The UNESCO Universal Declaration on Bioethics and Human Rights Background, principles and application Edited by Henk A. M. J. ten Have and Michèle S. Jean The UNESCO Universal Declaration on Bioethics and Human Rights Published by the United Nations Educational, Scientific and Cultural Organization 7, place de Fontenoy, 75352 Paris 07 SP, France © UNESCO 2009 All rights reserved ISBN 978-92-3-104088-7 The designations employed and the presentation of material throughout this publication do not imply the expression of any opinion whatsoever on the part of UNESCO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. The authors are responsible for the choice and the presentation of the facts contained in this book and for the opinions expressed therein, which are not necessarily those of UNESCO and do not commit the Organization. Typeset by UNESCO Publishing Printed by Nouvelle Imprimerie Laballery, Clamecy Printed in France • • • • fifth proofs • • • • THE UNESCO UNIVERSAL DECLARATION ON BIoethICS AND HUMAN RIGhts BACKGround, PRINCIPLES And APPLICATION Edited by Henk A. M. J. ten Have and Michèle S. Jean Ethics series UNESCO Publishing • • • • fifth proofs • • • • Contents PREFAce 9 CONTRIbutors 11 1. IntroductIon 17 Henk A.M.J. ten Have and Michèle S. Jean 2. The PREAMBLE 57 Héctor Gros Espiell 3. ARTICLE 1: SCOPE 67 Michael Kirby 4. ARTICLE 2: AIMS 81 Michael Kirby 5. ARTICLE 3: HUMAN DIGNITY AND HUMAN RIGHTS 91 Roberto Andorno 6. ARTICLE 4: BENEFIT AND HARM 99 Edmund D. Pellegrino 7. ARTICLE 5: AUTONOMY AND INDIVIDUAL RESPONSIBILITY 111 Donald Evans 8. ARTICLE 6: CONSENT 123 Regine Kollek 9. ARTICLE 7: PERSONS WITHOUT THE CAPACITY TO CONSENT 139 Jean F. Martin 10. ARTICLE 8: RESPECT FOR HUMAN VULNERABILITY AND PERSONAL INTEGRITY 155 Maria Patrão Neves 11. ARTICLE 9: PRIVACY AND CONFIDENTIALITY 165 Jeanine-Anne Stiennon 12. ARTICLE 10: EQUALITY, JUSTICE AND EQUITY 173 Gabriel d’Empaire • • • • fifth proofs • • • • 6 THE UNESCO UNivErSAl DEClArATiON ON BiOETHiCS AND HUMAN rigHTS 13. ARTICLE 11: NON-DISCRIMINATION AND NON-STIGMATIZATION 187 Glenn Rivard 14. ARTICLE 12: RESPECT FOR CULTURAL DIVERSITY AND PLURALISM 199 Michel Revel 15. ARTICLE 13: SOLIDARITY AND COOPERATION 211 Alphonse Elungu 16. ARTICLE 14: SOCIAL RESPONSIBILITY AND HEALTH 219 Adolfo Martínez-Palomo 17. ARTICLE 15: SHARING OF BENEFITS 231 Hans Galjaard 18. ARTICLE 16: PROTECTING FUTURE GENERATIONS 243 Takayuki Morisaki 19. ARTICLE 17: PROTECTION OF THE ENVIRONMENT, THE BIOSPHERE AND BIODIVERSITY 247 P. N. Tandon 20. ARTICLE 18: DECISION-MAKING AND ADDRESSING BIOETHICAL ISSUES 255 M.A. Hamdan 21. ARTICLE 19: ETHICS COMMITTEES 265 Claude Huriet 22. ARTICLE 20: RISK ASSESSMENT AND MANAGEMENT 271 Michèle S. Jean 23. ARTICLE 21: TRANSNATIONAL PRACTICES 283 Leonardo D. de Castro 24. ARTICLE 22: ROLE OF STATES 293 Hélène Boussard 25. ARTICLE 23: BIOETHICS EDUCATION, TRAINING AND INFORMATION 303 Giovanni Berlinguer 26. ARTICLE 24: INTERNATIONAL COOPERATION 309 Ousmane Blondin Diop 27. ARTICLE 25: FOLLOW-UP ACTION BY UNESCO 317 Nouzha Guessous Idrissi • • • • fifth proofs • • • • CONTENTS 7 28. ARTICLE 26: INTERRELATION AND COMPLEMENTARITY OF THE PRINCIPLES 327 Eugenijus Gefenas 29. ARTICLE 27: LIMITATIONS ON THE APPLICATION OF THE PRINCIPLES 335 Patrick Robinson 30. ARTICLE 28: DENIAL OF ACTS CONTRARY TO HUMAN RIGHTS, FUNDAMENTAL FREEDOMS AND HUMAN DIGNITY 343 Patrick Robinson CONCLUDING WORDS 349 Pierre Sané UNIVERSAL DECLARATION ON BIOETHICS AND HUMAN RIGHTS 355 PUBLICATIONS ON THE UNIVERSAL DECLARATION ON BIOETHICS AND HUMAN RIGHTS 367 • • • • fifth proofs • • • • PREFACE In October 2005, the General Conference of UNESCO adopted by acclamation the Universal Declaration on Bioethics and Human Rights. The Declaration addresses ethical issues related to medicine, life sciences and associated technologies as applied to human beings, taking into account their social, legal and environmental dimensions, and states fundamental principles that are relevant from a global perspective. It is the first time in the history of bioethics that Member States committed themselves and the international community to respect and apply such fundamental principles. Since its adoption, the Declaration has very quickly become a reference text. A growing number of scholarly and popular publications are discussing and examining the Declaration. Several books have been published in various languages analyzing the provisions of the Declaration. The text of the Declaration has been translated into approximately 30 national languages. The Declaration is also increasingly used as a resource and as teaching material in educational programmes for young scientists and health care professionals. UNESCO is currently developing a proposal for a bioethics course based on the principles set out in the Declaration. The Declaration has furthermore inspired Member States to establish national bioethics committees and to take legislative measures to give effect to the principles included in the Declaration. The present book provides a new impetus to the promotion and dissemination of the Declaration and is part of the continuous effort of the Organization to provide information on the Declaration worldwide and to contribute to the understanding of its principles. Presenting an article by article commentary, each chapter highlights the discussion of the relevant article during the process of drafting and elaborating the Declaration so that the historical background of the adopted text is clarified. It also provides suggestions for the use and application of the relevant article in considerations and debates concerning salient bioethical issues and questions. In doing so, • • • • fifth proofs • • • • 10 THE UNESCO UNivErSAl DEClArATiON ON BiOETHiCS AND HUMAN rigHTS each chapter promotes opportunities for informed pluralistic public debate, as requested in the Declaration itself. The chapters have been written by authors who, with a few exceptions, have themselves been involved in the drafting and elaboration of the text of the Declaration, as members of the International Bioethics Committees, the Intergovernmental Bioethics Committee or as governmental representatives in expert meetings, the Executive Board and the General Conference. It is obvious that what they present is not the official view of UNESCO as regards the interpretation of the Declaration. But the authors’ involvement in the development of the Declaration in its various stages assures well-informed and high-level contributions to the promotion of the Declaration. Koïchiro Matsuura • • • • fifth proofs • • • • CONTRIbutors Andorno, roberto Senior Research Fellow at the Institute of Biomedical Ethics of the University of Zürich, Switzerland; former Adjunct Professor of Civil Law at the University of Buenos Aires, Argentina; member of the International Bioethics Committee (1998–2005). Berlinguer, giovanni Emeritus Professor of Medicine at the University ‘la Sapienza’, Rome, Italy; member of the International Bioethics Committee (2000–2007); Honorary President of the Italian National Bioethics Committee; member of the European Parliament (2005–2009). Boussard, Hélène PhD researcher, European Institute, Florence, Italy; Scientific Officer, Global Ministerial Forum on Research for Health, Geneva, Switzerland. De Castro, leonardo Professor of Philosophy at the University of the Philippines, Manila; member of the International Bioethics Committee since 2000; Vice-Chairperson of the International Bioethics Committee (2002–2007). D’Empaire, gabriel Magister in Bioethics; Professor of Bioethics at the School of Medicine, Central University of Venezuela; President of the Association of Clinical Bioethics; member of the International Bioethics Committee since 2004. • • • • fifth proofs • • • • 12 THE UNESCO UNivErSAl DEClArATiON ON BiOETHiCS AND HUMAN rigHTS Diop, Ousmane Blondin Master of Anthropology-Ethnology and Religious Studies, University Paris VII; Permanent Delegate of Senegal at UNESCO; Chair of the Drafting Group of the Meeting of Governmental Experts on the Universal Declaration on Bioethics and Human Rights. Elungu, Alphonse Doctor of Philosophy (Paris-Sorbonne) and Doctor of Literature (Paris IX); Honorary rector of the National University of Zaire, Kinshasa, Kisangani and Lubumbashi campus; Emeritus Professor at the University of Kinshasa, Democratic Republic of Congo; member of the International Bioethics Committee since 2004. Evans, Donald Professor and Director of the Bioethics Centre, University of Otago, New Zealand; elected member of the Academy of Humanitarian Research, Moscow; international member of the Canadian Institutes of Health Stem Cell Oversight Committee since 2004; member of the International Bioethics Committee since 2004. galjaard, Hans Emeritus Professor of Cell Biology and Human Genetics at Erasmus University Rotterdam, the Netherlands; member of the International Bioethics Committee (1998–2005). gefenas, Eugenijus Associate Professor and Director of the Department of Medical Ethics at the Medical Faculty of Vilnius University, Lithuania; Chairman of the Lithuanian Bioethics Society; member of the Council of Europe Bioethics Committee; member of the Executive Bureau of the European Society for Philosophy of Medicine and Health Care; member of the Board of Directors of the International Association of Bioethics; member of the International Bioethics Committee. • • • • fifth proofs • • • • CONTriBUTOrS 13 gros Espiell,