The EU's Pharma Reform

On 11 December 2025, the Council of the European Union and the European Parliament reached a provisional political agreement on the long-anticipated comprehensive reform of EU pharmaceutical legislation coined the "pharma package". This package is poised to improve patient access to medicine, make the EU's pharmaceutical sector fairer and more competitive, and strengthen security of supply to prevent and manage shortages.

Whilst the provisional agreement requires formal endorsement by both the Council of the European Union and the European Parliament before formal adoption, it provides a reliable roadmap for how the EU intends to recalibrate innovation incentives, timely generic competition, and ultimately the resilience of supply.