Another promotional investigation of the Hungarian pharmaceutical authority closed

In series of recent decisions, the Hungarian pharmaceutical authority (OGYÉI) declared several infringements and imposed a total fine of HUF 34 million (EUR 95,730) on one of Hungary's largest pharmaceutical companies.

The infringements included the following:

• failing to comply with the requirements applicable to professional brochures;
• providing prohibited items of gifts, hospitality and financial benefits to healthcare professionals (HCPs);
• failing to notify the OGYÉI on company-organised events;
• exceeding the maximum value of hospitality provided to HCPs in company-organised events;
• providing free samples and product donations directly HCPs; and
• failing to submit documentation confirming the fulfilment of payment obligations after the company’s medical sales representatives.

Brochures: The OGYÉI established medium-level infringements as the source of professional quotations, tables and other representative materials, the publication thereof as well as the legally required symbols and warning texts were missing from the company’s materials.

Prohibited benefit: Although the value of gifts granted to HCPs was in line with the legal limit, the OGYÉI found that the gifts were not in connection with the HCPs’ healthcare activities. The OGYÉI also established that it qualifies as prohibited benefit if, other than in the framework of a professional event, the HCP is granted hospitality by the employee of the company due to such benefit not being related to the professional activities of the HCP. The OGYÉI also noted that the infringement exists regardless of what was discussed during the meeting and the nature of the parties’ relationship.

HCP contracts: under the investigated contractual engagements, HCPs were actively involved in the development of the company's marketing materials and commercial communications. OGYÉI found it problematic that the company could not substantiate the actual occurrence of such expert activity since it was carried out orally in personal meetings. Due to the lack of written evidence, the OGYÉI could not establish whether this practice qualified as unlawful commercial activity, so it concluded that the company granted unlawful financial benefits to HCPs in the context of their contractual relationship. The OGYÉI also identified contracts under which HCPs prepared case studies in the company’s publication. The OGYÉI concluded that such engagements were not aimed to share the independent and impartial experience of the HCP, but to facilitate the promotion of the company’s product. The OGYÉI could not identify references to either the merits or the quality of the professional work in these contracts.

Event notification: The OGYÉI identified company-organised events, which were not notified to the OGYÉI and about which the company later acknowledged the failure to notify the authority. The OGYÉI also established that the company failed to prepare attendance sheets during the company-organised events.

Samples and donations: The OGYÉI disclosed that the company repeatedly gave free medicinal samples, not through the chief pharmacists, but through persons authorised to order medicinal products. The OGYÉI also found that the company handed over product donations directly to persons authorised to prescribe medicinal products for hospital departments.

Confirmation on the payment obligation: The company failed to submit documentation to the OGYÉI that confirmed fulfilment of payment obligations after the company’s medical sales representatives.

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