12/12/2025 — Following eleven hours of intense negotiations overnight, the European Union (EU) clinched a landmark agreement on the most significant pharma reform of its medicines market in over 20 years. Reached in the final moments of the Danish EU Presidency’s mandate, the deal aims to strike a critical balance stimulating pharma innovation, particularly for critical new antibiotics and rare disease drugs, but also speeding the development of generics to ensure more affordable treatment in all 27 member states.
The EMA welcomed the pharma reform package in a statement published shortly after the deal was announced, with Emer Cooke, EMA’s Executive Director, hailing it as a “historic milestone for European medicines regulation and for patients across the EU.” However, leading industry representatives warned that the compromise does not go far enough to ensure Europe’s global competitiveness and attract investment.
Source : Health Policy Watch
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