EU advances Critical Medicines Act to boost drug supply chain resilience

The European Parliament and the Council have reached a provisional agreement to advance the Critical Medicines Act (CMA), marking a significant step toward strengthening the resilience, sustainability, and security of the European Union’s supply of critical medicines — including antibiotics, insulin, vaccines, and treatments for chronic diseases.

First proposed in March 2025, the CMA is designed to diversify pharmaceutical supply chains, expand manufacturing capacity within the EU, and improve cooperation among member states to ensure more reliable access to medicines, according to the European Commission.

The push to establish the CMA has been driven by growing vulnerabilities across the pharmaceutical supply chain, ranging from manufacturing disruptions and shortages of key raw materials to the concentration of production in a few countries. Those weaknesses were exposed during the COVID-19 pandemic and have since been amplified by rising geopolitical instability and global competition for critical resources.

Europe’s dependency on critical medicines is a vulnerability that could “severely undermine” its security and defense capabilities, according to an op-ed from the health ministers of 11 European Union member states that was published shortly before the CMA was first proposed in 2025. The ministers warned that drug shortages across Europe are “largely due to fragile supply chains that rely on long, complex value chains and just-in-time deliveries.” 

More recently, those concerns have been amplified by escalating instability in the Middle East, including the conflict involving Iran, which has exposed how quickly geopolitical disruptions can ripple through the global pharmaceutical supply chain. Industry experts warned that rising oil prices, strained logistics networks, and disruptions around key shipping corridors are increasing transportation costs and creating delays, particularly for temperature-sensitive medicines and pharmaceutical ingredients.

Addressing systemic weaknesses

Under the CMA provisional agreement, member states will be required to promote greater resilience and diversification in medicine supply chains during public procurement procedures. For critical medicines, procurers will need to prioritize reliable and diversified supply sources.

The CMA also calls for the creation of strategic projects aimed at expanding or modernizing EU manufacturing capacity for critical medicines and their active pharmaceutical ingredients (APIs) through easier access to funding and accelerated administrative support.

Collaborative procurement mechanisms will also be made available to help member states address disparities in the availability of critical medicines, orphan drugs, and other medicines considered strategically important across the EU.

In a written statement, the European Federation of Pharmaceutical Industries and Associations (EFPIA) called the provisional agreement a “welcome step” towards strengthening the resilience and security of supply of critical medicines in Europe, while preserving competitiveness and patient access.

“With the exception of certain targeted areas, the scope of the legislation appears to remain limited to critical medicines and/or critical medicines with vulnerabilities,” said Nathalie Moll, director general of EFPIA. “This shows that a risk-based approach has been taken by policymakers. That a more pragmatic and flexible stance has been taken on ‘EU preference’ criteria compared to earlier proposals, and that the focus remains on genuinely critical medicines, is also positive.”

The provisional CMA agreement is now subject to formal approval by the European Parliament and the Council of the European Union. The announcement follows an earlier agreement reached in December on the modernization of the EU’s pharmaceutical legislation, which aims to boost innovation and investment in Europe’s pharma sector while ensuring medicines remain safe, effective, and accessible to patients throughout the region.