Persisting Medicine Shortages in EU Continue to Cause Frustration
The European Union (EU) is facing a persistent issue with critical medicine shortages, a problem that the European Court of Auditors has identified as requiring significant improvement in the current system.
In 2023 and 2024, the number of medicine shortages reported by EU countries reached record highs, with 136 critical shortages reported between January 2022 and October 2024. This situation poses serious consequences for patients, threatens public health, and imposes high costs on doctors, pharmacies, and countries.
One of the key challenges lies in the fragmented European market for medicines. The lack of free trade and unequal access for citizens contributes to the problem. Moreover, many medicines are only approved for individual countries, and even those approved for the entire EU are not always available in all countries.
The European Medicines Agency (EMA) has played a role in mitigating the impacts of these shortages, but it is not legally empowered to support EU countries beyond health crises. Additionally, the EMA lacks necessary data to address existing medicine shortages due to late and incomplete information from the pharmaceutical industry.
The European Commission has identified vulnerabilities in supply chains as a cause for medicine shortages, with a significant portion of antibiotics and painkillers being produced in Asia. The Commission has proposed changes to certain EU regulations that could improve the system, but these may not solve all problems.
One proposed solution is the Critical Medicines Act and a new pharmaceuticals law proposed by the European Commission. These are currently being reviewed by EU legislators. The European Council submitted proposals for a new Pharmaceuticals legislation in 2025, which are under review by EU Parliamentarians. Trilogue negotiations between the Council, the European Parliament, and the European Commission started under the Danish Council Presidency after the Council of Member States approved the mandate text in June 2025.
However, the current legal frameworks for addressing critical medicine shortages are insufficient. The European Commission has not ensured that barriers to EU-wide trade are removed, making it difficult to redistribute medicines to alleviate shortages. Furthermore, different medicine packaging from country to country makes redistribution challenging.
Tackling these issues presents many challenges, including the pharmaceutical industry's ineffective commitment to ensuring a continuous supply of medicines. Timely reporting of medicine shortages and appropriate countermeasures from the pharmaceutical industry are crucial.
As of now, an effective system for addressing critical medicine shortages is still not in place in the EU. The persisting issue underscores the need for concerted efforts from all stakeholders to improve the current system and ensure the continuous supply of essential medicines for all EU citizens.
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