**Brussels**: On 11 March 2025, the European Commission unveiled the Critical Medicines Act, aiming to secure vital medicinal supplies across the EU. The initiative promotes strategic projects and financial support to address supply vulnerabilities amid growing concerns over dependence on limited suppliers.
On Tuesday, 11 March 2025, the European Commission announced the introduction of a legislative proposal known as the Critical Medicines Act (CMA), with the intention of securing a stable and continuous supply of vital medicinal products across the European Union. This move marks a significant effort to bolster the resilience of the pharmaceutical supply chain amid concerns about reliance on a limited number of suppliers for essential medicines, active pharmaceutical ingredients (APIs), and other vital components necessary for medicine production.
The proposal is a key element of the political agenda set forth by European Commission President Ursula von der Leyen, aiming to address vulnerabilities in the supply chain and enhance the EU’s self-sufficiency regarding critical medicinal products. This legislative initiative outlines several measures intended to strengthen the availability and security of these medicines, which are listed in the Union List of Critical Medicinal Products. While the CMA also encompasses “medicines of common interest,” it should be noted that, at this stage, there is no formal list or methodology for their designation.
Central features of the CMA include:
-
Facilitation of EU-based Strategic Projects: National authorities in Member States are encouraged to support companies designated as project promoters engaging in strategic projects, which are defined as those enhancing the manufacturing capacity of critical medicines or APIs. The Act proposes that such support encompasses expedited permit processes, administrative assistance, and regulatory guidance from both national and EU authorities.
-
Financial Incentives and Obligations: The CMA allows national governments to prioritise funding for projects that address supply chain vulnerabilities. Companies benefiting from this financial support would be obligated to ensure the availability of their products within the EU market and maintain continuity in supply.
-
Procurement Processes: National procurement frameworks will be mandated to consider factors beyond just price, such as supply chain security, stockholding requirements, and the performance record of suppliers. Authorities will be encouraged to favour suppliers based in the EU, guided by public health priorities and considerations.
-
Collaborative Procurement Initiatives: The legislation promotes joint procurement efforts facilitated by the European Commission. This would allow EU Member States to come together to collectively procure critical medicines, thereby improving efficiency and responsiveness to identified supply chain vulnerabilities.
-
Establishment of the Critical Medicines Coordination Group: This newly proposed group would consist of representatives from each EU Member State and would serve as a platform for strategic discussions about financial support, cooperation among procurement authorities, and the evaluation of critical medicines’ vulnerabilities.
The proposal has drawn reactions from various industry stakeholders. Medicines for Europe, representing the generic and biosimilar medicine sectors, viewed the CMA as a significant step towards greater strategic autonomy for Europe. However, they expressed the need for enhanced procurement reforms and stronger funding mechanisms, advocating for a dedicated EU fund for critical medicines manufacturing and obligatory stockpiling initiatives. Conversely, the European Federation of Pharmaceutical Industries and Associations (EFPIA) called for clearer guidelines on how collaborative procurement can accelerate patient access to these essential medicines, suggesting that a generic implementation might complicate rather than resolve existing access challenges.
The proposed CMA is currently under review by both the European Parliament and the Council of the European Union as part of the ordinary legislative process. Amendments may be proposed by these institutions before inter-institutional negotiations take place, also involving the European Commission. As the discussions progress, two key committees within the European Parliament—the Public Health Committee and the Industry, Research and Energy Committee—are competing to take the lead on this legislative dossier. A decision on committee leadership has yet to be made.
Source: Noah Wire Services
Subscribe to Industry Updates
