European Commission publishes proposal for strengthening the availability, supply and production of critical medicines within the EU

3 settembre 2025

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Purpose and Context: The Critical Medicines Act (CMA) aims to strengthen the EU’s resilience and security of supply for critical medicinal products and improve access to medicines of common interest. It responds to increasing medicine shortages, geopolitical tensions, and overreliance on non-EU suppliers, particularly for active pharmaceutical ingredients (APIs).
Key Measures Proposed:
- Strategic Projects: Support for EU-based manufacturing through fast-tracked permits, regulatory/scientific support, and financial incentives.
- Public Procurement Reform: Mandates non-price criteria (e.g. supply resilience, EU production) in procurement of critical medicines.
- Collaborative Procurement: Enables joint or Commission-led procurement to pool demand and improve access, especially for smaller Member States.
- Strategic Partnerships: Encourages cooperation with third countries to diversify supply chains.
Governance and Coordination: Establishes a Critical Medicines Coordination Group (CMG) to align national and EU actions, coordinate funding, and advise on supply chain vulnerabilities and procurement strategies.
Expected Impacts:
- Improved availability and affordability of critical medicines.
- Reduced dependency on third countries.
- Enhanced EU pharmaceutical competitiveness and innovation.
- Lower long-term costs from fewer shortages and better supply chain resilience.
Stakeholder Support: Broad backing from Member States, industry, and civil society, with over 300 organisations contributing to the Critical Medicines Alliance’s strategic recommendations.