EU Planning Orphan Drug Regulations

24 September 1997

In November, the European Commission plans to issue long-awaitedlegislation aimed at promoting the development of drugs to treat rare diseases, Patrick Deboyser, head of the Commission's pharmaceuticals unit, told a conference in Brussels, Belgium last week. The proposals could become law by December 1998, say Reuters reports.

The Commission proposes giving orphan drug makers 10 years' exclusive marketing rights to these products, plus automatically entitlement to use the European Medicines Evaluation Agency's centralized procedure for approval, for which the usual 200,000 Ecu ($219,380) fee would be waived. The definition of orphan status should be a prevalence of one patient per 1,200 people, it says; the USA sets prevalence at one in 1,300.

In the USA, said Abby Meyers, president of the US National Organization for Rare Disorders, some companies have turned orphan drugs such as human growth hormone into big money makers. The question for Europe, she said, is how to ensure that companies are allowed to earn reasonable profits from orphan drugs, yet prevent them from abusing the law's intent by earning extraordinary profits. Mr Deboyser said the Commission is still debating whether a company could continue to enjoy market exclusivity if the drug's price became excessive.

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