Hungary's pharma authority issues fines for promotional infringements

The Hungarian pharmaceutical authority (OGYÉI) published five new decisions concerning promotional activities of pharmaceutical, dietary supplement and medical aid companies in Hungary.

The decisions concern the Hungarian subsidiaries of a Slovenian pharmaceutical company, a Swiss pharmaceutical company, a multinational, Spanish-based food product corporation, and two Hungarian medical aid producer/distribution companies.

Two of the decisions resulted from repeated proceedings by the OGYÉI as ordered by the Hungarian courts in judicial reviews initiated against the OGYÉI by the companies concerned.

The infringements established by the OGYÉI in the decisions concern, among others, the following topics:

• failure to submit documentation to the OGYÉI attesting to the payment of fees payable after sales representatives.
• conducting promotional activities either without registration as a promoter company or via persons not registered as sales representatives.
• exceeding the limit specified in point 8 of Article 3 of Act XCVIII of 2006 during company-organised events.
• granting in-kind support to healthcare professionals (HCPs), which were not directly linked to professional events and trainings.
• conclusion of contracts with HCPs for the provision of “role-play” services where the HCPs participated in situational practice while acting as their regular selves.
• failure to report events and sponsorships to the OGYÉI in time.
• failure to submit protocols to the OGYÉI related to the donation of medicinal products reimbursed by the social security system.

The fines imposed by the OGYÉI range from HUF 3 million (EUR 8,600) to HUF 36 million (EUR 103,000).

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