BioWorld International Correspondent

BRUSSELS, Belgium - European Union ministers Monday at last gave their formal and final backing to the proposed €17 billion (US$16 billion) research assistance program that will provide significant support for biotechnology research through 2006. The seal of approval was given, without debate or fanfare, at a meeting of the EU Employment and Social Affairs Council in Luxembourg, where it had been added to the agenda at the last minute.

That brings to a successful conclusion more than two years of EU debate over research support, during which the fate of EU biotechnology research support hung frequently in the balance. Even until the last days of discussion, the decision was delayed because ethical questions, mainly relating to stem cell research, left Austria, Germany, Ireland and Italy less than entirely happy with the compromise package agreed to during April and May with the European Parliament.

But in the end, the decision was made, and biotechnology - within the program's definitions of genomics and biotechnology for health and welfare - has a direct allocation of €1.3 billion, while biotechnology research also will benefit from other parts of the program, notably the €1.2 billion earmarked for combating major diseases, as well as other allocations for environment and biodiversity, agriculture and food safety, and research infrastructure and training.

The first calls for proposals should now emerge from the European Commission by the end of the year. But before then, the discussion must be completed on the mechanisms and rules for taking part. That is still under way in the European Parliament and among EU ministers. On May 28 the European Parliament's industry committee agreed on the format it wants to see for those rules, including such administrative aspects as creating a two-stage application procedure, so that potential participants are not deterred by disproportionate and costly preparation of proposals at an early stage. Instead, an initial application should be possible on the basis of a simpler dossier, which would be supplemented with more detail once a real prospect of success had been signaled by the assessors of applications, the committee said. Other changes it wants include clearer rules on liability (to avoid all participants in a project being responsible for reimbursement of funds if another of the participants goes into liquidation during the project).

The European Parliament will finalize its vote on the rules in its plenary session in Strasbourg, France, in mid-June.

The draft rules also contain specific provisions on biotechnology research. One of the Parliament committee's senior members, William van Velzen of the Netherlands, urged that the wording be brought more into line with the wording of the research program itself, to remove possible ambiguities. So he wants a passage making clear that some "special rules" should apply: "Research on the use of human stem cells may be financed depending both on the contents of the scientific proposal and the legal framework of the member state(s) involved; research using adult stem cells and reprogrammed adult cells should get priority for financing; [and] there is no restriction on financing research on stem cell lines already existing in scientific laboratories. In addition, research on embryo or fetal stem cells deriving from spontaneous or therapeutic abortion may be funded," he said.

Similarly, "research on supernumerary' early stage (up to 14 days) human embryos (embryos genuinely created for the treatment of infertility but no longer needed for that purpose and when destined for destruction) may be funded provided that such research is legally permitted in the member state(s) where it will be conducted under the rules and strict supervision of the competent authorities." And "research promoting the understanding of legal, ethical and social implications of the new knowledge in the field of human genetics may also be financed."

In this way, he said, the rules will refer to the same ethical principles that the European Parliament has already agreed to for the program as a whole. He also won support from committee members for greater emphasis on the need to fund molecular mechanisms, which he wants inserted into the rules listing areas of biotechnology eligible for support. The modified rules thus run: "The sequencing of the human genome and many other genomes heralds a new age in biology, offering unprecedented opportunities to improve human health and to stimulate industrial and economic activity. In making its contribution to realizing these benefits, this theme will focus on integrating post-genomic research and related molecular mechanisms into the more established biomedical and biotechnological approaches, and will facilitate the integration of research capacities (both public and private) across Europe to increase coherence and achieve critical mass."

Van Velzen also authored an amendment that would make specific provisions for funding research into vaccinations and cancer "as they represent important fields where biotechnology could be of great use."

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