Today, the Commission has proposed a regulation to enhance the availability of critical medicines in the EU. The aim is to protect public health by encouraging supply chain diversification and strengthening pharmaceutical manufacturing within the EU. This initiative supports the EUs pharmaceutical sector, a significant contributor to our economy. The Act also seeks to improve access to other essential medicines that may not be readily available in some markets. It contributes to the European Health Unions goal of ensuring EU patients have access to the medicines they need, when they need them.
President von der Leyen announced the Critical Medicines Act in her political guidelines to reduce dependencies and enhance the EUs resilience, particularly for medicines and active ingredients where there are only a few suppliers. It complements existing legislative proposals addressing medicine shortages in the EU, notably the pharmaceutical reform.
In recent years, member states have faced severe medicine shortages. Global challenges like the COVID-19 pandemic and geopolitical tensions have highlighted significant vulnerabilities in the EUs pharmaceutical supply chain. Shortages can endanger patients lives and place heavy burdens on healthcare systems. These issues can arise from manufacturing problems, supply chain vulnerabilities, or global competition for resources. The Critical Medicines Act provides an industrial toolkit to address these challenges, making the EU a more attractive market for producing critical medicines.
The Act will facilitate investments for companies boosting EU production of critical medicines, while promoting actions that enhance supply chain resilience. Member states will also have the opportunity to collaborate to increase their purchasing power.
Key elements of the Critical Medicines Act include:
- Strategic Projects aimed at creating, expanding, or modernizing EU manufacturing capacity for critical medicines or their ingredients. These projects may benefit from easier access to funding and expedited administrative, regulatory, and scientific support.
- State aid guidance has been published to assist member states in financially supporting such Strategic Projects.
- Member states can use public procurement to diversify and incentivize supply chain resilience. For critical medicines, procurers must include broader requirements in their procurement processes, such as diversified sources of input materials and supply chain monitoring. In cases of high dependency on a single or limited number of countries, they must also use procurement requirements that favor critical medicine production in the EU. This is also possible for other medicines of common interest when justified.
- The Commission will support collaborative procurement among different member states upon request, to address availability and access disparities of critical medicines and other essential medicines across the EU.
- International partnerships with like-minded countries and regions will be explored to broaden the supply chain and reduce dependencies on single or limited numbers of suppliers.
Background
Addressing shortages and ensuring access to medicines have been EU priorities for many years. The 2020 Pharmaceutical Strategy for Europe outlined regulatory measures and additional industry support to promote research and innovation in medicinal products, while addressing shortages and patient access issues. It also initiated a Structured Dialogue on the industrial dimension of supply security with stakeholders. In 2022, the European Medicines Agency (EMA) was given a stronger mandate to manage shortages. Since then, it has played a key role, alongside national authorities, in monitoring and responding to critical medicine shortages.
In 2023, the Commission proposed an ambitious overhaul of the EUs pharmaceutical legislation to improve access and strengthen medicine supply chains. This reform is currently under negotiation by the European Parliament and Council. Further initiatives include publishing a Union list of critical medicines to help identify and monitor essential medicines and a Commission Communication on addressing medicine shortages in the EU.
The Critical Medicines Act complements these measures with industrial policy tools to address supply chain vulnerabilities of critical medicines and reduce EU dependencies in this strategic area.
For more information
Proposal for a Critical Medicines Act
Questions and answers on the Critical Medicines Act
Factsheet – EU Actions to address medicines shortages