EC: Proposal for the Critical Medicines Act

The European Commission (EC) has proposed the Critical Medicines Act to enhance the availability of essential medicines in the EU. The regulation aims to diversify supply chains, boost EU pharmaceutical production, and improve access to critical medicines.

The Act responds to medicine shortages caused by supply chain vulnerabilities, global competition, and manufacturing issues. It provides an industrial toolkit to make the EU more attractive for pharmaceutical production and strengthen resilience. Key measures include:

• Strategic Projects to expand or modernise EU manufacturing, supported by faster funding access and streamlined regulations.
• State aid guidance to help Member States finance these projects.
• Public procurement rules requiring diversified supply sources and incentives for EU production.
• Collaborative procurement to improve medicine availability across the EU.
• International partnerships to reduce dependence on limited suppliers.

This initiative complements the EU pharmaceutical reform and EMA’s expanded role in managing shortages, reinforcing the EU’s efforts to secure medicine supply chains.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the efforts to introduce criteria beyond price for the public procurement of critical medicines but raised concerns with the inclusion of strengthened collaborative procurement options. The options “may be appropriate under very specific circumstances where they accelerate patient access to critical medicines,” EFPIA said, but “a systematic application could create more harm than offering a more permanent solution to access related issues.” 

The trade group emphasized the need for clarity in identifying situations where collaborative procurement could enhance access beyond current national pricing and reimbursement systems.

Sources:

EC: Press corner

EC: Questions and answers on the Critical Medicines Act

EFPIA response to the Critical Medicines Act