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The European Union's pharmaceutical market, characterised by its fragmentation, has been a stumbling block in ensuring a continuous supply of medicines. This fragmentation hinders the free circulation and availability of medicines, leading to record levels of medicine shortages in EU countries in 2023 and 2024.
In response to these increasing shortages, many EU countries have started building up their medicine stocks. However, without mutual coordination, these actions could exacerbate shortages in other EU countries. A critical shortage occurs when a country does not have suitable alternatives, and coordinated EU action is necessary to resolve it.
Between January 2022 and October 2024, EU countries recorded critical shortages of 136 medicines. The European Commission has proposed changes to EU law, including the 2025 Critical Medicines Act and the 2023 Pharmaceutical Regulatory Proposals, which, if approved, could bring significant improvements to the system.
The European Medicines Agency (EMA) has played a role in reducing the impact of such shortages. However, the system currently lacks a suitable legal framework and timely, useful information. The EMA does not receive sufficient information on shortages to prevent them, and industry notifications are often late and incomplete.
The first EU-level list of critical medicines is an important step, but the work done so far has not guaranteed their availability. The European Court of Auditors found that the system for preventing and mitigating critical medicine shortages needs improvement. The Court warns that these changes may not address all issues, including the need to report shortages in a timely manner or influence industry action in case of critical shortages.
Most medicines are authorized nationally in the EU, and those authorized for the entire EU are not marketed in all countries. This, coupled with the Commission's inadequate addressing of cross-border barriers to trade, contributes to the complexity of the issue.
The packaging of medicines varies from one country to another in the EU, adding another layer of complexity. The name of the person responsible at the European Court of Justice for reviewing reports on critical medicine shortages within the EU is not specified in the available search results.
The European Medicines Agency (EMA) lacks legal powers to help EU countries overcome a health crisis. The Court found that there was a critical supply shortage for some of the listed critical medicines. Medicine shortages can affect all categories of medicines, including patented innovative medicines, non-patented generics, and vaccines.
As of now, no effective system is yet in place to tackle critical medicine shortages in the EU. It is clear that more work needs to be done to ensure the continuous supply of medicines and to prevent critical shortages in the future.
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