BioWorld International Correspondent

BRUSSELS, Belgium - European Union member states have failed to reach agreement on two key biotechnology-related issues in the last week, demonstrating yet again the difficult political background the biotechnology industry has to work against.

The first failure came on Dec. 3, on the divisive issue of whether the EU should or should not fund research projects involving the use of human embryos and human embryonic stem cells. The ministers responsible for research in each of the 15 EU member states converged in Brussels specifically to reach a political agreement for the final stage in the year-long discussion - and went away without being able to make a decision.

Italy, the current holder of the rotating EU chair, urged a cautious compromise, essentially preventing all funding for work on all human embryos cells. But the predominantly Catholic southern European countries, deeply opposed on ethical grounds to such work, could find no accommodation with the more pragmatic northern countries, and Letizia Moratti, the Italian minister for education, universities and research, was obliged to conclude by the end of the meeting that no agreement could be reached.

Not only did most EU member states fail to unite behind the Italian compromise, but also they failed to agree on a revised - and slightly restrictive - proposal from European Research Commissioner Philippe Busquin, also present at the meeting. And, to complete the disarray, the commissioner confirmed that he could not endorse the Italian compromise, either.

The question facing EU ministers was not whether such research should be legally permitted in the EU - that remains a matter for each member state to decide. The question was whether such research should be funded from the EU budget, and under what conditions.

Paradoxically, the result of that confusion is that the prospects might improve for EU funding of research activities involving the use of human embryos and human embryonic stem cells. The one-year moratorium - a sort of cooling-off period for reflection - that member states and the European Commission agreed to last year will expire at the end of December. And since the member states have failed to find a joint formula to impose controls on that type of research, the EU research program can go ahead as initially planned. Applications can be made for funding of stem cell research, and each application will be judged on its own merits by the EU committee responsible for running the program.

In that new situation, Busquin made clear that funding will be available over the next few weeks for the study of only banked or isolated human embryonic stem cells in culture. And he will make sure the guidelines that his officials proposed in their own compromise (and the member states failed to agree upon) are followed in assessing applications. Those guidelines are rigorous scientific and ethical review and procurement of stem cells only from supernumerary human embryos created before June 27, 2002, as a result of medically assisted in vitro fertilization designed to induce pregnancy. But longer term, the opportunities will increase for winning EU funding for that type of work in the member states that allow it.

The chairman of the European Parliament research committee, Spanish socialist Luis Berenguer Fuster, expressed his disappointment at the deadlock. He blamed Italy for proposing a compromise that already had been rejected by the European Parliament in its vote last month, which expressed strong support for allowing research to be financed under the EU research program with tight ethical conditions.

For different reasons, monsignor Noel Treanor, secretary general of the European conference of Catholic bishops, regretted that EU ministers "failed to agree on ethical restrictions for EU funding of stem cell research." He said bishops were "deeply concerned that this might result in the European Commission taking decisions on such funding in a context of legal and ethical uncertainty."

The second issue on which the EU member states dropped the ball was on biotechnology sweet corn, on Dec. 8. An expert committee with senior representatives from each member state was due to decide on whether to authorize imports of genetically modified sweet corn - Syngenta AG's Bt11. Again, it failed to reach a decision.

Finland, Sweden, Ireland, the UK, the Netherlands and Spain were in favor, but Greece, Denmark, France, Austria, Portugal and Luxembourg were against. Belgium, Italy and Germany abstained. Under the EU's complex voting rules, that amounted to what footballers call a no-score draw - a null decision.

The organization Friends of the Earth immediately welcomed what it saw as a decision not to let new GMO foods onto the European market. Its European spokesman, Geert Ritsema, said: "There is clearly no scientific consensus over the safety of this modified sweet corn. The decision not to approve it is a victory for public safety and common sense."

But again, the failure of ministers to reach a decision leaves the way open for EU officials to make a technical decision on the application, which could well result in an authorization being issued early in 2004.