Strengthening EU Pharmaceutical Supply Security Through the Critical Medicines Act
Enhancing EU Supply Security for Essential Pharmaceuticals
The EU’s Critical Medicines Act proposal is a key initiative to strengthen EU pharmaceutical supply security amid ongoing shortages of vital drugs like antibiotics, insulin, and vaccines. This act targets vulnerabilities in Europe’s healthcare infrastructure by diversifying supply chains, encouraging collaborative procurement among member states, and boosting domestic production of active pharmaceutical ingredients (APIs). These efforts aim to lessen reliance on external suppliers, ensuring steady access to treatments for critical conditions such as cancer, heart diseases, and diabetes, while integrating with wider pharmaceutical reforms.
Critical Medicines Defined Amid Supply Risks
Critical medicines as those vital for healthcare system operations, especially during crises, as defined by the European Medicines Agency based on disease severity, few treatment options, and importance across member states. Examples encompass antibiotics, insulin, painkillers, vaccines, and therapies for chronic or acute issues like diabetes and cancer, where shortages could lead to grave health threats or deaths. The act counters recent hurdles, such as post-COVID-19 supply breaks and the January 2023 EMA alert on amoxicillin shortages, by honing in on APIs—the essential elements in drug manufacturing—where the EU imports heavily, with 80% from just five countries, including 45% from China, per a 2021 European Commission study. This heavy dependence heightens risks, driving the proposal to ramp up EU pharmaceutical supply security through local manufacturing and smarter procurement to counter threats from pandemics or chain disruptions.
Council’s Push for Procurement Overhauls
To address these gaps, the Critical Medicines Act advances focused changes, like broadening supply chains to cut dependence on limited sources, rewards for joint buying to simplify purchases and trim expenses for member states, and funding for EU-based production of key drugs. A major step came on December 2, 2025, when the Council approved its stance, stressing data exchange on emergency reserves for better visibility, lowering the joint procurement threshold from nine to six states to ease teamwork, and requiring resilience factors to outweigh price in tender assessments. These shifts put EU pharmaceutical supply security first over mere savings, protecting against interruptions while syncing with the pharma package’s updates on shortages.
Industry Views on Practical Rollout
The European Federation of Pharmaceutical Industries and Associations (EFPIA) backs the Council’s strategy as progress in guaranteeing medicine availability and reach, especially for truly critical items facing clear market gaps. EFPIA pushes for a sharp definition of “medicinal products of common interest” to sidestep overly wide rules that might burden resources or mix supply woes with access hurdles, favoring optional joint procurement that keeps reliability, guards price secrets, and allows side-by-side national steps to avoid holdups. On evaluation standards, EFPIA warns against excessive resilience rules that could splinter global networks or hurt EU edge, while urging uniform EU rules on emergency stocks to prevent mismatched national demands and market twists, confined to at-risk critical medicines. EFPIA Director General Nathalie Moll highlights the act’s role in boosting patient access within a competitive setup that spurs innovation and production.
Economic Shifts and Market Impacts
The Critical Medicines Act carries major effects by pivoting from cost-cutting to robust supply chains, which may reshape pricing and reimbursement paths across the EU. Prioritizing resilience in buying could raise the worth of homegrown critical medicines, spurring investments in EU manufacturing to cut import needs and risks. In access terms, easier joint procurement might drop costs via scale benefits for states, but EFPIA’s worries point to pricing splits if resilience tilts toward favored sources, possibly straining national reimbursement systems. Echoing larger patterns like the pharma package’s shortage focus, this move could refine future research with steadier data on medicine supply, and bettering patient reach in crises while upholding economic strength.
