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EU’s Plans for Regulatory Data Protection ‘Unworkable’

 
• By Ian Schofield

The European Commission will have a fight on its hands when it comes to the data protection part of its proposals for EU pharma legislative reform.

European Flags in front of the European Commission Headquarters building in Brussels, Belgium
The European Commission has proposed a raft of revisions to the pharmaceutical legislation • Source: Shutterstock

A real challenge, almost impossible, unworkable. Just a few of the comments made by life science lawyers keeping a close eye on the European Commission’s proposals for new rules on regulatory data protection (RDP) periods.

The general consensus seems to be that as part of its planned revision of the EU medicines legislative framework, and despite vociferous protests from the R&D-based pharmaceutical industry, the commission...

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