The Council of the European Union and the European Parliament have reached a provisional agreement on the Critical Medicines Act, advancing an EU-level framework that links shortage prevention with procurement policy, collaborative purchasing and industrial capacity. The deal still needs endorsement by both institutions, followed by legal-linguistic revision and formal adoption.
The agreed text requires contracting authorities to apply resilience-related requirements in public procurement procedures for critical medicines. It also keeps flexibility around the ‘EU preference’ approach, which is intended to support EU-based manufacture of critical medicines and active pharmaceutical ingredients where supply chains depend heavily on non-EU sources.
The agreement also lowers the threshold for collaborative procurement. Five Member States, rather than nine, will be able to ask the European Commission to procure critical medicines or medicines of common interest on their behalf. That change gives smaller coalitions of countries a more practical route to joint purchasing, and potentially stronger negotiating leverage, where availability problems affect several markets.
The scope of the Act has also been widened to include orphan medicines in certain areas, including strategic projects and collaborative procurement. The European Medicines Agency said the Act complements shortage and supply measures in the revised EU pharmaceutical legislation, and noted that state aid and joint procurement may support access and availability, although these elements sit outside EMA’s direct remit.
Industry reaction has focused on the same boundary between supply resilience and access policy. The European Confederation of Pharmaceutical Entrepreneurs, EUCOPE, has warned that including orphan medicines and medicines of common interest in collaborative procurement could create uncertainty for smaller developers and alter pricing dynamics if joint purchasing becomes a stronger payer tool.
The Act therefore adds a strategic purchasing and manufacturing layer to the EU access landscape. Its practical effect will depend on how Member States use procurement flexibility, how state aid is directed to strategic projects, and how safeguards are applied where collaborative purchasing reaches beyond established shortage-prone products.
Source: Council of the European Union
Link: Critical medicines act: Council and Parliament reach provisional deal
Date: 12 May 2026
