Hungary's pharma authority publishes interpretations on amended promotional law 

Hungary

The Hungarian pharmaceutical authority (OGYÉI) recently provided an interpretation on omnibus Act CI of 2021 amending, among other matters, the promotional provisions of the Medicines Thrift Act (Act XCVIII of 2006), and addresses the following: the definition of a commercial practice, commercial communications regarding homeopathic medicines, scope of promotions, conflict of interests in case of HCPs, prohibited benefits, promotional events, notification obligations, the prohibition on advertising to children, the prohibition on providing prizes to patients, patient support programmes and the investigation rights of the OGYÉI.

The most important conclusions in the interpretation are listed below:

Definition of commercial practice:
According to the OGYÉI, the amended commercial practice definition clarified that commercial practice should be carried out through the transfer of professional-scientific arguments and information (promotion) to healthcare professionals (HCPs) and not solely by using marketing and other influencing tools. The OGYÉI emphasises that it is entitled to investigate not only the aim (the intention), but also the result or effect of the activity in question. Furthermore, it has also been confirmed that the position of Medical Science Liaison should not be considered a sales representative provided that he is not engaged in commercial practices in any way.

The scope of promotion: The OGYÉI states that the provision previously in force held the same meaning as the text currently in force. The text, however, was grammatically imprecise, which has now been corrected. According to the OGYÉI, an activity qualifies as promotion if it meets the following main criteria: the recipients are HCPs, and the activity is aimed at or likely to promote the sale of the product in scope.

Conflict of interest for HCPs: A new provision explicitly prohibits HCPs from engaging or participating in the commercial practice of the promoters with the exception of scientific activities and copyright-protected activities. The OGYÉI interprets scientific activities broadly and considers all activities to be included if they are carried out through the use of independent professional knowledge having a scientific value in the ordinary sense and/or they produce scientific results (e.g. professional proofreading).

Promotional events: It is expressly stated in the modified provision that any events arranged for HCPs by promoters are events that support promotion and may be arranged solely for professional, scientific and educational reasons. The OGYÉI emphasises that it considers all company-organised events to be fostering promotion, regardless of whether actual promotion is realised during these events. It was also confirmed that all promotional events should be reported to the OGYÉI.

Regarding the newly introduced limit for the costs of a promotional event, the OGYÉI states that it interprets the definition of costs narrowly but provides some examples that should be included and excluded when calculating costs. For instance, speaker fees are excluded from the calculation.

For further information on the Hungarian pharmaceutical industry, contact your regular CMS advisor or local CMS experts.

Article co-authored by Diána Galambosi.