Commission publishes evidence document for critical medicines supply legislation
The European Commission has published a Staff Working Document presenting evidence to support a legislative proposal aimed at reinforcing the availability, supply security, and production of critical medicinal products within the EU. The document underpins proposed amendments to Regulation (EU) 2024/795 and outlines a framework to address persistent medicine shortages and supply chain vulnerabilities. It recommends measures to reduce reliance on non-EU suppliers, improve access to medicines of common interest, and enhance manufacturing capacity through investment, regulatory coordination, and strategic procurement. The evidence includes assessments of economic, environmental, and social impacts, and incorporates input from the Critical Medicines Alliance to inform implementation.