Reviewing orphan drugs law: A tough equation

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. [Shutterstock / Sk Elena]

The Orphan Regulation was introduced in 2000 and its main objective was to address the challenge of regulating medicines which treat patients with rare diseases.

Around 246,000 people suffer from such diseases across the EU,

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.

In this Special Report, EURACTIV will try to analyse how the regulation has worked so far for different stakeholders involved as well as the implications of a potential review.

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