EU Critical Medicines Act Enters Trilogue Phase as Drug Shortages Persist Across Europe
The EU Critical Medicines Act enters trilogue negotiations as drug shortages persist. The Parliament proposes broader powers for a new coordination group, binding stockpiling, and expanded MEAT procurement criteria. EMA recorded 136 critical shortages from 2022-2024.
The European Union's proposed Critical Medicines Act (CMA) has entered the trilogue phase, with the Commission's and Council's proposals largely aligned while the Parliament proposes significantly more far-reaching amendments across all chapters. The CMA aims to complement regulatory obligations in the proposed Pharma Package by focusing on enhancing industry opportunities and tackling the root causes of medicine shortages, as the EU faces persistent and worsening drug shortages across member states.
From January 2022 through October 2024, the European Medicines Agency (EMA) recorded 136 cases of critical medicine shortages — situations in which countries were unable to ensure access to specific drugs or find alternatives without coordination at the EU level. In 2025, the EU began developing bloc-wide mechanisms to coordinate the supply of medicines, including expanding production, organizing joint procurement, and attracting new pharmaceutical companies to the market.
A 2025 report published by the European Association of Hospital Pharmacists (EAHP) found that 89% of pharmacists consider shortages a serious problem, a view shared by 84% of physicians, 68% of nurses, and 86% of other healthcare workers. The report documented that 59% of respondents said shortages led to delays in treatment, 43% said they resulted in the selection of less-than-optimal therapies, and 35% said they left patients without care. In 2023, the medicines most frequently reported as being in short supply were antibiotics, painkillers, and anesthetics (including narcotic agents).
The CMA establishes a "Critical Medicines Coordination Group" (CMCG) to facilitate implementation. The Parliament proposes broadening CMCG membership to include the EMA (specifically the MSSG) and representatives from patient organizations and healthcare professional organizations, with observer status for the Parliament. The Parliament also gives the CMCG additional powers, including deciding on prior approval for redistribution requests of critical medicinal products in the event of a shortage or supply disruption, assessing national stockpiling strategies, and assessing whether proposed strategic projects would result in significant duplication of existing manufacturing capacities.
All three EU institutions agree that public procurement for critical medicines must move beyond a lowest-price approach, though they diverge on details. The Parliament requires MEAT (Most Economically Advantageous Tender) criteria to outweigh price and defines what constitutes a "significant proportion" of EU manufacturing, while the Council replaces this with broader "resilience requirements" and narrows available exceptions.
Stockpiling remains a key point of contention. The Parliament proposes binding redistribution and a Union stockpile as last-resort measures, along with quarterly reporting obligations for Member States. The Council reemphasizes the autonomy of Member States to impose stock requirements, but with the obligation to notify the new CMCG of their intention to do so.
The provisions of the CMA apply to critical medicines on the Union list established under the Pharma Package, and to medicines of common interest — products for which, in three or more Member States, the market does not sufficiently ensure availability and accessibility. The Parliament proposes broadening the scope of "medicinal products of common interest" to explicitly include orphan drugs and contraceptive or abortifacient medicinal products. Older, off-patent, and generic medicinal products make up the majority of the Union list of critical medicinal products.