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).

Hungary has amended laws on clinical trials to adjust them to CTR requirements. In addition, new provisions have been adopted to regulate non-commercial trials, patient recruitment and patient cards.

The National Institute of Pharmacy and Nutrition (“OGYÉI”) issued a Guidance on 20 September which contains useful information on the OGYÉI’s interpretation of the recent legislative amendments of Act XCVIII of 2006 concerning medicine promotion, events and contracts with HCPs.

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.

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.

In brief The National Institute of Pharmacy and Nutrition (“OGYÉI”) has issued new decisions on its webpage concerning pharmaceutical promotional activities and interactions with HCPs in which the commercial practices of two pharmaceutical companies were investigated and fines were imposed due to alleged infringements. The key findings of the decisions…

In brief On October 14, 2020 the Hungarian Parliament adopted Act C of 2020 on Healthcare Service Relationship (“Act”) which fundamentally transforms the employment relationships at State-owned healthcare service providers. The Act envisages substantial increase in the statutory wages of physicians depending on seniority over the coming three years. Contents…