Hungarian court repeatedly orders pharmaceutical authority to conduct new proceeding

The Budapest Capital Regional Court ordered the Hungarian pharmaceutical authority (OGYÉI) to conduct a new proceeding for the second time concerning the promotional investigation of a Hungarian pharmaceutical company after ruling that the OGYÉI's subsequent resolution was unlawful.

This was the second time the OGYÉI had issued a resolution in this case, and the second time its resolution had been overturned by the Hungarian courts.

The Hungarian Supreme Court had found fault in the OGYÉI's first resolution, which the pharmaceutical authority issued after conducting a promotional investigation and ruling that the company in question had, among others, provided unjustified gifts to healthcare professionals and failed to report promotional activities and the sales representatives engaged therein. After receiving a fine of approx. EUR 167,400 from the OGYÉI, the company requested judicial supervision of the resolution.

Dismissed by the first instance court, the company appealed, and the case went to the Supreme Court, which ruled that the OGYÉI’s reasoning was too general and failed to specify the exact facts substantiating the amount of the fine. As a result, the Supreme Court overruled the OGYÉI’s resolution and ordered the authority to conduct a new proceeding regarding the fine.

In a second proceeding in 2019, the OGYÉI issued a new resolution, which the company again took to the courts.

In its recent decision, the Budapest Capital Regional Court annulled the OGYÉI’s second resolution, stating that it remained unlawful in respect to the fine and ordered the OGYÉI to conduct a new proceeding. The court’s decision is final and binding.

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