EC Unveils Critical Medicines Act Proposal To Ensure the Availability, Supply & Production of Critical Medicines within the EU

EC Unveils Critical Medicines Act Proposal To Ensure the Availability, Supply & Production of Critical Medicines within the EU

On 11 March 2025, the European Commission (EC) proposed the Critical Medicines Act (CMA), which aims to improve the availability, supply and production of critical medicines within the EU.

The CMA also aims to increase access to other medicines of common interest, such as those for rare diseases, and to address the fact that some medicines are not available in certain markets.

The CMA includes the following key features: 

• Strategic Projects for critical medicines or their ingredients can be designated, so that they benefit from easier access to funding and fast-tracked procedures.
• Public procurement to incentivise the resilience of supply chains of critical medicines or to improve access to other medicines of common interest.
• Collaborative procurement among different Member States will be supported by the EC at the request of member states, to address availability and access disparities of critical medicines and other medicines of common interest.
• International partnerships with like minded countries/regions will be explored, to broaden the supply chain and reduce dependencies on single suppliers.
• State aid guidelines to assist member states in financially supporting such strategic projects.

The Act has been proposed in the context of the European Health Union, which seeks to ensure all citizens have access to medicines, and it complements the reform of the EU Pharmaceutical Legislation, which took place in the previous EU legislative mandate. 

The Critical Medicines Act proposal is available here.

A Critical Medicines Act Fact sheet is available here.