Pharma sector key to EU competitiveness. Várhelyi: ‘innovation must reach everyone

Brussels – An industry that invests 37 billion a year in research and development, employs 800 thousand highly qualified people, and represents an added value of over 100 billion on international markets. However, a sector that remains highly fragmented, where shortcomings risk becoming structural. This is the complex state of the European pharmaceutical industry as photographed today at the Connact Pharma event entitled “The relaunch of European competitiveness through the pharmaceutical sector.” The relaunch inevitably passes through the reforms that Brussels is working on: the pharmaceutical package and the law on critical medicines. 

Opening the round table was the director of the European Parliament’s office in Italy, Carlo Corazza, who set the goal: “We must strengthen a sector that is absolutely essential for our strategic autonomy.” To do so, the European Commission put on the table as early as April 2023 a reform package for pharmaceutical legislation, which is now ready to go through inter-institutional negotiations between the EU Council and the European Parliament. Alongside the reform, this spring, Health Commissioner Olivér Varhelyi submitted a law to ensure the supply of essential medicines to member states.

 In a video message, Varhelyi emphasized to the audience that there are “enormous opportunities to put the EU at the forefront of the world.” Positive signs are not lacking: the trade surplus in pharmaceutical products, the Hungarian noted, “has risen from 157 billion in 2023 to 194 billion in 2024.” According to the Commissioner, the first step is the creation of a European Health Data Space, “an unprecedented federated system for the use of big data in medical research.” 

After that, there is a need for “modern, flexible, and streamlined” regulations. The current pharmaceutical legislation, after all, is over 20 years old. Now, the priorities are to “reduce bureaucracy, shorten the evaluation time for the authorization of new medicines on the market, simplify the structure of the EU Medicines Agency.” Most importantly, to respond to the worrying periodic shortages of medicines that occur in some Member States. As the European Court of Auditors said just yesterday, there are still “too many barriers to free flow” of pharmaceutical products.

 Innovation “must reach those who need it, regardless of where they live in the EU,” said Varhelyi, who is convinced that the reform in the pipeline “will create the conditions for better access for patients without compromising the interests of companies.” In particular, the Critical Medicines Act envisages a new regime for state aid, increased support for strategic projects, and the establishment of cross-border collaborative procurement and international partnerships.

Member states adopted their positions on the pharmaceutical package before the summer break and began discussions on the critical medicines law. Regarding the former, “Italy, in close coordination with France, reiterated the importance of a fair balance between access to medicines and support for innovation,” explained Tommaso Foti, Italian Minister for European Affairs. On the latter, Rome highlighted “the very bureaucratic structure and inadequacy to the strategic nature of the issue.”

The minister warned of the risk of “weakening intellectual property” inherent in the reform of European legislation, emphasizing that for Italy, “the priority is to value national production districts and guarantee the decision-making role of member states in evaluating the vulnerability of the supply chain.” To strengthen European production capacity and avoid dependence on third countries, Foti suggests focusing on “simple incentives, procurement criteria that are not based exclusively on price” and, above all, on eliminating “obligation duplication for producers,” which is a “madness that produces bureaucracy upon bureaucracy that is completely useless.”

At the national level, Foti announced that today, “the Council of Ministers will approve  a draft bill” to “reorganize and innovate the entire structure of Italian pharmaceutical legislation.” The objectives are “to ensure fairer and more timely access to pharmaceuticals, more efficient monitoring and control of pharmaceutical expenditure, and a strengthening of the role of territorial pharmacies as proximity health centers.”