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The Protection of the Human Embryo in Vitro

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Strasbourg, 19 June 2003 CDBI-CO-GT3 (2003) 13 STEERING COMMITTEE ON BIOETHICS (CDBI) THE PROTECTION OF THE HUMAN EMBRYO IN VITRO Report by the Working Party on the Protection of the Human Embryo and Fetus (CDBI-CO-GT3) Table of contents I. General introduction on the context and objectives of the report ............................................... 3 II. General concepts............................................................................................................................... 4 A. Biology of development ....................................................................................................................... 4 B. Philosophical views on the “nature” and status of the embryo............................................................ 4 C. The protection of the embryo............................................................................................................... 8 D. Commercialisation of the embryo and its parts ................................................................................... 9 E. The destiny of the embryo ................................................................................................................... 9 F. “Freedom of procreation” and instrumentalisation of women............................................................10 III. In vitro fertilisation (IVF).................................................................................................................. 12 A. Presentation of the procedure ...........................................................................................................12 B. Critical discussion on IVF .................................................................................................................. 14 C. Number of embryos created for IVF ..................................................................................................16 D. Information and consent .................................................................................................................... 19 E. Embryo “donation” ............................................................................................................................. 20 IV. Research ........................................................................................................................................... 22 A. Introduction to research on the embryo............................................................................................. 22 B. The principle of “freedom of research” .............................................................................................. 22 C. Embryonic stem cells: scientific aspects ...........................................................................................23 D. Use of embryos that are no longer part of a parental project for research (including for collection of stem cells).........................................................................................................................................24 E. Creation of embryos for research (including for the collection of stem cells).................................... 28 V. Preimplantation diagnosis (PGD) (for genetic diagnostic purposes) ........................................ 30 A. Presentation of PGD: procedures and conditions .............................................................................30 B. Ethical aspects and social consequences, in particular the issue of eugenics.................................31 C. Selection of sex .................................................................................................................................35 D. PGD use for immunocompatibility analysis .......................................................................................36 VI. Conclusion........................................................................................................................................ 37 APPENDIX I................................................................................................................................................38 Figure 1.......................................................................................................................................................38 Chronology of embryo development until implantation ..............................................................................38 Figure 2.......................................................................................................................................................39 First stages of embryo development ..........................................................................................................39 APPENDIX II...............................................................................................................................................40 Glossary......................................................................................................................................................40 APPENDIX III..............................................................................................................................................42 Selected European reference documents .................................................................................................... 42 APPENDIX IV .............................................................................................................................................43 Experts........................................................................................................................................................43 2 Report on the protection of the human embryo in vitro I. General introduction on the context and objectives of the report Reflecting on ethical questions concerning the protection of the human embryo in vitro and the use of medically assisted procreation have formed an important part of the Council of Europe’s work in bioethics for nearly fifteen years. The extent of this reflection is a measure of the complexity and difficulty of the ethical questions concerned, of the significant scientific developments that have taken place over that period, and of the evolution of opinion on these difficult matters. In 1989, the Ad hoc Committee of Experts on Bioethics (CAHBI), the predecessor to the current Steering Committee on Bioethics (CDBI) issued a report on human artificial procreation. Although not a legally binding text, that report set out a number of principles that were useful as a source of guidance to member States in an area which was still at a relatively early stage of development. In 1992, the CAHBI, and then the CDBI, began its work to develop a framework convention, setting out common general standards for the protection of the human person in the context of the biomedical sciences. That work culminated in the opening for signature of the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Convention on Human Rights and Biomedicine; ETS 164) in April 1997. Article 14 of that Convention sets out the general principle of prohibition of the use of techniques of medically assisted procreation for the purposes of sex selection except in very restricted health-related circumstances. Article 18 of the Convention is a general provision concerning research on embryos in vitro. The general standards set by the Convention on matters such as consent, professional obligations and standards and the prohibition of financial gain from the human body and its parts, as such, would be as relevant to medically assisted procreation as they are to other health care interventions. The need to undertake a more wide ranging reflection on questions concerning the protection of the embryo in vitro and the use of medically assisted procreation lead to the setting up in 1995 of a Working Party, chaired initially by Mr Jean MICHAUD (France) and then by Professor Daniel SERRAO (Portugal), to examine these questions. (The membership of the Working Party, as well as the experts not members of the Working Party who contributed to the report, can be found in Appendix IV). To confront the different opinions on these questions and to contribute to the reflection to be undertaken by the Working Party, a symposium on medically assisted procreation and protection of the human embryo was organised on 15 – 18 December 1996 (see the proceedings of the symposium on the web site: http://www.coe.int/bioethics). The birth of Dolly the sheep in 1997 lead to worldwide concerns about the possibility of the reproductive cloning of human beings. These concerns were addressed by the Working Party which was then entrusted with the task of preparing a draft additional Protocol to the Convention on cloning. The Protocol to the Convention on Human Rights and Biomedicine on the Prohibition of Cloning Human Beings (ETS 168) was opened for signature in January 1998. After the symposium, to further assist the reflections of the Working Party, a comparative study of the position of the then member States, and those States having observer status with the CDBI on relevant issues was conducted and published in 1998 (see document CDBI-INF(98)8 Medically assisted procreation and the protection of the human embryo: comparative study on the situation in 39 States; Cloning: comparative study on the situation in 44 States). Whilst on many of the issues covered by this report there is a broad consensus at European level, on other matters a considerable diversity
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