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EU Pharma Reform Talks Heat Up As Health Ministers Prepare To Challenge Proposals

 
• By Ian Schofield

In a sign of difficult negotiations to come on the European Commission’s pharma reform package, the presidency of the Council of the EU has drawn up its own set of proposals on regulatory data protection and market exclusivity that differ in several respects from those of the commission and the European Parliament.

A view of a banner in the EU Council offices marking the taking over of the rotating presidency of the European Council by Belgium in Brussels on January 16, 2024.
EU health ministers are debating the pharmaceutical reform package • Source: Shutterstock

The Belgian presidency of the Council of the EU says it agrees in principle with the European Commission’s proposed “modulated approach” to regulatory data protection (RDP) and market exclusivity (ME), including a cut in the baseline RDP period, as part of the pharmaceutical reform package.

However, it believes it is “too early” to decide what the actual reduction in the baseline RDP period should be: from eight years to six as per the commission’s proposal or from eight years

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