Sky-high medicine shortages in the EU, according to auditors' report
The European Union is grappling with a surge in medicine shortages, according to a report published by the European Court of Auditors (ECA) in 2024. The report, which highlights the severity and record levels of medicine shortages across the EU in 2023 and 2024, underscores the need for a stronger and more effective EU framework to prevent and mitigate these shortages.
The ECA's report emphasizes that the issue cannot be solved at the national level and that EU action has so far fallen short. One of the main obstacles highlighted in the report is the fragmentation of data across the EU, including information on stock levels, shortage notifications, and medicine approvals.
The European Commission has proposed the EU list of critical medicines and the Critical Medicines Act to address this issue. However, the Commission's efforts to tackle the underlying causes for medicine shortages are still at an early stage, according to the ECA's report. The implementation of the proposals and the availability of funding will take several years to have a significant effect on medicine shortages.
The process of manufacturers notifying regulators of a shortage varies between countries, with different rules for notification timelines. The ECA stressed that reporting on medicine shortages does not always work well in practice, is late, or absent. Some member states in the EU do not provide information on their medicine supply chains, further complicating the issue.
The Commission is confident that their recent proposals will make a substantial difference and address many of the challenges outlined in the report. The proposals lack enforcement mechanisms, such as sanctions, to ensure industry compliance with reporting obligations. The Commission spokesperson acknowledged the need for a stronger and more effective EU framework to prevent shortages.
The report highlights the absence of a common framework to handle medicine shortages and pan-EU compliance tools as worsening the situation. Matthias Blaas, an expert advocating for a stronger and more effective EU framework to prevent medicine shortages, calls for improved coordination and regulatory measures across member states.
In March 2024, 34 medicines were in shortage, according to the EMA, with sixteen of these being on the European Commission's list of essential medicines. Klaus-Heiner Lehne, the ECA's President, stated that medicine shortages pose a problem for patients, a challenge for health systems, and a sign of the EU's strategic vulnerability in medicine supply.
Between 2022 and October 2024, national authorities reported 136 critical medicine shortages to the European Medicines Agency (EMA). The next package of pharmaceutical legislation, currently being discussed, could impose more obligations on manufacturers to provide better data on their supply chains, potentially helping to address the fragmentation of data and improve the EU's ability to prevent and mitigate medicine shortages.
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