On Thursday 26 February, at the informal meeting of European health ministers in Nicosia, the Cyprus Presidency of the EU Council proposed the creation of a non-binding European Centre of Clinical Excellence for Pharmaceuticals.
The aim of this Council would be to “enhance transparency, the quality of decisions and the coherence of European health systems”, explained the Cypriot Minister of Health, Neophytos Charalambides. It is expected to strengthen trust in clinical assessments, support consistent and high-quality decision-making, and consolidate the EU role in global pharmaceutical policy, while laying the groundwork for a more cohesive and patient-centred European health system, said the Cyprus Presidency of the EU Council in a press release.
“The Member States recognised the need for greater scientific coordination at EU level (...) and stressed that national competences in terms of pricing, reimbursement and organisation of healthcare, as well as the sovereignty of the Member States, must be fully respected”, explained Neophytos Charalambides. He added that some delegations had felt that the effectiveness of the Centre would depend on a clear governance model, its independence and a clear definition of responsibilities to avoid overlap with other health bodies.
Welcoming the proposal, according to Mr Charalambides, ministers called for further technical consultations to clarify the Centre’s mandate and structure.
Ministers also discussed mental health and inclusion, particularly among young people. They stressed the need to integrate inclusion into national mental health strategies and to strengthen cooperation at EU level in order to combat inequalities and improve results.
Finally, they discussed the implementation of the European Health Data Space Regulation. “Ministers broadly agreed on the transformative potential of the European Health Data Space for healthcare provision, research and public health, by enabling secure, interoperable and reliable cross-border use of health data”, highlighted Mr Charalambides. Effective governance, appropriate mechanisms, including the clear designation of national authorities, and active participation in the European Health Data Space Board were deemed essential.
Ministers highlighted sustainable funding, gaps in digital infrastructure, a shortage of specialist expertise and the complexity of coordinating multiple stakeholders at national level as challenges. According to Mr Charalambides, many countries have called for greater European coordination, technical assistance, capacity building and financial support to ensure balance and effective implementation across the EU.
Ministers also stressed the need for the rapid adoption of implementing and delegated acts, clear technical standards and practical guidelines in order to ensure legal certainty and avoid fragmentation. “We will be presenting all the implementing regulations needed for the European Health Data Space to function fully. This will happen this year”, promised the European Commissioner for Health, Olivér Várhelyi.
The Commissioner also called for the pharmaceutical package to be finalised, hoping that “the Presidency will exert strong pressure so that this package is finally finalised and adopted”.
He also called for progress on legislation on critical medicinal products, as well as on the reform of medical devices and biotechnology legislation. “All these proposals will also take time to implement. We still have to submit them to the European Parliament. So there really is no time to lose and I hope that the Presidency will do everything possible to enable us to finalise these files with the Irish Presidency by the end of the year”, added Mr Várhelyi. (Original version in French by Camille-Cerise Gessant)