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EU Pharma Reform Proposes Cuts In Regulatory Protections & Faster Drug Approval Times

 
• By Ian Schofield

Proposals for the overhaul of the EU pharmaceutical legislation will make medicines more widely available, accessible and affordable while supporting innovation and boosting the “competitiveness and attractiveness” of Europe’s pharma industry, the European Commission claims. The research-based industry thinks otherwise, saying cuts in regulatory protections will undermine R&D.

The EU regulatory reform package includes changes to incentives for pharma firms • Source: Shutterstock

The European Commission’s long-awaited package of proposals for overhauling and modernizing the medicines legislative and regulatory framework was finally released on 26 April, comprising a new draft Regulation and Directive alongside two initiatives to help tackle antimicrobial resistance.

As widely expected, the package includes cuts in the regulatory data and market protection periods for new drugs, albeit with the possibility to build up additional years of protection by, for example, launching the product in all EU markets or targeting major unmet medical needs

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