The Council on 1 December 2026 published an opinion from the European Committee of the Regions (CoR) on the proposed Critical Medicines Act, which aims to strengthen the security of supply, availability, and accessibility of critical medicines within the EU. The CoR proposes integrating medicine security into the EU's defence strategy, recognising regional authorities in evaluating strategic projects, creating an independent Critical Medicines Coordination Group with regional representation, and lowering the threshold for joint Member State procurement facilitated by the Commission.
The opinion, adopted by the CoR, responds to the European Commission's proposal for a Regulation (COM(2025) 102 final) that would also amend Regulation (EU) 2024/795. The document is non-binding but signals the views of regional and local authorities across the EU on the legislative file.
Policy orientations and trade-offs The CoR's proposals reflect a tension between EU-level coordination and national/regional sovereignty. Integrating medicine security into defence strategy would elevate the issue to a security priority, potentially unlocking defence-related funding and coordination mechanisms. However, it could also shift decision-making away from health authorities towards security institutions, raising concerns about securitisation of health policy. Recognising regional authorities in evaluating strategic projects would give subnational governments a formal role, increasing local input but potentially slowing down project approvals. Creating an independent Critical Medicines Coordination Group with regional representation would add a new layer of governance, improving inclusivity but risking bureaucratic overlap. Lowering the threshold for joint procurement would facilitate more frequent joint purchasing, increasing solidarity and bargaining power but potentially reducing flexibility for Member States with specific needs.
Impact on stakeholders EU pharmaceutical producers may benefit from increased demand and strategic support if medicines are classified as defence-related, but could face additional security compliance costs. National health authorities may see their role in procurement and supply chain management partially shifted to EU-level coordination, especially if joint procurement thresholds are lowered. Regional authorities would gain formal influence in evaluating strategic projects and representation in the coordination group, enhancing their voice in EU health policy. EU taxpayers could face increased public spending if defence integration leads to higher subsidies or procurement costs, but may benefit from improved medicine security and reduced shortages.
Expected institutional follow-up The opinion will be considered by the European Parliament and the Council as they negotiate the final text of the Critical Medicines Act. The Commission will also take it into account when revising its proposal. The next steps involve discussions in the Council's working parties and the European Parliament's committees, with a view to reaching a political agreement in 2026.
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