Critical medicines act [EU Legislation in Progress]

Written by Laurence Amand-Eeckhout.

CONTEXT

In light of the current geopolitical situation, and in response to the growing issue of medicine shortages in the EU, on 11 March 2025 the European Commission put forward a proposal for a regulation on a critical medicines act. The proposed regulation seeks to strengthen the availability of critical medicines in the EU and the security of supply of these medicines by reducing the dependency on single suppliers and third countries and boosting pharmaceutical manufacturing in the EU. It also aims to improve access to certain medicines of common interest that encounter market failures.

The proposal, which complements the ongoing revision of the pharmaceutical legislation and the enhanced role of the European Medicines Agency in managing shortages, contributes to the European health union’s goal of ensuring that all EU patients have access to the medicines they need, wherever they are and whenever they need them. Going beyond public health, the proposal is about security and resilience. By securing stable and reliable medicine supply chains, the EU is expected to be able to improve its preparedness and strengthen its overall security. The proposal is also one of the actions set out in the competitiveness compass published by the Commission in January 2025.

LEGISLATIVE PROPOSAL

2025/0102(COD) – Proposal for a regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 – COM(2025) 102, 11.3.2025.

NEXT STEPS IN THE EUROPEAN PARLIAMENT

The European Parliament committee responsible for this file is the Committee on Public Health (SANT). For the latest developments in this legislative procedure, see the Legislative Train Schedule: 2025/0102(COD)

Read the complete briefing on ‘Critical medicines act‘ in the Think Tank pages of the European Parliament.