Medicine shortages persist as a significant issue across the EU, with a recent report from the European Court of Auditors (ECA) highlighting the lack of a comprehensive system to effectively address these severe shortages, reports 24brussels.
Despite recent EU measures aimed at addressing the problem, fundamental structural shortcomings continue, leaving many Europeans vulnerable to shortages of essential medications, including common antibiotics and other critical treatments. The situation has worsened, with EU member states experiencing a peak in reported shortages during 2023 and 2024, totaling 136 medicines critically short between January 2022 and October 2024.
Shortages encompass all types of medicines, from innovative patented options to off-patent generics and vaccines. These deficiencies become especially severe when suitable alternatives are unavailable, demanding coordinated EU action for resolution. Klaus Heiner Lehne, the ECA member overseeing the audit, commented, “Medicine shortages can have severe consequences for patients, compromise public health and come at a high cost for doctors, pharmacies and countries alike.”
“The EU needs an effective remedy to cure critical shortages and must tackle them at their roots, also as a matter of European strategic autonomy.”
The auditors emphasize that improvements are necessary in the system intended to prevent and mitigate critical medicine shortages, which currently suffers from inadequate legal frameworks and a lack of timely, actionable information. Although the European Medicines Agency (EMA) has seen its role evolve during the COVID-19 pandemic, enhancing coordination efforts to alleviate shortages, it lacks the legal authority to assist EU nations outside of health crises. Furthermore, its access to information regarding shortages remains insufficient, as data submissions from industry stakeholders are often delayed or incomplete.
The European Commission has pinpointed several root causes of these shortages, such as vulnerabilities in supply chains, particularly for antibiotics and painkillers, most of which are produced in Asia. Efforts to resolve these issues are just beginning and encounter numerous challenges. Notably, the industry’s obligation to maintain a consistent supply of medicines has proven ineffective in practice. In response to increasing shortages, several EU countries have begun stockpiling medicines, which risks exacerbating shortages in other member states due to a lack of coordination. Therefore, the introduction of the first EU-wide list of critical medicines marks a pivotal step, though the findings indicate that some of these medicines are currently in critically short supply.
The fragmented nature of the EU’s single market for medicines hinders their free movement and availability, leading to unequal access. Most medicines receive national authorization, and those approved for the entire EU are not universally marketed across all countries, with packaging varying from one nation to another. Additionally, the Commission has not adequately tackled cross-border trade barriers, complicating efforts to redistribute medicines to mitigate shortages effectively.
Initial steps taken by the Commission involve proposing amendments to EU law. If passed, these legislative changes could enhance the overall system significantly; however, auditors caution that they may not fully address existing challenges, such as timely reporting of shortages and influencing industry actions during critical shortfalls.
