Academic journal article The Hastings Center Report

The European Convention on Bioethics

Academic journal article The Hastings Center Report

The European Convention on Bioethics

Article excerpt

Nearly fifteen years after the Council of Europe first called for a pan-European convention on issues in bioethics to harmonize disparate national regulations, in November 1996 the council's Committee of Ministers approved the Convention on Human Rights and Biomedicine for formal adoption. The draft convention, released in July 1994, provoked strong public, professional, and governmental debate among European nations, particularly regarding provisions for biomedical research with subjects unable tO give informed consent. If ratified, the "bioethics convention" will become the first such document to have binding force internationally.

The Council of Europe wishes to secure respect of human rights in biomedical research and to harmonize various regulations on bioethics in Europe. This initiative, if successful, would create the very first international convention on bioethics. In June 1996 the Steering Committee on Bioethics (CDBI) approved the final form of the draft Convention on Human Rights and Bioethics,[1] bringing that success a step closer. Somewhat unexpectedly, a large majority of delegations approved the 1996 document. In the fall of 1996 the Parliamentary Assembly of the council approved the draft and the convention was formally adopted by the Committee of Ministers.

This gives cause for pride and satisfaction to those who have struggled to develop international consensus in a rather controversial field. The time has come, therefore, to examine the convention, to highlight some of its major articles and offer a provisional appreciation of what it has achieved. Since the drafters of the convention consider the chapters on consent, especially in research and organ donation by living donors a major achievement, we shall focus our discussion on consent--in particular, on consent involving participation in research and transplantation by persons who are not able to give consent themselves.

Why a Convention?

Before we begin that discussion, however, it would be helpful to sketch briefly the Council of Europe and the history behind the July 1996 draft. The Council of Europe, established in 1949, is one of the major organizations of post-war supranational Europe. It consists of representative ministers from the member states, mainly ministers of foreign affairs and, depending on the agenda, other ministers of relevant departments. In actual fact, the Committee of Ministers is the decisionmaking body of the Council. The Council has a Secretariat supporting the Secretary General, and a Committee of Permanent Representatives.

In 1982 Recommendation 934 of the Parliamentary Assembly of the Council of Europe called for "a European agreement on what constitutes legitimate application to human beings (including future generations) of the techniques of genetic engineering, [to] align domestic regulations accordingly, and work towards similar agreements at [the] world level."[2] (In light of this call for worldwide agreement, it should be noted that as of March 1996 the Council of Europe counted thirty-nine member states--in addition to the Parliamentary Assembly and the European Commission--and thirteen permanent observers. Some of those are countries: Australia, Canada, Croatia, the Holy See, Japan, and the United States. Others are committees: the International Commission on Civil Status, European Science Foundation, OECD, United Nations Education and Organization [UNESCO], and World Health Association [WHO], and two committees of the Council of Europe, the Steering Committee on Health [CDPS] and the Steering Committee on Human Rights [CDDH].[3]) Further, a comprehensive recommendation of 1987 and 1988 urged efforts to "provide for joint action by all Council of Europe member states, together with non-member states, so that in addition to purely national action they should contribute to the framing of a common legal instrument, such as a European convention on biomedicine and human biotechnology, which would be open to nonmember states also. …

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