EuropaBio supports the goal of the Critical Medicines Act (CMA) to strengthen security of supply for medicines in the EU. Medicine shortages have various causes and require tailored solutions. Addressing long-standing external dependencies and rebuilding manufacturing capacity will require sustained efforts over decades. Delivering the critical medicines of tomorrow demands urgent action today through reinforced global value chains and stronger EU leadership and competitiveness in biotech and life sciences innovation.

EuropaBio actively contributed to the work of the Critical Medicines Alliance to ensure a pragmatic, fit-for-purpose proposal. It is regrettable that many of the Alliance’s core recommendations were not taken up. The CMA lacks concrete measures to ensure sustainable access to raw materials and feedstock and to build strategic partnerships, two vital elements for long-term resilience. The absence of a comprehensive impact assessment raises serious concerns. Without a robust analysis of the proposed measures and their interplay with other legislations such as the revision of the EU General Pharmaceutical Legislation (GPL), it is impossible to fully evaluate the cumulative effects of the CMA.

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