Hungary: The Hungarian pharmaceutical authority adopts two decisions on promotional activities

The National Institute of Pharmacy and Nutrition (“OGYÉI”) has recently adopted two relevant decisions on “qualifying promotional activities”.

In the first decision, against Pfizer Gyógyszerkereskedelmi Kft. (“Pfizer”), OGYÉI held that advisory board meetings are subject to the notification obligation under the Medicinal Thrift Act (Act XCVIII of 2006). Pfizer argued that only events involving at least five to eight health care professionals (“HCPs”) fall under the notification obligation. OGYÉI found that the relevant laws do not support such interpretation and held that such event shall be deemed a promotional event and fall under the notification obligation, if it, organized by the promoter of medicinal products:

• implements a commercial practice with regard to a certain medicinal product, its composition, effects or use, and
• is aimed at HCPs.

OGYÉI further investigated Pfizer’s agreements with HCPs for scientific presentations and found that the subject of the presentations was not a certain therapeutic area but the promotion of Pfizer’s medicines. It held that such agreements infringe the relevant laws prohibiting an HCP, who is entitled to prescribe medicine, from being in a legal relationship with the promoter that would result in changing the HCP’s professional opinion. Consequently, HCPs should not have made such presentations since the presentations addressed the promotion of Pfizer’s medicines. In this regard, OGYÉI also established that since the HCPs were not allowed to make such presentations, the agreements with the HCPs violated the law by providing prohibited financial benefits to HCPs.

As a result of the above infringements, along with deficiencies in the content of Pfizer’s promotional brochures and other infringements related to promotional activities, OGYÉI imposed a HUF 23 million (approx. EUR 77,000) fine on Pfizer.

In the second decision, OGYÉI examined the promotional activities of GYSGY REHA Orvostechnikai Eszközöket Előállító és Forgalmazó Kft. (“GYSGY”). GYSGY regularly exhibited at conferences, promoted its products in brochures and flyers, and regularly visited health care institutions for the purpose of promoting its products. OGYÉI also found that GYSGY rented exhibition stands at conferences and, on one occasion, supported the participation of HCPs at a conference.

OGYÉI concluded that the above activities, despite the contradictory opinion of GYSGY, qualified as promotional activities under the relevant laws because certain GYSGY products (medical aids) were clearly presented. GYSGY’s purpose with these activities was the incitement of the sale of these products and these practices were aimed at HCPs. Therefore, GYSGY should have notified OGYÉI of such promotional activities.

OGYÉI further found that GYSGY supported the participation of five HCPs at an event without performing its notification obligations as to the support.

For the above infringements, OGYÉI imposed a HUF 4 million (approx. EUR 13,500) fine on GYSGY.

If you would like information on how these decisions affect your business, please contact us.