BRUSSELS, Belgium ¿ The European Parliament gave its backing on March 9 to the European Union (EU) plan from July 1998 to stimulate development of orphan drugs, a measure which is explicitly intended to offer assistance to biotechnology firms, and particularly smaller firms, in developing treatments for unprofitable rare diseases. The proposal offers incentives such as accelerated marketing authorization procedures, exemptions from registration fees, and market exclusivity for 10 years for treatments for diseases that affect less than five people per 10,000 of the EU population.

The parliament¿s discussion, in its first reading of the measure, centered on a report from its committee on public health and consumer protection, drafted by one of the parliament¿s senior medical members, French Euro-MP Christian Cabrol. This report broadly welcomes the European Commission¿s proposal. But it wants some changes to make it more attractive to industry, and the parliament lent its weight to the report in the course of the plenary session in Strasbourg, France, last week.

For example, the parliament called for more flexibility in the proposed special provisions for clinical trials. It is not enough merely for the EU to offer ¿assistance in the development of a protocol and for the follow up of clinical investigations¿ from the EU¿s European Medicines Agency, in London. The parliament said the agency should be empowered ¿in exceptional cases¿ to allow a medicine to be made available ¿under specific conditions, before marketing authorization has been granted.¿ It also called for special budgetary aid from the EU to ease the costs of marketing authorization ¿on a scale sufficient to cover all the applications submitted and thus able to produce the maximum incentive.¿

The committee wants to widen the scope of the measure, too, so that ¿ even when more than five-per-10,000 are affected ¿ it can cover not only medicines for life-threatening or seriously debilitating communicable disease (as the EU is already proposing) but also any ¿serious and chronic disease.¿

Because it is impressed with U.S. experience with orphan drugs, the parliament¿s public health committee was seeking a more robust EU commitment to support for orphan drug development, with a clear assertion that ¿it is unlikely that, without incentives, the marketing of the medicinal product in the EU would generate sufficient return to justify the necessary investment.¿

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