Proposal for Critical Medicines Act
Proposal for Critical Medicines Act
The European Commission has presented its proposal for a Critical Medicines Act. The main purpose of the proposed Act is to limit the EU dependence on third country sources of critical medicines and encourage domestic production. The products included within the definition of a "critical medicine" are those that fall within the list published by the European Medicines Agency in December 2024. These are human medicines whose continued supply is considered a priority in the EU. To encourage the manufacture of critical medicines in the EU the draft Act includes a process to identify strategic pharmaceutical projects. EU Member States would designate a national authority to identify appropriate projects and ensure that the relevant permit granting processes are carried out as quickly as possible. EU Member States may also give priority as regards financial support to strategic projects that address a vulnerability in the supply chains of critical medicinal products. Manufacturers who benefit from this support will be required to prioritize supply of the products to the EU market and use their very best efforts to ensure that the related critical medicine remains available in the EU Member States where it is being marketed.
One provision of the draft Critical Medicines Act that has given rise to discussion is the proposal to expand existing collaborative procurement possibilities between EU Member States and the Commission. This includes joint procurement by EU Member States, centralized procurement by the European Commission on behalf of or in the name of EU Member States, and joint procurement by EU Member States and the European Commission. Procurement provisions in the draft Act require EU Member States to apply procurement requirements other than price-only award criteria. These would include procurement requirements that promote the resilience of supply in the EU. For critical medicines for which a vulnerability in the supply chains has been confirmed due to the high level of dependency on a single or a limited number of third countries, the contracting authorities will be required, where justified, to apply procurement requirements that favor suppliers that manufacture a significant proportion of these critical medicinal products in the EU.
The draft Act also includes provisions governing the supply of medicinal products of common interest. These are defined as products other than critical medicinal products, for which, in three or more EU Member States, the functioning of the market does not sufficiently ensure the availability and accessibility to patients in the quantities and presentations necessary to cover the needs of patients in those EU Member States. Where justified by market analysis and public health considerations, the contracting authorities in these EU Member States may apply procurement requirements that favor suppliers that manufacture at least a significant proportion of these medicinal products within the EU.