What does the Critical Medicines Act aim to achieve and how?
The Critical Medicines Act aims to address the issues above, by:
- strengthening Europe’s manufacturing capacity;
- diversifying supply chains;
- reducing the EU’s dependencies;
- incentivising resilience;
- leveraging demand.
This will help to ensure that Europe has a more stable supply of critical medicines. It will also help to increase access and availability of other medicines of common interest, where disparities between countries exist, such as certain medicines for rare diseases.
To achieve this, the Act sets out a series of industrial policy measures, such as the designation of Strategic Projects which aim to create, increase or modernise manufacturing capacity of critical medicines in the Union. Such Strategic Projects would benefit from certain incentives and facilitations. Access to EU funding will be facilitated for projects and actions that address vulnerabilities in the supply chain through the Strategic Technologies for Europe Platform (STEP).
The Act also proposes measures related to public procurement as a way to incentivise secure supply chains and make markets more attractive for manufacturers, whilst giving Member States access to a stable supply of medicines. For critical medicines, public procurers will have to include a broader set of requirements in their procurement procedures, such as diversified sources of input material and monitoring of supply chains. In case of high dependency on a single or a limited number of countries, where justified, they will also have to use procurement requirements that favour critical medicine production in the EU. This will also be possible for other medicines of common interest in certain circumstances.
To ensure the safe supply of critical medicines from multiple sources, the EU will also seek to enhance existing bilateral cooperation in this area and build new strategic partnerships.
Questions and answers on the Critical Medicines Act *
Brussels, 11 March 2025