BioWorld International Correspondent

BRUSSELS, Belgium - Wracked by ethical anxieties, the European Union is planning new guidelines on what it will pay for in terms of human embryonic stem cell research.

Under the EU's 2003-2006 research program, the funding of human embryonic stem cell research is permitted for the fight against major diseases. But, EU officials proposed last week, if stem cells are derived from human supernumerary embryos with no parental project, there must be a framework of strict ethical guidelines.

The provisions will ensure that no funding is made available for a specific research activity in a member state where that research is forbidden. Italy is the principal opponent of stem cell research from supernumerary embryos, and the new rules are a payback for Italy to signing up - conditionally - to the program. Therapeutic cloning is already excluded from the scope of EU research funding.

To meet the concern that EU funding would provide indirect incentives for the production of more embryos than needed for in-vitro fertilization, the proposed new rules would allow the use only of supernumerary embryos created before June 27, 2002, the date the EU research program was formally adopted. And funding would be made available only after a rigorous scientific peer review and an ethical review. Potential research project partners applying for EU funding would have to get ethical advice at the 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 would be funded only when it is demonstrated that it meets particularly important research objectives, and no adequate alternative (particularly existing embryonic or adult stem cell lines) exists. All research consortia would be obliged to make available new human embryonic stem cells to other researchers. Informed consent must be given by the donors, and they would not be allowed to make any financial gain. Data and privacy protection of donors must be guaranteed, but traceability of stem cells will be required.

The planned guidelines do not constitute universal ethical principles, the EU pointed out as it announced the plan. That, it said, is not a role for the EU: "Each EU member state must decide for itself on this issue," it said. The initiative is the EU response to a commitment it gave back in 2002 when national ministers approved the EU research program. The go-ahead for the program as a whole was conditional on the establishment before the end of 2003 of new ethical rules for any funding of human embryonic stem cell research.

At the same time, the EU published a call for proposals for setting up a European registry of stem cells and for helping establish public stem cell banks. That is aimed at creating optimal EU access to stem cells, so that results from research are made more quickly available. "Collaborative research at the EU level should contribute to a reduction of the use of human embryos," the proposal says.

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