European Commission welcomes political agreement on Critical Medicines Act

The European Commission proposed the Critical Medicines Act (CMA) in March 2025. On 11 May 2026, the Council and the European Parliament reached political agreement on this legislation. The Act is now subject to formal approval by these bodies.

The Commission summarises the key provisions of the Act:

• "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, they will 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."