Key Summary
- All categories of medicines or vaccines are vulnerable to shortage
- Shortages peaked in 2023 and 2024, with countries running critically short of 136 medicines between January 2022 and October 2024
- Auditors claim EU lacks an adequate legal framework as well as timely and actionable information to deal with shortages
The European Court of Auditors (ECA) has said that though medicine shortages have been a recurring issue throughout the EU, it still lacks a system to tackle severe shortages.
While EU has taken some measures in recent years, certain structural problems persist and efforts to deal with the root causes of shortages are at an early stage.
Hence, Europe continues to be at risk of running short of medicines, including common antibiotics and other vital treatments, the ECA warned.
All categories of medicines, including innovative patented medicines, off-patent generics, or vaccines, are vulnerable to shortage.
They become critical when a country has no suitable alternatives and coordinated EU action is needed to resolve the shortage, it added.
The ECA said that shortages in the EU peaked in 2023 and 2024, with 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,” he added.
The auditors called for improving the system for preventing and mitigating critical medicine shortages, 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 it 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 sufficiently aware of shortages to be able to prevent them. The audit revealed EMA also lacked data to help mitigate 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, has only started and faces many challenges. The obligation for industry to provide a continuous supply, for example, does not work well in practice.
The ECA is against the practice of stockpiling medicines, which is done by many countries, as it would only worsen shortages in other EU countries.
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.
The legislative proposals made by the Commission are currently still on the EU lawmakers’ table, including Critical Medicines Act from 2025 and its proposals for new pharmaceutical legislation from 2023.
The auditors are hopeful that these could bring significant improvement to the system, but warn that it may not address all the issues.
