Cyprus’s proposal for a new European Centre of Clinical Excellence for Pharmaceuticals has entered Europe’s health policy debate. The presidency frames it as a tool to strengthen scientific coordination without encroaching on national competences.
The initiative to form of a non-binding pharma clinical excellence centre saw the light of day at the informal meeting of EU health ministers in Lefkosia on 26 February. It aims to enhance trust in clinical assessments and to reduce fragmentation in decision-making. Likewise, it seeks to support more predictable patient access to innovative medicines across the Union.
The proposal comes at a time when Europe’s clinical research ecosystem is under pressure. Meanwhile, fresh economic data underscore the high stakes.
Not a new regulator
On the clinical excellence initiative, the presidency reported that member states acknowledged the need for stronger scientific coordination at EU level. This is particularly timely, given the “rapid therapeutic innovation, increasingly complex clinical evidence and mounting pressure on health systems”, said Neophytos Charalambides, Cyprus’s health minister at Thursday’s press conference.
Mr Charalambides made it clear that ministers stressed that national competences in pricing, reimbursement and healthcare organisation must remain fully respected. The centre is therefore envisaged as a non-binding complementary mechanism. It would support existing national and European structures, rather than replace them.
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Ministers highlighted the importance of coherence with the EU Health Technology Assessment (HTA) Framework and existing authorities, including national HTA bodies, the European Medicines Agency and the Heads of Medicines Agencies.
According to the presidency, the centre could “facilitate consistent uptake of joint clinical assessments. And improve interpretation of emerging evidence and promote structured scientific dialogue among member states”. A shared scientific foundation at EU level was described as a way to reduce divergences in national decision-making timelines. It also could support more predictable patient access while preserving national priorities.
Avoid overlap
Several delegations underlined that the effectiveness of the centre would depend on a clear governance model. It would also rely on independence and precise delineation of responsibilities to avoid overlap with existing bodies.
Despite these conditions, ministers welcomed the proposal, recognising its potential to deliver “clear European added value” by enhancing transparency, strengthening methodological quality and consistency in clinical evaluations, and reducing duplication among national authorities.
However, the Presidency made clear that the initiative remains at an early stage. “The discussion about the Centre is at the initial stage. It was presented recently at the European level,” the minister said. He added: “I need to be honest, the ministers expressed concerns today mostly about the finances, about other authorities, and whether these would interact in any way with the HTA, the European Medicines Agency and other authorities.” The minister said the presidency would take the concerns into account and seek to reflect the issue in the Council conclusions as a basis for further discussion.
Clinical trials: the competitiveness backdrop
The discussion on scientific coordination comes against a broader concern that Europe is losing ground in global clinical research. New analysis by Frontier Economics, published by EFPIA, estimates that industry-sponsored clinical trials already generate €35.7bn annually across the European Economic Area. This includes €21.7bn from trial activity itself, €3.6bn in R&D spillover effects and €10.4bn from improved workforce productivity through the prevention of 26.9m sick days. In total, the activity supports around 165,000 jobs across Europe. Yet Europe’s share of global industry-sponsored clinical trials has fallen from 22 per cent in 2013 to 12 per cent in 2023. Over the same period, China’s share rose from eight to 18 per cent.
The European Commission, the European Medicines Agency and the Heads of Medicines Agencies have set a target of an 11 per cent increase in multinational clinical trials, equivalent to roughly 500 additional trials over the next five years. If achieved, EFPIA estimates that 35,000 additional European patients could gain access to clinical trials. Other positive effects include €4bn in additional annual economic value and 18,000 new jobs.
More ambitious scenarios, restoring “lost trials” or matching the pace of the US and China, would require increases of 25 to 50 per cent in activity. This would potentially unlock up to €17.9bn in additional gross value added.
Where innovation happens
Beyond the economic impact, the debate over clinical trials has increasingly been framed as a question of industrial strategy and long-term competitiveness. Health Commissioner Olivér Várhelyi linked clinical trials directly to industrial strategy during the meeting.
The discussion about the Centre is at the initial stage. It was presented recently at the European level. — Neophytos Charalambides, Cyprus’s health minister
“Where the medicines are innovated and where they are clinically tested, it is the most likely that they are going to be manufactured and that they will be entering the markets,” the commisisoner said. He framed clinical research capacity as central to preserving Europe’s universal access model and strengthening its competitiveness in life sciences.
The proposed centre is to focus on scientific coordination rather than trial authorisation. This is part of the broader effort to reinforce Europe’s position in the global innovation landscape.
Mental health and inclusiveness
Beyond pharmaceuticals, the meeting addressed mental health and inclusiveness, particularly for young people. Ministers expressed concern about rising levels of anxiety, depression and psychological distress among adolescents and young adults.
The third pillar of the meeting focused on the effective implementation of the European Health Data Space (EHDS) Regulation. Ministers broadly agreed on the transformative potential of interoperable health data to support innovation, artificial intelligence and evidence-based policymaking. The EHDS is seen as a key building block of the European Health Union, connecting national systems while preserving competences.
