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Splits Over Data Protection Could Hamper EU Pharma Revision

 
• By Ian Schofield

The chances of reaching agreement on proposals to overhaul the EU pharma rules before the European Parliament elections in June 2024 are receding as disagreements emerge over key issues such as regulatory data protection and how to encourage antimicrobial R&D.  

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Lawmakers are gearing up for what could be a long and arduous debate over the European Commission’s proposals for revising the EU pharmaceutical legislation. The revision package, consisting of a draft regulation and a draft directive, is wide-ranging and covers a multitude of areas relating to pharmaceutical regulation. First published in April 2023, it was formally presented to the European Parliament in September.

The contentious nature of many of the proposals bodes ill for a smooth journey through the legislative machinery at the European Parliament and the Council of the EU.

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