Brussels, 29 October 2003
OPINION of the European Economic and Social Committee on the Proposal for a Council Decision amending Decision 2002/834/EC on the specific programme for research, technological development and demonstration: "Integrating and strengthening the European research area" (2002-2006) COM(2003) 390 final - 2003/0151 (CNS)
Full text of Opinion in MS Word file on ESC website
[...] Introduction and point of departure
The Commission proposal deals with the limits that are to apply, under the sixth EU R&D framework programme, to research into the medical and biological potential of human stem cells procured from "supernumerary" (frozen) human embryos.
Life sciences and medicine are key aspects of the sixth framework programme of the European Community for research, technological development and demonstration activities. The first point of the specific programme covering this thematic area is the application of "life sciences, genomics and biotechnology for health", including " somatic gene and cell therapies (in particular stem cell therapies)" and "immunotherapies." The sixth framework programme adopted by the Council and the Parliament provides the legal basis for the Commission proposal.
Community funding of stem cell research using human somatic stem cells and embryonic stem cells from supernumerary human embryos is provided for under research priority (i) Advanced genomics and its applications for health in the section Application of knowledge and technologies in the field of genomics and biotechnology for health. For example, in this section: "Research will focus on:&. development and testing of new preventive and therapeutic tools, such as somatic gene and cell therapies (in particular stem cell therapies, for example those on neurological and neuromuscular disorders) and immunotherapies".
The specific programme adopted by Council on 30 September 2002 allows the funding of research activities involving the use of human embryos and human embryonic stem cells except in three areas:
research activity aiming at human cloning for reproductive purposes (reproductive cloning); research activity intended to modify the genetic heritage of human beings which could make such changes heritable (germline gene therapy); research activities intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer (commonly referred to as therapeutic cloning).
At the Council meeting of 30 September 2002, the Council and the Commission agreed, however, that -detailed implementing provisions concerning research activities involving the use of human embryos and human embryonic stem cells shall be established by 31 December 2003.- Until that time, the Commission will not propose to fund such research, with the exception of proposals for projects that involve the use of banked or isolated human embryonic stem cells in culture.
The Commission's purpose in submitting the present Proposal for a Council Decision amending Decision 2002/834/EC on the specific programme for research, technological development and demonstration: "Integrating and strengthening the European research area" (2002-2006) is thus to establish the implementing provisions mentioned in point 1.4.
The Commission's proposal was drawn up in the light of an interinstitutional seminar on bioethics that took place on 24 April 2003. This seminar provided an opportunity for a discussion and sharing of views between experts (scientific, legal, and in ethics) and representatives of the European Parliament, the Council, the Commission, the Member States and the accession and candidate countries. However, the proposed guidelines also draw on the principles laid down by the European Group on Ethics, and in particular this group's opinion no. 15 on Ethical aspects of human stem cell research and use.
This group was guided by the following principles:
This proposal comes in response to the request made by the Council to the Commission in September 2002. It addresses those points in the implementing provisions of the sixth R&D framework programme that the Council felt required regulation.
The proposal on this sensitive but, given the opportunities it affords, nonetheless vitally important issue adopts a moderate and, if anything, restrictive approach, treading a "middle way" between the different national laws that apply in the Member States. It thus represents a compromise between diverging individual viewpoints.
The proposed rules meet the challenge. They allow support to be given to key scientific research serving important medical and biological ends. They give special priority to projects fostering international coordination and cooperation. They establish clear criteria and procedures to comply with the appropriate ethical and legal factors.
The Committee respects the views of those, including some of its own members, who reject, on ethical grounds, any procurement of human stem cell lines from supernumerary embryos, and thus also reject the Commission proposal.
In the light of all the factors involved, however, the Committee recommends that, bearing in mind the detailed points made above, the Commission proposal be accepted.
The Committee again asks the Commission to ensure that, in implementing the scientific programme, the programme elements are broadly structured in such a way so as not to rule out the involvement of top-rate scientific institutions in some Member States.
It again calls on Member States to pursue the same objective in future revisions of national legislation and to seek an overarching consensus on what is, admittedly, a very difficult issue, thereby broadening the scope of the fundamental agreement that currently exists on core issues (see point 1.3 above) to encompass a future coherent set of rules accepted by all Member States.
New HES lines, which are procured with support under the sixth framework programme, should be stored in a public stem cell bank and be freely accessible to European researchers.