European Commission proposes a new Critical medicines Act
- Date
- March 12, 2025
- Category
EU Regulations
- Description
On 11 March 2025 the European Commission published a draft Critical Medicines Act, which aims to support manufacturing and improve the availability of critical medicines in the EU.
Medicine shortages are mostly caused by manufacturing problems, supply chain risks and global competition for resources. The new Act aims to overcome these challenges. Key elements include:
- improving EU manufacturing capacity for critical medicines through strategic projects
- use of public procurement to encourage reliable supply chains of critical medicines or improve access to other medicines
- supporting collaborative procurement among EU countries to ensure fair access to important medicines across the EU
- exploring international partnerships to reduce dependence on a single or limited number of suppliers
Tackling shortages and ensuring access to medicines has been a priority for the EU for many years. The new Critical Medicines Act complements legislative proposals already put forward to address this, notably through the reform of the EU’s pharmaceutical strategy. The European Medicines Agency, together with national authorities, plays a key role in monitoring and responding to these critical medicine shortages.