Persistent Drug Shortages Remain a Significant Issue for the European Union
The European Union's pharmaceutical industry plays a crucial role in supplying medicines, with the number of centrally approved medicines varying significantly between countries. However, the obligation to continuously supply drugs is not consistently practiced, leading to serious consequences for patients and imposing significant costs on healthcare providers and Member States.
The issue of medicine shortages is a chronic problem in the EU, as evidenced by the record numbers of shortages reported in 2023 and 2024. The European Court of Auditors released a report stating that medicine shortages remain a significant issue, affecting access to essential medicines for patients.
The special report 'Critical Medicine Shortages: EU's efforts have yielded results, but structural issues persist' highlights the vulnerabilities in the supply chain for antibiotics and painkillers, largely outsourced to Asia, as a cause of drug shortages. Moreover, the system to prevent and mitigate drug shortages needs improvement, as it lacks a convenient legal framework and up-to-date, practical information.
The European Medicines Agency (EMA) has contributed to mitigating the effects of medicine shortages, but there is still no effective system in place to manage critical medicine shortages. The first EU-wide list of critical drugs has been created, but it hasn't ensured availability.
The EU's internal market for drugs is fragmented, hindering free flow and access, and contributing to unequal access. The Commission has proposed changes to EU legislation, which, if adopted, could significantly improve the system. However, the legislative proposals put forward by the Commission for critical medicines from 2025 and new pharmaceutical legislation from 2023 are still pending before the EU legislators.
Many EU countries have started stockpiling drugs, risking to exacerbate shortages in other countries due to lack of coordination. Moreover, the Commission did not sufficiently address barriers to cross-border trade, making it difficult to alleviate shortage situations through redistribution of drugs.
EMA lacks legal powers to assist EU countries when no health crisis is ongoing. This lack of power is a significant challenge in managing medicine shortages effectively. The Commission's efforts to address these issues are ongoing, but face challenges due to the complexity of the problem and the need for coordination between multiple stakeholders.
The European countries whose governments have supported the project to improve the system for preventing and addressing medicine shortages since 2023 include Belgium, Denmark, Germany, Finland, France, Greece, Italy, the Netherlands, Poland, Portugal, Spain, and Sweden. These countries recognise the importance of addressing this issue and are working towards improving the system to ensure continuous supplies of essential medicines for all EU citizens.
In conclusion, medicine shortages pose a significant threat to public health in the EU. The issue is complex, with multiple factors contributing to the problem. However, with the support of EU governments and the ongoing efforts of the Commission, there is hope for improvement in the system to prevent and mitigate medicine shortages in the future.
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