Principles of international biolaw: Seeking common ground at the intersection of bioethics and human rights
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Principles of international biolaw - Roberto Andorno
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ISBN : 9782802742029
Collection DROIT, BIOÉTHIQUE ET SOCIÉTÉ
Directed by Brigitte FEUILLET-LIGER
Professor of Law at the University of Rennes I,
Member of the Institut Universitaire de France,
President of the International Academic Bioethics Network
Director of CRJO (IODE, UMR, CNRS no. 6262)
The life sciences and in particular, biomedical science, have considerably progressed over the decades to offer a multitude of new treatments. Going beyond its initial therapeutic goal, medical practice offers the unique opportunity to respond to society’s expectations related to individual personal desires. Men and women are now able to access techniques which allow them to have children; to assert their social identity; to decide about their end of life... in all, to respond to suffering instead of merely treating disease. Recourse to medical technologies has become, at least in part, a social and cultural phenomenon.
However, despite the unquestionable benefits of such progress, it also brings with it clear risks for fundamental human rights and can even impact upon the structure of families. Faced with increasing demands, we can observe the emergence of a market of ‘well-being’ medicine. The fundamental problem is to find a way to reconcile individual freedom, based on personal autonomy with the protection of the human being. Legal norms appear to be one of the best tools to address this goal, even if we rely increasingly on ethical norms to regulate the area of biomedicine. However, different cultures respond to the challenges of biomedicine in different ways. Biomedical practices deal with issues related to life, to the human body, to sexuality, reproduction and death. Yet, there is no single understanding of these concepts: it will depend on individuals, on culture or on religion. If we agree that the law of different countries translates the different social options it should however be analysed through the prism of other disciplines, such as anthropology, philosophy, sociology, psychoanalysis, psychology... in order to enable us to understand (and to respect) the cultural differences and to reflect upon a possible (universal?) harmonisation. The Droit, Bioéthique et société
Collection strives to contribute to the diffusion and promotion of multi-disciplinary reflection on these critical questions.
Books published in the same collection:
– Procréation médicalement assistée et Anonymat - Panorama international, sous la direction de Brigitte Feuillet-Liger, 2008.
– Who is my Genetic Parent? Donor Anonymity and Assisted Reproduction: a Cross-Cultural Perspective, edited by Brigitte Feuillet-Liger, Kristina Orfali and Thérèse Callus, 2011.
– Adolescent et Acte Médical, regards croisés, sous la direction de Brigitte Feuillet-Liger et Ryuichi Ida, 2011.
– Adolescents, Autonomy and Medical Treatment-Divergence and Convergence across the globe, edited by Brigitte Feuillet-Liger, Ryuichi Ida et Thérèse Callus, 2012.
– Les proches et la fin de vie médicalisée. Panorama international, sous la direction de Brigitte Feuillet-Liger, 2013.
– Families and End-of-Life Treatment Decisions. An International Perspective, edited by Brigitte Feuillet, Kristina Orfali, Thérèse Callus, 2013.
Foreword
The struggle for human rights is like an overflowing river that floods down across the valley making the fields ever more fertile
. (¹) This metaphor has been used to describe the expanding force of the human rights movement, which tends to cover all new areas in which human dignity and human rights are being challenged. The most recent field to be fertilized
by the principles of human rights law is biomedicine, i.e. the application of biological and medical technologies to human beings. Because rapid advances in this area present new and complex ethical and policy issues for individuals, society, and humankind as a whole, it has become increasingly clear that specific legal responses are necessary to ensure that biomedical technologies are used in a way which is respectful of human dignity and human rights.
But the new challenges are so formidable and far-reaching that individual countries alone cannot satisfactorily address them. As science becomes increasingly globalized, a coherent and effective response to the new dilemmas raised by science should also be global. This is why coordinated intergovernmental action is required to harmonize legal standards and to establish appropriate mechanisms to ensure that such standards are effectively implemented.
This volume aims to present the recent global efforts to develop common biolegal norms, as well as some of the specific human rights issues that are at stake in this field. It brings together and updates a number of papers and contributions to edited volumes that I have written over the past decade in relation to this emerging discipline that can be called international biomedical law, or simply international biolaw.
Section I of this book sets forth the pivotal issues in this field, including the overarching principle of respect for human dignity and a number of other principles that the international community has agreed should guide biomedical research and clinical activities.
Chapter 1 briefly sketches fourteen common principles that can be drawn from the international instruments relating to biomedicine. Among those principles are the requirement of informed consent, confidentiality of health data, non-discrimination on health grounds, beneficence and non-maleficence, special protection for vulnerable persons, and equitable access to health care. Certainly, most of these principles are not completely new, but are derived from previous international human rights instruments. Indeed, the greatest merit of biolegal instruments is not that they have invented
new principles, but rather that they have adapted existing human rights standards to the specific field of biomedicine, and have drawn them together into coherent legal frameworks.
Chapter 2 examines the first and overarching principle of international biolaw –respect for human dignity– and its concretization by means of human rights. After some preliminary remarks about the relationship between bioethics and law, and about the status of soft law, this chapter explores the meaning and value of the notion of human dignity. Basically, it argues that the combined recourse to human dignity and human rights is the best, if not the only available ground for developing international legal standards in the field of biomedicine.
Chapter 3 is focused on the precautionary principle, which provides guidance to policy makers in deciding the action to be taken if there is good reason to believe that certain products or technologies may be seriously harmful to public health or the environment but when, at the same time, the risk is not currently fully understood. Strangely, while this principle has been formally enshrined in virtually every international treaty dealing with environmental protection, it is lacking in the international instruments relating to biomedicine. This is strange, not only because promoting public health is no less important than protecting the environment, but also because this principle already plays a central role in the domestic and regional (notably, European) policies in the public health area. This chapter aims to highlight the scope of the precautionary principle and to identify the conditions for its reasonable use.
Section II of this volume analyzes the work of two major intergovernmental bodies –UNESCO and the Council of Europe– in the development of biolegal principles. Chapter 4 examines the Universal Declaration on the Human Genome and Human Rights of 1997, which embodies the first concerted effort of the international community in setting up global standards on genetic issues. The Declaration aims to ensure the protection of the human genome against improper manipulation and all uses of genetic information that are incompatible with respect for human dignity and human rights. Taking this general purpose into account, this chapter explores, among other features of the document, the status of the human genome as the heritage of humanity
.
Chapter 5 argues that the Universal Declaration on Bioethics and Human Rights, adopted by UNESCO in 2005, represents an important step in the search for a comprehensive framework of principles in the field of biomedicine. Drawing on my experience as a member of the International Bioethics Committee between 1998 and 2005, and on my involvement in the drafting of the Declaration, I sketch the principal features of this document before responding to two general charges that have been leveled against both UNESCO’s engagement in the field of bioethics and the Declaration itself.
The European Convention on Human Rights and Biomedicine (Oviedo Convention) is analyzed in Chapter 6. This instrument is unique in that it is the only comprehensive binding intergovernmental instrument addressing issues at the intersection of health law and human rights. In addition, despite the fact that it is a regional rather than a global instrument, it has an undeniable global significance, as its wide ranging approach has inspired the drafting of the Universal Declaration on Bioethics and Human Rights.
Section III elaborates upon certain human rights issues that are the subject of contemporary international standard-setting efforts in the field of biomedicine, including biomedical research, population biobanks, the right not to know one’s genetic information, and advance directives. Chapter 7 examines the ethical and policy dilemmas raised by the establishment of large-scale biobanks from the perspective of the rights of participants. To this end, it focuses on the experiences of Iceland and Estonia during the 2000s, and analyzes the special laws passed by both countries to regulate this matter. The comparative study of the experiences of both countries, very different in many respects, provides a basis upon which to suggest possible solutions to specific issues raised by biobanks, in particular those regarding the modalities of the informed consent; the importance of confidentiality safeguards; the feedback to participants; and issues of property and benefit-sharing.
Dealing also with the field of genetics, Chapter 8 focuses on the right not to know one’s genetic status. Despite having being formally recognized by several international instruments relating to bioethics, the basis and conditions for the exercise of this right still remain unclear. This chapter provides arguments in favor of such a right and tries to specify the conditions for its exercise. It argues, firstly, that individuals may have a legitimate interest in not knowing their genetic makeup to avoid serious psychological consequences; secondly, that this interest, far from being contrary to autonomy of patients and research subjects, may constitute an enhancement of their autonomy; thirdly, that the right not to know cannot be presumed, but must be activated
by the individual’s explicit choice; and fourthly, that this right is not absolute, in the sense that it may be restricted when disclosure is necessary in order to avoid a risk of serious harm to third parties, especially, family members.
Chapter 9 aims to highlight the human rights approach to biomedical research adopted by the Council of Europe’s Biomedicine Convention, and to contrast it with the more market-oriented provisions of the EU’s Clinical Trials Directive. While admitting that this difference of approach is understandable in the light of the dissimilar objectives of both European bodies, it stresses that this discrepancy has resulted in a number of unfortunate inconsistencies which might lead to less protection of research participants, in particular those who are most vulnerable.
The final chapter of this volume is devoted to an end of life issue which has generated much controversy in recent years, especially in Europe: the legal efficacy of advance health care directives. This chapter first outlines the strengths and shortcomings of Article 9 of the Biomedicine Convention, which specifically deals with this matter. Then, it analyzes the Council of Europe’s Recommendation (2009)11 on continuing powers of attorney and advance directives for incapacity, which attempts to fill some of the gaps of the Convention in this regard.
(1) A.
Papisca
, L’internazionalizzazione dei diritti umani: Verso un diritto panumano
, in C.
Cardia
(ed.), Anno Duemila. Primordi della storia mondiale, Milan, Giuffré, 1999, p. 139.
Acknowledgements
Early versions of this book’s chapters appeared as articles in various academic journals and as contributions to edited volumes. I would like to acknowledge the publishers for the permission to reprint them. The original sources of publication are the following:
Chapter 1: First steps in the development of an international biolaw
, in Ch. Gastmans, K. Dierickx, H. Nys, P. Schotmans (eds.), New Pathways for European Bioethics, Antwerp, Intersentia, 2007, pp. 121-138.
Chapter 2: Human Dignity and Human Rights as a Common Ground for a Global Bioethics
, Journal of Medicine and Philosophy, 2009, vol. 34, issue 3, pp. 223-240. Publisher: Oxford University Press.
Chapter 3: The Precautionary Principle: A New Legal Standard for a Technological Age
, Journal of International Biotechnology Law, 2004, n° 1, pp. 11-19. Publisher: De Gruyter.
Chapter 4: Seeking Common Grounds on Genetic Issues: the UNESCO Declaration on the Human Genome
, in J. Sandor (ed.), Society and Genetic Information. Codes and Laws in the Genetic Era, Budapest, Central European University Press, 2003, pp. 105-123.
Chapter 5: Global bioethics at UNESCO: in defence of the Universal Declaration on Bioethics and Human Rights
, Journal of Medical Ethics, 2007, vol. 33, pp. 150-154. Publisher: BMJ Group.
Chapter 6: The Oviedo Convention: A European Legal Framework at the Intersection of Human Rights and Health Law
, Journal of International Biotechnology Law, 2005, n° 2, pp. 133-143. Publisher: De Gruyter.
Chapter 7: Population Genetic Databases: A New Challenge to Human Rights
, in C. Lenk, N. Hoppe, R. Andorno (eds.), Ethics and Law of Intellectual Property. Current Problems in Politics, Science and Technology, Aldershot, Ashgate, 2007, pp. 27-45.
Chapter 8: The right not to know: an autonomy-based approach
, Journal of Medical Ethics, 2004, vol. 30, issue 5, pp. 435-440. Publisher: BMJ Group.
Chapter 9: Regulatory discrepancies between the Council of Europe and the EU regarding biomedical research
, in A. den Exter (ed.), Human Rights and Biomedicine, Antwerp, Maklu Press, 2010, pp. 117-133.
Chapter 10: Regulating Advance Directives at the Council of Europe
, in S. Negri (ed.), Life, Death and Dignity. Regulating Advance Directives in National and International Law, Series: Queen Mary Studies in International Law, Leiden, Brill Academic Publishers, 2012, pp. 73-85.
I am also indebted to Katherine Wade for her invaluable help with the editing of several chapters of this book.
Section I Principles of International Biolaw
Chapter 1 Principles of International Biomedical Law
By the end of the 1990s, some intergovernmental organizations started to develop common standards relating to biomedicine. (¹) Two organizations in particular have been at the forefront of this ambitious endeavour: the UNESCO (United Nations Educational, Scientific and Cultural Organization) and the Council of Europe. This chapter aims to show that a coherent set of principles already emerge from the instruments that have been adopted since 1997, and to argue that we are witnessing the emergence of the foundational core of an international biomedical law, which is an extension of international human rights law into the specific field of biomedicine.
I. – Intergovernmental instruments relating to Biomedicine
Rapid advances in the biomedical field present new and complex challenges for individuals and society. The current situation calls for the development of legal rules to ensure that technologies are used in a way which is consistent with full respect for human dignity and human rights. However, bioethical issues are so formidable and far-reaching that individual countries alone cannot satisfactorily address them. Concerted international efforts are required to establish a framework of common standards and to create appropriate mechanisms to promote their effective implementation at the domestic level. This need has been perceived by a number of intergovernmental bodies, in particular UNESCO and the Council of Europe, which have made significant efforts to build an international consensus on a number of human rights principles relating to biomedical practice and research.
Since the end of the 1990s, UNESCO has adopted three international legal instruments on bioethics: the 1997 Universal Declaration on the Human Genome and Human Rights (UDHG); the 2003 International Declaration on Human Genetic Data (IDHGD), and the 2005 Universal Declaration on Bioethics and Human Rights (UDBHR). These three instruments have been approved by all Member States of UNESCO, that is, by virtually all countries in the world. Considering the sensitive nature of bioethical issues, which are closely related to socio-cultural and religious values of each society, this unanimity has great value in terms of granting legitimacy to the principles embedded in the declarations.
The main purpose of the UDHG is to preserve the human genome from improper manipulations that may endanger the identity and physical integrity of future generations. To this end, it recognizes the human genome as the heritage of humanity
(Article 1), and declares contrary to human dignity
practices such as human reproductive cloning
(Article 11) and germ-line interventions (Article 24). In addition, the Declaration intends to prevent genetic reductionism and any use of genetic information that would be contrary to human rights and human dignity.
The IDHGD can be regarded as an extension of the 1997 Declaration. It sets out a number of rules for the collection, use and storage of human genetic data, which cover, among other issues, informed consent in genetic testing, confidentiality of genetic data, the ban on genetic discrimination, the anonymization of personal genetic information, population-based genetic studies, the right not to know one’s genetic make-up, genetic counselling, international solidarity in genetic research, and benefit sharing.
The UDBHR has a much broader scope than the two previous documents as it aims to provide a comprehensive framework of principles and procedures to guide States in the formulation of their legislation, policies and other instruments in the field of bioethics
(Article 2a). The overall objective of the document is to promote the development of biomedical practice and research in conformity with respect for human dignity, human rights and fundamental freedoms
(Article 3.1).
Also the Council of Europe has made an important contribution to the establishment of transnational norms on this matter with the development of the Convention on Human Rights and Biomedicine (Biomedicine Convention), which is the only intergovernmental binding instrument that comprehensively addresses the linkage between human rights and biomedicine. It was opened for signature on 4 April 1997 in Oviedo, Spain. So far, it has been signed by 35 States and ratified by 29 of them. (²)
Although the Biomedicine Convention is a regional, not a global instrument, its global significance should not be overlooked. It is interesting to note that the Preamble of the UDBHR explicitly refers to the European Biomedicine Convention. This is worthy of note because it is unusual that UN declarations cite regional instruments. It shows that the comprehensive approach to bioethics of the Council of Europe has inspired the drafting of the UNESCO Declaration. (³) In this regard, it has been said that the global work being carried out by UNESCO with the drafting of the UDBHR has built on, and been informed by, the work done by the Council of Europe at the regional level. (⁴) In addition, it is noteworthy that the Biomedicine Convention has theoretically the potential to extend its applicability beyond European borders, as Article 34 leaves open the possibility of inviting non-member States of the Council of Europe to adhere to the document.
II. – Three features of international Biomedical Law
A first comparative analysis between the three UNESCO declarations and the European Biomedicine Convention reveals that they share at least three important features: 1) The recognition of human dignity as an overarching principle; 2) The use of a human rights framework; 3) The adoption of a set of broad principles.
A. – The recognition of human dignity as an overarching principle
The new intergovernmental instruments relating to bioethics assign a central and multifaceted role to the notion of human dignity. The UDBHR is paradigmatic in this regard, as respect for human dignity embodies not only the key purpose of the instrument (Article 2.c), but also the first principle governing the whole field of biomedicine (Article 3), the main reason why discrimination, including for instance, genetic discrimination, must be prohibited (Article 11), the framework within which cultural diversity is to be respected (Article 12), and the highest interpretive principle of all the provisions of the Declaration (Article 28).
Similarly, the purpose of the European Biomedicine Convention is defined by reference to the notion of human dignity. (⁵) The Explanatory Report to the Convention states that the concept of human dignity (…) constitutes the essential value to be upheld. It is at the basis of most of the values emphasized in the Convention
(Paragraph 9). The Convention’s Preamble refers three times to human dignity: the first, when it recognizes the importance of ensuring the dignity of the human being;
the second, when it recalls that the misuse of biology and medicine may lead to acts endangering human dignity;
and the third, when it underlines the need to take the necessary measures to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine
.
It is true that the recourse to human dignity is not new in international law. In this regard, the instruments relating to biomedicine follow a well-established tradition in international human rights law, which repeatedly appeals to the inherent dignity of all members of the human family
(⁶) and refers to the concept as the source of all human rights. (⁷) Nevertheless, it is interesting to note that the instruments dealing with bioethics emphasize the notion of human dignity in a much powerful and pressing manner than the founding human rights instruments. In this regard, we are not presented here with a mere shift in style, but a true shift in substance that deserves to be carefully considered. (⁸)
B. – The use of a human rights framework
The notion of human dignity alone is unable to provide a concrete response to most of the challenges raised by biomedical practice and research. To be operative, it needs other more specific and articulated notions, such as informed consent, bodily integrity, non-discrimination, confidentiality, etc., which are usually formulated using the terminology of rights. It is therefore not surprising that most international instruments relating to bioethics, including declarations, guidelines, recommendations, opinions and codes, are framed using a rights-based approach. This is particularly evident in the UNESCO declarations on bioethics and in the European Biomedicine Convention, which even include a reference to human rights in their titles. According to the chairman of the drafting group of the 2005 UNESCO Declaration, the most significant achievement of the Declaration
is to have closely