On 11 March 2024, Minister of Interior Decree No. 16/2024 (III. 11) on the issuance of the list of strategic medicinal products (“Decree”) was published. The Decree introduces a new stockpiling obligation on medicinal product wholesale license holders.
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.