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In AI Act

AI Developers to Access Hungarian Health Data by 2026

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From 2026, Hungarian legislation will allow access to health-related data stored in its National eHealth Infrastructure (EESZT) for AI development on a case-by-case basis. With this change, Hungary could capitalise on its investments into launching the EESZT platform in 2017 and standardising the health data collected by healthcare providers using the platform in the past years. In this article, we highlight the key differences compared to the EU’s European Health Data Space (EHDS) proposal and…

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In Pharmaceuticals & Biotech

ECJ Ruling: Pharma Payments to State Health Insurers Are Rebates, Not Taxes

by , and 2 Mins Read

Pharmaceutical companies can breathe a sigh of relief following the European Court of Justice’s recent ruling in the Novo Nordisk A/S case (C-248/23 ). This decision marks the third time the ECJ has softened the rules around deducting pharmaceutical subsidies from the VAT base. Previously, in the German and Hungarian Boehringer cases (C-462/16 and C-717/19), the ECJ allowed subsidies to be deducted if paid to private insurers and later extended this to public insurers under…

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In EU Pharmaceutical Package

What to Expect From Hungary’s EU Presidency?

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Hungary has taken over the EU Council’s rotating presidency as of 1 July 2024. Hungary’s EU presidency comes at a time when the European Parliament (EP) has already adopted its position on the EU pharma reform, and the file is now in the Council’s hands. In this article, we review Hungary’s EU presidency program and related press statements to provide a brief overview on what the industry should expect. In more detail Prior to taking…

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In Healthcare Services

Termination of Hungary’s OGYÉI as an Independent Authority – A Look Back at OGYÉI Case law

by and 6 Mins Read

OGYÉI’s integration into the new authority As of 1 August 2023, the National Institute of Pharmacy and Nutrition (OGYÉI) shall be merged into the National Public Health Center. The new authority will be called the National Center for Public Health and Pharmacy (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…

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In EU Pharmaceutical Package

Hungarian Pricing and Reimbursement Reforms Aiming to Remove Hurdles to Late Market Access of Innovative Pharmaceuticals

by and 3 Mins Read

In brief 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…

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In Digital Health

Hungarian Regulator Decision Weighs in on MSL Position

by and 4 Mins Read

In brief 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…

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