Commission proposes new rules to ensure stable supply of critical medicines

Patients in the EU should have access to the medicines they need, when they need them. Unfortunately, in recent years EU countries have been confronted with severe medicine shortages, made worse by global events such as the COVID-19 pandemic. The Critical Medicines Act, proposed by the Commission today, 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.

For more information

Press release: Commission proposes Critical Medicines Act to bolster the supply of critical medicines in the EU 

Questions and answers on the Critical Medicines Act 

Factsheet on Critical Medicines Act

Modernising the EU pharmaceutical legislation

European Medicines Agency

European Critical Medicines Alliance