Life Sciences Bulletin: Hungarian Medicines Authority resumes investigations into pharma promotions

The Hungarian National Centre for Public Health and Pharmacy (NNGYK or the Authority) has issued its first decision in more than a year concerning the promotional activities of pharmaceutical companies. The resolution identifies deficiencies on the part of a Hungarian subsidiary of an international pharmaceutical company (the Company), resulting in a fine of EUR 37,000.

Unauthorised promotional activities by non-registered individuals

The Authority found that the Company engaged healthcare professionals (HCPs) to deliver lectures that were clearly promotional in nature, both in content and messaging. Four presentations, which covered both prescription-only and over-the-counter products, were deemed to constitute promotion.

The Company failed to notify the Authority of the presenters as medical sales representatives and, in one case, the presenter maintained an active contract with a healthcare organisation at the time of the presentation, resulting in a breach of the conflicts of interest rule.

Inadequate event notification practices

The Company classified several company-sponsored events as outside the scope of the notification obligation on the basis that they were not organised for HCPs. However, the Authority established that these events were attended by numerous HCPs, as well as representatives of integrative and alternative medicine. Some events were also specifically targeted at pharmacies.

Given the educational and scientific nature of the programmes, the Authority held that the Company was required to provide notification of these events.

Unauthorised attendees at professional events

The Authority also established that individuals not authorised to attend professional events were also present at these company-sponsored events.

Please note that as of 1 January 2025, the law has been amended and persons other than HCPs may be invited to events only in justified cases.

Regulatory implications

The NNGYK found breaches of key provisions of the Medicines Thrift Act, including the following:

• Promotion through unregistered medical sales representatives (Section 13(1)).
• Infringement of conflicts of interest (Section 13(3)).
• Failing to notify professional events and the invitation of non-HCPs to professional events (Sections 14(2), (10), and (13)).

This decision underlines the importance of strict adherence to promotional regulations, particularly regarding the:

• notification of speakers, compliance with the conflict-of-interest rule and provision of detailed requirements/expectations for presentations;
• the notification of professional events if HCPs are present; and
• restricting attendance to eligible participants.

Given that the NNGYK is expected to continue its rigorous oversight activities, companies operating in Hungary should expect increased scrutiny and consider reviewing their practices accordingly.