Hungary has taken over the EU Council’s rotating presidency as of 1 July 2024. Hungary’s EU presidency comes at a time when the European Parliament (EP) has already adopted its position on the EU pharma reform, and the file is now in the Council’s hands. In this article, we review Hungary’s EU presidency program and related press statements to provide a brief overview on what the industry should expect.

In more detail

Prior to taking over the EU presidency, the Hungarian Government announced that its presidency will focus on the EU’s competitiveness, defense policy, enlargement policy, illegal migration policy, cohesion policy, agricultural policy and addressing demographic challenges. Although healthcare is not mentioned as a priority, the presidency program clarifies that Hungary considers both the EU’s pharma reform and patent packages as crucial for enhancing EU competitiveness.

According to the detailed program, Hungary intends to achieve progress on both the EU pharma reform and patent packages but it is unclear how this progress should be measured. Considering the packages’ complexity and also that Hungary’s presidency follows shortly after the EP elections, with key EP roles and fractions still in flux, finalising either package in the next six months is an unlikely prospect. Nevertheless, Hungary intends to continue technical work on both proposals.

Regarding the EU pharma reform specifically, Hungary intends to continue the negotiation process with a view to achieve a competitive, sustainable and patient-oriented regulation of medicinal products. On a related note, Hungary implemented a new stockpiling obligation for strategic medicinal products this May, which might represent Hungary’s stance on handling shortages also at an EU level.

From a broader public health perspective, cardiovascular disease prevention is a priority for Hungary, and the presidency intends to adopt Council conclusions on this topic. Cardiovascular diseases are currently the second leading cause of death in Hungary (following malignant cancer), according to the statistics published by the Hungarian Central Statistics Office.

The Hungarian presidency also expects to answer practical questions around organ transplantation, since the EU’s Substances of Human Origin Regulation was adopted shortly before the presidency.

The above subjects will be reflected in the agendas of both high-level professional conferences and informal EPSCO policy discussions. Additionally, Hungary proposes further topics such as rare diseases, the potential link between mental health and public health emergencies, as well as possible cooperation between member states on the affordability of medicinal products.

Lastly, Hungary’s Minister for National Economy has signed a cooperation agreement with the Hungarian Pharmaceutical Manufacturers Association (MAGYOSZ). The related press statement emphasises that the pharmaceutical industry represents a significant part of research and development (R&D) spending in Hungary and therefore a high added value for the economy. Among other things, the parties hope that their agreement may also result in increased cooperation for EU research and innovation, which would be beneficial for both domestic pharmaceutical manufacturers and the Hungarian economy. We will be following the EU presidency closely and continue to monitor the EU pharma reform’s legislative procedure for significant developments. If you have any questions, please do not hesitate to contact us.

Author

Helga Bíró is a partner in Baker McKenzie's Budapest office where she specializes in regulatory and commercial aspects of the life sciences industry

Author

Máté Laczkó is an associate in the Budapest office where he is a member of the Pharmaceutical and Healthcare practice. Máté can be reached at mate.laczko@bakermckenzie.com.