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Dr. Helga Bíró M.Jur.

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.

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.

As of 1 August 2023, the National Institute of Pharmacy and Nutrition will be merged into the National Public Health Center. The resulting new authority will be called the National Public Health and Pharmaceutical Center (NNGYK).
The new authority will be headed by the Chief Medical Officer, and in terms of administrative hierarchy, the NNGYK will be under the supervision of the Minister of the Interior, acting in the capacity of Minister responsible for Health.

Reimbursing medicinal products is critical to ensure that treatments are widely available to patients. This is especially true for innovative products and is expected to become even more important with the EU Pharma reform package. Pricing and reimbursement (P&R) is an area regulated at Member State level, and on average the regulatory approach in Hungary has been on the stricter side for new medicinal products causing delay to market access. However recent legal reforms in Hungary on P&R aim to improve the situation and ensure earlier access for patients to innovative medicines.

Pharma companies often employ Medical Science Liaisons (MSLs) in order to provide healthcare professionals (HCPs) with high-quality professional and scientific information that lacks promotional content thereby distinguishing it from the information provided by medical sales representatives.
In a recently published decision, the National Institute of Pharmacy and Nutrition (NIPN) stated that it does not support distinction between professional and promotional communication. This position leaves pharma companies with two options: either to register MSLs with the NIPN as a medical sales representative, or to try to severely restrict the information an MSL may share with HCPs.

In the last month, the Hungarian National Institute of Pharmacy and Nutrition (NIPN) published five new decisions on its website relative to the promotional practices of companies under investigation. The NIPN imposed fines for infringements within the range of HUF 3 million (approx. EUR 7,700) to HUF 31 million (approx. EUR 79,500).

Recent amendments of Act XCVIII of 2006 („Medicine Economy Act”) have significant impact on medicine and device promotion, interactions with healthcare professionals as well as the pricing and reimbursement of medicinal products. The amendments blur the distinction between promotional and professional/scientific activities and communication which will require assessment of the types of events organized and HCP engagements concluded by pharma companies.