Cut EMA red tape, break down barriers to data and clear resources: how to revitalise EU through pharmaceutical industry

Brussels – The potential is there, the challenges are not lacking, the opportunities will not disappear, but what is needed is a change of pace in rules and policies, both national and European, to make health and pharmaceuticals that strategic sector capable of responding to the calls for competitiveness set out in the Draghi report and propelling the EU into a whole new economic and innovative dimension. The Connact Pharma event entitled “The revival of European competitiveness through the pharmaceutical sector” tries to assess the situation and, above all, provide future-proof answers. 

Fabrizio Conicella, Vice President and Head of the Centre of Open Innovation and Competence at The Chiesi Group, considers the time it takes for medicines to reach the European market, and according to him, the figures do not add up. “Only 9 per cent of the medicines that go through the European Medicines Agency (EMA) use accelerated procedures, when in the United States the rate is 50 per cent,” he denounces. “The EMA, which has a fundamental role, is a bureaucratic structure“, and in this criticism, there is a call for a reorganisation of a body that can bring about a change of pace.

But there is also an entirely industrial knot, since at present “50 per cent of medicines in clinical phases come from start-ups and not from large companies.” This aspect, continues Conicella, indicates that “Europe has a problem in getting small companies to grow,” a problem that is measured above all in its poor ability to compete, here, with China and the United States. Here then is the suggestion: “Strong patent protection and bolder capital markets could strengthen competitiveness and innovation.” 

Then there is the question of data, which is fundamental for mapping needs and therefore directing supply. One problem for Italy in this area is the excess of regionalism, that “devolution” that has been so strongly promoted. “Article 5 of the Constitution is an obstacle. As much as there is interoperability, the different management of data in two regions is an obstacle.” Even Piero Rijli, Corporate Director Regulatory Affairs & Market Access of the Menarini Group, shares the call for decisive action on data sharing. “Data is extremely important,” he says. “We need to break down these barriers, which in Italy are regional and in Europe between member states, because by doing so we gain time and support the production process, and thus be more competitive and accelerate innovation.” 

Beyond that, it is clear to Rijli that the pharmaceutical industry must be supported. “Financial incentives of €82 million for the two-year period 2026-27 are an insufficient contribution compared to the enormity of the challenge.” Money is needed; there’s no point beating about the bush, but, as the Menarini Group representative emphasises, “we are not asking for unlimited resources: the resources already allocated can be used better.” How? “A part of the 800 billion defence fund could be used to strengthen production capacity, since patient safety must be part of our defence strategy.”  

Regarding budgets and resources, “with the new multiannual budgetary framework (MFF 2028-2034) the money earmarked for health and critical care must be ambitious,” emphasises Rainer Becker, 
Director for Medical Products and Innovation at the European Commission’s DG for Health and Food Safety

(DG SANTE). The Commission has presented its proposal for the MFF, but the ball is now in the Council’s court, and “we must ensure that governments support the increase in resources here,” stresses the senior EU official. “There should also be European money, but this is a shared responsibility,” and therefore, the political choice governments will make is crucial. Becker, therefore, calls on citizens to “make themselves heard” so that informed choices can be made. 

Politics promises and reassures. “We seek to support the competitiveness of the pharmaceutical sector, which has become a driving force for the Italian and the European systems,” Nicola Procaccini, co-chairman of the European Conservatives Group (ECR), chimes in. While Michele Picaro MEP (FdI/ECR), a member of the Environment and Public Health committees, admits that “there are deep-seated fragilities in our supply chains” and that “this is where the effort to improve comes from.” In this sense, “relocation of production becomes a priority, with targeted incentives and joint procurement, together with a list of essential medicines. We also need a monitoring system to intervene before shortages occur.” Looking to the immediate future, he continues, we need to “incentivise investment in active ingredients and innovative production, quality, reliability, and sustainability must be rewarded in public tenders, without just looking at the lowest price.” Citizens and patients rest assured: in Europe, “there is an aim to create an integrated industrial policy and to make Europe an attractive location for research and innovation.”