BioWorld International Correspondent
BRUSSELS, Belgium - The European Parliament's ad hoc committee on genetic engineering and new technologies in modern medicine started a series of hearings of experts.
First to take the stand, on Jan. 30, was Noëlle Lenoir, chairman of the European Union's group on ethics. And despite the ambitions of the committee to create "the basis for coherent biotechnology legislation in Europe," Lenoir focused on what she called the "culture shock" that still separated EU member states in their attitudes on biotechnology. In embryo research, for instance, the UK is opening the door to scientists, while Italy is keeping it firmly closed.
This type of divergence means that in effect it still has to be left up to each member state to make its own decisions, Lenoir said, suggesting that at present the EU may be able to do no more than offer broad guidelines in the most sensitive areas. She also said she sees no possibility of easing patent law in respect to patents on living matter. Even if the patent system obliges users to pay royalties, she said she could see no alternative to this established feature of research.
The committee has set itself a target of the end of this year to deliver its report. In addition to a program of further hearings of experts (the next is with experts from the European Molecular Biology Laboratory in Heidelberg, Germany, in March), it is planning a roundtable in June with committees from national parliaments in the 15 EU member states, and a hearing with representatives of civil society in July. It also intends to create an Internet site "to facilitate direct dialogue with European citizens," according to its chairman, Luxembourg Euro-MP Robert Goebbels.
CPMP Expects 70 Applications This Year
The EU's top-level scientific advisory committee on medicines, the Committee for Proprietary Medicinal Products within the European Medicines Evaluation Agency, held its first meetings under its new chairman, Daniel Brasseur, of Belgium, backed up by Eric Abadie, of France, as its new vice chairman.
The committee, set up to evaluate all European marketing authorization applications for biotechnology medicines, faces a tough schedule over the coming year as it likely will evaluate more than 70 applications in 2001, as compared to just over 50 in 2000, EMEA officials told BioWorld International.
Brasseur is therefore determined to streamline the committee's work during its three-year term, and has already proposed new timetables and working practices for the committee. Under this new structure, the weeklong meetings of the CPMP each month will now have a regular spot for reports from the committee's biotechnology working party. And according to the timetable adopted, the biotechnology working party is for the first time scheduled to meet every month during 2001, even in the normally sacrosanct holiday month of August.
The Committee for Proprietary Medicinal Products also adopted at its January meetings three reports developed by its biotechnology working party: a concept paper on the stability and traceability requirements for vaccines intermediates; a note for guidance on plasma-derived medicinal products; and a note for guidance on cell culture inactivated influenza vaccines, which is now to be circulated for a six-month consultation period.