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EU Regulatory Reforms Mean Many Orphan Drug Producers Won’t Benefit From Incentives

 
• By Francesca Bruce

The EU’s regulatory reform package if unchanged could make orphan drug development less attractive, warn industry representatives.

Bridge and uncertainty
EU Pharmaceutical Regulation Reform Could Mean Uncertainty For Orphan Drug Developers • Source: Shutterstock

The European Commission’s proposals for reforming the pharmaceutical legislation could make it harder for orphan drug manufacturers to benefit from the available incentives, according to the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE).

Drastically limiting the market exclusivity periods of new orphan indications for existing products and linking additional market exclusivity to high unmet medical need could hamper investment and access to new innovation, warn Alexander Natz, EUCOPE

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