Hungary: New trend in authority investigation of medicinal product promotion

In brief

In its latest decision on medicinal product promotion, the National Institute of Pharmacy and Nutrition (OGYÉI) issued a fine of HUF 33 million (approx. EUR 75,000) for infringements of the rules on medicine promotion.
 


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In depth

OGYÉI investigated the contractual relationships between the company and healthcare professionals (HCPs). The OGYÉI identified a number of presentations that were identical in many respects, but the compliance investigation was rendered impossible by the fact that the company did not keep a record regarding which supporting material was provided to which speaker, and for which presentation. This "bad practice" of the company infringed Act XCVIII of 2006, which states that the person subject to investigation is obliged to provide to the OGYÉI with evidence which demonstrates that its actual conduct is in line with the laws and do not constitute an unlawful commercial practice. Essentially, the burden of proof is shifted from the OGYÉI to the company under investigation.

Further, the OGYÉI noted that supporting materials provided to the speakers by the pharmaceutical company - at the speaker's express written request - can be used in the presentation, but their content may not be promotional and may not give the majority of the presentation because it may improperly influence the speaker's professional independence.

OGYÉI stated that a company promoting medicinal products may not separate its activities from its promotional intents, therefore, the provision of business meals to HCPs beyond events was considered to be an unlawful gift because a meal is not associated with the HCP's professional practice.

In relation to the events organized by the company, OGYÉI found that the company failed to register certain medical sales representatives with OGYÉI and they also infringed the conflict of interest rules by promoting through an HCP.

OGYÉI further investigated the compliance of the hospitality provided, as well as fulfillment of the event notification obligation in relation to the events organized by the company. OGYÉI found that the company ignored the maximum amount of hospitality that could be legally provided per HCP actually participating and the company failed to notify advisory board meetings.

OGYÉI also found that the company provided gifts to HCPs that were not related to the healthcare activities, thus constituted improper benefits.

In connection with the company's charitable donation practices, OGYÉI found that the donated medicinal products were not handed over through the chief pharmacist of the institute in case of outpatient departments and branches of inpatient healthcare institutions, and therefore the hand-overs were unlawful.

This case continues a recent trend in OGYÉI's practice. According to this new trend, the OGYÉI is more active, imposes higher fines, and its investigations extend to longer time periods and to all practices of pharma companies instead of focusing on specific infringements as before.


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