On Tuesday, 11 March, European Commissioner for Health and Animal Welfare Olivér Várhelyi introduced the Critical Medicines Act (CMA), sharing that the proposal is needed to ensure the security of supply and availability of essential medicines in Europe. Várhelyi highlighted that the Act builds on the work of the Critical Medicines Alliance and will have a positive impact on EU competitiveness by creating a more stable and predictable market.
The Act was initially mentioned in European Commission President Ursula von der Leyen’s political guidelines and promised to be announced within the first 100 days of the Commission’s mandate. Member States are experiencing severe medicine shortages, with geopolitical tensions exposing significant vulnerabilities in the EU’s pharmaceutical supply chain.
The Act will facilitate investments for companies that increase EU manufacturing of critical medicines while incentivising actions that make supply chains more resilient. Key elements of the Act include:
-Strategic projects: to create, increase or modernise EU manufacturing capacity for critical medicines or their ingredients.
-State aid guidance: to assist Member States in financially supporting such strategic projects.
-Public procurement: will be used to diversify and incentivise the resilience of supply chains. Procurers will be required where justified to favour manufacturers who create critical medicines within Europe.
-Collaborative procurement: among different Member States will be supported by the Commission to address availability and access disparities of critical medicines and other medicines throughout the EU.
-International partnerships: with like-minded countries and regions will be explored, to broaden the supply chain and reduce dependencies on a single supplier.
At the plenary debate in Strasbourg on 11 March, there was a broad consensus on the need to reduce dependence on third countries and strengthen EU-based production. Across the political groups, there is an agreement that current reliance on external suppliers, particularly China and India, poses a strategic risk. Similarly, many MEPs emphasised that for European manufacturing to be viable, it must be profitable and competitive, requiring targeted investment and incentives.
Furthermore, the common theme of EU autonomy is evident in discussions on supply chain security and stockpiling. The debate also highlights financial constraints, as multiple MEPs pointed to the disparities between health and defence budgets. There is also political alignment on the urgent need for pharmaceutical resilience and affordability.
With the publication of the Critical Medicines Act (CMA), the European Parliament and Council will start work on the file through the ordinary legislative procedure.
