A new report from the European Court of Auditors (ECA) has found that medicine shortages across the EU reached record levels over the past two years. Although measures have been introduced to address the issue, auditors warn that delays in implementation could leave the region exposed to further disruption.
Medicine shortages can affect both innovative and off-patent products, and can become critical when no suitable alternatives are available. In such cases, coordinated EU-level action is required. According to the ECA, shortages peaked in 2023 and 2024, with 136 medicines being categorised as being in critical shortage between January 2022 and October 2024.
The ECA audit was led by Klaus Heiner Lehne, who commented: “Medicine shortages can have severe consequences for patients, compromise public health and come at a high cost for doctors, pharmacies and countries alike.”
Supply chain vulnerabilities have been highlighted by the European Commission as a driver of shortages. Heavy reliance on outsourced production in Asia, particularly for antibiotics and painkillers, leaves EU supply susceptible to regional and global trade disruptions. Additional risks arise from stockpiling and the lack of cross-border coordination on critical medicine availability.
Several initiatives have been introduced to mitigate these risks, including incentives for localised production and the launch of the EU’s first common list of critical medicines. However, the auditors cautioned that existing mechanisms require stronger legal underpinnings. They pointed to the proposed Critical Medicines Act, announced by the European Commission earlier this year, as an important step but emphasised the need for further action.
“The EU needs an effective remedy to cure critical shortages and must tackle them at their roots, as a matter of European strategic autonomy,” Lehne added