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EFPIA: One Fifth Of Future Products ‘Unviable’ Under EU’s Plans To Modulate Regulatory Data Protection

 
• By Eliza Slawther

The European Commission’s pharmaceutical legislation overhaul could result in a loss of 50 expected new products by 2035 and an annual fall in R&D spending of €2bn, the European pharma industry federation EFPIA claims.

EU flag with gavel, European law concept
• Source: Shutterstock

The European Commission’s plans to cut the standard regulatory data and market protection periods for new drugs as part of its proposed pharmaceutical legislation overhaul could see a 22% drop in the number of new drugs expected to be developed by 2035, a new report from Europe’s pharma industry federation EFPIA has warned.

EFPIA has voiced its concerns about the commission’s draft revisions, particularly those relating to a reduction in the statutory regulatory data protection (RDP) for new medicines, on numerous occasions since the draft legislative framework was announced in April

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