In a decision dated October 27, 2017, the Hungarian Competition Office (“HCO”) imposed a fine of HUF 105,000,000 (EUR 337,620) on SANDOZ Hungaria Kft. (“SANDOZ”) for the unlawful advertising of its well-known OTC brand, “ACC”.
The HCO examined whether the advertising of the product complied with the summary of its product characteristics (“SmPC”). Specifically, the HCO analysed the following statements:
“quick solution for rheumatic cough”;
“quickly clears respiratory tracts”; and
“ACC, it acts quickly”.
During the proceedings, the HCO requested the professional opinion of the National Institute of Pharmacy and Nutrition (“OGYEI”) on whether the SmPC supports the above statements – namely, the quick mechanism and effect of the product. OGYEI concluded that the SmPC does not support the quick effect of the product. Therefore, these claims were not in line with the SmPC.
The HCO also established that the “ACC” advertisements were not in compliance with the SmPC as the used claims gave an overall better impression of the efficacy of the product than is supported by the SmPC. The HCO ruled that these statements were “excessive” and “too general”. Therefore, SANDOZ infringed on provisions for the advertisement of medicinal products.
In fixing the amount of the fine, the HCO took into account the total costs and scope of the campaign. However, as mitigating factors, it considered that SANDOZ (i) gave up on its practice as a result of the competition proceedings, and (ii) implemented a detailed compliance system, which – according to available evidence – has already prevented further infringements.
According to the HCO decision, not only the statements that contradict or are non-compliant with the SmPC are considered by the HCO as unlawful but those claims as well that go beyond the indications, effects or mechanism set forth in the SmPC.