Long-Awaited EU Review Questions 10-Year Orphan Exclusivity
Prevalence Criterion Also Under The Spotlight
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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The European Commission’s latest consultation on overhauling the EU legislation on medicines for children and for rare diseases has drawn some sharp responses from stakeholders.
Companies wanting to get involved in long-running plans to overhaul the EU orphan drugs and pediatric medicine legislation can make their contribution through a public consultation that began on 10 May.
Innovators warn against slashing incentives and argue a lack of a common definition of unmet need is a stumbling block to proposals.