Hungarian Competition Authority fines pharma distributor for OTC advertising

The Hungarian Competition Authority (HCA) fined a Hungarian pharmaceutical distributor for the unlawful advertisement of over‑the‑counter (OTC) medicinal products after determining that the promotional claims made with reference to the authorised Summaries of Product Characteristics (SmPC), required under applicable regulations, were misleading. The HCA’s decision serves as a reminder for advertisers that SmPC‑based communication must be handled with care.

Legal background

Under Hungarian law, OTC medicinal products that receive no social security subsidies can be advertised to the general public, but only if the advertisement meets the conditions laid down in Act XCVIII of 2006, known as the Medicines Thrift Act. These restrictions apply along with general advertising rules and limitations. Among others, an advertisement must do the following: 

• present the medicinal product based on the authorised SmPC; and
• encourage the rational use of the medicinal product by presenting it objectively and without exaggerating its properties. 

The above restriction does not mean that the advertisement must be identical to the SmPC, especially since the SmPC is primarily intended for healthcare professionals. The restriction does, however, prohibit the advertiser from suggesting therapeutic indications or other characteristics that are contrary to the approved SmPC. The authority assessing compliance with the Medicines Thrift Act is generally the National Centre for Public Health and Pharmacy. The competent authority in the case of consumer-facing advertising that materially affects competition is the HCA.

What did the HCA examine?

The HCA reviewed an advertising campaign run by Opella Healthcare for certain probiotic products. The investigation focused on the distributor’s use of the term “SMART”, including claims that the product contained “SMART spores” and was “the smartest choice”.

Importantly, the “SMART” label was not invented entirely independently of the SmPC. Instead, it was constructed as an acronym referring to specific characteristics listed in the SmPC (e.g. “active”, “resistant”, etc.). This, however, did not satisfy the HCA.

According to the authority, the fact that each individual characteristic making up the acronym was included in the SmPC was not decisive. Rather, the overall acronym “SMART” carried an additional, independent meaning that the product was the smartest or best choice on the market. When assessing an advertising claim relating to an OTC medicinal product, it is not the factual content of the claim that is primarily important, but whether the claim presents the product in accordance with the approved SmPC. Because this additional connotation was not contained in the SmPC, the HCA concluded that the communication went beyond the SmPC and failed to meet the requirement of objectivity.

Following the finding of infringement, the HCA imposed a fine of HUF 105 million (EUR 275,000), which reflected a 20% reduction granted for the distributor’s prompt discontinuation of the campaign when the investigation was launched.

Key takeaways for advertisers

This decision confirms that OTC medicinal products remain a high‑priority area from both consumer protection and antitrust perspectives. (Two new antitrust investigations into the Hungarian OTC market were launched just last month.)

More specifically, the case illustrates that while claims aligned with the SmPC are in principle permissible, referencing the SmPC does not provide a “blank cheque”. The overall message and cumulative effect of claims must remain strictly within the scope of the SmPC. Even subtle additions (e.g. acronyms, umbrella slogans, or general superiority implications) may be considered unlawful if they introduce meanings not expressly reflected in the SmPC. Failure to comply can result in serious regulatory and financial consequences, including significant fines. Distributors and marketing authorisation holders should carefully evaluate the content of their planned or published advertisements to avoid making claims or connecting creative meanings that are not covered by the approved SmPC and could mislead consumers, thereby breaking rules on consumer protection or pharmaceutical advertising.

For more information on how the HCA decision could affect your Hungarian business or questions on pharmaceutical or competition law, contact your CMS client partner or the CMS experts who contributed to this article. 

This article was co-authored by Lili Benyovszki.