Pharmaceutical scarcity persists within the EU
The European Commission has identified vulnerabilities in the supply chain as the underlying causes of critical medicine shortages in EU countries, which reached record highs in 2023 and 2024. The internal market for medicines in the EU is fragmented, hindering free movement and equal access to medicines.
Cross-border trade barriers have not been adequately addressed, making potential redistribution of medicines not a simple solution to mitigate shortages. Many EU member states have started building up medicine stocks, which lack coordination and threatens to exacerbate shortages in other countries.
The European Court of Auditors has published a special report titled 'Critical Medicine Shortages - EU Measures Had Added Value, But Structural Problems Persist'. The report highlights that most medicines are approved at the national level in the EU, and those approved for the whole EU are not always marketed in all countries.
The report also states that there is a wide range in the number of centrally approved medicines marketed in EU countries, with large price differences between countries and low transparency of market prices. The auditors warn that the proposed changes will likely not solve all problems related to medicine shortages in Europe.
In an effort to improve the system, the European Commission has proposed changes to EU laws. These include the critical medicines regulation of 2025 and new medicines legislation of 2023, which are currently with the EU legislators. If adopted, these changes could significantly improve the system.
However, the European Medicines Agency lacks sufficient data to continuously help reduce existing medicine shortages and lacks legal powers to help EU countries during non-health crises. Despite this, the agency has helped mitigate the impact of medicine shortages in Europe.
For more information, please contact the European Court of Auditors at [email protected], or Damijan Fišer at (+352) 621 552 224. It is important to note that medicine shortages can affect all categories of medicines, including innovative patented medicines, generic medicines, and vaccines. The first EU-wide list of critical medicines has been created, but efforts so far have not ensured their availability in all countries.
The packaging of medicines varies per country in the EU, which further complicates the issue of medicine shortages. It is hoped that the proposed changes will address these issues and ensure that all EU citizens have equal and timely access to the medicines they need in Europe.
