New EU directive: Optimizing pharma launch sequences and navigating IRP challenges

Published on September 3, 2024

 

Pharmaceutical companies may face a more complex international reference pricing (IRP) landscape under a new European directive. Article 58a requires specific deadlines for pricing and reimbursement submissions. Our experts explain how this affects launch sequence optimization, the challenges and opportunities, and the strategies pharma companies should adopt. 

Context for the proposed directive on medicinal products for human use, replacing Directive 2001/83/EC and Directive 2009/35/EC:

On April 10, 2024, the European Parliament adopted in first reading the “pharmaceutical package,” which includes a new directive and a new regulation to revise the EU Pharmaceutical Legislation. Its overall objectives are to make medicines more available, accessible, and affordable, while supporting the EU pharmaceutical industry’…

EU_amendment

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