NEW BILL TO AMEND THE SPECIAL AND EQUITABLE SUBSIDIARY SYSTEM OF MEDICINES AND MEDICAL DEVICES

On 10 June 2024, the Prime Minister's Office submitted Bill No. T/8560 on the Amendment of Certain Acts Affecting the Operation of the State (“Bill”), which is intended to amend the scope of the special and equitable subsidiary system of medicines and medical devices set forth in Act LXXXIII of 1997 on the Services of the Compulsory Health Insurance System (“Compulsory Health Insurance System Act”) with effect from 1 January 2025.

Under the Bill, from 1 January 2025, a new entity, the László Batthyány-Strattmann Foundation ("Foundation"), will determine the fate of applications for subsidy in connection with medicines and medical devices, which otherwise would be subject to individual fairness-based procedure but have not yet been included in the social security subsidy system for any indication. This category includes medicines that are registered but not yet subsidized and are supplied through a pharmacy, as well as orphan medicines for rare diseases.

The Foundation, within its competence in a non-authoritative procedure, acting in the spirit of the protection of human life and health and of social and economic responsibility, would determine whether or not to grant the requested subsidy.

Under the Bill, after 1 January 2025, the National Health Insurance Fund of Hungary ("NEAK") will be able to provide individual fairness-based assistance only for the purchase of allopathic medicinal products, dietary supplements for special nutritional needs and medical aids that have already been included in an indication but are not eligible for social security support in the given indication category.

The procedures administered by the Foundation would be set up in a vertical system, meaning that the Foundation would only provide benefits in cases for which it has entered the original decision, while NEAK would continue to act in ongoing cases.

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