Hungarian pharmaceutical authority ordered to conduct new proceeding against pharma company

After a judicial supervision procedure found flaws in an investigation by the Hungarian pharmaceutical authority (OGYÉI), the Budapest Capital Regional Court ordered the OGYÉI to conduct a new proceeding against the Hungarian affiliate of a Slovenian-based pharmaceutical company that was previously investigated and fined.

In its promotional investigation concluded in 2019, the OGYÉI found that the affiliate committed several infringements in promotional practices during the investigated period, such as exceeding the limit for hospitality, providing in-kind support not related to professional events and the trainings of healthcare professionals, and failure to set up a scientific organisational unit to manage commercial communication activities. After the affiliate was hit with a record fine of HUF 72,000,000 (approx. EUR 200,000), it requested a judicial supervision of the OGYÉI resolution.

During the supervision, the court established that certain findings by OGYÉI were unlawful, including the charge that the affiliate did not comply with the legal requirements when it failed to set up a scientific organisational unit within its own organization, despite the fact that such a unit operated with its parent company, which is the holder of the marketing authorisation of the medicinal products distributed in Hungary.

The court’s decision is final and binding. In the retrial, OGYÉI will have to pass a new resolution on the applicable legal consequences based on unchanged facts, but is not allowed to take into account the facts in respect of which the court decided in favour of the affiliate.

For further information on the Hungarian pharmaceutical industry, contact your regular CMS advisor or local CMS experts: Dóra Petrányi, Miriam Fuchs or Mercédesz Farkas.