On 11 March 2025, the European Commission presented its strategy for preventing drug shortages at the European Parliament’s plenary session in Strasburg through its proposed Regulation – the Critical Medicines Act (CMA).
Background
The European Union (EU) relies heavily on foreign suppliers for medicines and their ingredients, particularly for cheaper generic drugs. This dependency leaves EU supply chains vulnerable to disruptions, such as the COVID-19 pandemic, resulting in severe medicine shortages across Member States.
In response, the CMA (read the press release here) proposes to address these severe shortages of medicines and medical devices (particularly for essential drugs such as antibiotics, insulin, and painkillers) by focusing on the domestic production of critical medicines, and by providing the necessary financial framework to accelerate and scale up investments in manufacturing capacity for critical medicines within the EU.
The Act
The CMA proposes to overhaul the current drug procurement rules by:
- improving EU manufacturing capacity for critical medicines through strategic projects;
- utilising public procurement to encourage secure supply chains of critical medicines or improve access to other medicines;
- supporting collaborative procurement among EU countries to ensure fair access to necessary medicines across the EU; and
- exploring international partnerships to reduce dependencies on limited numbers of suppliers.
However, it remains to be seen if the CMA will significantly change drug shortages within the EU as Member State health ministers must still contend with budget constraints when procuring medicines.
For more information on the CMA, please contact Charleen O’Keeffe or your usual William Fry contact.
Contributed by Imogen Boles Gray
