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Explanatory Report to the Convention on Human Rights and Biomedicine (Part 1)This Explanatory Report to the Convention on human rights and biomedicine was drawn up under the responsibility of the Secretary General of the Council of Europe, on the basis of a draft prepared, at the request of the Steering Committee on Bioethics (CDBI), by Mr Jean MICHAUD (France), Chairman of the CDBI. It takes into account the discussions held in the CDBI and its Working Group entrusted with the drafting of the Convention; it also takes into account the remarks and proposals made by Delegations. The Committee of Ministers has authorised the publication of this Explanatory Report on 17 December 1996. The Explanatory Report is not an authoritative interpretation of the Convention. Nevertheless it covers the main issues of the preparatory work and provides information to clarify the object and purpose of the Convention and to better understand the scope of its provisions. Introduction 1. For several years now, the Council of Europe, through the work of the Parliamentary Assembly and of the ad hoc Committee of Experts on Bioethics (CAHBI), later renamed the Steering Committee on Bioethics (CDBI), has concerned itself with the problems confronting mankind as a result of advances in medicine and biology. At the same time, a number of countries have done their own internal work on these topics, and this work is proceeding. So far, therefore, two types of endeavour have been undertaken, one at a national and the other at international level. 2. Basically, these studies are the fruit of observation and concern: observation of the radical developments in science and their applications to medicine and biology, that is fields in which people are directly involved and concern about the ambivalent nature of many of these advances. The scientists and practitioners behind them have worthy aims and often attain them. But some of the known or alleged developments of their work are taking or could potentially take a dangerous turn, as a result of a distortion of the original objectives. Science, with its new complexity and extensive ramifications, thus presents a dark side or a bright side according to how it is used.
3. It has subsequently become necessary to ensure that the beneficial side prevails by developing awareness of what is at stake and constantly reviewing all the possible consequences. No doubt the ethics committees and other national bodies and legislators, as well as the international organisations, have already applied themselves to this task, but their efforts have remained either restricted to a particular geographical area or incomplete because of their focus on a particular topic. On the other hand, common values are more often than not claimed as a basis for the various texts, opinions and recommendations. But differences may, nonetheless, become apparent in connection with certain aspects of the problems dealt with. Even simple definitions may give rise to profound differences.
4. It has consequently become apparent that there was a need to make a greater effort to harmonise existing standards. In 1990, at their 17th Conference (Istanbul, 5-7 June 1990), the European Ministers of Justice, following the proposal of Ms Catherine Lalumière, Secretary General of the Council of Europe, adopted Resolution No. 3 on bioethics which recommended that the Committee of Ministers instruct the CAHBI to examine the possibility of preparing a framework convention “setting out common general standards for the protection of the human person in the context of the development of the biomedical sciences”. In June 1991, taking up the contents of a report submitted on behalf of the Committee of science and technology by Dr Marcelo Palacios (see Document 6449), the Parliamentary Assembly recommended, in its Recommendation 1160, that the Committee of Ministers “envisage a framework convention comprising a main text with general principles and additional protocols on specific aspects”. In September of the same year the Committee of Ministers, chaired by Mr Vincent Tabone, instructed the CAHBI “to prepare, in close co-operation with the Steering Committee for Human Rights (CDDH) and the European Health Committee (CDSP) ... a framework Convention, open to non-member States, setting out common general standards for the protection of the human person in the context of the biomedical sciences and Protocols to this Convention, relating to, in a preliminary phase: organ transplants and the use of substances of human origin; medical research on human beings”. 5. In March 1992 the CAHBI, then the CDBI, which has been chaired in turn by Mrs Paula KOKKONEN (Finland), Dr Octavi QUINTANA (Spain) and Mrs Johanna KITS NIEUWENKAMP née Storm van’SGravesande (The Netherlands), set up a Working Party to prepare the draft Convention, which was chaired by Dr Michael ABRAMS (United Kingdom). Until his untimely death, Mr Salvatore PUGLISI (Italy) was a member of this Group, after having been Chair of the Study Group set up to examine the feasibility of the draft Convention.
6. In July 1994, a first version of the draft Convention was subjected to public consultation and was submitted for an opinion to the Parliamentary Assembly. Taking account of this opinion and of several other positions taken, a final draft was established by the CDBI on 7 June 1996 and was submitted to the Parliamentary Assembly for an opinion. The latter put forward Opinion No. 198 on the basis of a report submitted on behalf of the Committee on Science and Technology by Mr Gian-Reto PLATTNER and for the Committee on Legal Affairs and Human Rights and the Social, Health and Family Affairs Committee by Messrs Walter SCHWIMMER and Christian DANIEL respectively. The Convention was adopted by the Committee of Ministers on 19 November 1996. It was opened for signature on 4 April 1997.
7. The Convention sets out only the most important principles. Additional standards and more detailed questions should be dealt with in additional protocols. The Convention as a whole will thus provide a common framework for the protection of human rights and human dignity in both longstanding and developing areas concerning the application of biology and medicine.
Title 8. The title of the instrument is “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”. 9. The term “Human Rights” refers to the principles laid down in the Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950, which guarantee protection of such rights. The two Conventions share not only the same underlying approach but also many ethical principles and legal concepts. Indeed, this Convention elaborates some of the principles enshrined in the European Convention for the Protection of Human Rights. The concept of the human being has been used because of its general character. The concept of human dignity, which is also highlighted, constitutes the essential value to be upheld. It is at the basis of most of the values emphasised in the Convention. 10. The phrase “application of biology and medicine”, was preferred to “life sciences” in particular, which was considered too broad. It is used in Article 1 and restricts the scope of the Convention to human medicine and biology, thereby excluding animal and plant biology insofar as they do not concern human medicine or biology. The Convention thus covers all medical and biological applications concerning human beings, including preventive, diagnostic, therapeutic and research applications. Preamble 11. Various international instruments already provide protection and guarantees in the field of human rights, both individual and social: the Universal Declaration of Human Rights, the International Covenant on Civil and Political Rights, the International Covenant on Economic, Social and Cultural Rights, the Convention on the Rights of the Child, the Convention for the Protection of Human Rights and Fundamental Freedoms, the European Social Charter. Several instruments of a more specific nature prepared by the Council of Europe are also relevant, such as the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data. 12. They must now be supplemented by other texts so that full account is taken of the potential implications of scientific actions. 13. The principles enshrined in these instruments remain the basis of our conception of human rights; hence they are set out at the beginning of the preamble to the Convention, of which they are the cornerstone. 14. Starting with the preamble, however, it was necessary to take account of the actual developments in medicine and biology, while indicating the need for them to be used solely for the benefit of present and future generations. This concern has been affirmed at three levels: – The first is that of the individual, who had to be shielded from any threat resulting from the improper use of scientific developments. Several articles of the Convention illustrate the wish to make it clear that pride of place ought to be given to the individual: protection against unlawful interference with the human body, prohibition of the use of all or part of the body for financial gain, restriction of the use of genetic testing, etc. – The second level relates to society. Indeed, in this particular field, to a greater extent than in many others, the individual must also be considered to constitute part of a social corpus sharing a number of ethical principles and governed by legal standards. Whenever choices are involved in regard to the application of certain developments, the latter must be recognised and endorsed by the community. This is why public debate is so important and is given a place in the Convention. Nevertheless, the interests at stake are not equal; as indicated in Article 2, they are graded to reflect the priority in principle attached to the interests of the individual as opposed to those of science or society solely. The adjective “alone” makes it clear that care must be taken not to neglect the latter; they must come immediately after the interests of the individual. It is only in very precise situations, and subject to the respect of strict conditions that the general interest, as it is defined in Article 26, would take priority. – The third and final concern relates to the human species. Many of the current achievements and forthcoming advances are based on genetics. Progress in knowledge of the genome is producing more ways of influencing and acting on it. This knowledge already enables considerable progress to take place in the diagnosis and, sometimes, in the prevention of an increasing number of diseases. There are reasons to hope that it could also enable therapeutic progress to take place. However, the risks associated with this growing area of expertise should not be ignored. It is no longer the individual or society that may be at risk but the human species itself. The Convention sets up safeguards, starting with the preamble where reference is made to the benefits to future generations and to all humanity, while provision is made throughout the text for the necessary legal guarantees to protect the identity of the human being. 15. The preamble refers to the developments in medicine and biology which should be used only for the benefit of present and future generations and not be diverted in ways that run counter to their proper objective. It proclaims the respect due to man as an individual and as a member of the human species. It concludes that progress, human benefit and protection can be reconciled if public awareness is aroused as a result of an international instrument devised by the Council of Europe in line with its vocation. Stress is laid on the need for international co-operation to extend the benefits of progress to the whole of mankind. |
