Recommendations for the Trilogue negotiations on the Critical Medicines Act

EPF sets out patients’ priorities for the Critical Medicines Act Trilogue negotiations

As negotiations between the European Parliament, the Council and the European Commission enter the trilogue phase on the Critical Medicines Act (CMA), EPF has published its key recommendations to ensure that the final legislation delivers tangible benefits for patients across Europe.

In recent years, patients in all Member States have experienced increasing difficulties in accessing essential medicines, from everyday treatments and antibiotics to highly specialised therapies. These shortages have serious consequences for patient safety, quality of care and health system functioning. EPF believes that the CMA, if strengthened with the right safeguards, can play a decisive role in improving the availability, affordability and accessibility of medicines across the EU.

As trilogue negotiations progress, EPF is calling on EU institutions to ensure that the final text puts patients at the centre and addresses growing inequities in access to medicines across Member States. 

Six priorities for a patient-centred CMA

EPF calls for:

  • Stronger Patient Involvement – Ensure meaningful, structured and continuous patient involvement by including two patient representatives as permanent members of the Critical Medicines Coordination Group
  • Stronger Focus on Equal Access to Medicines – Safeguard the EU Joint Procurement provisions and ensure that collaborative procurement can work in practice
  • Stronger Public Procurement Policies – Promote a genuine shift in public procurement criteria away from price alone towards criteria that prioritise quality, long-term security of supply, sustainability and resilience
  • Stronger Safeguards for Public Funding Received – Include effective, proportionate and dissuasive penalties in cases of non-compliance with specific criteria for strategic projects
  • Stronger Transparency – Create formal channels for ongoing engagement with patient representatives, publish regular public reports and monitoring results, and provide open access to information on CMA implementation and associated activities
  • Stronger Coordination – Facilitate structured dialogue on the implementation of the CMA within the Critical Medicines Coordination Group to enhance coordination between the EU and Member States, and establish / maintain digital reporting systems providing real-time updates on national contingency stocks and stockpiles

EPF also stresses that the CMA must be evaluated against measurable outcomes, including reduction of shortages, improved access across Member States, and protection from increased out-of-pocket costs. 

As negotiations continue, EPF stands ready to work with EU institutions to ensure the final Act delivers equitable, safe and affordable access to medicines for all patients.

Read more: summary of key reccomandations and full paper.