Alexandra Stoicescu – Managing critical medicine shortages in the EU: Unus pro omnibus, omnes pro uno
The European Union has long recognized the importance of preventing medicines shortages. This issue has gained renewed urgency in light of recent events, such as the COVID-19 pandemic and ongoing geopolitical tensions, which have exposed significant vulnerabilities within the EU’s pharmaceutical supply chains. In recognition of these challenges, the need for additional measures has been articulated, with particular emphasis on ensuring the availability of so-called “critical” medicines.
At the European level, medicine is deemed critical based on two main criteria: the severity of the targeted disease and the availability of appropriate alternatives. On this basis, both innovative and generic medicines were included in the Union List of Critical Medicines, which was created and published in December 2023 by the European Commission, the EMA and the Heads of Medicines Agencies of the Member States and subsequently updated in December 2024 (“Union list”).
On March 11, 2025, the European Commission adopted the Proposal for a Regulation 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 (“Proposal”). While the Proposal primarily targets medicines listed as critical in the Union list, it also encompasses measures aimed at enhancing the access to and availability of other key medicines referred to as “of common interest”, for which a market failure exists in three of more Member States (i.e. medicines for rare diseases or novel antimicrobials).
The ideal: Collaborative and individual actions to secure the supply of critical medicines
The Proposal is structured around two core pillars: supply-side measures aimed at strengthening manufacturing capacity through “strategic projects” and demand-side measures focusing on specific procurement requirements and collaborative structures.
Strategic projects
Strategic projects are referred to in the Proposal as projects located in the European Union that establish, expand, or modernize the EU’s manufacturing capacity for one or more critical medicines, their active substances or other key components.
Each Member State will be required to designate an authority responsible for assessing and confirming, at the request of the promoter, whether a national strategic project meets the specific criteria set out in the Proposal.
Strategic projects are afforded specific facilitative measures and benefits from both the Member States and the European Union, including accelerated administrative procedures as well as regulatory, scientific, and financial support. Where such financial support is granted, the beneficiary undertaking is required to prioritize supply within the European Union and to undertake all reasonable efforts to ensure the continuous availability of the critical medicine.
Public procurement mechanisms
Regarding the public procurement procedures, the Proposal mandates the use of award criteria other than price-only for critical medicines (i.e. stockholding obligations, number of diversified suppliers, monitoring of supply chains). Furthermore, in the case of medicines with high dependency risks, the contracting authorities will be expected to apply requirements that encourage the production of critical medicines within the EU, giving priority to suppliers that manufacture a significant portion of such medicines within the UE. Such incentives may also be applied to other medicines of common interest, provided there is adequate justification.
Moreover, Member States will be required to develop a national strategy— national programmes—to guide procurement practices, encouraging the uniform application of procurement criteria by contracting authorities, as well as the adoption of multi-winner approaches where supported by market analysis. These programmes may also include pricing and reimbursement measures for critical medicines not procured through public procurement procedures.
The Proposal also stipulates that supply security measures (including contingency stocks requirements) adopted by one Member State must not negatively affect other Member States. Furthermore, Member States must ensure that any obligations imposed on the companies in the supply chain regarding the maintenance of contingency stocks are proportionate and adhere to the principles of transparency and solidarity.
Additionally, the Proposal outlines several types of collaborative procurement mechanisms, each with its own set of conditions and thresholds:
- Cross-border procurement by the Member States, facilitated by the European Commission (applicable only to other medicines of common interest).
- Procurement conducted by the European Commission on behalf of/in the name of the Member States.
- Joint procurement coordinated by the Commission, in collaboration with the Member States.
The implementation of the Regulation is to be coordinated by the Critical Medicines Coordination Group, composed of representatives from the Member States and the European Commission. The Group’s responsibilities include facilitating the exchange of information on the financing of strategic projects, facilitating the coordination of national programmes, facilitating dialogue and coordination on public procurement policies, periodically discussing the potential role of strategic partnerships, engaging in dialogue on collaborative procurement initiatives.
International collaboration is also envisaged by the Proposal, with the Commission set to explore strategic partnerships and build on existing cooperation to diversify supply sources and reinforce the EU’s manufacturing capacity for critical medicines.
The concrete: The key role of proper implementation
The proposal is currently at the first reading stage in the European Parliament, with adoption expected by the fourth quarter of 2025. Following its approval, a transitional start-up period is anticipated between 2026 and 2027, leading to full-scale application of the future regulation beginning in 2027.
Given the ambitious nature of the Commission’s proposed measures, it remains to be seen how smoothly the transition from concept to concrete action will unfold during the implementation phase within Member States. In the meantime, the framework for regulating and safeguarding critical medicines in Romania is gradually taking shape, though the journey toward its full fruition remains ongoing[1].
[1] Adopted on May 30, 2024, the Memorandum on “Interinstitutional Management of European Initiatives in the Pharmaceutical Sector” reflects Romania’s strategic commitment to improving equitable access to affordable medicines for its population and to stimulating active participation in the development of production chains at the European level through its own pharmaceutical industry. Building upon this foundation, Order 662/2025 approved the Methodology for compiling Romania’s List of Critical Medicines, which defines three evaluation criteria: a) the therapeutic indication of the medicine; b) the availability of appropriate therapeutic alternatives; and c) the reported supply disruptions. At the time of writing this article, the national List of Critical Medicines is under development.
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