Hungary: Individual equity drug applications transferred back to NEAK

The Government has submitted a bill to amend the Mandatory Health Insurance Act (Act LXXXIII of 1997, “the Ebtv.”), transferring responsibility for individual equity pharmaceutical applications from the Batthyány-Strattmann László Foundation for Healing (“BSLA”) to the National Health Insurance Fund of Hungary (“NEAK”).

The bill was adopted by the Hungarian Parliament on 14 July 2026.

Background

BSLA was established in 2024 to assume responsibility from NEAK for the assessment of individual equity applications relating to medicinal products and medical aids not covered by social insurance. It became operational on 14 February 2025. However, it encountered significant operational difficulties: thousands of applications accumulated without decisions, several board members resigned and the organisation lacked the pricing and cost-control tools available to NEAK.

Five reasons cited by the Government for the transfer

During the parliamentary debate, the Government identified the following shortcomings of the BSLA model:

• Funding model failure – The BSLA received HUF 47.2 billion (EUR 133 million) in state funding for 2026 but attracted only HUF 2.5 million in private and corporate contributions in 2025, failing to channel public donations as originally envisaged.
• Unsustainable operational model – Internal procedures were not fully operational at launch, resulting in delays in decision-making.
• Lack of price-control tools – The BSLA often paid higher prices for the same products than NEAK and some manufacturers avoided applying for social insurance reimbursement because the BSLA offered more favourable pricing.
• Patient-safety risks – Changes in board membership could directly affect access to healthcare services.
• No professional feedback loop – In some cases, prescribing physicians selected equity-funded therapies instead of already available reimbursed treatments without demonstrable health benefits and the BSLA structure provided no mechanism to address this issue.

Key provisions of the bill

The Government argues that NEAK (to be renamed the National Health Insurance Fund) is the appropriate body because it has: (i) the legal mandate; (ii) bargaining power vis-à-vis manufacturers; (iii) a unified and transparent decision-making framework; (iv) institutional continuity independent of changes in board membership and (v) an existing infrastructure for providing professional feedback to healthcare providers.

Pending applications must be resolved by NEAK by 31 August 2026. Unspent BSLA funds will revert to the NEAK budget.

The Health Minister announced that NEAK will publish quarterly reports on application outcomes, health gains and costs.

An amendment would guarantee that future budgetary allocations for equity support cannot fall below the 2026 level of HUF 47.2 billion.

Suggested actions

The return to the previous model is expected to provide greater predictability and certainty for clients. At the same time, given the significant backlog of pending applications, companies may need to allocate internal resources to support the application process and engage proactively with NEAK during the transition period.