UK pharmacology journal calls for more incentives for specialist drugs in Europe

European pharmaceutical companies should be given more incentives to develop orphan drugs for rare conditions, a report in the British Journal of Clinical Pharmacology has said.

Researchers found that only 18 orphan drug applications made between 2000 and 2004 for rare diseases were approved ? only seven per cent of the total 255 submitted to the EMEA’s Committee for Orphan Medical Products.

At the same time the organisation received 193 non-orphan drug submissions, of which 153 were approved. Drugs are defined as orphan when their development is deemed to benefit only a small number of people.

“It’s difficult to find a balance between the urgent need for drugs for patients with rare diseases and guaranteeing their quality, efficacy, safety and, where necessary, making comparisons with existing drugs,” said Professor Silvio Garattini, the report’s co-author.

He said that the small number of people affected by the diseases treated by drug orphans made it difficult to produce a reliable way of evaluating a drug’s safety or efficacy.

Regardless, Mr Garattini said: “It is clear that less stringent criteria are acceptable for orphan drugs than for drugs for more common diseases, particularly in view of the small number of patients.”

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