Granting women equal rights: the origin of discrimination In many parts of the world, women suffer the same indignities and breaches of their human rights as men; in addition, however, they are vulnerable to particular genderbased violations relating to their reproductive function and the way societies limit their role and potential. In this respect, international human rights laws have focused almost exclusively on the public arena and neglected the private sphere of home, family, and community in which women are traditionally enclosed. Possibly because of a new focused attention on the topic, defending the right of women to equal treatment in every aspect of life has become fashionable, something that must be discussed at every important meeting. Yet, this is usually done in a superficial way: Kind words are spoken, but often, no action follows, and women continue to find multiple obstacles in their struggle to be granted rights equal to those males enjoy. This is why women’s rights advocates must to go beyond conventional wisdom and find

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out what really lies behind this battle of civilization. To fully comprehend the situation, we must try to understand where male supremacy and violent behaviors come from and, to do so, we must seek the help of other disciplines and retrace the history of the progress of humanity. Only in this way can we hope to acquire sufficient understanding of where the solution might be found. Anthropologists have speculated that in the very early days of our genus, males based their reproductive choices on two simple mechanisms: Ensure continuity of an individual male through the passage of his genes to the largest feasible number of females, and select those females who would provide the highest possible quality of oocytes (Benagiano 2002). Thus, basic human instincts dictate the selection of a young female with the best physical characteristics and, indeed, youth and health have always been considered strong indicators of fertility. An important determinant of the strategy of mating younger partners is the persistence in genus Homo of the ancestral age-specific female fertility decline, while senescence in other aspects of physiological performance has slowed down (Hawkes 2003). To be successful, such a strategy presupposes two important additional determinants: male-male competition and the possibility that a female may choose her male partner. A combination of these two factors leads to success, since it has been demonstrated that, compared with males that remain unmated, males selected through their strength or female preference pass on genes that, on average, are capable of increasing the fitness of their offspring (Agrawal 2001; Siller 2001). In contradistinction to males, females choose males on the basis of resources they can make available (Bateson 1983). This usually means a man with wealth, health, maturity, ambition, and industriousness who can provide protection and support (Buss and Schmitt 1993). Thus, throughout their evolutionary process, females of great apes and of the genus Homo have sought a male capable of providing the best means for their survival and that of their offspring. Reasons are obvious: In the early days, a woman invested a substantial quantity of energy in each pregnancy and child-bearing period; therefore, she needed to maintain her fitness by restricting sexual activity to one high-quality male or, at most, a few. In addition, because acquiring resources for her offspring was of paramount importance, a woman tried to attract wealthy, high-status men who were willing and able to help her (Buss and Schmitt 1993). Besides wealth, status may hold other advantages, since not only are highly respected men usually capable of protecting a woman from unwanted attentions by other men but children of high-status men are more likely to be treated better by others as well (Cashdan 1997). A point worthy of mention because it conditioned the evolution of human sexuality is the lack of recognizable signs of impending ovulation in females of the Homo genus. In theory, this could have become an evolutionary disadvantage for a sexuality focused on reproduction; however, a female without estrus can more easily “escape” from the guardianship of dominant males, while at the same time offer herself at any time and receive continuous protection. Protection, given the extremely long period required for a human female to raise her children, is uniquely important; for her to be abandoned would have made it almost impossible to survive and raise her infant (Kaplan and Hill 1985). In conclusion, early male humans, confronted with a female having the unique characteristics of being sexually freely accessible throughout her fertile life to other males while at the same time being dependent on men for support, resorted to violence to

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protect their “property.” When humans became carnivorous and started hunting for food, women, burdened by children, had to rely on men for their survival, and men became aware of the advantage of having a subdued female concentrating in the care of their children (Ardrey 1976). This dominant behavior was strengthened by the discovery of agriculture and the ensuing concept of land ownership: properties needed to be left as inheritance and, for a man to become an heir, his lineage had to be provable. The best proof would come from physically preventing a woman from being accessible to other men. It is at this stage that male dominance became established: Men pretended to have exclusive possession of their females – to subdue them and to be considered their owners. If we believe anthropologists, male supremacy was born and enforced throughout millennia as a consequence of the different roles men and women have in reproduction. If this is true, then the fight for equality must begin in the field of reproduction, where it all started. Over a century ago, Sigmund Freud became fully aware of how women could be freed. He stated, “Theoretically, it would be one of the greatest triumphs of humanity if the act responsible for procreation could be raised to the level of voluntary and intentional behavior in order to separate it from the imperative to satisfy a natural urge” (Freud 1989). Freud was obviously right; what he perhaps did not see is the fact that the moment his dream became true and men and women were able to separate with fairly high accuracy the reproductive from the non-conceptive aspects of sexuality, a real social revolution took place: For the first time, sexuality could be expressed without fear of conception, and women could pretend change in their role in society. It is this new situation that made it possible for women to successfully challenge male supremacy. It was inevitable that the final drive for equality of the sexes needed to start from the biological phenomenon that caused it in the first place: the difference in reproductive strategies between men and women. To realize a society of equals, women had to harmonize their role as mothers with all the other roles they claimed for themselves.

3.2.1 Cornerstones of women’s rights There are three major aspects of the fight to grant women rights equal to those men enjoy: absolute respect for their dignity, body integrity, and freedom from violence; equal treatment under the law and in their communities; and full and unconditional access to health care.

3.2.1.1 Dignity, body integrity, and freedom from violence According to the European Charter of Human Dignity (2010), “The dignity of the human person is not only a fundamental right in itself but constitutes the real basis of fundamental rights.” The Universal Declaration of Human Rights has enshrined this principle in its preamble: “[R]ecognition of the inherent dignity and of the equal and inalienable rights of all members of the human family is the foundation of freedom, justice, and peace in the world” (United Nations General Assembly 1948). Being the basis of all other rights, none of them may be used to harm the dignity of another person, and therefore the dignity of the human person must be always respected, even where a right is restricted.

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There is a point worth mentioning: What represents dignity for a person must be defined by the individual, not by others. This consideration may create problems when, for example, a woman feels that her dignity is represented by the Islamic veil or even the so-called burqa, the use of which is not prescribed by religious observance. Indeed, there is no law in Islam that punishes a woman for not veiling, and, as observed by Waseem (2009), whereas the extent to which a Muslim woman covers her face may vary according to her situation and to practical needs, the act of veiling is not considered a disgrace or a hindrance for a woman. Instead, it is seen as honoring her and freeing her from the bondage of society and the obstacles that prevent her intellectual, moral, and spiritual advancement. Clearly, the situation is entirely different when the use of the veil or of the burqa is imposed by men as a sign of subservience, or to prevent women from fully participating in daily life. This sad situation exists in some Muslim nations where cruel treatment of women is tolerated or even imposed (Waseem 2009). This does not mean that the veil cannot be banned in specific circumstances, as it is in French schools (Henley 2004), or that the burqa cannot be prohibited in public places, as has been done is France and in Belgium (European Institute 2010; Zeenews Bureau 2010). Rather, it means that such prohibitions cannot be based on the need to defend the dignity of the individual concerned; for instance, the ban can be justified using arguments similar in nature to the prohibition against going naked in public. There are, however, specific cases in which the community, the law, and international conventions must intervene to defend the dignity of a woman; the most important of them is female genital mutilations (FGMs). Although they are performed in about 30 countries, mostly in Africa and to a lesser extent in Asia and the Middle East, there is an increasing prevalence of these operations among migrants who have settled in Europe, the United States, Canada, Australia, and New Zealand (see, for example, Benagiano, Carrara, and Filippi 2010). The reason national and international laws must ban FGMs is simple: Over and above the presence of laws prohibiting bodily harm in general, there is the fact that young girls cannot provide full and informed consent; on the contrary, they overwhelmingly oppose being mutilated. Besides body integrity, a woman’s dignity requires that she be fully protected against violent male behavior. Unfortunately, all over the world and in a variety of ways, men continue their efforts to exercise dominance over women (often their partners or prospective partners) to the point of resorting to violence. Even in the most technologically advanced societies, domestic violence is widely present, deeply affecting the relationship between men and women (Benagiano and Schei 2004; Cook and Dickens 2005). In 2005, UN secretary general Kofi Annan stated, ”Violence against women remains pervasive worldwide. It is the most atrocious manifestation of the systematic discrimination and inequality women continue to face, in law and in their everyday lives, around the world: It occurs in every region, country, and culture, regardless of income, class, race, or ethnicity” (United Nations 2005). It affects millions of women, preventing them from enjoying human rights specifically sanctioned by the international community (Sandis 2006). Forms of violence vary widely, but they all have in common the fact that women and girls are judged and condemned in terms of what society dictates for their behavior. Critical in this respect is the belief that they should have less power and less public space than men have (Finney 2000). Also, the European Commission (EC) has mobilized its resources and, in the document “Strategy for Equality Between Women and Men,” reminded the European Parliament,

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the European Council, the European Economic and Social Committee and the Committee of the Regions that “[i]t is estimated that in Europe, 20% to 25% of women have suffered physical violence at least once during their lives and there are estimates that up to half a million women living in Europe have been subjected to genital mutilation” (European Commission 2010a). Accordingly, the EC created an Action Plan to implement the so-called Stockholm Programme (European Commission 2010b), which puts emphasis on the protection of victims of crime, including female victims of violence and genital mutilation, and announces a comprehensive EU strategy on gender-based violence. In addition, the Women’s Charter envisages putting into place a comprehensive and effective policy framework to combat gender-based violence as well as measures, including criminal law, within the limits of its powers, to eradicate female genital mutilation once and for all across Europe.

3.2.1.2 Equality and empowerment Women’s rights depend on equality between genders, and the United Nations Educational, Scientific and Cultural Organization (UNESCO) recently placed much emphasis on the need to achieve equality between genders. Its Action Plan for 2008–2013 is accompanied by the booklet “Priority Gender Equality” (UNESCO 2008), in which it is clearly stated, “Gender equality is a fundamental human right, a commonly shared value, and a necessary condition for the achievement of the internationally agreed development objectives, including all Millennium Development Goals (MDGs).” The text also states, “Women’s Empowerment is about women taking control over their lives: setting their own agendas, gaining skills, building self-confidence, solving problems, and developing self-reliance. Although only the individual can empower herself to make choices, processes that nurture the empowerment of individuals or groups can be supported by others.” It must be stressed that the concept of empowerment is related to gender equality but distinct from it. The core of empowerment lies in the ability of a woman to control her own destiny. This implies that to be empowered, women must not only have equal capabilities (such as education and health) and equal access to resources and opportunities (such as land and employment), they must also have the ability to use those rights, capabilities, resources, and opportunities to make strategic choices and decisions through leadership opportunities and participation in political life (United Nations Development Programme 2008). According to “The Gender Equality Strategy 2008–2011,” a publication of the United Nations Development Programme (UNDP) (2008), women’s empowerment and their struggle for equality are based on five major components: • women’s sense of self-worth • the right to have and to determine choices • the right to have access to opportunities and resources • the right to have the power to control their own lives, both within and outside the home

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• the ability to influence the direction of social change to create more just social and economic order, nationally and internationally This strategy has been designed to complement and reinforce the UNDP’s overall Strategic Plan and aims at defining in more detail how attention to gender equality and women’s empowerment will strengthen their action in all our areas of work by fully recognizing the role of gender relations in economic life, and the contribution of both paid and unpaid (“women’s”) work to economic growth.

3.2.1.3 Full, unconditional access to health care services As pointed out by the EC, gender-based inequalities are present in health care and long-term care, as well as in health outcomes, even within the borders of the European Union (European Commission 2010a). What needs to be borne in mind, an issue that is very relevant when discussing access to assisted reproduction technology, is the fact that women and men are confronted with gender-specific health risks and diseases that need to be adequately addressed in medical research and health services. Therefore, there is a need to ensure that social and health services continue to adapt to the specific needs of women. Equal relationships between women and men in matters of sexual relations and reproduction, including full respect for the integrity of the person, require mutual respect, consent, and shared responsibility for sexual behavior and its consequences (Fathalla 2008). Prevention and management of diseases of the reproductive system is an important component in women’s health care. The system is subject to trauma, infections, and tumor development. Although the overall incidence of cancer, in general, is not much different in men and women, genital cancer accounts for a much larger percentage of all cancers in women and has special implications for women’s health. Obstetricians/ gynecologists, as specialists in women’s health, have a specific, pivotal role to ensure that women have access to high-quality services, protecting their rights and fostering their cause. It is also important to recognize that, even dealing with diseases and conditions of body systems outside the reproductive tract and affecting men and women, sex and gender are important. Until recently, however, informed work on female-specific diseases did not carry over to diseases men and women share. Mental health is a good example of these gender differentials, and it is well known that gender is a critical determinant of mental health and mental illness because gender determines the differential power and control men and women have over the socioeconomic determinants of their mental health and lives; their social position, status, and treatment in society; and their susceptibility and exposure to specific mental health risks. This is especially true in the prevalence rates of some common mental disorders, such as depression (unipolar depression, predicted to become the second leading cause of global disability burden by 2020, is twice as common in women), anxiety, and somatic complaints affecting women much more than men and representing a serious public health problem (World Health Organization 2010).

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Therefore, there is a need to ensure that social and health services continue to adapt to the specific needs of women. In this connection, the words pronounced by Hiroshi Nakajima, director-general of the WHO, in Beijing in 1995 come to mind. Nakajima affirmed that to make a difference in women’s lives, it is not necessary to ask for privileges for women; rather, the world must realize that equitable care does not mean identical care, particularly when physiological differences obviously call for specialized health services. He added that the world will see sustainable progress only when women will be finally empowered to make free, informed, and responsible choices and to assert themselves as leaders in their own right within their societies (Nakajima 1995). For years, now the WHO has insisted on this theme: Saving on women’s health and education is unacceptable from an ethical point of view and a grave miscalculation from an economic and social viewpoint, simply because no country or community “can afford to lay half of their natural resources to waste, to neglect half of their human potential” (Nakajima 1995).

3.2.2 A right to treat infertility It is well known that in a number of countries, childlessness is a real curse, and that infertile women can be divorced simply on the ground that they cannot provide a heir for their families. Tragically, this curse is much more serious in the developing world, where access to ART is problematic, to say the least. On a practical level, many families in developing countries depend on children for economic survival. For these reasons, the academic discussion whether infertility is a disease becomes irrelevant for two reasons: First, infertility is always the consequence of an abnormal, often pathologic, situation; second, it is a social and public health issue as well as an individual problem (Papreen et al. 2000; Widge 1999). In addition to the personal grief and the moral suffering it causes, the inability to have children, especially in poor communities in the developing world, can produce broader problems for women; indeed, a female’s social and economic status depend on her ability to reproduce; therefore, an infertile woman is blamed by her family. This condition creates a social stigma, economic hardship, social isolation, and violence, which may drive a woman to suicide or expose her to the risk of being killed (Pennings 2008); a study conducted in India reported that approximately 70% of infertile women would be punished for their “disability” with physical violence (Daar and Merali 2002). Ombelet et al. (2008) have clearly described the psychological and social consequences of infertility in at least some developing countries and summarized them in fTab. 3.1 (Dyer et al. 2002a, 2002b, 2004; Hollos 2003; Leonard 2002; Orji et al. 2002; Sundby et al. 1998; Umezulike and Efetie 2004) Recently, a report appeared in the journal Nature (Pilcher 2006) describing the story of a woman named Betty Chishava, from Harare, Zimbabwe, who was thrown out of her family home because she failed to conceive and refused to sleep with her brother in-law to increase her chances of getting pregnant. She did not have access to treatment, and in her culture she could not negotiate her status in her family and society outside motherhood. In commenting this episode, Vayena (2009) pointed out that this is unfortunately not a rare story; rather, it is the reality for many infertile women in developing countries. In addition, infertility is not usually considered a developing-world problem, and, for

Tab. 3.1: Psychological and social consequences of infertility in developing countries. From Ombelet et al. (2008). (1) Loss of Social Status (Dyer et al. 2002a, 2002b, 2004) † Fertility = blessing of God J Infertility = curse, punishment † Social status of woman = dependent on number of children (sons) † Burdened with additional social tasks by extended family (2) Social Isolation (Dyer et al. 2004) † Subject to ridicule, scorn, and gossip † Marginalized in family/community † Excluded from community functions † Accusations of witchcraft; ostracism † Excluded from contact with children (3) Marital Instability (Dyer et al. 2002a, 2002b, 2004; Orji et al. 2002; Umezulike and Efetie 2004) † Unhappiness, sexual dissatisfaction † Alcohol abuse † Migrant labor † Psychological, emotional, and physical abuse † Abandonment/divorce: —Return of bride wealth —Poverty —Second wife —Strategy to overcome infertility —Increased risk of STDs, including HIV (4) Loss of Social Security (Papreen et al. 2000; Sundby et al. 1998; Hollos 2003) † Marital instability; lack of assistance in domestic tasks † Land claims negotiated through number of children † Lack of old-age security † Death of a spouse: few rights to inherit from husband † Right to live in deceased husband’s compound dependent on the presence of a son (5) Gender Identity (Dyer et al. 2004; Hollos 2003) † Infertility arrests transition from child to adult (6) Psychological Consequences (Papreen et al. 2000; Dyer et al. 2004) † Most common: guilt, depression, shame, grief, disbelief, sense of worthlessness † Greater width and depth of distress when compared with Western societies (7) Continuity: Funeral Tradition (Hollos 2003; Leonard 2002) † No child to conduct funeral/mourn for deceased † No burial; fear for diminished fertility of the soil † Infertile women excluded from reincarnation

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good reasons, the provision of infertility services and especially assisted reproduction are not on the resource-allocation agenda. Since the International Conference on Population and Development, held in Cairo, affirmed the basic right of all couples and individuals to decide freely and responsibly the number, spacing, and timing of their children (United Nations 1995), helping couples have children has represented the other side of the coin for fertility by choice, especially because the social burden of infertility falls disproportionately on women and they go to great length in their quest for a baby (Fathalla 2008). In discussing the right to access to infertility care, there is a sentence in the Cairo definition of reproductive health that can be interpreted only as establishing a right for couples to see that, whenever possible, their infertility should be treated. The sentence states, “Reproductive health therefore implies that people ... have the ability to reproduce” (United Nations 1995). Establishing such a right is not a small endeavor, since it has been calculated that – already 20 years ago – as much as 60 million to 80 million people, most of them living in developing countries where their right to treatment remains a dream, experienced infertility around the world (World Health Organization 1991). Moreover, the International Covenant on Economic, Social, and Cultural Rights, adopted by the UN General Assembly in December 1966 and entered into force in January 1976, recognized the right of everyone to enjoy the benefits of scientific progress and its applications, and to reach the highest standard of physical and mental health (United Nations General Assembly 1966). One of the first scientists to raise the issue of a right to treatment of infertility was an Indian (Rao 2005), indicating that this issue is also considered important in the developing world. Nevertheless, over the last decades, as pointed out by Pennings (2008), people from Western countries have cultivated the belief that overpopulation, not infertility, is the major problem of developing countries, creating a practical but important barrier to even consider infertility treatment in resource-poor countries. On the other hand overpopulation and infertility are different but closely related features of the same problem: Countries with the highest fertility rates, owing to a high prevalence of secondary infertility due to untreated sexually transmitted diseases and postabortion and postpartum infections, also have high infertility rates (Fathalla 2002). Moreover, what this approach fails to take into consideration is the fact that we are dealing not with global solutions but with the personal suffering of individuals, and that we cannot avoid helping them. Indeed, the major physical, psychological, social, and economic consequences of infertility for a woman should represent a good enough reason to allocate even a small part of developing countries’ resources for the promotion of infertility treatments (Akande 2008). Furthermore, in a developing country, costs of fertility treatments can exceed half the annual income of the average citizen (Collins 2002); in addition, they are often provided almost exclusively privately and therefore are available only to the upper classes. Evoking the principle of equality and in particular what has been called the “ethics of envy,” one may conclude that if access to fertility treatments cannot be guaranteed for everyone, no one should have access to them (Pennings 2008). If we believe that this argument is absurd, we must conclude that an effort must be made to make infertility treatment available more widely.

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At the same time, we must make every effort to reduce cost, independently of availability, because it will certainly increase the number of people who can have access to it (Collins 2002; Pennings 2008). The solution, therefore, seems to rest on inducing governments to promote the development of low-cost IVF, integrating infertility management into health care services, simplifying diagnostic and therapeutic procedures, and organizing training courses for medical and paramedical personnel (Ombelet et al. 2008). To be fair, though, to achieve these goals, developing countries should allocate a sizable portion of their scarce resources to infertility, an unreal objective when considering that, if resources are used for this end, the opportunity is lost for using the same resources to solve other important health emergencies, such as infections and malnutrition (Rao 2005). To complicate matters even further, as Indian economist Amartya Sen has forcefully stated, rights cannot be denied on the basis of governments’ lack of economic resources, giving as an example that this reasoning has been applied when denying women the right to education (Leonard 2002). Also, Sen correctly observes that a careful examination of governmental budgets in both developing and developed nations frequently reveals major mismanagement of funds, especially when it comes to armaments. Confronted with this array of arguments and counterarguments, Pennings (2008) has further elaborated that infertility treatment can be considered only when two conditions are fulfilled: first, that a minimal level of political stability and a minimal basic structure of health care provisions exist, and second, that not only high tech interventions like IVF but also simpler strategies should be considered. This second prerequisite may be difficult to fulfill, since – as already stated – a good proportion of cases of infertility in developing countries is due to consequences of sexually transmitted infections; in these cases, only more complex reproductive technologies, such as IVF, can resolve the situation (Akande 2008). The European Society for Human Reproduction and Embryology (ESHRE) recently established the Task Force on Infertility and Developing Countries to debate the problem and to look for ART innovations that can be used in the developing world (Vayena et al. 2009). There is also a nonprofit organization, the Low Cost IVF Foundation, established in 2007 to encourage development of low-cost ART and to demonstrate that the “material costs for a cycle of IVF can be less than €200.” The foundation’s principal goals are establishment of low-cost IVF clinics in developing countries, training of medical personnel involving with the low-cost procedures, oversight of the clinics to ensure that procedures are correct and appropriate, and monitoring of success rates as well as educational programs for raising awareness on issues related to reproductive health (Low Cost IVF Foundation 2010). In conclusion, the new attitude toward ART in developing countries is represented by a more constructive approach consisting of exploring new possibilities and innovative ways of ART that take into account the needs and the particular situations of low-resource settings (Low Cost IVF Foundation 2010).

References Agrawal AF. Sexual selection and the maintenance of sexual reproduction. Nature. 2001; 411:692–695.

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Akande EO. Affordable assisted reproductive technology in developing countries: pros and cons. ESHRE Monographs. 2008. http://www.eshre.com/01/MyDocuments/8_ AFFORDABLE_ART_IN_DEVELOPING_COUNTRIES_PROS_AND_CONS.pdf. Accessed October 12, 2010. Ardrey R. The Hunting Hypothesis. New York: Atheneum Publishers; 1976. Bateson P, ed. Mate Choice. Cambridge and New York: Cambridge University Press; 1983. Benagiano G. Reproductive strategies for human survival. Reprod BioMed Online. 2002; 4(suppl 1):72–76. Benagiano G, Schei B. A FIGO initiative for the 21st century: Eliminate all forms of violence against women worldwide. Int J Gynaecol Obstet. 2004;86:328–334. Benagiano G, Carrara S, Filippi V. Social and ethical determinants of sexuality: 2. genderbased violence. Eur J Contracept Reprod Health Care. 2010;15:220–231. Buss DM, Schmitt DP. Sexual strategies theory: an evolutionary perspective on human mating. Psychol Rev. 1993;100:204–232. Cashdan E. Women’s mating strategies. Evol Anthropol. 1997;5:134–143. Collins J. An international survey of the health economics of IVF and ICSI. Hum. Reprod. Update. 2002;8:265–277. Cook RJ, Dickens BM. Dilemmas in intimate partner violence Int J Gynaecol Obstet. 2005;106:72–75. Daar AS, Merali Z. Infertility and social suffering: the case of ART in developing countries. In: Vayena E, Rowe E, Griffin D, eds. Current Practices and Controversies in Assisted Reproduction. Geneva: World Health Organization; 2002:15–21. Dyer SJ, Abrahams N, Hoffman M, Van der Spuy ZM. “Men leave me as I cannot have children”: women’s experiences with involuntary childlessness. Hum Reprod. 2002a;17:1663–1668. Dyer SJ, Abrahams N, Hoffman M, Van der Spuy ZM. Infertility in South Africa: women’s reproductive health knowledge and treatment-seeking behaviour for involuntary childlessness. Hum Reprod. 2002b;17:1657–1662. Dyer SJ, Abrahams N, Mokoena NE, Van der Spuy ZM. “You are a man because you have children”: experiences, reproductive health knowledge, and treatment-seeking behaviour among men suffering from couple infertility in South Africa. Hum Reprod. 2004;19:960–967. European Commission. Communication 491 (final) from the European Commission to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions. Strategy for equality between women and men. 2010–2015. SEC(2010) 1079 SEC(2010) 1080, 2010a. European Commission. Communication 171 (final) from the European Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Plan of action for 2010–2015. SEC(2010) 1079 SEC(2010) 1080, 2010b. European Institute. French Parliament’s ban on full-face veils is popular in EU, but controversial in U.S. 2010. http://www.europeaninstitute.org/July-2010/muslim-full-body-veilfrench-ban. Accessed October 6, 2010. European Union. European charter of human dignity. 2010. http://www.eucharter.org/home. php?page_id=8. Accessed October 4, 2010. Fathalla M. Current challenges in assisted reproduction. In: Vayena E, Rowe P, Griffin D, eds. Current Practices and Controversies in Assisted Reproduction. Geneva: World Health Organization; 2002:3–12. Fathalla MF. Issues in Women’s Health and Rights: International, Arab Regional, and Egyptian Perspective. Cairo: International Planned Parenthood Federation, Arab World Region; 2008. Finney HR. Breaking the earthenware jar. Katmandu: UNICEF Regional Office for South Asia; 2000:11.

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Freud S. Die Sexualität in der Ätiologie der Neurose. Vienna: Wiener Klinische Rundschau, II; 1898. Hawkes K. Grandmothers and the evolution of human longevity. Am J Hum Biol. 2003; 15:380–400. Henley J. French MPs vote for veil ban in state schools. Guardian. http://www.guardian.co.uk/ World/2004/feb/11/schoos.schoolsworldwide#history. Accessed October 4, 2010. Hollos M. Profiles of infertility in southern Nigeria: women’s voices from Amakiri. Afr J Reprod Health. 2003;7:46–56. Kaplan H, Hill K. Hunting ability and reproductive success among male Ache foragers. Curr Anthropol. 1985;26:131–133. Leonard L. “Looking for children”: the search for fertility among the Sara of southern Chad. Med Anthropol. 2002;21:79–112. Low Cost IVF Foundation. http://www.lowcost-ivf.org. Accessed October 17, 2010. Nakajima H. Fourth World Conference on Women: Action for Equality, Development, and Peace, Beijing, September 4–15, 1995. http://www.un.org/womenwatch/daw/beijing/ unastatements.html. Accessed on October 4, 2010. Ombelet W, Cook I, Dyer S, Serour G, Devroey P. Infertility and the provision of infertility medical services in developing countries. Hum. Reprod Update. 2008;14:605–621. Orji EO, Kuti O, Fasubaa OB. Impact of infertility on marital life in Nigeria. Int J Gynaecol Obstet. 2002;79:61–62. Papreen N, Sharma A, Sabin K, Begum L, Ahsan SK, Baqui AH. Living with infertility: experiences among urban slum populations in Bangladesh. Reprod Health Matters. 2000;8:33–44. Pennings G. Ethical issues of infertility treatment in developing countries. Hum. Reprod. 2008;8:15–20. Pilcher H . IVF in Africa: fertility on a shoestring. Nature. 2006;442:975–977. Rao KA. Infertility treatment is a human right. Indian J Med Ethics. 2005;2:128. Sandis EE. United Nations measures to stop violence against women. Ann NY Acad Sci. 2006;1087:370–383. Siller S. Sexual selection and the maintenance of sex. Nature. 2001;411:689–692. Sundby J, Mboge R, Sonko S. Infertility in the Gambia: frequency and health care seeking. Soc Sci Med. 1998;46:891–899. Umezulike AC, Efetie ER. The psychological trauma of infertility in Nigeria. Int J Gynaecol Obstet. 2004;84:178–180. UNESCO. Priority gender equality. Action Plan 2008–2013. 2008. http://www.unesco.org/fr/ genderequality. Accessed October 4, 2010. United Nations. Secretary-general, in message on International Day, says violence against women atrocious manifestation of continued systematic discrimination, equality. November 22, 2005. http://www.un.org/News/Press/docs/2005/sgsm10225.doc.htm. Accessed December 30, 2009. United Nations. Convention on the elimination of all forms of discrimination against women. 1979. http://www.unchr.ch/html/menu3/b/e1cedaw.htm. Accessed September 5, 2009. United Nations. International Conference on Population and Development, “Summary of the programme of action.” 1995. http://www.un.org/ecosocdev/geninfo/populatin/icpd.htm. Accessed October 4, 2010. United Nations Development Programme. Empowered and equal. Gender equality strategy 2008–2011. 2008. New York: United Nations. United Nations General Assembly. The universal declaration of human rights. 1948. http:// www.un.org/en/documents/udhr/index/shtml. Accessed October 4, 2010. United Nations General Assembly. Resolution 2200 A (XXI). International Covenant on Economic, Social, and Cultural Rights. Berlin; New York: United Nations, 1966.

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United Nations General Assembly. Declaration on the elimination of violence against women. New York: United Nations; 1993. Vayena E. Assisted reproduction in developing countries: the debate at a turning point. In: Simonstein F, editor. Repro-Genethics and the Future of Gender. Berlin: Springer; 2009:65–77. Vayena E, Peterson H, Adamson D, Nygren KG. Assisted reproductive technology in developing countries: are we caring yet? Fertil Steril. 2009;92:413–416. Waseem S. Ban the burqa? Reflecting on the French president Sarkozy’s comments. Rev Religion. 2009;104:44–48. Widge A. Infertility. Unisa. 1999;67–72. http://www.searo.who.int/LinkFiles/Reporductive_ Health_Profile_infertility.pdf. Accessed October 17, 2010. World Health Organization. Infertility: a tabulation of available data on prevalence of primary and secondary infertility. Geneva: World Health Organization, 1991. World Health Organization. Gender and women’s mental health. http://www.who.int/ mental_health/prevention/genderwomen/en. Accessed October 10, 2010. Zeenews Bureau. France, Belgium to ban burqa from public spaces. 2010. http://www. zeenews.com/news621061.html. Accessed October 6, 2010.

4 Right to reproduce Harpreet Kaur and Kamini A. Rao The right to procreate has been considered to be the basic human right from ages. In 1948, the United Nations Universal Declaration of Human Rights laid down, in Article 15, “that men and women of full age, without limits due to age, race, nationality, or religion, have the right to form a family.” In 1950, the European Convention for the Protection of Human Rights and Fundamental Freedoms, in Article 12, stated that “men and women of marriageable age have the right to marry and to found a family, according to the national laws governing the exercise of this right.” In 1998, the United Kingdom adopted the convention, including Article 12, by passing the Human Rights Act. “Health, as defined in the constitution of the World Health Organization (WHO), is not merely the absence of disease or infirmity but a state of complete physical, mental, and social well-being” (Preamble 1946). Reproductive health, therefore, implies that people are able to have a satisfying and safe sex life and that they have the capability to reproduce and the freedom to decide if, when, and how often to do so. People perceive the suffering from infertility as very real, and as compromising their health. There is no single discipline, perspective, standard practice, or ethic that will resolve the many dilemmas in the protection of reproductive and sexual health. New advances in reproductive technology have opened new frontiers in assisted conception, leading to many legal and ethical issues, so it becomes meaningful to discuss reproductive rights in this era of assisted reproductive technology. Reproductive rights may include some or all of the following: • the right to legal or safe abortion • the right to birth control • the right to access high-quality reproductive health care • the right to education and access in order to make reproductive choices free from coercion, discrimination, and violence Reproductive rights may also include the right to receive education about contraception and sexually transmitted infections, and the right to freedom from coerced sterilization, abortion, and contraception, plus protection from gender-based practices such as female genital cutting and male genital mutilation.

4.1 Socioeconomic issues Throughout human history, up until the present, humans have almost universally taken for granted an absolute right to have children regardless of either their capacity to care for and support children or the consequences of exercising this right (i.e., the fate of the resulting children). Should there be an unqualified, absolute right to procreate, untethered to the consequences for the resulting children? Is it ethical to knowingly and predictably bring children into the world when one cannot really fulfill the responsibility of parenthood

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or if the child will predictably suffer, due to hunger, poverty, war, disease, etc.? Should a child, in effect, have a right to not be born into a state of great poverty, suffering, disease, and severe limitation on the possibility for a decent quality of life, to the extent that this is knowable or predictable in advance? Declarations of the right to reproduce came about in the post–World War II era as a response to mass sterilization in Nazi concentration camps. In effect, this means that everyone of marriageable age has the right to found a family. In more elaborative form, the right can be stated in two ways: 1. A negative right: a right simply not to be prevented from forming a family. 2. A positive right: a right to be helped by others, specifically the state, in the founding of a family. If the right is taken as positive, protecting the right will not be easy for the government (e.g., for every infertile couple), because it will have to pay the whole cost of treatment. But if the right is merely negative, the government would not be morally obliged to help couples found a family; it would merely be obliged not to prevent them from doing so. This means that the couple has to pay for the treatment. And considering the cost involved in assisted reproductive technology (ART), treatment would be available only to those able to pay. What about the right of those who cannot afford do so? Then there is the issue of the difference between assisted conception and natural pregnancy. With natural pregnancy, we do not have baby licenses, nor should we. So, why prevent people from having assisted conception. If we believe that everyone has right to reproduce, what about the rights of the resulting children? In practice, all of us believe that every child or potential child has a right to a decent childhood. Since the Human Fertilisation and Embryology Act of 1990, fertility clinics have been allowed to provide treatment only after they have taken into account the welfare of “any child who may be born as a result of treatment.” The act’s “Welfare of the child” clause states that a woman should not be provided with infertility services unless account has been taken of the welfare of any child who may be born as a result of the treatment, or of any child who might be affected as a result of the birth. Due to lack of clear cut guidelines, the clinical team has great responsibility for decision making as to who should be treated, and who should not. This raises problems about how these people might assess the welfare of the child – a child that is not yet in existence and may never come into existence. It has been said that perhaps the criteria used for adoption should be used. There is very little published data on how the welfare of the child is assessed in practice. The assumption that people have a right to have children is considered in relation to the question of whether society has an obligation to allocate resources to make clinical IVF available, at least to married couples where the woman is infertile and the couple provides the ovum and sperm. The issues that need to be addressed include the distress that accompanies infertility versus the fact that infertility is not a life- or health-threatening condition; the distinction between basic needs or desires on the one hand and claiming rights on the other; and the costs and benefits of relieving infertility through IVF versus other means (Uniacke 1987). Infertility raises different ethical implications in different societies, although it is more uniformly a matter of emotional distress to people who want to have children. In some societies, male factor infertility in

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a couple is denied, and women bear the blame for not conceiving, at times to the point of divorce, shame, or destitution. Attempts have been made to analyze the socioeconomic conditions that affect the realization of a woman’s reproductive rights. The term reproductive justice has been used to describe these broader social and economic issues. Proponents of reproductive justice argue that while the right to legalized abortion and contraception applies to everyone, these choices are only meaningful to those with resources, and that there is a growing gap between access and affordability. Unlike as with many other medical conditions, the private medical sector dominates the treatment of infertility. In this context, the right to reproduce is akin to a marketing slogan that can encourage people to persist in treatment. In many parts of the world (especially the developing world), reproduction is a social issue, controlled by family and religious customs, and not merely a personal choice. A stigma of being childless puts a pressure on the couple to have children, and, for many infertile couples, infertility is a life crisis.

4.2 Religious issues After the birth of the first IVF baby, though the Roman Catholic Church published the “Donum Vitae” and welcomed Louise Brown as a gift and as a unique person, it expressed doubts about the process of IVF and the science of human embryology. The Church sees human life as sacred, with the parents as co-creators of new life – the baby is the result of the love the couple have for each other. IVF takes the new baby away from the expression of love and becomes simply part of a process. IVF with embryo transfer is brought about outside the bodies of couple through actions of third parties whose competence and technical activity determines the success of the procedure. The Church also sees every human life, from the first moment of conception and at every stage of development, however early, as worthy of protection (Oliphant and Mayled 2007). In the Islamic world, couples are encouraged to have the children they can support, but the integrity of family lineage is an important issue, and third-party sperm donation is not acceptable. Taken in the context of infertility, IVF can be seen as a practical solution to the problem, but this is different from right to have children, as the latter may simply lead the couple to demand more liberal adoption laws. In many parts of the world, egg donation and embryo donation are not permitted, and not all religions allow surrogacy.

4.3 Legal and historical aspects Reproductive rights (i.e., access to sexual and reproductive health care and autonomy in sexual and reproductive decision making) are human rights; they are universal, indivisible, and undeniable. These rights are founded on principles of human dignity and equality and have been enshrined in international human rights documents. Reproductive rights embrace core human rights, including the right to health, to be free from discrimination, to privacy, to not be subjected to torture or ill treatment, to determine the number and spacing of one’s children, and to be free from sexual violence.

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The WHO defines reproductive rights as follows: Reproductive rights rest on the recognition of the basic right of all couples and individuals to decide freely and responsibly the number, spacing, and timing of their children and to have the information and means to do so, and the right to attain the highest standard of sexual and reproductive health. They also include the right of all to make decisions concerning reproduction free of discrimination, coercion, and violence. (World Health Organization 2011a) The Universal Declaration of Human Rights, the first international legal document to delineate human rights, does not mention reproductive rights. It simply states that “[m]arriage shall be entered into only with the free and full consent of the intending spouses” (Articles 5 and 16.2). The International Covenant on Civil and Political Rights says, “Everyone has the right to liberty and security of person,” that “[n]o one shall be subjected to unlawful interference with his privacy,” and that “[s]tate parties shall take appropriate steps to ensure equality of rights and responsibilities of spouses as to marriage, during marriage, and at its dissolution” (Articles 9.1, 17.1, and 23.4). Reproductive rights began to appear as a subset of human rights in the 1968 Proclamation of Teheran, which states, “Parents have a basic right to decide freely and responsibly on the number and spacing of their children and a right to adequate education and information in this respect.” In 1984, at the United Nations World Population Conference in Mexico City, population-control policies came under attack from women’s-health advocates who argued that the policies’ narrow focus led to coercion and decreased quality of care and that these policies ignored the varied social and cultural contexts in which family planning was provided in developing countries. In the 1980s, the HIV/AIDS epidemic forced a broader discussion of sex into the public discourse in many countries, leading to more emphasis on reproductive-health issues beyond reducing fertility. A nonbinding Programme of Action adopted in 1994 at the International Conference on Population & Development (ICPD) in Cairo asserted that governments have a responsibility to meet individuals’ reproductive needs, rather than demographic targets. It recommended that family-planning services be provided in the context of other reproductive-health services, including services for healthy and safe childbirth, care for sexually transmitted infections, and postabortion care. The ICPD also addressed issues such as violence against women, sex trafficking, and adolescent health. The Programme of Action is the first international policy document to define reproductive health, stating, Reproductive health is a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity, in all matters relating to the reproductive system and its functions and processes. Reproductive health therefore implies that people are able to have a satisfying and safe sex life and that they have the capability to reproduce and the freedom to decide if, when, and how often to do so. Implicit in this last condition are the right of men and women to be informed about and to have access to safe, effective, affordable, and acceptable methods of family planning of their choice, as well as other methods for regulation of fertility which are not against the law, and the right of access to appropriate health-care services

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that will enable women to go safely through pregnancy and childbirth and provide couples with the best chance of having a healthy infant [para. 72]. In 1999, recommendations at the International Conference on Population and Development (ICPD+5) were expanded to include commitment to AIDS education and research, and prevention of mother-to-child transmission, as well as to development of vaccines and microbicides. The 1995 Fourth World Conference on Women in Beijing, in its nonbinding declaration and platform for action, supported the Programme of Action’s definition of reproductive health but established a broader context of reproductive rights: “The human rights of women include their right to have control over and decide freely and responsibly on matters related to their sexuality, including sexual and reproductive health, free of coercion, discrimination, and violence (Cook, Mahmoud, and Fathalla 1996). Equal relationships between women and men in matters of sexual relations and reproduction, including full respect for the integrity of the person, require mutual respect, consent, and shared responsibility for sexual behavior and its consequences” [para. 96]. But, in the exercise of this right, men and women should take into account the needs of their living and future children and their responsibilities toward the community. The United Nations Population Fund and the World Health Organization advocate for reproductive rights, with a primary emphasis on women’s rights. In this respect, the UN and the WHO focus on a range of issues, from access to family-planning services and sex education to menopause and the reduction of obstetric fistula to the relationship between reproductive health and economic status. The reproductive rights of women are advanced in the context of the right to freedom from discrimination and the social and economic status of women. The group Development Alternatives with Women for a New Era (DAWN) explained the link in the following statement: Control over reproduction is a basic need and a basic right for all women. Linked as it is to women’s health and social status, as well as the powerful social structures of religion, state control, and administrative inertia, and private profit, it is from the perspective of poor women that this right can best be understood and affirmed. Women know that childbearing is a social, not a purely personal, phenomenon; nor do we deny that world population trends are likely to exert considerable pressure on resources and institutions by the end of this century. But our bodies have become a pawn in the struggles among states, religions, male heads of households, and private corporations. Programs that do not take the interests of women into account are unlikely to succeed. (Freedman and Isaacs 1993) Men’s reproductive rights have been claimed by various organizations, both for issues of reproductive health and for other rights related to sexual reproduction. Three international issues in men’s reproductive health are sexually transmitted diseases, cancer, and exposure to toxins (Best 1998). Recently, men’s reproductive right with in the context of paternity have become a subject of debate in the United States. The term “male abortion” was coined by Melanie McCulley, a South Carolina attorney, in a 1998 article (McCulley 1998). The concept begins with the premise that when a woman becomes pregnant, she has the option of abortion, adoption, or parenthood; it argues, in the

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context of legally recognized gender equality, that in the earliest stages of pregnancy, the putative (alleged) father should have the right to relinquish all future parental rights and financial responsibility, leaving the informed mother with the same three options. An article from the WHO calls safe, legal abortion a “fundamental right of women, irrespective of where they live” and unsafe abortion a “silent pandemic.” The article says that “ending the silent pandemic of unsafe abortion is an urgent public-health and human-rights imperative” (World Health Organization 2011b). It also states that “access to safe abortion improves women’s health, and vice versa, as documented in Romania during the regime of President Nicolae Ceausescu” and that “legalization of abortion on request is a necessary but insufficient step toward improving women’s health,” adding that in some countries, such as India, where abortion has been legal for decades, access to competent care remains restricted because of other barriers. The WHO’s Global Strategy on Reproductive Health, adopted by the World Health Assembly in May 2004, noted, “As a preventable cause of maternal mortality and morbidity, unsafe abortion must be dealt with as part of the Millennium Development Goals on improving maternal health and other international development goals and targets.” The WHO’s training program Development and Research Training in Human Reproduction (HRP), whose research concerns people’s sexual and reproductive health and lives, has an overall strategy to combat unsafe abortion. When reproductive rights are denied or limited, so are women’s human rights. Working to protect reproductive rights emphasizes the equality and dignity of women and the universality of human rights (Amnesty International USA 2010).

4.4 Moral aspects We have successfully cloned a sheep; it is not unreasonable, then, to believe we may soon be able to create human life. So, some sort of quality control is needed to ensure that cloned human beings shall not exist in pain or be severely compromised with respect to basic biological or biochemical functioning. And it should be illegal to knowingly create a life that will be spent in pain and/or that will be severely substandard. Merely having a capability does not entail the right to exercise that capability. Reproduction, with its attendant responsibilities, should be a privilege, not a right. Recognizing the inevitability of successful human cloning, numerous states and countries have enacted prophylactic bans on the technique. Assisted reproduction violates the holistic nature of reproduction, and ARTs take the principle of autonomy to the extreme, undermining the full capacity for freedom that accompanies naturally excellent behavior. It is a well-known fact that humans are not the masters of sources of life. They are moral individuals, implying that no person has an absolute right to the bodily property of another at any stage of that person’s life. Extending the principle of justice to its end, therefore, it can be confidently asserted that no person has a right to bear or raise a child, or to use another human being – at any stage of life – as a laboratory for medical treatments or operations of any kind. The very presence of blastocysts invites potential for exploitation at all stages of a procedure, from the harvesting of the egg to the fertilization to the implantation itself. Justice is only perfect when all parties involved are regarded as equals by those administering it, and ARTs have

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created two classes of viable embryos, those with realized totipotency and those subject to the whim of a physician or mother. The latter, clearly, are not receiving justice.

4.5 ART-related aspects The right to reproduce has gained importance in the modern era owing to technical advances in assisted reproduction. It could be argued that the right to reproduce is simply a basic need or desire to continue the human race. By means of assisted reproduction, it is now possible for a child to have up to five parents: a genetic father, a rearing father, a genetic mother, a gestational mother, and a rearing mother. Rights in relation to ART include rights of gamete donors, potential parents, embryo before implantation, surrogate rights, liability of the physician and the hospital, and public interest expressed through government regulations related to ART. The question as to whether a couple should undergo ART is a complex one that requires appropriate evaluation of the patient’s history, physical examination, and prior treatment. This must be combined with an understanding of the desires of the couple. Cost-benefit analysis of all the options available to each couple should then be carried. The benefit of any choice must then be balanced against the costs of the possible options. There are five types of direct or indirect costs involved in ART: The first is financial, which is influenced by the actual dollar cost, the insurance coverage, the couple’s financial resources, and their desire to spend their money on infertility care. The second cost is time related, having to do with the patient’s age, the duration of time to obtain results from the intended choice, and the amount of time the couple must commit to pursuing the option. The third cost is that of health-related issues such as side effects and complications of treatment. The fourth, and largest, cost is usually that of high-order multiple pregnancies with ART procedures. The fifth cost is the emotional or psychological cost of pursuing the different options. Ethical issues raised by ART have been found to be so profound that several countries have created national commissions to propose legal regulatory discipline. The International Federation of Gynecology and Obstetrics’s Committee for the Ethical Aspects of Human Reproduction and Women’s Health has made statements and recommendations, notably on ethical guidelines on the sale of gametes and embryos (1996), donation of genetic material for human reproduction (1994), and ethical aspects of gamete donation from known donors (directed donations) (2000) (Ethical Issues in Obstetrics 2009). The American Society for Reproductive Medicine (ASRM) has laid down guidelines for embryology laboratories and sperm, oocyte, and embryo donation (American Society for Reproductive Medicine, 2008). Some of the rules and regulations related to embryology laboratories and IVF practice follow: • The ART laboratory must undergo certification and accreditation by an appropriate agency. • No ART procedure shall be performed on a women under 21 years old. Oocyte donors should be of legal age, preferably 21–34 years old. • ART clinics should ensure that patients, donors of gametes, and surrogate mothers are eligible for ART procedures and have been medically tested for sexually transmitted and other communicable diseases.

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• It shall be the responsibility of an ART clinic to obtain, from a semen bank, all relevant information, other than the name, personal identity, and address of possible gamete donors, and assist the couple or an individual desirous of the donation in choosing the donor. • ART clinics shall explain to couples or individuals, as the case may be, the choice or choices of treatment available to them and the reason or reasons of the clinic for recommending a particular treatment, and shall clearly explain the advantages, disadvantages, limitations, and cost of any recommended or explained treatment or procedure and ensure that information about clients, donors, and surrogate mothers is kept confidential. • No ART clinic shall consider conception by surrogacy for patients for whom it would normally be possible to carry a baby to term. • A written informed consent is a must before performing any treatment or procedure of assisted reproductive technology. • No ART clinic shall use any human reproductive material to create an embryo or use an in vitro embryo for any purpose without the specific consent in writing of all the parties to whom the assisted reproductive technology relates and without seeking permission from regulatory board. • No research is conducted on any human embryo unless such research is necessary in public interest, and no work is done leading to human reproductive cloning. • Detailed records should be maintained by all ART clinics up to at least a period of 10 years. • The number of oocytes or embryos that may be placed in a woman in any one cycle shall be according to the rules and regulations laid down. • The ART clinic shall never mix semen from two individuals before use. • Preimplantation genetic diagnosis shall be used only to screen the embryo for known, preexisting, heritable, or genetic diseases or as specified by the registration authority. PGD for the sake of sex determination is not permissible, owing to the concerns about female feticide. • A semen bank shall not supply the sperm of a single donor for use more than 75 times, and no woman shall donate oocytes more than 6 times in her life, with not less than a three-month interval between the oocyte pickups. It is suggested that in a population of 800,000, limiting a single donor to no more than 25 births would avoid any significant increased risk of inadvertent consanguineous conception. • The highest possible standards should be followed in the storage and handling of gametes and embryos in respect of their security, and with regard to their recording and identification. • The sale, transfer, or use of gametes, zygotes, and embryos, or any part thereof or information related thereto, directly or indirectly to any party outside the country is prohibited. According to the Indian ART bill, ART shall be available to all persons including single persons, married couples, and unmarried couples. In case ART is used by a married or unmarried couple, there must be informed consent from both the parties. (FDA, ASRM Guidelines 2008; Indian ART Bill 2008) Some opponents of ART claim that it offends the collective rights to human dignity. Many international documents opposing reproductive cloning invoke the same

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ART related Religious aspects

Legal aspects Right to reproduce

Socioeconomic issues

Moral aspects Ethical issues

Fig. 4.1: Right to reproduce: Various aspects.

concept. Against this, the right under the International Covenant on Economic, Social, and Cultural Rights to the benefit of scientific progress supports resort to new reproductive technologies. The general right to found a family, recognized in many human rights conventions, supports medical assistance to prevent and to overcome the effects of infertility, whether or not scientific technology is applied (fFig. 4.1). Couples may claim unimpaired access to ART services they can afford, but may not require the state to provide these services, which, like cosmetic medicine, fall into a category of luxury medicine. With the availability of ART, will it be possible to provide these services equally over the globe (Freedman and Isaacs 1993)? If right to reproduce is considered in general, what about the countries where population growth is threatening the very health and safety of society in general, where medical care is unable to cover the existing population, and where many people don’t have access to basic health care? The main challenges to be addressed are the tension between demographic priorities and reproductive choice and the tension between international standards and local customs. There also may be number of local religious and ethical issues involved (e.g., surrogacy is not permitted in many countries of world). If great poverty and suffering are bad, and we feel obliged to intervene to ameliorate this, then how can it be ethical to knowingly or predictably create suffering or impoverishment by bringing a child into the world when this is the likely, predictable outcome?

References American Society for Reproductive Medicine, Practice Committee. 2008 guidelines for gamete and embryo donation: a Practice Committee report. Fertil Steril. 2008;90:S30–S44. Amnesty International USA. Stop violence against women: reproductive rights. Amnesty International USA Web site. 2010. http://www.amnestyusa.org/Stop_Violence_Against_ Women_SVAW/Reproductive_Rights/page.do?id=1108242&n1=3&n2=39&n3=1101. Accessed December 26, 2010. Best K. Men’s reproductive health risks: threats to men’s fertility and reproductive health include disease, cancer, and exposure to toxins. Family Health International Web site. Spring

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1998;18:3. http://www.fhi.org/en/RH/Pubs/Network/v18_3/NW183ch2.htm. Accessed December 26, 2010. Cook R, Mahmoud J, Fathalla F. Advancing reproductive rights beyond Cairo and Beijing. Int Fam Plan Perspect. 1996;22(3):115–121. Ethical issues in obstetrics and gynecology. The FIGO Committee for the Study of Ethical Aspects of Human Reproduction and Women’s Health; October 2009. http://www.figo.org/ files/figo-corp/Ethical%20Issues%20-%20English.pdf. FDA, ASRM Guidelines. Practice Committee of the American Society for Reproductive Medicine, and the Practice Committee of the Society for Assisted Reproductive Technology. Fertility and Sterility. 2008;90(suppl 3):S30–44, S45–59. Freedman L, Stephen P, Isaacs L. Human rights and reproductive choice. Stud Fam Plann. 1993;24(1):18–30. Indian ART Bill. The Assisted Reproductive Technologies (Regulation) Bill – 2010. Ministry of Health & Family Welfare. Government of India, New Delhi; 2008. McCulley, Melanie G. The male abortion: the putative father’s right to terminate his interests in and obligations to the unborn child. J Law Pol. 1998;7(1):1–55. Oliphant J, Mayled J. OCR Religious Ethics for AS and A2. Abingdon, UK: Routledge; 2007:134–35. Preamble to the Constitution of the World Health Organization as adopted by the International Health Conference, New York, 19–22 June, 1946; signed on 22 July 1946 by the representatives of 61 States (Official Records of the World Health Organization, no. 2, p. 100) and entered into force on 7 April 1948. Uniacke S. IVF and right to reproduce. Bioeth, 1987;1(3):241–254. World Health Organization. Gender and reproductive rights. World Health Organization Web site. 2011a; http://www.who.int/hrp/en/index.html/WHO. Accessed April 7, 2011. World Health Organization. Unsafe abortion: the preventable pandemic. World Health Organization Web site. 2011b; http://www.who.int/reproductivehealth/publications/ unsafe_abortion/ua_paper/en/index.html. Accessed April 7, 2011.

5 Informed consent for treatment of fertility Yosi Green 5.1 Introduction The court system reflects society’s values, among them the protection of human dignity, which includes the right to experience parenthood. Every person has the natural right of self-fulfillment and perpetuation of the family unit. The depth and strength of the parental bond has made familial autonomy a value having preeminent judicial standing, the impairment of which is tolerated only in special, extremely exceptional cases (Anonymous v Anonymous 2002). The doctrine of informed consent manifests the judicial system’s acknowledgment of patient autonomy and the right to share in decisions pertaining to a patient’s medical treatment. Underpinning the doctrine is the recognition that patients, like any other human beings, are autonomous beings who control their own lives and are responsible for their fates. The right to autonomy, which is grounded in human rights of dignity and privacy, gives rise to the autonomy of the family unit, the right of family planning, and the freedom to choose the form in which parenthood will be achieved (Davis v Davis 1992). Difficulty in procreating naturally and infertility, in and of themselves, impairs neither the right to experience parenthood nor its scope. Yet, since fertility treatments are provided by the state, parental autonomy is juxtaposed with other interests that should be balanced out. For example, restricting access to fertility treatments (due to considerations of cost, age, and the good of the future newborn) is legitimate despite the risk (or the possibility) of breach of parental autonomy. Hence, it is not enough that the patients give their informed consent for treatment, since the rights to both autonomy and parenthood are qualified rights that may be restricted. Advances in medical reproductive technology have made available to those having difficulties in procreating naturally a variety of reproduction treatments, inter alia, artificial insemination and in vitro fertilization (IVF). In most cases, the treatments are invasive and performed solely on the woman. The medical achievements that make it possible to conceive, other than naturally, via donation of reproductive cells (sperm and egg), and even posthumously, mandate a different approach to fertility-treatment consent than that required for other medical treatments. This is so due to certain unique characteristics of fertility treatments: first, the aim of fertility treatment and the measure of its success is the creation of a live newborn infant. Hence, the good of the future child should be considered, as should the patients’ capability to undertake parental responsibility. Consideration of the good of the child restricts and encroaches on patient autonomy. Second, fertility treatments are generally lengthy and difficult (physically and emotionally) and are conducted in cyclic sessions. The possibility that one of the spouses and/or the physician might seek to withdraw the initial consent and discontinue the treatment is not unreasonable. Third, the existence of cryopreserved (frozen) sperm cells and/or fertilized eggs in storage makes it possible to proceed with the reproductive process even after the dissolution of the family unit and/or the death of the donor of reproductive cells. Fourth, when the patients are a couple, the consent of both spouses

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is required, even though in most cases the treatment is performed on the woman, unlike in other types of treatment. Considering the unique characteristics of fertility treatments and the weight that should be attached to the right to experience parenthood, this discussion will focus on three issues: first, the right to experience parenthood; then, the informed consent requirement and its underlying rationale, principles, scope, limitations, and application to fertility treatments; and last, the discussion of three problems unique to fertility treatment consent. The first concerns the justification for requiring the consent of both spouses. The other two concern the validity of the consent over time, whether there should be an option to withdraw consent (by both spouses or either one of them, or by the physician) and whether the process should be continued based on the initial consent even after the death of either spouse. The discussion will be followed by recommendations and conclusions. The prevailing practice in Israel will be used to demonstrate the problems entailed in the consent requirement for fertility treatment.

5.2 The right to experience parenthood and its standing Informed consent for fertility treatment is a twofold issue: It concerns both the right of autonomy and the right to experience parenthood. Therefore, any discussion of the validity of informed consent for fertility treatment that ignores the existence of the right to be a parent and its constitutional standing is inevitably deficient. It is self-evident that every person is entitled to experience parenthood, which is a human right and one of humanity’s highest values. Embodied in the right to parenthood are the right to autonomy, the right to self-fulfillment, and the right of freedom of choice. It incorporates a group of rights and obligations that may change one’s personal status and materially affect one’s life emotionally and economically. The right to parenthood embraces two important aspects of family life: the right to have offspring (the biological act) and the right attached to it – which is also an obligation – to raise the children. These two interlacing aspects entail legal consequences with implications on the twofold right of parenthood: the positive one of being a parent and the negative one not to impose parenthood on a person who does not wish to experience it. All men and all women have the right to fertility treatment and to realize their desire to become parents, including by means of IVF. This is not to say that the right to experience parenthood and the patient’s consent impose on the state the duty to assist every person who needs this form of reproduction. Yet even if the state is not obliged to assist every one, the divide is great between this and preventing access to treatments and intervening in procreation. Indeed, the state controls the procedure through the organs acting on its behalf, both by allocating resources for developing advanced medical technologies and by determining the medical services available to health-fund members. This is why the imposition of restrictions on fertility treatments requires extra caution. Even if the state has the power to narrow down the population that is entitled to receive fertility treatments and even if is justified morally, economically and legally in doing so, it must exercise restraint in adding insult to injury to the infertile couple. This leads to the question whether the right of parenthood extends posthumously. Apparently, the answer is no, since when people dies, their rights – other than their right

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to dignity, (i.e., honoring the dead) – expire. However, the dignity of the dead is more than just respectful burial; it also means enhancing and realizing processes and plans that were begun while the deceased was alive, provided there is proof that the deceased wished them to continue after death. And that certainly includes perpetuating a man’s name by achieving parenthood through his spouse, or even by a couple waiting for donation of reproductive cells (Green 2008).

5.3 The informed-consent doctrine 5.3.1 The doctrine and its nature Informed consent has two components: the patient’s consent, which is given after receiving the information that enables the patient to arrive at that consent. In order for the patient’s consent to be legally valid, it must be voluntarily provided, free of coercion or extraneous influence, following proper disclosure by the physician of all the items of information required for informed consent. In complying with duty of disclosure, the physician must give the patient, as early as possible, every detail required to make the decision whether to accept or reject treatment. The physician must advise the patient not only of the risks entailed in the treatment but also about the procedure itself and its prospects of success. The patient should also be informed of treatment alternatives and whether the treatment is innovative. Physicians who fail to comply with the duty of disclosure expose themselves to civil and even criminal proceedings (Eyal 2008). Since consent for medical treatment is a contract between physician and patient and entails legal consequences, the consent giver must be legally qualified to give consent. The patient must be able to understand the explanation given, and grasp and process it, and only then decide whether to accept or reject the treatment. (Rejection must also be informed.) The application of the laws of contracts to the consent requirement gives both the patient and the physician the freedom to decide whether to enter into an “agreement for medical treatment” and even to withdraw from it. Notwithstanding the aforesaid, the patient is not entirely autonomous in deciding about treatment. Human life is a value in itself, supreme in the pecking order of most societies’ values. Therefore, a society that respects the sanctity of life would not permit life to be harmed without legal justification. Hence, despite the acknowledgment of patient autonomy, in certain cases the patient may be treated even without consent. By way of inference, it is also possible to withhold life-threatening treatment or treatment that might harm the patient’s health. The rationale is that if a patient’s autonomy may be breached in order to save the patient’s life, a fortiori, consent to harm may be qualified.

5.3.2 Application of the doctrine to fertility treatments Due to the unique nature of fertility treatment, as elaborated below, the physician requesting patient consent for fertility treatment, as well as the patients themselves, should be aware of the following: first, the legal grounds for the consent requirement is not just patient autonomy but also the patient’s right and desire to become a parent. Therefore, although the weight of the patients’ consent in the physician-patient relationship and in the relationship between the patients themselves is great, it is nevertheless qualified,

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due to its subordination to the good of the future child. Therefore, the sufficiency of the patients’ consent to begin fertility treatment is not a matter of course. Second, the parties involved in the treatment should be alert to the distinction between the consent of a single woman who cannot find a spouse and wishes to experience motherhood by way of IVF and the consent of a couple wishing to become parents by the same means. In both cases, the consent for treatment is the external manifestation of their willingness to do all that is required, including taking risks, in order to achieve the desired pregnancy, and in both cases the treatment is generally performed on the woman’s body. However, when the patients are a couple, the consent of the spouse is also required. The reason lies in the partnership between the spouses in the reproductive process and their willingness to share the responsibility derived from parenthood. Their joint signature on the consent form is the manifestation of said partnership. Third, the patients should be aware that due to the continuation of the treatment and its cyclic nature, the life span of the consent, the subject of their signatures, should be defined. The couple should determine whether the consent should lapse automatically after the first round of treatment, and should agree on their conduct in the event that the family unit is dissolved or one or both of them die. They must also decide prior to the commencement of treatment whether the physician may withdraw his consent. Fourth, the consent should be given in writing, a material requirement due to the responsibility entailed in the process, and due to the need to have a clear indication of the intention of the patients. As a general rule, written consent for treatment is indicative of the serious intentions of patients, and their understanding and grasping of the medical information relayed to them. Likewise, a written consent may assist the court in discerning the true facts should a claim be filed against the physician due to administering treatment without the patient’s consent, or should any other dispute be brought before the court for its decision.

5.4 Mutual consent of spouses 5.4.1 Joint process According to the standard practice in Israel, any act entailed in IVF of a married woman is to be carried out subject to her husband’s consent, which must be given in the same document. I do not dispute the necessity of obtaining the spouse’s consent for fertility treatments. Procreation is a joint process, the fruit of a mutual decision of both spouses, even if medically assisted. Parenthood is also mutual; the birth of a child entails legal consequences, and the responsibility and concern for the well-being of the minor is imposed equally on both parents. Yet, should a consent form for treatment be the document that binds the spouse to the future child? Is the treating physician the appropriate authority to accept the undertaking of the couple and to test their parental capability prior to the commencement of treatment? There is no dispute that the treatment consent form is designed solely for consenting to treatment. Yet, since both spouses are involved in the act of procreation on various levels, mutual consent is warranted. Judge Tova Strasberg-Cohen (in a minority opinion) discussed this issue in the Nachmani case. This famous Israeli case involved an infertile

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couple who planned surrogate pregnancy. Eggs and sperm from the couple were fertilized in vitro and cryopreserved. However, even before the surrogate pregnancy could be carried out, the husband left his wife and refused his wife’s request to use the fertilized eggs. According to Strasberg-Cohen, The process of fertilization towards joint parenthood embodies, by virtue of its very nature and as a necessary prerequisite, the consent of both spouses. What is the nature of the consent in the case of such a critical, sensitive, and intimate issue as procreation? In general, consent is a meeting of the minds of two or more persons that transforms their individual wishes into a mutual desire. Consents between a married couple may be classified as a general, primary, and central consent, which is consent to a mutual life as a couple, and as purposeful consents for attaining a specific objective within the framework of the marriage, the most important of which is the consent to bring children into the world. (Nachmani v Nachmani 1995) Indeed, both spouses experience the developing pregnancy, although it takes place in the woman’s womb. The same applies, heaven forfend, to unsuccessful treatment and the termination of the pregnancy. Both also share the tension accompanying the treatment, the difficulties, anxieties, and hopes. It is therefore just to require the mutual consent of the spouses to treatment.

5.4.2 The good of the child and consideration of parental capability Implicit in the consent requirement of the spouse is the assumption, justified in itself, that the good of the child also extends to the pre-procreation stage. Therefore, due regard should be given to the question of whether the couple’s consent is sufficient to begin treatment, since, if it culminates in the birth of a live newborn, the child will also and apparently primarily bear the consequences of the treatment for better or worse. Therefore, the birth of a child assisted by the state and its agents, unlike any medically unassisted birth, endows the state with the standing and right, and even the duty, to intervene in procreation to the extent of even preventing it. Indeed, as previously noted, the state does not routinely intervene in parental autonomy, but since the good of the child – a decisive consideration in every litigation involving a minor – is at stake, the state’s intervention is necessary in order to protect the child to be born, despite the encroachment on parental autonomy (Convention on the Rights of the Child 1989). Thus, the organs operating on behalf of the state should carefully consider the capability of the patients to ensure the well-being of the newborn prior to commencing the fertility treatments. Every child has a right to expect that society will do everything within its power to ensure that it is given a good chance to grow up in a normal, warm, and harmonious family. Every child is entitled to be provided with the material and psychological conditions required for its growth and education by parents capable of fulfilling this role successfully (Green 2008). Yet, undoubtedly, the medical institution and the treating physician before whom the couple sign their consent for treatment are not the appropriate authorities for testing parental capability and determining the good of the child. Therefore, in order to avoid future mishaps and legal proceedings, consent for fertility treatments should be

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stipulated on a proper prior undertaking by both spouses before a competent authority. The role of such authority should be to test the ability of the patients to function as dedicated parents for the benefit of their child. It is doubtful whether this requirement, which may impede the process, is practical, and therefore, the couple should be aware that their consent for treatment implies consent to bear the legal consequences of their parenthood. Physicians should also know that they might expose themselves to legal claims by a child born defective, or in the case that it was known prior to the treatment that the child’s parents were unqualified to raise it.

5.5 Validity of the consent The test of a successful fertility treatment is, as previously noted, the birth of a live child – and, to the extent possible, a biological offspring. However, until the desired pregnancy is achieved, many couples undergo lengthy, painful, and recurring treatments. Due to the prolonged treatment, its cyclic nature, physical and emotional strain, and the potential for disappointments, alternative options (adopting a child), and dissolution of the family unit, the spouses may well despair, recoil, and withdraw their consent for treatment. The same applies to a physician concerned about a foreseeable or unforeseeable risk to the life of the female patient, which might develop in the course of treatment. The question, then, is, what is the life span of the (initial) consent for treatment and to what extent are the parties to the treatment agreement bound by their initial consent?

5.5.1 Effect of the initial consent Consent for lengthy or cyclical treatments (such as dialysis) raises the question, what is the scope of the initial consent? The same question applies to the consent given by the couple for fertility treatment: Does a written, signed consent given at the commencement of treatment extend also to recurring treatments, or should the physician obtain the renewed consent of both spouses prior to each treatment? The answer lies in the interpretation given to the intention of the concerned parties prior to signing the treatment consent form. One interpretation suggests that, once the patients were advised that the treatment would be lengthy and would consist of several sessions, by signing the consent form, they manifested their intention to have a child and agreed to each stage of the treatment. According to a different interpretation, the patients’ initial consent remains in effect for each procedure required in the course of the treatment, as long as neither one of them reports its withdrawal. According to a third interpretation, the information pertaining to lengthy treatment is meant to make it clear to the patients that until pregnancy is achieved, numerous invasive acts might be necessary. The initial consent, under the third interpretation, is thus solely for the first round of treatment. If additional interventions are required, the couple will have to give their renewed consent prior to each act in order to continue with the process. The first interpretation is more logically correct. The consent is given not for each phase and every procedure but rather for achieving pregnancy. Yet this interpretation is too sweeping; it binds the couple to their initial consent and breaches their autonomy. Therefore, practically speaking, the third interpretation, which requires renewed consent for every invasive intervention, is preferable.

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5.5.2 Withdrawal of patient consent Apparently, as determined by the court in the Nachmani case, once “the birth journey” begins, it cannot be stopped on a whim of either of the patients (Nachmani v Nachmani 1982). The birth journey begins at the signing of the consent form, and this court decision is consistent with the first interpretation. The Israeli Supreme Court, in the appeal on this case, did not dismiss this claim, but it held that under the circumstances, in the tension between the two aspects of the right to be a parent, the right not to impose parenthood on any person who does not wish to become a parent supersedes the right to become one. Nevertheless, it should be recalled that the reason for the litigation in the Nachmani case was the dissolution of the family unit while frozen fertilized eggs were still in storage, a fact that indicated that the process was at an advanced stage. Moreover, the fertilized eggs had been created following a series of laborious treatments. The “have” was therefore preferred over the “have not” (i.e., discontinuing the process). On the other hand, if one accepts the third, practical interpretation, then for each procedure, the renewed consent of both spouses would be required, and the insertion of the fertilized eggs into the uterus would also require the renewed consent of the spouse, since the initial consent has expired. Refusal to give consent would lead to termination of the treatment, so, in effect, a veto right is given to each of the spouses. According to this interpretation, it makes no difference whether consent withdrawal is requested prior to the creation of the fertilized eggs or thereafter, when they are already frozen in storage. Withdrawal of consent should be permitted whenever it is requested by either one of the spouses.

5.5.3 Physician’s withdrawal of consent As a general rule, fertility treatments are not life threatening. Nevertheless, since the treatment includes intervention in the woman’s hormonal balance and invasive procedures of one kind or another, complications that could become life threatening for the patient should not be ruled out. The question that arises is whether the physician may discontinue treatment despite the patients’ request to proceed with it. Is the physician entitled to be released from his consent due to a change of circumstances, such as concern about the birth of a defective child or the loss of parental capability? In effect, two systems of rules govern the treatment agreement between the physician and the patient. The first, which regulates the rights of the patient, whether by bill of rights or by law, is reflected in the doctrine of informed consent. However, stipulating the medical treatment on the patient’s informed-consent agreement does not impose any obligation on the physician unless the physician undertakes to treat the patient. In the absence of a legal duty obligating the physician to treat the patient, the other governing system is the rules of medical ethics, which determine the norm of conduct expected of the physician. Conflicts pertaining to the relevance of the two systems may arise between the autonomy of the patient to respect the sanctity of life and the weight that should be attached to this principle when making a life-threatening decision. The doctrine of informed consent, which acknowledges the patient’s right to refuse even a life-saving treatment by way of informed decision, in weighing the complex of considerations, gives greater weight to the autonomy of the patient over the sanctity of life.

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On the other hand, for the physician, in weighing the complex of considerations, the sanctity of life prevails over patient autonomy. The first duty of a physician is to benefit the patient, and to do no harm. In my opinion, in the conflict between the patient’s autonomy and the physician’s conscience, the latter should prevail, and a physician should be entitled to be released from consent even if this is contrary to the patient’s wishes. If physician may withdraw consent, surely they re not obliged to commence any treatment their conscience will not permit them to do. Yet, there are those who maintain that respect for the patient’s dignity and privacy shifts the balance toward honoring the patient’s autonomy; hence, the physician should provide medical treatment, including fertility treatment, to any patient who requests it (Agmon-Gonnen and Deutsch 2005).

5.5.4 Consent after death One of the achievements in the assisted reproductive technology of artificial insemination is the ability to store frozen reproductive cells and to continue with the process even subsequent to the dissolution of the family unit or after consent is withdrawn. This ability extends the procreation process but is a foreseeable result for those who embark on the reproductive process. If so, due regard should be given to this option in the consent form, and a proper mechanism should be provided for determining the fate of the frozen reproductive cells if and when the family unit is dissolved. However, a distinction should be made between a family unit that dissolves during the lifetime of both spouses and one dissolved on the death of one of them. When one of the spouses wishes to withdraw consent during his or her lifetime, it is possible to adhere to the arrangement stipulated in the consent form. It is doubtful, however, whether this can be done in the case of death, since the rights of a person expire at death – in this instance, both ownership of the frozen reproductive cells, insofar as such ownership is possible, and right to parenthood. Yet a more thorough examination should allow for two interpretations: one, that when people agree to fertility treatments, they manifest their wish to become parent in their lifetime and to enjoy raising their children, and the other, that consent for fertility treatments is evidence of patients’ wishes to have children, both to enjoy them during the patients’ lifetime and to perpetuate the family line after their deaths. According to the first interpretation, the right of parenthood does not extend posthumously, but it does according to the second interpretation. To remove any doubt, prior to signing the treatment consent form, the couple is advised to make a will in which the spouses should explicitly state what shall be done with the reproductive cells subsequent to the death of both spouses or either one of them. Still, the court should be vested with the authority to sanction the use of frozen reproductive cells, subject to the complex of considerations, the first of which is the good of the child.

5.5 Conclusion The informed-consent doctrine is grounded in the law’s recognition of patient autonomy. For this reason, medical treatment should not be administered to a patient without consent. Ostensibly, all medical treatments are subject to this rule, but this is not so.

References

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Consent to fertility treatment is not the same as consent to any other medical treatment. Due to the character of fertility treatment, and primarily because of the intention to assist in reproduction, due regard should be given to the question of whether the consent of the couple should suffice for commencing treatment. On the one hand, the couple’s autonomy and the wish of the couple should be respected; on the other hand, both the patients and the future child should be protected. In my opinion, the protection of the child should prevail, and therefore the mutual consent of the spouses should be required prior to treatment, and in extreme cases treatment should even be withheld. Nevertheless, I doubt there are legal grounds for obligating the spouse to sign the treatment consent form. Therefore, it would be correct to stipulate the commencement of treatment on the undertaking of both spouses, before a competent (administrative) authority, to agree to provide for the needs of the future child. As to the validity of the consent in light of lengthy treatments, two conclusions may be presented: First, despite the initial, general consent to the birth of a child, the consent should expire at the end of each invasive procedure, and the physician should obtain a renewed consent for each subsequent procedure. This approach is harsh and cumbersome, and interferes with the rationale underlying the informed-consent doctrine, yet it is a reasonable approach under the circumstances. The other conclusion is that there is nothing to prevent withdrawal of the initial consent prior to each procedure. This is so as long as there are no frozen eggs in storage and either party wishes to discontinue the treatment, but not if there are fertilized eggs in storage, an indication that the reproduction process is at an advanced stage. In such a case, in any conflict between the creators of the fertilized eggs, the right of the spouse wanting to continue with the process should prevail, provided that the eggs are not defective and will not produce a defective child. The same applies to the right of the physician to discontinue treatment. The consent of the couple does not bind the physician, since physicians are not legally bound to act against their medical conscience. Last, achievements in medical technology allow for procreation even after the death of the patient or the couple, but this mandates a legal arrangement. In principle, if the surviving spouse is capable of providing for the child and caring for its needs, there is no obstacle to allowing the process. However, the couple’s consent or constructive consent are not sufficient for it to be put in motion. The couple should first prepare a will to be attached to the consent form, and forming an integral part thereof. In this will, the patients should clearly state whether they wish to proceed with the process following the death of either or both of them. Finally, running through the entire discussion is the conclusion that due to the complexity of fertility treatment, its nature and uniqueness, the consent of the patients must be clear and unequivocal. They should be prescient and arrange for the possibility of withdrawal from the process or its continuation posthumously. This can be achieved only through primary legislation.

References Agmon-Gonnen M, Deutsch K. Physician’s right to withhold fertility treatment. Med Law. December 2005;33:13. Anonymous v Anonymous, leave to appeal (civil case), 3009/02 Supreme Court Judgments 56(4), 872, 894;2002.

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5 Informed consent for treatment of fertility

Convention on the Rights of the Child, UN General Assembly Resolution 44/25, November 20, 1989. Davis v Davis, SW2d 588,604 [Tenn 1992], 842;1992. Eyal N. The doctrine of consent and the Patient’s Rights Act. Srigim-Leon, Israel: Nevo; 2008:287–414. Green Y. Procreation in the Modern Era: Legal and Halachic Perspectives. Tel Aviv: Pro Book; 2008:57–60, p. 110–112. Nachmani v Nachmani, Opening Motion 599/82, District Court Judgments 54(1), 142; 1982. Nachmani v Nachmani, Civil Further Hearing 2401/95, Supreme Court Judgments 50(4), 661, 680; 1995.

6 Specific ethical and legal aspects of ART practice in eastern European countries Jiri Dostál 6.1 Introduction At the time of assisted reproduction techniques (ART) developing as an autonomous branch of science, Europe was politically divided into Eastern and Western blocs. From Western Europe, ART spread rapidly throughout the world, and by the late 1980s it became a standard method of infertility treatment in developed countries. In the Eastern bloc, the availability of this method was limited. Although the first pregnancy after in vitro fertilization (IVF) in Eastern Europe was achieved as early as in 1982 in former Czechoslovakia (Pilka 1982), the actual development of ART did not occur there until the 1990s. Since the late 1990s, Europe has witnessed an integration process leading to formation of the European Community and, later, the European Union (EU). In May 2004, the prior EU, consisting of 15 member states (EU-15), was enlarged by 10 new member states, predominantly from the former Eastern bloc. In 2007, two more Eastern European countries – Bulgaria and Romania – joined the EU (fTab. 6.1). As yet, this was the most extensive enlargement of the union, creating a relatively compact area with no internal borders inhibiting the free movement of goods, money, inhabitants, and services, including health care. Whereas in the EU-15 countries, public and political discussions about ethical and legal aspects of ART had been held since the late 1970s, the new member states started to participate only after their integration in the union. The disordered state in the former Eastern bloc countries was repeatedly dealt with by the Task Force on Ethics and Law of the European Society for Human Reproduction and Embryology (ESHRE), and it was desirable to assess the situation in this region. Data and descriptions concerning ART in Eastern Europe could be obtained by using the IFFS Surveillance 07 ( Jones 2007) together with results of a questionnaire survey conducted in the new EU member states (Dostál 2007) and updated information from the ESHRE Web site (European Society for Human Reproduction and Embryology 2010). In this way, data were summarized from countries in Eastern Europe, including Bulgaria, Croatia, Macedonia, Montenegro, Romania, Russia, Serbia, and Ukraine. Despite the integration process in various areas of its social life, Europe remains divided in terms of ART availability and practice in its individual member states. From this point of view, Eastern European countries make up a specific region.

6.2 Situation in eastern European countries 6.2.1 Number of centers One of the parameters that may be used to characterize the availability of ART is the population-adjusted number of ART centers.

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6 Specific ethical and legal aspects of ART practice in eastern European countries

Tab. 6.1: European Union member states. Before April 30, 2004

Accepted May 1, 2004

Accepted January 1, 2007

Austria

Cyprus

Bulgaria

Belgium

Czech Republic

Romania

Denmark

Estonia

Finland

Hungary

France

Latvia

Germany

Lithuania

Greece

Malta

Ireland

Poland

Italy

Slovakia

Luxembourg

Slovenia

Netherlands Portugal Spain Sweden United Kingdom

The densest network of ART centers in Eastern Europe is that in the Czech Republic (fTab. 6.2). This may be explained by both relatively favorable conditions for patients in its system of reimbursement of care from health insurance companies and the fact that the Czech Republic has become a destination country offering cross-border reproductive care. At the opposite end of the spectrum with respect to ART availability in the new EU member states is Poland. There, the situation is not transparent even for the local ART centers. This undoubtedly results from the ambiguous attitude to the moral status of the human preimplantation embryo.

6.2.2 Legal regulation of ART In the studied countries, the methods of legal regulation of ART may be divided into three categories: 1. Legal regulation under the law – a set of rules passed in the legislative process and containing penalties for nonobservance. 2. Legal regulation under various guidelines (public notices, codes of practice, directives) – a set of rules to be observed, proposed by official or unofficial organizations such as a health ministry, a professional society, an organization with voluntary membership, a religious organization, or another nongovernmental organization. 3. Without legal regulation.

6.2 Situation in eastern European countries

冷 65

Tab. 6.2: Number of centers. Nation

Number of ART centers

Population in millionsb

Population in millions/center

Bulgaria

14

7.6

0.54

Croatia

6

4.4

0.73

31

10.2

0.32

Czech Rep. Estonia

4

1.4

0.35

11

10.1

0.92

Latvia

4

2.3

0.57

Lithuania

3

3.5

1.16

Hungary

Macedonia

2.0

Montenegro

0.6 a

Poland

27/24

38.2

1.41/1.59a

Romania

15

21.7

1.44

Russia

51

142.2

2.78

Serbia

7.5

Slovakia

6

Slovenia

3

Ukraine a Different data provided by various respondents. b See Wikipedia, 2010.

5.4

0.9

2

0.67

48.4

As seen from Table 6.3, the most prevalent approach to ART in the group of Eastern European countries is legal regulation under the law. Whereas two countries (the Czech Republic and Slovakia) have both laws and guidelines, one country (Romania) has no legal regulation of ART.

6.2.3 Coverage or reimbursement of ART Coverage or reimbursement of ART procedures by third-party payers (i.e., health insurance companies and the state contribution from public resources toward infertility treatment) is a subject for permanent debate over allocation of limited financial resources. It is affected by the interests of infertile couples, pharmaceutical companies, health insurance companies, the society, the state, and other subjects. The medical examination of an infertile couple is fully covered or reimbursed in the vast majority of Eastern European countries. Medication for the treatment is covered or reimbursed, in most cases partially. Such a situation is undoubtedly related to the price of IVF and embryo-transfer (IVF-ET) medications, insufficient evidence for calculating the price, activity, and safety ratios of individual preparations, and, last but not least, the lack of political will to define the scope of care that is standard (essential) and above standard. Coverage or reimbursement of ART laboratory techniques is similar to that

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6 Specific ethical and legal aspects of ART practice in eastern European countries

Tab. 6.3: Legal regulation of ART. Nation

Law

Guideline

None

Bulgaria

+

–

–

Croatia

–

+

–

Czech Rep.

+

+

–

Estonia

+

–

–

Hungary

+

–

–

Latvia

+

–

–

Lithuania

–

+

–

Poland

–

+/–a

– / +a

Romania

–

–

+

Russia

+

–

–

Slovakia

+

+

–

Slovenia

+

–

–

+

–

Macedonia Montenegro

Serbia

Ukraine – a Different data provided by various respondents.

of medication, with relatively favorable conditions for patients in the Czech Republic, Hungary, Macedonia, Montenegro, and Slovenia.

6.2.4 Marital status in ART Some aspects of ART interfere with the traditional understanding of the structure of family relations influenced by the long-term development of national societies. The traditional perception of motherhood and fatherhood is defined by laws in most countries, and the technical potential of infertility treatment may induce a collision between the interests of gamete donors, treated couples, children born after ART, health care facilities, and the society. It is for the benefit of all the involved parties that ART is performed in accordance with family law valid in a given country. The awareness of potential collision is manifested by recommendations or legal regulation concerning the marital status of the treated couple. In the countries where ART is regulated under the law (fTab. 6.3), requirements concerning the marital status of couples asking for ART are not uniform; a stable relationship is required in most cases. The survey suggests that the society prefers traditional heterosexual families (marriage or a stable relationship) and is hesitant to provide unlimited access to ART to alternative partnership groups. Yet in 5 countries (Bulgaria, Estonia, Hungary, Latvia, and Russia), single women may be treated. As the society becomes more familiar with all aspects of ART, the requirements concerning the marital status

6.2 Situation in eastern European countries

冷 67

Tab. 6.4: Coverage or reimbursement of a medical examination of an infertile couple. Nation

Is the examination covered or reimbursed?

Who is the examination covered or reimbursed by?

Bulgaria

–

Croatia

+a

national health plan

Czech Rep.

+, fully

national health plan

Estonia

+, partially

national health plan

Hungary

+, fully

national health plan

Latvia

–

Lithuania

–

Macedonia

+

Montenegro

+

national health plan

Poland

–b/+

national health plan

Russia

+

national health plan

Serbia

+

national health plan

Slovakia

+, fully

national health plan

Slovenia

+, fully

national health plan

national health plan

Romania

a

Ukraine + a Yes, if performed in a public center, not in a private one. b Different data provided by various respondents.

national health plan

in ART are gradually liberalized. An example may be the Czech Republic, where ART was originally allowed only in married couples. After a period of ambiguous legislation when ART was performed, with the exception of donor sperm, also in unmarried couples, the current legal regulation allows treatment only after the man and the woman apply in writing. This provision may suggest that the state has partly renounced its authority to ensure that children are born solely into traditional family models by confining this to material security of the children.

6.2.5 The number of transferred embryos in ART The most serious current problem of ART, multiple pregnancies, may be solved by decreasing the number of transferred embryos. The strategy for defining the number of transferred embryos is influenced by attempts to achieve pregnancy by transferring more than one embryo on the one hand and by the awareness that multiple pregnancies are the leading cause of neonatal morbidity and mortality on the other hand. Although most Eastern European countries specify the maximum number of transferred embryos, the upper limit of the number of transferred embryos is generally too high and does not correspond with the state-of-the-art medical science.

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6 Specific ethical and legal aspects of ART practice in eastern European countries

Tab. 6.5: Coverage or reimbursement of medication. Nation

Is the medication covered or reimbursed?

Who is the medication covered or reimbursed by?

Bulgaria

+

national health plan

Croatia

+a

national health plan

Czech Rep.

+, partially

national health plan

Estonia

+, partially

national health plan

Hungary

+, partially

national health plan

Latvia

–

Lithuania

–

Macedonia

+

national health plan

Montenegro

+, partially

national health plan

Poland

–

Romania

–

Russia

+

national health plan

Serbia

+

national health plan

Slovakia

+, partially

national health plan

Slovenia

+, fully

national health plan

Ukraine – a Yes, if performed in a public center, not in a private one.

The issues related to the maximum number of transferred embryos are an example of the slow progress of law amendments in Eastern Europe. At present, stimulation protocols may be individualized, both the embryo culture to the blastocyst stage and cryopreservation of embryos are easier, and the chance of implantation may be predicted with relative precision. Therefore, the recommended or ordered standards for the maximum number of transferred embryos should be altered. Worldwide, the trend is to transfer a maximum of two embryos in women younger than 35 years of age. Moreover, some countries (such as Belgium) have adopted legislation concerning elective singleembryo transfer in the first IVF-ET cycle (Gerris 2004). Now, there is enough space for informing experts, as well as patients, the general public, and politicians in Eastern Europe, that from the medical, ethical, and economic points of view, multiple pregnancies are not the desired result of IVF-ET (Fiddelers 2007). If this option is not sufficient, the next step should involve making amendments to the current legislation or adopting new guidelines and laws, including penalties for their violation.

6.2.6 Cryopreservation The main aim of embryo cryopreservation is to provide further possibilities for conception after the stimulated cycle and fresh embryo transfer. Embryo freezing contributes to a potentially lower risk of multiple pregnancies by transferring fewer embryos in the initial stimulated IVF-ET cycle. Cryopreservation has also decreased the risk of ovarian

6.2 Situation in eastern European countries

冷 69

Tab. 6.6: Coverage or reimbursement of IVF-ET laboratory techniques. Nation

Are the laboratory techniques covered or reimbursed?

Who are the laboratory techniques covered or reimbursed by?

Bulgaria

+, partially

national health plan

Croatia

+, partiallya

national health plan

b

c

+ , fully

national health plan

Estonia

+, partially

national health plan

Hungary

+d, fully

national health plan

Latvia

–

Lithuania

–

Macedonia

+, fully

national health plan

Montenegro

+, fully

national health plan

Poland

–

Romania

–

Russia

+, partiallye

national health plan

Serbia

+, partially

national health plan

Slovakia

+, partially

national health plan

Slovenia

+, fully

national health plan

Czech Rep.

– Ukraine a Yes, if performed in a public center, not in a private center. b Age over 40 years, 3 cycles with embryo transfer. c ICSI, AH, prolonged culture, cryopreservation, MESA, and TESE are not covered or reimbursed. d 5 cycles with embryo transfer. e Yes, but only 10% of all IVF cycles are reimbursed.

hyperstimulation syndrome (OHSS) by a compromise involving cancellation of fresh transfer, cryopreservation of embryos, and their transfer after managing this healthand life-threatening complication of ART. A well-functioning program of embryo cryopreservation also simplifies the process of oocyte donation. As for gamete cryopreservation, the technique of sperm freezing has been well mastered. However, oocyte preservation is much more difficult due to the effects of the cryoprotective compounds and temperature variations on zona pellucida, cortical granules, spindle microtubules, cytoplasmic microfilaments, and other organelles. Therefore, oocytes are frozen and thawed successfully, but the efficacy of their cryopreservation remains low all over the world. Succeeding in the process of freezing oocytes instead of embryos would facilitate the establishment of oocyte banks. Their existence would enable broader prevention of OHSS and premature ovarian failure. Moreover, fertility would be maintained in oncology patients or following radical surgery in the lower pelvis. Similarly, available cryopreservation of ovarian or testicular tissues in oncology patients would provide a suitable option for preserving their reproductive functions.

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6 Specific ethical and legal aspects of ART practice in eastern European countries

Tab. 6.7: Marital status in ART. Nation

Recommended or required marital status of the couple asking for ART

Bulgaria

no requirement

Croatia

marriage or stable relationship

Czech Rep.

stable relationshipa

Estonia

no requirementb

Hungary

marriage/stable relationship; permitted for single womenc

Latvia

no requirement; permitted for single women

Lithuania

marriage

Macedonia Montenegro Poland

stable relationship/no requirementd

Romania

not an issue

Russia

marriage/stable relationship; permitted for single women

Serbia Slovakia

stable relationship

Slovenia

marriage/stable relationship

Ukraine a ART may be performed after the man and the woman who intend to undergo the treatment together apply in writing. b ART is permitted in single women; the law does not deal with lesbian couples. c Marriage or a living partner must be authenticated by a notary public. d Different data provided by various respondents.

There is a consensus about the importance of and need for a well-functioning cryopreservation program. Thanks to this, the overall reproductive potential of every stimulated cycle may be used to benefit the patients by summing up the pregnancies achieved after fresh embryo transfer and then cryopreserved, acquired from a single stimulation and a single oocyte-harvest cycle. Oocyte cryopreservation is performed in 6 countries but, for technical reasons, has not been widely used. Cryopreservation of ovarian or testicular tissues in oncology patients is performed in 5 Eastern European countries.

6.2.7 Posthumous ART Available cryopreservation has enabled women to achieve pregnancy after the biological parent’s death. Nevertheless, posthumous assistive technologies (PAR) may provoke numerous dilemmas concerning the informed consent of the deceased and the process of decision making in those asking for treatment. Therefore, some centers have produced informed-consent forms that enable the use of gametes and embryos after the other partner’s death. Posthumous sperm retrieval for ART is allowed in 1 country, banned in 3, and practically performed in 1 country.

6.2 Situation in eastern European countries

冷 71

Tab. 6.8: The number of transferred embryos in ART. Nation

Limits on numbers of embryos that can be transferred

Bulgaria

not specifieda

Croatia

3 or less

Czech Rep.

2

Estonia

3

Hungary

4b

Latvia

3

Lithuania

not specified

Macedonia

3

Montenegro

not regulated

Poland

3c

Romania

3

Russia

not regulated

Serbia

4

Slovakia

3

Slovenia

3

Ukraine

3d

a

5, depending on the age, number of previous failures and cryopreservation. 3 or even 4 if the patient is older than 35 years of age or she has had unsuccessful IVF treatment(s). c No exceptions, depending on the internal regulations of a given center, different data provided by various respondents. d Not regulated, 1–2 recommended, a maximum of 3. b

6.2.8 Gamete donation Donation of gametes may be the only solution for couples wishing for a baby but lacking their own gametes. It enables the accomplishment of a parental role of an infertile couple at the cost of the loss of a genetic line. Gamete donation may also help avoid transmission of serious genetic conditions to the offspring if medical or social reasons prevent the use of preimplantation genetic diagnosis (PGD). Whereas donor sperm have been used for more than 50 years, oocyte donation was able to be introduced into ART soon after IVF-ET methods were developed. Embryo donation has been used in the past two decades, albeit relatively rarely. Gamete and embryo donation presents social and cultural problems rather than medical ones. These arise from the historical, national, cultural, and religious development in a particular country; in some countries, genetic parenthood is the fundamental prerequisite for the application of family law. Sperm and oocyte donation is easily available in Eastern European countries – in fact, much more available than in Western Europe ( Jones 2007). Therefore, Eastern European

72 冷

6 Specific ethical and legal aspects of ART practice in eastern European countries

Tab. 6.9: Cryopreservation. Nation

Embryo cryopreservation allowed/performed?

Oocyte cryopreservation allowed/performed?

Ovarian or testicular tissue cryopreservation allowed/performed?

Bulgaria

+/+

+

not mentioned

a

Croatia

+ /+

not mentioned

+

Czech Rep.

not mentioned/+

not mentioned/+

not mentioned/+

Estonia

+/+

not mentioned

not mentioned

Hungary

+/+

not mentioned/+

+/+

Latvia

+/+

not mentioned

Lithuania

not mentioned/+

Macedonia

+/+

Montenegro

+/+

Poland

+/+

Romania Russia Serbia

+/+

not mentioned/+ not mentioned/–

not mentioned

not mentioned

not mentioned/+

not mentioned/+

–

+/+

+/+

not mentioned

Slovakia

not mentioned /+

not mentioned

not mentioned/+

Slovenia

+/+

+/+

+/+

Ukraine +/+ a Only permitted if the woman is endangered by embryo transfer in the current cycle.

countries are favorite destinations for those seeking cross-border reproductive care (Shenfield et al. 2010).

6.2.9 Anonymity The issues concerning the mutual anonymity of donors and children are not perceived unanimously in all Eastern European countries. Respecting the rights and interests of autonomy and privacy of the parents, the rights and interests of the donors, and the right of the children to know their origin means that finding a consensual solution to their mutual anonymity would be rather difficult. The worldwide trends shift from complete anonymity to registration and identification of donors ( Jones 2004, 2007). The attitude to providing the children conceived from ART with information about the donors is rather hesitant in Eastern European countries. Only 5 of them allow the provision of nonidentifying information, while identifying information is available in 3 countries. The practice of providing data on donors in Eastern Europe is so different from that in Western European countries ( Jones 2007) that the guarantee of anonymity is another reason for cross-border reproductive care (Shenfield et al. 2010). In the process of European integration, Eastern European health care facilities should prepare for the impact of potential future requests for donor identification.

6.2 Situation in eastern European countries

冷 73

Tab. 6.10: Posthumous ART. Nation

Is PAR allowed?

Is PAR performed?

Bulgaria

–

–

Croatia

not mentioned

Czech Rep.

not mentioneda b

Estonia

+

Hungary

not mentionedc

Latvia

not mentioned

Lithuania

not mentioned

+ not known not known

Macedonia Montenegro

Poland

–

–

Romania Russia

not mentioned

Serbia

Slovakia

not mentioned

Slovenia

–

–

Ukraine a

The written application by the couple and the man’s consent to IVF of the woman may not be older than 24 months; the consent must be repeated every time IVF is performed. b Within 1 month after death. c Only if the father dies after IVF or ICSI, the embryos already exist at the time of death, and the couple did not rule out ET in case of death.

6.2.10 Micromanipulation The micromanipulation method of intracytoplasmic sperm injection (ICSI) has become a standard method used in ART, facilitating fertilization especially in male factor infertility. Although higher rates of congenital developmental disorders have not been proven in children after ICSI as yet, the rates of disorders linked to sex chromosomes is slightly increased in them. The patients should be informed about the risk in advance. Assisted hatching (AH) is proposed as a method increasing the capacity of the embryos to implant. The efficacy of AH with respect to all cycles of IVF with ICSI is the subject of controversy. Another type of micromanipulation is cytoplasmic transfer (CT). The technique enables, among other things, the transfer of mitochondria, organelles of heterologous origin providing adenosine triphosphate to all cellular activities that require energy. This technology is prohibited in many countries worldwide because of concerns raised over the introduction of third-party mitochondrial DNA that appears to be maintained in the offspring.

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6 Specific ethical and legal aspects of ART practice in eastern European countries

Tab. 6.11: Gamete donation. Nation

Sperm donation allowed/performed?

Oocyte donation allowed/performed?

Embryo donation allowed/performed?

Bulgaria

+/+

+/+

not regulated

Croatia

+/+

+/+

–

Czech Rep.

+/+

+/+

+/+

Estonia

+/+

+/+

Hungary

+/+

+/+

+/+

+/+

–

+/+

a

Lithuania

+/+

b

Macedonia

+/+

+/+

+/+

Montenegro

+/+

+/+

–

Poland

not regulated

not regulated

not regulated

Romania

+/+

+/+

Russia

+/+

+/+

+/+

Serbia

+/+

+/+

+/+

Slovakia

+/+

not regulated/+

not regulated/+

+/+

–

Latvia

Slovenia

+/+

b

–

Ukraine +/+ +/+ +/+ a Donor sperm are used for intrauterine insemination, and as many as 3 children may be born; however, there is no institution to guarantee that. b Only as a part of IVF.

ICSI has become the standard method of choice in Eastern Europe. Similarly, AH is used in most of these countries, although it is not specifically legally solved. An exception is Hungary, where AH is not only mentioned in legislation, but the method is also covered by the national health plan and, possibly therefore, widely practiced. CT is not included in legislation in any of the studied countries and it is practiced only in the Czech Republic.

6.2.11 In vitro maturation of oocytes In vitro maturation (IVM) of oocytes is mostly indicated in polycystic ovary syndrome (PCOS) and a high risk for OHSS. It is also being used in severe male infertility, those with repeated poor-quality embryos or poor responders, and in natural cycles. More recently, it has been used in oocyte donation and for fertility preservation in oncology patients. The method has been widely practiced in some countries with restrictive legislation on ART (e.g., Italy) where cryopreservation of embryos is banned ( Jones 2007). Most of the studied countries do not have oocyte maturation in their legislation. At present, oocyte maturation is under study in only a small number of centers all over the world ( Jones 2007), and the results have been limited. For a satisfactory solution of the

6.2 Situation in eastern European countries

冷 75

Tab. 6.12: Information about the donor provided to the offspring by the health care facility in accordance with the law or the guidelines. Nation

Nonidentifying information

Identifying information

Bulgaria

not mentioned

+a

Croatia

not mentioned

–

b

–

Czech Rep.

+

Estonia

+

–

Hungary

+

+a

c

Latvia

–

Lithuania

not mentioned

not mentioned

Macedonia

not regulated

not regulated

Montenegro

not mentioned

–

Poland

–

–

Romania Russia

–

not customary not mentioned

not mentioned

–

–

Serbia Slovakia Slovenia

+

d

–

Ukraine + + a In the oocyte-donation program, the donor must be a relative. b On request from persons born from ART who have come of age. Minors born after ART must be represented by their guardians. c Potential parents are able to get information only about genetic and anthropometric data. d Medical reasons.

IVM issues, larger studies are needed. The results are awaited not only by PCOS patients but also by oncology patients in whom ovarian-tissue cryopreservation is carried out.

6.2.12 Welfare of the child The goal of ART is to allow an infertile couple to have a normal and healthy child. The birth of such a child, however, exceeds its parents’ interests from the point of view of both the child and the society. For ART, the concept of welfare of the child is essential, as ART has causally contributed to the child’s birth, and the doctors are considered responsible in case the child is born with a congenital defect. The welfare of the child has at least two components: a physical one and a psychosocial one. The former is more closely related to ART, since it includes potential complications of ART as well as the risk of transmission of viral or genetic diseases. Although the psychosocial component is more difficult to grasp, the identification of the child in the family or a group of peers is known to have an essential impact on the development and integrity of the child’s personality (Shenfield and Surreau 2006).

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6 Specific ethical and legal aspects of ART practice in eastern European countries

Tab. 6.13: Micromanipulation. Nation

Is ICSI allowed/ performed?

Is AH allowed/ performed?

Is CT allowed/ performed?

Bulgaria

not mentioned

not mentioned

not mentioned

Croatia

+/+

+/+

not mentioned

Czech Rep.

not mentioned/+

not mentioned/+

not mentioned/+

Estonia

+/+

not mentioned

Hungary

+/+

+/+a

not mentioned

Latvia

+/+

not mentioned/+

not mentioned

Lithuania

+/+

not mentioned/+

not mentioned/–

Poland

+/+

not mentioned/+

not mentioned/+/–b

Romania

/+

Russia

+/+

+/+

not mentioned

not mentioned/+

not mentioned/+

not mentioned

Macedonia Montenegro

Serbia Slovakia Slovenia

+/+

b

+/– /+

not mentioned

Ukraine a Costs covered by the national health plan, widely practiced. b Different data provided by various respondents.

In Eastern European countries, the psychosocial component of the welfare of the child after ART is not specifically addressed by the law. Therefore, it can only be deduced from current legislation on family matters and parental responsibility. The informed consent of those applying for treatment, irrespective of their marital status, is the only assurance of responsibility toward the child born from ART. In those studied countries that are EU members, the following European Commission directives are applied: 2004/23/EC, 2006/17/EC, and 2006/86/EC (European Commission 2004, 2006a, 2006b). These directives aim at ensuring the quality of care provided in ART and, especially in the case of donation, at minimizing the risk of transmission of viral or genetic diseases. From this point of view, the directives are directly related to the welfare of the child born from ART.

6.2.13 Multifetal-pregnancy reduction Multifetal pregnancy reduction (MFPR) refers to the technique used to reduce the adverse outcome of multiple gestation after ART. This does not mean termination of pregnancy. Numerous studies have shown the reduction, mostly to two embryos, to be a method beneficial for the birth of healthy offspring. In most of the studied countries, MPR is an accepted technique for preventing complications related to them. Psychosocial and emotional stigmatization of the treated

6.2 Situation in eastern European countries

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Tab. 6.14: In vitro maturation of oocytes. Nation

Is IVM allowed/ performed?

Is IVM not allowed/ not performed?

Is IVM not mentioned/ performed?

Bulgaria

+/

Croatia

+/

Czech Rep.

+/+

Estonia

+/–

Hungary

+/

Latvia

+/+

Lithuania

+/–

Macedonia Montenegro +/+a

Poland Romania

/+

Russia

+/

Serbia Slovakia Slovenia

+/+ +/+

Ukraine a Attempted by several centers.

couples remains a serious problem even in those countries where termination of pregnancy is a legal procedure. At present, there are no available data on the frequency with which MPR after ART is performed or on long-term follow-up of children born. The causal solution of the need for reduction is lowering the number of transferred embryos.

6.2.14 Preimplantation genetic diagnosis Medical genetics is capable of providing the parents-to-be with information about their child’s genetic and phenotypic characteristics as early as prior to the birth. The time of providing such information tends to shift to earlier stages of pregnancy and even before conception. State-of-the-art specialized medicine has led to a union, and not quite an accidental one, of two specializations – medical genetics and ART. Whereas ART facilitates blastomere isolation and embryo culture, medical genetics is able to analyze the isolated blastomeres even prior to the embryo transfer. After this stage of technological development was reached in the two specializations, early prenatal diagnosis – PGD – was made possible. PGD may prevent mental suffering of future parents who, in the past, had to consider the termination of pregnancy in cases of fetal abnormalities. PGD still requires moral decisions to be made between the termination of pregnancy and discarding affected embryos that will not be transferred. However, both patients and the society

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Tab. 6.15: Welfare of the child. Nation

Does the law or do the guidelines impose on the ART center any admonition about the welfare of any resulting offspring?

Bulgaria

+

Croatia Czech Rep.

+

Estonia

+

Hungary

+

Latvia

+

Lithuania

+

Macedonia Montenegro Poland

+

Romania

+

Russia Serbia Slovakia

+

Slovenia

+

Ukraine

perceive this as more positive than pregnancy termination, which in many cases is repeated. In addition to that, PGD is used for aneuploidy screening (PGD-AS); it is possible, that is, to recognize embryos with aneuploidy prior to the transfer and to transfer only embryos with a normal karyotype. PGD-AS is mostly performed in women older than 36 years of age, in cases of repeated implantation failure and repeated spontaneous abortions. In Eastern European countries, PGD is an available method able to decrease the incidence of genetically determined pathological conditions in the fetus. Both patients and society perceive PGD as more positive than, in many cases repeated, pregnancy termination. As compared with Western Europe ( Jones 2007), PGD is more easily available in Eastern Europe, and, once again, it has become a subject of cross-border reproductive care (Shenfield et al. 2010).

6.2.15 Surrogacy The following paragraphs are concerned with the so-called full surrogacy, or IVF surrogacy. For women with functioning ovaries but no uterus, due to agenesis or hysterectomy, or those with a uterus that does not allow a successful pregnancy, surrogacy is the only option of having their own genetic children. The sperm are obtained from the partner of the woman who should care for and bring up the child.

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冷 79

Tab. 6.16: Multifetal pregnancy reduction. Nation

Is MFPR allowed/ performed?

Is MFPR not allowed/ not performed?

Bulgaria

+/

Croatia Czech Rep.

+/ +/+

+

Estonia Hungary

Is MFPR not mentioned/ performed?

+/ +/+a

Latvia

+/+

Lithuania

+/–

Macedonia Montenegro Poland

+/+b

Romania

/+

Russia

+/+

Serbia Slovakia

+/–

Slovenia

+/+

Ukraine a Reduction to 2 embryos is allowed; reduction to 1 embryo is allowed in specific cases such as womb operation or congenital abnormalities of the womb. b Abortions are banned under the Polish legislation; different data provided by various respondents.

This procedure should be distinguished from the so-called partial surrogacy, with the surrogate mother supplying not only the uterus but also the oocytes. The sperm are supplied by the affected woman’s partner. This type of surrogacy necessitates no or only symbolic medical assistance and is often performed in the absence of a physician. Therefore, it is not detailed in this text. Full surrogacy and adoption of the baby who is born require perfect jurisdiction explicitly mentioning these issues to avoid the risks for the participants including the health care facility, as ambiguity may potentially result in lawsuits. Bans or uncertainty concerning the legality of the procedure and problems connected with adoptions make the method unavailable or difficult to use in Eastern Europe. If the social attitude toward these issues is to be reconsidered, all legal and practical aspects of the procedure will have to be taken into account using the experiences from countries where surrogacy is practiced.

6.2.16 Research on the embryo At present, research with the use of embryos is generally considered essential for the improvement of ART. However, similar consensus has not been reached about

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Tab. 6.17: Preimplantation genetic diagnosis. Nation

Is PGD allowed/performed? Yes

Bulgaria

+/

Croatia

+/–

Czech Rep.

+/+

Estonia Hungary

No

Not mentioned

Is PGD-as allowed/performed? Yes

+

No

Not mentioned +

+/+ +/+

+/

+/+

+/

Latvia

+/+a

+/

Lithuania

+/–

+/–

+/–

+/–

Macedonia

+/

Montenegro

+/

Poland Romania

+/–

Russia

+/+

+/– +/+

Serbia

+/

+/

Slovakia

+/+

+/+

Slovenia

+/+

+/

Ukraine +/ a Biopsies are taken in Latvia; genetic laboratories are located in Finland and Russia.

research carried out directly on the embryo and involving its destruction, such as embryonic stem cell (ESC) research. All aspects related to research on the embryo are closely interconnected with the issues of the moral status of the embryo, which are perceived differently in individual national communities and are discussed separately. In some of the studied countries, research on the embryo is allowed. ESC collection is banned in some countries (Latvia, Lithuania, and Slovakia) and allowed in others (the Czech Republic, Estonia, and Slovenia). In Latvia, interestingly, research on embryos is banned, while experiments with ESC obtained commercially or through scientific exchange are not.

6.2.17 Cloning The term cloning refers to the process of producing genetically identical individuals. Artificial production of genetically identical human individuals using ART – reproductive cloning – is ethically unacceptable due to concerns about medical and social consequences for humankind. Participation in trials related to reproductive cloning has been refused in medical circles worldwide. Yet the process of cloning probably has great research potential. Somatic cell nuclear transfer (SCNT) may provide cell lines that could be used for therapeutic purposes. Experimental cloning of this type has to be clearly distinguished from reproductive

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Tab. 6.18: Surrogacy. Nation

Is surrogacy allowed/ performed?

Is surrogacy not allowed/ not performed?

Bulgaria

+/+

Croatia

+/+

Czech Rep.

+/+

Estonia Hungary

Is surrogacy not mentioned/performed?

+/+ +/–

Latvia

+/+

Lithuania Macedonia Montenegro

+/+

Poland

+/+

Romania

/+

Russia

+/+

Serbia

+/+

Slovakia

+/

Slovenia Ukraine

+/+ +/+

cloning, as it does not aim at producing an identical human individual. The goal is to produce tissue cultures that could be utilized in transplants. Such a type of SCNT is generally termed research or therapeutic cloning. In the Eastern European region, therapeutic cloning is allowed and performed in 2 countries (the Czech Republic and Russia), banned in 3, and not mentioned in legislation of most countries.

6.2.18 Gamete intrafallopian transfer The first successful gamete intrafallopian transfer (GIFT) was described in 1982 (Pilka 1982). At the time of acquiring laboratory experience with human embryo cultures, this technique was an alternative to IVF-ET in cases of fallopian tubal factor infertility. But GIFT is more complicated than IVF, as it necessitates the use of laparoscopy. Therefore, it is practiced to a limited extent and in special situations only, and it is no longer used in Eastern European countries.

6.2.19 The moral status of the embryo Evaluating the moral status of the human embryo in a given country is key to the acceptability of most ARTs. Creating a consensual attitude is a dynamic process, based on the confrontation of schools of thought, which may be affected by the state of knowledge in biology and medicine as well as philosophy and jurisprudence. It depends on the current prevailing

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Tab. 6.19: Research on the embryo. Nation

Is it possible to use the embryo for research?

Is research on ESC possible?

Bulgaria

–

Croatia

–

Czech Rep.

+

+

Estonia

+

+

Hungary

+

Latvia

–

+a

Lithuania

–

–

Macedonia Montenegro Poland

+/–b

Romania

+

Russia

–

Serbia Slovakia

–

–

Slovenia

+c

+d

Ukraine a Not banned on ESC lines acquired commercially or through scientific exchange. b Different data provided by various respondents. c Embryos cannot be created for research purposes unless benefit for embryos can be demonstrated. d Only on embryos not suitable for transfer or those frozen embryos that will be left to die after 5 years of storage.

social consensus whether the protection of the embryo is absolute or relative and from which stage of its development it will be applied. If there is a social need, the current consensus will result in formulation of legal norms regulating the activities concerned with the human embryo, including ART. In Eastern European countries, there is no consensus on when a human life begins and when an embryo is considered a human person. In the region, no two countries use an identical time span to define the term “human person.” This may be due to a different interpretation of the term in medical circles (Dostál 2007). The experts on ART in Eastern European countries do not consider the issues related to assessing the moral status of the human embryo to be essential for performing ART.

6.3 Conclusions Since the early 1990s, following the breakup of the Eastern bloc, these countries have reached the current average European standard in providing medical care using ART

6.3 Conclusions

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Tab. 6.20: Therapeutic cloning. Nation

Is therapeutic cloning allowed/performed?

Is therapeutic cloning not allowed/not performed?

Is therapeutic cloning not mentioned/ performed?

Bulgaria

+/

Croatia

+/

Czech Rep.

+/+

Estonia

+

Hungary

+/

Latvia

+

Lithuania

+/

Macedonia Montenegro Poland

+/

Romania Russia

/+ +/+

Serbia Slovakia Slovenia

+ +/

Ukraine

methods. At present, the full range of therapeutic procedures is provided there. The rapid spread of ART in these countries was facilitated by sufficient professional potential that was limited by unavailable modern technologies prior to the breakup of the Eastern bloc. And, last but not least, there was no legislation limiting ART, which enabled rapid increase in the number of ART centers. Therefore, the availability of ART health care in Eastern Europe is comparable with that in the most developed countries of the EU and the rest of the world. Eastern European legislation on ART began to emerge in the early 1990s. Although based on the experiences from the EU-15 countries, it took into account specific cultural and legal contexts of the Eastern European region. Despite this fact, ART remains less legally regulated in Eastern European countries when compared with Western Europe (Dostál 2007). In the united European region, local differences still exist that play a role in the range of ART techniques that are available and utilized. One of the differences is related to the use of donor gametes in ART. Although the overall availability of donated gametes is higher in the EU-15 countries than in the 12 new member states (Dostál 2007; Jones 2007), their limited availability in Austria, Germany, Italy, and the United Kingdom is striking. Patients from these countries seek medical care abroad, often traveling to the Czech Republic and Slovenia (Shenfield et al. 2010). The reasons for cross-border reproductive care include a more favorable legislative environment, lower payments for medical care, and, last but not least, the quality of provided care guaranteed by EC directives (European Commission 2004, 2006a, 2006b).

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Tab. 6.21: Is there a recognized time during human development after which human person is considered to exist? Nation

Yes, by Law

Guidelines

No

Cultural or religious beliefs

Bulgaria

+

Croatia

+

Czech Rep.

+

12 weeks of pregnancy

Estonia

+

Hungary Latvia

What is the recognized time?

+

2 weeks after fertilization if the newborn is registered as born alive

+

Lithuania

+

Macedonia Montenegro Poland

+a

oocyte fertilization, birth of a viable childa

+a

Romania

+

Russia

+

Serbia Slovakia Slovenia

+ a

+

+

a

14 days can be cultured in vitro or prior to the birth if the fetus is to be born alivea

Ukraine a Different data provided by various respondents.

Similarly, PGD is explicitly banned in Italy and possible in a very limited range of indications in Germany ( Jones 2007). On the contrary, PGD is not mentioned in legislation of most of the 12 new EU member states; if mentioned, it is always allowed. Therefore, the situation in the Czech Republic, where PGD is allowed, is understandable. The Czech ART centers offer PGD not only to domestic patients but also to those from nearby countries (Germany and Italy). Although cross-border reproductive care can be viewed as a safety valve, the phenomenon is often associated with a high risk of health dangers, frustration, and disparities (Ferraretti 2010). From this perspective, the growing phenomenon of cross-border reproductive care requires a higher level of responsibility from doctors in countries where this care is provided. Keeping the broader context in mind, another responsibility of ART specialists must be mentioned: They are expected to provide both politicians and the general public with clear information on ART. Politicians, in turn, may adopt legislation that is consistent

References

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with generally accepted ethical principles, international obligations, and effective domestic legislation, and whose application is in the best interest of the infertile couples, future children, public health, health care facilities, and society. Integration of the European region provides a setting suitable for exchange of experience and formulation of common trends.

References Dostál J. Ethical and Legal Aspects of Assisted Reproduction: Situation in the Member States That Joined the European Union in 2004. 1st ed. Olomouc: Palacký University; 2007. European Commission. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells. 2004. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:102:0048:0058:e n:PDF. Accessed April 5, 2011. European Commission. Commission Directive 2006/17/EC implementing Directive 2004/23/ EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement, and testing of human tissues and cells. 2006a. http:// eur-lex.europa.eu/LexUriServ/site/en/oj/2006/l_038/l_03820060209en00400052.pdf. Accessed April 5, 2011. European Commission. Commission Directive 2006/86/EC implementing Directive 2004/23/ EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events, and certain technical requirements for the coding, processing, preservation, storage, and distribution of human tissues and cells. 2006b. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:294:0032:0050: EN:PDF. Accessed April 5, 2011. European Society for Human Reproduction and Embryology. Europe map legal. 2010. http:// www.eshre.eu/ESHRE/English/Specialty-Groups/Data-collection-Consortia/Europemaplegal/page.aspx/738. Accessed August 1, 2010. Ferraretti AP, Pennings G, Gianaroli L, Natali F, Magli MC. Cross-border reproductive care: a phenomenon expressing the controversial aspects of reproductive technologies. Reprod BioMed Online. 2010;20:261–266. Fiddelers AA, Severens JL, Dorosen CD, Dumoulin JC, Land JA, Evers JL. Economic evaluations of single-versus double-embryo transfer in IVF. Hum Reprod Update. 2007;13:5–13. Gerris J, De Sutter P, De Neubourg D, et al. A real-life prospective health economic study of elective single embryo transfer versus two-embryo transfer in first IVF/ICSI cycles. Hum Reprod. 2004;19:917–923. Jones HW, Cohen J. IFFS Surveillance 04. Fertil Steril. 2004;81(suppl 4):S1–S54. Jones HW, Cohen J, Cooke I, Kempers R. IFFS Surveillance 07. Fertil Steril. 2007;87(suppl 1): S1–S67. Pilka L, Tesarˇík J, Dvorˇák M, Trávník P. Pregnancy after transfer of the oocyte fertilized in vitro into the fallopian tube. Ceska Gynekol. 1982;47: 564–70. Shenfield F, Surreau C. The welfare of the child: whose responsibility? In: Shenfield F, Surreau C, ed. Contemporary Ethical Dilemmas in Assisted Reproduction. Abingdon, UK: Informa Healthcare; 2006:73–83. Shenfield F, de Mouzon J, Pennings G, et al. ESHRE Task Force on Cross-Border Reproductive care: cross-border reproductive care in six European countries. Hum Reprod. 2010;25:1361–1368. Wikipedia. Europe, 2010. http://en.wikipedia.org/wiki/Europe#Political_geography. Accessed August 1, 2010.

7 Sperm donation and sperm-bank management Dan Gong and Zheng Li 7.1 Introduction In cases of severe male infertility, such as nonobstructive azoospermia after testicular sperm retrieval, no sperm confirmed, and some male genetic diseases, the use of donor sperm is often the only approach to infertile couples to farther children. Sperm banks, or cryobanks, have been resources and platforms to supply for cryopreserved donor sperm to be used to artificial insemination or in vitro fertilization, especially with advances in human sperm cryopreservation. Such facilities have reduced the fertility challenges facing many couples wishing to conceive. The basic operating principle of sperm banks is that they pay sperm donors a fee for their donation and women who wish to acquire donated sperm then contact the sperm banks and pay a corresponding amount for this service. In managing a sperm bank, it is important to consider both physical health and ethical concerns on behalf of the sperm donor, the sperm recipient, and donor offspring. Recommendations and guidelines concerning sperm donation vary among sperm banks around the world. This chapter looks at the major policies in place as proposed by agencies concerned with the health and ethics of sperm donation and considers these issues from the perspectives of all three parties involved. The major topics explored include • limiting the number of donor offspring. • minimizing the risk of infection and genetic complications from sperm donors. • age requirements for sperm donors. • anonymity versus nonanonymity of sperm donors. • sperm-donor compensation. • informed consent and counseling. Among these topics, those concerned with the ethical nature of sperm donation are most controversial. While most guidelines come from governmental, nongovernmental, or academic institutions, religious organizations can also offer opinions that the public values. For example, Catholic teaching on infertility treatment and reproductive technology emphasizes the ethical need for children to be conceived and born of the marriage union (Ford 2008). Any sperm banks should abide by regulations or laws of a state or country, and they must take into consideration cultural tradition, public or patients’ opinions, different religions, economic development, and population numbers. These concerns of heterogeneity are especially relevant for sperm banks in developing countries adopting practices of sperm banks in developed countries. Last, all sperm banks should attempt to continually update their understanding of the environment in which they operate. Even in countries where sperm-donation guidelines have been well established, surveys of private citizens have been conducted to assess feedback on current ethical guidelines. Such information has led to the current understanding that counseling has a beneficial impact on donors (Weinberg 2008).

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7.2 Limiting the number of donor offspring A primary consideration when assessing the eligibility of sperm donors is the number of donor offspring per donor. The International Federation of Gynecology and Obstetrics (FIGO), the key global organization that brings together professional societies of obstetricians and gynecologists, sets a general guideline to limit the number of donor offspring in order to avoid the future danger of consanguinity and/or incest (International Federation of Gynecology and Obstetrics 2006). While every nation agrees that preventing consanguinity and/or incest is a primary concern, different countries have developed varying guidelines to achieve this goal. The most important factors in determining this limit on donor offspring are the size, density, and mobility of the country’s population. Below are the regulations that two national organizations have recommended for sperm banks in their nations. Their recommendations illustrate some of the difficulties associated with assigning a limit to the number of donor offspring.

7.2.1 United States In the United States, there is no federal or state law limiting sperm donation. The American Society for Reproductive Medicine recommends that institutions, clinics, and sperm banks maintain sufficient records to allow a limit to be set for the number of pregnancies for which a given donor is responsible. The ASRM argues that it is difficult to provide a precise number of times that a given donor can be used because one must take into consideration the population base from which the donor is selected and the geographic area that may be served by the donor. One suggestion is that in a population of 800,000, limiting a single donor to no more than 25 births would avoid any significant increased risk of inadvertent consanguineous conception. However, this recommendation is not a fixed rule. The ASRM acknowledges that for more mobile populations, more than 25 births may be permissible and that fewer than 25 births is recommended for less mobile, more isolated populations (American Society for Reproductive Medicine 2006). The ASRM’s recommendations show the difficulty in assigning a specific limit to the number of donor offspring. To carry out these recommendations fully, knowledge of the population served is crucial. However, since such knowledge may not be transparent to sperm-bank management, keeping track of the successful artificial insemination procedures per donor is necessary and critical.

7.2.2 United Kingdom The Human Fertilisation and Embryology Authority is the United Kingdom’s independent regulator overseeing the use of gametes and embryos in fertility treatment and research. The HFEA restricts gametes (or embryos created using gametes) of an individual donor from producing children for more than 10 families as a result of licensed assisted-conception services. However, gametes from an individual donor may be used in any licensed assisted-conception treatment for the purpose of producing a genetically related sibling for an existing child of the woman’s family to be treated. Whereas the ASRM, in the United States, tends to allow for more donor offspring per sperm donor, the HFEA’s concern stems beyond merely the adverse genetic outcomes of consanguinity and also includes the emotional and psychological effect on donor offspring thinking that there may be a large number of half-siblings living in the same population (Human

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Fertilisation and Embryology Authority 2006). While increasing the sperm-donor limit would increase the availability of infertility treatment without increasing the statistical risk of consanguinity to levels deserving concern, the HFEA’s recommendations show that a society must be concerned with not only the donor party and the recipient party but also the resulting offspring. Such ethical concerns may be hard to forecast for the parties immediately involved, and surveys of donor offspring can help illuminate the degree to which psychological concerns of being a donor offspring should be relevant.

7.3 Minimizing the risk of infection and genetic complications from sperm donors All regulatory agencies and sperm banks agree that sperm donors should undergo rigorous medical evaluation and screening to ensure that no sexual or genetic diseases are passed on to the potential offspring. The screening process usually includes taking a medical history from the donor and performing laboratory tests on the semen sample. FIGO provides basic guidelines that “donors of genetic material should be healthy persons of normal reproductive age who are free from sexually transmitted diseases and hereditary disorders” (International Federation of Gynecology and Obstetrics 2006). The ASRM provides more detailed guidelines for donor selection. Fundamentally, it agrees with FIGO that “the main qualities to seek in selecting a donor for [therapeutic donor insemination] are an assurance of good health status and the absence of genetic abnormalities.” To achieve this, donors must undergo genetic screens for Mendelian disorders, including Huntington disease; karyotypic abnormality as a result of chromosomally unbalanced gametes; and other heritable diseases common to the population. A medical history is also necessary to examine the hereditary and sexual background of the sperm donor, obtained by asking about unsafe sexual behavior or intravenous drug use. Individuals with a high risk for HIV, sexually transmitted infections, or other diseases transmittable via gamete donation should be excluded. A physical examination should also be administered to evaluate urethral discharge, genital warts, genital ulcers, blood type, and Rh factor. If any adverse findings are found, the donor should be notified and directed toward treatment and counseling resources (American Society for Reproductive Medicine 2006). While a genetic screen, a medical history, and a physical examination must be administered for every sperm donor, certain variations across countries and regions may be acceptable. While the ASRM recommends testing for cystic fibrosis in all individuals regardless of race (American Society for Reproductive Medicine 2006), each sperm bank must determine what genetic diseases are most relevant in the context of the population they serve. Thus, sperm banks in Asia may not need to test for cystic fibrosis but should test for other diseases that are more common in those countries. Again, one lesson here is that regulations that work for established sperm banks may not work for new sperm banks. Attention to geographical differences is necessary to best adopt and tailor established procedures.

7.4 Age requirements for sperm donors All sperm banks must also decide what age limits to impose on sperm donors. Physical health and psychological health are two factors to consider when determining these

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requirements. FIGO recommends only that sperm donors be of healthy reproductive age (International Federation of Gynecology and Obstetrics 2006), which is in accordance with the ASRM’s guidelines requiring that “the donor should be of legal age and, ideally, less than 40 years of age, because increased male age is associated with a progressive increase in the prevalence of aneuploid sperm” (American Society for Reproductive Medicine 2006). Beyond the viability of semen from sperm donors, another consideration yet to be discussed is the psychological health of sperm donors. The ASRM recommends that psychological counseling and evaluation be administered to all sperm donors, as complex relationships are developed via sperm donation. Relationships between sperm donors and sperm recipients can be complicated, as one may wish to seek the other, or both may wish to seek each other, before or after artificial insemination. Sperm donors may also feel attached to their biological offspring as a result of successful donations. The feelings that the donating party will experience should be discussed prior to donation (American Society for Reproductive Medicine 2006). As older donors will tend to have developed the maturity to handle these complex concerns, a lower age limit is important to impose for psychological reasons as well.

7.5 Anonymity versus nonanonymity of sperm donors Anonymous versus nonanonymous sperm donation is an important issue to both the recipient and the donor. Sometimes, donors will try to find out who the recipient will be. More often, recipients want to know as much about the donor as possible before undergoing artificial insemination. How much can recipients know about their donors? Should donor identities be revealed to provide recipients with the proper information to make a decision about undergoing artificial insemination? These are all questions that sperm banks must tackle. In addition, donor offspring may later inquire about the genetic father’s identity. A key but long-unresolved question in sperm donation is whether offspring should be informed of their biological father and, if so, how much and when information about donors should be revealed. Parents, donors, and offspring may have different interests and views on anonymous versus nonanonymous sperm donation, which creates a difficult situation for sperm banks that hold information regarding the identity of the parties involved. This section will discuss arguments for anonymous sperm donation and for nonanonymous sperm donation, which sperm banks can use to evaluate their own policies.

7.5.1 Anonymous sperm donation Those who support anonymous sperm donation insist that anonymity is beneficial to the donor, the recipients, and the donor offspring. They express concerns that telling the child of his or her birth by sperm donation will subject the child to social or psychological disorders, which can be especially unsettling if the child wants to find out more information about the donor but cannot. A study of donor offspring (Golombok 1999) has shown that they are not harmed psychologically by anonymity or nondisclosure. However, the children studied may be too young for researchers to draw convincing conclusions. In addition, anonymous donation allows parents to maintain the issue of infertility as a private matter, which may be vital to them for a variety of reasons.

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For example, they may be concerned that the child will reject the nongenetic parent, or they may wish to conceal the fact of donation from disapproving family members, especially those from cultures less accepting of sperm donation (Frith 2001). A survey in Denmark found that in 2002, 25% of donors stated that they would continue as donors if anonymity were abolished, whereas in 1992, 32% said that they would be donors under such conditions. When donors were asked whether they would accept contact from the children, 22% agreed in 1992 but only 13% did so in 2002. From their survey, the authors argued that maintaining anonymity was important for the vast majority of the donors (Ernst et al. 2007). While proponents of nonanonymous sperm donation look to the issue of adoption for support for greater disclosure, Patrizio and colleagues (2001) argue that nonanonymous donation distinguishes gamete donation from adoption. They believe that it is both wrong and discriminatory to force potential parents to tell children of their genetic origin as a requirement for admission into a fertility-treatment program. Furthermore, they argue that no reasonable, practical system can be envisaged to guarantee compliance with mandatory disclosure. Most importantly, Patrizio and colleagues state that while in adoption cases, the legal guardians are not biologically related to their child, in spermdonation cases, the rearing mother is usually also the genetic and biological mother, and the rearing father is the social father, who may prefer to keep the donation private. In the United States, the ASRM recommends anonymous or directed (nonanonymous or known) sperm donation (American Society for Reproductive Medicine 2006). Traditionally, most donations have been anonymous, but no-anonymous donations are also acceptable if all parties have agreed prior to the treatment. Directed or nonanonymous donors should undergo the same evaluation as anonymous donors. However, it is important to understand that cultural differences in family values are important considerations for determining the appropriate policies for sperm banks.

7.5.2 Nonanonymous sperm donation In recent years, a strong tendency in favor of non-anonymous sperm donation has emerged in Europe. Several countries have enacted laws or are taking into consideration permitting artificially inseminated children to gain access to information about their genetic fathers. Sweden is the first country to pass legislation about disclosure by establishing the right of the child to find out the identity of the gamete donor once the child has reached maturity (Gottlieb et al. 2000). In 2005, British legislation was changed to require any donor of sperm used in artificial insemination or in-vitro fertilization (IVF) to agree to the disclosure of their identity to any offspring reaching the age of 18 (Frith et al. 2007). Proponents of nonanonymous sperm donation argue that human beings have a fundamental interest, and perhaps even a legal right, to know their biological origins. Not telling the child of his or her origins violates that child’s autonomy. Disclosure is a key part of open and honest communication with children, which helps avoid secrets in the family that can damage family relationships and generate possible strains and anxieties. Recent findings (Crawshaw 2008) show an increase in donor programs that offer open-identity relationships between donors and offspring. The psychological wishes of sperm donors and their attitudes toward nonanonymity and disclosure are increasingly given consideration. The majority of prospective parents have stated their intention to

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disclose the method of conception to their children even prior to the legal changes. Possible influences on their intention to disclose include the culture within the center, movements toward openness within the wider society, and these parents’ lack of confidence regarding how to go about disclosure. Follow-up studies are needed to improve our understanding of whether influences on decision making carry through to patterns of actual disclosure, whether involvement in counseling affects outcomes, and whether access to professional assistance at the time of planned disclosure is helpful. Research has looked at a sample of donor offspring aware of the nature of their conception ( Jadva et al. 2009). Those told later in life report more negative feelings regarding their donor conception than those told earlier. Regarding feelings toward their own parents, offspring told later in life about their conception have more varied attitudes, with some reporting more positive feelings and others reporting more negative feelings. Among those who feel as though they were misled after being told about their conception, offspring from heterosexual-couple families are more likely to feel angry toward their mothers than their fathers. The most common feeling towards fathers was “sympathetic.” Age of disclosure is important in determining donor offspring’s feelings about their donor conception. This study seems to suggest that it is less detrimental for children to be told about their donor conception at an early age. From the perspective of sperm banks, sperm-donation procedures must be conducted such that the welfare of all participants – the donors, recipients, and offspring – are all respected. Sperm banks should provide the necessary counseling and information services to both sperm donors and recipients in order to address their concerns and should be open regarding the ethical issues in this complicated process.

7.6 Sperm-donor compensation For any sperm bank, one area of particular importance is the amount of compensation one should pay the sperm donor. This issue is important both in terms of the financial management of a sperm bank but also the motivations behind sperm donation. FIGO’s recommendation is clear in that “the donation of genetic material should be altruistic and free from commercial exploitation” (International Federation of Gynecology and Obstetrics 2006). As a result, the amount of compensation should cover for expenses the sperm donor incurs, which may include time, travel, and effort. However, FIGO argues against turning this process into a transaction between money and service. What FIGO does not provide, however, is a recommended amount for compensation. The ASRM states that payment to donors “should not be such that the monetary incentive is the primary motivation for donating sperm,” and it also recognizes that the amount of compensation “varies from area to area” (American Society for Reproductive Medicine 2006). Both organizations argue that sperm donation should remain a “donation” in nature rather than a market transaction. Commercializing sperm donation raises a number of issues. One, inequality may arise if sperm banks compensate sperm donors with greater amounts of money such that sperm banks must charge more for their services, thus biasing the types of people who can undergo artificial insemination procedures. Second, if sperm can be bought on a market, then sperm recipients may desire specific characteristics in their sperm donor based on factors such as intelligence or athleticism.

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Sperm donors with high-demand characteristics would be compensated more than other donors, creating inequality in the pool of sperm donation. Third, if compensation amounts rise for sperm donors, then more men may be willing to “donate” sperm, but they may not think about the ramifications of this process as thoroughly as those who are willing to donate sperm altruistically. While sperm banks must consider the potential problems of creating a free market system for sperm donation, it may also be beneficial to society if supply-and-demand laws determine prices. Setting artificially low ceilings for compensation may limit the supply of sperm from donors, thus failing to keep up with the demand of sperm from infertile couples who wish to undergo artificial insemination. Balancing sperm supply and equality of access creates the difficult situation of determining what the appropriate amount of compensation should be for sperm donors. Research on both spermdonor attitudes and sperm supply for the area in which a sperm bank operates can help determine the appropriate amount.

7.7 Informed consent and counseling From the perspective of all the parties involved in sperm donation, informed consent and counseling are important resources. The ASRM recommends that psychological evaluation and counseling be offered to both sperm donors and recipients (American Society for Reproductive Medicine 2006). The sperm-donation process is incredibly complex and has both physical and emotional ramifications. Thus, it is imperative that all parties be informed of the process fully so that expectations will be in line with reality. For sperm donors, they should recognize that their donation may lead to offspring they may never meet. While arrangements for the biological father and the donor offspring to meet may be possible, the donor offspring or the sperm recipient may not agree to such meetings. From the perspective of the recipients, they should recognize that their donor offspring may inquire about the nature of their conception in the future, especially if they suspect that one parent might not be the biological parent. Such expectations are important to factor in to the recipient’s decision-making process. Moreover, men who have partners undergoing artificial insemination may need to recognize that family-identity issues may arise, as their relationship with donor offspring is familial but not biological in nature, whereas the women undergoing artificial insemination will be genetically related to their offspring. The importance of informed consent and counseling is such that the parties involved will have realistic expectations of what the sperm-donation process may entail both in the present and in the future.

7.8 Conclusions As demand for sperm banks and sperm bank services continues to rise, health and ethical considerations on behalf of the sperm donor, the sperm recipient, and donor offspring remain critical issues to consider. This chapter explored six such issues, including • limiting the number of donor offspring. • minimizing the risk of infection and genetic complications from sperm donors. • age requirements for sperm donors.

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• anonymity versus nonanonymity of sperm donors. • sperm-donor compensation. • informed consent and counseling. From the perspective of sperm bank management, factoring in these considerations is important for both legal considerations and the satisfaction of their clients. From a societal standpoint, recognizing these considerations can help facilitate the sperm-donation and insemination process to best achieve the goals of both the sperm donor and the recipient.

References American Society for Reproductive Medicine. 2006 guidelines for gamete and embryo donation. Fertil Steril. 2006;86(suppl 5):S38–S50. Crawshaw M. Prospective parents’ intentions regarding disclosure following the removal of donor anonymity. Hum Fertil. 2008;11(2):95–100. Ernst E, Ingerslev HJ, Schou O, Stoltenberg M. Attitudes among sperm donors in 1992 and 2002: a Danish questionnaire survey. Acta Obstet Gynecol Scand. 2007;86(3):327–333. Ford NM. A Catholic ethical approach to human reproductive technology. Reprod BioMed Online. 2008;17(suppl 3):39–48. http://www.rbmojournal.com/article/S1472-6483(10)60 329-X/abstract. Accessed April 4, 2010. Frith L. Beneath the rhetoric: the role of rights in the practice of non-anonymous gamete donation. Bioethics. 2001;15:473–484. Frith L, Blyth E, Farrand A. UK gamete donors’ reflections on the removal of anonymity: implications for recruitment. Hum Reprod 2007;22(6):1675–1680. Golombok S. New families, old values: considerations regarding the welfare of the child. Hum Reprod. 1999;13:2342–2347. Gottlieb C, Lalos O, Lindblad F. Disclosure of donor insemination to the child: the impact of Swedish legislation on couples’ attitudes. Hum Reprod. 2000;15:2052–2056. Human Fertilisation and Embryology Authority. Limitations on the use of gametes (or embryos created using gametes) from an individual donor. HFEA Practice Guidance Note, 2006. International Federation of Gynecology and Obstetrics. Ethical Issues in Obstetrics and Gynecology. London: FIGO House; 2006. Jadva V, Freeman T, Kramer W, Golombok S. The experiences of adolescents and adults conceived by sperm donation: comparisons by age of disclosure and family type. Hum Reprod. 2009;24(8):1909–1919. Patrizio P, Mastroianni AC, Mastroianni L. Disclosure to children conceived with donor gametes should be optional. Hum Reprod. 2001;16:2036–2038. Weinberg R. The moral complexity of sperm donation. Bioethics. 2008;22(3):166–167.

8 Oocyte donation: medical and legal perspectives Sarit Avraham and Daniel S. Seidman Delayed age of childbearing is increasing in industrialized nations and is related to deferment of marriage and postponement of pregnancy in marriage, as well as frequent occurrence of divorce and remarriage. As a result, more women in their late 30s to early 40s are now seeking their first pregnancy. Success of infertility treatments, including those using assisted reproductive technologies (ART), decreases significantly as the age of the female advance, especially among women age 40 or more. Oocyte donation is a common form of third-party reproduction, associated with significant success rates (fFig. 8.1). It gives older couples an opportunity to bear children, almost regardless of the maternal age. Human oocyte donation was first introduced into clinical practice in 1983 and has been developing rapidly, as demonstrated in data published by the European IVF Monitoring (EIM) Program. In 2001, 289,690 treatment cycles were initiated, including 7,171 egg donations. The number of reported ART cycles reached 418,111 in 2005, including 11,475 egg donations (Andersen 2005, 2009). For the United States, the Centers for Disease Control and Prevention (CDC) reported that 12% of the 142,435 ART cycles performed involved eggs or embryos donated by another woman. Overall in 2007, 11,275 fresh-donor cycles and 6,130 frozen-donor cycles were performed in the United States (Centers for Disease Control and Prevention 2009).

8.1 Indications for egg donation In the past decade, oocyte donation has become a widely used ART, with reported pregnancy rates consistently exceeding 50%, often higher than those for conventional in vitro fertilization (IVF) (Centers for Disease Control and Prevention 2009) (fFig. 8.1). Recipients of donated oocytes included initially women with gonadal dysgenesis and Turner’s syndrome. Today, egg-donation recipients include mainly women with premature ovarian failure (POF) or severe genetic disorders, those who respond poorly to ovarian hyperstimulation, women over 40 years of age, and postmenopausal women (Dean 1994). Over the years, indications have further expanded to patients with contraindications for spontaneous or induced ovulation such as Von Willebrand’s disease, and for women after gonadectomy or repeated IVF failure, female survivors of cancer, and those who have suffered severe endometriosis, as well as for same-sex surrogacy (Allahbadia and Merchant 2009). A retrospective analysis by Saratani and Allali (1997) of 319 egg-donation transfers for 184 couples compared the effectiveness of oocyte donation among various indications, ages, and treatments. Transfers were divided into seven groups according to indication: POF with normal karyotype (n = 122), surgical POF (n = 26), postchemotherapy and postradiation therapy POF (n = 23), genetic-disease carrier (n = 11), IVF failure (n = 69), primary amenorrhea (n = 58), and POF with abnormal karyotype (n = 10). Oocytes were donated by volunteer donors less than 38 years old. The results, according to the indication, were similar except for postchemotherapy and postradiation therapy POF,

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Percent

50 40 30 20

Donor eggs Own eggs

10 0 48

Fig. 8.1: Live-birth percentages per fresh-embryo transfers using own and donor eggs by patient’s age, 2006.a a

Adapted from Centers for Disease Control and Prevention, et al. 2008.

for which the rate of clinical pregnancies, as well as the rate of ongoing pregnancies, were particularly low.

8.2 Preparation of donor and recipient In women with ovarian failure, artificial menstrual cycles are required before proceeding to oocyte donation. Estrogen may be delivered in the form of oral tablets or using transdermal patches and vaginal application, in order to bypass the gastrointestinal tract and thus avoid first-pass metabolism in the liver. Progesterone may be administered in the form of oral tablets, intravaginal suppositories or rings, and intramuscular injections. In women with retained ovarian function, synchronization of donor-recipient cycle presents a special problem, as there is strong evidence that a temporal window of maximal endometrial receptivity exists. Cryopreservation of donated embryos may be used to overcome the problem, but this approach has the important drawback of embryonic loss occurring after freezing and thawing. A common method utilizes the administration of gonadotrophin-releasing hormone (GnRH) agonists to render the patients functionally agonadal in order to circumvent cycle asynchrony between the donor and recipient (Devroey and Pados 1998). Estradiol replacement of 11 to about 40 days, but not exceeding 9 weeks, yields the best results. Lower serum estradiol concentrations and higher abortion rates are observed in patients after short estrogen exposure (5–10 days) (Gonen and Goldman 2009). Sequential ultrasound scans allow monitoring and assessment of endometrial receptivity in a noninvasive way.

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According to Shapiro and Cowell (1993), transvaginal sonography before progesterone administration is more accurate than endometrial biopsy in predicting a successful donor egg cycle. The endometrium has been classified into three categories as seen on the day of human chorionic gonadotropin (hCG) administration. Type A (homogeneous hyperechogenic) is associated with zero chance of pregnancy, while Type C (multilayer, “triple line”) is the most likely to favor pregnancy. Different studies dealing with the start of progesterone supplementation in ART cycles have shown that the problem apparently is the correct timing. Nawroth and Ludwig (2005) discussed the data on the start of progesterone replacement in oocyte-donation programs. It seems to be appropriate to start progesterone administration before transfer in oocyte-donation programs, as well as transfer of cryopreserved/thawed cells, as soon as the endometrium is developed sufficiently (t8 mm, trilaminar pattern). Embryo transfer should not be performed before day 3–4 of progesterone treatment (i.e., embryo development on day 2–3). Studies examining the influence of too early a rise of progesterone in fresh IVF cycles have shown different results. In fact, high progesterone levels seem to reflect a high response but not a lower probability of conception. Furthermore, high progesterone levels on the day of embryo transfer in fresh IVF cycles could lower myometrial contractility and therefore increase implantation rates. Since the experience from oocyte-donation programs shows the benefit of a longer preparation time using progesterone, and high progesterone levels seem to have a benefit during embryo transfer, this would suggest extending progesterone administration before transfer. Evidence accumulated in IVF cycles suggests that the use of long-acting forms of GnRH agonists for pituitary desensitization may impair the outcome of IVF as compared to classical short-acting formulations. Whether the negative effects are directed against the corpus luteum, the endometrium, or both is unknown. However, the presence of high-affinity binding sites for GnRH in the human endometrium suggests a possible role of these analogues on this target organ, affecting embryo implantation. Pellicer and Neuspiller (1998) tested direct effects of two forms of GnRH agonists on implantation using the ovum donation model. Patients were prospectively allocated to one of the three study groups: the short-acting form of the analogue leuprolide acetate (group I; n = 64), the long-acting form of the same analogue (group II; n = 58), and the long-acting preparation of the analogue tryptorelin (group III; n = 61). A total of 68 cycles of embryo transfer was carried out in group I, whereas 67 were performed in group II and 65 in group III. Cancellation rates were respectively 18.1%, 17.3%, and 18.8% because of bleeding while being on the waiting list for anonymous oocyte donation. The number of oocytes donated, fertilization rates, and embryos replaced in each group were similar. As a result, pregnancy rate per transfer was 38.2%, 49.3%, and 44.6%, respectively. Implantation rates per embryo replaced were respectively 13.4%, 19.1%, and 17.0%. They concluded that the use of a long-acting form of GnRH agonists provides success rates similar to the short-acting preparations, resulting in more convenient medication for patients with ovarian function included in ovumdonation programs. In a retrospective study, Llata and Moraga (2004) compared GnRH agonists and antagonists for avoiding premature ovulation in controlled ovarian hyperstimulation in oocyte donors. One hundred forty-one oocyte donors underwent ART, receiving either 0.25 mg daily of a GnRH antagonist (Cetrorelix) from day 6 of stimulation (51 patients)

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or a long protocol with a GnRH agonist (Leuprolide acetate) (90 patients). rFSH, alone or with HMG or rLH, were employed for ovarian stimulation. Both groups were homogeneous for age, day 3 FSH, type, and total dose of gonadotrophins utilized. There were no significant differences in follicles number, estradiol levels on the day of hCG, and fertilization rates. The mean number of oocytes retrieved and metaphase II oocytes was significantly lower in the GnRH agonist group. There were no statistical differences in pregnancy and implantation rates between agonist and antagonist groups. They summarized that the high number of metaphase oocytes and the high pregnancy rate observed in the oocyte donors provides evidence that use of GnRH antagonists does not impair ovarian response, embryo quality, or pregnancy rates (Llata and Moraga 2004). In oocyte donor cycles, the GnRH antagonist is a valid alternative to GnRH agonist, providing the benefit of more flexibility in patients’ scheduling.

8.3 Outcome determining factors Soares and Velasco (2008) summarized the current knowledge about clinical factors related to the oocyte recipient, other than those associated with uterine cavity abnormalities, which influence the outcome of oocyte-donation cycles. Their conclusions were that recipient age and the presence of hydrosalpinx are clearly associated with a poorer outcome in oocyte-donation cycles. The negative impact of tobacco consumption was also recently confirmed. The exact relevance of an elevated body-mass index is still under debate, but it is likely that it may be related to a lower ongoing pregnancy rate. Endometriosis may adversely influence endometrial receptiveness in the context of a natural cycle, but no negative impact was detected when standard endometrial priming protocols were used in oocyte donation. The same may be true for adenomyosis, although its relevance to endometrial receptiveness is less clear. Uterine fibroids are a common gynecological disorder that affects 20–40% of women. Horcajadas et al. (2008) summarized the present knowledge concerning fibroids effect on infertility. There seems to be a general agreement that submucous or intramural leiomyomas, protruding into the endometrial cavity, are associated with decreased implantation and pregnancy rates. Therefore, myomectomy is recommended in such cases. Subserosal leiomyomas, however, do not affect implantation and usually should not be removed. The reproductive impact of intramural leiomyomas that do not directly affect the endometrial cavity remains controversial.

8.4 Obstetric and perinatal outcomes Several studies have indicated that the obstetrical complications, especially pregnancyinduced hypertension (PIH), moderate or severe pre-eclampsia, and gestational diabetes, are significantly increased in pregnant women after oocyte donation. Furthermore, the cesarean section rate in this patient population is extremely high, exceeding 80% (Tarlatzis and Pados 2000). The indications are usually advanced maternal age, PIH, gestational diabetes, a previous uterine scar, and multiple pregnancies (Sheffer-Mimouni et al. 2002). This association may be associated in part with the known effect of very advanced maternal age on the rate of cesarean delivery (Dulitzki et al. 1998).

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First-trimester bleeding is the most frequently observed obstetric complication reported to occur in 12–15% of pregnancies that result from oocyte donation. Second-trimester bleeding is less frequent and is associated with adverse fetal outcome. The most frequent medical complication is PIH, occurring in up to 50% of pregnancies (Sheffer-Mimouni et al. 2002). Older women are at increased risk. Wiggins and Main (2005) reviewed the obstetric and perinatal outcomes of pregnancies achieved by egg donation and compared these pregnancies with those of women of similar socioeconomic status who also needed similar ART. A retrospective review of 50 consecutive pregnancies achieved by egg donation and 50 consecutive pregnancies achieved by standard IVF was performed. Comparisons were made for demographic and medical confounding factors and for outcome measures. Key obstetric outcomes did not differ between the two groups, with the exception of PIH. In patients who underwent egg donation, 26% had PIH, whereas PIH occurred in only 8% of the control group, a statistically significant difference. The highest rates of PIH were reported among young oocyte-donation recipients (Keegan and Krey 2007). Preterm delivery was not found to be significantly more common in pregnancies following oocyte donation. Preterm delivery among parturients after oocyte donation was significantly associated with PIH, second-trimester vaginal bleeding, and maternal smoking (Sheffer-Mimouni et al. 2002).

8.5 Ethical aspects Donation of genetic material and ART has raised ethical, legal, social, and religious issues, not always answered by regulations (Schenker 2008). One of the most debated issues is commercial egg donation, raising questions concerning exploiting poor women and distorting the reproductive paradigm. Resnik (1998) argued that people who donate sperm or eggs claim to have a right to remuneration for goods and services. If a person has a right to sell blood or hair, then that person should have a right to sell gametes. However, the commodification of tissues that have the potential to become adult human beings may threaten human dignity and other moral values. According to the Kantian argument, commodification of the human body treats people as things that can be bought and sold. If human beings can be bought and sold, then they have a market value and can be treated as mere objects by themselves or other people. Resnik (1998) concluded that gametes and genes may be treated as incomplete commodities, while whole genomes, zygotes, and embryos should not be commodified at all. Markets in gametes and genes should also be regulated in order to prevent potential threats to human dignity and other moral values. The current situation of oocyte donation in the United States serves as a useful paradigm for a laissez-faire free-market model of egg-donor reimbursement, based on supply and demand. Financial compensation to egg donors for their time and inconvenience in donating is established in the United States as ethically and legally acceptable. There is a rapidly emerging consensus of what would be considered desirable attributes in an egg donor, which would in turn determine her market value in financial reimbursement. First is the race and ethnicity of the donor. As expected, the shortage of egg donors from some ethnic groups, such as East Asians and Jews, has resulted in higher reimbursement

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rates for donors of such ethnicity. Second is the educational attainment of the donor, in particular high scores on the Scholastic Reasoning Test and degrees from prestigious universities. Third is the employment status and career of the prospective donor. Last are the personal esthetics of the egg donor – her physical appearance, from complexion to stature. These attributes can be summarized as the Four Es: ethnicity, education, employment, and esthetics (Heng 2007). The current guidelines of the Human Fertilisation and Embryology Authority (HFEA), in the United Kingdom, do not allow direct payment to donors but do accept the provision of lower cost on free IVF treatment to women in recognition of oocyte donation to an anonymous recipient. In 2004, 1,676 patients were treated with donors’ eggs; this figure fell to 1,306 patients by 2008. To tackle the shortage of sperm and eggs donated for IVF treatment, the HFEA gathered views before it began to carry out a full consultation into its donation policies beginning January 2011. HFEA chair Lisa Jardine was quoted (O’Dowd 2010) as saying the authority was considering adopting the Spanish system, which would see the payment cap rise to £800 (Uroz and Guerra 2009). Allahbadia and Seidman (2009) reviewed cross-border reproductive care, known popularly as medical tourism, as an increasing phenomenon in respect to egg donation due to the lack of legal restrictions, lower costs, and shorter waiting times in many countries. The European Society for Human Reproduction and Embryology’s Task Force on Ethics and Law defines cross-border reproductive care as a phenomenon that “[i]ndicates the movements by patients looking for infertility treatment from one country or jurisdiction where treatment is unavailable for them to another country or jurisdiction where they can obtain the treatment they need” (Devroey and Pennings 2008). Seidman and Allahbadia describe the situation in the United Kingdom as an example of inadequate monetary compensation and the threat to remove the donor’s anonymity, which encourages British couples to seek treatment in the United States, where donated oocytes are available because of generous financial remuneration to oocyte donors. By contrast, U.S. women travel abroad for low-cost treatment. Cheaper prices, high-quality health care, and the availability of donor eggs and surrogates are drawing an increasing number of couples to Cyprus, India, Russia, Thailand, and Ukraine. In a further twist, frozen sperm from a recipient’s partner is now routinely shipped to foreign clinics to fertilize donor oocytes. The resulting embryos are shipped back cryopreserved in fluid nitrogen, or transported across borders fresh, using custom-made incubators, for transfer to the recipient. Among the numerous ethical concerns raised by this practice of so-called mail order oocyte donation, the most obvious are that underprivileged women from poorer countries could be exploited, fertility physicians from richer countries could abdicate responsibility for the welfare of donors, and responsibility could become an issue of contention if transmission of disease to the oocyte recipient or congenital defects in offspring born from such oocyte donation were to occur. Moreover, savings from utilizing donors from poorer countries ought to be shared with oocyte recipients (Heng 2006). Another long-raging debate surrounds the issue of very advanced maternal age and postmenopausal pregnancy. Community attitudes toward oocyte and embryo donation and toward ART after the menopause were assessed in this survey of 1,131 Australians. Of the respondents, 64.2% believed that oocyte or embryo donation was an acceptable treatment for infertile couples, 54.6% felt that it was acceptable for a woman to have

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her own embryos transferred after the menopause, and 37.9% are accepting of the donation of eggs or embryos to postmenopausal women. There were no significant differences in response among different religious groups or in relation to gender or income level. Significantly higher levels of acceptance were noted for all categories among those respondents age 800 couples coming forward for gender selection of their children. Hum Reprod. 1995;10:968–971.

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Thomasma DC. Ethical issues and transplantation technology. Camb Q Healthc Ethics. 1992;1(4):333–343. Verlinsky Y, Kuliev A. Preimplantation genetics. J Assist Reprod Genet. 1998;15(5):215–218. *Verlinsky Y, Rechitsky S, Schoolcraft W, Strom C, Kuliev A. Preimplantation diagnosis for Fanconi anemia combined with HLA matching. JAMA. 2001a;285(24):3130–3133. *Verlinsky Y, Rechitsky S, Verlinsky O, et al. Preimplantation diagnosis for p53 tumour suppressor gene mutations. Reprod BioMed Online. 2001b;2:102–105. http://www.rbmojour nal.com/article/S1472-6483(10)62233-X/pdf. Accessed April 7, 2011. Verlinsky Y, Rechitsky S, Sharapova T, et al. Preimplantation HLA testing. JAMA. 2004;291 (17):2079–2085. Viville S, Pergament D. Results of a survey of the legal status and attitudes towards preimplantation genetic diagnosis conducted in 13 different countries. Prenat Diagn. 1998;18(13):1374–1380. Wang CW, Hui EC. Ethical, legal, and social implications of prenatal and preimplantation genetic testing for cancer susceptibility. Reprod BioMed Online. 2009;19(suppl 2):23–33. http://www.rbmojournal.com/article/S1472-6483(10)60274-X/pdf. Accessed April 7, 2011. Wertz DC, Knoppers BM. Serious genetic disorders: can or should they be defined? Am J Med Genet. 2002;108:29–35. Wilton L, Thornhill A, Traeger-Synodinos J, et al. The causes of misdiagnosis and adverse outcomes in PGD. Hum Reprod. 2009;24(5):1221–1228. Wolbert W. Is there a duty to create saviour siblings? Hum Reprod and Gen Ethics. 2008;14;(1):22–28. Wolf SM, Kahn JP, Wagner JE. Using preimplantation genetic diagnosis to create a stem cell donor: issues, guidelines, and limits. J Law Med Ethics. 2003;31:327–339.

24 Posthumous reproduction: ethical and legal perspectives Bethany Spielman 24.1 Introduction Posthumous reproduction – conceiving a child or implanting an embryo shortly before or anytime after the death of one or more of its parents – occurs under circumstances that are often both technically and socially complex. The potential sources of human reproductive materials are multiplying, as are the retrievable reproductive materials, stages of life when the material may be successfully retrieved, relationships of the requestors to the deceased or dying, times when the materials may be used for reproductive purposes, and persons with whose reproductive materials they may be combined. Parties who would never be able reproduce if assistive reproductive technologies could not be used posthumously, now have the opportunity to reproduce, but posthumous use of ART also introduces the possibility that all of the reproductive collaborators may be dead when a child is born and needs parents. This chapter examines the ethical and legal issues arising in posthumous use of ART. The ethical issues touch on fundamental beliefs about respect for the dead and dying, familial and intergenerational relationships, and human identity. Religious and secular ethical traditions frame and resolve these issues in a variety of ways; some religious traditions such as Roman Catholicism prohibit the use of ART altogether, while others, such as Judaism and most secular traditions, permit use of posthumous ART under certain conditions. Some legal regimes, such as the revised Uniform Anatomical Gift Act in the United States, are permissive about posthumous retrieval for ART use, while others, such as that in Germany, prohibit posthumous reproduction. In this chapter, four roles in posthumous ART will be used to organize issues: the source of the reproductive material, the requester of retrieval, the reproductive partner(s), and the children produced by postmortem ART. The issues that arise with the use of postmortem ART resemble, but are not identical to, those arising in the use of ART significantly before the end of life. Distinctive issues arise in posthumous ART because of major differences in these roles: First, in retrieval significantly before death, the source from which the reproductive material will be retrieved and the requester of retrieval are the same person, unless the source is a minor or other incompetent and a parent or agent makes the request. In postmortem retrieval, however, the source and the requester of retrieval are different, unless the source had given specific authorization during life. That might occur, for example, if an adult participates in fertility-preserving gamete retrieval before treatment for cancer. Second, in retrieval of human reproductive material significantly before death, the one who requests retrieval is usually not a reproductive partner; in posthumous retrieval, however, the requester of retrieval is often (one of ) the prospective reproductive partner(s). Third, in reproduction significantly before death, the reproductive partner(s) is or are, by definition, alive; in postmortem reproduction, at least one of the partner(s) is, by definition, dying or dead. Few of these role differences in use of ART after death are addressed comprehensively or taken fully into account in ethical and legal guidelines. This chapter will therefore

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identify important questions related to the four roles in posthumous use of ART, and attempt to determine how several ethically or legally difficult posthumous ART cases would be resolved under the guidelines. Representative guidelines from the following national and international groups and governments that permit posthumous ART will be used: the commissioners of the Uniform Anatomical Gift Act of 2006 and 2007, as interpreted in the case of Daniel Thomas Christy; the American Bar Association (ABA); the Ethics Committee of the American Society of Reproductive Medicine (ASRM); the Task Force on Ethics and Law of the European Society of Human Reproduction and Embryology (ESHRE); Canada’s Assisted Human Reproduction Act; and Israel’s attorney general. The approaches these groups have adopted do not answer all the questions that arise in posthumous ART. They do, however, give a rough picture of whether any general areas of consensus are emerging around issues distinctive to posthumous use of ART, and how many questions still remain unresolved.

24.2 The source Questions about the source(s) of human reproductive materials are distinctive in posthumous use of ART because the source is often different from the requester. The questions are ethically important because it is disrespectful to perform actions on the bodies or body parts of the dead or dying to which they have objected or would object, to exploit them, or to coerce them into giving consent to those actions. The principle of autonomy and the concepts of consent, human dignity, and bodily integrity, as well as legal notions of the right to procreate or not to procreate, generally capture these values. Questions about the source of human reproductive materials generally fall into three major categories: questions about what counts as the source’s consent, questions about coercion (if the source is still alive), and questions about whether certain sources of reproductive material should be used at all.

24.2.1 What counts as consent? In the following case, a threshold question is about consent: whether the consent for retrieval of eggs to preserve a woman’s fertility should also be construed to include consent to reproduce posthumously. A 1994, a 26-year-old California woman had her eggs retrieved and fertilized with sperm from an anonymous donor after she was diagnosed with lymphoblastic leukemia. She then underwent radiation therapy but later died of the cancer. A year after her death, a surrogate hired by her parents was implanted with the embryos. The biological mother had no intention of raising the child, nor did her parents. The surrogate eventually miscarried (Weiss 1998). Other questions related to consent under these circumstances also arise: What kind of consent during life is sufficient for retrieval or use of human reproductive material after death? Assent? Failure to refuse? Informed probable intent? Inferred consent rather than explicit consent? Although guidelines for consent are more comprehensive than guidelines for other issues in posthumous ART, no ethical or legal guidelines explicitly answer all of these questions. No guideline that is directly relevant to this case, however, would permit use

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of the woman’s eggs or embryo for posthumous reproduction, and several would prohibit it. Since the egg retrieval was performed during the woman’s lifetime, the Uniform Anatomical Gift Act could not apply. Both Canada’s act and ESHRE’s recommendations require specific consent for posthumous use. The consent requirements of the ABA’s Model Act Governing Assisted Reproductive Technology include disclosure of the parental rights of all participants if collaborative reproduction is used. (In the case described above, disclosure of the parental rights of the gestational surrogate hired by the woman’s parents after the woman’s death was not made to the woman.) And the Israeli guidelines apply to retrieval of sperm, not retrieval or use of eggs. In other cases, different questions could arise about consent of the source: Can consent be general, rather than specifically for posthumous retrieval and reproduction – for example, consent to organ and tissue retrieval, as suggested by the Uniform Anatomical Gift Act? What kind of evidence of this consent must be produced? Verbal? Written? When? If the means of reproduction or retrieval are experimental, should consent standards be the same as for other kinds of human experimentation? If the source of human reproductive material is a brain-dead pregnant woman, is her consent necessary, or can the interests of the state in potential life trump concerns about her consent?

24.2.2 Coercion In addition to the questions above, questions can also arise about the voluntariness of consent: What counts as undue coercion of potential sources of human reproductive material at the end of life? Should ART programs be able to deny procedures based on concerns about undue pressures on the prospective donor, or about unhealthy family dynamics? If so, are the kinds of procedures developed to prevent coercion in the context of intrafamilial organ donation appropriate and sufficient in the context of intrafamilial postmortem gamete donation? In the case of the California woman, nothing suggests she was coerced to consent to retrieval so that her gametes could be used for posthumous reproduction. Had that been a concern, several guidelines might have helped prevent or avoid a coerced consent. The Uniform Anatomical Gift Act addresses coercion of terminally ill donors by stating that a donor may make an anatomical gift during a terminal illness, but it must be addressed to at least two adults, and at least one of the two must be a disinterested witness. A disinterested witness is defined as an individual other than the source’s spouse, children, parents, siblings, grandparent, grandchild, guardian, or friend who exhibited special care and concern (National Conference of Commissioners on Uniform State Laws 2006). The ABA’s Model Act states that “[a]ll participants known to the ART provider must undergo a mental health consultation in accordance with the most recently published standards of ASRM and SART [Society for Assisted Reproductive Technology] prior to the ART procedure. Providers of the consultation must demonstrate contemporaneous knowledge and consideration of the most recently published guidelines of ASRM and SART. The results of this consultation shall not be used to arbitrarily deny any intended parent the right to procreate. During the consultation, the provider must offer additional counseling to each participant. The offer of counseling is mandatory, but the participant’s acceptance of additional counseling is voluntary” (American Bar Association 2008). The ASRM guidelines also permit denying ART procedures on grounds of “consistent concerns about undue pressures on the prospective donor or surrogate, or

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about unhealthy family dynamics.” They also suggest that screening and counseling procedures developed for intrafamilial organ-donation optimism could be imported into the area of intrafamilial gamete donation (Ethics Committee for the American Society for Reproductive Medicine 2003). Neither Canada’s Assisted Human Reproduction Act nor the Israeli attorney general’s guidelines address the issue of coercion, but under the Canadian act, an individual may withdraw consent in writing under certain conditions (Manseau 2007; Ravitsky 2004).

24.2.3 Minors as sources Questions about the appropriateness of certain sources of reproductive material are important because of concerns about the lack of capacity to consent, exploitation, and concerns about resulting familial relationships. In 2006, an Israeli teenager was diagnosed with sarcoma. Some of his sperm was preserved before he underwent radiation therapy. After his death, his parents asked a court to acknowledge the preserved sperm as part of their son’s estate so that they could use it to produce posthumous offspring. In 2009, An Israeli Family Court overruled an opinion of the Israeli attorney general and decided that the hospital must retain the sperm for five years so that the family could use it to produce posthumous children (Zarchin 2009). Should minors be sources of material for posthumous reproduction? Recognizing that it is difficult to counsel a sick minor about fertility preservation while he or she faces treatment for a life-altering and life-threatening disease such as cancer, should consent for posthumous reproduction be incorporated into the process? Under only one of the guidelines surveyed in this chapter would posthumous reproduction in the circumstances of the Israeli teenager be permitted: the Uniform Anatomical Gift Act. Under the act, either an emancipated minor or a minor who is old enough to apply for a driver’s license may make a gift of cadaveric tissue or refuse to make such a cadaveric gift (National Conference of Commissioners on Uniform State Laws 2006). According to the Christy case, the gift of reproductive material is not different from other gifts of organs or tissue (Spielman 2009). Even when a minor has made a refusal to donate, parents may donate upon the minor’s death (National Conference of Commissioners on Uniform State Laws 2006). Under the ABA’s Model Act, reproductive material may not be collected from incompetent individuals; this would include minors (American Bar Association 2008). The ASRM’s guidelines on posthumous reproduction assume that only couples – not minors – will be involved (American Society for Reproductive Medicine 2004). The society’s guidelines addressing living gamete donors state that programs should not allow minors to participate as gamete donors (Ethics Committee of the American Society for Reproductive Medicine 2003). Because free and informed consent is a fundamental principle of Canada’s Assisted Human Reproduction Act, minors who are not capable of informed consent cannot be used as sources of reproductive material (Manseau 2007). ESHRE recommends that posthumous reproduction be in the context of a couple’s “parental project”; presumably, such couples would not be minors. (Pennings et al. 2006). The Israeli attorney general’s guidelines, which were overruled in the case of this Israeli teenager, allow sperm retrieval from a male adult who is part of a couple, but do not speak to sperm retrieval from minors (Ravitsky 2004). (A related, complex set of questions arises about the use of fetuses, but it will not be addressed here.)

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24.3 Requesters of retrieval Questions about those who request retrieval of reproductive material are important because the requester may be in a position to put a dying source at risk for the sake of another’s reproductive wishes. (The term surrogate can be confusing in the context of posthumous ART. It may mean the person who makes health care decisions for a patient source who is incapable of making decisions near the end of life, it may mean a woman who is a gestational surrogate, or it may mean the person who requests retrieval reproductive material from the source. To avoid confusion, the term “requester of retrieval,” rather than surrogate, will be used when referring here to the person who requests retrieval of reproductive material from the source.) To the extent requesters replicate the dead or dying person’s wishes, they respect the dead and dying, but to the extent they represent only their own or a third party’s preferences (such as when they desire a souvenir child or grandchild), they may hasten death or harm the interests of the dead. Questions about requesters’ knowledge, interests, and desires could be raised in circumstances such as the following: In 2010, the husband and parents of a 36-year-old woman with anoxic brain injury stated that the woman would have wanted oocyte retrieval and posthumous reproduction. However; there was no other evidence that the woman would have wanted to reproductive posthumously, and she had not appointed a power of attorney for health care. Physicians thought that it might not be possible to keep her alive for the ovarian hyperstimulation, and that retrieving the oocytes would increase her risk for brain herniation and possibly hasten her death. The team did not offer the procedure. The patient was extubated and died shortly afterward (Greer et al. 2010). In this particular case, one might ask, if consent to retrieval was not given by the woman of the reproductive material during life, how much knowledge of the deceased’s preferences must the requester have in order to authorize retrieval of reproductive material? May the requester ever disregard the known preferences of the deceased? What conflicts of interest may requesters have in posthumous reproductive cases that surrogates in other kinds of decision making do not have? Should a requester’s desire for a future child or grandchild be regarded as a conflict of interest? May a request to retrieve oocytes from a dying female be honored if procedures necessary for retrieval could hasten her death (Greer et al. 2010)? In the circumstances described above, none of the guidelines would require that the family’s request be honored, and some would prohibit doing so. Under the Uniform Anatomical Gift Act, an individual who is acting as the patient’s agent (such as a power of attorney for health care decisions) may make a gift that becomes effective upon the patient’s death. But since the woman had not appointed a power of attorney for health care, neither her parents nor her husband, who were making medical decisions for her, could, while she was dying, authorize retrieval (to take effect after her death). As medical decision makers without power of attorney, they could authorize the medical procedures necessary for retrieval, but since those procedures could hasten death, her physicians would – as they did – be expected to decline (National Conference of Commissioners on Uniform State Laws 2006). The ABA’s Model Act states that only a fiduciary with express authorization to consent to postmortem retrieval may do so, and no one was such a fiduciary in this case (American Bar Association 2008). The ASRM states that a request for retrieval need not be honored without express consent or the

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known wishes of the dead (American Society for Reproductive Medicine 2004b). Under Canada’s Assisted Human Reproduction Act, no one other than the source may consent to retrieval from the source (Manseau 2007). Under the recommendations of ESHRE’s Task Force on Ethics and Law, only the source may authorize retrieval (Pennings et al. 2006). Finally, the Israeli attorney general’s guidelines do not speak to the circumstances of this case (Ravitsky 2004).

24.4 Reproductive partners Questions about partners or collaborators in reproduction are ethically important because they touch on notions about family, boundaries between families and other groups, fairness, and nondiscrimination. These questions include the following: Is it necessary for the requester of retrieval of reproductive materials to have in mind any particular partner or time frame for use? Should any restrictions on possible partners, such as gender, sexual orientation, race, or religion, be permitted or encouraged? Should a proposed recipient of human reproductive materials have a particular relationship to the deceased and the deceased’s plans to reproduce, or is a stranger who contracts for reproductive materials or services sufficient? If an embryo is preserved and one source of reproductive materials dies, what presumptions should hold about use by the other partner? By others? Some of these questions came to the fore in the following case. In 2010, a high-profile transgender activist in the United States announced that she had begun the medical-interview process for a uterine organ transplant. Several years earlier, the hospital where she hoped to receive the transplant had reported human uterus retrieval from a multiorgan cadaveric donor. The woman hoped to become the world’s first transgender woman to give birth (Baker 2010). Applying guidelines to a socially and technically complex case such as this is difficult because it is a situation not clearly anticipated by drafters. Under the Uniform Anatomical Gift Act, anatomical gifts (including, according to the Christy case, reproductive material such as a uterus) may be directed to any individual designated by the person making the gift; the act does not limit the class of recipients to those with whom the decedent intended to reproduce, or to those with whom the decedent might not object to reproducing (National Conference of Commissioners on Uniform State Laws 2006). The ABA’s Model Act states that live participants (in this case, the potential embryo donors) should execute an agreement spelling out the intended use and disposition of embryos in the event of divorce, illness, or death, as well as the circumstances in which embryos shall be deemed abandoned (American Bar Association 2008). Those intended uses might include experimental uses (such as uterine transplants) but are not likely, at least currently, to specifically include or exclude transgender persons. The ASRM’s Ethical Guidelines on Family Members as Gamete Donors and Surrogates prohibits each of the following donations: brother to sister, sister to sister-in-law (brother’s wife), father to daughter, and maternal or paternal aunt to infertile wife of nephew (Ethics Committee of the American Society for Reproductive Medicine 2003). It is difficult to say with any certainty how those guidelines could best be applied in this case. The report of ESHRE’s Task Force on Ethics and Law, which states that the reproductive partner must be part of a couple, would not permit posthumous use of sperm, eggs,

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embryos, or uterus in this case (Pennings et al. 2006). The Israeli attorney general’s guidelines state that the reproductive partner must be the female member of a couple; therefore, posthumous use of ART would not be permitted in this case (Ravitsky 2004).

24.5 Children Questions about the children produced by means of postmortem ART are important because of concepts of parental responsibility, and the principles of beneficence, nonmaleficence, and justice. Children who are born decades after both genetic parents are dead may feel orphaned and suffer some harm, although this has yet to demonstrated empirically. Children who are legally prevented from receiving an inheritance are financially disadvantaged, while other potential heirs would be disadvantaged if estates were to be kept open indefinitely because human reproductive material from their parents remained preserved. Questions that arise about the children produced through posthumous use of ART include the following: Should there be a time limit on how long human reproductive material can be preserved? What should the time limit be? Should terms in wills such as “heirs” or “my children” be interpreted so as to include or to exclude posthumous children? Some of these questions arise in the following case: In 1996, a Tasmanian man died without a will. The man and his wife had participated in an in vitro fertilization program, which had resulted in the freezing of two fertilized ova. A Tasmanian court held that the zygotes would become children of the deceased only upon being born alive (Law Reform Commission 2007). Attempting to apply guidelines to this set of facts does not produce a consistent result. The Uniform Anatomical Gift Act does not speak to issues of parentage and inheritance (National Conference of Commissioners on Uniform State Laws 2006). Under the ABA’s Model Act, the deceased man would not ever be a parent of the resulting children. The Model Act states, “Except as otherwise provided in the enacting jurisdiction’s probate code, if an individual who consented in a record to be a parent by assisted reproduction dies before placement of eggs, sperm, or embryos, the deceased individual is not a parent of the resulting child unless the deceased spouse consented in a record that if assisted reproduction were to occur after death, the deceased individual would be a parent of the child.” Neither the ASRM nor Canada’s Assisted Human Reproduction Act addresses these issues. Under ESHRE guidelines, “a child that is born after the death of a parent (i) (would be) recognized as the child of that person, and (ii) inheritance rights (would be) secured.” But the posthumous children would have to be born within a maximum period of five years (Pennings et al. 2006). The Israeli attorney general’s guidelines instruct the state to register the child legally as a child of the deceased father (Ravitsky 2004).

24.6 Summary The distinctive legal and ethical issues that arise in posthumous use of ART are a moving target; they change as technological and social possibilities change. Among the groups surveyed above, all of whom permit posthumous ART in some cases, there is a developing consensus about two issues: First, explicit, specific consent to posthumous reproduction should be given during the life of the source of the reproductive material.

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Second, there is weak consensus that unless the deceased has specified otherwise, some restrictions should be in place for use of reproductive materials by reproductive partners other than the deceased’s partner during life. Whether that consensus will hold as reproductive use of cadaveric uteruses becomes medically possible is uncertain, and will depend on whether the norms for retrieving reproductive materials for ART use evolve into the norms for retrieving cadaveric organ and tissues. In jurisdictions where posthumous ART is permitted, it is a challenge for judges and legislators to harmonize laws governing posthumous ART with those governing end-oflife care for sources, organ and tissue donation, family law, and law governing parentage and inheritance, so that clinicians, donors, patients, intended parents, and resulting children and their siblings are less frequently caught in situations fraught with legal uncertainty. Similarly, a challenge for ethical traditions that accept posthumous ART is to develop a sound and coherent view of posthumous ART in the context of issues related to end-of-life care, organ and tissue donation, families, parentage, and heritage.

References American Bar Association. Section of Family Law Committee on Assisted Reproductive Technology and Genetics, Model Act Governing Assisted Reproductive Technology. 2008. http://apps.americanbar.org/family/committees/artmodelact.pdf. Baker R. Trans woman seeks uterine transplant. 2010. http://www.dallasvoice.com/transwoman-seeks-uterine-transplant-1020293.html. Accessed August 31, 2010. Ethics Committee of the American Society for Reproductive Medicine. Family members as gamete donors and surrogates. Fertil Steril. 2003;80(5):1124–1130. Greer DM, Styer AK, Toth TL, Kindregan CP, Romero JM. Case 21–2010: A request for retrieval of oocytes from a 36-year-old woman with anoxic brain injury. N Engl J Med. 2010;363:276–83. Manseau F. Assisted Human Reproduction Act. Canada Gazette 2007;141:13. National Conference of Commissioners on Uniform State Laws. Revised Uniform Anatomical Gift Act, 2006. http://www.law.upenn.edu/bll/archives/ulc/uaga/2009final.htm. Law Reform Commission. NSW Government Lawlink, Report 116. 2007. http://www.lawlink. nsw.gov.au/lawlink/lrc/ll_lrc.nsf/pages/LRC_r116toc. Accessed August 31, 2010. Pennings G, DeWert F, Shenfield JC, et al. European Society for Human Reproduction and Embryology Task Force on Ethics and Law 11: Posthumous assisted reproduction. Hum Reprod. 2006;21:12:3050–3053. Ravitsky V. Posthumous reproduction guidelines in Israel. Hastings Cent Rep. 2004;34:2:6–7. Spielman BJ. Pushing the dead into the next reproductive frontier: post mortem gamete retrieval under the Uniform Anatomical Gift Act. J Law Med Ethics. 2009;37:331–340. Weiss R. Babies in limbo: laws outpaced by fertility advances. 1998. http://www.washington post.com/wp-srv/national/science/ethical/fertility1.htm. Accessed August 31, 2010. Zarchin T. Court orders deceased teen’s sperm saved for posthumous conception. 2009. http:// www.haaretz.com/news/court-orders-deceased-teen-s-sperm-saved-for-posthumousconception-1.278098. Accessed August 31, 2010.

25 Human reproductive cloning: ethical perspectives David A. Jensen 25.1 Introduction Two developments in recent decades have made the possibility of human reproductive cloning (HRC) a matter of serious thought. One is the dramatic progress in assisted reproductive technologies (ARTs) such as in vitro fertilization (IVF), fertility drugs, and fetal therapies. The other was the first, and unexpected, cloning of a mammal, a sheep named Dolly, by Ian Wilmut in 1996. Together, these developments have raised the possibility of HRC, cloning for the sake of producing a child that will, in principle, grow into adulthood as a normal member of society. HRC is to be distinguished from therapeutic cloning and cloning with research aims. Therapeutic human cloning involves human cloning in order to produce some new product, treatment, or technique. Producing a clone for the sake of harvesting organs would be such a case. Human cloning with research aims would involve cloning for the sake of furthering our knowledge, such as producing a series of cloned embryos in order to understand the influence of different environments on embryos with identical genetic make-ups. My concern in this chapter is with the ethics of HRC, the extent to which we should regard HRC as either morally problematic or morally permissible. I will argue that given its likely uses, the prospects for the ethical justification of HRC are dim, and therefore we should conclude that HRC is prima facie morally wrong. I will begin in section 2 by surveying the reasons in favor of HRC. In doing this, I will consider its potential value in three contexts: to society as a whole, to families, and to individuals who are products of HRC. I conclude that its likely potential for value is only in the context of the family. In section 3, I will consider the ethical concerns with HRC from both deontological and consequentialist perspectives, two of the major ways of framing our ethical intuitions. In section 4, I will argue on the basis of these considerations from sections 2 and 3 that we should conclude that HRC is prima facie morally wrong. I will consider as well possible responses based on both deontological and consequentialist grounds.

25.2 The potential value of HRC Ethical debate and discussion is typically concerned with matters of right and wrong, good and bad. More broadly, however, ethics concerns those things that are of fundamental human value, and hence bears on broad questions of how we should live our lives and how we should structure our society. Inasmuch as we think of procreation – including the rearing of children in families – as one of those things of fundamental value, the aim of HRC seems immediately pertinent to ethical matters. How, then, might HRC, as a kind of procreation, contribute to those things of fundamental value? We can consider three areas of potential value: its value to society as a whole, to families in particular, and to the individuals who are products of HRC. The value of HRC to society as a whole does not look promising. One might think that cloning would allow the replication of people of great talent, genius, or leadership. Surely, our society would benefit from an increased number of such people. A primary

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concern with this sort of motive, however, involves the influence of genetic make-up on the outcomes of a life. While it is undeniable that genetic make-up influences, if not enables, the achievements of an individual life, it is hardly any guarantee of such outcomes. Thus, a clone of Albert Einstein, while perhaps having exceptional intellectual abilities, will not necessarily make great scientific discoveries. The problem is not only that having these abilities does not guarantee significant outcomes but also that a given individual may not choose such a course of action. With all the possibilities to pursue in one’s life – especially for one who lives in a society technologically advanced enough for HRC – it is likely that interests will diverge. Further, the pressures of being an Einstein (in some literal sense), of being created to serve a societal need or desire, would likely be a significant emotional or psychological burden on the individual. This would not only count against the ethical propriety of HRC but would also seem to render even more unlikely the result that the clone child would produce great achievements of benefit to society. One might also think that HRC could be of value to society through the replication of stronger humans. In lieu of natural procreation, we might implement procreation through HRC to avoid diseases and defects otherwise propagated by natural procreation. Additionally, such a method could be used to promote more desirable traits among the human population. If this is pursued in a coercive manner – those with flawed genetic make-ups may not procreate naturally – it would obviously be problematic. Likewise, it would be problematic if used to promote racial or cultural cleansing of any sort. However, even if it were pursued noncoercively and without immoral aims – it is offered, for example, as an option to parents when one of them carries a serious genetic disease – it still seems unlikely that it would have much success. Consider two parents, one of whom has a genetic problem that he or she wishes to not pass on. If the parent without the genetic problem is cloned, the other parent will lose the genetic relationship with the child. Such a result may be preferable, for the parents in question, to natural procreation and passing on the disease. However, a child genetically related to the parent without the genetic problem could be obtained by either sperm or egg donation, and without the odd result of having a child that is genetically a twin to one of its parents. This is not to claim that some would not prefer HRC to sperm or egg donation: Some parents might wish to have a child that is genetically related without having genetic material from outside of the parents. But with regard to societal value, this sort of scenario presents two problems. One, it does not seem like enough people would be interested in this option (over already practiced methods of sperm and egg donation) to make a societal impact; thus it would not be of value to society as a whole. Two, because the problem of sterility can already be solved by sperm or egg donation (not to mention adoption), this does not constitute a unique benefit to society on the part of HRC, though it may present a unique benefit to the parent or parents who desire a child without outside genetic material. In sum, given the ethical sensibilities of our modern societies, and the realities of genetic make-up, HRC does not look to hold significant value for society as a whole. A radical change in our societal needs or aims might change this, but such changes do not seem likely in either the near or distant future. A second and more promising area of potential value is to the family. Since procreation and the rearing of children occur, almost without exception, in biological family units, what value might HRC hold for a family? There appear to be two reasons an

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individual or couple might procreate through HRC: Either one cannot procreate through normal means. or one does not wish to do so. The first case applies to a sterile individual or couple that wishes to have a genetically related child. Of course, the result of HRC is not the normal product of natural procreation or even other ARTs, because the child is not a genetically related though a unique individual; rather, the child is a genetically related and genetically identical individual. The second case – where one does not wish to procreate through normal means – applies to three situations: an individual who wishes to procreate without a partner and without outside genetic material, a same-gender couple that wishes to have a biologically related child without introducing outside genetic material, and a heterosexual couple in which one member is sterile or carries a significant genetic disease and that wishes to reproduce without introducing outside genetic material. Notably, all these situations have other means of obtaining children: adoption, or sperm or egg donation. Thus, for anyone in these situations motivated by HRC, the value the person attributes to HRC must lie in being genetically related in a way that excludes genetic material from outside of the parent or parents. Although HRC does exclude outside genetic material, and in this respect it does replicate natural procreation, it of course does not replicate it exactly, since the child is a clone and not a unique combination of the parents. In natural procreation, the child is both related to the parents and unique; one who seeks a child by HRC necessarily gives up the latter characteristic of natural procreation. What other values might HRC offer to the family? Because adoptions are often hard to come by, some might think that HRC is the best way to get a child for those who are reproductively challenged. The problem with this motive for HRC is that obtaining male genetic material for a woman who wishes to reproduce is fairly easy. For a male who wishes to reproduce, HRC requires an egg and a surrogate as much as procreation through IVF. Thus, to the extent that the difficulty of adoption is a motive for HRC, it would be a motive only if current methods of sperm or egg donation and surrogacy are undesirable. This would obtain only if the person wants a genetically related child without outside genetic material. Thus, the difficulty of adoption as a reason for HRC comes back to the previous reason for HRC: the desire for a genetically related child without outside genetic material. Could HRC be valuable to families in the case of recreating a lost child? The obvious problem is that this motive is based on the misconception that we are genetically determined. Of course, a parent who has lost a child may recognize this fact but still desire to recreate as much of the lost child as possible by HRC. After all, it is not uncommon for parents who lose a child to have another child through natural procreation to fill the emptiness they feel as a result of the loss of the child. Why not go a step further and genetically reproduce the lost child? The concern here is that the parent will think about the replacement child in terms of the lost child. Indeed, the motive of the parent in this case is not to fill the emptiness of a lost child with a new child but to fill it with the same child as much as possible. This problem of expectations will be discussed in section 3, and it is particularly acute in this case. In the case of the reproductively challenged couple that desires a genetically related child without outside genetic material, we can at least grant that their primary motive is not to create a clone. But this is the motive of the parent of the lost child, and hence the harm that may come from this – from a parent’s having a set of expectations based on his or her knowledge of the individual who is cloned – will be more pronounced than in cases in which this is not the motive.

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In sum, inasmuch as biological families are valuable and HRC provides some sort of biologically related family where it might otherwise not be possible, there is some potential value here for HRC. Notably, it is the sterile person or sterile couple that has the strongest case. They have no means of having genetically related children. Couples in which one of the persons could reproduce normally – even if not with the other, since the partners are of the same gender or one member is sterile – have less of a case on this basis. Finally, what value might cloning hold to the individual? Might we say of someone, for example, that she is very fortunate to be a clone of one of her parents rather than inheriting a disease from the other parent? Or, might we say, of someone, that he is fortunate to be a clone of one of his parents rather than to be adopted and not genetically related to either of them? It seems to me that we cannot say either of these things, and that we must conclude that HRC does not hold value for the individual. The problem is that HRC is an act of creation, not a technique applied to something that is already created. Thus, we cannot talk about its benefit to an individual, since that would assume that there is already an individual, at the time of creation by HRC, with an alternate way of being. Consider, by contrast, a growing fetus with a severely disabling defect. The only way to prevent this defect is to apply a therapy that will render the child a clone of one of the parents. Here would be a case where we could say that HRC brought about a benefit to the child, since we can meaningfully speak about what would have otherwise been. But this is a case in which the child already exists, and therefore a case in which the child could have been other than it is (had the therapy not been applied). Unless we have some view of preembodied existence, we cannot talk this way with regard to HRC. Further, this would require not only a view that we existed prior to embodiment but one that we were, so to speak, assigned to our parents. Thus, when one’s parents choose to reproduce through HRC as opposed to natural means, one’s future would be changed. In sum, HRC does not seem to offer much value to the individual. One objection might be raised at this point: One might think that HRC is of value to those who desire to reproduce in this manner, whatever their reason. Alternatively, one could say that their desire to so reproduce is their reason. This sort of reasoning presents at least two problems: First, that one desires to do something is not enough to render it good to do, valuable, justified, or something one has a reason to do. For one thing, there are obvious counterexamples to this kind of reasoning. For another, we can always ask of people who justify their action by the fact that they desire to (or want to), why, in fact, do they desire to so act? If his answer to that question is not satisfactory, we need not recognize the desire as constituting a reason: Desires present no automatic reason-generating force. Second, in this chapter I am considering considerations for or against HRC on the basis of things generally recognized to be of value. We generally recognize, for example, that healthy individuals are valuable to society; hence, it is thought that HRC might be of value in this manner. Likewise, we recognize that having genetically related children is of value; hence, we see in HRC a potential for value to the family. Therefore, unless one’s motive for HRC can be connected to things of value, the motive of mere desiring to procreate through HRC does not hold much weight. In certain legal contexts, it may be important, but as an ethical or rational justification, it is weak.

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25.3 Ethical concerns with HRC I have argued in the previous section that the only likely area of value for HRC is to a family or potential family. By “potential family,” I mean to include a person who, by himself or herself, wants to have a child and thus have a family. If there should be significant and widespread changes in our societal needs and aims, perhaps there would be potential for additional value (societal value, individual value) to HRC, but at present, this potential is very distant. Further, although the only likely value for HRC is found in the family unit, HRC may by morally problematic with regard to individuals – clone children, in particular – or to society as a whole; thus, the matter of its moral permissibility is more broad than the context of the family. In considering its moral permissibility, I will primarily review arguments that oppose HRC. This approach is justified by the fact that procreation for familial purposes is prima facie morally justified; thus, the moral conclusions we draw about HRC – as one type of procreation – will largely depend on whether we can find adequate arguments against it. Alternatively, the justification of the moral permissibility of HRC appears to lie largely in the ability to refute arguments against it. Because the distinction between deontological and consequential ethical considerations best reflects our intuitions about morality, I will consider HRC in both of these frameworks. I understand deontological ethical considerations as considerations that do not directly depend on the consequences or outcomes of an action for their moral value. Talk of moral rights, for example, is included in this category, as is typically the moral theory of Immanuel Kant. From a deontological point of view, a number of arguments have been raised against HRC. One kind is that HRC violates a person’s fundamental moral standing. This is stated in a variety of ways: HRC violates our dignity, treats the cloned child as a mere means, not as an end in itself, or violates our autonomy. All these distinctions have origins in the enormously influential ethical theory of Kant, and the language of Kant’s theories has so infused our ethical thinking that many people use the terms without any notion of their Kantian origins. This fact points to the very problem of such arguments: These terms have become so widespread as to become almost useless for moral argument. Thus, it is readily agreed that human rational creatures have dignity – that is, a moral standing that prima facie cannot be violated. But what does this amount to? Perhaps it follows from one’s having dignity that one may procreate in whatever manner one sees fit. Or, perhaps it follows from our having dignity that one may not procreate by HRC, since the latter violates the dignity of the clone child. Either claim is plausible when framed merely using the language of dignity. The same holds for the other characterizations: Does my autonomy make my procreating by HRC morally justified, or does giving a child a nonrandom genetic make-up, unlike what is normally done in procreation, which is a violation of its autonomy? To make any of these claims in terms of broad deontological distinctions such as dignity is more appropriate for stating the conclusion of a moral argument; these distinctions are not adequate starting points for making such arguments (Tannert 2007). Another kind of similarly vague argument is that HRC is the expression of inherently immoral motives: It is an expression of arrogance, trying to play God, or some sort of grotesque desire. The problem with these claims, or their variants, is that these motives do not seem to have any necessary connection with the rightness or wrongness of an act. That one might be arrogant in a pursuit does not make it amoral. Indeed, the person

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who wishes to procreate by HRC to have a child just like him or her may be arrogant, but normal procreation shares this same characteristic already to an extent: We value having genetically related children, children that are like us. Indeed, the vast amounts of money reproductively challenged persons spend on IVF is aimed at producing just this result. As for playing God, arguably, all our attempts at healing, natural procreation, and so forth could be so characterized. As with claims in terms of dignity, these claims are too vague to make for useful arguments against HRC. That the desire to procreate through HRC is wrong because it is grotesque (or disgusting, repugnant, etc.) appears ultimately to beg the question. For one thing, many things that are gross or repellent are nevertheless good. As Gillon (Gillon 1999) points out with regard to HRC, “Doctors, especially surgeons, cut people up quite a lot; they (we) also stick their fingers in people’s bottoms. Most of us, I imagine, would feel quite deeply that both of those activities are rather disgusting and not to be done; yet we know, through thought and reflection in our medical studies, that we had better overcome these deep feelings because in some circumstances it is right to cut people and in some circumstances it is right to put our fingers in people’s bottoms” (Gillon 1999, 4). So, to maintain that HRC is wrong because it is grotesque, one must mean by grotesque something like moral grotesqueness. I suspect that this is exactly what many may mean. But that HRC is morally grotesque is just what needs to be argued; hence the claim, by itself, begs the question. One grotesque-style argument, however, deserves special note. Kass has argued that HRC offends us at our deepest level and that we ought to reject it outright (Kass 1998). He characterizes this as an instance of the “wisdom of repugnance.” Straightforwardly, this appears to be a sort of grotesque-style argument: The thought of HRC is something we deeply and intuitive find repugnant and so ought to reject. But Kass’s point, even if not explicitly made, seems more sophisticated – namely, all moral argument has to start from the assumption of things that are valuable and things that are lacking in value. This is, it turns out, an instance of a general fact about all argument and any theory building: They must have starting points. Thus, claims Kass, the revulsion we feel toward HRC is an instance of the same sort of revulsion we feel toward cannibalism, incest, or bestiality (Kass 1998). These kinds of moral wrong are so deeply incorporated into our conception of wrongness that we cannot entirely articulate an argument for their wrongness, nor need we. While I will not pursue this line of argument directly, it is true that all argument about instances of right and wrong ultimately depends on some sort of appeal to starting points, and thus Kass makes a point that is not as easily dismissed as Gillon and others have suggested. A third sort of deontological concern is that it violates some moral right of the child, some sort of particular thing of value we think all persons deserve. In particular, it has been suggested that it violates a right to an open future, a right to personal identity, a right to one’s unique genetic make-up, and so forth (Feinberg 1980; Brock 1998). All these claims share an essential similarity: There is something valuable about having a unique genetic make-up, and HRC deprives the child of this. So, for example, it is argued that to produce a clone is to give the child a life that has already been lived – or, more precisely, a genetic make-up that has already been played out. Or, the argument is raised that to be raised by a parent who is one’s twin will amount to being raised by someone with inappropriate expectations – hence, the lack of openness – given their knowledge of one’s genetically based qualities. Two general responses to this have been made by proponents of HRC: One, the significance of these purported rights depends

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on accepting genetic determinism, something that is false. Two, the existence of such a moral right would conflict with the existence of identical twins, and so we cannot have such a right (Harris 1998). Both of these responses are relevant, but they are not good objections. While it is true that we are not determined by our genetic make-up, it strongly influences our lives and our personal identities. One of the most important and most evident ways in which this occurs is in our looks: People sharing the same genetic make-up will largely share the same look. Genetic make-up also contributes to our various abilities, and hence limit and enable what we can and cannot do in our lives. Thus, while a person who shares the same genetic make-up as a parent is not determined to live the same life, he or she will certainly share similar abilities and characteristics. Is this sharing enough to compromise a right to an open future, or personal identity? This is hard to say, but the fact that most people would object, we can assume, to having their DNA stolen and replicated in a new person is evidence that we think genetic make-up is important to personal identity. We might suppose, in contrast, that someone steals my DNA and creates a clone of me who lives in a foreign country and does not become famous or widely known. That would appear to have little effect on either my or the clone’s personal identity, our feelings of an open future, and so forth. While this may be true, it is certainly not true with someone I live with and am the parent of. Thus, the claim that HRC may violate a right to personal identity, or a right to an open future, does not depend on accepting genetic determinism; it depends only on the very reasonable view that genetic make-up is important to who we are, who we can become, how we think about ourselves, and how we think about and relate to our parents. With regard to having a right to an open future or a personal identity, it is claimed that we cannot have such a right given the existence of identical twins – and that in fact, if it were a right, one of each set of identical twins would have to be killed (Gillon 1999). This objection involves two obvious problems with how it conceives of rights: First, even if twins violate one another’s right to personal identity, it does not follow that one can or must be killed. I may violate a person’s property rights by setting up a tent on her front lawn, but this does not mean this person can kill me to right the violation. Rights violations have never been taken to justify any means to undo or remedy the violation. Second, it is not possible for nonrational events to cause rights violations. So, for example, when a swimmer is attacked by a shark and killed, that shark does not violate the person’s right to life. Nor are one’s property rights violated when an avalanche falls on and destroys one’s house. Sharks and avalanches are not part of the moral realm; they do not make rational choices. If someone caused the avalanche intentionally, in contrast, then that person (though still not the avalanche) might have violated one’s property rights. Twinning that occurs naturally, and not as the result of some intentional choice, therefore does not produce rights violations. (Intentional twinning, made more possible with some ARTs, might, however, conflict with a right to an open future, personal identity, or unique genetic make-up.) This matter of a right to a unique genetic make-up – and the associated open future and personal identity – seems to be the strongest deontological point against HRC, and it is something I will return to in the next section. Its significance is supported by HRC itself. That is, we do value our unique genetically based identity, and this is the motive for HRC in the first place: One wants a child that is like oneself genetically and not like another.

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Turning to consequentialist ethical considerations, I understand these as morally relevant considerations based on the outcomes or effects of an action. An action that promotes good or valuable outcomes would be a morally permissible action, and one that promotes bad outcomes would be morally impermissible. Although consequentialist thinking figures strongly in public policy and decision making, as an ethical consideration it is often thought to be subservient to deontological concerns. And, in fact, many consequentialists seek to give a theory of the good that, while based on consequences, essentially has the same result as a deontological theory (Mill 1906). In section 2, I considered the potential value of HRC to society, families, and individuals, and in so doing I was essentially considering the positive outcomes of HRC that might, at least prima facie, make it desirable. Now, we will consider negative aspects as well. As discussed, HRC does not appear to provide significant positive outcomes for society as a whole apart from the fact that it may help families or individuals in society. What about negative outcomes? One negative outcome to society might be, as some suggest, that the practice hurts society since it portrays life as manufactured, and so will lessen our respect for life. IVF has been accused of doing the same thing – I believe incorrectly – and is often thought to be a counterexample to this claim against HRC. Another problem is that the manufacturing claim risks beg the question: It lessens our respect for life only if we think the practice is wrong. So this cannot be a ground for moral wrongness. In addition, it is notoriously difficult to draw the line between the concepts of natural and unnatural or manufactured in some way that is useful in moral argument. That said, it is true that children who are clones of parents do not occur without dramatic technological intervention. While IVF might be said to manufacture the normal product of natural procreation, HRC does not. HRC produces something entirely new. As discussed in section 2, HRC appears to have some potential value to the family: It allows reproductively challenged persons to have a child that is genetically related to them. The question is whether this has negative outcomes. If it has negative outcomes for the parents who choose to use HRC, these may not figure strongly in an argument against HRC, since the parents have knowingly chosen to undertake HRC. In general, willingly accepting hardships for oneself by a certain course of action overrides the extent to which those hardships contribute to the moral wrongness of the action. For example, if I choose a career that will be very difficult for me to succeed at but that I really want to do despite the hardship, we will not regard my choice as morally wrong, though it is perhaps unwise. However, since the clone child who is a product of HRC does not choose to be a product of HRC, the potentially negative outcomes to the child will count against the moral permissibility of HRC. In light of this, whatever morally relevant negative outcomes HRC will have to the family will occur through the individual clone child, thus, we will turn to negative outcomes of HRC for the individual. Two sorts of concerns are relevant to the individual. One is the concern of living a life that has already been lived, lacking a distinct personal identity, or lacking an open future. These were considered previously in terms of rights of the child that are violated by HRC; here, we consider them merely as potential harms to the child. Thus, even if it were true that children lack a right to an open future, it is surely a good thing to have, and so actions that inhibit a child’s having an open future would potentially be wrong. Further, even if a child’s being raised by a parent-twin were not to compromise the child’s personal identity, if the child believes that it does, and this

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belief causes the child harm, this would count as a morally relevant harm. While we may require adults to be rational – and so adults are responsible for distinguishing genuine harms from merely perceived harms – the same demand cannot necessarily be made of children, and therefore we must take into account their misunderstandings. The second concern to the individual stems from the clone child’s living in a strange relationship, that of being the sibling to his parent (and parent to his siblings?). In this respect, HRC recreates a situation similar to cases of incest, where, for example, a daughter, through her father, bears a child-sibling. The wrongness of incest does not seem merely to be about the sexual intercourse: a father and daughter that procreate through IVF seems similarly disconcerting for the child who is the product of and is raised by such a couple. Admittedly, it is hard to say what it would be like to be a clone of one’s parent, since it has never occurred. Will such a child’s sense of identity really be compromised? Will the child, in fact, be harmed by having a twin-parent? Some will point to the case of identical twins as evidence that HRC will not produce harms, but there are two significant differences in these cases. First, one twin is not the parent to the other; there is an equality between the two, not a subordinate relationship. Second, twins live their lives together, not one before the other. Thus, to the extent that children discover and develop their abilities, and their identities, as they grow into adulthood, both twins experience this anew and individually. Some have presented a sort of a priori argument to dismiss the possibility of harms to a clone child Gillon 1999). The argument runs essentially as follows: The alternative to being a clone is to not exist, and whatever disadvantages may come from being a clone, they are not worse than not existing. Therefore, the disadvantages of being a clone cannot count as harms. But this argument is clearly problematic because we cannot make comparisons with nonexistence. As noted in section 2, if a child were to die unless it received a treatment that rendered it a clone of its parent, we could say that it would be better to be alive and a clone than to be dead. However, this is a case of comparing an existing child with that same child under different circumstances. By contrast, we cannot compare an existing person with a nonexisting person; we cannot make sense of what it would be like to not exist. As noted in section 2, this sort of argument would require something like a theory of preembodied existence with assignment to parents. We could then say of a clone child that she had the option of being born a clone or remaining an unembodied existent. With a further theory of what it is to be an unembodied existent (with potential for human embodiment), we could then draw a conclusion about whether it would be better to be a clone. This is not to deny that we can harm future people. This is a complex topic, but a few examples will suffice to ground the intuitive position: Suppose I poison some baby formula weeks before a particular child is conceived. Once born, the child drinks the poisoned formula and becomes ill. Intuitively, I have harmed the child even though the child did not exist at the time of the act. The harm of a harmful act need not occur at the time of the act. Likewise, suppose we do consider HRC a harm to those children produced through it, and I poison a woman so that, unbeknownst to her, her future children will be clones of herself. When she has her first child, we will rightly consider that I have harmed the child by my poisoning act. This is separate from the fact that we cannot compare the child’s life as a clone with his not existing.

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25.4 HRC and the value of our unique genetic make-up It seems that from both a deontological and a consequentialist point of view, the strongest consideration against HRC is that it deprives the child of a unique genetic make-up, and in turn, a sense of personal identity and an open future. The value of these things is compromised not merely by the fact that it is a clone but also by the fact that it lives with and is parented by the person it is cloned from. Inasmuch as our personal identity is significantly influenced by our family relationships, this distortion of the genetic and social relations has potential for being problematic to a clone child. I note that whether the child has a moral right to a unique genetic make-up does not entirely matter: Having a unique genetic make-up is a valuable thing to have, so to deprive a child of it is to deprive it of something valuable. Supporting this view, ironically, is the very thing that is thought to be the strongest point in favor of HRC: the desire of the parent to have a child that is genetically related. As I have argued elsewhere, this sort of consideration is self-defeating ( Jensen 2008). The argument goes essentially as follows: The person who reproduces by HRC values having a child that is genetically related and additionally, in some cases, not related to anyone else. But such procreation deprives the child of its unique genetic make-up. Unless it can be shown that a unique genetic make-up is not valuable, procreation by HRC is prima facie morally wrong. The proponent of HRC will thus argue that a unique genetic make-up is not valuable. But if so, then what is the value of reproduction through HRC? How can the proponent of HRC maintain justification of it? The fact that one desires to replicate by HRC as opposed to another means validates the very importance the proponent of HRC places on one’s unique genetic make-up, and so makes procreation by HRC morally wrong. The objection that the proponent of HRC values genetic relatedness and not genetic uniqueness does not resolve this problem for the proponent of HRC. In some sense, all humans are genetically related: We all share a vast amount of our genetic makeups. However, what makes me, for example, related to my children, and not to other humans – in the way we think of natural parent-child relationships – is the fact that I have a unique combination of characteristics I then share with my child but not with other humans. To value genetic relatedness is to value a certain genetic uniqueness that enables this relatedness. Thus, for a parent to value a child’s being genetically related to the parent and not to someone else is for that parent to value the parent’s own unique genetic make-up. In sum, the most ethically promising scenario for HRC is the reproductively challenged parent or parents that wish to procreate by HRC so as to have children that are genetically related. I have not made an argument that we should value genetic relatedness, but I recognize that we do. This motivates HRC, IVF, and other means of procreation and ARTs apart from adoption. At the same time, the most worrisome aspect of HRC is that the clone loses something valuable – perhaps something it has a right to: its unique genetic make-up. That this is valuable is confirmed by the very motive for HRC in the first place. Thus, I conclude that given the likely uses for HRC, it is ethically suspect, and therefore we ought to conclude that HRC is morally wrong. I will briefly mention two responses that might be made: One response, from a deontological point of view, is that people have a right to procreative autonomy. In

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virtue of this right, they may procreate in whichever manner they choose, including by HRC. Discussion of this right sometimes wavers between procreative autonomy as a political right and procreative autonomy as a moral right. Indeed, it may be the case that politically, we have a right to procreate however we choose. Thus, while it would be morally wrong for a terminally ill individual to procreate, knowing she will die soon after the birth and the child will be orphaned, one might nevertheless maintain that there should be no laws against her procreating in such a situation. My concern in this chapter, however, is with the ethics of HRC, not the legality, with what morally should be done, not what (legally) can be done. In terms of a moral right, it is difficult to think that one can have a right to do something that severely impairs another innocent being. Thus, if it is thought that HRC deprives the child of something of value, it would be difficult to accept the conclusion that a right to procreative autonomy makes such procreation morally permissible. This is not to say that we do not have some sort of moral right to procreative autonomy, only that it does not justify HRC. A second response, from a consequentialist point of view, may avoid some of the problems of HRC. If we were to clone certain individuals, and then adopt them out to families without revealing that they are clones, it seems to me that many of the problems of cloning could be overcome. For one thing, the clone child is not raised by a parent-sibling, is not continually faced by the person who is like it, and it does not even know that it is not genetically unique. If the child is cloned from someone who is dead and someone of little fame, the chance of the child discovering that it is a clone would be even less likely. Admittedly, it is not clear what benefit this sort of procreative strategy, given its limitations, would present for a society that would implement it. Nor does it satisfy the primary (justified) motive for HRC: the desire of a person to have and rear genetically related children. But if for some reason there were a need to, say, clone certain individuals for societal needs, some sort of system of adoption like this could perhaps alleviate the harms.

25.5 Conclusion To the extent that HRC is ethically justified, it must be shown to provide something of value. Indeed, the strongest justification for HRC is that if fulfills a need or desire to have genetically related children. Although I accept genetically related children as valuable, as most do, in some respects HRC doesn’t fulfill this need at all: It doesn’t produce a genetically related child in the way parents are normally interested in. Thus, it seems to me that interest in HRC is premature. Reproductively challenged parents ought not to look at HRC as a possibility; it disadvantages the child and frankly does not give the parents what they want: a unique but related child. However, the fact that we have become capable of cloning mammals does signal hope for continued progress in ARTs. The sort of technological advances that enable HRC might contribute to those that enable artificial gamete creation through a process of artificial meiosis. Like IVF, this kind of ART would involve significant technological intervention; however, like IVF, it would produce the same product as natural procreation, and so secure a greater chance at ethical justification.

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References Brock DW. Cloning human beings. In: Nussbaum M, Sunstein CR, eds. Facts and Fantasies about Human Cloning. New York: Norton; 1998:141−164. Feinberg J. A child’s right to an open future. In: Aiken W, ed. Whose Child? Totowa, NJ: Rowman & Littlefield; 1980:124−153. Gillon R. Human reproductive cloning. J R Soc Med. 1999;92:3−12. Harris J. Goodbye Dolly? J Med Ethics. 1997;23:353−360. Jensen DA. Abortion, embryonic stem cell research, and waste. Theor Med Bioeth. 2008;29,1:27−41. Kass LR. The wisdom of repugnance. Val U L Rev. 1998;32,2:679−705. Mill JS. Utilitarianism. 13th ed. Chicago: University of Chicago Press; 1906. Tannert C. The autonomy axiom and the cloning of humans. Hum Reprod Genet Ethics. 2007;13,1:4−7.

26 ART practice – religious views Joseph G. Schenker 26.1 Introduction It is important to those who practice reproductive techniques to learn about different religious perspectives related to reproductive-health problems. Religious groups are active in influencing the public with bioethical positions, and this is particularly evident with issues concerning procreation, abortion, and infertility therapy. Religion, concerned with affairs regarded as extraordinary and as having unique importance in life, is such an integral part of the texture of many cultures that it is not always easily isolated for separate analysis. The developments in reproductive medicine raise new ethical questions for different religions that do not always have clear answers. The role of theology in bioethics is foremost to clarify, for the different religious communities, the perceived attitudes toward these developments. At least three factors determine the influence of religious viewpoints: the size of the relevant community, the authority of the current viewpoints within the community, and the unanimity and diversity of opinion in the relevant community. The weight and authority of specific religious viewpoints will influence the number of adherents who draw on these views when considering public policy issues. At one extreme are communities that emphasize the importance of individual judgments. These include religious communities such as Baptists and evangelicals. At the other extreme are traditions with centralized teaching authorities, such as the Roman Catholic Church. In between are communities that formulate general policies at organized centralized meetings but that see these policies as reflections of current thinking rather than as authoritative teachings. These include the decisions of the General Convention of the Episcopalian Church, the General Assembly of the Presbyterian Church, and the General Conference of the United Methodist Church. Also in between are communities that emphasize the authority of leading religious scholars, while recognizing that these scholars may disagree. These include the Muslim and Jewish communities. The final factor to consider is the diversity of opinion in the relevant community. The greater the diversity of opinion, the less constrained individual infertile couples will feel when confronting choices about particular treatment decisions and the less the community in question will be able to influence public-policy decisions. It is often difficult to dissociate the influence of distinctly religious factors from other cultural conditions affecting women’s reproductive health. As medical knowledge about infertility has increased, the ethics of reproduction is no longer the concern solely of the religious authorities. When infertility was considered a predestined state, infertile couples were probably more influenced by religious interpretations. Religious commentators’ objections to some reproductive technology are still having much influence on either the decisions of infertile couples or on the attitudes of the general public. Public policy is likely to reflect secular, ethical, and legal concerns. Religious leaders in some countries still exert a powerful influence on the development and practice of reproductive technology. In some countries, religious groups’ main

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influence will stem from their direct influence on medical protocols. Therefore, it is important for practitioners in the field of reproductive medicine to understand attitudes toward reproduction that derive from different religions. According to the Web site Adherents.com, the numbers of adherents in the “Big Five” world religions are as follows: Judaism (14 million, 0.22%), Christianity (2.1 billion, 34%), Islam (1.5 billion, 24%), Hinduism (900 million, 14%), Buddhism (376 million, 6%) (Adherents.com 2007).

26.2 The Jewish law Halakha – the world is derived from the Hebrew root that means “to go or to walk” (Schenker and Halperin 1997) – is the collective body of Jewish religious law, including the biblical law (the 613 mitzvot, or commandments) and the later Talmudic and rabbinic law as customs and traditions. The Jewish religion is characterized by a strict association between the faith and practical religious rulings, occasionally classified as orthopraxia. In order to understand the Jewish cultural developments, it is essential to have a deep insight into the various components of the halakhic literature – the Jewish law. In principle, the halakhic literature is a composed of two divisions: 1. The Written Law 2. The Oral Law The foundation of the Written Law is the Torah – the first five books of the Scripture, which are the origin of authority. The Oral Law interprets and elucidates the written Torah and regulates new rules and customs. Its authority is derived from the written Torah (Schenker and Halperin 1997). Likewise, the authority of the poskim – the rabbinical scholars that represent the Oral Law toward the public – is derived from the Torah (Deut. 17:8–11). The oral Torah, including thousands of books, owes its name to the old prohibition to write its recollections (Babylonian Talmud. Gitin 60: b). This prohibition practically ended about 1700 years ago as a result of the difficulties caused by the suppressed Jewish liberty in Israel (Maimonides. Introduction to the Code). The dominant parts of the Oral Law are 1. 2. 3. 4.

the Mishnah. the Talmud. the post-Talmudic codes. the responsa.

26.2.1 Torah The foundation of the Written Law and the origin of authority is the Torah, the first five books of the Scripture. As stated above, the Written Law is defined as the origin of authority. This definition is derived from the ancient tradition and the belief concerning the original revelation on Mount Sinai, when God ascribed the Torah to Moses and to the Jewish people, the recipients.

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The Torah is not an ordinary text of law. It is an expression of God’s revelation, teaching and guidance for man. The attitude to the Torah is therefore as to a unique and holy divine text, which includes moral values as well as practical laws. The Oral Law interprets, expands and elucidates the written Torah and regulates new rules and customs. Its authority is derived from the written Torah.

26.2.2 The Mishnah This early textbook was compiled systematically by numerous scholars over a few centuries. Its final form was established early in the third century. The Mishnah includes early traditional and original interpretations of the written Torah, ancient regulations that are not written in the Torah, and post-biblical regulations. The Mishnah consists of six major section-orders that cover all aspects of human life: Zeraim (laws regarding agriculture), Moed (laws regarding holidays), Nashim (laws regarding women and family life), Nezikin (civil law), Kodashim (laws regarding the Temple), and Toharot (laws regarding ritual purity). Two of the orders, Nashim and Toharot, are relevant to Judaic family practices.

26.2.3 The Talmud For approximately three centuries after the final compilation of the Mishnah, the great interpreters studied the six orders to the Mishnah and wrote a monumental composition, the Talmud. The great interpreters (Amoraim) included within the Talmud commentaries and interpretative studies of the Mishnah and the Midrashim, or investigations, and established regulations and new customs. The Amoraim in Babylon composed the Babylonian Talmud, while the Amoraim in the Holy Land composed the Jerusalem, or Palestinian, Talmud. During the period of Jewish sovereignty in Judea, laws were made by the Sanhedrin, a body of 71 leaders gathered for this purpose, and by local courts with 23 judges. After the fall of the Second Temple, halakha became primarily the creation of rabbinic Judaism.

26.2.4 Post-Talmudic codes An enormous amount of Talmudic knowledge was essential for accurate ruling. These post-Talmudic codes were compiled with the intention of assisting access to the laws, regulations, and customs of the Talmudic halakha. Up to the 16th century, different scholars summarized and reviewed the halakhic conclusions of the Talmud in the post-Talmudic codes. Among the scholars were Rashi (1040–1105), Rabbi Moshe Ben Nachman (1195–1270), and Rabbi Menachem Ben Shlomo Hameiri (1249–1316). The most prominent post-Talmudic codes are the Sheilot, Halakhot, Maimonides, the Piskey Harosh, and the Shulchan Aruch.

26.2.5 Responsa The various attitudes of rabbinic scholars about the way halakha should be applied in a changing world is analyzed and discussed with regard to the legal codes. Throughout

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the ages, written opinion has been given by qualified authorities to questions about aspects of Jewish law. Responsa is a term usually confined to written replies given to questions on all aspects of Jewish law by qualified authorities from the time of the later Geonim to the present day. About 1,000 volumes, containing more than half a million separate responsa, have appeared in print. Contemporary rabbinic scholars deal with new problems that arise with the investigation and treatment of infertility. Thus, techniques as new as artificial insemination and in vitro fertilization (IVF) in humans are already the subject of numerous responsa. Moreover, the responsa of later rabbinic authorities are often short monographs in which every text remotely relevant to the point at issue is quoted or discussed. (Assisted reproduction techniques according to halakha will be discussed in a separated chapter in this volume.) Different groups have developed among Jews from ancient times and especially in the modern era. The Orthodox, Reform, and Conservative movements are the three major ones today. Orthodoxy is the only movement formally and legally recognized by Israel; Non-Orthodox movements have remained largely a feature of Judaism in the Diaspora.

26.2.6 Orthodox Judaism Orthodox Judaism is a formulation of Judaism that adheres to a relatively strict interpretation and application of the laws and ethics canonized in the Talmudic texts (the oral Torah) and subsequently developed and applied by the later authorities known as the Geonim, the Rishonim, and the Acharonim. Although Orthodox Jews are expected to observe all 613 mitzvot, certain core practices are generally considered essential to being Orthodox: • Refraining from murder, idolatry, and certain biblically prohibited sexual practices, such as adultery and incest, at the cost of life if necessary • Observing Shabbat, by refraining from activities that violate the Jewish Shabbat, and Jewish holidays • Practicing kashruth, the Jewish dietary laws • Following taharat hamishpacha, the laws of family purity, restricting sexual relations for a prescribed period around menstruation and after childbirth • Circumcision for males In Israel, because the orthodox rabbinate has an official position insofar as Jews are concerned, its Halakhic decrees are binding in religious matters.

26.2.7 Reform Judaism Reform Judaism, a religious movement that has modified or abandoned many traditional Jewish beliefs and practices in an effort to adapt Judaism to the modern world, originated in Germany in 1809 and spread to the United States in the 1840s under the leadership of Rabbi Isaac Mayer Wise. Reform gained ground with the children and grandchildren of these immigrants, especially in the 1930s among refugees from Nazi Europe. By the mid-1960s, Reform Judaism had become sensitive to a growing

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desire among non-Orthodox Jews for some traditional practices; responding to this, it reintroduced ritual into synagogue services and home observances. Many of the changes in Reform Judaism have to do with women’s participation in public worship and in religious affairs. First, women are permitted to become rabbis. Second, Reform synagogues have mixed seating, as distinct from segregation during Orthodox worship, where in united synagogues women sit in a gallery and in ultraOrthodox congregations they are located behind a mechitza, or curtain. Third, women in Reform Judaism can be honored in the synagogue and called up to read from the Torah scroll. Girls have bat mitzvah and bat chayil ceremonies, and women may wear a tallit, or prayer shawl, and be included on synagogue boards of management. Reform Judaism does not observe daily public worship, strict dietary laws, or the restriction of normal activities on the Sabbath. The Reform movement first considered questions of the new treatment of infertility in 1952. Its early leadership agreed that all efforts should be made to help infertile couples, in part to meet the individual’s need to challenge of a declining population. All its authorities in 1952 approved of artificial insemination by husband (AIH), but they split over artificial insemination by donor (AID), although all agreed that AID did not involve any question of adultery. By the 1970s, Reform opinion had definitely accepted AID and supported openness and full disclosure in such matters. Therefore, the religious leadership was not troubled by IVF or surrogate motherhood. Reform thought identifies the semen and ovum donors as the legal parents of the child. Also, Reform opinion had concluded that embryos below 40 days old were not in any way people and could be used for experimentation, so there should be no problem with disposing of unimplanted zygotes in IVF and the use of therapeutic cloning (Washofsky 2009).

26.2.8 Conservative Judaism The Conservative movement developed in Europe and the United States in the 1800s as Jews reacted to the changes brought about by the Enlightenment and Jewish emancipation and as a reaction not to Orthodox Judaism but to Reform Judaism, which was increasing felt to be abandoning too many of the tenets of traditional Judaism. The time of Conservative Judaism’s greatest expansion was during and after the horrors of World War II, which led many Jews to want to reidentify with some form of religion. From its earliest days, the Conservative movement showed a willingness to respond to contemporary issues, which attracted increasing numbers of followers, the majority of whom were not committed to the rigid observance of halakha. They felt easier with Conservative Judaism’s ideology of tradition and change. Committed to a more egalitarian form of worship, it gradually introduced mixed seating, mixed choirs, and bat mitzvah ceremonies. Conservative Jewish opinion has evolved over a period of time. In 1967, the Committee on Jewish Law and Standards opposed AID for essentially the same reasons found in the Orthodox view. However, even then, leading Conservative figures were far from unanimous in that opposition. In more recent years, most Conservative leaders have come to accept the legitimacy of AID with the consent of the husband as a final

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alternative when nothing else has helped. This seems to be emerging as the attitude toward IVF as well. Finally, with similar reservations, in 1985, the committee approved the practice of surrogate motherhood. At present, because of political circumstances, rigid Orthodox Judaism is the only form officially recognized in Israel – for example, in solemnizing marriages. Jews living outside of Israel are generally subjected to the laws of the country in which they reside, except in cases where they are required to obey the Jewish traditional personal-status regulations. In such cases, the rules applicable in Israel, when such exist and are recognized, will also be applied by local rabbinical authorities. Since in Jewish communities and especially in Israel, religious groups have been active in pressing their bioethical concepts on the public arena, it is of importance to those who practice assisted reproduction to learn about the religious attitudes related to the problem of infertility and its therapeutic approach.

26.3 Christian denominations The Christian attitude related to assisted reproduction and infertility therapy differs inside its divisions of Catholicism, orthodoxy, and Protestantism.

26.3.1 Roman Catholic Church The Roman Catholic Church is a Christian church characterized by an episcopal hierarchy, with the pope as its head and belief in seven sacraments and the authority of tradition. (A Catholic ethical perspective on human reproductive technology will be presented elsewhere in this volume.) The Catholic dogma contains three leading principles related to the status of the family, the child, and reproduction. The first principle commands the protection of the human being from the moment of its conception, and thus, most assisted reproductive technologies (ARTs) are forbidden. The second principle is related to the duty of procreation: A child is the fruit of marriage, premarital sex is not allowed, and the Church condemns having a child outside the institution of marriage. The newborn has to embody the love between a husband and his wife and is considered the symbol of their eternal union. A third principle, related to integrity and dignity norms, must be taken into consideration when it comes to ethics in assisted reproduction. The Vatican has had a clear position against assisted reproduction ever since 1956, when Pope Pius XII defined artificial fecundation as immoral and illegal because it affects human lives by separating procreation and sexual normal function. The Vatican’s instruction on respect for human life made an important contribution to discussions on the practice of new reproductive technologies. It was issued by the Congregation for the Doctrine of the Faith in February 1987 (Congregation for the Doctrine of the Faith 1987), signed by Cardinal Joseph Ratzinger, and approved by Pope John Paul II. The document is a response to inquiries from episcopal conferences and individual bishops about the propriety of interventions into human reproduction. The key value in the instructions is respect for the dignity of the human person. The instruction is quite clear in its judgment on reproductive technology. Although augmented by modern concepts of human dignity and moral rights, this position relies heavily on the traditional natural law analysis that intercourse has inseparable procreative and unifying dimensions.

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Therefore, medical techniques used in assisted reproduction, such as embryo cryopreservation, embryo transfer (ET ), application of embryonic stem cells, gamete manipulation, IVF, preimplantation genetic diagnosis, sex preselection, and surrogate motherhood are not accepted by the Church.

26.3.2 Anglican Church The Anglican Church is a body of churches in all parts of the world that are in communion with the Church of England. The establishment of an independent Church of England came during the reign of Henry VIII (1509–47), when Pope Clement VII refused to approve the annulment of Henry’s marriage to Catherine of Aragon. There are 44 churches in the Anglican Communion, including the Anglican Church of Canada, the Scottish Episcopal Church, the Church in Wales, the Church of Ireland and the Nippon Sei Ko Kwai Church in Japan. The communion consists of regional churches, provinces, and separate dioceses bound together by mutual loyalty as expressed in the in the Lambeth Conference in 1930. There are nearly 77 million members worldwide. There is no single Anglican Church with universal juridical authority, as each national or regional church has full autonomy, and Anglicans do not refer to one central authority to make decisions regarding morals issues. The titular head of the Anglican Communion is the Archbishop of Canterbury, and its leadership consists of bishops, who, since 1868, have met once a decade within the framework of the Lambeth Conference, The Church of England, the Anglican Church of Canada, the Episcopal Church of the United States of America, and the Anglican Church of Australia independently carried out studies on their views of reproductive issues and advise their respective governments. The studies published by the various churches related to reproduction on the values of family, marriage, the child’s well-being, and the provision of infertility treatment exerted an important impact on the laws in different countries. The Anglican Church allows assisted reproductive techniques, IVF, and ET and permits doctors to use sperm obtained after masturbation; however, it forbids gametes donation. The church, which believes moral status can be given only to an individual with a well-established personality, does not offer it to the embryo. Those within the Anglican Church have varying opinions about gametal donation: There are those who think that the genetic origins of a child are fundamentally important and those who think that what is more important is a loved child in a stable relationship. Some think that if donation takes place within a stable marital relationship, it is good, while others hold that it threatens marriage, as understood by Christians, and that it should be strongly discouraged. Some argue that gametal donation, such as AID, where one of the spouses is replaced by another person for the purpose of procreation, is a threat to the family, because even if such procedures do not constitute adultery and infidelity in the sense of sexual intercourse with a person who is not one’s spouse, they introduce a third party into the intimacy of procreation and family life. There is no consensus as to whether egg donation, in principle, is the same as AID. Some argue that the reasons for not considering egg donation on a par with AID would be that it separates gestational motherhood from genetic motherhood and is a more complicated procedure than AID, and that it exposes the donor to a risk. There is

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unanimous agreement that surrogacy arrangements are unacceptable, and it is argued that while there is nothing wrong with adoption, there is something undesirable about creating children specifically for the purpose of adoption. It also states that the idea of surrogacy contracts entail legal complications and that it is an indignity for a woman to be paid for womb-letting services.

26.3.3 The Protestant Church The Protestant Church is one of the three major branches of Christianity, originating during the 16th-century Reformation. The term Protestant applies to the beliefs of Christians who do not adhere to Roman Catholicism or Eastern Orthodoxy. Protestantism resulted chiefly from the Reformation, a religious and political movement that began in Europe in 1517. At its foundation was protest against the bureaucracies and policies of the Roman Catholic Church. Protestantism is widespread mainly in Germany, the Netherlands, Switzerland, the United Kingdom and its former dominions (Australia, Canada, New Zealand), and the United States, as well as in the Scandinavian countries. It includes a number of autonomous churches and sects that differ somewhat in worship and organization but are linked by common origin and dogma. The three fundamental principles of Protestantism are 1. the supremacy of the Bible. 2. justification by faith alone. 3. the universal priesthood of believers. Some Protestant denominations can be considered pro-life, while others may be considered pro-choice. Protestant churches have not only refrained from establishing doctrine about IVF but have shied away from public discussions of the topic. Moderate and liberal Protestant denominations in the United States, which include the American Baptist Churches USA, the Episcopal Church, the Evangelical Lutheran Church in America, the Presbyterian Church (USA), the United Church of Christ, and the United Methodist Church, tend to affirm the right of individuals to discern for themselves how to make use of reproductive technologies. Conservative Protestantism includes the Assemblies of God, the Southern Baptist Convention, Vineyard USA, and a variety of independent, evangelical fundamentalist churches that, like the others, emphasize the primary authority of the Bible, but are generally distinguished by an insistence on a literal interpretive framework. Their positions on reproductive matters tend to include an active opposition to abortion, but assisted reproduction has not been much considered in formal church statements. In general, they “tend to approve of methods intended to correct physical problems that cause couples to be infertile, but they disapprove of methods that would violate the sanctity of the marriage bond by using donated sperm and eggs, as well as any method that would tamper with or discard a fertilized embryo” (Green and Numrich 2002, 11).

26.3.4 Eastern Orthodox Church The Eastern Orthodox Church, formally established in 1054 when it split from the Roman Catholic Church, consists mostly of several independent and self-governing churches. The most ancient self-governing churches are in Istanbul and Antakya in

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Turkey, as well as Alexandria, Damascus, and Jerusalem. The largest national churches are in Armenia, Bulgaria, Cyprus, Georgia, Greece, Romania, Russia, and Serbia. Eastern Orthodox congregations are also located in central Africa, Asia, North America, and Western Europe but are not fully self-governing. Orthodox Christianity claims to have fully preserved the traditions and doctrines of the original Christian church established by the apostles. There are an estimated 225–300 million Christians in the Eastern Orthodox Church worldwide. The Eastern Orthodox Church’s stand on assisted reproductive practice is not as strict as the Roman Catholic Church’s, allowing the medical or surgical treatment of infertility, but it is against IVF and other ARTs, surrogate motherhood, donor sperm insemination (which it considers adultery), and embryo donation. The Russian Orthodox Church has condemned the practice of IVF methods. The Church’s position is based on the belief that “an embryo is a future human being and not just an accumulation of cells or a part of a mother’s body,” and it “defends the dignity of human life from the moment of its conception until the natural demise of a human” (Balashov 2010). IVF often involves the use of the so-called donor genetic material, which “creates moral problems for the person born as a result of such procedure.” As in the case of surrogate motherhood, the use of such methods could “question the identity of the human being, his self-understanding (Balashov 2010). The Greek Orthodox position on the ethics of assisted reproduction is similar to the Vatican’s. The Church cannot recommend it as the solution to infertility; instead, it proposes a nonsecularized perception on life that guarantees simplicity, peace, abstinence, and mutual trust between spouses. It does not oppose resorting to medical help, but, at the same time, it suggests that men and women render their life into the hands of God (Metropolitan Nikolaos 2008). The Coptic Church accepts IVF only under the circumstances where the oocyte and sperm are taken from the husband and wife and fertilization occurred in vitro, with no doubt about gamete mixing. ET must be performed on the mother who is the source of the oocytes. All the steps of IVF should occur with the approval of the husband and wife, the treating physician should be alert to the fact that no mixing of gametes should occur, and there should be no doubt in anyone’s mind regarding the source of the gametes. Surrogacy is an option when the sperm and oocyte are obtained from the married couple when the wife has lost or does not have the ability to carry a pregnancy (Bishop Grigorios 1988).

26.4 Hinduism Hinduism is a diverse body of religion, philosophy, and cultural practice predominant in India, characterized by a belief in reincarnation and a supreme being of many forms and natures. Hinduism is the religion of the old Indo-European population, and the predominant religion of Bangladesh, India, Nepal, part of Pakistan, and Sri Lanka, as well as communities in other parts of the world. The religion is based in the teachings of the sacred Vedas. Hindu believers are governed by the three doctrines of dharma, or universal law; karma, or the cumulative effects of personal actions; and samsara, or the cycle of

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rebirth, liberation from which is the first goal of life. Hinduism has no single book, such as the Bible, that serves as the source of its doctrine, but it has many writings, all of which have contributed to its fundamental beliefs. A central belief of Hinduism is that an individual’s soul or self is eternal. In Hinduism, the soul is believed to be passed from one living being to another in a process called reincarnation. While views on the moral status of the human embryo differ, in traditional Hindu belief, conception is the beginning of a soul’s rebirth from a previous life. Some Hindu traditions place the beginning of personhood between three and five months of gestation, while a few believe that the soul’s rebirth can occur as late as the seventh month. Regarding fertility, the emphasis on reproduction is not just to on having children but on having male offspring. There is a huge stigma attached to being infertile in Indian society, especially for the woman. In Indian society, men need children to have heirs and to prove their masculinity. Society puts pressure on woman to become pregnant and give birth even though the male may be the one who is infertile. In Indian society, there is a strong desire for a son to continue the family line and perform religious rituals for the salvation of departed souls. Most of the infertile women began allopathic treatment and visits to holy places to specific temples of some Hindu goddesses. ARTs are acceptable in Hinduism because there is no single authority to accept or reject it on behalf of the faith. The most important condition is that the egg and sperm are from a legally married couple. In practice, artificial inseminations of donor and oocyte and embryo donation are performed with an anonymous donor. It is preferable that the sperm donor be a close relative of the husband. According to some Hindu tradition, “When a man could not produce a child with his wife, he was given the benefit of the doubt and allowed to marry again, and again. If, in spite this, he failed to father a child, it was concluded (but never explicitly stated) that he was sterile. In such circumstances, the Dharmashastras suggested that another man be invited to cohabit with the wives. This practice was known as niyoga, or levirate. In Hindu families, niyoga is followed even today, whereby sterile men make their wives cohabit with relatives or with holy men. Though religiously sanctioned, this practice is socially frowned upon and so no one talks about it openly” (Allahbadia 2009). Modern Indians resort to ART, including oocyte and embryo donation, surrogacy, and sex preselection, enthusiastically. India became a leading country for reproductive tourism, especially for surrogacy. The reasons for the surrogacy boom in India are the relative low cost and easy availability of women for surrogacy, especially those from socioeconomically disadvantaged backgrounds (Kumar 2007).

26.5 Buddhism Buddhism, one of the major religions of the world, was founded in India about 500 BC by the Buddha. At various times, Buddhism has been a dominant religious, cultural, and social force in most of Asia, especially in China, India, Japan, Korea, Tibet, and Vietnam. In each area, Buddhism has combined with elements of other religions such as Hinduism and Shinto.

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The Four Noble Truths in Buddhism are that 1. 2. 3. 4.

suffering is universal (to be born is to suffer). the cause of suffering is desire (desire propels the cycle of Samsara). suffering can be eliminated (through man’s own untiring efforts). there is a path to the cessation of suffering (the practice of dharma, or dhamma).

The Five Precepts in Buddhism are abstinence from 1. 2. 3. 4. 5.

killing all forms of life. sexual misconduct. lies and deceit. theft. intoxicants.

All Buddhists have faith in the Buddha, his teaching, called the dharma, and the religious community he founded, called the sangha. The basis of what Buddha preached in the dharma is that existence is a continuing cycle of death and rebirth. Each person’s position and well-being in life are determined by his or her behavior in previous lives. The word sangha sometimes refers to the ideal Buddhist community, which consists of people who have reached the higher stages of spiritual development. The ritual or worship of early Buddhism is very simple in character. Buddhism has never been organized around a central authority, therefore, Buddhists of all types in various countries are individualistic, and even their scriptures are not rigid. There is no central Buddhist authority to pronounce religious positions. They have no sacraments to administer or rites to perform for the people; every Buddhist is his or her own priest. Marriage within Buddhism does not have the high priority that it has in monotheistic religions. According to Buddhism, the three factors necessary for the rebirth of a human being are the female ovum, the male sperm, and the karma. This karma energy is sent forth by the dying individual at the moment of his or her death. Any technology that is used to achieve conception is morally acceptable, and treatment can be given to unmarried as well as to married women. IVF has been practiced in Japan since 1982 and is also practiced in other countries with Buddhist populations. The problem that arises is whether the oocyte and sperm have to be in their natural environment or not. If the crucial factor in the formation of human beings is the karma energy, it is not necessary for the sperm and the ovum to be in their natural environment, and therefore IVF is acceptable. In Buddhism, donation of sperm is not prohibited. But this procedure should be used as little as possible because the parents in general may feel difficulties in taking care of a child who does not have their own genes. There is also a danger that donation of sperm or an oocyte from a third party would involve commercialization and cause social problems, and donation of gametes could lead to eugenics. In Japan, sperm donation is practiced, but ovum donation is prohibited. However, a child who is already born following sperm donation is accepted as the legitimate child of the social father who has given consent to therapeutic donor insemination and of the mother who delivered the child. The child also has a right to know his or her genetic father or mother when it reaches maturity.

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In Buddhism, reincarnation is described as the rebirth of the self. These beliefs that the soul or the self are reborn may lead to a greater acceptance of cloning technology. To many Buddhists, cloning appears to be closely related to the transmigration of a person’s soul from one body to another or to a rebirth of the self. According to a Japanese Web site, some Buddhists who originally believed that biological fetal life begins at fertilization now believe life starts with blastocyst formation (Maeda 2008). The view of Buddhists may be influenced by the success of artificial reproductive procedures followed by normal fetal development. The Buddhists’ permissive views of scientific advances may be related to early Buddhism, where Buddha achieved philosophical enlightenment through spiritual meditation, which could be defined as scientific (Maeda 2008).

References Adherents.com. The Adherents.com collection of religious adherent statistics, August 9, 2007. www.adherents.com/Religions_By_Adherents.html. Allahbadia GN, Allahbadia SG, and Sulbha A. Hinduism and reproduction. In: Blyth E, Landau R, eds. Faith and Fertility: Attitudes Towards Reproductive Practices in Different Religions from Ancient to Modem Times. London: Jessica Kingsley; 2009. Balashov N. Spokesman for the Russian Orthodox Church on IVF and Surrogacy Interfax-Religion, October 6, 2010. HG Bishop Gregorios. The Christian opinion in in VITRO fertilization and embryo transfer. Bisphoric of Higher Studies, Coptic Culture and Scientific Research, 1988, Cairo, Egypt. Congregation for the Doctrine of the Faith. Donum Vitae: Instruction on Respect for Human Life in Its Origin and on the Dignity of Procreation: Replies to Certain Questions of the Day. Washington, D.C.: United States Catholic Conference; 1987. Green CM, Numrich PD. Religious Perspectives on Sexuality: A Resource Guide. Chicago: Park Ridge Center; 2002:11. Kumar A. Ethical aspects of assisted reproduction – an Indian viewpoint. Reprod BioMed Online, 2007;14:1,140–142. Metropolitan Nikolaos. The Greek Orthodox position on the ethics of assisted reproduction. Reprod Med Online 2008;(suppl 1):33. Schenker JG, Halperin M. Jewish family practice and their evolution. Glob Bioeth. 1997;33:1–35. Wahofsky M. Faith and fertility in Reform Jewish thought. In: Blyth E, Landau R, eds. Faith and Fertility: Attitudes Towards Reproductive Practices in Different Religions from Ancient to Modern Times. London: Jessica Kingsley; 2009.

27 A Catholic ethical perspective on human reproductive technology Norman Ford 27.1 Catholic position on respect for the human embryo 27.1.1 Biblical perspective The Bible is the Book of Life par excellence on the significance of human life, the beginnings of human history, how to live in this world, and God’s loving plan for human beings to be with Him for a happy eternal life. God’s revelation in the Genesis account of creation of the universe and of Adam and Eve is enlightening. Their creation is viewed as very good – a unique divine gift for humans alone, who were made in the image of God, who said, “Let us make man in our image, in the likeness of ourselves, ... God created man in the image of himself, in the image of God he created him, male and female he created them” (Gen. 1:26–27, Wansbrough 1985). The Bible is not a scientific account of the beginnings of human life or of human embryology. Some biblical texts seem to presuppose the ancient Aristotelian view that human life is conceived when menstrual blood solidifies after it mixes with semen (Ford 1988). Human life from conception was regarded as sacred in the Old Testament. Direct dominion over human life is not given to anybody, since all human beings belong to God in a special way (Ford 2002; Grisez 1970). It did not seem necessary to condemn abortion, because it is “completely foreign to the religious and cultural way of thinking of the People of God” ( John Paul II 1995).

27.1.2 Christian tradition From early Christian times, human life has been regarded as sacred and morally inviolable from conception. One of the earliest non-biblical Christian writings is the Didache, written in Syria. It contains moral instructions for Christians, some of whom would have lived alongside pagans or were formerly pagans themselves before they converted to Christianity. It is known that abortifacient medicines were used in the Mediterranean world when the Christian faith was spreading beyond Israel. There was a need for Christians to be given moral instruction. Here is a typical list of prohibitions: “You shall not murder.... You shall not practice magic.... You shall not mix poison. You shall not murder a child, whether by abortion or by killing it once it is born.” (Attridge 1998) In the second century, Clement of Alexandria wrote, “For those women who conceal their sexual wantonness (fornication) by taking stimulating drugs to bring on an abortion wholly lose their own humanity along with the fetus” (Grisez 1970). Toward the end of the second century and before he became a heretic, Tertullian (AD 160–240) wrote, “For us, murder is once for all forbidden; so even the child (conceptum) in the womb, while yet the mother’s blood is still being drawn on to form the human being, it is not lawful for us to destroy. To forbid birth is only quicker murder” (Tertullian 1931). Though many in the Greco-Roman world wavered or approved the use of abortifacient medicines, Christians did not.

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Throughout the following centuries, it was unanimously held that it was gravely immoral to destroy a life that had been conceived, because it belonged to God, in whose image it was made. The canonical penalty for abortion was regularly excommunication after ensoulment was deemed to have occurred (Noonan 1970). The terms life and “being formed in the womb” abound in the Old Testament. Such texts show the goodness of human life and its formative process from conception. God’s special creative involvement makes human life sacred and confers on it unconditional moral inviolability. The early Christians instinctively recoiled from the pagan practices of abortion and exposing unwanted newborn infants.

27.1.3 Embryo defined The term embryo is derived from a Greek word meaning “growing within.” The successful fusion of sperm and egg results in the formation of a new diploid cell, the zygote, again derived from a Greek word, this one meaning “yoked together.” This occurs at the stage called syngamy, which represents the beginning of the zygote. It makes no difference whether it is naturally conceived, an embryo obtained through in vitro fertilization (IVF), or a cloned human embryo. The zygote is said to be totipotent because, in virtue of its human genome, it is intrinsically capable of giving rise to the whole offspring. A single cell from a two-cell embryo and possibly a four-cell embryo is likewise totipotent because it also has the inherent potential to form the entire offspring, including placental tissues, in a continuous, coordinated biological process. This implies that dividing a two-cell embryo gives rise to two cells, each of which would be an embryo. A human totipotent cell has the intrinsic capacity to develop into the whole offspring. From a philosophical perspective, a human embryo may be defined as a totipotent cell or a group of cells or a multicellular organism, which has the inherent actual potential to continue organized human development in a suitable environment. Clearly, a living blastocyst is an embryo. A frozen embryo exists in suspended animation, but it is an embryo, because it still has the inherent actual potential to continue development once it is successfully thawed. But failed fertilization does not result in the formation of an embryo, nor do disorganized embryonic teratoma: These do not have the intrinsic potential to develop as an embryo to become a fetus. This is far from implying that an embryo with a congenital abnormality that will cause death before birth is not an embryo. A totipotent cell or group of contiguous cells is an embryo because of what it is and its actual potential. An embryo cannot exist before human development begins. On the other hand, once a blastocyst is disaggregated and loses its inherent potential for development, it ceases to exist, even though the embryonic stem cells that are derived from it can live on and multiply in culture for some time. A clump of embryonic stem cells left alone on a dish is unable to produce trophoblast or placental tissue or form a body plan. It cannot develop in a coordinated way isolated from a suitable female reproductive environment.

27.1.4 Catholic Christian teaching An authoritative statement of this tradition was made by the Second Vatican Council: “Life once conceived must be protected with the utmost care; abortion and infanticide

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are abominable crimes” (Second Vatican Council 1975). Human life is to be respected from conception because it is human life. This theological insight for protecting human life from conception encapsulates a profoundly human perception of the value of human life. Pope John Paul II, in his 1995 Encyclical Letter Evangelium Vitae (Gospel of Life) N. 53, wrote, approvingly quoting Donum Vitae, “Human life is sacred because from its beginning it involves ‘the creative action of God’ and it ever remains in a special relationship with the Creator, who is its sole end. God alone is the Lord of life from its beginning to its end: no one can, in any circumstance, claim for himself the right to destroy directly an innocent being.” With these words the Instruction Donum Vitae sets forth the central content of God’s revelation on the sacred and inviolability of human life. ( John Paul II 1995) Pope John Paul continues in N. 60: [T]he Church has always taught and continues to teach that the result of human procreation, from the first moment of its existence, must be guaranteed that unconditional respect which is morally due to the human being in his or her totality and unity as body and spirit: “The human being is to be respected and treated as a person from the moment of conception.” And therefore from that same moment his rights as a person must be recognized, among which in the first place is the inviolable right of every innocent human being to life. ( John Paul II 1995) The pope further develops this teaching, countering the claims that for some days the human embryo could not be deemed a person, in N. 60 quoting from the Church’s 1974 Declaration on Procured Abortion, [F]rom the time that the ovum is fertilized, a life is begun which is neither that of the father nor of the mother; it is rather the life of a new human living being (novi viventis humani) who grows of its own accord. It would never be made human if it were not human already ... and modern genetic science offers clear confirmation. It has demonstrated that from the first instant there is established the structure or program of this living being: namely a man (hominem), and indeed this individual man with his own proper operations already well determined. Right from fertilization the adventure of a human life begins, and each of its capacities requires time – a rather lengthy time – to find its place and to be in a position to act. ( John Paul II 1995) The Church continues to adopt a position of prudential certitude regarding the presence of individual and personal life once the process of fertilization results in the constitution of a zygote. With the approval of Pope Benedict XVI, the Church in 2008 published the Instruction Dignitatis Personae on Bioethics, which endorsed and developed the teaching of Pope John Paul II: Although the presence of the spiritual soul cannot be observed experimentally, the conclusions of science regarding the human embryo give “a valuable indication for discerning by the use of reason a personal presence at the moment of the

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first appearance of a human life: how could a human individual not be a human person?” ... The human embryo has, therefore, from the very beginning, the dignity proper to a person. (Dignitatis Personae, N.5., Congregation for the Doctrine of the Faith, Vatican City, 2008)

27.1.5 A person from conception God’s design in creating humans as male and female is quite enlightening. Throughout history, it has been known new human lives are meant to originate from sexual intercourse and the formation of the zygote following the fusion of sperm and egg to form a diploid cell, whose unique genetic identity or genotype remains practically unchanged during normal development. It is scientifically and philosophically credible to hold that the normal unidirectional and continuous biological development and growth suffice to establish the zygote as the one and same living being as the future human adult. The zygote may be regarded as an actual human individual and not merely a potential human individual, in much the same way as an infant is an actual human being with potential to develop to maturity. In virtue of the creation of the spiritual (immaterial) soul within the emerging embryonic human being, it is credible to hold that a natural human person begins when the embryonic human individual is formed. Hence, the spiritual soul would account for the human individual’s rational nature and personhood from conception. As I have written earlier, “Each newly formed zygote is endowed with its own unique genome which functions as a live blueprint. There are obvious indicators of purpose, finalism, and direction in the interactions of cells, the formation of a human body plan, and the orderly development of tissues and organs to achieve this end. Respect for human embryos is based on the divinely conferred natural actual potential of their genome, given a suitable environment, to direct and organize continuous development and growth from conception to birth and to adulthood. The formative process of the developing human embryo is naturally linked to the terminus of the process (i.e., a human being with a rational nature)” (Ford 2007b). Philosophical reasoning also supports this position. The teleology manifested in the developmental process from the embryo to a newborn infant provides grounds for arguing that the human being must somehow be present in the zygote from its constitution. The ontological character of this ongoing teleological causal influence in the developing embryo provides good grounds for accepting that the human zygote is the same living being as the fetus and newborn child. These considerations suffice to provide credible scientific and philosophical reasons in support of the first cell, the zygote, being deemed a human being, a natural person worthy of absolute moral respect (Ford 1998, 2002, 2007b). Human nature enables human embryos to develop to the stage where, without ceasing to be the same living beings, they can exercise rationally selfconscious and free acts. As I have written, “There is no justification for the reductionism that sees human embryos as no more than genetic products. From a theistic perspective, the early embryo has moral significance and a claim to unconditioned moral respect” (Ford 2002). The deliberate destruction of human embryos cannot be morally justified.

27.1.6 Ethics and destructive research on human embryos During IVF procedures, some embryos are deemed to be suboptimal and may be discarded, donated for destructive research, or simply allowed to die in the laboratory.

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Preimplantation genetic diagnosis (PGD) enables a couple at risk of transmitting an inheritable disease to have recourse to IVF so that their embryos may be tested for it. Embryo biopsy is a procedure whereby one or two cells are excised from an eight-cell embryo to test them for a genetic disease such as thalassaemia or for a non-inheritable congenital disability such as trisomy-21. If the biopsied cells are affected by the abnormality, the respective embryos are usually likewise affected. Embryos found to be free of disease or disability are selected for implantation and the remaining embryos are discarded. PGD can also be used to determine the sex of an embryo in suspected cases of sex-linked diseases like hemophilia or Duchenne muscular dystrophy or to ensure a family’s gender balance. The deliberate destruction of abnormal embryos in a laboratory is unethical even if this means avoiding subsequent abortions and less suffering for children with a disease or severe disability. Clearly, PGD is eugenic, since its purpose is to reduce the number of children born with congenital abnormalities. Permitting destructive research on embryos while reasonable doubts persist concerning their individual and personal status is morally, socially, and politically irresponsible. The practice of discarding embryos is ethically inexcusable: It shows how low the value of human life has fallen in many societies. It is regrettable that the law permits the elimination before birth of embryos and fetuses found to have genetic disabilities and whom antidiscrimination laws protect after birth. The cloning of embryos for the treatment of diseases or degenerated neural tissue is subject to the same ethical objections as destructive research on normal IVF human embryos.

27.1.7 Morality and personalized natural law The notion of good is a basic notion – it is pivotal for the morality of actions, since its meaning is related to the concept of the human person: Good means good for the person, oneself and relevant others. It includes reference to the human person’s nature with its objective psychological, bodily, and spiritual needs, as well as the capacity to exercise reason and make free choices. What is truly good for a person is also a good of the person. Pope John Paul II rightly taught that “natural inclinations take on moral relevance only in so far as they refer to the human person and his authentic fulfillment which for that matter can only take place in human nature” ( John Paul II 1993). The moral order is essentially related to the true good of persons, and this in turn hinges on a personalized understanding of human nature inasmuch as the person operates in and through a rational human nature. The Vatican Council gave the following helpful indication as a guide to solve moral problems: “[O]bjective criteria must be used, criteria drawn from the nature of the human person and the nature of human acts” (Second Vatican Council 1975). Thus the true integral good of the human person is linked to rational human nature and provides the foundation and rationale for morality. Moral behavior is a requirement of being true to ourselves as human persons: It is not an extrinsic imposition on us or our freedom. Believers in God as creator can take the foundations of morality further, since our true good ultimately depends on our common rational human nature, created according to God’s provident design. We are endowed with a human nature and personal dignity from our conception as human individuals. Intuition has its importance in moral discernment, but reason is the criterion par excellence of moral truth because reasoning is required for the complex task of analysis,

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comparison, and evaluation of actions. Opposing moral views abound in society, but they cannot all be true. This is why right reason has been traditionally adopted as the criterion of objective morality. This implies reason has to be employed with a suitable method and in an appropriate framework to be reasonable and logically consistent. The concept of the human person with a human nature is the referral point for the moral evaluation of all actions in relation to the true good of persons for every occasion and circumstance.

27.1.8 Secular ethics and the human embryo Many scientists and philosophers such as Helga Kuhse (Kuhse and Singer 1990), Michael Lockwood (1985), Peter Singer (1990), and Michael Tooley (1983) who do not believe in the existence of any spiritual reality do not accept that a spiritual soul is needed to account for a rational nature (Ford 2002, 7–9). Neither would they accept that human beings are made in God’s image. Logically, they would not admit that early embryos are people or that the sanctity-of-life principle is applicable to human embryos. Likewise, they would not attribute personhood to human beings before some minimal signs of rational and self-conscious acts appear. Their intellectual horizon is practically limited to the empirical domain to the exclusion of transcendent reality. By way of a reply to these views, it can be said, “It is true that human experience is the referral point for the significant and fruitful employment of all our concepts and objects of thought. However, simply because our ideas are originally derived from empirically observable situations and are most clearly employed in the world of our everyday experience, there is no need to describe their employment as meaningless or false in cases where empirical criteria could not be available for their application. This would disregard the way we do successfully employ some meaningful concepts that go beyond our experience. We are able to think of abstract realities like virtue, God or spirit and an unrestricted notion of reality that can refer to empirical and non-empirical beings alike. This kind of knowledge goes beyond matter alone” (Ford 2002, 14). In short, typical human discourse focuses on our experience in ordinary life. A person’s awareness of the truth that water is boiling cannot be reduced to sense knowledge alone. Such awareness “implies a turning back on itself, like total selfpresence that transcends the capacity of material senses and requires an intellect of an immaterial nature. Each part of a body is only present where it is, not elsewhere. Aristotle (d. 322 BC) knew that a body could not know truth as such, ‘for no bodily activity has any connection with the activity of reason.’ Aristotle and Aquinas rightly understood that intellectual acts require an immaterial soul to perform what a bodily organ alone cannot do. Traditionally, it has been said that this type of knowledge is made possible by a human spiritual soul or life principle” (Ford 2007a). A human individual’s underlying spiritual power is needed to account for typically human knowledge over and above what is needed for sense knowledge alone. A strong philosophical case then can be made for the existence of a human person’s immaterial soul, and hence for the existence of immaterial reality and entities. The basic criterion of morality, however, relates to the true good of the person who is the agent and the subject of interests in the light of the person’s integral good, including significant relationships with others and the environment. Once an action is found to be bad in itself, calculations of benefits are to be discounted. One may not do evil

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that good may result. We may have to renounce our own interests in the light of the more pressing needs of our neighbor for assistance. As any parent or health professional knows, to be moral, it is often necessary to subordinate personal interests for the benefit of others.

27.1.9 Challenge to find ethical alternatives Human embryonic stem cells are eagerly sought by researchers for both scientific and therapeutic purposes. They are called ES cells because they are usually derived from IVF or cloned human embryos. Regrettably, human ES cell research has a serious ethical drawback: It involves the destruction of human embryos. The likelihood of cell therapies derived from human ES cells entering clinical practice is real. Catholic health care facilities could not ethically have recourse to any therapies that depend on the use of human ES cells or their cell derivatives, as this would involve ongoing unethical material cooperation with the destruction of human embryos. It is imperative that Catholic health care facilities find alternative cell therapies by seeking to obtain suitable stem cells similar to human ES cells but not derived from human embryos (Ford 2003, 2006). Ethical alternatives to destructive embryonic research should be sought by developing stem cells of wide potentiality without involving human embryos. Okita and Yamanaka (2010) have recently reprogrammed human somatic cells into pluripotent stem cells by introducing into them a combination of several transcription factors. Human stem cells can also be derived from umbilical cord blood, bone marrow, fetal tissue, and even the nose’s olfactory mucosa. These are nonembryonic, more popularly known as adult stem (AS) cells. Some AS cells can adapt to certain parts of the body and repair damaged tissues. Horowitz (2004) estimates that over 45,000–50,000 patients worldwide annually receive transplants of hematopoietic AS cells to treat blood diseases. Proponents of human ES cell research claim that AS cells lack the required versatility and universal plasticity of ES cells. This claim is true because ES cells are pluripotent (i.e., once transplanted, they can become any kind of cell within a living body to repair tissue, but they cannot form a whole offspring). But pluripotent AS cells are rare and hard to find (e.g., in placental cord blood). However, researchers have recently “isolated human amniotic fluid-derived stem cells that ... differentiate into cell types representing each embryonic germ layer” (De Coppi 2007). This is good news because effectively some pluripotent stem cells could be ethically derived without the need of creating cloned human embryos.

27.2 Catholic ethics, marriage, and reproductive technology 27.2.1 Catholic Christian position on children of the marriage union Catholic teaching stresses that children should be conceived and born of the marriage union and morally opposes the use of those means of reproductive technology that “separate procreation from the fully human context of the conjugal act” ( John Paul II 1995). Simply being the genetic offspring of a married couple does not suffice for a child to be the child of the marriage union. The Church teaches that on account of their personal dignity, the “child should be conceived, carried in the womb, brought into the world, and brought up within marriage: It is through the secure and recognized relationship to

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his own parents that the child can discover his own identity and achieve his own proper human development.” (Congregation for the Doctrine of the Faith 1987). Rachowsky (2002) reports that “[h]umans have a low natural fecundity, as the probability of establishing a viable pregnancy in any one menstrual cycle is 20–25% for a healthy, fertile couple.” This fertility rate is low compared to that of sheep or cows – farmers know this well. Many infertile women have recourse to assisted reproductive technology, but most fail to succeed in having a baby by means of ART in any one treatment cycle. Patrizio’s research showed that of 441 fresh embryos transferred to women patients less than 35 years of age, there were 71 live babies born, a rate of embryo transfer to live birth of 16.1%. From 249 fresh embryos transferred to women ages 38–40, there were 20 live babies born. This older cohort had a much lower rate, only 8% (Patrizio 2009). Regardless of these results, and for quite different reasons, Catholic teaching is opposed to IVF and artificial insemination with the husband’s sperm because they separate the unitive and procreative meanings of marriage acts. The Church is morally opposed to extracorporeal conception whereby embryos are formed as a result of a technological intervention rather than a personal marriage act, and possibly subject to quality control. The more human procreation diverges from the Creator’s design for the transmission of human life, imprinted in the nature of the human person as a truly human expression of married love, the more human embryos are at risk of being viewed as impersonal objects, not equal to their parents in dignity and value. Marriage has a privileged status in most societies. Marriage is also an important wellunderstood social and legally defined institution for the benefit of spouses and their children. Marriage enshrines a moral right to seek to have and to rear children within the marriage. Infertility is a cause of much suffering for a couple, which deserves sympathy for the anguish they experience. The community readily understands and supports couples’ desire to seek assistance to enable them to have their own children. The Church admits that when spouses use their own gametes for IVF and no embryos are placed at any risk of harm, “fertilization is not marked by all that negativity found in extra-conjugal procreation; the family and marriage continue to constitute the setting for the birth and upbringing of the children” (Congregation for the Doctrine of the Faith 1987). The Church does point out, however, that notwithstanding an IVF conception, “every child who comes into the world must in any case be accepted as a living gift of the divine goodness and must be brought up with love” (Congregation for the Doctrine of the Faith 1987). It is common knowledge that infertile Catholic couples avail themselves of treatment at IVF clinics, but most would probably not agree to accept donor gametes or to donate their embryos for destructive research.

27.2.2 Assisted insemination Catholic teaching does permit the use of artificial means for insemination in “those cases in which the technical means is not a substitute for the conjugal act but serves to facilitate and to help so that the act achieves its natural purpose” (Congregation for the Doctrine of the Faith 1987). In moral theology, this is termed assisted insemination. Technological assistance may be required to enable semen deposited in the vagina to reach the fallopian tubes, where conception normally occurs. Sperm retrieved after the marriage act may be placed in a catheter with eggs separated from sperm by an air

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bubble. They may then be injected into the fallopian tube for conception to occur where it normally does. This procedure is called gamete intrafallopian transfer, and, from a moral point of view, it is deemed to be a form of assisted insemination.

27.2.3 Rights of children and natural parents We have an appreciation of the importance of our genetic identity that determines many of our traits and personal characteristics in addition to nurturing and a loving upbringing by natural parents. Breeding methods suited to animals lack the respect due to the dignity of persons about to be conceived. Children need to know and to love and be loved by their own genetic parents and to be raised as members of their own family as far as possible. The network of family relationships is very significant for them. It is regrettable that some children, through no fault of their own, are deprived of the knowledge and benefit of their genetic relations. Many adopted children yearn to know their own biological parents. It would be normal for young persons to experience some suffering as a result of the deprivation of a loving relationship with their genetic parents. Social workers are well aware of the suffering and harm experienced by children due to the absence of their unknown natural fathers. However, it is one thing to make provision for the adoption of infants and children deprived of one or both of their natural parents by death or marriage breakdown; it is quite another thing to systematically and deliberately engineer situations that result in children being born who will be unable to know one or both of their natural parents, and consequently be unfairly deprived of their love and care. To discount the importance of genetic parents is to underestimate their crucial role in maintaining our personal identities. It is also of paramount importance that children be raised by loving parents in a stable family.

27.2.4 Donor gametes Infertility may be caused by defective sperm or eggs on the part of one or both partners. One treatment option is to use healthy donor sperm or eggs. The Church does not approve the use of donor gametes, because the child conceived by the use of donor sperm or egg is not the child of the marriage union. It deprives growing children of the knowledge and love of at least one of their genetic parents and family relations, since the donors are usually anonymous.

27.2.5 Surrogacy Surrogacy could undermine the importance of natural motherhood, which includes genetic links, gestation, and the rearing of the child. In cases of surrogacy, the true mother really is the birth mother. Her role should not be reduced to gestation alone as though she were just an incubator, divorced from ongoing maternal relationships with her child. Society should not undermine fundamental family relationships of the natural mother, parental responsibilities, and the long-term interests of children. The social and legal sanctioning of surrogacy risks blurring children’s identity, disrupting the natural links between marriage, conception, and the marriage union, as well as those between gestation, birth, and the rearing of children. Adults involved in surrogacy arrangements should not behave as though they alone are involved. Individualistic concepts of

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autonomy and reproductive freedom overlook the rights of children, who may be easily treated as impersonal objects. The notion of harm should not be restricted to exclude its likely psychological aspects.

27.2.6 Access to ART by single women and lesbians The commitment of natural mothers and fathers to each other should extend to their children who need the presence, care, and love of both their natural parents during their formative years. This is not merely an ideal but also a requirement that responds to the natural needs of developing children. These irrevocable genetic relationships are the basis of their unique ties with their extended family, which can facilitate building up personal confidence, mutual acceptance, and lasting reassurance. The interests of children conceived by reproductive technology should be of paramount importance for parents and public policy and should be protected by the state, as mentioned in the United Nations Universal Declaration on Human Rights, Article 16 (3). A child has a natural right to be reared by both mother and father. It would be akin to natural injustice for children of single and lesbian women to be deliberately deprived of the chance of being raised by their genetic fathers. It is unethical to deliberately plan to break the bonds designed by nature in order to deprive children of their natural fathers by allowing single women and lesbians access to reproductive-technology clinics. Of course, this does not imply that single women and lesbians cannot be good parents. Many children during the last two world wars were raised well by mothers alone while their spouses were away. However, as a matter of social policy, access to reproductivetechnology clinics should be restricted to heterosexual couples to prevent children being deliberately conceived and brought into the world without much of a chance of having a beneficial relationship with their genetic fathers.

27.2.7 Human reproductive cloning As Dolly was a real sheep derived from a cloned embryo, a cloned child would be a real child derived from a cloned human embryo. However, the nonsexual cloning of children would be such an atypical mode of creating children as to be grossly disrespectful to their dignity as persons. It would deprive them of their genetic fathers and mothers and other family relations. It would be akin to a natural injustice against the cloned children.

27.3 Conclusion The biblical and Christian tradition expressed in Catholic teaching provides clear natural-law moral principles in the sphere of infertility treatment and the use of human reproductive technology. These principles are reasonable and are accepted by Catholics. Secular philosophers differ from Catholic teaching on these issues because they have different concepts of the human person and of moral theories. Catholic teaching argues strongly in defense of human life from conception as well as for the need of children to be conceived and born of the marriage union and to be raised by both natural parents. This teaching sees these issues as goods worth defending. The Church is opposed to destroying human embryos and to conception of children by reproductive

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techniques outside the marriage union. This seems to be negative to many who view the moral issues differently. In reality, the Church is defending important goods of the human person by arguing against certain technical procedures practiced in some research laboratories and infertility clinics.

References Aristotle. De generatione animalium, Platt A, trans. In: Smith JA, Ross WD, eds. The Works of Aristotle Translated in English, vol. 5. Oxford: Clarendon Press; 1912:736b. Attridge HW. The Didache: A Commentary by Kurt Niederwimmer. Maloney LM, trans. Minneapolis: Augsburg Fortress Press; 1998. Congregation for the Doctrine of the Faith. Donum Vitae – Instruction on Respect for Human Life in Its Origin and on the Dignity of Procreation. Vatican City: Polyglot Press; 1987:II,1. Congregation for the Doctrine of the Faith. Instruction Dignitas Personae on Bioethics, liberia Editrice Vaticana, Vatican City, 2008., n.5. De Coppi P, Bartsch G Jr, Siddiqui MM, et al. Isolation of amniotic stem cell lines with potential for therapy. Nature Biotech. 2007;25(1):100–106. Ford NM. When Did I Begin? Conception of the Human Individual in History, Philosophy, and Science. Cambridge: Cambridge University Press; 1988. Translated into Italian: Quando Comincio Io? Milan: Baldini & Castoldi, 1997; Kiedy Powstalem? problem poczatku jednostki ludzkiej w historii, filozofii i w nauce, Polish translation of updated version of When did I begin? by Waclaw Jan Popowski. Warsaw: Polish Scientific Publications PWN Ltd.; 1995: 266. Ford N. Are all cells derived from an embryo themselves embryos? Dodet B, Vicari M, eds. Pluripotent Stem Cells: Therapeutic Perspectives and Ethical Issues. Paris: John Libbey, Eurotext: 2001, 81-87. Ford NM. The Prenatal Person: Ethics from Conception to Birth. Oxford: Blackwell; 2002 Ford, NM. Stem cell research and ethics. In: Stem Cells: Science, Medicine, Law and Ethics. NM Ford and M Herbert, ed. St Pauls Publications Strathfield: St Paul Publications; 2003: 71–85. Ford N. Human pluripotent stem cell research and ethics. Monash Bioethics Review. 2006:31–41. Ford N. The moral significance of the human foetus. In: Ashcroft RE, Dawson A, Draper H, McMillan JR, eds. Principles of Health Care Ethics. 2nd ed. Chichester, UK: Wiley; 2007a:387–392. Ford NM. Moral respect due to the human embryo. Ethics Education: A Journal for Applied Philosophy and Ethics in the Christian Tradition; 2007b:13(1):13–20. Grisez G. Abortion: The Myths, the Realities, and the Arguments. New York: World; 1970. Horowitz M M. Uses and growth of hematopoietic cell transplantation. In: Blume KG, et al., eds. Thomas’ Hematopoietic Cell Transplantation. Malden, MA: Blackwell Science; 2004. John Paul II. Veritatis Splendor: Encyclical letter on certain fundamental questions of the Church’s moral teaching, Liberia Editrice Vaticana, 1993:50, 51, 79. John Paul II. The Gospel of Life. Vatican City: Liberia Editrice Vaticana; 1995. Kuhse H, Singer P. Individuals, humans, and persons: the issue of moral status. In Singer P, et al., eds. Embryo Experimentation. Cambridge: Cambridge University Press; 1990. *Lockwood, M. When Does a Life Begin? Ch. 1, Moral Dilemmas in Modern Medicine, Ed. M. Lockwood, Oxford University Press, 1985, 9-31. Noonan JT Jr. Almost an absolute value in history. In: Noonan JT, Ed. The Morality of Abortion: Legal and Historical Perspectives. Cambridge, MA: Harvard University Press; 1970. Okita K, Yamanaka S.Induction of pluripotency by defined factors. Exp Cell Res. 2010;316(16):2565–2570.

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Patrizio P. From oocyte to baby: a clinical evaluation of the biological efficiency of in vitro fertilization. Fertil Steril. 2009; 91(4):1061–1066. Rachowsky C. High rates of embryonic loss, yet high incidence of multiple births in human ART: is this paradoxical? Theriogenology. 2002;57 (1):87–96. Second Vatican Council. The pastoral constitution of the Church in the modern world. In: Flannery A, ed. Vatican Council II: The Conciliar and Post Conciliar Documents. Dublin: Dominican Publications, 1975. N.51. 955; The Declaration of Religious Liberty N.14: 811. Singer P. Practical Ethics. 2nd ed. Cambridge: Cambridge University Press; 1993, 72, 141. Tertullian. Apologeticus, ix. 8. London: Heinemann; 1931. Tooley M, Abortion and Infanticide, Oxford: Clarendon Press, 1983, 123; 123-34, 146. Wansbrough H, ed., The New Jerusalem Bible. New York: Doubleday; 1985.

The author acknowledges that this chapter is a shortened revised version of his earlier article A Catholic ethical approach to human reproductive technology published by Reproductive Healthcare Ltd, in Ethics, Bioscience and Life, Vol.3 No, 3, November 2008, 39–48. The author is grateful to the publisher for permission to re-publish a revised version.

28 Islamic laws and reproduction Gamal I. Serour 28.1 Islamic laws The teaching of Islam covers all the fields of human activity: spiritual and material, individual and social, educational and cultural, economic and political, national and international. Instructions that regulate everyday activity of life an observant Muslim should adhere to are called sharia. There are two sources of sharia: primary and secondary. The primary sources of sharia, in chronological order, are the Koran; the very words of God; the sunna and the hadith; the authentic traditions and sayings of Mohammed as collected by specialists in hadith; and igmaa, the unanimous opinion of leading Islamic scholars; and qiyas (analogy), intelligent reasoning used to rule on events not mentioned by the Koran and the sunna by matching them against similar or equivalent events previously ruled on. The secondary sources of sharia are istihsan, the choice of one of several lawful options; views of Mohammed’s companions; current local customs, if lawful; public welfare; and rulings of previous divine religions if they do not contradict the primary sources of sharia. An observant Muslim resorts to secondary sources of sharia in matters not dealt with in the primary sources. If an action is forbidden, it may be undertaken if the alternative would cause harm, according to the principle of necessity permitting the forbidden. Thus, an observant Muslim is permitted to break fasting if they are sick, traveling, or pregnant. The sharia is not rigid. It is flexible enough to adapt to emerging situations in different times and places. It can accommodate different honest opinions as long as they do not conflict with the spirit of its primary sources and are directed to the benefit of humanity (Gad El Hak 2000; Serour 1994). Islam is a religion of yusr (ease) not usr (hardship), as indicated in the Koran (Sura Al-Baqara 2, 185). The broad principles of Islamic jurisprudence are permissibility unless prohibited by a text (ibaha), no harm and no harassment, and permission to do the prohibited to choose the lesser harm (Serour 2008). Science and religion have been interrelated since the beginning of human history. This is particularly true in the case of biology and, within it, reproduction. Although the term bioethics is relatively new, bioethical issues have a long history. The basic four ethical principles of beneficence, nonmalificence, justice, and autonomy have their beginnings in sharia (Serour 1994). The novelty is that only during the last three decades have we witnessed the secularization of bioethics, and religious influence on bioethics has subsequently declined. Bioethics today is no longer dominated by religion and medical traditions, as it was in the past (Serour 2008); it has become dominated more by philosophical, social, and legal concepts (Serour 2005a). However, in the Muslim world, religion still has a powerful meaning and greatly influences behavior, practices, and policymaking in the Muslim countries and among the Muslim communities in non-Muslim countries.

28.2 Reproduction in Islam The primary sources of sharia have affirmed the importance of marriage, family formation, and procreation, as indicated in several verses of the Koran (Sura Al Shura 49–50; Surat

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Al-Nahl 72; Surat Al-Ra’d 38). A central feature of Muslim identity and family structure is authenticity of lineage. Individuals’ family names often disclose their paternity, and adoption and transfer of family names are not acceptable. Though the Koran explicitly prohibits legal adoption, it encourages the charitable upbringing of orphans (Sura AlAhzab 32, 4–5). In Islam, treatment of infertility in married couples is encouraged, as it involves procreation and preservation of humankind (Gad El Hak 2000). The prevention and treatment of infertility are of particular significance in the Muslim world. The social status of Muslim women and their dignity and self-esteem are closely related to their procreation potential, both for the family and for society as a whole. Childbirth and child-rearing are regarded as family commitments of both partners, not just biological and social functions. As assisted reproductive technology (ART) was not mentioned in the primary sources of sharia, patients and Muslim doctors alike initially felt that seeking assisted reproduction was a challenge to God’s will by trying to render barren women fertile. Furthermore, ART made it possible to handle human gametes and embryos in the laboratory with a possibility of a third-party contribution to the process of reproduction. ART was widely accepted only after prestigious scientific and religious bodies and organizations in many of the Muslim countries issued guidelines, which were adopted by medical councils and accepted by concerned authorities in different Muslim countries.

28.3 ART and Islam Since the birth of Louise Brown, the first baby conceived through in vitro fertilization (IVF), in England in 1978 (Steptoe and Edwards 1978), ART has evoked great interest and debate among ethicists, religious leaders, philosophers, and the public at large. This resulted in the publication of guidelines by many religious institutes and scholars, which played a major role in the in the change of attitude of society and individuals in the Muslim world. These guidelines included a fatwa, or opinion, from Dar al-Ifta, in Cairo (1980) and a fatwa from the Islamic Fiqh Council in Mecca (1984 and 1985), as well as guidelines from the Islamic Organization for Medical Sciences, in Kuwait (1983), Qatar University (1993), the Islamic Organization for Education, Science, and Culture, in Rabat, Morocco (2002), the United Arab Emirates (2002), and Al-Azhar University’s International Islamic Centre for Population Studies and Research, in Cairo (Al-Siyasa 1984; El Bayoumi and Al Ali 2000; Gad El Hak 1980, 1991; Kattan 1991; Islamic Education, Science, and Culture Organization 1993; Serour 1992, 1997, 2000a, 2000b). These bodies stressed the fact that Islam, in its primary sources, within the frame of marriage, encourages family formation and procreation. Treatment of infertility, including ART when indicated, is encouraged to preserve the lineage in otherwise incurable infertility. These guidelines changed the attitude of patients from rejection, doubt, feeling of shame, guilt, and secrecy when seeking assisted reproduction in the 1980s to openly seeking and demanding ART in the 1990s (Serour, El Ghar, and Mansour 1991). The introduction of effective intracytoplasmic sperm injection (ICSI) treatment for male infertility played a role in the change of attitude of many couples to ART (Serour 2002). In family affairs, particularly reproduction, decisions are usually taken by the couple, but the husband’s decision is usually the dominant decision. Husbands became very enthusiastic about ART after introduction of ICSI. They encourage their wives to seek ART treatment for male, female, or unexplained infertility.

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28.4 Islam and various ART practices Today, the basic guidelines for assisted reproduction in the Muslim world are as follows: If assisted reproduction is indicated in a married couple as a necessary line of treatment, it is permitted within the validity of marriage contract with no mixing of genes, but if the marriage contract has come to an end because of divorce or death of the husband, ART cannot be performed on the female partner, even when using sperm cells from former husband. These guidelines are followed by most Sunni Muslims. However, the Shia guidelines, via fatwa from Ayatollah Ali Hoseyni Khameini in 1999, have opened the way to a third-party donation. This fatwa allows third-party participation, including egg donation, sperm donation, embryo donation, and surrogacy. Recently, there has been some concern about sperm donation among Shia, and most scholars today forbid sperm donation. All these practices of third-party participation in ART are based on the importance of maintaining family structure and integrity among the Shia family (Serour 2008).

28.5 Surrogacy Surrogacy is practiced among the Shia, whereas most Sunni do not accept it. The fatwa of the Islamic Fiqh Council of Mecca in 1984 allowed surrogacy by replacing the embryos inside the uterus of the second wife of the same husband who provided the spermatozoa. In 1985, however, the council withdrew its approval of surrogacy. The debate has recently been reopened among Sunni scholars: While some religious authorities think that it could be practiced, others believe that, because of the many social, cultural, and legal problems associated with surrogacy, it should not be approved (Serour 2006).

28.6 Multifetal pregnancy reduction Multifetal pregnancy, particularly high-order multiple pregnancy, should be prevented in the first place because of its associated fetal and maternal complications (Serour 1998). Should HOMP occur in spite of all preventive measures, then multifetal pregnancy reduction may be performed, according to the jurisprudence principle that necessity permits the prohibited and the choice of the lesser harm. Multifetal pregnancy reduction is practiced because the prospect of carrying the pregnancy in HOMP to viability is markedly reduced and the risks to the life and health of the mother are increased. It is performed with the intention not to induce abortion but to preserve the life of remaining fetuses and minimize complications in the mother (Serour, Aboulghar, and Mansour 1995; Serour and Dickens 2001; Tantawi 1991).

28.7 Pregnancy in postmenopause In the past, before cryopreservation was developed, the possibility of postmenopausal pregnancy or pregnancy in women with premature menopause was dependent on ovum donation, which in Islam is disapproved of in principle, as it involves mixing of genes. In addition, pregnancy in postmenopause is associated with increased risks for the mother and violation of the right of the child to enjoy having a young-acting mother capable of

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its neonatal care and upbringing for many years during infancy and childhood. Accordingly, it was unacceptable in the Muslim world (Serour 1997). However, with the development of cryopreservation, it is now possible to have pregnancy in postmenopause using one’s own cryopreserved embryos or even oocytes and, possibly in the future, autografted cryopreserved ovaries. Taking into consideration the special care necessary for the safe induction and completion of pregnancy in a woman who is of advanced years or beyond normal childbearing years, and the children’s needs for parents likely to have a reasonable chance of surviving at least into their mid-adolescence, postmenopausal pregnancy is discouraged. Postmenopausal pregnancy in advanced age may be permissible in exceptional cases, justified by the maintenance of integrity of a child’s genetic parentage, the pressing nature of the circumstances, the relative safety to mother and child, and the parental capacity to discharge child-rearing responsibilities (Serour 2006; Serour and Dickens 2001).

28.8 Sex selection The use of sperm-sorting techniques or preimplantation genetic diagnosis (PGD) for nonmedical reasons such as sex selection or balancing sex ratio in the family is guarded. These techniques are a better alternative to prenatal diagnosis, which necessitates abortion for sex selection. Most Muslim scholars adhere to the view that human life requiring protection commences two weeks from conception and uterine implantation (Serour 2002b). This concept was affirmed in November 2007 at an international seminar held in Cairo organized by the Islamic Organization for Medical Sciences in collaboration with ISESCO; the Islamic Fiqh Council in Jeddah; the United Nations Educational, Scientific and Cultural Organization; and the World Health Organization’s Regional Office for the Eastern Mediterranean Region. Accordingly, decisions not to attempt replacement of embryos produced in vitro on the grounds that they show serious chromosomal or genetic anomalies, such as aneuploidy, cystic fibrosis, muscular dystrophy, or hemophilia, are accepted. PGD is encouraged, where feasible, as an option to avoid clinical pregnancy terminations for couples at exceptionally high risk (Serour 2000a; Serour and Dickens 2001). More contentious is sex selection for nonmedical purposes (Serour 2008). Arabs more than 1,400 years ago, before Islam, used to practice infanticide for gender selection. The Koran described this act and condemned it (Sura Al-Nahl 16, 58–5; Sura Al-Takwir 81, 89). It states, in one version, “On God’s Judgment Day, the entombed alive female infant is asked, for what guilt was she made to suffer infanticide?” Sex-selection technologies have been condemned on the grounds that their application will discriminate against female embryos and fetuses, so perpetuating prejudice against the girl child (Fathalla 2000) and social devaluation of women. Contrary to what is being practiced in some Muslim countries, such discrimination and devaluation are condemned in Islam. However, universal prohibition would itself risk prejudice to women in many present societies, especially when births of sons or girls remain central to women’s well-being. Sex-ratio balancing in the family is considered acceptable, for instance, where a wife has delivered three or four daughters or sons and it is in her and her family’s best interests that another pregnancy should be her last. Employing sex-selection techniques to ensure the birth of a son or a daughter might then be approved to satisfy a sense

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of religious or family obligation and to save the woman from increasingly risk-laden pregnancies (Serour 2002c, 2004, 2005b; Dickens et al. 2005). Application of PGD or sperm-sorting techniques for sex selection should be discouraged in principle but resolved on its particular merits with guidelines to avoid discrimination against either sex, particularly the female child. It should not be used for selection of the sex of the first child or for selection of one sex only in the family. Also, it is applied only to families that have children of one sex only and have an intense desire to have one more child of the other sex. The service is provided only after proper counseling with a geneticist, a reproductive-medicine physician, a psychologist, and a social scientist. Centers performing the procedure should keep a record of all performed cases to ensure that they are not choosing one sex only. Sex selection in these cases with these guidelines is different from sex selection merely to satisfy the preference of the parents to have a child of one sex or another, which is strongly condemned (Dickens et al. 2005; International Federation of Gynecology and Obstetrics 2006a). In ethical and legal analysis, the principle of justice that like cases be treated alike receives considerable attention. Less attention is given, however, to the ethical injustice of treating different cases as if they are alike, and of applying an approach to a problem that is appropriate in one setting to a different setting in which that problem does not exist (Dickens et al. 2005).

28.9 Cryopreservation The excess number of eggs or fertilized eggs, or even the ovarian cortex, can be preserved by cryopreservation, particularly vitrification techniques. The frozen embryos are the property of the couple alone and may be transferred to the same wife in a successive cycle, but only during the validity of the marriage contract (Serour 1992, 1997, 2000a). Marriage ends at death or divorce, and procuring pregnancy in an unmarried woman after divorce or after the death of her husband is forbidden by religious principles of the children’s rights to be reared by two parents and by the child’s right to inheritance. Cryopreservation of gametes or gonads before exposure to radiotherapy or chemotherapy or for social reasons is allowed. These gametes or gonads can be used for conception later on by their owner. The cryopreserved gonads can be reimplanted after the end of chemotherapy or radiotherapy, or later in life, based on the request of the owner of the gonads. However, neither gametes nor gonadal tissues can be donated to another person during the lifetime or after the death of their owner (Serour 2006, 2008).

28.10 Embryo implantation following husband’s death Transfer of embryos produced during a valid marriage contract after death of the husband created a vigorous, principled debate (Serour and Dickens 2001). The strict view is that marriage ends at death, and procuring pregnancy in an unmarried woman is forbidden by religious laws on the basis of children’s rights to be reared by two parents and on the basis of their rights to inheritance. After due time, the widow might remarry, but she could not then bear a child that was not her new husband’s. An opposing view, advanced as reflecting both Islamic compassion and women’s interests as widows, was that a woman left alone through early widowhood would be well and tolerably served

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by bearing her deceased husband’s child to result in the enjoyment of the child’s companionship, discharge of religious duties of child-rearing, and later support (Serour and Dickens 2001). The then grand mufti of Cairo, in a personal communication with the author, stated that permission had once been given for embryo implantation in a wife following her husband’s death, based on the circumstances of the particular case. However, this should not be taken as a generalization, and each case should be considered on its own merits (Wassel 2000).

28.11 Embryo research The development of the embryo/fetus advances step by step with its morphological development and growth, from a clot to a lump of flesh, then boned flesh and finally a fully grown infant (Sura Al-Hajj 22, 5; Sura Al-Mu’minoon 23, 14). Until 40 days after fertilization, the embryos in the mother’s womb is a nutfa, then an alaqa for an equal period, then a mudgha. According to Islamic teaching, organ differentiation occurs 42 days after fertilization. Enrollment of the fetus occurs after 120 days following fertilization, although some authorities consider it to occur as early as 42 days postfertilization (Hadith Sharif ). The old threshold of 40 days and upward from conception has been brought back to 14 days, because recent progress in embryology has established that individuality of the new being cannot begin before this date (Serour 2002b). This concept was recently affirmed by scholars and researchers from various Muslim countries during the international seminar on Dilemma of Stem Cell Research held in Cairo in November 2007 (vide supra). Embryo research, for advancement of scientific knowledge and benefit of humanity, is therefore allowed before 14 days after fertilization on surplus embryos donated for research with the free informed consent of the couple. However these embryos should not be replaced in the uterus of the owner of the eggs or in the uterus of any other woman (Gad El Hak 1980, 2000; Serour 2000a). Reflecting the unstructured ethical governance of research in several Muslim countries, each country should form a national research ethics committee to which any proposed research involving the use of gametes or embryos outside the body should be submitted for prior review and approval (Serour and Dickens 2001). Such research should be conducted in state, not private, centers.

28.12 Gene therapy Genetic alteration of embryos before their cells have reached differentiation – that is, while they are still totipotent – would constitute germline manipulation, and there is a prevailing condemnation of this practice in the Muslim world (Serour and Dickens 2001). Gene therapy is a developing area that may be used with assisted reproduction in the future. It is critical that its use be clearly beneficial, focused on alleviating human suffering. The focus on therapeutic applications would exclude purely cosmetic uses and goals of enhancement of nonpathological conditions. Alleviation of genetic diseases and pathological conditions alone would exclude such applications as to make people who would be within the normal range of physical aspect, capacity, and aptitude taller, stronger, and more likely to achieve athletic success or be more intelligent or artistically sensitive or gifted. The background concept is that gene therapy might be

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legitimate not to promote advantage or privilege but to redeem genetically or otherwise physiologically inherited disadvantage (Gad El Hak 1980, 2000; Serour 1992, 1997; Serour and Dickens 2001).

28.13 Cloning Reproductive cloning for the creation and birth of a cloned person, who would be the genetic twin of one born previously, is condemned. Some authorities are sympathetic to consideration of reproductive cloning of cells of a childless sterile man if his wife was willing to bear the child in order to permit discharge of religious duties and relieve family distress and risk of marriage breakdown through the wife’s right of divorce. There would be no violation of the rules against third-party involvement or against confusion of lineage. However, the husband’s father, not the father, would be considered the genetic father of the child, introducing problems of his consent and inheritance laws (Serour and Dickens 2001). Generally, it is considered premature to recommend departing from the prevailing condemnation of reproductive cloning. Nonreproductive cloning, particularly for stem cell production, study, and research intended for human therapy and benefits, is encouraged and not limited by recognition that use of deliberately created embryos is likely to be involved.

28.14 ART practices in different Muslim countries Comparisons of ART practices are quite useful but are relatively infrequent in the scholarly literature on ART (Blyth and Landau 2004, 2009). Rarely are Muslim countries included in contemporary comparisons (Birenbaum-Carmeli and Inhorn 2009). Yet comparisons can help to demonstrate the timeline of ART invention, establishment, and diffusion, and the astounding rapidity with which ARTs have globalized (Inhorn 2003); delineate the similarities in clinical ART practice around the world, thereby demonstrating the scientific literacy and modernity of physicians and patients living in nations on the receiving end of global ART transfers (Inhorn 2003); and indicate the ways in which societies differ in their practice of ART, differences that are most often based on social, cultural, legal, religious, and bioethical norms (Birenbaum-Carmeli and Inhorn, 2009). Traditional Catholic Spain (with its large and growing Muslim Andalusian population), because of its liberal policies allowing all manner of third-party donation, is now the European epicenter of so-called reproductive tourism (Matorras 2005). In 1980, only two years after Louise Brown’s birth in the United Kingdom, the grand mufti of Egypt issued the first fatwa on ART, which permitted ART for Muslims but disallowed any form of third-party reproductive assistance, including surrogacy. By 1986, the first ART center had opened in Egypt, and the first Egyptian ART baby was born in 1987. By 2003, the Egyptian ART industry had truly blossomed, with approximately 50 clinics, 5 of them at least partially state subsidized. However, none of these clinics offer third-party reproductive assistance to Egyptian patients (Inhorn 2003). This ban on third-party assistance has been upheld in many fatwas and bioethical decrees issued since 1980 in the Sunni Muslim countries, including Kuwait, Qatar, Saudi Arabia, and the United Arab Emirates. Such a ban on third-party reproductive assistance of all kinds is now effectively in place in the Sunni world, which represents

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approximately 80–90% of the world’s 1.6 billion Muslims. The ban on third-party reproductive assistance is vociferously upheld for the moral implications of third-party donation for marriage, specifically the comparison to zina, or adultery; the potential for incest among the half-siblings of anonymous donors; and the destruction of nasab, or genealogical lineage to known parents (especially patrilineal fathers), with its devastating implications for kinship, inheritance, family life, and the psychological state of the donor child (Inhorn 2003). However, Ayatollah Ali Hoseyni Khameini, the head of state in Iran, had recently (1999) issued a fatwa effectively permitting both egg- and sperm-donor technologies to be used (Clarke 2009; Inhorn 2006a). The moral justification for allowing donor technologies was included in the text of Khamanei’s fatwa – namely, preserving the marriage of the infertile couple through the birth of donor children in order to prevent the marital and psychological disputes that would inevitably arise from remaining childless indefinitely. Preservation of marriage mattered more to Khamanei than preservation of lineage – an opinion at odds with the majority Sunni thinking on the subject. This millennial moment in Iran had an almost immediate impact in Lebanon. Conservative Shia Muslims, including members of Lebanon’s Hezbollah party, were the first to press for third-party donation, because they followed Khamanei’s spiritual guidance (Clarke 2009). Shia ART physicians began to respond to these requests, developing informal egg- and sperm-donation arrangements within their clinics. The door to donation was opened in Lebanon in 2000 as a direct result of the Iranian lifting of the third-party ban in 1999. Starting with entrepreneurial Shia IVF physicians who cited the new Iranian guidelines, the local Lebanese Shia clergy soon followed, issuing formal fatwas to their followers about the permissibility of third-party reproductive assistance, especially egg donation, which most agreed was now halal, or religiously permitted (Clarke 2009; Inhorn 2006a, 2006b). The lifting of the ban on third-party donation in Lebanon has certainly had its detractors, including physicians, patients, and religious authorities. For those who do contemplate third-party donation – mostly Christians and some Shia Muslims (especially followers of Hezbollah) – donor technologies are widely regarded as a last resort, a kind of necessary evil, or an act of desperation when all else fails (Inhorn et al. 2010). However, not all ART physicians agree with the lifting of the donor ban in Lebanon. Contrary to the generally held presumption that Muslim law is very restrictive on assisted reproduction, Muslim ethics is far more liberal than its Christian counterpart on various practices in assisted reproduction. Furthermore, egg donation, embryo donation, and surrogacy are practiced by Shia Muslims. Multifetal-pregnancy reduction, sex selection, PGD, and nonreproductive cloning are acceptable practices for many Muslims. When offering assisted reproduction services for patients, it is the duty of the physician to satisfy the needs of the patients according to patient’s ethical percepts if doing so does not conflict with the accepted standards of health care. If the physician has a conscientious objection to treatment, it is an ethical obligation for the physician to refer the couple to where their needs can be met, as indicated by the Committee for the Ethical Aspects of Human Reproduction and Women’s Health of International Federation of Gynecology and Obstetrics (International Federation of Gynecology and Obstetrics 2006b).

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References Al-Siyasa (newspaper). Proceedings of Seventh Meeting of the Islamic Fiqh Council in IVF and ET and AIH, Mecca, March 1984. Birenbaum-Carmeli D, Inhorn MC, eds. Assisting Reproduction, Testing Genes: Global Encounters with New Biotechnologies. New York: Berghahn; 2009. Blyth E, Landau R, eds. Third-Party Assisted Conception Across Cultures: Social, Legal, and Ethical Perspectives. London: Jessica Kingsley; 2004. Blyth E, Landau R, eds. Faith and Fertility: Attitudes Towards Reproductive Practices in Different Religions from Ancient to Modern Times. London: Jessica Kingsley; 2009. Clarke M. Islam and New Kinship: Reproductive Technology and the Shariah in Lebanon. New York: Berghahn; 2009. Dickens BM, Serour GI, Cook RJ, et al. Sex selection: treating different cases differently. Int J Gynaecol Obstet. 2005;90,171–177. El Bayoumi AA, Al Ali K. Gene Therapy: The State of the Art. Rabat, Morocco: Islamic Educational, Scientific, and Cultural Organization; 2000. Fathalla MF. The girl child. Int J Gynaecol Obstet. 2000;70:7–12. Gad El Hak AGE. In vitro fertilization and test tube baby in book of fatwa. Dar El Iftaa, Cairo, 1980;1225:1:115:3213–3228. Gad El Hak AGE. Islam: a religion of ethics. In: Serour GI. ed. Proceedings of the First International Conference on Bioethics in Human Reproduction Research in the Muslim World. IICPSR, Cairo, 1991;37–39. Gad El Hak AGE. In: Serour GI, ed. Some Gynecological Problems in the Context of Islam. International Islamic Center for Population Studies and Research. Al-Azhar University, Cairo, 2000. Hadith Sharif, reported by Bokhary and Muslim. Inhorn MC. Local Babies, Global Science: Gender, Religion, and In Vitro Fertilization in Egypt. New York: Routledge; 2003. Inhorn MC. “He won’t be my son”: Middle Eastern Muslim men’s discourses of adoption and gamete donation. Med. Anthropol. 2006a;20:94–120. Inhorn MC. Making Muslim babies: IVF and gamete donation in Sunni and Shia’aa Islam. Cult. Med. Psychiat. 2006b;30,427–450. Inhorn MC, Patrizio P, Serour GI. Third party reproductive assistance around the Mediterranean: comparing Sunni Egypt, Catholic Italy, and multisectarian Lebanon. Reprod BioMed Online. 2010;21(7):848–853. International Federation of Gynecology and Obstetrics, Committee for the Ethical Aspects of Human Reproduction and Women’s Health. Ethical guidelines on sex selection for non-medical purposes. Int J Gynaecol Obstet. 2006a;92:329–330. International Federation of Gynecology and Obstetrics, Committee for the Ethical Aspects of Human Reproduction and Women’s Health. Ethical guidelines on conscientious objection. Reprod Health Matters. 2006b;14(27):148–149. Islamic Education, Science, and Culture Organization. Ethical Reflection of Advanced Genetic Research. Doha, Qatar; 1993. Kattan IS. Islam and contemporary medical problems. In: al Awadi ARA, ed. Kuwait: Organization of Islamic Medicine; 1991:365–374. Matorras R. Reproductive exile versus reproductive tourism. Hum. Reprod. 2005;20:3571. Serour GI. Islam and the Four Principles. In: Gillon R, ed. Principles of Health Care Ethics. London: Wiley; 1994. Serour GI, ed. Ethical Guidelines for Human Reproduction Research in the Muslim World. Proceedings of the First International Congress on Bioethics in Human Reproduction

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Research in the Islamic World. International Islamic Center for Population Studies and Research. Cairo: Al-Azhar University: 1992. Serour GI, ed. Ethical Implications of the Use of ART in the Muslim World. International Islamic Center for Population Studies and Research, Al-Azhar University, Cairo: 1997. Serour GI, ed. Ethical Implications of the Use of ART in the Muslim World: Update. International Islamic Center for Population Studies and Research. Al-Azhar University, Cairo: 2000a. Serour GI. Reproductive choice: a Muslim perspective. In: Harris J, Soren H, eds. The Future of Human Reproduction. Clarendon Press, Oxford; 2000b:191–202. Serour GI. Attitudes and cultural perspective on infertility and its alleviation in the Middle East area. In: Vayena E, ed. Current Practices and Controversies in Assisted Reproduction [report]. World Health Organization, Geneva: 2002a:41−49. Serour GI. Embryo Research: Ethical Implications in the Islamic World. Islamic Education, Science, and Culture Organization, Rabat, Morocco; 2002b. Serour GI. Family and sex selection. In: Healy DL, ed. Reproductive Medicine in the TwentyFirst Century. Proceedings of the 17th World Congress on Fertility and Sterility, Melbourne, 2002c:97–106. Serour GI. Transcultural issues in gender selection. In: Daya S, Harrison R, Kempers R, eds. Recent Advances in Infertility and Reproductive Technology. International Federation of Fertility Societies (IFFS). 18th World Congress on Fertility and Sterility, Montreal, 2004. Serour GI. Islamic perspectives of ethical issues in ART. Middle East Fertil Soc J. 2005a;10:185–190. Serour GI. Ethical guidelines for gender selection: are they needed? Proceedings of the International Conference on Reproductive Disruptions Childlessness, Adoption, and Other Reproductive Complexities, University of Michigan, Ann Arbor: May 2005b:18–22. Serour GI. In: Shenfield F, Sureau C, eds. Religious Perspectives of Ethical Issues in ART: Contemporary Ethical Dilemmas in Assisted Reproduction. London: Informa Healthcare; 2006:99–114. Serour GI. Islamic perspective in human reproduction. Reprod BioMed Online. 2008; 17(3):34–38. www.rbmonline.com/Article/3387. Accessed May 20, 2008. Serour GI, Dickens BM. Assisted reproduction developments in the Islamic world. Int J of Gynaecol Obstet. 2001;74:187–193. Serour GI, Aboulghar MA, Mansour RT. Bioethics in medically assisted conception in the Muslim world. J Assist Reprod Genet. 1995;12:559–565. Serour GI, El Ghar M, Mansour RT. In vitro fertilization and embryo transfer in Egypt. Int J Gynaecol Obstet. 1991;36:49–53. Steptoe PC, Edwards RG. Birth after the reimplantation of human embryos. Lancet: 1978; 312(8085):366. Sura Al-Ahzab 33: 4–5. Koran. Sura Al-Baqara 2: 185. Koran. Sura Al-Nahl 16: 58–59. Koran. Sura Al-Takwir 81: 8–9. Koran. Sura Al-Hajj 22:5. Koran. Sura Al-Mu’minoon 23:14. Koran. Sura An-Nahl 16: 72. Sura Al-Ra’d 13: 38. Sura Al Shura 26: 49–50. Tantawi S. Islamic Sharia and selective fetal reduction. Al-Ahram (newspaper), 1991: 4. Wassel NF. Personal communication, 2000.

29 Jewish law (halakha) and reproduction Joseph G. Schenker 29.1 Introduction Jewish attitudes toward infertility can be discerned from the fact that the first command from God to Adam was, “Be fruitful and multiply” after he was created (Gen. 1:28). This commandment has been interpreted as an obligation on the part of the man to reproduce. The Torah records that all the patriarchs and matriarchs suffered from prolonged infertility: Abraham and Sarah had given up hope of ever having their own children when God gave Abraham the promise that he and Sarah would have a son whose offspring would be greater than the stars in the sky.... God fulfilled his promise with the birth of Isaac. (Gen. 16–21) Rebekah was barren.... It was 20 years after their marriage that the Lord blessed Isaac and Rebekah with twin sons, Jacob and Esau. (Gen. 25:21) Rachel suffered from prolonged infertility; she tried everything she could think of to have children. Once in anguish, she cried out to Jacob, “Give me children, or else I am dead” (Gen. 30:1). She bore Joseph and Benjamin and died giving birth to Benjamin. A Talmudic saying from the 2nd century states, “Any man who has no children is considered as dead.” This position arises from the Bible itself and refers to the words of Rachel, who was barren: “Give me children or else I am dead” (Gen. 30:2). Indeed, many halakhic authorities view infertility as illness. The laws of Shabbat are intricate and form an integral part of the life of the halakhic-committed Jew. However, in cases where life is threatened, these laws are suspended. Many halakhic authorities maintain that infertile couples are considered to be in the category of those who are dangerously ill but whose lives are not in danger. Therefore, it is permitted to ask a nonJew to perform work, to provide infertility treatment on Shabbat for such a person even when a biblical prohibition is involved. A rabbinic disagreement in the Mishnah, the rabbinic literature, deals with the number of children required to fulfill the divine command of procreation. The Shammai school claimed that two sons were sufficient and referred to Moses with his two sons as a proper model. The Hillel school insisted that one son and one daughter were essential. As in most cases, the Talmudic preference is in accord with the Hillel school (as taught by Maimonides). Although a man who has fulfilled the basic command of servant procreation is not obliged by the Torah to continue procreating, he is obliged to be married and not to live in celibacy. The Mishnah raises an interesting question: Does the command to procreate rest equally on men and women, or is it an exclusive obligation of men while women, who bear all of the risk of childbearing, bear no responsibility.

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A directive is given in Isaiah 45:18, which reads, “He did not create the world to be isolate, but rather inhabited.” The quote from Isaiah, commentators have explained, pertains both to men and women – thus, women are included in the obligation to fill the world. Marriage is a legal contract between a man and a woman. The couple commit themselves to their mutual duties and create between them a binding religious relationship that also affects others. From a practical perspective, marriage is a mitzvah, or religious duty, and is considered to be among the most useful means of preventing sexual sins. It is also the proper framework in which to fulfill God’s command to be fruitful and multiply. The duty to marry and procreate is independent of social status or religious position. Moses and other biblical heroes married and had children. In the Temple, the high priest was not allowed to serve on the Day of Atonement unless he was married. Sex is part of human life. The Jewish approach to sex has always been free, healthy, and lacking frustration, and Jewish law recognizes sexual desire. Each partner has conjugal duties toward the other. The wife has conjugal rights based on the mitzvah onah, one of the three elementary duties of the husband: supporting his wife with food and clothing. The frequency of sexual relations to which she is entitled depends on the man’s occupation and his style of life.

29.2 Homosexuality The Torah mentions homosexuality twice in the book of Leviticus: Thou shalt not lie with mankind, as with womankind; it is abomination. (Lev. 18, 22) And if a man lie with mankind, as with womankind, both of them have committed abomination: they shall surely be put to death; their blood shall be upon them. (Lev. 20, 13) The severity of the punishment indicates the seriousness with which the Bible views the act. The historical prohibition of homosexual acts is grounded in a worldview that sees heterosexuality as natural and heterosexual marriage as the only route to religious and personal fulfillment. Modern Orthodox Judaism has begun reevaluating homosexuality. Currently, according to the Orthodox view, homosexuals are diseased and in need of compassion and treatment. Reform Judaism by contrast, holds that, in light of what is seen as current scientific evidence about the nature of homosexuality as a biological sexual orientation, a new interpretation of the law is required.

29.3 Lesbianism In contrast to the biblical prohibition against male homosexual intercourse, lesbian sexual relations are not as controversial from a halakhic perspective, since there is no biblical prohibition. However, the sages consider fornication between women to be similar to that of male homosexual sex – “the doing of Egypt” (Maimonides, IsureyBi’aa 21:8, based on Torat-Kohanim), although the Scriptures make no mention thereof

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nor does it mention a punishment. Only Rav Huna considered such women as true prostitutes, consequently prohibited from marrying a priest (Babylonian Talmud. Shabat 65: a). The dominant opinion in the Talmud considers lesbianism to be mere obscenity without major legal consequences (Babylonian Talmud. Yevamot 76: a). Nevertheless, the post-Talmudic codes advise the court to give a preventive penalty to active lesbian women. The codes also decreed that a man should prevent his wife from associating with women “known to indulge in such practices.” Nonetheless, he is not required to divorce his wife if she is a lesbian (Maimonides. Isurey-Bi’ aa 21–8; Shulchan Aruch. Even- Ha’ezer 20:2). In conclusion, Jewish law forbids lesbianism but treats it less severely than male homosexuality (Schenker and Halperin 1995).

29.4 Evaluation of the infertile couple According to Jewish law, the infertile couple should be diagnosed and treated as a single unit (Schenker 1997). The medical treatment is different for men and women. When evaluating an infertile couple, one should first evaluate the female partner. If pathology is not found, one may proceed to investigate the male. The male factors that should be evaluated are inadequate or abnormal sperm production, ejaculation, or deposition of spermatozoa. The chief halakhic impediment to the standard method of extracting semen (masturbation) is that doing so anywhere but inside one’s wife is prohibited, because it is considered “wasting seed.” Although the halakha prohibits ejaculation outside the woman’s body, poskim ( Jewish legal scholars) have found some flexibility in this prohibition. Examination of the semen for infertility workup is not included in the prohibition against “spilling one’s seed.” According to Jewish law, the preferred method of seminal fluid analysis should be the postcoital test, which is based on examination of motile sperm in a mucus sample collected several hours after coitus. If the results are inconclusive or abnormal (repeated several times), ejaculate should be collected following coitus interruptus, using a special condom. If the methods mentioned above are not possible because of mechanical or emotional reasons, some rabbis permit the collection of an ejaculate induced by masturbation.

29.5 The laws of niddah The laws concerning niddah (the state of menstruation) are some of the most fundamental principles of the Halakhic system. Infertility diagnosis and treatment are likely to raise questions in area of Jewish laws of niddah. The Halakhot (religious laws) surrounding a woman’s menstrual cycle govern the normal sexual life of a religiously committed Jewish couple. Understanding their basic concepts is indispensable to professionals providing fertility therapy to an observant couple. A menstruating woman is called niddah in the Bible and in Talmudic and postTalmudic literature. As long as she is within the status of niddah, sexual contact with her is forbidden. The Bible differentiates niddah, or menses, and zavah, or dysfunctional uterine bleeding. In the case of niddah, the duration of menstrual prohibition is 7 days, even if the bleeding is of much shorter duration.

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A mikveh, or ritual bath, is required for restoration of her regular status. In the case of zavah, mikveh is required after shiva nekiim, a period of 7 entirely clean days. The laws concerning niddah are some of the most fundamental principles of the halakhic system, and the historical development of the relevant tracts through the centuries is also extremely complicated. A summary of the contemporary halakhic rules concerning niddah is as follows: 1. Since the 4th century, there has been no distinction between niddah and zavah. 2. Cohabitation is forbidden until 7 clean days have passed from the end of uterine bleeding. This time interval must be followed by a ritual bath (immersing). 3. Uterine bleeding of short duration requires a minimum abstinence of 5 days plus 7 clean days. 4. Postpartum bleeding is subject to the same rules. These significant family laws are discussed in the Mishnah, the Talmud, the post-Talmudic codes, and the extensive responsa literature (the body of scholarly legal rulings). In practice, any minute amount of bleeding or spotting with or without associated symptoms and regardless of its timing invokes the stringencies of both niddah and zavah: All bleeding must cease before observing the required interval of seven clean days. The woman must go to the mikveh on the evening of the seventh clean day (days begin and end at sunset, not sunrise), and only then are intimate relations permitted. Any amount of bleeding or spotting during the 7 clean days cancels this sequence retroactively, requiring a new 7-day interval. One exception found in the Talmud and the Shulchan Aruch, the Code of Jewish Law, rules that bleeding from a wound or lesion does not render the woman as niddah, even if the wound is in the uterine lining itself. Whereas traumatic bleeding does not create a state of niddah, it is medically significant for a woman beginning the sequence of clean days. All bleeding must cease for 7 days to enable a realistic and accurate internal examination. Mid-cycle bleeding and continuous bleeding contribute to the problem of niddah and can be solved with different hormonal agents to delay ovulation such as clomiphene citrate or treatment with oral estrogen preparations. According to halakha, infertility of 10 years’ duration is an indication for divorce if the wife is still of childbearing age, and modern-day halakhic authorities concur.

29.6 Infertility treatment There are three basic principles, which, with certain restrictions, favor the permissibility of fertility treatment: 1. The commandment to “Be fruitful and multiply.” 2. The mitzvah gemilut hasadim (loving-kindness). 3. Family integrity. Obviously, a childless couple is within the category of personal suffering, and, according to the commandment of loving kindness, there exists a clear obligation to assist them in every permissible way, as long as no one else is thereby harmed.

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Assisted reproduction, according to Jewish law, is based on the following principles: The Mishnah emphasizes that only prohibitive, strict decisions require judicial substantiation, while permissibility or leniency needs no supportive precedent. The absence of a prohibitive substantiation is to be equated with halakhic permissibility. This implies that any technological innovation is permissible unless there is a halakhic reason for prohibiting it. In order to be certain, a competent halakhic authority should be consulted. Jewish law differentiates between the authority to abrogate a temporary prohibition and the authority to determine permanent permissibility. Faced with uncertainty or insufficient information, individuals are entitled to be strict with themselves; no special authority is needed to refrain from action. On the other hand, in order to establish permissibility, there must be unequivocal sources. When there is no clear precedent in halakha to decide the issue at hand, one must be thoroughly versed in all traditional sources before confirming that no comprehensive reason for prohibition exists. There are renowned traditional protocols for deciding controversial issues. If, for example, there is doubt in a matter prohibited by the Torah, the ruling is negative; if the doubt is related to a rabbinical ruling, the decision is usually positive (Talmud Bavli). In order to implement in vitro fertilization (IVF) and embryonic transfer in Israel, support of halakhic authorities is required. In Israel, special legal problems arise due to the exclusive jurisdiction in matters of personal status that is vested in the rabbinical courts (Schenker and Frenkel 1987). Although Israeli law is secular, legislated by the Knesset, Israel’s parliament, matters of personal status are governed by halakhic law and enforced by special rabbinical courts. Matters concerning marriage, divorce, paternity, legitimacy, and bastardy and cases of Jewish identity are therefore adjudicated according to Judaic law by these rabbinical courts. In many other countries, the so-called test tube baby is recognized as a legitimate child of the married couple according to state law, while in Israel the infant must be recognized by the rabbinical court. Cases concerning the other religious denominations living in Israel are governed by their respective communal laws and are referred to the appropriate communal courts. From the Judaic point of view, the two chief rabbis of Israel – one Ashkenazi (representing Jews of European descent) and the other Sephardic (representing Jews of Asian origin) – support extracorporeal fertilization and transfer of the embryo. Jews living outside Israel are subject to the law of the land and, if they wish to, obey the Judaic law on personal status as well. In such cases, the laws applicable to the Jews in Israel are applied to them by local rabbinical authorities when such exist and are recognized (Schenker 2000). While the commandment to be fruitful and multiply is of foremost importance, the question arises as to whether this requirement is fulfilled by having children in any form or by fathering them only in the natural way, in which case having children born through ART would not be a fulfillment of this Halakhic requirement. Various Orthodox poskim have debated the question of whether one fulfills the obligation to be fruitful and multiply through assisted reproductive technology (ART), and the opinion of most is clear: The Scriptures have directed Jews to procreate, and this directive is so critical that Torah scholars agree it can be accomplished by natural or artificial means. Some individual rabbis take a strict position and suggest that legal and biological ties are severed with the removal of the egg and that the fact that the host environment is

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sustained by means of medical intervention could change the biological and legal status of the child (Schenker 2005). Rabbi Eliezer Waldenberg, a leading authority on medical issues in Israel, expressed his opinion that a child conceived through IVF is the offspring of neither the semen donor nor the ovum donor Waldenberg (1983). The Jewish majority’s religious point of view, however, as formulated by the chief rabbis, is that halakha only imposes certain restrictions on the practice of ART, such as the use of gamete donation, surrogacy, sex preselection, cloning, and so on.

29.7 The beginning of human life The development of ARTs has made it necessary to consider the question of the beginning of life and the moral status of the embryo from different perspectives (Schenker 2008). Life is a process that has a beginning and an end. The consensus about the time when human life really begins is still not reached among scientists, philosophers, ethicists, sociologists. Procreation is acknowledged in the Bible to be the gift of God. The halakhic interpretation of when human life begins is extracted predominantly from the halakhic sources. The Bible does not make any direct references regarding the beginning of human life. The first detailed description of the creation of a human being by God points to the moment when human life begins. “Yahveh God formed the man from the dust of the earth and breathed into his nostrils the breath of life and the man became a living nephesh” (soul). Life began for human being when God breathed breath into him (Gen. 2.7). Additional statements in the Torah demonstrate that breath is understood to be essential to life and that when the breathing stops, life ends: “And all flesh that moved on the earth perished, birds, cattle, wild animals, all swarming creatures that swarm upon the earth and all human beings. Everything which had the nishmat (breath) of life in its nostrils, all that were on dry land died” (Gen. 7.21–22). The Bible does not make any other direct references regarding the beginning of human life. The conclusion as to when human life begins can be obtained from the Torah’s stated position on the issue of abortion: And if men strive together, and hurt a woman with a child, so that her fruit depart [if she miscarries] and yet no harm follow, he shall be surely fined, according as the woman’s husband shall lay upon him; and he shall pay as the judges determine. But if any harm follow, then shalt thou give life for life. (Ex. 21: 22–23) According to the Jewish interpretation, if this passages refers to the survival of the woman following her miscarriage, there is no capital guilt involved, and the attacker is merely liable to pay compensation for the loss of her unborn child. “But if any harm follow” (i.e., the woman is fatally injured), the man responsible for her death has to give “life for life.” In that event, the capital charge of murder exempts him from any monetary liability for the aborted fruit ( Jakobovitz 1979). From this interpretation of this passage, it can be inferred that the killing of an unborn child is not considered murder punishable by death in Jewish law. What is explicitly stated in the Jewish law is that murder

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is an offense that is punishable by death: “He that smiteth a man, so that he died, shall surely be put to death” (Ex. 21:12). The responsa literature based on these two passages concludes that the capital charge of murder should be used for death of a man, but not a fetus, which means that complete human life does not begin at the embryonic or fetal stage of development. The Jewish Talmudic law assumes that the full title to life arises only at birth. Accordingly, the Talmud (Talmud, Tohoroth II Oholoth 7:6) describes the situation in which a woman’s life is endangered during childbirth: “If a woman is in hard labor [and her life cannot otherwise be saved], one cuts up the child within her womb and extracts it parts by parts, because her life comes before that of the child. But if the greater part [or the head] was delivered, one may not touch it, for one may not set aside one person’s life for the sake of another.” The legal text states that the fetus must be dismembered and removed limb by limb. However, if “the greater part” of the fetus has already been delivered, the fetus should not be killed. This is based on the belief that the fetus becomes a person only when most of its body emerges from the birth canal. Before personhood has been reached, it may be necessary to sacrifice a potential life in order to save a fully existent human life (i.e., the pregnant woman in labor). After the forehead has emerged from the birth canal, the fetus is regarded as a person, and neither the baby nor the mother can be killed to save the life of the other. A second consideration is that of self-defense. Some Jewish authorities have asserted that if the fetus placed its mother’s life at risk, the mother should be permitted to kill the fetus to save herself, even if the greater portion of its body has already emerged from the birth canal. This ruling, sanctioning embryotomy to save the mother in mortal conflict with her unborn child, is also the sole reference to abortion in the principal codes of Jewish law. It adds only the further argument that such a child, being in pursuit of the mother’s life, may be destroyed as an aggressor following the general principle of self-defense. This formulation of the attitude toward abortion in the classic sources of Jewish law implies that 1. the only indication considered for abortion is a hazard to the mother’s life. 2. otherwise, the destruction of an unborn child is a grave offence, although not murder. 3. it can be viewed that the fetus is granted some recognition of human life, but it does not equal that of the mother’s and can be sacrificed if her life is in danger. Rashi, the great 12th-century commentator on the Bible and the Talmud, states clearly of the fetus, “Lav nephesh hu” (“It is not a person”). Objection to abortion in Jewish law is thus strong but not absolute. It is not permitted even if the fetus carries a genetic conditions or other congenital malformation, nor for social reasons. Abortions are not permitted for economic reasons, to avoid career inconveniences, or because the woman is unmarried. However, some rabbinical authorities have been known to approve abortion in the early stages of gestation, within the first 40 days, during which it is, according to one Talmudic statement, “mere water. The Babylonian Talmud Yevamot 69b states, “[T]he embryo is considered to be mere water until the fortieth day.” Afterward, it is considered subhuman until it

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is born. The fetus has great value because it is potentially a human life. It gains “full human status at birth only.” Each case of abortion must be decided individually by a rabbi well versed in Jewish law.

29.8 Artificial insemination by husband There is near unanimity of opinion that the use of semen from the husband is permissible if no other method is possible for the wife to become pregnant. However, certain qualifications exist: There must have been a reasonable period of waiting since marriage (2, 5, or 10 years or until medical proof of the absolute necessity for artificial insemination by husband, or AIH), and, according to many authorities, the insemination may not be performed during the wife’s period of ritual impurity. It is allowed by most rabbis to obtain sperm from the husband both for analysis and for insemination, but a difference of opinion exists as to the method to be used in its procurement. Masturbation should be avoided if at all possible, and coitus interruptus or use of a condom seem to be preferred methods. Since many important legal and moral considerations that cannot be enunciated in the presentation of general principles may weigh heavily on the verdict in any given situation, it seems advisable to submit each case to rabbinic judgments, which, in turn, will be based on expert medical advice and other prevailing circumstances.

29.9 Artificial insemination by donor Therapeutic artificial insemination by donor (AID) is accepted by the secular Jewish population in Israel (Mor-Yosef and Schenker 1995). According to the regulations of Israel’s Ministry of Health, it is allowed under special conditions. AID is not morally acceptable to all infertile couples or their physicians, however, and it is unacceptable to most rabbinical authorities. Rabbis have been discussing the principles involving AID for many centuries. Their discussions are based on ancient sources in the Talmud and codes of Jewish law dating back to the 5th century. Talmudic passages show that procreation without intercourse was recognized as possible by the sages with regard to the Midrashic legend (one of biblical interpretation) of Ben-Sira’s birth (Schenker 1996). The legend is that the prophet Jeremiah went to the bathhouse, where his semen entered the bathwater. Soon after, Jeremiah’s daughter came and had a bath and became pregnant by her father, resulting in the birth of Ben Sira, recognized as a legitimate child. The legend has since been quoted many times in medical literature and in rabbinical responsa dealing with AID. Some rabbinical scholars, however, deny the legend of Ben Sira’s birth as having followed a conception sine concubitu, or without intercourse. Another ancient source indicating the possibility of conception without sexual intercourse is mentioned by Rabbi Elishah of Corbell in his work Haggahot Semak in the 13th century: “A woman may lie on her husband’s sheets but should be careful not to lie on sheets upon which another man has slept lest she becomes impregnated by his semen.” In the modern era, rabbinical authorities have devoted many discussions to the practice of AID that focus on two issues: Is it permissible, according to Jewish law, to

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perform AID, or is the very act a transgression to adultery? What is the status of the AID offspring? All Jewish legal experts agree that AID using the semen of a Jewish donor is forbidden, but it is the severity of the prohibition that is debatable. The question is whether AID constitutes adultery, which is strictly forbidden by the Torah, or whether the injunction stems from the sources – mainly, the legal complications of the birth of an AID offspring – as most of the experts hold. Some rabbinical authorities permit AID when the donor is a non-Jew. This eliminates some of the legal complications related to the personal status of the offspring. If the semen donor is a gentile, the child is pagan, and blemished; if the child is a female, she is forbidden to marry a priest. AID, according to the Jewish law, is prohibited for a variety of reasons (e.g., the possibility of incest, a lack of genealogical identity, and the problem of inheritance). In addition, semen donors for AID, as well as the physicians who use the semen, are violating the severe prohibition against masturbation. Some halakhic authorities prohibit a married woman who undergoes AID to continue to live with her husband. However, most rabbis state that without intercourse being involved, the woman is not guilty of adultery and is not prohibited from cohabiting with her husband. If the woman undergoes AID without her husband’s knowledge and consent, she must accept a divorce and forfeit any rights to financial support, including her ketubah, or prenuptial agreement, and alimony. AID, also, may not be used to fulfill the requirement of levirate (the obligation a man has to marry his deceased brother’s wife). The child conceived through AID is considered by many rabbinical scholars as having the status of mamzer, or bastard. This status, in keeping with Jewish law, severely limits the offspring’s prospects of marriage, and this implies a severe functional handicap from a social point of view. Some rabbis consider the offspring to be legitimate, as Ben Sira was considered, while others consider it a safek mamzer (probable mamzer). Although it is difficult to equate test tube fertilization with an act of adultery (even if this involves IVF donor sperm), there may still be legal prohibition against IVF of the oocyte of a married woman with a third party’s sperm. This implies that even if that is forbidden, the same prohibition would not affect an unmarried woman.

29.10 Oocyte donation In order to start the clinical trial of an oocyte-donation program in the Hadassah Medical Center at the Hebrew University of Jerusalem, the authorization of a chief rabbi was required. The trial resulted in the world’s first birth using oocyte donation (Navot et al. 1986). In egg donation or embryo donation, the problem that arises is that of who should be considered the mother – the donor of the oocyte or the one in whose uterus the embryo develops, the one who gives birth. If one of the women is Jewish and the other is not, problems will arise, since according to Jewish law, the religious status of the child is determined by his mother. This interesting subject has an apparent precedent in the literature. According to ancient tradition found in the Talmud and the Midrashim, Dinah, the daughter of Leah and Jacob, was first conceived in Rachel’s womb, and Joseph, the son of Jacob and Rachel, was first conceived in Leah’s womb. But in the end, they were exchanged so that the male embryo that was in Leah’s womb was removed and

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implanted in that of Rachel and the female embryo was removed from Rachel’s womb and implanted in Leah’s. The result was that Leah gave birth to a daughter called Dinah and Rachel gave birth to a son called Joseph. This description is based on a Talmudic writing. Throughout the Bible, Dinah is considered the daughter of Leah and Joseph the son of Rachel. Contrary to the Talmudic interpretation, in Jewish law the father of the child resulting from AID is the sperm donor. With regard to motherhood in the case of ovum donation or embryo donation, there is a divisible partnership ownership of the egg and the environment in which the embryo is conceived. Jewish law states that the child is related to the one who finished its formation, the one who gave birth. A judgment is found in the Mishnah that in a case where a person who starts an action but does not complete it and another person comes along and completes it, the one who completed the action is considered to have done all of it. Nevertheless, in spite of the sources just mentioned, it is difficult to rely on them in giving a final determination as to the maternity and Jewishness of the child. The general opinion is that the gestational mother is regarded as a mother. The religious law decrees that only the offspring of a Jewish mother is regarded as a Jew. According to halakha, the donor should be a single woman. The halakha view had influence on the recent legislation in Israel regarding oocyte donation (Knesset 2010).

29.11 Surrogacy The surrogate mother is defined by the British Medical Association as “a woman who carries a fetus and bears a child on behalf of another person or persons, having agreed to surrender that child to this or these persons at birth or shortly thereafter” (British Medical Association 1989). Surrogacy is a source of great controversy in society and in the medical profession. The three forms of surrogacy follow: 1. Partial natural surrogacy 2. Partial surrogacy 3. Complete surrogacy Partial natural surrogacy has been known for thousands of years: The husband of the infertile woman has intercourse with another woman (the surrogate mother), who donates her genetic material and the use of her womb. The child is then given to the man who donated the sperm and to his legal wife, without adoption procedures. The first mother to become a partial natural surrogate was Hagar: “Now Sarai, Abram’s wife, bore him no children. Sarai said unto Abram, go into my maid: it may be that I may obtain children by her. And Abram harkened to the voice of Sarai. And he went into Hagar, and she conceived” (Gen. 16:1–6). The second surrogate mother was the maid of Rachel, who bore a child with Jacob. Surrogacy of this form has been practiced by various tribes and cultures for thousand of years. There are three basic halakhic principles that, with certain restrictions, favor the acceptability of the practice of surrogacy: First, there is the commandment “Be fruitful and multiply.” Second, there is the gemilut hasadim, the mitzvah of benevolence, which

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originates in the verse “Love thy neighbor as thyself” (Lev. 19:8). In cases of personal distress (material, mental, or both) a Jew is duty bound to practice the mitzvah and help one’s neighbor. A childless couple falls within this category, in which a clear obligation exists to assist in every permissible way as long as no one else is thereby harmed. Third, domestic harmony and the integrity of the family are extremely important in Jewish law. Israeli legislation on surrogacy is partly based on halakha.

29.11.1 Legalizing surrogacy in Israel In 1991, Israel’s ministers of health and justice nominated the Aloni Public Committee (the minority report of which was prepared by this article’s author, as a member of the committee) to inspect the social, ethical, religious, and legal aspects of IVF. It was commissioned to prepare a proposal for legislation, with special attention to the question of the surrogate mother. Its main recommendation was that surrogate motherhood through IVF should be allowed but had to be regulated primarily to obtain a priori approval from a statutory body (Ministry of Health 1994). This liberal recommendation reflected the belief of the majority of the committee that principles of autonomy and privacy require minimum state interference in human reproduction. Based on the committee’s recommendations, in 1996, the Knesset passed the Embryo Carrying Agreements Law (Law 5756, 1996), the first state law concerning infertility, as previous legislation was based on current legal regulations established by the Ministry of Health (Schenker and Frenkel 1987). The new law, which states that every case of surrogacy must be authorized by a special committee (Benshuhan and Schenker 1997), resulted in a compromise between the restrictions of Orthodox regulations and the liberal views of secular Israelis.

29.11.2 The state-appointed permission committee A multidisciplinary committee nominated by Israel’s minister of health includes seven members: 1. 2. 3. 4. 5. 6.

Two physicians qualified in obstetrics and gynecology. A physician qualified in internal medicine. A clinical psychologist. A social worker. A lawyer, acting as public representative. A clergyman, representing the religion of the parties involved.

The decisions of the committee must be accepted by the majority of its members and must be made in the presence of at least five of the members, including the chairman.

29.11.2.1 Guidelines set by the committee for surrogacy The guidelines include the following: 1. Full surrogacy is permitted only when the gametes are provided by both parties of the commissioning couple (CC), who are married according to the law of the country. In

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special cases, the committee can authorize surrogacy with ovum donation. Sperm donation is not allowed, since, according to Judaism, it would make the child illegitimate. The parties in the agreement are adult Israeli citizens. ( This requirement is designed to prevent the abuse of women from underdeveloped countries or illegal commercialization of the procedure.) The surrogate mother should be single, widowed, or divorced; otherwise, according to Judaism, the child is illegitimate. In very extreme cases, the committee can authorize an agreement involving a married woman. The surrogate mother is anonymous and not a relative of one of the parents. (Relatives such as mothers, daughters, granddaughters, sisters, aunts, or cousins are excluded. Adopted relatives are permitted.) This avoids any potential pressure on relatives to become surrogate mothers, with subsequent complications within the family. Since the Israeli population is made up of diverse ethnic and religious groups, including Jews, Moslems, Christians, and others, attitudes of the various religions are considered. According to Judaism, the religion of the child is determined by the religion of the mother. Therefore, the surrogate mother and the CC should be of the same religion, although if not all the parties are Jewish, the committee may allow an interreligious agreement following consultation with the clergy on the committee. However, since Moslems and Christians do not allow surrogacy, they are unlikely to approve such an agreement.

29.11.2.2 Expenses One of the main objects of the approving committee is to prevent illegal commercialization of the procedure. The committee supervises the agreement of expenses and can recommend monthly payments to the surrogate mother to cover actual expenses, including medical care, insurance, legal consultation, loss of time and income, suffering, or any other reasonable compensation.

29.11.2.3 Legal status of the newborn Only following the court’s approval will the CC become the child’s sole parents for all matters. In extreme cases, such as in which the child has a malformation at birth or becomes HIV positive during pregnancy, or in any circumstances in which the CC withdraws from the agreement, the surrogate mother becomes the legal guardian of the newborn. In cases in which the surrogate mother refuses to raise the child, its custody will be transferred to the state welfare authorities.

29.11.2.4 Surrogate mother’s withdrawal from the agreement The court will approve the withdrawal of the surrogate mother from the agreement only in cases in which the report of the committee’s social worker provides convincing evidence of a change in circumstances that justifies it and when the well-being of the

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child would not be compromised. After the adoption act has been finalized, the court cannot authorize withdrawal from the agreement. In cases in which the court approves the withdrawal, it should nominate the surrogate mother as the only legal mother and guardian of the child. The court can also rule on the relationship between the child and one or both members of the CC. In the event that the court has granted custody to the surrogate mother, it can order the repayment of expenses to the parties.

29.11.2.5 Legal rights of the surrogate mother The new law should not contradict the rights of the surrogate mother to medical treatments or prevent her from either procuring a medical procedure of her own free will or having it performed, including interruption of pregnancy under the terms set by the law. Neither the CC nor any other body has the right to control the surrogate’s way of life during pregnancy, including nutrition, drinking habits, sexual behavior, or use of drugs. The CC cannot intervene in the prenatal care received by the surrogate mother, nor can it force her to undergo invasive or noninvasive perinatal procedures, such as amniocentesis, against her will.

29.11.2.6 Enforcement of the law According to this law, establishment of a surrogacy agreement without the authorization of the permitting committee is a criminal offence, carrying a prison sentence of one year.

29.11.2.7 Right to privacy Publication of details from the committee’s discussions that include information that could identify any of the parties involved is forbidden and carries a prison sentence of one year.

29.11.2.8 Illegal financing A party that offers, gives, or demands money or benefits for participation in such an agreement without the approval of the committee is committing a criminal offence.

29.11.2.9 Legal adoption Deliverance or acceptance of a child without the presence of the social worker or without a court order carries a prison sentence of one year. The Jewish religion does not forbid the practice of surrogacy. According to Judaism, in cases of partial surrogacy, the father of the child is the sperm donor and therefore is the biological and social father.

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From the religious point of view, in cases of full surrogacy, which was created by the donation of oocyte and sperm by the CC and transferred to the surrogate, the child will belong to the donor of the sperm and to the mother who gave birth. On the other hand, halakha also presents some problems for surrogacy that are only partially resolved. The principal problems are mamzerut, or illegitimacy, and the risk of a biological brother and sister marrying in the future, which would amount to incest. In case the gestational mother is not Jewish, the child born will not be recognized as a Jew. Orthodox halackhic authorities and legal authorities hold that the child is the legal offspring of the birth (host) mother rather than of the ovum donor (Schenker 1998). The fetus, though conceived as a non-Jew, becomes a Jew upon the woman’s conversion. It follows that maternity is established through birth and not through conception. Reform Jewish thought (Washofsky 2008) rejects this ruling and recognizes the oocyte donor as the mother of the child.

29.12 Fetal reduction In recent years, there has been a dramatic increase in multiple pregnancies throughout the world. Undoubtedly, the main factor has been the use of ovulation-inducing drugs and of multiple embryo transfer in the treatment of infertility. Multiple pregnancy has very serious implications for the mother and for her offspring and for the family, the community, and health care resources. Multifetal pregnancy reduction (MFPR) was initially used selectively to terminate a fetus affected by a genetic disorder, but this procedure is now, in general, considered an efficient and safe way to improve the outcome. According to Jewish law, the fetus is regarded as a part of the mother’s body and not as a separate being until it begins to egress from the womb during parturition and attains the status of nephesh. Prior to this time, the fetus is not considered a person. In fact, until 40 days after conception, the fertilized egg is considered to be mere fluid (Eisenberg and Schenker 1997). Abortion on demand is repulsive to the ethics of the halakha; however, in many situations, a pregnancy may be terminated. If, for example, the mother’s life is in danger, each fetus is a rodef, an aggressor who may or must be killed in order to save the individual in danger. Most rabbis permit and even mandate abortion when the health or life of the mother is threatened. Some authorities are stringent and require the mother’s life to be in actual danger, however remote that danger, whereas others permit abortion for a serious threat to the mother’s health. The procedure is prohibited for fetal or social reasons. The question of MFPR was debated in the responsa literature by rabbinical authorities. If the mother’s life is in danger, each fetus is a rodef and can be killed to save the mother. But if the danger is to the fetuses and not to the mother, each fetus is, with equal status for each role, both an aggressor and a victim. In this case, it might not be permissible to put aside one soul for the sake of another. Searching for a legal analogy for this situation, some rabbis focused on the case of a group of people who are in mortal danger and who can be saved by sacrificing one innocent member of the group. Most halakhic authorities agree that in such a case, each person must be prepared to allow himself or herself to die rather than sacrifice an innocent person. If, however, it is absolutely certain that all would be lost unless one is forfeited, these same authorities

29.13 Gender preselection

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would allow some innocent people to be selected randomly and sacrificed to save the others. This conclusion is applicable to cases of a viable person. In the case of fetuses who are already condemned to death, MFPR might well be allowed. Rabbi Shlomo Zalman Aurbach, who was among the most influential rabbinic experts of the late 20th century, was approached with two cases, one involving a woman pregnant with sextuplets and the other involving a woman whose pelvis was too small to support her quadruplet pregnancy. He permitted MFPR in cases where continuing the pregnancy had a high risk of ending in miscarriage of all the fetuses, ruling that each fetus had the status of a rodef. Therefore, he allowed a doctor to abort one or more fetuses after 40 days of gestation. The number of fetuses to be destroyed is a medical question that should be decided by the doctors involved, who must determine the minimum number that need to be reduced to ensure a good prognosis for the mother and the remaining fetuses.

29.13 Gender preselection Interest in sex preselection has its roots in ancient cultures. Examination of current methods of preconceptual gender selection revealed that in vivo methods, such as timing of intercourse, the use of ovulation-induction medications, and artificial insemination, do not appear to affect the sex ratio to a clinically significant degree. Recent scientific advances have made highly reliable preconceptual sex selection possible by using preimplantation genetic diagnosis (PGD) or sperm separation by flow cytometry combined with AIH or IVF (Schenker 2002). Jewish attitudes toward infertility can be discerned from the fact that the first command from God to Adam was, “Be fruitful and multiply.” This is also expressed in a Talmudic saying from the 2nd century, “Any man who has no children is considered as a dead man.” A rabbinic disagreement in the Mishnah deals with the number of children required to fulfill the divine command of procreation. It would have been impossible for the human race to propagate had not one of each sex been created. For the preservation of the race, however, it is necessary for every man to have children of both sexes. With two males, a man has not fulfilled the mitzvah of pru urvu (“Be fruitful and multiply”). The requirement for a Jewish man to procreate by having a minimum of two children, a boy and a girl, is obligatory according to Jewish law. According to both schools, Shammai and Hillel, in order to fulfill the obligation of procreation, at least one son is required. Therefore, the application of sex preselection for nonmedical indications may be of practical importance. Rabbi Ovadia Joseph, Rabbi Mordechai Eliyahu, and Rabbi Shlomo Amar permitted PGD for genetic reasons, and for sex by couples who had several children of the same sex. Using the method of sperm separation or sex selection of a preembryo by PGD is allowed, with some limitations, in Israel for family balancing (Schenker 2002).

29.14 Cryopreservation To date, successful results based on pregnancy rates have been obtained with cryopreserved spermatozoa, embryos, oocytes, and ovarian tissue (Shufaro and Schenker 2010).

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The possibility of cryopreserving sperm for future use is generally welcome when the situation involves a married couple facing an infertility problem. Cryopreservation of the husband’s sperm before the insemination may actually solve certain halakhic problems concerning infertility treatment related to niddah. Some of authorities prohibit an unmarried man from cryopreserving his semen in anticipation of chemotherapy that might leave him sterile. Such a procedure is allowed only to fulfill the halakhic obligation to procreate; it cannot be permitted to secure the semen by masturbation. Cryopreservation of preembryos is at present nearly routinely practiced in IVF programs. The freezing of the preembryo raises the basic question of whether cryopreservation, which stops the development and growth of the embryo, cancels all rights of the preembryo’s father with regard to the mother. The problem is simplified, since the embryo is transferred into her uterus later and will renew the mother-embryo relationship. With regard to the relationship to the father, whose main function is to fertilize the oocyte in order to form the preembryo, the period of freezing may cause a severing of the relationship between the child and his father. Freezing of sperm and preembryos is permitted in Judaism only when all measures are taken to ensure that the father’s identity will not be lost.

29.15 Posthumous reproduction It is possible for posthumous reproduction to occur naturally, where one of the procreators dies after conception but prior to the birth of the child. Advanced in ART makes possible conception after the death of the male or female biological parent through techniques such as the use of gametes that have been stored during his or her lifetime or that were collected immediately after his or her death. Requests have been made to collect sperm from the terminally ill or newly deceased male. Techniques as stimulated ejaculation, microsurgical epididymal sperm aspiration, or testicular sperm extraction might be employed. The advent of IVF and the potential for cryopreservation of ova and ovarian tissue may extend the options for posthumous conception, but with the added requirement of a surrogate uterus for gestation to achieve a pregnancy. The procedures for gamete harvest are technically simple. In addition, embryos obtained while a couple is alive can be frozen for later use by them, but they could also be used for transfer to establish a pregnancy after either the female or male partner or both are deceased. As with frozen ova, a surrogate uterus is required if the woman dies and there is a desire to use the embryo to establish a pregnancy. The use of frozen embryos after the death of one of the contributors can be more complicated in the case of the death of the woman, as it involves a third party – namely, a surrogate mother. In the case of the father’s death, Israeli law allows transfer of such embryos to the wife up to one year after the death of her husband even in the absence of consent, while in cases in which the wife has died, the frozen embryos cannot be used by the biological father with transfer to a surrogate. The Israeli law is relatively liberal; even an Israeli Supreme Court ruling acknowledged a woman’s right to use frozen embryos over the objection of her ex-partner.

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The legal, ethical, social, and religious aspects of posthumous conception are discussed in medical and law literature (Benshushan and Schenker 1998). In the Bible, in a case in which a married man dies without having children, his brother or nearest relative has an obligation to marry the widow and the oldest son is named after the deceased (Deut. 5:25). (Three thousand years ago, this was the most feasible means of ensuring a genetic heir.) If the brother-in-law refuses to marry the woman, he is obliged to go through a humiliating public ceremony because of his unwillingness to establish his brother’s heirs. In fact, King David is the grandson of Ovad, son of Ruth, who was born as a result of this law (Ruth 4:7–10). This practice is no longer observed, but the widow must participate in a symbolic ceremony, releasing the brother-in-law’s obligation. Posthumous reproduction was debated in the halakhic literature. Jewish law permits posthumous reproduction by using cryopreserved sperm and by sperm retrieval after death, to the extent that they are used within the context of a traditional marriage and the husband’s consents. Without the man’s consent, the procedure is forbidden. But if it is clearly known that he would have wanted the procedure done, there is no prohibition against performing postmortem sperm retrieval (Halperin 2001). There is a clear halakhic difference between unknown and uncertain paternity. With postmortem insemination using frozen sperm or with postmortem sperm retrieval, the biological father is known and the controversy over paternity is strictly legal. Therefore, if a widow who was not pregnant at the time of her husband’s death was later inseminated with sperm he donated while still alive and becomes pregnant and gives birth, her deceased husband should be considered as having fulfilled the mitzvah of pru urvu.

29.16 Cloning The cloning of Dolly the sheep (Wilmut et al. 1997) has proved that cloning of adult animals can be accomplished. Animal models have demonstrated that in several mammalian species, such as mice, sheep, and cows, somatic-cell nuclear transfer has resulted in live births that developed into adult animals; this might suggest that reproductive cloning could be achieved in humans. Perspectives for applying cloning technology to human reproduction have generated much controversy. Worldwide legislation, including that in Israel (Knesset 1999, 2004, 2010), has banned reproductive cloning. There has been considerable debate throughout the world regarding the propriety of cloning. The halakhic world has also engaged in considerable discussion of this important issue. These include the questions of whether halakha regards a clone as human, whether a man who produces a child by cloning has fulfilled the mitzvah of pru urvu, and the propriety of an unmarried man or woman cloning himself or herself. A particularly tantalizing possibility has been raised that cloning can prevent a mamzer or mamzeret (a female mamzer) from passing his or her status on to the next generation. Cloning was not mentioned in the Torah; it was not prohibited, and therefore it may be discussed. Human cloning technology has only limited potential in infertility treatment, but cloning is a potential solution mainly to the problems of couples who are

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childless as a result of some etiology of the husband’s infertility (Tanos and Schenker 1998). Some Jewish scholars who hold a fairly positive view of cloning rely on historical tradition and sacred writings, which largely focus on human destiny. A positive view with regard human cloning was expressed by Broyde (1998): 1. There is a parental relationship to the offspring created by in vitro fertilization. 2. There is therefore no prohibition of hash’hat at zeta (destruction of sperm). 3. The mitzvah pru urvu (“ Be fruitful and multiply”) is fulfilled. As with any ART conception, the halakhic mother of a cloned somatic-cell newborn is no doubt the gestational/birth mother. In the case of a male clone, the one who contributed the whole DNA, the paternity should not be questionable, as a natural genetic father is recognized as one who contributes half of the child’s DNA. In the case of a female clone, the potential mother would be more problematic from both the medical aspect and the halakhic one. The potential application of cloning for treatment of infertility may be in the limited cases of female infertility of genetic etiology. If a woman is cloned, who is the clone’s father? It is possible that this creation has no father at all. Some Jewish thinkers fear that cloning human beings might harm the family by changing the roles and relationships between family members that define their responsibilities to one another, as well as patterns of inheritance. In Judaism, religious status is passed down through the mother, and tribal designation is passed down through the father. Thus, a child needs both a mother and a father. However, many regard cloning of a family member as more acceptable than donor insemination or egg donation. One of the fundamental tenets of Judaism is that God wants human beings to use all of their capacities to improve the health of others. In addition, Jewish law does not recognize the human embryo as a human being. Therefore, therapeutic cloning, using embryonic stem cells to cure diseases, is supported by most Jewish scholars.

29.17 Preembryo research The legal status of the preembryo is difficult to establish. If one suggests it is a person, or even a potential person, it has no legal status according to the law in most countries. There is a suggestion that the embryo is property, and by this definition it offends ethical principles. The above suggestions leave open the legal question of the right to use, dispose of, sell, and purchase an embryo. A preembryo or embryo seems not to be a human being for the purposes of criminal law. Deliberate destruction of a preembryo is not a criminal abortion act. According to the Talmud, during the first 41 days from fertilization until the completion of organogenesis, the embryo is defined, for the purpose of certain laws, as plain water. An embryo under the age of 40 days is not considered to be a person in any legal sense. According to this, preembryo research may be permissible if it is carried out in order to enable the sperm owner to have his own child. It is prohibited to use a preimplantation preembryo for research unless the research is essential for saving the preembryo’s life.

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The destruction or use of a preimplantation preembryo for research is forbidden as long as it has the potential to implant. The in vitro creation of preimplantation preembryos for research is allowed if there are real chances that the person providing the spermatozoa may benefit and have his own a child as a result of this research. When this does not apply, the creation of a preembryo for research purposes is strictly forbidden. There is obviously a clear distinction between the preimplantation preembryo and the postimplantation embryo. However, the arbitrary 14-day limit is not recognized by Jewish law. Furthermore, any action or policy that would theoretically lead to an increment in the number of abortions in violation of halakha is against its values. However, once abortion has been performed, the abortus may be utilized for research if doing so will reasonably lead to saving human life. Orthodox Jewish law does not forbid preembryo research, although some rabbinic expositors would permit it in spare embryos only, those left over in IVF treatment, and not in embryos created for the sole purpose of research. Judaism does not consider a human embryo to be a person before 40 days postfertilization, so it can be used for experimentation. The view held by law in Israel is that preembryo research is forbidden (Eisenberg and Schenker 1997; Schenker 2007). Preimplantation diagnosis, which some rabbinic authorities already accept, is likely to be acceptable to most Jewish legal experts when used to prevent serious diseases in offspring. Use of surplus preembryos for embryonic stem cell lines is permitted. The creation of embryos for the purpose of taking their stem cells is a complex issue. While no responsa yet exist specifically dealing with this question, it is likely that rabbinic authorities will not favor such leniency.

References Benshushan A, Schenker JG. Legitimizing surrogacy in Israel. Hum Reprod. 1997;12:1832– 1834. Benshushan A, Schenker JG. The right to an heir in the era of assisted reproduction. Human Reprod. 1998;13:1407–1411. British Medical Association. Council of the British Medical Association, Annual Report, 1989. Broyde M. Cloning people: a Jewish law analysis of the issues. Connecticut Law Rev. 1998;30:2. Eisenberg V, and Schenker JG. The ethical, legal, and religious aspects of pre-embryo research. Eur J Obstet, Gynecol, Reprod Biol. 1997;75:11–24. Halperin M. Post-mortem sperm retrieval. Assia Jew Med Ethics. 2001:4:9–13. Jakobovitz I. Jewish view on abortions. In: Rosner F, Bleich, J, eds. Jewish Bioethics. New York: Sancherin; 1979:118. Knesset. Surrogacy Law, State of Israel, 1996. Knesset. Termination of Pregnancy Law, State of Israel, 1977. Knesset. Prohibition of Human Cloning, 1999, 2004, 2010. Knesset. Oocyte Donation, 2010. Ministry of Justice. Public Professional Commission in Matters of In-Vitro Fertilization. Ministry of Health, Jerusalem, 1994. Mor-Yosef S. and Schenker JG. Sperm donation in Israel. Hum Reprod. 1995;10:965–969. Navot D, Laufer N, Kopolovic J, et al. Artificially induced endometrial cycles and establishment of pregnancies in the absence of ovaries. N Engl J Med. 1986;314:806–811.

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Schenker JG. Religious views regarding gamete donation. In: Seibel MM, Crockin SL, eds. Family Building Through Egg and Sperm Donation. Boston: Jones and Bartlett; 1996:238–250. Schenker JG. Infertility evaluation and treatment according to Jewish law. Eur J Obstet Gynecol Reprod Biol. 1997:71:113–123. Schenker JG. Pre-embryo donation: ethical and legal aspects. Int J Gynaecol Obstet. 1998;60:51–55. Schenker JG. Women’s reproductive health: monotheistic religious perspectives. Int J Gynaecol Obstet. 2000;70:77–86. Schenker JG. Gender selection. J Assist Reprod Genet. 2002;19:400–410. Schenker JG. Assisted reproductive practice: religious perspectives. Reprod Biomed Online. 2005;10:310–319. Schenker JG. Assisted reproductive technology in Israel. J Obstet Gynaecol Res. 2007;33 (suppl 1):551–555. Schenker JG. The beginning of human life. J Assist Reprod Genet. 2008;25:271–276. Schenker JG and Frenkel DA. Medico-legal aspects of in vitro fertilization and embryo transfer practice. Obstet Gynecol Surv. 1987;42:405–410. Schenker JG and Halperin M. Jewish family practice and their evolution. Global Bioeth. 1995;1:35–47. Shufaro Y, Schenker JG. Cryopreservation of human genetic material. Ann NY Acad Sci. 2010;1205:220–224. Tanos V, Schenker JG. Is human cloning justified? J Assist Reprod Genet. 1998;15:1–9. Wahofsky M. Faith and fertility in Reform Jewish thought. In: Blyth E, Landau R, eds. Faith and Fertility: Attitudes Towards Reproductive Practices in Different Religions from Ancient to Modern Times. London: Jessica Kingsley; 2009. Waldenberg EY. Resp, Tziz Elieze, no 45. Jerusalem, 1983. Wilmut I, Schnieke AE, McWhir J, Kind AJ, Campbell KH. Viable offspring derived from fetal and adult mammalian cells. Nature. 1997;385:810–813.

30 Commercialized assisted reproduction Filip Krˇepelka 30.1 Position of reproductive treatment in the economy Reproductive treatment contributes to an increasing number of newborns in developed countries (Mouzon et al. 2009). Many women and men are infertile when they wish to raise children in socioeconomic conditions they find appropriate. Only a small proportion of the population needs reproductive treatment in a particular year. Therefore, its impact on health care, which contributes up to 10% of the gross domestic product in the most developed countries (Pearson 2009), is minor. Reproductive treatment, however, is expensive. The costs of standard in vitro fertilization (IVF) exceed US$10,000 in most countries for most age groups (www.ivfcost.net, Table 2: Average IVF cost worldwide). Therefore, billions are spent on it worldwide, and a reproductive industry has emerged in many countries.

30.2 Commercialization of assisted reproduction Health care is generally based on a consensus of providers and patients. Certainly, the duty to treat in emergency situations, the obligation to care for all patients, mandatory vaccination and quarantines, and involuntary treatment of the insane, plus price and quality regulations, are examples of government interventions in the health care market. Reproductive treatment, however, is more commercialized than other areas of health care. Apart from measures against discrimination, no compulsion to treat is imposed on providers. Exclusively, people showing a desire to be treated are treated. Public reimbursement is limited, and many people pay the whole price for treatment out of their own pockets. Commercialization is apparent in deliveries of genetic material and services. Egg donation is a burdensome and risky procedure that cannot be expected without remuneration. Payments, however, are labeled as compensation for inconvenience, time lost, and related risk. Even sperm is usually not free. An excellent example of commercialization in reproductive medicine is surrogacy, in which the biological mother is paid for to become pregnant. Technologies related to reproductive medicine are also commercialized with patented pharmaceuticals and with licenses. Desperate women and men suffering from infertility can be misguided by inappropriate advertisements from the profit-oriented reproductive industry (Robertson 2007).

30.3 Divergent national policies toward reproductive treatment Many aspects of manipulation with eggs, sperm, and embryos outside the human body are controversial, including donation of gametes (anonymity, remuneration), use of gametes in altered conditions (duration of storage, withdrawal of consent, death of

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donor), use of surplus material, specific patients (single mothers, same-sex couples, or older women), preimplantation diagnosis, and implantation of several embryos and subsequent partial abortion, in addition to surrogate pregnancy. Even IVF based on the egg of a wife and sperm from her husband and subsequent implantation of a resulting single embryo in the wife’s uterus is considered objectionable. The Roman Catholic Church is the most prominent critic of this and other practices in assisted reproduction. National policies vary significantly, based on different religious, cultural, and political attitudes toward reproductive treatment in general and toward its various methods and specific groups of patients. Many nations do not find consensus on assisted reproduction or its aspects. As a consequence, there is often a lack of appropriate legislation or timely changes of applicable law. (For example, Italy switched in 2004 from a liberal stance to restrictions. Nevertheless, its restrictive “legge 40” faced referendum seeking its annulment in 2005 and was restricted by the constitutional court in 2009. Future victory of leftist parties can result in removal of restrictions.) Laws often do not address specific situations, and it is hard to legislate appropriately on quickly developing procedures of reproductive treatment even if there is consensus. Diverse attitudes toward various types of reproductive treatment based on an estimation of their benefits for both affected men and women and for society are reflected in different levels of government spending for various procedures. An absence of global consensus on assisted reproduction is apparent. There is no standardization with international treaties and little effort to adopt them in pertinent organizations such as the United Nations Educational, Scientific, and Cultural Organization and the World Health Organization. Nevertheless, these organizations organize in-depth studies of the issue, useful for comparison of political, social, economic, and legal conditions (Vayena, Rowe, and Griffin 2002). Diverging laws and various economic conditions result in variations in the availability of reproductive treatment. Reproductive tourism can solve problems for infertile women and men. I don’t concur with suggestions (Mattoras 2005) to describe this movement as reproductive exile, because that implies an evaluation of restrictions, and reproductive tourists seek other services abroad due to restrictions in their home country.

30.4 International economic integration and assisted reproduction Liberalized trade in goods among the member states of the World Trade Organization is not applicable for assisted reproduction. Nevertheless, contemporary global economic integration based on voluminous trade contributes to establishment of an international marketplace where commercialized assisted reproduction is feasible. International migration is curtailed, but a short-term stay is sufficient for reproductive treatment. Reproductive tourists are generally welcomed as consumers of services that pump money into national economies. Similarly, people are usually encouraged to travel abroad. There are also no significant restrictions on transfer of moneys necessary for compensation of services purchased abroad.

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Free exchange of knowledge seems to be similarly important as part of economic liberalization. Progress in developing procedures in reproductive medicine result from international cooperation. The purchasing power of women and men seeking infertility treatment is, however, a principal consideration. Many people cannot afford it. Three-fourths of the world’s population lives in countries with a gross domestic product per capita and per year that is significantly lower than the costs of IVF. Advanced procedures of infertility treatment such as IVF are thus available primarily for people living in developed countries.

30.5 Absence of effective restrictions on reproductive tourism Countries with restrictive reproductive policies are incapable of preventing their citizens from seeking reproductive treatment abroad. Travelers’ intentions can be easily hidden; even careful body searches and examinations of luggage would not likely reveal their true purpose for traveling. Return after successful treatment is also easy. Generally, a baby resulting from IVF cannot be distinguished from a child produced by traditional methods. Sanctions for participating in reproductive tourism would hardly be acceptable even with hypothetically effective controls. Restrictions are based on the conviction that human dignity is compromised with assisted reproduction. However, a baby, no matter how it conceived, is no monster. No country could compel a woman who becomes pregnant thanks to reproductive treatment that is restricted in her home country to submit to abortion, especially it emphasizes protection of unborn children. Similarly, fines and imprisonment for women and men seeking restricted treatment abroad are hard to enforce and are thus usually not expected. However, Turkey recently introduced legislation permitting prosecution of parents using donated sperm or eggs for concealing biological ancestry (Telegraph 2010). Certainly, countries with restrictive policies can try to discourage reproductive tourism with campaigns highlighting safety problems, low efficacy, and adverse effects. Ultimately, people who agree with the restrictive policies of their home country would not seek treatment abroad.

30.6 Natural barriers to reproductive tourism Nevertheless, national restrictions are partially effective. First, transportation costs increase, especially if the treatment requires repeated attendance at a foreign reproductive center. Second, reproductive tourists often face a language barrier, and reproductive medicine requires a good understanding about the nature of the treatment. Third, trust in safety and quality of goods and services from abroad is a highly sensitive issue in reproductive treatment. Both reproductive centers and their clients are capable of surpassing these barriers. However, facilities face increased costs and are thus compelled to charge higher prices. As a result, demand decreases to some extent, although there are always infertile people with a strong desire for a child.

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30.7 Intellectual property and assisted reproduction The progress of reproductive treatment is based on a worldwide exchange of experience and knowledge. Nevertheless, such exchange is not free from an economic point of view. Certainly, basic knowledge can be found in textbooks, and experts find information in the professional literature. Similarly, patients can easily find numerous Web pages where aspects of infertility treatment are intensively debated. Modern pharmaceuticals administered to many infertile patients are patented. Their prices thus include royalties or profits for patent holders having a temporary monopoly on production. It is hard to estimate to what extent patenting of pharmaceuticals increases their prices. These costs vary significantly from one country to another due to other reasons. Patenting is harmonized globally with the multilateral conventions administered by the World Intellectual Property Organization. The World Trade Organization, meanwhile, has improved protections of inventions while making that a precondition for further liberalization of international trade. New pharmaceuticals are usually patented worldwide. On the contrary, most countries – the only significant exception is the United States – reject patenting of medical procedures, and attempts to collect royalties face resistance there also (DeBlasio 2004). Worldwide, physicians express their objections, as revealed in a statement of the World Medical Association (1999). In reality, patenting of medical procedures has little importance, at least as far as its consequences for reproductive treatment are concerned. Nevertheless, commerce in knowledge and technology is thus not excluded. Leading centers of reproductive medicine such as Australia’s Sydney IVF make their organization, technology, and equipment available to other centers. An important aspect is reputation: Centers are expected to advertise such cooperation, which, understandably, is compensated. Information about costs and other conditions of such franchising is, however, not disclosed. Similarly, the quality of reproductive treatment is increased with widespread recourse to quality-management systems (ISO 9001).

30.8 Doing business in the reproductive industry The development of methods of reproductive treatment is connected with gynecology and obstetrics clinics at university hospitals and other major health care facilities. Special departments at these hospitals continue to progress in advanced infertility treatment. Nevertheless, reproductive care has been privatized significantly in many countries. Private clinics, managed by senior physicians who have acquired experience in university hospitals, specialize in assisted reproduction or offer the treatment together with other gynecological health care. Joint employment in these hospitals and private business is common, and many of these physicians are also university professors. In addition, these physicians and their colleagues often hold shares in the companies operating the centers. The economic success of assisted reproduction and expectations that the number of women and men facing infertility issues will increase attracts institutional investors.

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Takeovers and mergers in the industry are expected, suggested, and realized, and multinational providers emerge.

30.9 Assisted reproduction in united Europe Both assisted reproduction and antireproductive interventions show limits of consensus of European countries. Many European countries have liberal policies. Nevertheless, Germany and Italy impose significant restrictions on IVF, and various restrictions are also proposed in Poland (Brown 2010). The Council of Europe respects this lack of consensus. The Oviedo Convention on Human Rights and Biomedicine, which clarifies the fundamental rights for health care, avoids addressing controversial issues, and it condemns sex selection and the creation of embryos for research. In addition, the Council of Europe monitors the various policies of its member states. Similarly, the European Court for Human Rights refused to interpret the Convention for the Protection of Human Rights and Fundamental Freedoms against national legislation in many controversial issues. Regarding assisted reproduction, the court accepted, in Evans v. United Kingdom (2007), a ban on the use of embryos created with the sperm of a former partner who has withdrawn his consent. The recent judgment of S. H. and others v. Austria (2010), however, condemns the prohibition of the use of donated eggs and sperm as discrimination. This decision indicates possible future interventions against national restrictions in the name of individual liberty and equality. Liberalization of cross-border economic activities in 27 member states of the European Union makes reproductive tourism easier there than elsewhere. The free movement of services, including health care, is guaranteed. Border controls have ceased, and payments are largely uncontrolled. Socioeconomic cohesion and the harmonization of standards contribute to an improvement in the quality of health care. Directive 2004/23/EC of the European Union addresses the quality of tissues, including gametes (European Union 2004). Approaches toward abortions are similar. The European Union’s Court of Justice has underlined the economic nature of abortions while avoiding a decision on compliance of restrictions with fundamental rights. The European Court for Human Rights rejected for decades most complaints against both restrictive and liberal policies of European countries. This restraint has not evaporated in a recent judgment regarding A, B, C v. Ireland. Similarly, there is also antireproductive tourism in Europe: Women seeking abortion travel from countries with restrictions (i.e., Ireland and Poland) to nations where it is allowed (United Kingdom). Few judgments of the Court of Justice deal accidentally with reproductive treatment (an embryo existing in vitro as a situation analogous to pregnancy protected by labor laws, patentability of biotechnological inventions). There is no judgment examining the different policies of member states toward reproductive treatment and their impact on internal markets. Nevertheless, it would be easy to apply economic freedoms of the European Union on any hypothetical restrictions of reproductive tourism. Reproductive care can be also affected when the Court of Justice requires reimbursement of treatment sought abroad under the same conditions as at home. The member states finance IVF to a limited extent. Differing prices and the ability of infertile women and men to move abroad make it feasible.

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Zealous application of economic freedoms of the European Union by national courts can be seen in R. v. Human Fertilisation and Embryology Authority, ex parte Blood, which found a ban on sperm exportation from the United Kingdom incompatible with the principle of free movement of goods.

30.9.1 Case study: German patients in Czech centers Czech reproductive centers – both departments of university hospitals and private clinics – serve many Czech patients. Over the last two decades, increasing numbers of older women and men there have decided to have children, and thus, demand for reproductive treatment is increasing. Public financing of infertility treatments is considerable (up to four IVF cycles for women under 40 years of age). Nevertheless, there is also a significant foreign clientele, and many patients come from Germany. This exportation of reproductive care can be detected in Web sites for Czech reproductive-treatment facilities. German-language versions of such sites are available, the presence of German-speaking staff is identified, and certificates awarded by German institutions are publicized. Similar Italian and Russian versions of these Web sites indicate other important foreign clienteles. English, of course, omnipresent as the language of global communication, is also represented. Divergent policies among various nations is one explanation for cross-border migration for reproductive treatment. Certain procedures (anonymous donation of gametes, creation of embryos in excess) are prohibited in Germany, whereas Czechs, many of whom are not religious, generally support reproductive medicine. Disputed methods (i.e., anonymous donation, preimplantation genetic diagnosis, partial abortion) are allowed under certain conditions, while others (i.e., surrogate pregnancy) remain unaddressed due to little interest among Czech lawmakers. Assisted reproduction was unregulated in the Czech Republic for decades, but provisions addressing assisted reproduction were inserted in the national health care code in 2006.

References Brown S. Poles apart: focus on reproduction. January 2010, 30–34. http://www.eshre.eu/01/ default.aspx?pageid=912. Accessed April 8, 2011. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine. Council of Europe Treaty Series 164 (the Oviedo Convention). DeBlasio SL. Patents on medical procedures and the physician profiteer. Findlaw. 2004. http:// library.findlaw.com/2004/Sep/19/133572.html. Accessed April 8, 2011. European Union. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Evans v. United Kingdom. ECHR judgment on complaint 6339/05. April 10, 2007. Kraske M, Ludwig Z. Die Babygrenze. Der Spiegel, 2005, 46. http://www.spiegel.de/spiegel/ print/d-43103148.html. Accessed April 8, 2011. Mattoras R. Reproductive exile versus reproductive tourism. Hum Reprod. 2005;20(12): 3571–3573. Mouzon J, Lancaster P, Nygren KG, et al. World collaborative report on assisted reproductive technology, 2002. Hum Reprod. 2009;24(9):2310–2320.

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Pearson M. Disparities in health expenditures in OECD countries: why does the United States spend so much more than other countries? Written Statement to Senate Special Committee on Aging. 2009. http://www.oecd.org/dataoecd/5/34/43800977.pdf. Accessed April 8, 2011. R. v Human Fertilisation and Embryology Authority, ex parte Blood. 1997 2 All ER 687 (Court of Appeal, United Kingdom). Robertson JA. Book review essay: Commerce and regulation in the reproductive treatment industry. Texas L Rev. 2007;85:665–702. http://www.utexas.edu/law/journals/tlr/assets/cur rent/Robertson.Proof.Final.pdf. Accessed April 8, 2011. S. H. and others v Austria. ECHR Judgment on complaint 57813/00. April 1, 2010. Shenfield F, Mouzon J, Pennings G, et al. Cross border reproductive care in six European countries, Hum Reprod. 2010:1–8. http://humrep.oxfordjournals.org/cgi/content/full/deq 057v1. Accessed April 8, 2011. Telegraph. Turkey bans trips abroad for artificial insemination. Telegraph (London), March 15, 2010. http://www.telegraph.co.uk/news/worldnews/europe/turkey/7450571/Turkey-banstrips-abroad-for-artificial-insemination.html. Accessed April 8, 2011. Vayena E, Rowe PJ, Griffin PD, eds. Current practices and controversies in assisted reproduction (report). Medical, Ethical, and Social Aspects of Reproductive Treatment, World Health Organization Geneva, September 17–21, 2001. World Medical Association. Statement on patenting medical procedures, 51st Assembly of the World Medical Association, Tel Aviv, 1999. http://www.wma.net/en/ 30publications/10policies/m30/index.html. Accessed April 8, 2011.

31 The intersection between economic and ethical aspects of ART Georgina M. Chambers 31.1 Introduction Economic and ethical aspects of assisted reproductive technologies (ART) are inextricably linked. There is perhaps no other medical procedure that has such a diverse range of regulatory and funding arrangements between and within countries. Such differences have important ethical implications in terms of challenging existing moral norms, distributive justice, equity of access, clinical practice, and, ultimately, the health outcomes of mothers and babies. There is little doubt that over the last three decades, ARTs have evolved from being considered experimental techniques to becoming a suite of mainstream medical procedures. Latest estimates of worldwide activity indicate that 1.5 million cycles are performed globally each year (International Committee for Monitoring Assisted Reproductive Technology 2010). Utilization in many developed countries has increased by 5–10% annually over the last five years, with the United States and Europe combined accounting for almost 70% of world activity (International Committee for Monitoring Assisted Reproductive Technology 2010; Centers for Disease Control and Prevention 2009; European Society for Human Reproduction and Embryology 2009). It is now estimated that 4.3 million infants have been born worldwide following ART treatment, and in many countries ART children now account for 2–5% of all children born (European Society for Human Reproduction and Embryology 2009; Wang et al. 2009). As such, ART treatments exhibit an important economic and demographic influence on many societies and have a significant impact on the health of nations. The increasing use of ART in developed countries likely reflects the trend of later childbearing and its associated impact on age-related fecundity, rising rates of obesity and some sexually transmitted diseases, as well as increasing awareness, success, and acceptance of reproductive technologies (de Graaff et al. 2011; Kovacs et al. 2003). The picture of ART activity is not as clear in less developed countries, which undertake a fraction of the ART cycles performed in developed countries despite having a similar prevalence of subfertility at about 9% of women of reproductive age (World Health Organization 2003; Boivin et al. 2007). Despite the growth in ART activity, there is a limited understanding of the economics of ART to guide clinical practice and to inform policy regarding decisions around funding and access to treatment. Furthermore, there are a number of features that distinguish ART from other health care interventions that pose unique challenges for health economists and policymakers. Such differences mainly arise from the difficulty in comparing outcomes of fertility treatment to those of other health care interventions – with fertility treatments generating new life, while most other medical interventions are judged by their ability to save, extend, or improve quality of life. Moreover, fertility treatments have considerable ethical, moral, and religious associations that cannot be easily measured or valued by economic methods but that form part of the societal context that informs ART funding decisions and regulation.

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This chapter will first describe a framework to reflect the important intersections and pathways between ethical and economic aspects of ART. It will then elaborate on a number of economic themes, including theories of distributive justice as they relate to ART; the economic costs of ART, including a discussion of the costs associated with ART multiple-births; attempts made to value ART treatment in economic terms; and, finally, a discussion of how consumer affordability influences ART utilization and clinical practice.

31.2 A framework for economic and ethical aspects of ART Figure 31.1 presents a simplified graphical framework of the complex pathways by which sociocultural and moral norms influence ART utilization and clinical practice through their influence on funding arrangements, guidelines and legislation, and patient and clinician behavior. The sociocultural and moral context of a society reflects differing historical, cultural, religious, economic, and political forces that combine to exert a pervading influence on who has access to treatment, who takes it up, and how it is provided and funded. This framework will be used to guide the remaining economic themes described in this chapter. Referring to fFig. 31.1, sociocultural and moral norms are important determinants of a chosen society's funding arrangements for health care in general, and ART in particular. The level of public funding and private insurance for ART in turn influences the affordability of treatment from a patient’s perspective, and ultimately the extent to which financial barriers and incentives drive utilization and clinical practice. Sociocultural and moral norms also influence professional ART guidelines and legislation that govern which ARTs can be legally provided and to whom within a politico-geographic border. Finally, sociocultural and moral norms play an important role in determining patient and clinician behavior. Patients from different sociocultural groups tend to exhibit culturally distinctive treatment-seeking behavior for fertilityrelated problems. In addition, different cultures exhibit varying degrees to which clinical decision making is a joint process between clinician and patient. These culturally driven behaviors exert an important influence in a field such a reproductive medicine, where patient and clinician preferences are high (Bitler and Schmidt 2006). Aside from sociocultural and moral norms there are other societal contructs that influence funding arrangements, guidelines and legislations, and individual preferences and behaviors within a society. For example, ART funding is also influenced by the size of the national or regional health care budget, guidelines and legislation may be restricted due to a specific negative case, and patient behavior is influenced by the extent to which patients believe that having a baby will result in increased personal utility (satisfaction). Furthermore, as shown by the upwardly directed arrows in fFig. 31.1, there are a number of additional factors that influence ART utilization and clinical practice, including the prevalence of infertility in a society (e.g., due to the age distribution), the availability of ART clinics, the degree of underlying medical governance within a health care system, and scientific advances in medically assisted reproduction. There is also a feedback loop whereby the sociocultural and moral norms of a society are shaped by their experience of how ART is practiced and the health outcomes of ART mothers and babies.

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Sociocultural and moral norms

Funding arrangements

Guidelines and legislation

Patient/clinician behavior

Affordability

Utilization and clinical practice

Prevalence

Availability

Medical governance

Scientific advances

Fig. 31.1: Pathways by which sociocultural and moral norms influence ART.

31.3 Distributive justice and funding of ART 31.3.1 International differences in funding There is extensive variation in funding arrangements and reimbursement policies for ART between, and often within countries. These range from generous public funding arrangement in Australia, Belgium, France, and Israel to almost no public funding in the United States, a number of Latin American countries, and most developing countries (fFig. 31.2). The latest survey from the International Federation of Fertility Societies (IFFS) reported that of the 107 countries surveyed, 50 responded to requests regarding insurance coverage for ART, and of those, 32 reported some form of public or private insurance for ART (International Federation of Fertility Societies 2011). Where funding arrangements exist, they tend to reflect the theories of distributive justice that prevails in a particular society. Theories of distributive justice are normative principles that provide the basis for a morally justifiable allocation of benefits and burdens, including the distribution of health care (Beauchamp and Childress 2009). There are a number of key normative theories regarding distributive justice that influence the level of public and private responsibility for purchasing health care, particularly for ART. Utilitarian theories emphasize maximizing net social welfare or utility, placing less of an emphasis on rights and equity. The information provided by techniques of health care economic evaluation, such as cost-effectiveness analysis (CEA), cost-utility analysis (CUA) and cost-benefit analysis (CBA), are primarily based on utilitarian principles where resources are allocated to maximize societal health based on the greatest expected benefit. Economists have devised such methods to focus on the technical considerations of allocative efficiency rather than issues of justice and fairness. These

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High subsidization

Israel: Public funding all cycles up to the birth of two children. Australia: “Unrestricted” public funding with co-payments for procedures and drugs. Private insurance available for hospital procedures. France: Public funding for 4 cycles without co-payments in public clinics for medical infertility. Co-payments in private clinics. Sweden: Public funding all cycles in public hospitals. Partial funding in private clinics. Reimbursement of drugs. Belgium: Public funding of laboratory costs linked to embryo transfer policy. Up to 6 cycles covered in a lifetime. Germany: 50% co-payment required for ART treatment. United Kingdom: Restricted public funding through the National Health Service, dependent on local Primary Care Trust allocation. Most offer 1 cycle for patients who meet strict inclusion criteria. Japan: Means tested partial reimbursement for a limited number of cycles during a limited treatment period. Canada: Ontario the only province to offer reimbursement for 3 IVF cycles for tubal infertility. United States: No public funding. 14 states have state-mandated insurance coverage for fertility treatments, but only 5 cover ARTs.

Low subsidization

Poland: No public funding for ARTs. Indonesia: No public funding or private insurance coverage for ARTs.

Fig. 31.2: Examples of funding arrangements in selected countries, 2008.

evaluation techniques seek to provide information to policymakers to assist them in distributing available resources. The methods involve valuing both the inputs (costs) and outputs (consequences) of competing interventions, or no intervention, and choosing between them based on maximizing expected health outcomes. Consequences are expressed as a single measure. In the case of CEA, it is a natural unit of output such as the live-birth rate from ART treatment. In CUA, the single outcome measure is usually in terms of life years, such as life years gained (LYG), quality-adjusted life years (QALYs) or, as has been adopted by the World Health Organization, disability-adjusted life years gained (DALYs). In CBA output measures are expressed in fiscal terms therefore, the consequences of ART treatment – namely, the birth of a child – are measured in monetary units (Drummond et al. 2005). These three broad categories of economic-evaluation techniques have been adopted as central decision-making tools to inform decisions about health care funding regarding the introduction of new technologies and pharmaceuticals around the world. Agencies that regularly use these decision-making tools including the United Kingdom’s National Institute for Clinical Excellence (NICE), the Canadian Agency for Drugs and Technologies in Health, and the Australian Health Technology Advisory Committee. Utilitarian principles of justice can lead to unjust distributions of resources and do not consider those who are, absolutely or relatively, worse off. However, it has been argued that the utilitarian account of justice can be used to justify public funding for ART because once the number of QALYs of a child born through ART are included in the

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calculus, along with those of the prospective parents, ART becomes very cost-effective (Tännsjo 2007). However, there are difficulties in measuring the utility associated with conceiving a child through ART, with very little empirical evidence in this area. It is also questionable whether society values a QALY of an unconceived individual the same as a QALY from an individual that is already living – therefore, it is difficult to include this type of evaluation in priority setting for health care resource allocation. For example, the NICE Fertility Guidelines explicitly excludes the ethical and moral judgments relating to the value of live-births in their economic analyses (National Institute for Clinical Excellence 2004). Egalitarian theories of justice consider that people should receive basically an equal distribution of health care resources – the principle of equal access for equal need – but, permit inequalities that benefit the least advantaged or the absolutely or relatively worse off. The theory includes judgments of fairness, of a comparable share of resources and burdens with others, and fair equality of opportunity. Egalitarianism recognizes a positive societal obligation to reduce barriers that prevent equal access to opportunity, including disease or disability that prevent basic species-typical levels of functions (Beauchamp and Childress 2009). The implication of this is that each member of society, irrespective of wealth or position, should have equal access to adequate health care, contingent on available resources and decision-making processes. In addition to an adequate level of resources, from an egalitarian standpoint, whether ART treatment receives a share of society’s resources depends on whether society believes infertility to be a medical condition as opposed to a social need, the degree of pronatalism of a society, and whether ART techniques are viewed as morally acceptable. If these barriers are met, an egalitarian perspective would provide public funding for ART to remove inequalities relating to ability to pay or location. Many European countries, such as France and those in Scandinavia, which have a tradition of egalitarianism, provide generous funding for ART treatment through their universal health care systems. Libertarian theories focus not on societal welfare or health care needs, but on the unfettered operation of due processes to support free markets. Therefore, libertarian theories emphasize just procedures as opposed to just outcomes. As a result, a libertarian perspective supports a health care system in which health care insurance is privately and voluntary purchased and society is not morally obligated to provide health care, and should in fact refrain from coercing private property (taxation) for this purpose (Beauchamp and Childress 2009). The United States has traditionally left health care to operate within a free market, with the notable exceptions of Medicare for the elderly and disabled and Medicaid for those on low-incomes. As a consequence, health care is largely privately financed in the United States either directly or through private health insurance, but tens of millions of citizens remain without any form of health insurance. In the case of ART, only 14 states have mandates to include fertility treatment in insurance schedules, and only 5 of these provide insurance for ARTs (Chambers et al. 2009). This lack of insurance coverage, coupled with the high cost of ART treatment in the United States (approximately $12,500 for a fresh IVF cycle), represents a significant financial barrier to access ART. While the theories of distributive justice that dominant a society’s sociocultural and moral norms are reflected in the level and organization of funding for ART, no single theory fully explains the ART funding within a particular country. A number of countries clearly incorporate components of selected theories; for example, New Zealand uses a

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patient scoring system to take into consideration both utilitarianism (cost-effectiveness) and egalitarianism (equal access for equal need) in the decision to provide public funding for up to two ART cycles. However, patients can also fund their own treatment within a free-market setting reflecting libertarian traditions.

31.3.2 Provision of ART in developing countries Much of the global burden of infertility, in terms of numbers of cases, prevalence, and psychosocial stigma, is suffered by couples in developing countries, yet they experience a chronic lack of health care resources for reproductive health, including the treatment of infertility. As a consequence, ART is predominantly used by only a small proportion of worldwide sufferers of infertility – those in selected developed countries. There are a number of unique contradictions and challenges that characterize the picture of infertility and its treatment in developing countries. Despite the fact that developing countries have higher fertility rates (number of children per woman) than developed countries, the overall prevalence of infertility in these nations remains similar to that in developed countries, at about 9% of couples (Boivin et al. 2007). However, substantial geographical variation in the prevalence of infertility do exist, for example, estimates indicate that 30% of couples in Sub-Saharan Africa experience infertility (Nachtigall 2006). Furthermore, the etiology of infertility in developing countries is dominated by tubal factor infertility primarily associated with high rates of sexually transmitted diseases and postpartum infections. Paradoxically, ART remains the most cost-effective treatment to overcome bilateral tubal blockage, but high-cost ART treatment is out of reach of resource-poor developing countries. Furthermore, motherhood, is prized highly in most developing countries, so the problems of infertility are often compounded by a strong social sigma of remaining childless. For women, this substantially increases the risk of isolation, domestic violence, polygamy, and a significant loss of social and economic status. Despite this additional burden, fertility treatment, and in particular ART, are almost universally either unavailable or unaffordable in developing countries (Ombelet et al. 2008). The high rates in infertility in developing countries and the causal relationships between sexually transmitted diseases and reproductive health has been recognized by a number of international organizations and governments. In 2001, the World Health Organization called for the integration of infertility into sexual- and reproductive-health programs, specifically highlighting access to ART and recommending that public funding for ART be sought. Similarly, in 2005, at the United Nations’s World Summit on Millennium Development Goals, world leaders committed themselves to achieving universal access to reproductive health by 2015. However, despite these declarations, very little progress has been made in education and reproductive health care in developing countries (Fathalla et al. 2006). In 2006, the European Society for Human Reproduction and Embryology established the Task Force on Developing Countries and Infertility, which aims to develop simplified, low-cost, integrated approaches to infertility treatment that promote linkages to family planning and maternal and neonatal care (Ombelet et al. 2008). One of the great challenges of ART treatment is the use of expensive drugs, costly consumables, and sophisticated laboratory equipment. In an attempt to provide simplified, low-cost ART in developing countries, a philanthropic organization formed by leading international experts in ART, the Low Cost IVF Foundation, is funded three clinics located in South Africa, the Sudan, and Tanzania to pilot their budget IVF treatment

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package. Their aim is to provide ART treatment for $300 per cycle, a fraction of the cost of ART in developed countries (www.lowcost-ivf.org).

31.3.3 Morally challenging funding decisions The availability of funding for “social infertility”, as opposed to medical infertility, is also influenced by sociocultural and moral norms. Social infertility generally refers to unwanted childlessness by single women or same-sex couples and is excluded from public funding or legislated against by many countries and jurisdictions. Some proponents argue that ART does not solve infertility but overcomes childlessness, and therefore it is morally justifiable to provided funding to the socially infertile. With the changing nature of family structures in many communities and as the impact of ARTs are experienced in different cultures, decisions to restrict ART to married couples with medical infertility will continue to be challenged. For example, the United Kingdom’s Human Fertilisation and Embryology Act of 1990 was revised in 2008 to replace “need for father” with “supportive parenting” as a condition of granting a license to a fertility clinic (International Federation of Fertility Societies 2011). An increasing number of statutes and guidelines cover the idea of evaluating potential parents on behalf of the welfare of the future child (International Federation of Fertility Societies 2011). However, having clinicians decide who should be accepted for treatment, and thus receive funding, raises questions about their ability to make informed judgments on a future child’s behalf, and also raises questions about infringements on patient liberties. Another approach to evaluating the suitability of potential parents has been introduced in Victoria, Australia, whereby ART patients must undertake a check for criminal records and child-protection orders before undergoing IVF or intrauterine insemination treatment (www.health.vic.gov.au/art). The legislation has been criticized as breaching the rights of patients and adding an additional burden to fertility treatment, especially given that couples who conceive naturally do not have to undergo such checks. There is a growing use of donor gametes (sperm and eggs) and embryos for use in ART in most countries. The degree of legislation and commercialization governing donor treatment, and the demand for such services by patients, is greatly influenced by cultural and religious views. In countries that allow donations, several specifically prohibit financial compensation to the donor, including Australia, Canada, France, Greece, Korea, the Netherlands, and Vietnam, while others such as Spain and Czech Republic allow some compensation. By contrast, the United States allows payment for donor gametes and embryos, which has led to a growing, demand-driven market in that country (International Federation of Fertility Societies 2011, Spar 2006).

31.4 The cost of ART treatment 31.4.1 Treatment costs Costs associated with ART treatment can be characterized as direct costs, attributed to providing ART treatment itself, and indirect costs, those occurring as a consequence of ART treatment. Direct costs include medical consultations, ovulation-stimulation drugs, laboratory and embryology services, ultrasound scanning, medical procedures such as

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oocyte retrieval and embryo transfer, hospital charges, nursing and counseling services, and administrative and overhead charges. The cost of ART treatment shows considerable variation among countries. The direct cost of a standard fresh IVF cycle before subsidization by public or private insurance has been recently estimated to range from $12,500 in the United States to $4,000 in Japan and $3,100 in the Netherlands (in 2006 U.S. dollars). The costliness of treatment tends to reflect the costliness of the underlying health care system. For example, the United States is the most costly health care system in the world in terms of both the percentage of gross domestic product spent on health care and per capita spending on health care, with the United States expending almost 2.0 and 2.5 times as much per capita on health care than does the Netherlands and Japan respectively (Connolly et al. 2010). In addition to the costliness of ART treatment, the economic impact of ART is also related to the volume of treatments undertaken in a country, and how much of the total health care dollar this consumes. In a recent review of developed countries, ART treatment constituted more of the health dollar in countries offering public funding than in those not doing so. ART treatment amounted to 0.25% or less of total health care expenditure in all countries surveyed and as little as 0.06% in the United States which has no public funding (Chambers et al. 2009). Therefore, while ART treatment may be expensive from an individual’s perspective, it is not from a national health care perspective even when supported by public funding. This finding is also supported by a number of cost analyses of ART as part of medical insurance plans. For example, an analysis of state-mandated insurance in Massachusetts found that infertility treatment accounted for only 0.41% of insurance expenditures (Griffin and Panak 1998). Cost-effectiveness ratios for ART treatment are generally expressed as the average direct costs of treatment per live-birth (with twins and triplets counted as one live-birth). This ratio is calculated as the total direct ART treatment costs divided by the number of live-birth deliveries, therefore reflecting both the costliness and effectiveness of treatment. Because of the high treatment costs in the United States, cost-effectiveness ratios are relatively high (~$41,000 per live-birth) compared to countries such as Japan with less expensive treatment (~$24,000 per live-birth) (Chambers et al. 2009). Furthermore, because of the age-related decline in ART success rates and an increase in miscarriage rates, the average cost per live-birth for nondonor cycles increases significantly with female age. The live-birth rate per cycle in women 40 years or older is on average 5–10%, compared to approximately 20–30% in women in their 30s (European Society for Human Reproduction and Embryology 2009). Consequently, estimates from NICE indicate that the costs per live-birth are similar for ages 24 to 33 ($22,000), after which they begin to rise, with the cost per live-birth reaching $68,000 at age 42 (National Institute for Clinical Excellence 2004). It has been argued that it is not morally acceptable to use public money to fund medical treatment that has very little chance of success, as is the case with ART in older women. However, many would argue that it is unfair, based on egalitarian principles, to refuse treatment to these women.

31.4.2 The costs of multiple-births One of the most significant medical and ethical challenges facing ART treatment is the high incidence of multiple-birth pregnancies (twins and triplets) following the transfer of more than one embryos during treatment. The multiple-birth rate in the general population

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is 1–2% of births, but the multiple-birth rate following ART treatment is approximately 20% worldwide (International Committee for Monitoring Assisted Reproductive Technology 2010). However, it is important to recognize that there are significant variations in the multiple-birth rate between countries and regions; for example, rates are less than 10% in Australia, Belgium, Sweden, and New Zealand, over 20% in a number of Latin American and Asian countries, and over 30% in the United States. Most of the multiple-birth pregnancies are twins, but, again, the proportion of triplet or higher pregnancies differs significantly worldwide, from less than 0.5% of pregnancies in Australia, New Zealand, and a number of Northern European countries to over 4% of pregnancies in some Latin American and Asian countries (European Society for Human Reproduction and Embryology 2009; Wang et al. 2009; International Committee for Monitoring Assisted Reproductive Technology 2010). While efforts to reduce the number of embryos transferred have been introduced in a number of guises (i.e., legislation, guidelines, restrictions to public funding, professionally led strategic collaborations, patient education programs), ART multiple-births continue to pose an unacceptable hazard. Other fertility treatments that involve ovarian stimulation, with or without artificial insemination, also carry a significant risk of multiple-gestation pregnancy but with less controllable means of avoiding multiple pregnancies (Fauser, Devroey, and Macklon 2005). Multiple-births carry risks to both the mother and the unborn baby. A multiplegestation pregnancy carries significantly higher risks during pregnancy (e.g., preeclampsia, gestational diabetes, miscarriage) and at the time of delivery (e.g., cesarean section, hemorrhage, mortality). Compared to singleton births, twins and triplets have a fivefold and elevenfold risk respectively of being born with a low birth weight and/or preterm, and a threefold and fivefold risk respectively of perinatal mortality. Twins are also 4–6 times more likely to suffer cerebral palsy. A recent analysis of data from the United Kingdom conservatively estimated that 73 infant deaths could have been avoided in 2001 if all ART infants had been born as singletons (Oakley and Doyle 2006). In addition, there is well-documented evidence that parents and siblings of multiple-birth infants suffer adverse psychosocial, relationship, and financial outcomes compared to parents and siblings of singletons (Elster, 2000; European Society for Human Reproduction and Embryology 2000, 2003; Rand, Eddleman, and Stone 2005). While the poorer clinical outcomes of multiple-birth pregnancies are well described, the costs associated with caring for ART multiple-birth infants and their mothers are less appreciated. However, it has been estimated that the cost of care of ART multiples can exceed the cost of ART treatment itself (Collins and Graves 2000). fTab. 31.1 provides an overview of recent estimates of the perinatal health care costs associated with caring for ART singleton and multiple-birth infants and mothers. While the methods used to quantify the costs vary among studies, the economic burden placed on health care systems to care for ART twins and triplets is substantially greater than if the infants had been born as singletons. In addition, the costs of caring for multiple-birth infants have been shown to extend well beyond the perinatal period, reflecting the ongoing morbidity associated with a significant proportion of multiple-birth infants (Petrou, Sach, and Davidson 2001). For example, even nondisabled children with a low birth weight use health care and education resources more intensively to the age of 8–9 years compared to children with a normal birth weight (Stevenson et al. 1996). To limit the incidence of multiple-birth pregnancies, most ART clinical guidelines now recommend limiting the number of multiple-embryo transfers in favor of single-embryo

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Tab. 31.1: Estimates of health care costs of ART deliveries (infants and mothers) ($2006).

Country (year)

Singleton deliveries

Twin deliveries

Triplet deliveries

Time period

Study

United Kingdom (2002)

$6,796

$18,711

$66,365

Pregnancy to one year after birth

(Ledger et al., 2006)

The Netherlands (2002)

$3,298

$17,428

N.A.

Pregnancy to 6 weeks after birth

(Lukassen et al., 2004)

Finland (2001)

$7,839

$21,137

N.A.

Pregnancy to 27 days after birth

(Koivurova et al., 2004)

Australia (2003/04)

$6,640

$19,141

$74,821

Inpatient birth admission to first discharge

(Chambers et al., 2007)

Note: Costs are indexed to 2006 using medical consumer price indexes and converted to U.S. dollars using average 2006 interbank exchange rates.

transfer in most patient groups (American Society for Reproductive Medicine 2006; Human Fertilisation and Embryology Authority 2003). Furthermore, the importance of these indirect ART costs to the health care system are increasingly being recognized in the structuring of public financing and regulation of ART treatment by governments, such as those in Belgium, New Zealand, and Quebec. In Belgium, for example, to attract public funding, only one embryo can be transferred in the first two cycles and two embryos in cycles 3–6 in women less than 36 years old. In women age 36 years or older, two or three embryos may be transferred. Reports suggest that this has led to a reduction in multiple-birth rates to less than 5% without substantially affecting the overall pregnancy rate (Gordts et al. 2005; Karlstrom and Bergh 2007). Such initiatives are supported by a number of studies that have demonstrated that a policy of elective single-embryo transfer in women at risk of twinning, augmented by effective cryopreservation programs, is both clinically effective and cost-effective (Heijnen et al. 2007; Thurin Kjellberg et al. 2006).

31.4.3 Valuing ART treatment from an economic perspective As previously discussed, ART does not lend itself to the usual cost-effectiveness and cost-utility analysis methods for assessing value for money in health care. This is because ART treatment generates new life in addition to improving the quality of life and overcoming childlessness for ART patients. Therefore, ethical and equity considerations need to be included in the decision-making process about appropriate allocation and distribution of health care funding to ART. An alternative approach used to quantify the value of ART is to use cost-benefit analysis methods to measure the benefits of ART in monetary terms, specifically by capturing society’s willingness to pay for ART treatment. Although it is questionable whether willingness to pay methods are applicable to fertility treatments, one pilot study did attempt to quantify ART treatment from an ex-post (user-based) perspective and an ex-ante (insurance-based) perspective. Using contingent valuation to directly quantify

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the monetary value of a baby conceived through ART, the study estimated that the implied willingness to pay for a baby was $241,713 (2006 U.S. dollars) for potential child-bearers in the event that they were infertile, and $2.4 million for society to pay for insurance to allow couples access to ART. These values far exceed the treatment cost of achieving the birth of a child using ART treatment thus reflecting the high value that society places on fertility (Neumann and Johannesson 1994). A limited number of studies have also attempted to value ART-conceived children in terms of their financial return to governments. For example, findings from the United Kingdom indicate that the discounted net tax revenue paid to the state over the lifetime of a singleton IVF child born in 2005 is roughly $208,400 (2006 U.S. dollars). Again, this is considerable compared to the treatment costs of achieving an ART-conceived child, representing an eightfold return on investment for the government (Connolly et al. 2009a).

31.5 The affordability of ART treatment and its implications The main impact of different funding arrangements for ART treatment is their impact on the affordability of treatment from a patient perspective. Affordability is generally expressed as the percentage of household or disposable income that a good or service represents. In the context of ART, affordability is the economic burden placed on individuals or families to pay for ART treatment. The main drivers of affordability are the cost of providing ART treatment (and its substitutes) subsidization, and available income. Therefore, these three determinants – the direct costs and level of subsidization relative to income – combine to determine the degree of consumer affordability of ART. For example, ART treatment may be very costly, but if it is highly subsidized, it may become highly affordable for many patients. Affordability, in turn, is an important determinant of equity of access either by creating of removing financial barriers. Affordability also has important implications for how ART is practiced in terms of embryo transfer practices, patient mix, and in the use of alternate fertility treatments. As a result, affordability from a consumer perspective, as opposed to the perspective of a health care budget, has important repercussions for the safety of ART treatment and the health outcomes of both mothers and babies.

31.5.1 Affordability and utilization ART utilization rates are contingent on a number of interrelated factors (refer to Fig. 31.1). However, the few studies available on financial access to ART suggest that affordability is a powerful determinant of whether couples will pursue or discontinue of treatment, and their choice of fertility treatments (Staniec and Webb 2007). This is illustrated at the macro level by the considerable international differences in per capita utilization rates. A recent review of economic aspects of ART in developed countries with varying funding arrangements (Australia, Canada, Japan, the United Kingdom, and the United States, as well as Scandinavia as a region) showed that while the largest number of ART cycles were performed in the United States, it had one of the lowest utilization rates of developed countries, with 373 nondonor cycles per million of the population. By comparison, Australia and Scandinavia had relatively high utilization rates, at 1,574 and 1,465 nondonor cycles per million respectively (Chambers et al. 2009). Given that approximately one half of couples do not seek medical assistance for subfertility,

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there is potentially a high unmet demand for ART treatment in many countries (Boivin et al. 2007). The European Society of Human Reproduction and Embryology estimates that 1,500 couples per million of the population require ART treatment annually (European Society of Human Reproduction and Embryology 2001). Although couples may undergo more than one cycle in a given year, 1,500 cycles per annum is considered a conservative underestimate of true demand. Therefore, while Australia and Scandinavian countries achieved this benchmark, only 25% and 40% of the demand for ART treatment cycles was met in North America, and in the United Kingdom, respectively (Chambers et al. 2009). The review by Chambers et al. (2009), also found that the cost of a single fresh IVF cycle as a percentage of an individual’s annual disposable income ranged from 50% in the United States to approximately 20% in Australia, Scandinavian countries, and the United Kingdom, to 12% in Japan. After accounting for government subsidies, the resultant cost to the patient of an IVF cycle was unchanged in the United States and Japan (due to negligible public funding for ART treatment) but fell to approximately 12% of annual disposable income in Scandinavia and the United Kingdom. The greatest effect of public subsidization was in Australia, with a 71% reduction in the cost of an ART cycle as a percentage of disposable income – from 19% before government subsidization to 6% after government subsidization (fFig. 31.3). Such differences in the affordability of treatment would predict, and have indeed resulted in, substantial differences in the level of ART utilization, with a trend to higher per capita utilization in countries with more affordable treatment (e.g., Australia has one of the highest utilization rates of ART in the world, while the United States has one of the lowest). The measure of the responsiveness of demand to changes in consumer price is known as the price elasticity of demand and is often used by policymakers to predict how changes in user charges will impact consumer behavior and health care budgets. Few studies have explicitly measured the price elasticities of ART, but a recent analysis of data from Germany suggests that a 10% price increase in ART treatment (associated with the introduction of a copayment for ART in 2004) likely reduced utilization by 4.1% for IVF and 3.4% for intracytoplasmic sperm injection (Connolly et al. 2009b). There is also growing evidence that the patient mix of those who pursue ART is influenced by the affordability of treatment. A number of studies comparing ART utilization across different states in the United States with and without insurance coverage for fertility treatment show that even when the cost of treatment is subsidized, ART treatment tends to be more frequently used by older, wealthier, more highly educated white women. There is also some evidence that a greater proportion of patients with either a relatively poor prognosis or a relatively good prognosis access ART treatment when it is subsidized due to lower expected benefits from treatment (Reynolds et al. 2003). Further, racial, ethnic, and educational disparities to access fertility care are not generally reduced by state insurance mandates to cover fertility treatment (Bitler and Schmidt 2006; Jain 2006). For example, first-birth rates for African American women remain unaffected in states with mandates for insurance coverage for infertility (Bitler and Schmidt 2006). Due to the extensive differences in the regulation, availability, and cost between countries, an increasingly significant but unknown proportion of patients travel to

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another country to receive fertility treatment – so called cross-border reproductive care (European Society for Human Reproduction and Embryology 2008). Given the mobility of patients and corporations in a global economy, it is likely that cross-border ART treatment will continue to grow, with the only constraint to patients seeking treatment being their capacity to pay. A recent survey of the reasons patients sought cross-border reproductive care in six European countries was unable to fully quantify the impact of cost, but found that only 13% of patients who sought cross-boarder reproductive care received partial reimbursement and only 4% received total reimbursement in their native country. The survey found that the majority of patients cross borders for legal reasons – either because of a specific ban on some technique, such as gamete donation, or because of a prohibition against treating patients with specific characteristics, such as age or sexual preference (Shenfield et al. 2010). For example, while a number of countries allow the donation of gametes, they prohibit the explicit sale of gametes. A notable exception to this is the United States, where commercial markets for gametes and surrogates are growing due to increasing demand from infertile couples. Aided by the Internet, prospective patients can choose desirable features from catalogues and pay

Percentage of annual disposable income

60% Gross cost of a standard cycle as a percentage of disposable income. Net cost of a standard cycle as a percentage of disposable income after government subsidization.

50% 40% 30% 20% 10% 0% United States

Canada

United Kingdom

Scandinavia

Japan

Australia

Fig. 31.3: Average cost of a standard IVF cycle as a percentage of annual disposable income (consumer affordability) in selected developed countries in 2006. Reproduced from Chambers et al. 2009. Notes: Annual disposable income is based on a single person at 100% of average earnings with no dependents. The estimated percentage reduction in the average cost of a standard IVF cycle due to government subsidization was 71% for Australia, 11% for Canada, 0% for Japan, 25% for the United Kingdom, and 50% for Scandinavian nations. In the United States, there is negligible government subsidization for ART; however, the central role of private insurance in the United States was included in the analysis, reducing the average price of a standard cycle by 12%.

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in the tens of thousands of dollars to procure gametes or gestational carriers (Spar 2006). An ethical risk of cross-border care is that it can lead to different standards of care, exploitation of the local population, and less responsible embryo-transfer practices (European Society for Human Reproduction and Embryology 2008s). Furthermore, when such treatment is successful, the maternal, perinatal, and lifetime health care costs are borne by the native health care system. There is also some anecdotal evidence that a lack of affordable treatment incentivizes patients and clinicians to opt for cheaper fertility treatments, such as stimulated intrauterine insemination and ovulation stimulation, which have less controllable means of minimizing multiple-births. Further, such treatments are not as highly monitored by national registries and can often be undertaken by nonspecialist practitioners (Fauser, Devroey, and Macklon 2005).

31.5.2 Affordability and clinical practice Treatment affordability has also been shown to influence clinical practice and treatment choices. Analysis of data from the United States shows that fewer embryos are transferred per cycle in states with mandated complete ART insurance coverage than those with partial or no ART insurance coverage. States with mandated insurance coverage also have lower live-birth rates per cycle and lower multiple-birth rates (Henne and Bundorf 2008; Jain et al. 2002; Martin et al. 2011, Reynolds et al. 2003). Similar differences in embryo-transfer practices have also been observed between the United States, which is characterized by high treatment costs and low affordability, and Europe, which typically has less costly treatment and more generous funding arrangements (Gleicher, Weghofer, and Barad 2006). Similarly, there is a correlation between the level of consumer affordability and the average number of embryos transferred across a broad range of developed countries (fFig. 31.4). The predominant hypothesis proposed to explain these differences is that the substantial economic burden placed on individuals in markets without subsidization (through either public or private insurance) creates a strong financial incentive to achieve pregnancy in a limited number of cycles, theoretically leading to the transfer of multiple embryos. However, whether differences in live-birth rates and multiple-birth rates are solely due to differences in embryo-transfer practices, or are also partly due to differences in patient characteristics, remains unclear (Henne and Bundorf 2008; Reynolds et al. 2003). There is some evidence, for example, that a greater proportion of patients with a poorer prognosis access ART treatment when it is subsidized. These patients have fewer embryos to transfer and lower implantation rates, which in turn results in lower multiple-birth rates. Conversely, a greater proportion of patients with a good prognosis may also access ART when it is subsidized, rather than continue to attempt a spontaneous conception. In this group of patients, it would also be typical to transfer lower numbers of embryos per cycle, resulting in fewer multiple-births. There is also pressure on clinics operating in highly competitive markets to emphasize and advertise pregnancy rates as successful treatment, rather than singleton live-birth rates (Schlaff 2003). There is, however, a growing movement internationally to adopt universal measures of ART success that emphasize cumulative singleton livebirth rates over a number of treatment cycles, rather than intermediary measures such

Average number of embryo transferred (fresh), 2006

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3.0

2.5

Canada

United States

United Kingdom

2.0 Japan *

Scandinavia

1.5 Australia

1.0 0

10

20 30 Consumer affordability (%)

40

50

Fig. 31.4: Affordability and average numbers of embryos transferred in selected developed countries in 2006. *The estimate of the average number of embryos transferred in Japan is based on 2002 data. Notes: Unpublished data. Consumer affordability estimated as the net cost of a standard IVF cycle after government subsidization as a percentage of annual disposable income. Annual disposable income is based on a single person at 100% of average earnings with no dependents.

as pregnancy rates, the latter of which overestimates the success of ART and ignores multiple-births.

31.5.3. It makes economic as well as clinical sense to reduce multiple-births A small number of studies have shown that savings to the health care sector by reducing multiple-births though elective single-embryo transfer can offset the cost of additional ART treatment cycles needed to achieve similar cumulative live-birth rates. This was the argument used by Belgian opinion leaders in reproductive medicine to promote public reimbursement of ART treatments; savings from a reduction in multiple-births, through restricted embryo transfer policies, would provide funding for ART treatment to those who need it while ensuring better perinatal outcomes (Gordts et al. 2005). To illustrate this phenomenon, a recent study calculated the savings to the public health care system from the voluntary shift by clinicians and patients in Australia to single-embryo transfer. The shift to safer embryo transfer practices occurred against a backdrop of supportive public funding of ART services through the universal health insurance scheme. Australia witnessed an increase in the proportion of single-embryo transfer cycles from 29.5% in 2002 to 67.7% in 2008, with almost 100% of cycles transferring no more than two embryos in 2008. As a consequence, the ART multiplebirth rate dropped from 19% to 8% between 2002 and 2008. This resulted in savings

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in birth-admission costs alone of more than $40 million (2008 U.S. dollars), which theoretically funded over 50% of the increase in ART utilization over that time equating to the birth of 2,600 ART infants (Accepted for publication, Chambers, Illingworth, and Sullivan). Similarly, a British study estimated that 10,124 treatment cycles per year could be publicly funded in the United Kingdom by eliminating ART multiple-births (Ledger et al. 2006).

31.6 Conclusion The tremendously diverse funding arrangements for ART treatment illustrates the intrinsic relationship between sociocultural and moral norms and the allocation of health care resources to ART treatment. Oft-changing funding arrangements within politicogeographic borders also illustrate society’s sensitivity to aspects of ethical and distributive justice with regard ART. The use of ART can be expected to grow worldwide over the coming decade as the demand for treatment for medical and social subfertility increases. It is important that policymakers learn from the lessons of other countries while respecting the sociocultural and moral norms of their own society in making decision about funding of ART. The relative affordability of treatment from a consumer perspective has important implications for who has financial access to treatment, utilization rates and clinical practice. An important ethical problem is the continuing high incidence of multiplebirth infants in countries and regions where ART is not supported as part of public or private insurance plans. The medical and economic impact of caring for the increased incidence of adverse health outcomes suffered by ART twins and triplet is unquestionable, and can be avoided through the transfer of a single embryo during treatment. However, as has been shown in countries such as Australia, Belgium, and Sweden, this is best achieved against a backdrop of supportive funding for ART. Policymakers need to be aware that financial barriers to treatment not only create inequities in access but also impact clinical practice in such a way that the health outcomes of women who undergo ART treatment, and their babies, can be adversely affected. All children deserve the best possible start in life, including the children born with the assistance of ART who are particularly vulnerable to policy decisions and market forces that play out before they are even conceived.

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