EUCOPE concerns on the provisional trilogue agreement of EU Institutions on the Critical Medicines Act (CMA)

Brussels, 12 May 2026

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), representing mostly small- to mid-sized innovative pharmaceutical companies in the EU, takes note of today’s provisional trilogue agreement on the Critical Medicines Act (CMA), reached by the EU Institutions.

EUCOPE views this agreement as an important opportunity to strengthen the EU’s resilience in the manufacturing and supply of critical medicines. At the same time, EUCOPE expresses serious concern regarding the far-reaching implications of provisions related to so-called ‘medicinal products of common interest’ (MPCI), particularly in the context of ongoing geopolitical shifts, such as the US Most Favoured Nation (MFN) pricing policy, and their potential spillover effects on global reference pricing dynamics.

EUCOPE is concerned about the explicit inclusion of orphan medicinal products (OMP) within the definition of MPCI. Combined with related collaborative procurement mechanisms, this would create unnecessary operational burdens and uncertainty for OMP companies, particularly smaller innovators. The initial MPCI definition proposed by the Commission already allows for the inclusion of OMPs where appropriate and needed. Given the complexity of access pathways for OMPs, a blanket approach, which prioritises giving Member States more bargaining powers and lowering prices, as agreed during trilogues, is unlikely to deliver meaningful benefits and will introduce additional risks. The EU should leverage more appropriate legislative tools to improve the R&D and access framework – rather than introducing additional hurdles, especially when significant changes are already underway.

EUCOPE acknowledges the removal of joint procurement, as spelled out in the original article 23 of the CMA. Nevertheless, EUCOPE stresses that any other collaborative procurement approach, if used, should remain voluntary and include safeguards for both Member States and Marketing Authorisation Holders (MAH), in order to ensure predictability and avoid undermining the attractiveness of the EU market. Specific needs of Member States are often best addressed through bilateral agreements. Any form of compelled participation, whether through market or political leverage, may ultimately risk the effectiveness of the collaborative procurement mechanisms. This is particularly relevant as MAH are already adapting to significant regulatory changes, such as the Joint Clinical Assessment (JCA) under the EU HTA Regulation and access requirements in the new General Pharmaceutical Legislation (GPL).

EUCOPE supports measures aimed at strengthening supply chains and fostering diversified manufacturing of critical medicines. These proposals represent important steps towards improving resilience, as does the reinforcement of public procurement criteria, including multi-winner tenders. While recognising the emphasis on European preference, these initiatives must be accompanied by realistic requirements for industry. Public procurement criteria should avoid penalising companies operating within globally integrated supply chains, particularly when developing more innovative therapies across EU partner countries, such as EFTA/EEA.

EUCOPE stands ready to engage constructively in the upcoming implementation phase of the CMA, with the aim of ensuring both timely patients’ access to medicines and the long-term competitiveness of the EU’s pharmaceutical ecosystem.

Statement by Dr Alexander Natz, EUCOPE Secretary General:

“EUCOPE is concerned that bringing OMPs under the MPCI definition will create uncertainty for companies without clear added value for patients.

At a time of increasing global pricing pressures, including developments such as the US MFN policy, it is critical that collaborative procurement is not used solely to lower prices. This mechanism should remain a voluntary tool with appropriate safeguards, therefore preserving flexibility for both Member States and companies.”

EUCOPE Press Contact – Matthias Heck (heck@eucope.org).