Commission welcomes political agreement on Critical Medicines Act

This article is brought to you in association with the European Commission.

The European Commission welcomes the landmark political agreement on the Critical Medicines Act (CMA), last night by the Council and the European Parliament. This marks an important milestone in strengthening the resilience of Europe’s health sector by preventing medicine shortages and improving the security of supply of critical medicines across the EU.

The CMA will promote the diversification of supply chains and support pharmaceutical manufacturing within the EU, while enabling Member States to cooperate more closely to improve access to medicines in Europe. The CMA complements existing initiatives to address medicine shortages and strengthen supply in the EU, in particular the recently adopted pharmaceutical reform.

Key elements of the agreed Critical Medicines Act include:

• Member States will have to diversify and incentivise resilience in the medicine supply chains during public procurement procedures. For critical medicines, procurers will have to support the diversification and reliability of supply sources. In case of a high dependency on a single or a limited number of third countries, the CMA goes further, foreseeing the obligation for contracting authorities to favour “manufacturing in the EU”.
• The creation of Strategic Projects to boost, increase or modernise EU manufacturing capacity for critical medicines or their active substances, through easier access to (Member State and Union) funding as well as fast-tracked administrative support. In addition, projects for manufacturing of orphan medicines will also benefit from faster permitting.
• When Member States require companies to hold contingency stocks, theywill have to ensure that this does not negatively affect supply of critical medicines in other countries in the Union. Member States will also have to share up to date information on contingency stocks available for reallocation when a call for solidarity is launched through the Voluntary Solidarity Mechanism.
• Collaborative procurement will be available for Member States to address availability and access disparities of critical medicines, orphan medicines and other medicines of common interest throughout the EU.
• Strategic partnerships with international partners will be explored, to broaden the supply chain and reduce dependencies on single or limited numbers 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 have been a priority for the EU for many years. In March 2025, the European Commission proposed the Critical Medicines Act to improve the availability, supply and production of critical medicines within the EU.

Today’s agreement follows the agreement reached in December on the modernisation of the EU’s pharmaceutical legislation, which will also work to boost innovation and investment in the EU’s pharmaceutical sector, while ensuring that medicines are safe, effective and available for patients throughout Europe. Together, the Pharma reform and CMA will work to strengthen resilience of the EU pharmaceutical market.

For more information

Proposal for a Critical Medicines Act

Questions and answers on the Critical Medicines Act

Factsheet – EU Actions to address medicines shortages

Factsheet – Critical Medicines Act

State aid guidance

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