(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). COUNCIL OF EUROPE

Explanatory Report

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.

Drafting of a Convention

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.

Structure of the Convention

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.