BioWorld International Correspondent

BRUSSELS, Belgium - Even before the European Parliament makes up its mind about how advanced therapies should be regulated in the European Union, evidence emerged in Brussels last week of sharp divisions that also exist among the EU's member states.

Germany, not only the largest member state by far, but also the country that will preside over EU business during the first half of 2007, is openly opposed to the mandatory centralized authorization system now under discussion for somatic cell-therapy, gene-therapy and tissue-engineered products.

Spain, by contrast, favors mandatory centralized authorization for industry-produced medicines - but rejects the concept of a new committee at the European medicines agency in London to conduct assessments, and also is demanding an exemption from the centralized system for advanced therapies manufactured in hospitals.

Frank Niggemeier, the German diplomat who will be chairing talks among what will be 27 EU member states at the beginning of 2007 (when Bulgaria and Romania also accede), told an industry meeting in Brussels on Nov. 8 that the regulatory burden should not be too harsh on smaller firms making advanced therapies for national use only. Instead of obliging small firms to seek authorization through the London medicines agency, they should be allowed to continue using existing national channels. "The member states are able to assure adequate standards," he said.

Isabel de la Mata, the Spanish diplomat responsible for defending her country's position in the EU's attempt to legislate on advanced therapies, argued that an exemption for hospitals would help them to continue providing - as they do at present - advanced therapies in Spain. The obligation to authorize each product via the complex centralized procedures of the European medicines agency, including translation of the application into 22 other languages, would present an insuperable barrier to many hospitals, she claimed, and would therefore impede access to treatment.

Meanwhile, Finland - currently in the EU chair, and fervently committed to backing innovation-friendly new legislation - is confronted with continuing divergence of opinions from EU member states about the scope of the proposed new rules. Arto Koho, in charge of health affairs in Finland's embassy to the EU, said some member states favor extending the scope of the EU's separate legislation on medical devices to provide a regulatory framework for advanced therapies.

For the European biotech industry - and for European Union officials responsible for industry affairs - the stakes are high: They claim that effective legislation could provide vital incentives for research, and that persistent failure to agree a new framework will discourage innovation and damage competitiveness.

Divisions among member states are likely to compound the already complex discussions in the European Parliament - where the timetable for agreeing to a position on new legislation already has slipped badly in the face of profound disagreements. (See BioWorld International, Nov. 8, 2006.)

A mandatory centralized procedure is important, said Wills Hughes-Wilson, director of health policy for Genzyme in Europe. It should be phased in gradually over five years, and the European medicines agency should be given resources so that it can be made more user-friendly to smaller firms - but it was essential that the playing field should be level for all manufacturers of advanced therapies. And Andrea Rappagliosi, a vice-president of Serono International, focused on the need for predictability.

"This is the only way to promote the level of investment necessary to explore the potential of innovative therapy options," he said.

European Union officials also insisted on the merits of the centralized system they are proposing. Nicolas Rossignol, an official from the administration responsible for pharmaceuticals, said harmonization of the approach right across Europe would provide a sound base for companies of all sizes to pursue research. Not all member states were capable of operating their own national authorization systems, he said. Rossignol also expressed regret at the delay in agreeing on a new system: "We are at risk of wasting opportunities."

ThromboGenics Wins IND For Microplasmin

ThromboGenics NV, of Leuven, Belgium, said Nov. 13 that it is aiming to commence a Phase IIb trial in the U.S. before the end of the year for its microplasmin intraocular injection. The company said the FDA completed its review of the company's investigational new drug application and considers the proposed trial of microplasmin for vitreous injection safe to initiate. Preliminary positive results of a Phase IIa trial in Europe demonstrated that microplasmin could induce posterior vitreous detachment to ease vitrectomy surgical procedure.

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