European Parliament adopts the Critical Medicines Act: EUCOPE warns against unintended consequences on innovation

Brussels, 20 January 2026 – The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) acknowledges today’s adoption of the Critical Medicines Act (CMA) by the European Parliament, which upholds the approach set out in the Public Health Committee (SANT) report endorsed in December 2025.

EUCOPE reiterates the opportunities and concerns previously highlighted during the SANT Committee vote. Measures to strengthen supply chains and support diversified manufacturing of critical medicines represent important steps toward improving resilience, as does the reinforcement of public procurement criteria. These initiatives must be accompanied by proportionate obligations for industry and not penalise companies operating within globally integrated supply chains.

At the same time, EUCOPE urges caution regarding the extension of measures originally designed for critical medicines to medicinal products of common interest (MPCI). The inclusion of orphan medicinal products (OMP) under the definition of MPCI, and the related collaborative procurement mechanisms, would create unnecessary operational burdens and uncertainty for OMP companies, particularly smaller ones. These proposals risk unintended consequences on innovation, availability of novel treatments and, ultimately, European pharmaceutical competitiveness.

EUCOPE stands ready to engage constructively in the upcoming trilogue negotiations, with a view to ensuring the final agreement on the CMA supports both patients’ access to medicines and the long-term competitiveness of the EU’s life sciences ecosystem.

Statement by Dr. Alexander Natz, EUCOPE Secretary General:
“Collaborative procurement must remain strictly voluntary for both Member States and marketing authorisation holders, avoiding market distortions and destabilising access, particularly for SMEs developing orphan medicines. Clear safeguards – including minimum binding quantities, limits on parallel negotiations and regulatory flexibilities – are essential to provide predictability for companies. Crucially, these mechanisms do not address the root causes of access delays, which lie at national level. Rather than creating new EU structures, existing tools should be leveraged to ensure timely and equitable patient access.”

EUCOPE Press contact: Matthias Heck (heck@eucope.org)