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.
Technical guidance published on the websites of the Hungarian Competition Authority (HCA) and the Public Procurement Authority in…
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.
On 22 March 2023, the European Commission tabled a proposal for a Directive on substantiation and communication of explicit environmental claims.
The proposal aims to harmonize the evaluation and monitoring of voluntary environmental claims – often referred to as “green claims” – towards EU consumers and control the proliferation of public and private environmental labels. Complementing the March 2022 proposal for a Directive on empowering consumers for the green transition as a lex specialis by providing more specific requirements on the substantiation, communication and verification of green claims, it contributes to the fight against “greenwashing”.
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).
The European Commission launched a public consultation on 1 March 2022 inviting all interested parties to comment on two drafts revised Horizontal Block Exemption Regulations on Research & Development and Specialisation agreements and the draft revised Horizontal Guidelines.
Baker McKenzie’s Sanctions Blog published the alert titled “Russia imposes a ban on foreign aircraft flights from 36 states” on 1 March 2022. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
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.