EU Commission’s ‘risky’ move to re-visit orphan drugs regulation

The European Commission is expected to present by the end of July an evaluation study on the pros and cons of the application of orphan and paediatric regulations, which deal with a niche segment of rare diseases that affect fewer than five in 10,000 people.

The Orphan Regulation was introduced in 2000 and its main objective was to address the challenge of treating patients with rare diseases. The number of people who suffer from such diseases in the EU is around 246,000.

“Most patients suffer from even rarer diseases affecting one person in 100,000 or more,” the executive says.

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