Stem Cell Research (Extract from Background for the Competitiveness Council of 22 Sep)

Brussels, 18 Sep 2003

Ministers will hear over lunch a presentation by Commissioner Philippe Busquin of the European Commission proposal on the EU-funding of human embryonic stem cell research.

Last year, at the time of adoption of the Specific Research Programmes under the 6th Research Framework Programme, the Council and the Commission agreed by means of a political declaration to introduce a moratorium concerning research activities involving human embryos and human embryonic stem cells3. In the meantime, it was agreed that further ethical guidelines were necessary for monitoring EU funding of research projects involving the derivation of stem cells from human supernumerary embryos and that they should be established by 31 December 2003, following the consultation of the European Parliament.

Therefore, the Commission presented on 9 July 2003 a draft Decision stipulating that the funding provided by the 6th Research Framework Program for the derivation of new stem cells will only be made available if proposals successfully pass a rigorous scientific peer review and an ethical review. For this purpose, the draft Decision suggests the following criteria:

• The EU will not fund human embryonic stem cell research where it is forbidden by a Member State;
• Human embryonic stem cells can only be derived from supernumerary embryos that are donated for research by parents and that were created before June 2002, the date of the adoption of the Sixth Framework Programme. These embryos are destined to be destroyed at some point in time;
• Potential research project partners applying for European Union funding must seek ethical advice at national or local level in the Member States where the research will take place, even in countries where obtaining such ethical advice is not mandatory;
• Research will be funded only when it is demonstrated that it meets particularly important research objectives;
• Research will be funded only when there is no adequate alternative available. In particular, it must be demonstrated that one cannot use existing embryonic or adult stem cell lines;
• Supernumerary embryos will be used only if informed consent has been given by the donor(s);
• Embryo donor(s) will not be permitted to make any financial gain;
• Data and privacy protection of donors must be guaranteed;
• Tractability of stem cells will be required;
• Research consortia will be required to engage in making available new human embryonic stem cells to other researchers.

This proposal is based on article 166 (4) of the EC Treaty (qualified majority within the Council and consultation of European Parliament)

3 During this moratorium and pending establishment of detailed implementing provisions, the Commission would not propose to fund such research, with the exception of the study of banked or isolated human embryonic stem cells in culture.

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