EU plans new Critical Medicines Act: securing vital medicines!

EU plans new Critical Medicines Act: securing vital medicines!

On May 26, 2025, an important proposal from the European Commission will be on the committee's agenda: the “Critical Medicines Act” (CMA). This new law aims to strengthen the security of supply of critical medicines in the EU. This is not just about improving the availability, but also about the production of essential medicines within the Union. The proposal, which was initiated in March 2025, addresses the issue of availability of important medicines, particularly in markets where they are often not available.

A key concern of the CMA is reducing vulnerabilities in the supply chains for critical medicines. To this end, existing measures are to be supplemented and a comprehensive health policy and industrial policy instrument is to be made available. Public procurement will play an important role in promoting supply chain resilience and improving access to other essential medicines, including those for rare diseases.

Criticism and concerns in the committee

Despite the CMA's fundamental objectives, committee members are skeptical of the proposal. There are concerns that the European Social Fund Plus (ESF+) could be “overloaded” and its original tasks diluted. In particular, it is being discussed whether it is necessary to adapt the ESF+ objectives to the current challenges or not. The Ministry of Social Affairs has emphasized that the current priorities of the programs financed with ESF+ funds should be maintained.

Another important aspect of the CMA is the support of strategic projects for critical drugs or their components. This will allow easier access to financing and accelerated processes for the development and supply of these medicines. The Commission also plans to explore international partnerships with like-minded countries and regions to expand the supply chain and reduce dependencies on individual suppliers.

Guidelines and further measures

The CMA also includes specific state aid guidelines to help Member States provide financial support to strategic projects. The Commission will also promote joint procurement between different Member States to address disparities in availability and access to critical medicines.

Overall, the Critical Medicines Act is intended to make a crucial contribution to the European Health Union, which aims to ensure that all EU citizens have access to the necessary medicines. The CMA is therefore an important element of the ongoing reforms of the EU pharmaceutical legislation and covers a wide range of relevant aspects for the supply of medicines in Europe.