Rules for the Promotion of Medicinal Products and Supervision of Their Compliance

When promoting medicinal products, it is essential to proceed with great caution and adhere to legally established restrictions and obligations. The promotion of pharmaceutical products is regulated not only towards the general public but also towards healthcare professionals. Supervision of compliance with pharmaceutical advertising regulations is carried out by the State Institute for Drug Control (SÚKL), which annually imposes fines amounting to hundreds of thousands for violations.

Advertising Aimed at the General Public

According to information on sanctions imposed by the State Institute for Drug Control (hereinafter "SÚKL"), SÚKL most frequently issues fines in connection with advertising prescription-only medicinal products aimed at the general public, which is prohibited under § 5a(2)(a) of Act No. 40/1995 Coll., on the Regulation of Advertising and on Amendment and Supplementation of Act No. 468/1991 Coll., on the Operation of Radio and Television Broadcasting, as amended (hereinafter "Advertising Regulation Act"). Prescription-only medicinal products may only be promoted to professionals who can prescribe or dispense them (i.e., doctors, pharmacists, and pharmaceutical assistants).

In the past two years, these fines for violating § 5a(2)(a) of the Advertising Regulation Act have been mainly for promoting intravenously administered vitamin C infusion solutions. Fines for this offense, according to the Advertising Regulation Act, typically range from CZK 200,000 to CZK 350,000.

Section 5a of the Advertising Regulation Act also sets out other restrictions regarding advertising to the general public. Besides only being allowed to promote over-the-counter medicinal products, these products must be labeled as human medicinal products and identified by the name under which they are registered with SÚKL. The advertisement must include information on the correct use of the product and must also contain a call to read the package leaflet. Furthermore, the advertisement must not imply that the health of the user will improve upon using the product, nor should it suggest that not using the product could deteriorate one's health.

Another common instance of violating advertising regulations in the pharmaceutical field is the breach of § 5(4) of the Advertising Regulation Act, which requires that the provided information about a medicinal product corresponds to the data recorded in the register of this product maintained by SÚKL. In several cases of such breaches, SÚKL has imposed fines on pharmaceutical companies reaching up to CZK 350,000.

Food with Health Claims

Problematic can also be therapeutic or health claims, which may be used in the promotion of food. In a recent decision of the Supreme Administrative Court, case no. 10 As 136/2023-38, the court dealt precisely with the distinction between these two claims. Therapeutic claims (regulated by Regulation (EU) No. 1169/2011) are those that attribute therapeutic effects to a food or product, i.e., attributes properties that enable the prevention, alleviation, or cure of a human disease. Health claims, defined in Regulation (EC) No. 1924/2006, are those that state, suggest, or imply that there is a relationship between a food or its component and human health.

The boundary between a health and therapeutic claim can be very thin, and the Supreme Administrative Court concluded in its ruling that even associating therapeutic effects solely with an individual component or components of a food can constitute a therapeutic claim if such promotion can make the consumer believe that the food acts against diseases or has therapeutic effects.

Therapeutic claims are generally prohibited except for specific exemptions, and their use in food promotion constitutes a violation of § 5d(2) of the Advertising Regulation Act. Supervision of compliance with food advertising regulations is carried out by the State Agricultural and Food Inspection Authority, which can impose fines up to CZK 2 million for violations.

Advertising Aimed at Professionals

Sections 5 and 5b of the Advertising Regulation Act set the conditions for promoting medicinal products to the professional public. Medicinal products are often promoted to professionals through pharmaceutical company sales representatives. Sales representatives must not offer gifts or any other benefits to professionals as part of the advertisement, except for items of negligible value related to the professional activity (e.g., professional books, aids, etc.).

Pharmaceutical companies often invite doctors and pharmacists to professional training and conferences, which also constitutes advertising with its limitations. A pharmaceutical company may sponsor only scientific meetings attended by professionals and cover travel, accommodation, and meals during the event (i.e., max. 24 hours before the start and max. 24 hours after the end). Professionals attending these events must not be reimbursed for any additional benefits beyond this scope, such as an accompanying program of the stay.

Conclusion

Regardless of the type of advertisement, any advertising of a medicinal product must support its rational use by objectively presenting its properties without exaggeration.

When creating advertising campaigns and promoting medicinal products through sales representatives, it is also good to always keep in mind basic ethical principles. For these purposes, the Association of Innovative Pharmaceutical Industry or the Czech Association of Pharmaceutical Companies, for example, have compiled their ethical codes, compliance with which they require from their members.

If you have any questions related to healthcare or pharmaceutical law or related issues, do not hesitate to contact us. We are happy to learn more about your case and provide you with the appropriate legal assistance. 

Responsible Attorney: Mgr. Barbora Dlabolová, Lucie Stržínková contributed to this article.