Persistent drug shortages remain a continual issue for the European Union
The European Medicines Agency (EMA) is facing criticism for its lack of legal powers to help EU countries outside a health crisis and for not being adequately informed about shortages to prevent them. This issue comes as medicine shortages continue to pose a significant challenge across the European Union.
In recent years, the EU has witnessed record levels of medicine shortages, with 2023 and 2024 seeing particularly high numbers. According to reports, EU countries ran critically short of 136 medicines between January 2022 and October 2024.
The European Commission has identified supply chain vulnerabilities, particularly in the production of antibiotics and painkillers, as a root cause of these shortages. However, efforts to address these issues are still in their early stages and face challenges.
The system for preventing and mitigating critical medicine shortages needs improvement, lacking an adequate legal framework and timely, actionable information. The EMA also lacks data to continuously help mitigate existing shortages, as notifications from industry were often late and incomplete.
The first EU-wide list of critical medicines is an important step, but work so far has not ensured their availability, and some have been found to be in critically short supply. Critical medicine shortages occur when a country has no suitable alternatives, and coordinated EU action is needed to resolve the shortage.
The EU's single market for medicines is fragmented, hindering their free flow and availability and contributing to unequal access. Most medicines are authorized nationally, and those authorized for the entire EU are not marketed in all countries, while packages differ between countries.
The European Commission has proposed measures to improve the prevention and mitigation of critical medicine shortages. These measures include enhancing monitoring and early warning systems, streamlining supply chain transparency, encouraging better coordination among member states, and increasing production resilience within the EU.
However, challenges in implementing these measures include ensuring cooperation among diverse national stakeholders, overcoming complex regulatory environments, addressing supply dependencies on non-EU countries, and managing economic and logistical constraints linked to pharmaceutical manufacturing and distribution.
Industry is responsible for continuous supplies of medicines, with major price differences between countries and low market price transparency. Many EU countries have started stockpiling medicines to combat rising shortages, but this lack of coordination could worsen shortages in other EU countries.
The European Court of Auditors (ECA) released a report in September 2025, highlighting that medicine shortages remain a persistent issue in EU countries. The report warns that changes may fail to address all issues, including the need to report shortages in good time or influence industry action during a critical shortage.
Medicine shortages can affect all types of medicines, including innovative patented medicines, off-patent generics, and vaccines. The Critical Medicines Act from 2025 and the proposals for new pharmaceutical legislation from 2023 are currently still on the EU lawmakers' table, which, if passed, could bring significant improvements to the system.
In conclusion, the EU lacks a robust system to address severe medicine shortages, and efforts to tackle the root causes are still in their early stages. It is crucial for EU lawmakers and stakeholders to address these challenges to ensure the availability and accessibility of essential medicines for all EU citizens.
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