The Commission welcomes the political agreement on the Critical Medicines Act

The European Commission welcomes the historic political agreement on the Critical Medicines Act (CMA) reached by the Council and the European Parliament. This agreement marks a significant milestone in strengthening the resilience of the European healthcare sector, preventing medicine shortages and improving the security of supply of essential medicines across the EU.

The CMA will promote the diversification of supply chains and support the manufacture of pharmaceutical products in the EU, whilst enabling Member States to cooperate more closely to improve access to medicines in Europe. The CMA complements existing initiatives to tackle medicine shortages and strengthen supply in the EU, in particular therecently adoptedpharmaceutical reform.

Key elements of the agreed Critical Medicines Act include:

• Member States mustdiversify and incentivise resilience in medicines supply chainsduring public procurement procedures. In the case of critical medicines, purchasers must support the diversification and reliability of supply sources. In the event of high dependence on a single country or a limited number of third countries, the CMA goes further, providing for an obligation on contracting authorities to favour ‘manufacturing within the EU’.
• The creation of strategic projectsto boost, increase or modernise the EU’s manufacturing capacity for critical medicines or their active ingredients, through easier access to funding (from Member States and the Union) and streamlined administrative support. Furthermore, projects for the manufacture of orphan medicines will also benefit from faster permit processing.
• Where Member States require companies to maintainreserve stocks,they must ensure that this does not adversely affect the supply of essential medicines in other EU countries. Furthermore, Member States must share up-to-date information on reserve stocks available for reallocation when a call for solidarity is issued through the Voluntary Solidarity Mechanism.
• Member States may use collaborative public procurementto address disparities in the availability of and access to essential medicines, orphan medicines and other medicines of common interest across the EU.
• Strategic alliances with international partners will be explored to expand the supply chain and reduce dependence on a single supplier or a limited number of suppliers.

Next steps

The political agreement is now subject to formal approval by the European Parliament and the Council.

Background

Tackling shortages and ensuring access to medicines has been a priority for the EU for many years. In March 2025, the European Commissionproposed the Critical Medicines Actto improve the availability, supply and production of critical medicines within the EU.

Today’s agreement builds on the one reached in December on the modernisation of EU pharmaceutical legislation, which will also boost innovation and investment in the European pharmaceutical sector, whilst ensuring that medicines are safe, effective and available to patients across Europe. The pharmaceutical reform and the CMA will work together to strengthen the resilience of the EU pharmaceutical market.

More information: European Commission.