As we informed you in earlier articles and posts, starting from 26 May 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (hereinafter the “MDR”) will gradually enter into force.
In connection with the MDR, Act No. 89/2021 Coll., and in particular Act No. 90/2021 Coll., introduced into Czech legislation several changes related to the issue of medical devices, including an amendment to Act No. 40/1995 Coll., on the Advertising Regulation, as amended (hereinafter the “Advertising Regulation Act”).
In the following article, we would like to introduce you to the major changes brought about by the amendment in the area of advertising regulation with a special focus on the so-called health-targeted products.
Legal regulation of advertising aimed at human health
Prior to the entry into force of the amendment to the Advertising Regulation Act, only human medicines and food supplements received attention in consumer health advertising, while advertising for medical devices and other products containing claims that the product can cure a disease, health disorder or disability was completely neglected. In the event of the falsity of these statements, the advertisement with such defective content was then assessed according to the general laws, where it could be qualified as an unfair or misleading commercial practice within the meaning of the relevant provisions of Act No. 634/1992 Coll. on Consumer Protection, as amended, and therefore also prohibited advertising according to the provisions of Section 2(1)(b) of the Advertising Regulation Act, which imposes liability on both the advertiser and the processor and disseminator of the advertisement.
Supervision of advertising in the field of medical devices and similar products has so far been entrusted only to regional trade licensing authorities, which did not have the necessary expertise in this segment, and not to the State Institute for Drug Control (hereinafter as “SÚKL”), which field of expertise actually includes market with these products.
Although the MDR itself does not directly regulate advertising, the amendment to the Advertising Regulation Act introduces a hitherto completely absent and desirable specific regulation of advertising for medical devices, which includes both in vitrodiagnostic medical devices and medical devices in general, consisting in particular in setting legal requirements for the content of advertising messages, which are largely inspired by the existing regulation of advertising for medicinal products, both for advertising aimed at the general public and at professionals.
Another subject of the new legal regulation of advertising in the area of commodities that have a direct impact on consumers’ health is the advertising of health-targeted products, which will be discussed in more detail in the following paragraphs of this article.
Health-targeted products advertising
As already outlined, the amendment to the Advertising Regulation Act also incorporates a new provision of Section 5n, which introduces specific rules for the content of advertisements for the so-called health-targeted products, providing for a categorical prohibition of advertising for a health-targeted product that is neither a medicinal product, nor a medical device, nor an in vitrodiagnostic medical device, nor a food for special medical purposes, although it indicates that the product is legally one of such commodities.
Although it is not entirely clear from the amended wording of the Advertising Regulation Act what products belong to these health-targeted products, which are neither a medicinal product, nor a medical device, nor an in vitro diagnostic medical device, nor a food for special medical purposes, in this context, however, it can be clearly deduced that the referred category of products may include, for example, various types of food supplements or cosmetics, or products such as “healing” stones, lights or candles.
The advertising of such products is now also subject to a strict prohibition:
- on implying that the use of the product will improve or maintain the health of the person using it;
- on implying that the non-use of the product may adversely affect the health of persons;
- on recommending the product by reference to the recommendations of scientists, medical experts or persons whose actual or perceived social status might encourage the use of the product, e.g. celebrities and media personalities and influencers who are commonly used for similar products.
However, there is an exception for products for which the Advertising Regulation Act expressly provides otherwise. According to the interpretation of the Czech Agriculture and Food Inspection Authority (hereinafter the “SZPI”), these products include, for example, foodstuffs for which the Advertising Regulation Act provides special requirements that must be met by a given advertisement and which are based on legislation that takes precedence in this respect.
In this context, in the case of foodstuffs, including food supplements, it is therefore appropriate to rely on the provisions of Section 5d of the Advertising Regulation Act, which permits nutrition or health claims to be made under the conditions of a directly applicable European Union regulation, while, subject to the derogations provided for natural mineral waters and foodstuffs intended for particular nutritional uses, food information may not attribute any foodstuff properties enabling it to prevent, alleviate or cure a particular human disease or refer to such properties.
The aim and purpose of the new legal regulation of advertising is in particular to prevent claims on the basis of which the consumer could confuse the products with a medicine or a medical device, and in particular to eliminate, to the maximum extent possible, currently not unique advertising claims that attribute to these products often really exaggerated or even unrealistic beneficial effects on human health, such as the complete cure of diseases or correction of physical defects.
Thus, the introduction of the new legislation moves health-targeted products from the general legal regulation of advertising and consumer protection principles to a very strict legal regulation, which in our opinion even exceeds the legal framework set within the European Union by the MDR, as well as other substantively related legislation.
Transition period?
Unlike advertising campaigns for medical devices and in vitro diagnostic medical devices created or disseminated on the basis of contracts concluded prior to the effective date of the amendment to the Advertising Regulation Act, there is no 6-month time limit for advertising for health-targeted products, within which campaigns should cease to run under the existing legislation.
In view of the above, it is therefore necessary to comply without exception with the strict rules on the content of advertising for health-targeted products already on the date of entry into force of the amendment to the Advertising Regulation Act, i.e. as of 26 May 2021.
Compliance supervision and sanctions
While the compliance with the rules binding on advertising of medical devices will now be supervised in most cases by SÚKL, which has the necessary experience in the field of regulation of advertising of medicinal products.
However, in case of health-targeted products, despite this is desirable requirement for the experience of a supervisory authority in the field of advertising aimed at human health, the compliance with the rules binding on advertising will be supervised by the regional Trade Licensing Office based on of the residual clause under Section 7(i) of the Advertising Regulation Act. The supervision of infringements in the sector of television and radio advertising has been entrusted to the Council for Radio and Television Broadcasting, while at the same time the supervision of food advertising, including food supplements, which will continue to be entrusted to SZPI, has remained unaffected by the amendment.
In all of these cases, the advertiser and the processor (i.e. not the disseminator) of the advertisement are threatened with a sanction of up to CZK 2.000.000 by the supervisory authority for violating the conditions set out in the amendment to the Advertising Regulation Act for the content of advertisements for health-targeted products.
Nevertheless, the approach of the supervisory authorities in deciding the amount of fine will comprehensively take into account many variable factors, such as the turnover of the advertiser or the advertiser’s processor, the extent of the breach of the prohibition, negligent fault, multiple infringements and repetition, voluntary removal of the advertisement with objectionable content, cooperation with the supervisory authority, etc.
Conclusion
On the basis of the above, it can be concluded that the amendment to the Advertising Regulation Act introduces quite fundamental conditions imposed on advertisers and processors of advertising content for health-targeted products, which need to be reflected in advertising campaigns and commercial practices, as well as in other forms of promotion of the offered products, as soon as possible.
If you have any questions regarding human health advertising in the light of new and existing legislation, please do not hesitate to contact us.
Mgr. Tereza Dvořáková, attorney – dvorakova@plegal.cz
Mgr. Jakub Málek, partner – malek@plegal.cz
16. 06. 2021