Agreement for European Union funding of stem cell research in Framework 7

For the 7th Framework Programme, the European Commission proposes to continue with the same ethical framework for deciding on the EU funding of human embryonic stem cell research as in the 6th Framework Programme.  

The European Commission proposes the continuation of this ethical framework because it has developed, based on experience, a responsible approach for an area of science which holds much promise and that has proven to work satisfactorily in the context of a research programme in which researchers participate from many countries with very diverse regulatory situations.

1. The decision on the 7th Framework Programme explicitly excludes three fields of research from Community funding:
   • Research activities aiming at human cloning for reproductive purposes;
   • Research activities intended to modify the genetic heritage of human beings which could make such changes heritable;
   • 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.
2. No activity will be funded that is forbidden in all Member States.   No activity will be funded in a Member State where such activity is forbidden.
3. The decision on FP7 and the provisions for the ethical framework governing the Community funding of human embryonic stem cell research entail in no way a value judgement on the regulatory or ethical framework governing such research in Member States.
4. In calling for proposals, the European Commission does not explicitly solicit the use of human embryonic stem cells. The use of human stem cells, be they adult or embryonic, if any, depends on the judgement of the scientists in view of the objectives they want to achieve.   In practice, by far the largest part of Community funds for stem cell research is devoted to the use of adult stem cells.   There is no reason why this would substantially change in FP7.
5. Each project proposing to use human embryonic stem cells must successfully pass a scientific evaluation during which the necessity of using such stem cells to achieve the scientific objectives is assessed by independent scientific experts.
6. Proposals which successfully pass the scientific evaluation are then subject to a stringent ethical review organised by the European Commission. In this ethical review, account is taken of principles reflected in the EU Charter of Fundamental Rights and relevant international conventions such as the Convention of the Council of Europe on Human Rights and Biomedicine signed in Oviedo on 4 April 1997 and its additional protocols and the Universal Declaration on the Human Genome and the Human Rights adopted by UNESCO.   The ethical review also serves to check that the proposals respect the rules of the countries where the research will be carried out.
7. In particular cases, an ethical review may be carried out during the lifetime of the project.
8. Each project proposing to use human embryonic stem cells must seek the approval of the relevant national or local ethics committee prior to the start of the project.   All national rules and procedures must be respected, including on such issues as parental consent, absence of financial inducement, etc.   Checks will be made on whether the project includes references to licensing and control measures to be taken by the competent authorities of the Member State where the research will be carried out.
9. A proposal that successfully passes the scientific evaluation, the national or local ethical reviews and the European ethical review will be presented for approval, on a case by case basis, to the Member States, meeting as a Regulatory Committee.   No project involving the use of human embryonic stem cells will be funded that does not obtain approval from the Member States.
10. The European Commission will continue to work to make the results from Community funded stem cell research widely accessible to all researchers, for the ultimate benefit of patients in all countries.
11. The European Commission will support actions and initiatives that contribute to a coordination and rationalisation of HESC research within a responsible ethical approach. In particular, the Commission will support a European registry of human embryonic stem cell lines. Support for such a registry will allow a monitoring of existing human embryonic stem cells in Europe will contribute to maximise their use by scientists and may help to avoid unnecessary derivations of new stem cell lines.
12. The European Commission will continue with the current practice and will not submit to the Regulatory Committee proposals for projects which include research activities which destroy human embryos, including for the procurement of stem cells. The exclusion of funding of this step of research will not prevent Community funding of subsequent steps involving human embryonic stem cells".

Source: European Commission

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