2025: Breakthrough Year – Access, Incentives, Clinical Research Dynamics, and Diagnostics Centralization

Early in the year, the government introduced a new actor into named-patient reimbursement: the Batthyany-Strattmann Laszlo Foundation for Healing, a public-benefit foundation empowered to finance medicinal products and medical devices that, although professionally accepted, fell outside social-insurance reimbursement. Prior to this change, individualized access decisions sat solely with the National Health Insurance Fund. The foundation’s establishment diversified funding sources, helped alleviate administrative pressure, and introduced discretionary decision-making guided by considerations of life protection, social responsibility, and budget availability.

Its sole competence covers two broad categories: (i) unregistered therapies requiring special-import authorization, and (ii) registered products without any reimbursement in Hungary, including innovative oncology, immunology, gene, and orphan therapies already authorized at the EU level but not yet integrated domestically. Processing occurs outside formal administrative procedure rules, giving the foundation flexibility to respond to urgent patient needs. However, the model requires manufacturers to prepare access dossiers that address both clinical and compassionate-use considerations while monitoring variable funding conditions.

Incentivizing Innovation: Refundable R&D Tax Credit and Social Contribution Relief

Since 2023, Hungary has maintained a refundable R&D tax credit designed to strengthen its innovation base and align national incentives with global tax frameworks. Although introduced earlier, the scheme remains a key element of the 2025 landscape, offering companies the possibility to recover part of their research and development costs through a predictable and transparent mechanism. In parallel, social-contribution allowances continue to support employers in maintaining in-house research capacity.

Together, these measures aim to enhance competitiveness, encourage collaboration with academic and clinical institutions, and attract multinational investment. For life-science companies, the framework provides flexibility but also demands disciplined planning and documentation to ensure compliance and the long-term sustainability of R&D operations in Hungary.

Clinical Research Dynamics: Declining Enrollment and Competitive Pressures

Despite these incentive strengths, Hungary’s clinical-trial landscape showed signs of erosion. Patient enrollment in sponsored studies declined materially over recent years, pressuring a sector that historically contributed substantial economic value and supported thousands of specialized jobs. Although Hungary continued to host hundreds of new studies annually, its relative ranking within the European Union slipped as neighboring jurisdictions invested in infrastructure, streamlined approvals, and targeted trial incentives.

Contributing factors included reduced differentiation from EU-harmonized authorization timelines, administrative fragmentation, and gaps in digital systems used for data capture and secondary-use analysis. Experts cautioned that without targeted adjustments, such as simplifying authorization pathways, enhancing healthcare-data infrastructure, and coordinating decisions more efficiently, Hungary risked losing its comparative advantage as a preferred late-phase trial destination. For sponsors, this necessitated earlier feasibility assessments, stronger institutional relationships, and support for national capacity-building. It is also important to note that Hungary has an outstanding health database accumulated over decades that could be a key element for secondary use of health data.

Diagnostics Centralization: State Takeover of MRI and CT Services

From November 2025, Hungary began the state takeover of MRI and CT diagnostic services, ending reimbursement contracts with private providers operating within public hospitals. The reform aims to streamline capacity management and reduce waiting lists but raises strong concerns about staffing shortages and transitional disruptions. Private operators had previously delivered about one-third of the national imaging capacity. Their withdrawal places added pressure on state institutions already facing limited personnel and aging equipment. Experts warned that without sufficient radiology staff and operational planning, access delays could worsen, particularly for oncology and chronic-disease diagnostics.

The policy illustrates Hungary’s contrasting directions: strong incentives for private R&D and innovation alongside greater centralization of healthcare delivery. Since timely diagnostics underpin both patient care and clinical-trial feasibility, the effectiveness of this transition is highly questionable, as it will influence the country’s ability to maintain innovation competitiveness while ensuring equitable access to care.

Strategic Outlook: Balancing Innovation and System Centralization

Hungary’s 2025 life-sciences landscape reveals a complex balance between innovation incentives and expanding state involvement in healthcare delivery. The coexistence of these contrasting trends, strong private-sector incentives on one hand and increasing state control on the other, defines Hungary’s evolving policy framework. Maintaining this balance will determine whether the country can continue to attract research and innovation while safeguarding timely patient access and efficient healthcare delivery.

Author : Dr. Andrea Jádi Németh and Dr. Adrienne Mátés