Hungary’s authority maintains strict approach to pharmaceutical promotion
The National Centre for Public Health and Pharmacy (NNGYK) imposed fines on three pharmaceutical companies for breaching Hungary’s rules on the promotion of medicinal products under Act XCVIII of 2006 (the Medicines Thrift Act). The fines confirm the NNGYK’s strict interpretation of the definition of promotion and business hospitality, and other crucial questions for pharmaceutical companies such as the permissible content of brochures.
What did the NNGYK examine?
- Promotion through unregistered medical sales reps
All three companies carried out promotional activities through unregistered medical sales representatives: persons not listed in the NNGYK’s official register. In two decisions, healthcare professionals (HCPs) engaged to present at company-sponsored events were reclassified as de facto medial sales representatives, violating both registration and conflict of interest rules under Sections 13(1) and 13(3) of the Medicines Thrift Act.
- Misleading promotional brochures
One decision targeted misleading promotional brochures. Under the Medicines Thrift Act and EüM Decree 3/2009. (II. 25.) of the Minister for Health, information in brochures must be accurate, objective, verifiable and consistent with the Summary of Product Characteristics (SmPC). Across all reviewed materials, the NNGYK found omissions of SmPC warnings, contraindications, limitations and side effects. The authority identified several core violations:
- Brochures made absolute safety claims (e.g. “no contraindications” and “no drug interactions or cross-allergy”) that were directly contradicted or unsupported by the SmPC.
- Product mechanisms of action were presented as established when the SmPC explicitly stated they were not fully elucidated, and recommendations extended to age groups for which safety had not been confirmed.
- Preclinical data were misrepresented as clinical evidence with an inaccurate citation of the underlying literature with one brochure creating a misleading impression of improved renal safety when the study it cited linked the active substance to higher renal failure-related mortality.
- Non‑compliance with the notification obligation for professional and scientific events
Two companies failed to notify professional events within the statutory 15-day deadline. The NNGYK confirmed that the notification obligation regulated by the Medicines Thrift Act extends to online events.
- Business hospitality
One company was fined for providing business hospitality (only coffee and water) at its promotional stands during congresses. The NNGYK reasoned that Section 14(1) of the Medicines Thrift Act imposes a general prohibition on giving any gift, financial advantage or benefit in kind to health-care professionals to ensure that prescribing decisions remain free from external influence. The only statutory exception requires that the benefit must be below the statutory de minimis threshold and connected to the HCP’s clinical activity. Since business hospitality bears no connection to health-care activity, it falls outside the exception and constitutes a prohibited benefit in kind regardless of its value.
The NNGYK imposed fines totalling HUF 53 million on the three companies.
Key takeaways
These decisions signal intensified NNGYK scrutiny and carry the following lessons:
- Companies must ensure that every natural person performing promotional activities is always registered and holds a valid identification card.
- Sponsored presentations require caution – if the content promotes a specific product, the speaker may be classified as a medical sales representative, triggering conflict of interest rules.
- Promotional materials must present a balanced picture consistent with the SmPC, including limitations and side effects. Absolute claims, ambiguous wording and misrepresented data invite enforcement action.
- Event notification obligations are interpreted broadly, covering online events and third-party events financially supported by the company.
- Finally, no form of hospitality, including coffee, should be offered at congress stands.
For assistance on navigating these requirements, contact your CMS client partner, CMS’s Life Sciences Team or the CMS experts who contributed to this article.
This article was co-authored by Lili Benyovszki and Nyeste Lőrincz.
