BRUSSELS, Belgium - There are major divergences in European Union legislation on cloning, the European Commission said. And it wants the inconsistencies addressed before anarchy results. That is the underlying fear that is driving the Commission to stimulate new debate on the subject.
A recent briefing delivered in Brussels by leading Commission biotechnology experts revealed that hardly any of the 15 EU member states have the same legislation on cloning. There is no legislation in force at all in Greece, Luxembourg, the Netherlands, Portugal or Finland. But a law is now being drafted in Finland. A law also is in preparation in the Netherlands, where the government favors research if it is strictly controlled, but is against the creation of embryos for research purposes. In Portugal, a law now being drafted is likely to allow research if it is approved by an ethics committee.
In the other 10 countries of the EU, where legislation already exists, research on embryos and their cells is banned in five of them - and it is allowed in the other five. Austria bans embryo research and importation of embryos. In Ireland, the embryo is protected by the nation's constitution, so research using embryos would be unconstitutional. Denmark has a straightforward ban. Germany's current legislation is a partial ban - it allows research on imported embryos, but the legislation there is in any case now under review. And Italy currently bans all embryo research, but its parliament is discussing an easing of the ban.
In the five countries that allow research on embryos, Belgium allows it under certain conditions, and is currently revising its law so that research will also be allowed on surplus embryos. Spain imposes conditions. France allows it "in exceptional circumstances," and is likely to revise its legislation to allow research on surplus embryos. Sweden allows it for cells and for embryos of less than 14 days (and allows creation of an embryo as long as the project is approved by an ethics committee). And the UK authorizes research under conditions, while a new legislative initiative is aimed at authorized therapeutic cloning and the creation of embryos for research purposes.
The situation is further complicated by the fact that several member states have now signed up to a 1998 Council of Europe protocol to the convention on human rights and biomedicine, which prohibits cloning human beings - but only Greece has ratified the protocol, and several larger member states have not yet even signed it, so it is not yet in force.
The European Commission does not see its role as imposing the same rules in all countries, and doesn't have that power anyway. "We have to be realistic about the strong diversity and differences among the EU member states," Laurence Cordier, one of the Commission's ethics experts, told BioWorld International after the briefing. "We cannot expect to go forward very much on this topic.
"The risk is in places where there is no legislation. Debate is needed to create a framework. We'd like all countries to create an ethical framework," Cordier said. "The Commission does want to prevent a situation arising where the lack of appropriate legislation in any one country might lead to an advance in cloning that goes beyond anything that is currently viewed as scientifically and ethically acceptable."
No Commission official has yet said it in public, for fear of appearing to presume. But in private officials make clear that they fear human cloning occurring in some maverick research outfit in a country that provides loopholes because its legislation is inadequate. For that reason, the Commission is cautious about using its funds to back biotechnology research in countries with no legislation in this field.
At the same time, the Commission wants to keep options open. Legislation that closes off all possibilities of research would not be appropriate, it believes. "We are between a rock and a hard place," according to Andrea Dahmen, the spokesman for European Environment Commission Margot Wallstvm, one of the key figures in the growing debate. "How can you know what the possibilities are without research?" she asked.
Etienne Magnien, head of the Commission's biotechnology unit, also favors a middle-ground approach. "A ban can be instant, but it requires several years to regulate, and it requires decades to be successful in research," he said. "The aim of the Commission is not to seek confrontation on whether cloning or research on embryos is good or bad. The real question is how to handle this dilemma that puts the interests of patient groups against the interests of egg donors." He sees the Commission's role as an observer, ready to foster debate, to collect and compare opinions, the share best practices, and pursue research so as to deepen the debate.
In early November the Commission will organize a major symposium in Brussels on these questions, as the first step in trying to organize a genuinely European-level debate.