Proposed Council Decision on the Specific Programme for Research, Technological Development and Demonstration: "Integrating and Strengthening the European Research Area" (2002-2006) ("Bioethics / Stem

September 18, 2003

Brussels, 17 Sep 2003

Full text of Document 129/03
Suite of documents 129/03

­ Introductory note for the Council ("Competitiveness") on 22 September 2003

1. The sixth research framework programme of the European Community (FP6)1 provides that the research activities carried out under the programme should respect fundamental ethical principles. The framework programme decision of June 2002 contains a list of references to relevant international instruments to this effect, but does not provide detailed rules for applying these principles nor does it specify any particular activities which would be non-eligible for funding for ethical reasons. This was left to the subsequent Council Decisions on the specific programmes.

2. The Council Decisions on the specific programmes2, adopted on 30 September 2002, following consultation of the European Parliament, provide for the following in respect of research activities involving stem cells:

a) Under the thematic priority "Life sciences, genomics and biotechnology for health", research will focus, inter alia, on "development and testing of new preventative 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";

b) The following fields of research ("no-go areas") shall not be financed under the programme:

- research activities aiming at human cloning for reproductive purposes,
- research activity intended to modify the genetic heritage of human beings which could make such change heritable (research relating to cancer treatment of the gonads can be financed),
- 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 (often referred to as therapeutic cloning).

In addition, any research project involving the use of human embryos and human embryonic stem cells will be the subject of an ethical review and will be submitted to a Regulatory Committee assisting the Commission in the implementation of the programme. Also, funding of research activities that are prohibited in all the Member States is in all circumstances excluded.

3. The Council Decision on the specific programmes was accompanied by a Council and Commission statement1 where it was agreed, in particular, that:

- Detailed implementing provisions concerning research activities involving the use of human embryos and human embryonic stem cells which may be funded under the programme shall be established by 31 December 2003, to which effect the Commission undertook to submit a legislative proposal to amend the relevant specific programme and on which the European Parliament would be consulted;

1 Doc. 12523/1/02 ADD1 REV 1.

- During this period ("moratorium") and pending establishment of the detailed implementing provisions, the Commission will not propose to fund such research, with the exception of the study of banked or isolated human embryonic stem cells in culture;

Furthermore, it was noted that the ethical acceptability of various research fields is related to the diversity among Member States, and is governed by national law in accordance with the principle of subsidiarity and that research using human embryos and human embryonic stem cells is allowed in several Member States, but not in others.

4. In order to facilitate the process of establishing the implementing provisions, the Commission Services presented a report1 on human embryonic stem cell research and an inter-institutional seminar was held on 24 April 2003. This covered scientific aspects, as well as ethical and legal considerations.

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