Hungarian pharma regulator levies EUR 12,000 fine against BAUSCH HEALTH

In a recent resolution further to its regulatory role overseeing promotional activities in the pharmaceutical sector, the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI) ruled that BAUSCH HEALTH Hungary LLC breached pharmaceutical laws. So, the regulator fined the company HUF 4 million (EUR 12,000).

After an investigation of BAUSCH's activities, the OGYÉI found that the company violated the Medicinal Thrift Act and the Promotional Decree by:

• providing in-kind support to professionals that was not in direct connection with a professional event; and
• failing to submit documentation to the OGYÉI verifying the fulfilment of payment obligations in regard to the company’s medical sales representatives.

Besides establishing these breaches, the OGYÉI ordered the company to cease this unlawful conduct and to establish internal guarantees ensuring that its support of healthcare professionals participating in professional events and courses adhered to regulations. As stated, the OGYÉI also imposed a fine.

In regard to in-kind support of healthcare professionals, the OGYÉI explained that according to regulations such support can be provided for professionals participating in professional events and training courses only if it covers expenses (e.g. travel, accommodations, registration fees) directly connected to attendance.

The authority acknowledged that the law does not contain an explicit limit on the amount of in-kind support, but there must be a direct connection between the support and participation. Therefore, the term “direct connection” with the event present in the law is the key to the amount of in-kind support permissible and shall be applied as a general measure.

The OGYÉI stated that it shall be assessed on a case-by-case basis whether in-kind support is directly related to a given event based on the following criteria: the support shall apply to the start and end dates of an event and must have a realistic value considered generally acceptable in an international context.

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