Magyarország egészségügyi fejlődése: Dr. Mátés Adrienne interjúja a CEE Legal Matters oldalán

Hungary's Health Ecosystem: A Buzz Interview with Adrienne Mates of BPV Jadi Nemeth

Hungary’s legal and business landscape remains difficult to predict in the short term, given the intensity of the current election cycle. Nevertheless, several important developments are already taking shape in healthcare, life sciences, and related regulatory areas, according to BPV Jadi Nemeth Partner Adrienne Mates.

"One of the most notable recent developments in the life sciences space has been the launch of the named-patient reimbursement program, which began operating roughly a year ago," Mates begins. The scheme is designed to support innovative, authorized drugs not yet included in the standard reimbursement system. "Innovative drugs that are off-label or otherwise outside the system may now be funded through a dedicated state fund operating in coordination with the state health insurance fund," she explains.

However, Mates notes that the program is still in a trial phase. "The transparency, contracting model, and access process are all in a relatively early stage, and actionable feedback is limited," she says. "Stakeholders have voiced concerns that the framework is not yet user-friendly, so there is a clear hope for further refinement."

Focusing on broader health-data regulation, Mates highlights the emerging framework for secondary health-data use and its potential for research. She believes Hungary is uniquely positioned due to the depth of its data ecosystem: "Hungary has a significant health-data asset. The country has been proactive in building systems that connect practitioners, hospitals, and patients, in some respects moving ahead of wider EU legislative developments."

A pivotal change took effect on January 1, 2026, through an amendment allowing access to specific data sets for research, including AI training and the evaluation of medical devices. "The law is built around pseudonymized data as a rule – access is tightly conditioned on ethics committee authorization and strict purpose limitation. This is a major attraction for pharmaceutical companies, as data processing is now among the most valuable elements of R&D."

Mates points to the renewed focus on clinical trials. While Europe has seen a decline in competitiveness compared to the US and Asia, Hungary is working to reclaim its position. "There is a concerted effort to make the market more appealing by streamlining rigid structures," she adds, noting that further regulatory revisions are under discussion.

Shifting to the broader investment climate, Mates says other sectors are also generating increased legal attention. "We are seeing a more demanding FDI regulatory environment overall. Investors entering the Hungarian market must navigate two overlapping screening regimes. Where both regimes apply to a single transaction, separate filings must be submitted to two different ministers, each running their own review process. It is this layered structure – two competent authorities, two procedural tracks, and an evolving definition of what counts as strategic – that has made FDI due diligence in Hungary meaningfully more complex recently."

"Hungary is simultaneously pressing ahead in renewable energy and the battery sector, driven by a remarkable concentration of Asian investment – five of the world's ten largest battery manufacturers have now chosen Hungary as their European base. This has not only reshaped the industrial landscape but is actively driving regulatory evolution," she concludes.