Advertising of Medical Services and Medical Devices

 

March 5, 2022

BRACE Law Firm ©

 

Advertising is an effective way to attract new customers and expand the market for a product. The medical and pharmaceutical businesses are no exception. However, in this case, the advertised goods and services can cause harm to the health of citizens, mislead them about their health status, or cause a reluctance to consult a doctor. To avoid negative consequences, legislative restrictions on the advertising of medical services and medical devices have been established.

In this article, we will analyze the requirements established by law for the advertising of medical services and medical devices, taking into account the clarifications of the Federal Antimonopoly Service (hereinafter – "FAS Russia") and established law enforcement practice.

The Concept of Advertising

According to Article 3 of Federal Law No. 38-FZ dated March 13, 2006, "On Advertising" (hereinafter – the "Law on Advertising"), advertising is "information distributed by any method, in any form, and using any means, addressed to an indefinite circle of persons and aimed at attracting attention to the object of advertising, forming or maintaining interest in it, and its promotion on the market." Thus, the criteria for classifying information as advertising are:

• Its addressability to an indefinite circle of persons;
• Its orientation toward attracting attention to the object of advertising, forming or maintaining interest in it, and its promotion on the market.

These criteria do not always allow for an unambiguous determination of whether information is advertising or not. To fill these gaps, FAS Russia has repeatedly provided clarifications on the application of advertising legislation. In particular, Letter No. ATs/4624 dated April 5, 2007, defines an "indefinite circle of persons." This refers to those persons who cannot be determined in advance as the recipient of the advertising information and as a specific party to the legal relationship arising from the sale of the object of advertising. An indefinite circle of persons can also include a specific target audience (for example, company clients, TV channel viewers, or passers-by in a certain territory).

Another mandatory sign of advertising is attracting attention to the object of advertising to maintain interest in it and its promotion on the market. Information is recognized as advertising if it allows for the individualization of a product (work, service) and distinguishes it from among similar products for the purpose of market promotion. Thus, the following is not advertising:

• Information that does not contain specific details about the product and the conditions of its acquisition (for example, placing images of a product on a facade without individualizing features);
• Information aimed at attracting attention to the activities of a non-profit organization that is not entrepreneurial;
• Information, the disclosure, distribution, or bringing to the consumer of which is mandatory in accordance with federal law. For example, information to be posted on the websites of medical organizations for the purpose of independent quality assessment of services, or information placed on information stands in accordance with Article 9 of the Law of the Russian Federation No. 2300-1 dated February 7, 1992, "On Protection of Consumer Rights";
• Reference, information, and analytical materials (reviews of internal and external markets, results of scientific research and testing) that do not have the primary goal of promoting a product on the market and are not social advertising;
• Information placed on signs and pointers.

The latter causes a lot of debate regarding the distinction between mandatory signs (by law) and advertising structures. As stated by FAS Russia, the placement of an organization's name at its location, as well as other mandatory information for consumers directly at the place of sale of goods or provision of services (information on operating hours, products sold), is not advertising. Likewise, an indication of the profile of activity (pharmacy, shop), the assortment of goods and services sold, or location indicators (for example, "Welcome" or "Have a Safe Trip" signs at entrances and exits) is not considered advertising. However, it should be noted that this distinction lacks sufficient specificity and is not codified in law. When considering disputes, antimonopoly authorities evaluate both the content of the information and the circumstances of its placement.

It is also worth noting the methods of distributing advertising. As stated in the Law on Advertising, the method of distributing information can be any, including via the "Internet," messengers, mobile applications, telephone, and other communications. General legal requirements apply to them. Furthermore, according to Article 18 of the Law on Advertising, its distribution via telecommunication networks, including telephone, fax, and mobile radiotelephone communications, is permitted only with the prior consent of the subscriber or addressee to receive advertising. The advertiser is obligated to prove that consent was obtained. According to FAS Russia, consent obtained by filling out forms on websites that do not allow for the unambiguous identification of who exactly gave consent is improper, whereas a subscriber's consent to receive advertising contained in a written contract may be considered proper. In view of the widespread use of cellular communications and various messengers, regulatory authorities have considered a significant number of cases in recent years related to the lack of consent to receive advertising information. At the same time, one can agree with the position of antimonopoly authorities that the developers of messenger software and other applications are not considered advertisers.

General Requirements for the Advertising of Medical Services and Medical Devices

A general requirement for any advertisement, according to Article 5 of the Law on Advertising, is its good faith and reliability.

Advertising is recognized as unfair if it:

• Contains incorrect comparisons of the advertised product with others in circulation;
• Displaces honor, dignity, or business reputation;
• Represents advertising for a product whose advertising is prohibited by that method, at that time, or in that place, if it is carried out under the guise of advertising another product;
• Is an act of unfair competition. Actions regarded as such are defined by Chapter 2.1 of Federal Law No. 135-FZ dated July 26, 2006, "On Protection of Competition."

Advertising is recognized as unreliable if it contains information that does not correspond to reality regarding:

• Advantages of the advertised product over other products in circulation;
• Any characteristics of the product, composition, method and date of manufacture, consumer properties, etc.;
• Assortment and configuration of products, place and time of acquisition;
• Cost or price of the product, payment procedure, size of discounts, tariffs, and other conditions of acquisition;
• Conditions of delivery, exchange, repair, and maintenance of the product;
• Warranty obligations;
• Exclusive rights to the results of intellectual activity and equivalent means of individualization of a legal entity or product;
• Recommendations of physical or legal entities;
• Results of research and testing;
• Granting additional rights or advantages to the purchaser of the advertised product;
• The actual size of demand for the advertised or other product;
• Volume of production or sales of the advertised or other product.

Furthermore, advertising must not:

• Incite the commission of illegal acts;
• Call for violence and cruelty;
• Form a negative attitude toward persons who do not use the advertised products or condemn such persons;
• Contain pornographic information.

The following is also prohibited:

• The use of profanity, obscene and offensive images, comparisons, and expressions, including regarding gender, race, nationality, profession, social category, age, language, official state symbols (flags, coats of arms, anthems), religious symbols, or cultural heritage sites;
• The use of foreign words and expressions that may lead to a distortion of the meaning of the information;
• Indications that the object of advertising is approved by state authorities or local self-government bodies or their officials;
• Demonstrating the processes of smoking tobacco or consuming nicotine-containing products and alcohol;
• Indications that the advertised product was manufactured using human embryo tissues.

Advertising is not permitted in textbooks, teaching aids, or other educational literature intended for children in primary, basic, or secondary general education programs, nor in school diaries, notebooks, or on payment documents for housing and utility services (including on the back).

Signs of unreliable and unfair advertising are also found in the advertising of medical services and medical devices. Let’s look at the most common violations. In one case, the antimonopoly service recognized as a violation the use of the statement "Latest world-class equipment and facilities" in an advertisement for medical services, as it contained inaccurate information about the advantages of the advertised product over others. Similarly, comparisons using words like "best," "first," "most," "only," etc., are qualified as violations.

The omission of essential information about the advertised product or the conditions of its acquisition or use is considered misleading. For instance, an advertisement for a dental clinic stating: "10 years of successful work, CERAMET FOR ONLY 2500 RUB" was found improper because it only contained the price of the crown and not the full cost of the service, thereby misleading the consumer.

Regarding prohibitions on advertising specific types of goods and services:

• In accordance with Part 9 of Article 7 of the Law on Advertising, the advertising of medical services for the artificial termination of pregnancy is prohibited.
• Part 7 of Article 7 establishes a prohibition on the advertising of goods that require a license for production or sale if no such license exists. According to Clause 46 of Part 1 of Article 12 of Federal Law No. 99-FZ dated May 4, 2011, "On Licensing of Specific Types of Activities," medical activity is subject to licensing. Thus, advertising medical services is only permitted if the organization or individual entrepreneur has a license for the advertised types of services.

In practice, many disputes arise regarding services positioned as cosmetic, hairdressing, or household. If the advertised services match the names of medical services in the Nomenclature of Medical Services, antimonopoly authorities qualify such advertising as medical. For example, authorities recognize services such as ear piercing, classical massage, and laser hair removal as medical.

The Law on Advertising does not explicitly require license information to be included directly in the advertisement. Its absence is not a violation. Article 13 only establishes the obligation to provide proof of the license to the advertiser. However, law enforcement practice tends toward including license details in advertisements, which is advisable to avoid claims from regulatory authorities.

As the analysis of practice shows, cases of liability for violating general advertising requirements are frequent, even in the absence of intent for unfair competition. To avoid negative consequences, it is recommended to consider the clarifying letters of FAS Russia. Specifically, the general requirements, recommended and non-recommended words, phrases, and images are detailed in the FAS Russia Recommendations on compliance with legislation on the advertising of non-prescription drugs dated November 7, 2018, which can also be applied to medical services and devices.

Special Requirements for the Advertising of Medical Services and Medical Devices

In addition to general requirements, the Law on Advertising sets special requirements in Article 24.

Firstly, advertisements for medical services must not:

• Contain links to specific cases of cure or health improvement resulting from the use of the object of advertising;
• Contain expressions of gratitude by individuals in connection with the use of the object of advertising.
  • Note: This is only permitted where consumers are exclusively medical and pharmaceutical workers (exhibitions, seminars, specialized publications, etc.).
• Create an impression of the advantages of the object of advertising by referring to the fact of research mandatory for state registration;
• Contain statements or assumptions that consumers of the advertisement have certain diseases or health disorders.

Examining these through the lens of practice: references to health improvement and gratitude are common in medical device ads, while assumptions about diseases are still used in medical service ads. Violations include both direct statements ("You have arthrosis, osteochondrosis...") and assumptions phrased as statistics (e.g., "In Russia, 13-20 million people suffer from hearing loss, and their number continues to grow" or "Not only the elderly are at risk, but also patients with hypertension and diabetes").

Additional restrictions on medical devices:

• They must not be addressed to minors;
• They must not contribute to creating an impression in a healthy person of the need to use the product;
• They must not create an impression that consulting a doctor is unnecessary;
• They must not guarantee a positive effect, safety, effectiveness, or absence of side effects.

For example, an advertisement for a device claiming to be an "apparatus for restoring blood circulation and healing the entire body! guarantees efficiency and safety" was found to violate the law due to the guarantee of positive action and absence of side effects. Detailed descriptions of how to use a device (e.g., "can be used at home... no special technical knowledge needed... simplified to the maximum, even the elderly can use it without help") can be qualified as creating the impression that a doctor's consultation is unnecessary.

Secondly, advertisements for medical services and devices must be accompanied by a warning about contraindications, the need to read the instructions, or the need to consult a specialist. FAS Russia allows the use of one type of warning at the advertiser's discretion. Commonly used warnings are: "There are contraindications; it is necessary to read the instructions" or "There are contraindications; it is necessary to consult a specialist."

The law sets specific requirements for such warnings:

Place of Advertisement Placement	Warning Requirements
In a radio program	Duration of at least 3 seconds
In a TV, video, or film program	Duration of at least 5 seconds, frame area at least 7 percent
In advertisements distributed by other methods	Size – at least 5 percent of the advertising area (advertising space)

The law does not specify exactly how the text should be placed. The warning area should be calculated based on the ratio of the total advertisement area to the space occupied by the warning text.

Thirdly, Part 8 of Article 24 prohibits the advertising of methods of prevention, diagnosis, treatment, and medical rehabilitation, as well as medical devices that require special training for use, except in places for medical/pharmaceutical professionals.

The essence of the prohibition is that while advertising medical services is allowed to the general public, advertising the methods themselves is not. The "Law on the Basics of Health Protection" defines a "medical service" as a medical intervention or complex of interventions aimed at prevention, diagnosis, etc., having an independent finished value.

The term "method" is not defined in the basic health law, but FAS Russia suggests that since medical services are defined by the Nomenclature of Medical Services, any indication of the methods of action on the human body should be qualified as a "method." Advertisers should avoid the phrase "method of treatment" and detailed disclosures of how services are provided.

Regarding the overlap between service names and methods (e.g., "ultrasound diagnosis of pelvic organs"): the Supreme Court of the Russian Federation has ruled that if the information about a method is not disclosed independently and is distributed as part of a medical service advertisement, it does not violate the law.

As for "special training," FAS Russia clarifies that this refers to specialists with medical or pharmaceutical education (higher or secondary). Thus, the restriction applies only to devices intended solely for use by medical professionals.

Fourthly, there is a prohibition on using images of medical and pharmaceutical workers. This applies to the advertising of medical devices to a wide range of consumers. In medical service ads and ads intended solely for professionals, this is permitted under Part 5 of Article 5.

Liability for Violation of Advertising Legislation

Article 38 of the Law on Advertising establishes that violations entail liability in accordance with civil law. Injured parties may sue for:

• Damages, including lost profits;
• Harm to health or property;
• Compensation for moral harm;
• Public refutation of unreliable advertising.

The law distinguishes between the liability of the advertiser, the advertising producer, and the advertising distributor. Generally:

• The advertiser is liable for the content.
• The producer is liable for the design and preparation.
• The distributor is liable for the time, place, and means of placement.

In addition to civil liability, administrative liability applies. Fines under Part 1 of Article 14.3 of the Administrative Code (general violations):

• Individuals: 2,000 to 2,500 rubles;
• Officials: 4,000 to 20,000 rubles;
• Legal entities: 100,000 to 150,000 rubles.

Fines under Part 5 of Article 14.3 of the Administrative Code (special requirements for medical ads):

• Individuals: 2,000 to 2,500 rubles;
• Officials: 10,000 to 20,000 rubles;
• Legal entities: 200,000 to 500,000 rubles.

When appointing punishment, the nature of the offense and the financial position of the entity are considered. While the offense is formal (not requiring actual harm to occur), there is a practice of replacing fines with a warning for first-time offenses where no actual harm or threat occurred.

In conclusion, the consequences for violating advertising law are significant. These violations are often not due to a desire to bypass the law but rather to the vagueness of the legislation and the subjective assessment of regulatory authorities. It is highly recommended to involve lawyers for a legal assessment of all advertising materials.

 

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References

1. Letter of FAS Russia dated May 24, 2021 No. ATs/41745/21 "On the qualification as advertising of information about free services provided by a non-profit organization."
2. Letter of FAS Russia dated December 27, 2017 No. AK/92163/17 "On the distinction between the concepts of a sign and advertising."
3. Letter of FAS Russia dated November 11, 2019 No. DF/98054/19 "On proper evidence when identifying violations of the requirements of Part 1 of Article 18 of the Federal Law 'On Advertising'."
4. Letter of FAS dated June 24, 2019 No. AK/52901/19 "On clarification regarding advertising in messengers (Viber, Whatsapp), classification of information as advertising, and methods for identifying advertisers."
5. Resolution of the UFAS for the Novosibirsk Region dated July 28, 2021 No. 054/04/14.3-976/2021.
6. Decision of the UFAS for the Republic of Tatarstan dated March 6, 2020 No. 016/05/5-200/2020.
7. Decision of the UFAS for the Altai Territory dated August 23, 2019 No. 022/05/5-430/2019.
8. Order of the Ministry of Health of the Russian Federation dated October 13, 2017 No. 804n "On approval of the nomenclature of medical services."
9. Decision of the UFAS for the Republic of Mari El dated November 25, 2021 No. 012/05/24-958/2021.
10. Decision of the UFAS for the Altai Territory dated October 12, 2021 No. 022/05/24-791/2021.
11. Decision of the UFAS for the Bryansk Region dated July 31, 2020 No. 032/05/7-880/2020.
12. Resolution of the UFAS for the Ulyanovsk Region dated October 5, 2020 No. 073/04/14.3-450/2020.
13. Resolution of the UFAS for the Ulyanovsk Region dated August 30, 2019 No. 073/04/14.3-15818/2019.
14. Decision of FAS Russia dated September 14, 2015 No. 3-24-32/00-08-15.
15. Clarification of FAS Russia dated June 22, 2020 No. DF/52241/20 "On the advertising of medicines, medical devices and medical services, methods of prevention, diagnosis, treatment and medical rehabilitation, methods of traditional medicine."
16. Letter of FAS Russia September 25, 2017 No. AK/65861/17 "On the advertising of methods of prevention, diagnosis, treatment and medical rehabilitation."
17. Paragraph 25 of the Review of Judicial Practice of the Supreme Court of the Russian Federation No. 2 (2017), approved by the Presidium of the Supreme Court of the Russian Federation on April 26, 2017.
18. Letter of FAS Russia dated May 28, 2015 No. AD/26584/15 "On clarification of certain provisions of the Federal Law 'On Advertising'."