Calls for Improvements to the Critical Medicines Act

The ongoing discussions surrounding the Critical Medicines Act (CMA) have revealed significant concerns among EU lawmakers regarding the adequacy of the European Commission's plans to secure drug supply chains. The SANT Committee has expressed that the current proposals are insufficient, particularly in terms of promoting local production of pharmaceuticals within Europe.

During a recent debate, Tomislav Sokol, the committee's rapporteur from Croatia, emphasized the need for a greater focus on domestic manufacturing in the European Economic Area (EEA) during procurement processes. He highlighted that enhancing the competitiveness of the pharmaceutical manufacturing sector in the EU is crucial, alongside better coordination of emergency stockpiles.

Sokol's recommendations include a targeted approach to multiple procurement awards, advocating for a minimum of 50% production of critical medicines--such as emergency drugs and antibiotics--to occur within the EEA. For medicines deemed of common interest, like vaccines for specific infectious diseases, he has proposed even stricter production requirements.

Additionally, the SANT Committee suggests extending the coordination mechanism for critical medicines to encompass medicines of common interest. This initiative aims to enhance supply security, more effectively address shortages, and create a unified strategy for stockpiling and emergency preparedness.

The CMA is currently in the phase of position establishment within the European Parliament and Council, and it is expected that the trilogue negotiations among the Parliament, Council, and Commission will be wrapped up by the end of 2025. However, not all member states are fully supportive of these initiatives. For instance, Germany's Health Minister, Nina Warken, has expressed skepticism regarding the introduction of new structures that could lead to increased bureaucracy, asserting that member states' responsibilities for their healthcare systems must be maintained.

Despite these concerns, Warken acknowledged that the CMA lays a solid foundation for identifying the root causes of vulnerabilities in supply chains and addressing access issues for new medicines in the future.

As the legislative process continues, further amendments from members of the Parliament can be submitted until September 19, allowing for additional refinements to the proposal. The urgency to finalize this act reflects the broader commitment to ensuring the resilience and reliability of the pharmaceutical supply chain across Europe.