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Long-Awaited EU Review Questions 10-Year Orphan Exclusivity

Prevalence Criterion Also Under The Spotlight

Executive Summary

The EU Orphan Regulation and the Paediatric Regulation have helped to increase the number of products developed for rare diseases and children, but they both have some shortcomings that need to be addressed, according to an evaluation of the legislation carried out by the EU authorities. The European pharmaceutical industry has warned against opening up the legislation, saying it is “critical to maintain a stable and predictable incentives framework."

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