Fundamental changes in healtcare system due to new government in Hungary – Picture by FGK with help of AI
As you might be aware, Hungary recently elected a new government and with this, fundamental changes in the healthcare system have already taken place, and further impactful changes are to come. This is not only politically significant, but has a huge impact on clinical research activities, and sponsors should watch Hungary closely, as changes can make it a powerful country in their clinical study feasibility strategy.
The impact of changes in political leadership
On May 9th of this year, following the parliamentary elections, Péter Magyar was sworn in as the new Prime Minister in Hungary, ending the 16-year tenure of Viktor Orbán.
With this change of leadership, essential elements have been restructured, which are having a meaningful impact in our daily business: clinical research. Let’s go through the changes already established and those still to come.
The most impactful change already concluded is the restoration of the Ministry of Health as an independent Ministry, lead by MD Zsolt Hegedűs. While within the previous structure, healthcare topics were buried inside the broad Ministry of Interior, the new independence is enabling
- Faster regulatory approvals
Clinical trial authorisations no longer compete for priority with police or administrative tasks. Having one dedicated Ministry, bureaucracy is streamlined and decisions are guided by healthcare experts rather than political appointees.
> Patient care and scientific research come into focus. - Focus on digital health
The Ministry is launching a Digital Health Authority which focuses heavily on implementing data protection standards aligned with the European Health Data Space (EHDS), allowing safer, more transparent, and centralized access to anonymized electronic patient records, accelerating retrospective studies and patient recruitment.
> New tools which help sponsors identifying patients and access to real world data. - Increased funding and clinical capacity
The government’s goal to boost public healthcare spending up to 7% of GDP by 2030 means direct infrastructural upgrades for hospitals.
> The drain of doctors and nurses from the public sector is stopped (see also below about motivation of medical professionals). - Public vs. private healthcare
The new Hungarian government is replacing strict public-private healthcare separation with a “two-pillar” system that integrates both sectors to reduce waiting times and remove the “doctor monogamy rule.”
> This policy allows doctors to work in both public and private settings legally and allows private providers to perform public diagnostics, improving patient care efficiency and stabilizing doctor employment.
Further to these structural changes, the new ministry wants to restore the clinical research motivation among medical professionals, which in recent years declined in the area of domestic clinical research sites, because physicians working in state hospitals lost their financial and professional incentives to conduct clinical trials. To address this, the new administration proposes the following changes:
- Financial motivation
The goal is to allow investigating physicians and specialized nurses to receive fair and transparent supplementary income from clinical trials, which the previous regulations did limit drastically. - Bureaucracy and centralization
The very time-consuming process via central OKFŐ (National Hospital Directorate) to get study site contracts in place will be decentralized, enabling the sites to sit in the driving seat again, giving them the power to decide on budgets, equipment usage, legal liabilities, and staff compensation, and take responsibility on timelines. This will accelerate the execution of research contracts, increasing the international competitiveness of Hungarian hospitals. - Compassionate use system
While until now, each individual compassionate use drug application had to be approved by the Batthyány-Strattmann Foundation, the current endeavours to accelerate and make it attractive to conduct clinical trials in Hungary could potentially also improve this process, since many patients could access cutting-edge, innovative therapies quickly and free of charge within trial frameworks, resulting in a relief of workload for the foundation. - New culture
Hungary is transitioning to a “knowledge-based economy” by fostering a high-value, ethical clinical research sector supported by a transparent “learning culture”. By restoring powers to the Hungarian Medical Chamber, the government protects investigators, ensuring the data integrity necessary for international clinical trials.
Executive summary
Putting this all together, we see that in Hungary a broad approach of changes are undergoing, from foundation structural changes, over cultural opening, to concrete actions.
This not only sets a stable fundament of structures in the long run, but in the short term, makes Hungary an attractive country for clinical trials, with the following direct advantages for sponsors:
- New political focus sets financial and structural basis for improvements in clinical research
- Reduced bureaucracy results in faster contracting
- Initiatives for research professionals as well as research sites result in motivated staff and great infrastructure
- High acceptance of patients to get access to cutting-edge, innovative therapies quickly and free of charge
Seeing so many changes within one country, it becomes clear that a clinical trial partner with in-depth knowledge about local peculiarities is even more important.
FGK’s Hungarian office in Budapest has been supporting sponsors for 16 years in navigating country-specific requirements from submission through study conduct.
About the Author:
Gergely Molnár
Director General Management FGK Hungary
Gergely Molnár is General Manager of FGK’s Budapest office and has more than 16 years of experience in clinical research.
Having worked as a CRA, Senior CRA and Project Manager across various therapeutic indications, he combines extensive operational expertise with an in-depth understanding of Hungary’s local clinical research landscape.