EUCOPE: Council position on the Critical Medicines Act brings improvement – but further work is needed

On 2 December 2025, EU Ministers of Health in the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) formally adopted its General Approach on the Critical Medicines Act (CMA).

EUCOPE appreciates the clear distinction between measures applying to critical medicines and to medicinal products of common interest (MPCI). These categories face different challenges and require tailored solutions, and this differentiation is crucial for effective implementation.

Overall, EUCOPE supports that the Council retained most measures dedicated to critical medicines, while providing greater clarity on key aspects such as strategic projects and financial and administrative support. These provisions will help incentivise investment in EU manufacturing capacity and improve supply chain resilience.

While supporting efforts to boost EU-based manufacturing, EUCOPE stresses the need for flexibility where medicines are not produced exclusively in the EU, such as plasma-derived medicinal products (PDMPs). Strategic partnerships and global supply chains remain essential to ensure patient access.

EUCOPE also welcomes clarification of public procurement criteria beyond lowest price, addressing one of the main obstacles that contributes to shortages. Procurement should consider resilience, stockholding and diversified sourcing to avoid disadvantaging smaller companies.

Importantly, EUCOPE notes the removal of EU Joint Procurement (Article 23), which lacked clarity on its overlap with Commission-led collaborative procurement (Article 22). The Council’s approach to collaborative procurement introduces useful preconditions, such as minimum binding quantities and no subsequent negotiations. However, EUCOPE calls for additional safeguards, including prioritising negotiations at national level first, alignment among Member States with similar population, epidemiology and economic conditions, and respect for confidential pricing. Furthermore, allowing Member States to withdraw at any time, as indicated in recital 33, risks undermining negotiations and should be reconsidered.

EUCOPE reiterates that collaborative procurement must remain voluntary for both Member States and Marketing Authorisation Holders (MAHs). It is not a silver bullet nor a one-size-fits-all solution. Access to medicines is a national competence, and national pathways should be prioritised. Existing delays at national level must be addressed, and current legislation, such as the Transparency Directive, fully implemented before introducing new mechanisms.

Finally, EUCOPE cautions against mentioning specific categories of products as MPCI, particularly Orphan Medicinal Products (OMPs) and Advanced Therapy Medicinal Products (ATMPs), as collaborative procurement is ill-suited for these innovative therapies.

EUCOPE remains committed to working with EU Institutions and stakeholders to ensure that the CMA strengthens the EU’s resilience while safeguarding innovation and patient access.

Dr. Alexander Natz, Secretary General of EUCOPE:

“EUCOPE appreciates the Council’s efforts to clarify collaborative procurement rules. While these mechanisms can play a role in exceptional cases, they are not a silver bullet. Access remains a national competence. Before introducing new EU-level tools, existing delays at national level must be addressed and current legislation fully implemented. National pathways should be prioritised over collaborative procurements, in which participation should always be voluntary for both Member States and companies is essential.”