Navigating the legal boundaries in health advertising

The thin line between advertising a medical device or a health center, and the lack of compliance with current legislation with regards to such advertising, has been analyzed by the appeal court of Barcelona in its recent judgment nº. 816/2024, dated July 24, 2024 (ES:APB:2024:6850) (the "Judgment").

The Judgment confirms the lower court's decision and dismisses the actions for unlawful advertising filed by the Official College of Dentists and Stomatologists of Catalonia ("COEC") against a company that manages dental clinics (the "Company") for the publication of certain advertising materials. 

Context: legal regime and its complexities

The advertising of health services and products is subject to specific regulations aimed at ensuring the protection of public health and the dignity of health professions.

The legal regime is complex and, for the purposes of this analysis:

• Article 38(8) of Royal Decree 1591/2009, of October 16, which regulates medical devices ("RD on Medical Devices") prohibits the mention of recommendations made by scientists, health professionals, or other «notorious persons»  —important, relevant, famous, according to the definition of the Royal Spanish Academy— in the advertising of medical devices to the public, as this may encourage the use of such products.
  
  This provision is one of the few that remain in force from the RD on Medical Devices.
  
  There is a draft Royal Decree regulating the advertising of medical devices currently under review. In the draft, this prohibition is more specific and prohibits advertising materials that make references to «a recommendation made by scientists, health professionals, patient associations, or other persons who, due to their notoriety, may incite the consumption of products, such as particularly relevant users (…)».

• Article 6(2) of Royal Decree 1277/2003, of October 10, which establishes the general bases for the authorization of health centers, services, and establishments ("RD on Health Centers") authorizes health centers to use terms in their advertising that suggest the provision of services and activities for which they are authorized, without being misleading. 
  
  This provision is complemented by Article 6 of Royal Decree 1907/1996, of August 2, on advertising and commercial promotion of products, activities, or services with purported health purposes.

Unlike the RD on Medical Devices, the RD on Health Centers does not impose restrictions on the use of notorious persons.

Background

In the analyzed case, the Company published advertising materials in conventional media and on social media, featuring personalities with a strong presence on social media (i.e., actors, singers, models, and other public figures) and a health professional (the "Materials"). In the Materials, the personalities displayed or used transparent dental aligners of a specific brand and made statements to invisible orthodontic treatments, its advantages, and the Company's commercial offer. For example, «Align your smile with invisible orthodontics from (…)» or «Change your smile with invisible orthodontics (…) from €30 per month».

The COEC filed a lawsuit against the Company, for unlawful advertising under the Unfair Competition Law, on the grounds that the Materials, through personalities with a strong social media presence and a health professional, advertised a medical treatment related to the use of medical devices (i.e., invisible orthodontic treatment and its aligners) which is prohibited by the RD on Medical Devices.

On the contrary, the Company argued that the publication of the Materials was authorized by the RD on Health Centers.

In the first instance, the court dismissed the lawsuit, considering that the Materials were focused on the Company's health centers and the services rendered rather than on its medical devices. Thus, provided that the Company complied with the provisions of the RD on Health Centers, the publication of the Materials was permitted.

The Judgment and outcome of the case

The COEC filed an appeal against the decision in first instance, stating among others that the court of first instance made an «erroneous interpretation of the subject matter of the advertising, which is not the health centers but an invisible orthodontic treatment and its aligners (…)» and that «(…) this resulted in the application of an incorrect legal framework for resolving the dispute».

The court of appeal dismissed the appeal and upheld the judgment of the court of first instance after carrying out an overall analysis of the Materials and concluding that the advertising concerned a health center rather than a specific medical device.

Specifically, the court of appeal stated that:

• The Materials refer generally to a specific dental service (invisible orthodontics). Consumers are familiar with this service and know that it is not something the Company provides exclusively, but that it is provided by all or most dentists. Therefore, the average consumer «would perceive that what is being advertised are specific centers where that service is provided».
• The specific device (invisible aligners) does not constitute the subject matter of the Materials and does not properly integrate a reference to a specific medical device nor highlights its complete features, but the average consumer knows that this type of device constitutes «a common device in recent years for providing orthodontic services».
• The overall message that consumers would perceive is that «a dental company providing orthodontic services is being advertised, and that it uses invisible plastic aligners for that purpose» and that the reference to these services and devices «is nothing more than an indirect way of advertising a dental establishment. Therefore, the applicable legal regime is the one corresponding to the advertising of the establishment, not to the advertising of products or services, as understood by the appealed resolution».

Thus, the appeal court considers that the Company's conduct falls into Article 6(2) of the RD on Health Centers and that the Materials did not seek to «highlight the specific features of a particular manufacturer's product over others but merely serve as a means of informing the interested public that specific orthodontic services are provided and that they can be done in a specific way (with invisible aligners)» in compliance with the applicable regulations. 

As a final consideration, the appeal court acknowledges that operators cannot argue that they fall into the scope Article 6(2) of the RD on Health Centers in all circumstances. Instead, the Judgment clearly establishes that the RD on Medical Devices and other regulations will apply when «when advertising a health center or a health activity [subject to the RD on Health Centers], elements are introduced that can be perceived as  —direct or indirect— advertising of specific medical devices; and (ii) in those cases where the advertised activity or treatment involves the use of a specific medical device».