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Medicine shortages have been a recurring issue throughout the EU for years, but the EU still lacks a well-oiled system for coming to grips with severe shortages of medicines, according to a new report by the European Court of Auditors (ECA).
While EU measures in recent years have proven helpful, structural problems persist and efforts to tackle the root causes of shortages remain at an early stage. Since it could take time before they bear fruit, Europeans remain at risk of running short of medicines, including common antibiotics and other vital treatments.
Shortages can affect all categories of medicines, including innovative patented medicines, off-patent generics, or vaccines. They become critical when a country has no suitable alternatives and coordinated EU action is needed to resolve the shortage. In the EU, reported shortages peaked in 2023 and 2024, with EU countries running critically short of 136 medicines between January 2022 and October 2024.
“Medicine shortages can have severe consequences for patients, compromise public health and come at a high cost for doctors, pharmacies and countries alike,” said Klaus Heiner Lehne, the ECA Member leading the audit. “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 found that the system for preventing and mitigating critical medicine shortages needed to be improved as it lacked an adequate legal framework as well as timely and actionable information. Although the European Medicines Agency (EMA) has seen its role increase in recent years, particularly during the COVID-19 pandemic, and the agency has provided important coordination to help reduce the impact of shortages, it still does not have legal powers to help EU countries outside a health crisis. Moreover, it is not made sufficiently aware of shortages to be able to prevent them. The audit revealed EMA also lacked data to continuously help mitigating existing shortages as notifications from industry were often late and incomplete.
The European Commission has identified many root causes of shortages such as supply chain vulnerabilities, with parts of production, particularly for antibiotics and painkillers, largely outsourced to Asia. Its work to address them, however, is only starting and faces many challenges. The obligation for industry to provide continuous supply, for example, does not work well in practice. Faced with rising shortages, many EU countries began to stockpile medicines, which could worsen shortages in other EU countries as they failed to coordinate between them. The first EU-wide list of critical medicines is therefore an important step but work so far has not ensured their availability. In fact, the auditors found some to be in critically short supply.
The EU’s single market for medicines is fragmented, which hinders their free flow and availability, and contributes to unequal access to them. Most medicines are authorised nationally and those authorised for the entire EU are not marketed in all countries, while packages differ between countries. Moreover, the Commission did not properly address cross-border barriers to trade. As a result, it was difficult to mitigate shortages by a possible redistribution of medicines.
The Commission has taken initial steps by proposing changes to EU law. Once passed, these could bring significant improvement to the system, though the auditors warn that they may fail to address all issues, including the need to report shortages in good time or influence industry action during a critical shortage.
