EFPIA welcomes today’s adoption of the Council’s General Approach on the Critical Medicines Act (CMA). This is an important step toward strengthening the availability, accessibility and security of supply of medicines for patients across Europe.

We support the Council’s efforts to keep the CMA focused on genuinely critical medicines where targeted action can make a meaningful difference. To be effective, the Act must remain proportionate and avoid broad mechanisms that risk stretching resources and blurring the line between supply issues and wider medicines access challenges. In this context, EFPIA continues to seek a more precise definition of medicinal products of common interest, limited to cases of clear market failure.

Collaborative procurement can play a role in improving availability in selected circumstances such as health emergencies and demonstrable market failures. To be successful, it must not lead to a proliferation of procedures that reduce predictability and clarity for all parties involved or overstretch national and EU resources. Collaborative procurement should be voluntary; it should support, rather than complicate, supply predictability, protect price confidentiality, reward quality and innovation, and allow national processes to run in parallel to avoid delays if a collaborative procurement procedure does not proceed.

On public procurement criteria, EFPIA recognises the shared ambition to strengthen supply chain resilience. In particular, criteria such as “resilience,” “security of supply” or “strategic autonomy” should be proportionate, target critical medicines with demonstrated vulnerabilities and avoid preferential approaches that risk fragmenting global supply chains, infringing EU international commitments and ultimately undermining Europe’s competitiveness.

Contingency stock requirements:  We do not believe that the Council’s position goes far enough in enhancing measures to harmonise the growing trend of uncoordinated national contingency stock obligations. More consistent EU-wide rules would help align national approaches while ensuring that requirements remain efficient and avoid market distortions, provided they are limited to critical medicines with demonstrable supply chain vulnerabilities.

Nathalie Moll, Director General of EFPIA, said: “The Critical Medicines Act is an opportunity to improve supply security and patient access across Europe. Industry fully supports these goals, provided the measures are targeted, pragmatic and workable. Europe’s ability to secure the medicines patients need depends on a competitive environment where pharmaceutical innovation and manufacturing can thrive.”