On 12 September 2019, the Hungarian National Institute of Health and Pharmaceuticals (OGYÉI) published its draft guidance on the rules regulating the promotional activities of pharmaceutical companies.
The authority drafted the guidance to provide a summary of the topics that were discussed at the public consultation held earlier this year and to offer guidelines and assistance to companies carrying out promotional activities for medicinal products and medical aids.
The guidance's introduction gives readers an overview of the most important promotional terms (e.g. inexpensive gift, reasonable support, commercial practice, sales representative, etc.). This is followed by a summary of the principle rules for commercial practices relating to medicinal products and medical aids.
In formulating its summary and positions, OGYÉI’s aim was to group the guidance's dominant issues into two major categories: promotional visits and events.
OGYÉI provides a detailed guidance for visits, presenting the content elements of promotion and their delimitation from other communication activities. Since promotion is subject to registration and administrative service fees, the guidance then examines, amongst other, the relevant aspects of these obligations that should be taken into consideration. Further, this section also covers online promotion, patient information materials, gifts, incentives and business hospitality in detail.
The section on events includes company-organised events and events organised by third parties, providing information on the kind of support that is acceptable to provide participating healthcare professionals (HCPs), how the renumerations of the HCPs should be managed, and the other rules that must be taken into account vis-à-vis the notification obligation.
The OGYÉI's guidance also describes regulations for donations and samples, as they may also be related to the companies’ promotional activity. Lastly, the guidance examines patient organisations as potential partners in promotion and the obligation of promoters to maintain a medical unit within their organisation.
The draft guidance will be finalised after a 60-day public consultation period within which companies may comment on the draft on the authority’s website.