Part I — Situation overview

On 25 October 2026 the health ministry put out for public consultation a 36-page draft law that would tighten individual equity reimbursement of particularly expensive medicines. The draft was first reported by Népszabadság and quoted by HVG, Index and Portfolio. In this procedure the National Health Insurance Fund Manager (NEAK), on separate application, also finances products that are not on the list of regularly reimbursed medicines, typically for the treatment of rare diseases, cancers and other serious conditions. The draft would introduce two upper limits: for one patient’s treatment, less than ten times the per-capita gross domestic product (GDP) could be paid per year, and less than fifty times it over the whole course of treatment. Based on 2025 data from the Hungarian Central Statistical Office (KSH), this is nearly HUF 92 million a year and some HUF 459 million in total (Index, Portfolio). The limit would apply to the reimbursement actually paid by NEAK, reduced by discounts, not to the list price. A therapy reaching the limit could not receive individual reimbursement even if it is professionally justified and the patient has no other option.

The ministry announced further steps the same weekend. On Monday nationally uniform measurement of patient satisfaction started, and a healthcare whistleblower-protection system independent of workplace management is being prepared (Portfolio). Some GPs may be exempted from compulsory on-call duty (Telex, 24.hu). And the National Center for Public Health and Pharmacy (NNGYK) fined Szent Imre Hospital HUF 500,000 over a fatal heart attack that was recognised too late (Telex, HVG). In June MIAK called for public statistics on individual applications (The repeal of the heartbeat decree and the medicines reorganisation), and in October for public reasoning of reimbursement decisions (An independent medicines authority from November).

The reason for the tightening is real: according to the press, the procedure created for exceptional cases has become a system-level financing channel. In MIAK’s reading, the GDP-linked cap is a good budgetary tool but a bad clinical decision rule. If the limit is a ground for exclusion and there is no exception route alongside it, the risk is borne by the most seriously ill patients.

Part II — Grounding in the literature

Three sources provide a framework for assessing the draft. According to the joint State of Health in the EU 2025 synthesis report of the European Commission, the OECD and the European Observatory on Health Systems and Policies, member states, alongside curbing medicine spending, are increasingly opening a separate, predictable route for serious conditions with no alternative. In Greece, for example, an independent gatekeeper committee weighs unmet need and expected benefit. Yulia Litvinova, Pierre Lafolie and Dimitra Panteli, analysts at the Observatory, write in their Policy Brief 69 study on personalised medicine that the budgetary risk of very expensive therapies can be managed through risk-sharing agreements. In these, part of the payment depends on the actual outcome of the treatment. Elias Mossialos, professor of health policy at the London School of Economics, and his co-authors remind us in their volume Health Systems Governance in Europe that the EU transparency directive requires verifiable criteria in medicine reimbursement decisions. The detailed discussion of the literature — by author, with quotations — can be found in section 6.4 Literature in detail.

Part III — MIAK’s concrete proposal

MIAK proposes three measurable measures. The first secures legal certainty for patients already being treated, the second opens a controlled route for professionally justified cases above the cap, and the third decouples access from the financial situation of hospitals.

3.1 A statutory transitional guarantee for treatments already started (before the draft is submitted, at the close of the public consultation)

According to the press, the draft does not contain a transitional rule covering everyone affected. Nor is it clear whether the new conditions also apply to extensions of existing authorisations (Index, Portfolio). At a professional conference in October, NEAK Director-General Kaló Zoltán said that they do not intend to interrupt ongoing treatments. That intention is worth something only if it also appears in legislation. MIAK proposes that the Ministry of Health write into the bill going to the Government that a treatment approved before entry into force may continue under the original professional conditions, and that the cap shall not apply to extension applications. This guarantee is especially important for long treatments. According to the source, a treatment costing HUF 50 million a year would exceed the limit for the whole treatment within ten years. The proposal should be supplemented by an impact assessment of the version going to Parliament. Using anonymised, aggregated data, it should show how many ongoing treatments and how many patients the cap would affect without the transitional rule. This applies programme point I3 on legislative impact assessment. An individual manufacturer’s discount may remain a trade secret; the number of patients affected may not.

3.2 An independent exception procedure for cases above the cap, with outcome-linked payment (from the law’s entry into force)

Under the draft, a therapy reaching the limit cannot be reimbursed even if it is professionally justified and has no alternative. According to an expert quoted in the press, this way only the price of the medicine will be decisive in the decision (Index). MIAK proposes that the cap be not a ground for exclusion but a review threshold. Applications above the limit should be decided by an independent clinical-ethical panel whose members are not employees of NEAK or of the manufacturers. The panel should examine three conditions: whether there is another effective treatment, how large the expected health gain is, and whether the manufacturer accepts outcome-linked payment. The latter is the risk-sharing agreement (managed entry agreement), under which the full price is due only if the treatment brings a pre-defined improvement in the patient’s condition (see 6.4.2). The panel’s decisions must be published with reasoning, in anonymised form. Under patient decision-support programme point E5, the expected health gain must be communicated in absolute numbers: out of a hundred treated patients, for how many and for how long the condition improves. The Greek gatekeeper committee (see 6.4.1) shows that such a filter can serve sustainability and fairness at the same time.

3.3 A central reserve and manufacturer paybacks instead of the 10% hospital commitment (when the draft is finalised)

Under the draft, if the manufacturer does not give a discount of at least 50%, the head of the treating hospital must declare in advance that, if necessary, the hospital will cover 10% of the approved reimbursement. Without the declaration the application would be rejected (Index, Portfolio). For a treatment costing HUF 40 million, this is a conditional commitment of HUF 4 million. Hospitals’ financial situations differ, so the care of patients with the same disease may depend on which institution treats them. MIAK proposes that the conditional contribution should not be borne by hospitals. Instead, two elements should be written into the law. One is a central reserve set aside within NEAK’s individual equity reimbursement budget. The other is a manufacturer payback rule for cases where in-year spending exceeds the planned amount. If the legislator insists on the hospital element, at least the lack of a declaration should not be a ground for rejection, and NEAK should publish quarterly, by hospital, the number of applications and rejections. This applies transparency programme point E3 and radical transparency programme point G19. Consultations with manufacturers should be entered in the A4 lobbying register.

A common principle links the three proposals: the cost limit should be predictable, but its burden should not fall on the patient or their hospital. According to the literature, the budgetary risk of expensive therapies can be managed through contracts and verifiable criteria; automatic exclusion is not needed.

Part IV — Expected effects and risks

Dimension Expected effect Risk
Budget The cap and the central reserve make individual equity reimbursement spending predictable; manufacturer paybacks shift part of any overrun onto manufacturers If too broad, the exception procedure reopens the former system-level channel; the outcome-linked agreement creates an administrative burden
Patients Continuation of treatments already started is secure; for cases above the cap with no alternative, a professional route remains During the transition, manufacturers may delay discounts if the exception route looks certain
Hospitals They do not have to take on advance financial commitments for individual expensive treatments; access does not depend on the institution’s financial situation Dropping the hospital contribution may weaken the incentive for hospitals to apply sparingly; the rules for managing the central reserve compensate for this
Public administration Reasoned, public decisions by NEAK and the independent panel make the procedure verifiable The panel’s capacity may become a bottleneck; without deadlines, applications may pile up

The most important trade-off lies in proposal 3.2. The exception procedure reduces the force of the cap, and manufacturers may build on this: if they know there is a loophole, they are less motivated to offer discounts. The exception can therefore work only with outcome-linked payment and public reasoning. This way the manufacturer has to back up the high price with proven benefit. If these two conditions are missing, the proposal brings back the very practice the draft seeks to end. If, however, there is no exception route, the cap reduces a professional question to a question of price, and the consequences are borne by the patients in the most serious condition.

Part V — Measurability and summary

5.1 What is worth tracking? (proposed KPIs)

MIAK proposes tracking the following key performance indicators (KPIs):

  • Transitional guarantee: whether the bill going to Parliament contains an explicit rule on the continuation of treatments already started and on extensions.
  • Impact assessment: whether it is public at submission how many ongoing treatments and patients the cap affects (aggregated, anonymised data).
  • Rejections: 6 and 12 months after entry into force, how many applications were rejected solely because of the cap, and how many received reimbursement through the exception procedure.
  • Equal access: the spread of approval rates by hospital; the aim is that the treating institution’s financial situation should not explain the differences.

5.2 Summary

MIAK supports placing individual reimbursement of expensive medicines within a predictable framework and giving manufacturers an incentive to offer discounts. It asks the Ministry of Health to lay down, in the bill going to the Government, a transitional guarantee for treatments already started. It should open an independent, outcome-linked exception route for cases above the cap with no alternative, and handle overruns with a central reserve and manufacturer paybacks instead of the 10% hospital commitment. The proposal directly concerns two of MIAK’s foundational values. One is universal representation, because the small group of people with rare diseases is the least able to assert its interests in a budget debate. The other is transparency: the cap is fair only if it is public how many patients it affects and why the panel takes each decision.

Part VI — Reasoning and further sources

6.1 Press framing by spectrum

Liberal-left band. HVG framed the draft from the angle of involving hospitals: according to its headline, hospitals “may also be brought into” the financing of expensive medicines. It highlighted that the decision may depend both on the price of the medicine and on the hospital’s financial situation, and recalled an earlier statement by the NEAK Director-General on pricing. Instead of the medicines draft, Telex this weekend carried the GP on-call exemption and Direkt36’s article on Szent Imre. Its focus was thus on patient safety and doctors’ workload. HVG also reported on the Szent Imre case.

Public-affairs band. Index was the most detailed: it presented the Népszabadság report together with expert comments, including that with the cap “only the price of the medicine will be decisive”. It also highlighted the unresolved fate of treatments already started. 24.hu discussed the eligible group for the GP on-call exemption and the case of the doctor who died during a lawsuit. ATV published a video report on the months-long shortage of medicines used to treat pancreatic insufficiency.

Economic band. Portfolio covered the package in three articles. It framed the medicines draft from the angle of patients’ uncertainty (“the treatment of many patients may become uncertain”), and called the hospital condition a serious concern from the perspective of the right to equal-opportunity care. On patient-satisfaction measurement, it highlighted that according to the ministry the number of failings uncovered will initially rise, and that this is not a sign of deterioration.

Government-critical conservative band. In the material processed from Magyar Nemzet, no separate article on the medicines draft appeared; material from Mandiner and Népszava was not in the processed set.

6.2 Facts and data

Item Value Source
Annual cap for one patient’s treatment ten times per-capita GDP, nearly HUF 92 million based on 2025 KSH data Index; Portfolio
Cap for the whole treatment fifty times per-capita GDP, some HUF 459 million Index; Portfolio
Basis of the cap the reimbursement actually paid by NEAK (not the list price) Index; Portfolio
Manufacturer discount expected to avoid the hospital condition at least 50%, calculated from the three lowest producer prices in specified countries of the EU and the European Economic Area, plus initiating regular reimbursement listing Index; Portfolio
Conditional hospital commitment 10% of the approved reimbursement, if NEAK’s in-year spending exceeds the planned amount Index; Portfolio
Example for a HUF 40 million treatment, a conditional commitment of HUF 4 million Index
Example for the whole-treatment cap a treatment costing HUF 50 million a year exceeds the limit within ten years Index
Length of the draft 36 pages, under public consultation Index; Portfolio
National measurement of patient satisfaction from 26 October 2026 Portfolio
Planned scope of the GP on-call exemption doctors who are pregnant or raising a child under 3, raising a chronically ill child, or with a health impairment of at least 50% 24.hu; Telex
NNGYK fine on Szent Imre Hospital HUF 500,000 (the official procedure began more than a year after the complaint) Telex; HVG
Average time to reimbursement in the EU (from EU marketing authorisation, early-2025 data) 578 days State of Health in the EU 2025

6.3 Policy dimensions

  • Healthcare (programme points) — patient decision support with health gains communicated in absolute numbers (E5), publicity of access data by hospital (E3);
  • Transparency and anti-corruption policy (programme points) — a lobbying register for consultations with manufacturers (A4);
  • Economy (programme points) — public reasoning for budgetary decisions (G19);
  • Justice (programme points) — a public impact assessment of the bill (I3);
  • Public administration and e-government (background material) — procedural deadlines for NEAK and the independent panel, and the turnaround of official procedures, as also shown by the more than one-year wait in the Szent Imre case.

6.4 Literature in detail

6.4.1 European Commission, OECD and European Observatory: State of Health in the EU 2025

The synthesis report distinguishes four directions of pharmaceutical reform, including accelerated, predictable access. According to the authors, member states have to strike a balance between two goals. They should not pay more for a novelty that brings no added benefit, while patients should still receive the care they need:

“tailored approaches become necessary when existing alternatives are suboptimal or non-existent”

Among the report’s examples is that Hungary allows access during health technology assessment, and, together with Belgium, grants conditional reimbursement during the assessment or price negotiations. In Greece a new gatekeeper committee examines unmet clinical need and expected benefit. Malta, Latvia and Slovakia assess extraordinary applications for treatments not on the positive list in a separate procedure. Applied to the Hungarian draft, a professionally based exception route of the kind established in European practice can be added alongside the cap (3.2); there is no need to work with automatic exclusion.

📖 Source: European Commission, OECD, European Observatory on Health Systems and Policies: State of Health in the EU — Synthesis Report 2025: Health Policy Reform Trends in the EU, chapter on affordable access to medicines

6.4.2 Litvinova, Lafolie and Panteli: Personalized medicine for healthier populations

The study examines the financing of cell and gene therapies and targeted treatments, that is, precisely the group that makes up a large share of individual equity reimbursement applications. According to the authors, the price of advanced therapies often exceeds the capacity of health systems. Payers therefore typically conclude a risk-sharing agreement with the manufacturer: these come in a financial type (discount, price-volume agreement) and an outcome-based type, in which payment depends on the individual patient’s response to treatment. The condition for successful use is that the agreement’s administrative burden is low and its design genuinely serves the intended aim. The authors also recall that for severe, life-threatening diseases many systems apply a higher value threshold. Applied to the Hungarian draft, for cases above the cap the literature recommends not prohibition but outcome-linked payment (3.2), and the manufacturer payback (3.3) is also one financial form of this.

📖 Source: Yulia Litvinova, Pierre Lafolie, Dimitra Panteli: Personalized medicine for healthier populations — Key considerations for policy-makers (Policy Brief 69, European Observatory on Health Systems and Policies, 2025), chapter on financing and reimbursement (paraphrase)

6.4.3 Mossialos and co-authors: Health Systems Governance in Europe

In its chapter on the history of regulating the EU pharmaceutical market, the volume recalls that the 1989 transparency directive obliged member states to adopt verifiable criteria in setting medicine prices and in admitting medicines to social-insurance reimbursement. According to the authors, price regulation has remained a member-state competence, but more and more national systems want not only a lower price but also value for their money. This value-based pricing can make better use of the health budget and free up resources for better patient access. The Hungarian draft would introduce a simple, GDP-linked monetary limit that measures not the value of a treatment but only its cost. Under the transparency principle, it is therefore especially important that the application of the limit and the exceptions appear in reasoned, verifiable decisions (3.2, 3.3).

📖 Source: Elias Mossialos, Govin Permanand, Rita Baeten, Tamara K. Hervey (eds.): Health Systems Governance in Europe — The Role of European Union Law and Policy (Cambridge University Press, 2010), chapters on the EU pharmaceutical market (paraphrase)

6.5 International comparison

Exceptional access with a professional filter. According to State of Health in the EU 2025 (see 6.4.1), Belgium has extended its pre-authorisation access programmes for serious diseases. In Greece, the state wholesaler’s early-access programme is run by a new gatekeeper committee that weighs unmet need and expected benefit. This model can be adopted directly for proposal 3.2.

A separate budget for expensive, valuable treatments. According to the report, the Italian fund created for innovative medicines set aside EUR 1.3 billion in 2025 for medicines granted innovative status. This is a larger-scale equivalent of the central reserve in proposal 3.3: the budgetary risk is borne not by individual hospitals but by a ring-fenced budget.

Deadlines and confidential discounts. Lithuania introduced statutory deadlines for pricing and reimbursement decisions, but implementation is running into difficulties. Sweden keeps spending under control through wider use of confidential discounts and rigorous health technology assessment, while the median time to availability of new medicines is 361 days. The lesson for the Hungarian draft: confidential discounts are compatible with fast access if the decision rules and deadlines are public.

Healthcare

  • E3 — Transparency of waiting lists
  • E5 — Patient decision support

Transparency and anti-corruption policy

  • A4 — Lobbying register

Economy

  • G19 — Radical transparency in economic decision-making

Justice

  • I3 — Legislative impact assessment

Proposed new programme point: Fair access to expensive therapies — a transitional guarantee for treatments already started, an independent, outcome-linked exception procedure above the cost cap, a central reserve instead of the hospital contribution — for the Healthcare area.

6.7 List of sources

Press sources (MIAK press monitor, 26 October 2026 — topic 1):

Knowledge-base references (literature):

  • 📖 European Commission, OECD, European Observatory on Health Systems and Policies: State of Health in the EU — Synthesis Report 2025
  • 📖 Yulia Litvinova, Pierre Lafolie, Dimitra Panteli: Personalized medicine for healthier populations (Policy Brief 69, 2025)
  • 📖 Elias Mossialos, Govin Permanand, Rita Baeten, Tamara K. Hervey (eds.): Health Systems Governance in Europe (2010)

MIAK internal materials:

  • MIAK policy area: Healthcare (programme points; programme point ID: E3, E5)
  • MIAK policy area: Transparency and anti-corruption policy (programme points; programme point ID: A4)
  • MIAK policy area: Economy (programme points; programme point ID: G19)
  • MIAK policy area: Justice (programme points; programme point ID: I3)
  • MIAK policy area: Public administration and e-government (background material)
  • MIAK press monitor, 26 October 2026 — topic 1, score: 84/100

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