July 25, 2025
In the first quarter of 2025, the European Commission published its proposal for a Critical Medicines Act to improve the availability and secure the supply of critical medicines in the EU. The Commission defines critical medicines as those medicines for which no appropriate alternative is available and for which insufficient supply would result in serious harm or risk of harm to patients. An initial European Union list of critical medicines was shared in December 2023 and included more than 200 active substances used in human medicines.
The proposed regulation seeks to address the two key factors contributing to critical medicines shortages. The first is the impact of current geopolitical issues on EU pharmaceutical supply chains. The second is manufacturing issues, which the Commission estimates are responsible for 50 percent of reported medicines shortages.
Details of the proposal
The Commission outlined the central aims of the Critical Medicines Act, which include facilitating investments for companies to increase the manufacturing of critical medicines in the EU by providing easier access to funding, as well as fast-tracked administrative, regulatory, and scientific support. Companies who receive financial support as part of their participation in these so-called “Strategic Projects” will be obliged to prioritise the EU supply of critical medicines.
The Commission also hopes the Act will incentivise supply chain diversification and resilience through new guidelines for public procurement. These recommendations include requirements for companies to consider procurement criteria other than price in their public procurement procedures for critical medicines. The measure also requires that procurers favour EU production for specific critical medicines with high dependencies when justified.
In addition, the regulation seeks to enhance collaboration amongst participating Member States to leverage enhanced purchasing power to create economies of scale and reduce access disparities. Finally, the Act supports diversification by facilitating strategic partnerships with other countries or regions so that the manufacture of critical medicines isn’t concentrated with a few companies or countries.
The proposed Act covers three main categories of medicines: 1) critical medicines for which limited or no alternatives exist and shortages of supply may result in serious harm to patients; 2) critical medicines for which vulnerabilities have been identified in the supply chain, including high dependencies on a single or limited number of third countries; and 3) certain other medicines of common interest, such as those for rare diseases, which may not be accessible in certain markets.
Looking ahead
The proposed Critical Medicines Act is still being reviewed by the European Parliament and the European Council and could be amended significantly during the legislative process. However, the draft measure, as well as recent progress with the Commission’s proposed Regulation and Directive to reform EU pharmaceutical legislation, suggest that seeing these requirements become law will be a priority for the Commission.
Businesses in the pharmaceutical supply chain should closely monitor progress of the proposed Critical Medicines Act as it is considered by the Parliament and the Council. The regulation is likely to unlock additional opportunities for EU pharmaceutical companies. But when considered in the broader context of efforts to overhaul EU pharmaceutical legislation, it may be accompanied by additional burdens of compliance.
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