Search for:

In brief

Under the recently published Act XXIX of 2024 amending certain acts concerning the operation of the State, as of 1 January 2025, certain decisions on named patient reimbursement of medicinal products will be made by a newly created public benefit foundation in addition to the NEAK. Further, starting from 1 January 2026, the operator of the National eHealth Infrastructure (EESZT) may give access to the stored data for the purpose of AI development.


In more detail

Changes concerning named patient reimbursement:

  • From 1 January 2025, decisions on named patient reimbursement of medicinal products will be taken by a newly established public benefit foundation, the Batthyány-Strattmann László Alapítvány (“Foundation“), in addition to the National Health Insurance Fund (NEAK).
  • The Foundation may, upon the request of the insured person and on a named patient basis, reimburse the cost of medicinal products and medical aids that are professionally accepted in Hungary but which are not included in regular reimbursement.
  • The above powers of the Foundation do not extend to named patient supply of medicinal products and medical aids which are already included in regular reimbursement for any indication but which are not reimbursed under the indication requested by the applicant. In this case, the NEAK will continue to decide on the named patient reimbursement applications.
  • The Foundation, acting in its discretionary powers, will decide whether or not to reimburse on a named patient basis in a non-authoritative procedure, with a view to the protection of human life and health and social and economic responsibility.
  • The Foundation shall provide the named patient reimbursement to the extent of the assets made available to the Foundation and the budget allocations under its management. The statement of reasons of the Act explains that the legislator does not intend to set the criteria for the decisions, but rather leaves it to the Foundation to decide in the context of social and economic responsibility.
  • The statement of reasons also points out that the decision-making in the form of a foundation opens up the possibility of donating 1% of personal income tax, tax relief on payments and contributions from business organizations, thus creating a new source of revenue for named patient supply.
  • According to Judit Bidló, Deputy State Secretary for the Professional Management of Healthcare, the budget allocations made available to the Foundation will also be part of the health insurance fund’s budget allocations, but on a separate line. The creation of the Foundation is therefore not primarily about saving money, but about using the money more efficiently.

Access to health-related data stored in the EESZT for the purpose of AI development:

  • Starting from 1 January 2026, the operator of the EESZT may give access to the stored data for the purpose of training, testing and development of AI algorithms, as well as the evaluation and development of medical devices and digital health applications. The Act refers to these purposes together as AI development.
  • The EESZT operator provides access to the data if the applicant fulfills the following legal conditions:
  1. Obtains authorization to conduct scientific research issued by the relevant professional ethics committee of the Medical Research Council.
  2. Ensures that the data obtained in the course of the AI development will be used exclusively for the purpose of AI development.
  3. Guarantees that the AI development will be carried out using only anonymized data (AI development may be carried out using pseudonymized data if the applicant demonstrates that the development cannot be achieved by other means, provided that the applicant ensures that the pseudonymized data is not re-identified).
  4. Provides appropriate safeguards to prevent the data from being used for purposes other than those specified in the authorization and to protect the rights and interests of natural persons.
  5. Conduct a data protection impact assessment in accordance with the GDPR before starting the AI development.
Author

Dr. Helga Bíró has significant experience in competition, consumer protection and commercial law matters. She co-heads the Firm’s Pharmaceutical and Healthcare practice in Budapest, and is a former counsel of the Ministry of Health. Dr. Bíró mainly handles regulatory matters relating to the pharmaceutical, food, cosmetics and medical device industries — both at the national and regional levels.

Author

Mate Laczko is an Associate in Baker McKenzie, Budapest office.

Write A Comment