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EU to foster development of 'orphan drugs' for rare diseases BRUSSELS (July 28, 1998 5:05 p.m. EDT http://www.nandotimes.com) - The European Commission proposed incentives on Tuesday to encourage pharmaceutical companies to develop drugs to treat rare diseases. Following in the footsteps of the United States, Japan and others, the Commission said the European Union should promote research into "orphan drugs" -- products that can be unprofitable because they reach such small numbers of patients. The EU executive proposed a package including exclusive market authorization, streamlined approval procedures and a waiver of registration fees. Europe's pharmaceutical industry and patients groups have been lobbying for the initiative for several years. "I think that just before the summer vacation, this is very good news," said Cees Smit, coordinator of the Netherlands Hemophilia Society and chairman of the European Platform for Patients' Organizations, Science and Industry. He said the lack of incentives for orphan drugs had left Europe's pharmaceutical companies at a competitive disadvantage. If the legislation is approved by EU governments and the European Parliament, it would apply to drugs for illnesses affecting no more than five per 10,000 people in the EU. Other diseases could qualify under certain conditions -- for example, if they were life threatening and transmissible. Manufacturers would have exclusive distribution rights in the EU for 10 years, during which time no EU country could authorize any other product with the same active ingredient. However, that right could be withdrawn after six years if a drug's market grew beyond "orphan" status or if its price allowed the company to earn an "unreasonable profit." Orphan drugs would automatically qualify for the EU's centralized drug approval system, operated by the European Agency for the Evaluation of Medicinal Products in London. The agency's usual 200,000 Ecu fee ($220,000) would be partly or completely waived. A new committee -- including representatives of national governments and patients organizations and rare disease experts -- would be set up to consider applications for orphan drug status. The 15 EU countries could adopt additional incentives on their own, for example tax breaks for manufacturers. Juergen Reden, research and development adviser for the European Federation of Pharmaceutical Industries and Associations (EFPIA), said he hoped governments would take up that option. "Tax incentives and market exclusivity are the two key issues as we know from the U.S. experience," he said. The EU generally leaves tax matters up to national governments. The United States pioneered orphan drug incentives in 1983. By the end of 1997, more than 150 drugs with orphan drug status had been marketed there, mostly by small firms specializing in biotechnology and genetic engineering, according to a Commission report. Australia and Singapore have also introduced incentives. Reden said the EFPIA welcomed the EU proposal, though it hoped to change the language on "an unreasonable profit" since that would be too difficult to define. By Suzanne Perry, Reuters Copyright 1998 Nando.net Copyright 1998 Reuters News Service a new voice - http://www.newcountry.nu/pd/members/janet/index.htm janet paterson - 51/10 - endocarb/selegiline/fluoxetine almonte/ontario/canada - [log in to unmask]