BioWorld International Correspondent

BRUSSELS, Belgium The European Union’s principal advisory committee on ethics has come out strongly in favor of stem cell research.

Patents on stem cells enable further research, the committee said unambiguously in an opinion delivered Tuesday on the ethical aspects of patenting inventions involving human stem cells. And although the opinion is worded carefully on some of the most contentious issues raised by the subject, the overall tone is encouraging to EU research.

The European group on science and ethics delivered its opinion to European Commission President Romano Prodi, who had specifically asked it to define the conditions and limits of patenting stem cells. One of the focuses of the opinion, in response to that request, is to address the ethical dilemma that arises since patents can, on one hand, encourage scientific progress while, on the other hand, impair access to health care because fees would have to be paid to patent holders.

In theory, those questions were resolved by the 1998 EU directive on the legal protection of biotechnological inventions, but there has been continuing disagreement ever since on the exact scope of EU rules in that area.

The group said human stem cells lines that have been modified by an inventive process to get new characteristics for specific industrial applications are patentable. However, stem cells that have been isolated and cultured but have not been modified should not be considered as patentable inventions.

The group’s opinion also said that compulsory licenses should be encouraged when access to diagnosis and treatment is blocked by misuse of patent rights. It stressed the responsibility of individual EU member states to establish legal procedures for the delivery of compulsory licenses, and to examine if fair access to health care justifies invoking such a procedure.

There still are questions to be resolved in securing the right balance between inventors’ interests and society’s interests, the committee said. The EU should aim to guarantee that ethical principles and values are followed when there is conflict between the interests of the many players involved patients and patients’ associations, inventors, other researchers, donors, industry, health care providers and social insurance.

On cloning techniques aimed at obtaining human embryonic stem cells for therapeutic purposes, the group urged a cautious approach, and said such inventions should be excluded from patentability.

To ensure that patents on stem cells enable further research, the group also called for the creation of an EU registry of unmodified human stem cell lines. It should include both embryonic stem and embryonic germ cells lines. It would ensure transparency, and make access easier for the research community, the group said.

One member of the group, Gunter Virt of Austria, expressed a dissident view on the specific subject of stem cells of embryonic origin. In his view, the patentability of inventions involving embryonic stem cells is ethically unacceptable, as those cells require the destruction of a human embryo.

Noëlle Lenoir, a French lawyer who has chaired the group for the last eight years and has been a member since the group was set up in 1991, also said that she was standing down, because new work commitments in the U.S. would make it impossible for her to devote the necessary time to the job in the future. Prodi said her work had been “remarkable,” playing a determining role in designing a method of debate at the EU level on the ethical concerns raised by technological development.