Source: European Parliament
On 11 March 2025, the Commission adopted a proposal for a Critical Medicines Act[1] to improve the availability of critical medicines in the EU and access to other medicines of common interest.
The proposed Act provides a framework for Member States to request Commission support, under certain conditions, to use voluntary collaborative procurement tools for critical medicines and other medicines of common interest. Such procurements would help to make smaller markets more attractive to pharmaceutical companies, improving access and availability through economies of scale.
In addition, the proposed Act supports investments for companies that increase EU manufacturing capacity of critical medicines through the designation of Strategic Projects. These industrial projects may benefit from facilitated access to funding and fast-tracked administrative, regulatory and scientific support.
The proposed Act also provides measures to reduce reliance on third countries and strengthen the security and resilience of pharmaceutical supply chains through public procurement. For critical medicines, procurers would have to include a broader set of requirements in their procurement procedures. In case of high dependency on a single or a limited number of countries, they would also have to use procurement requirements that favour critical medicines production in the EU. This would also be possible for other medicines of common interest, when justified. Finally, strategic partnerships with other countries and regions would be explored to diversify the supply chains and reduce dependencies on single suppliers.
- [1] COM(2025) 102 final. Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795.