Pharma package a major focus for Hungarian presidency, innovation incentives seen as critical

The Hungarian presidency plans to carry on the negotiation process on the pharmaceutical legislation proposals to establish a competitive, sustainable, patient-centred pharmaceutical legal environment.

As negotiations are expected to pick up speed, the Hungarian administration will aim its attention during its tenure at the helm of the Council of the EU on those segments of health policy that were sidetracked by the COVID-19 pandemic and on other delayed reforms.

“The transition between presidencies is typically a long transition period,” a Hungarian diplomat told Euractiv – they asked not to be named to speak freely.

“Obviously, the negotiation of the EU pharmaceutical package will be a major focus. The Hungarian position on the proposal is secondary during the presidency, as we have to act primarily as an honest broker to facilitate a compromise,” the diplomat remarked.

The source highlighted that the goal is to find an agreement that improves access to medicines and financial sustainability and supports the competitiveness of the European pharmaceutical industry.

They added: “From this perspective, the reform of innovation incentives will be of critical importance, and we will try to keep all the essential elements of the Commission’s proposal, such as fulfilling unmet medical needs and the role of comparative studies.”

“However, we are in the hands of the member states, and their degree of flexibility will determine the outcome of the negotiations,” the diplomat said.

SoHO, organ donations and CVDs

Hungary also wants to remain active on topics of SoHO regulation and organ donation, with the topics appearing in the programmes of conferences and among policy discussion topics at the informal EPSCO meetings.

At an informal meeting in Budapest at the beginning of July, health associations, patient organisations, and cardiovascular experts met to discuss the presidency’s main priorities – joint action in cardiovascular disease and organ donation.

With the adoption of the Substances of Human Origins Regulation (SoHO), the Hungarian presidency intends to reflect on the practical issues of organ donation in the form of Council Conclusions.

Additionally, Council Conclusions are planned to reinforce the European Cardiovascular Health Plan with a special focus on prevention, innovation, and treatment.

The debate highlighted the need to prevent risk factors such as smoking, alcohol consumption, unhealthy diet, lack of exercise, poor mental state, and environmental risks, and improve treatment and rehabilitation options for patients.

Health data improve healthcare.

The implementation of the draft regulation on the European Health Data Space was on the agenda as well.

“Due to the different levels of development in member states, a gradual introduction has been recommended, with full application expected at the beginning of 2030,” State Secretary Péter Varga said in a press conference.

“Data is a resource that can fundamentally transform healthcare. As Hungary is entering a critical phase of the implementation of the EHDS, we are at a crucial moment to face these challenges,” said Zsolt Bubori, head of the Hungarian EIT Health InnoStars, at a roundtable meeting in June.

Widespread awareness and close cooperation are necessary so that member states can fully exploit the potential of the European Health Data Space (EHDS), believe the experts who formulated recommendations for the success of the initiative.

The European Commission hopes that, in addition to improving cross-border health care, the EU system will also expand research opportunities, as it offers researchers and market companies the opportunity to analyse large amounts of health data.

The data space would enable aggregated health data sharing, including data on pathogens, health claims and reimbursements, genetic data, and public health registry data, for public interest purposes, including research, innovation, policy making, education, and patient safety.

Additional goals

Hungary proposes looking further into topics such as rare diseases, exploring links between mental health and public health emergencies, and affordability of medicinal products.

The Hungarian presidency wishes to pay special attention to the topic of occupational health and safety and implement provisions within the European Occupational Health and Safety Framework Strategy.

A revised package on the occupational safety limits for carcinogenic, mutagenic, and reprotoxic substances is expected to be published in September.

[By Zsolt Kopári, Filip Áč, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]