Promotion and Advertising of Medicinal Products in Russia: Legal Aspect

 

June 1, 2021

Anna Ivanova, associate at BRACE Law Firm ©,

Roman Shabrov, attorney at law at BRACE Law Firm ©

 

Preceding a detailed examination of the legal aspects of the promotion and advertising of medicinal products, it is necessary to determine the legal content of the concepts of “advertising”  and “promotion.“

Regarding the term “advertising” Federal Law No. 38-FZ of March 13, 2006, “On Advertising (hereinafter – “The Law on Advertising”) stipulates that such is “information disseminated in any way, in any form and using any means, addressed to an indefinite circle of persons and aimed at attracting attention to the object of advertising, generating or maintaining interest in it and its promotion on the market”.

At the same time, as will be shown below, classifying certain information as advertising is of decisive importance for the application of legal requirements for advertising and corresponding restrictions, as well as for the imposition of liability for their non-fulfillment.

The term “promotion” is currently not legalised; however, in marketing, the promotion of goods/works/services is understood as a set of marketing activities aimed at increasing the share of goods/works/services supplied to the market, as well as increasing their recognition, attracting new customers, and increasing sales efficiency^[1].

In fact, the concept of “promotion“ is broader and includes, inter alia, advertising, holding scientific and other events (conferences, seminars, webinars, etc.) to provide information about a particular medicinal product, posting information about medicines on the Internet, publishing articles and other materials in publications intended for the professional community of doctors, etc.

At the same time, advertising can be highlighted as the most used promotion channel requiring separate legal regulation.

The choice of channels for promoting medicinal products is primarily determined depending on such characteristics as the method of dispensing (prescription/over-the-counter), composition (whether it contains narcotic substances), and a number of other factors.

Thus, according to the general rule of Article 67 of Federal Law No. 61-FZ of April 12, 2010, “On the Circulation of Medicinal Products“ (hereinafter – “The Law on Circulation of Medicinal Products”), information on prescription medicinal products must be contained only in:

• specialized publications intended for medical and pharmaceutical workers, veterinary specialists (may be contained in monographs, reference books, scientific articles;
• reports at congresses, conferences, symposia, scientific councils;
• as well as in instructions for the use of medicinal products).

Information on over-the-counter (OTC) medicinal products may, in addition to the indicated sources, be contained in the mass media and disseminated in other ways.

In this case, information of an advertising nature must comply with legislation on advertising.

Criteria for Classifying Information on Medicinal Products as Advertising

Let us examine in detail the specifics of such a channel for promoting medicinal products as advertising, as well as other features of promotion.

Under Federal Law No. 149-FZ of July 27, 2006, “On Information, Information Technologies, and Information Protection” (hereinafter – “The Law on Information”), information constitutes information (messages, data) regardless of the form of its presentation.

The main criteria for classifying certain information as advertising are:

• being addressed to an indefinite circle of persons;
• being aimed at attracting attention to the object of advertising, generating or maintaining interest in it, and promoting it on the market.

In practice, it is not always possible to easily distinguish which materials are advertising and which are not.

To fill this gap, FAS Russia has issued clarifications stating that an object of advertising may be a product intended for sale or other introduction into civil circulation, which can be individualized and distinguished within a homogeneous group of goods.

Accordingly, information is recognized as advertising if it allows for the clear designation and individualization of a specific object of advertising, distinguishes it from homogeneous goods, and generates interest in it for the purpose of promotion on the market, including cases where such information is placed on advertising structures.

Information that does not contain a reference to an object of advertising — including the name of the organization, names of goods (works, services), means of individualization of legal entities, goods, works, services, and enterprises that allow distinguishing a specific person or a specific product among a multitude of homogeneous ones — and is not aimed at their promotion on the market nor generates interest in them, is not advertising, since such information does not contain an object of advertising^[2].

The control body also provides clarifications regarding the classification of information posted on the Internet as advertising.

Information about an organization's activities posted on websites in the information and telecommunication network “Internet” that are not the official websites of such an organization is subject to assessment for classification as advertising or other information in each specific case, based on the content of such information and all circumstances of its placement.

When information posted on a website is aimed not so much at informing the consumer about the assortment of goods or the company's activities, but rather at attracting attention to a specific product and distinguishing it among homogeneous goods (for example, a pop-up banner), such information may be recognized as advertising^[3].

The place of advertising placement and its promotion channels play a rather large role.

For example, FAS Russia explains that if stands located at the entrance to the entrances of residential buildings are used to distribute advertising, are firmly connected to the ground or building, and their movement is impossible without using special devices or tools, such stands are classified as advertising structures, the placement of which must be carried out in accordance with the provisions of Art. 19 of the Law on Advertising, including regarding the existence of a permit for their installation and operation, as well as the inclusion of these structures in the advertising structure placement scheme^[4].

Recently, the promotion of advertising in messengers has caused quite a lot of disputes. In accordance with Part 1, Art. 18 of the Law on Advertising, the dissemination of advertising via telecommunication networks, including through the use of telephone, facsimile, and mobile radiotelephone communications, is permitted only subject to the prior consent of the subscriber or addressee to receive advertising.

In this case, advertising is deemed disseminated without the prior consent of the subscriber or addressee if the advertising distributor does not prove that such consent was obtained.

The indicated requirements apply, inter alia, to WhatsApp and Viber applications and other applications transmitting and receiving information using telecommunication networks.

At the same time, FAS Russia provides a rather fair explanation, in our opinion, that the dissemination of advertising using WhatsApp, Viber, and other applications transmitting and receiving information using telecommunication networks does not in itself constitute grounds for recognizing the developers of said software (e.g., WhatsApp, Viber) as advertising distributors^[5].

Important clarifications were provided by FAS Russia in 2021 regarding the issue of classifying information about the activities of non-profit organizations as advertising. The clarifications emphasize that information disseminated in any way, in any form, and using any means, addressed to an indefinite circle of persons and aimed at attracting attention to the activities of a non-profit organization that is not entrepreneurial activity, is not advertising, and the requirements of the Law on Advertising do not apply to such information^[6].

Furthermore, in judicial practice, the court concluded that the placement of individual information that obviously causes the consumer to associate it with a certain product, aimed at attracting attention to the object of advertising, should be considered as advertising of this product, since in the mentioned cases, depicting part of the information about the product is sufficient to attract attention and maintain interest in the product.

Nevertheless, since the placement of such information in the indicated place does not pursue goals related to advertising, the following should not be considered advertising:

• placement of the name (commercial designation) of the organization at its location;
• other information for consumers directly at the place of sale of goods or provision of services (for example, information about operating hours, goods sold)^[7].

Regional offices of FAS Russia currently rely on the above clarifications of FAS Russia when considering cases.

Thus, for example, the Tula OFAS considered a case on signs of violation of advertising legislation initiated against a pharmacy.

Specifically, an electronic display with changing advertisements for medicinal products was placed in the pharmacy's window opening.

At the same time, the advertisement, as required by the Law on Advertising, was not accompanied by a warning about the presence of contraindications to their use.

The pharmacy representative explained that this information is not advertising. However, the Tula OFAS noted that an object of advertising can be a product intended for sale or other introduction into civil circulation, which can be individualized and distinguished within a homogeneous group of goods.

Accordingly, product advertising always represents information about a specific product that can be individualized within a group of homogeneous goods.

Specific objects of advertising can be distinguished on the electronic display. In this regard, the control body concluded that this information constitutes advertising, and the violations were committed through the fault of the pharmacy^[8].

Questions also arise as to whether applying logos of a manufacturer of medicinal products or names of medicines to souvenir products (pens, notebooks, calendars, etc.) constitutes advertising.

FAS Russia provided the following clarifications on this matter: “The application of logos or trademarks to souvenir products is carried out for advertising purposes, regardless of the further distribution of this product to employees, partners of this organization, or third parties, including on a gratuitous basis”.

We believe that this is not entirely the correct approach, as the specified products may be used only within the company (for example, pens for organization employees).

Nevertheless, when deciding on applying logos to souvenir products, it is important to remember this position of the control body.

It is also important to pay additional attention to the taxation aspect of applying company logos to souvenir products, since the Federal Tax Service of Russia, based on the indicated clarifications of FAS Russia, has also begun to adhere to the position that expenses for souvenir products with organization logos are recognized as advertising^[9].

General Requirements for Advertising in the Context of Medicine Advertising

General requirements for any advertising are requirements for its good faith and reliability (Article 5 of the Law on Advertising).

Advertising is recognized as unfair if it:

• contains incorrect comparisons of the advertised product with goods in circulation that are produced by other manufacturers or sold by other sellers;
• discredits the honor, dignity, or business reputation of a person, including a competitor;
• represents advertising of a product, the advertising of which is prohibited by this method, at this time, or in this place, if it is carried out under the guise of advertising another product;
• is an act of unfair competition.

Advertising is recognized as unreliable if it contains information not corresponding to reality regarding:

• the advantages of the advertised product over goods of other manufacturers;
• any characteristics of the product, including its composition, purpose, consumer properties, shelf life of the product, etc.;
• the assortment and configuration, as well as the possibility of purchasing goods in a specific place or within a specific period;
• the cost or price of the product, the procedure for its payment. In this case, value indicators must be indicated in rubles, and if necessary, may additionally be indicated in foreign currency;
• conditions for delivery, exchange, repair, and maintenance of the product;
• warranty obligations of the manufacturer or seller of the product;
• exclusive rights to the results of intellectual activity and equivalent means of individualization of a legal entity, means of individualization of a product;
• rights to use official state symbols (flags, emblems, anthems) and symbols of international organizations;
• official or public recognition, receipt of medals, prizes, diplomas, or other awards;
• recommendations of individuals or legal entities regarding the object of advertising;
• results of research and tests;
• provision of additional rights or advantages to the purchaser of the advertised product;
• the actual size of demand for the advertised or other product;
• the volume of production or sale of the advertised or other product;
• the source of information subject to disclosure in accordance with federal laws;
• the place where interested persons can familiarize themselves with information that must be provided in accordance with federal laws before concluding a service agreement;
• the manufacturer or seller of the advertised product.

In addition, advertising must not:

• induce the commission of unlawful acts;
• call for violence and cruelty;
• resemble traffic signs or otherwise threaten traffic safety;
• form a negative attitude towards persons not using the advertised goods; contain information of a pornographic nature;
• allow the use of swear words, obscene and offensive images, comparisons, and expressions.

The placement of advertising in textbooks, teaching aids, other educational literature intended for teaching children under the main educational programs of primary general, basic general, secondary general education, school diaries, and school notebooks is not permitted.

Furthermore, in advertising, including advertising of medicinal products, the following is prohibited:

• use of foreign words and expressions that may lead to distortion of the meaning of information;
• indication that the object of advertising is approved by state authorities or local self-government bodies or their officials;
• demonstration of tobacco smoking and alcohol consumption processes.

Advertising of medicinal products must comply with all indicated requirements.

For example, FAS Russia recognized the message in an advertisement stating that “Supradyn – vitamins with the strongest formula” as violating the requirements of Article 5 of the Law on Advertising.

“The dosage in it is 3 times higher than in many“ considering that the medicinal product “Supradyn” has a dosage 3 times higher only for two vitamins – vitamins B1 and Biotin.

The control body considered such wording an incorrect comparison^[10]. One can also cite an example of recognizing the advertising of the medicinal product “Hexoral“ as unfair advertising. The control body noted that the statement used in the advertisement “Hexoral”. Pain extinguisher No. 1” indicates the superiority of this product compared to other goods, since “No. 1” implies that the advertised product is the first among other homogeneous goods, possessing higher merits and advantages over them^[11].

At the same time, comparison of preparations with identical registered indications for use (including with different International Nonproprietary Names (INN)) is permitted provided that clear and reliable comparison criteria are presented in the advertising material.

If necessary, the advertiser provides, upon the request of the advertising distributor or advertising seller, a letter confirming the information contained in the advertising material as of the date of the advertisement launch^[12].

As mentioned earlier, advertising that contains information not corresponding to reality is recognized as unreliable.

In particular, a fairly common violation committed when advertising medicines is indicating characteristics in the advertisement that do not correspond to the instructions for use of the medicinal product.

Thus, for example, FAS Russia identified such a discrepancy in the advertising of the medicinal product “Broncho-munal”.

According to the section of the instructions for use of this medicinal product, it has an immunostimulating effect, strengthening immunity against respiratory tract infections.

The advertisement reported that “Broncho-munal helps reduce the risk of complications by three times.“

However, the indicated characteristics were absent from the instructions for use, as a result of which the advertisement was recognized as unreliable^[13].

Also noteworthy is a case in which the Volgograd OFAS recognized an indication of pharmacy characteristics as unreliable advertising.

The pharmacy positioned itself as a “Low Price Pharmacy” However, as stated by a citizen, prices in the pharmacy for certain preparations were inflated compared to other pharmacy institutions.

Having revealed that the prices for a number of medicines in the specified pharmacy are higher than in other pharmacy organizations, the control body recognized the applicant's complaint as justified^[14].

Additionally, it is important to note that the general ban on indicating therapeutic properties — that is, a positive effect on the course of the disease — of the object of advertising does not apply to the advertising of medicinal products.

At the same time, advertising of medicinal products must not “guarantee the positive action of the object of advertising, its safety, efficacy, and the absence of side effects”.

The line between indicating therapeutic properties and guaranteeing the positive action of a preparation is often very thin, which gives rise to a large number of disputes in practice.

It is also permissible to use images of medical and pharmaceutical workers if the consumers of the medicine advertising are exclusively medical and pharmaceutical workers, as well as if the advertising is disseminated at places of medical or pharmaceutical exhibitions, seminars, conferences, and other similar events, or in printed publications intended for medical and pharmaceutical workers.

Further in this article, we will consider the requirements of legislation and law enforcement practice regarding the advertising of prescription and over-the-counter medicinal products, as well as Biologically Active Supplements (BAS).

Special Requirements for Advertising Medicinal Products

Article 24 of the Law on Advertising establishes that advertising of medicinal products must not:

• address minors;
• contain references to specific cases of cure from diseases, improvement of human health as a result of using the object of advertising;
• contain expressions of gratitude by individuals in connection with the use of the object of advertising;
• create an idea of the advantages of the object of advertising by referring to the fact of conducting studies required for state registration of the object of advertising;
• contain assertions or suppositions about the presence of certain diseases or health disorders in advertising consumers;
• contribute to creating an impression in a healthy person of the necessity of using the object of advertising;
• create an impression of the unnecessariness of consulting a doctor;
• guarantee the positive action of the object of advertising, its safety, efficacy, and the absence of side effects;
• represent the object of advertising as a biologically active supplement and food supplement or other product that is not a medicinal product;
• contain assertions that the safety and/or efficacy of the object of advertising are guaranteed by its natural origin.

In fact, the indicated requirements apply to all types of medicinal products with some exceptions, which will be indicated below.

Let us consider in more detail the features of the enforcement of the indicated requirements.

The ban on addressing minors in advertising materials is an important restriction, and special attention must be paid to advertising materials regarding medicinal products for children.

At the same time, there is no legislatively established ban on the participation of children in advertising.

Nevertheless, the participation of children in advertising has a number of significant restrictions. In particular, such advertising must not:

• induce children to commit acts that pose a threat to their life and/or health;
• cause children to desire to consume narcotic drugs, psychotropic and/or intoxicating substances;
• justify the admissibility of violence and/or cruelty or unlawful behavior;
• deny family values;
• contain obscene language or information of a pornographic nature^[15].

Also, advertising must not contain references to specific cases of cure or improvement from the use of the medicine.

However, this requirement is violated in practice. During a scheduled field inspection, OFAS employees discovered an advertisement for the preparation “Nurofen” on the pages of the magazine “Moy krokha i ya“ (“My Baby and Me”), which mentioned specific cases of cure from diseases as a result of using the painkiller^[16].

A fairly frequent case is a violation of the requirement regarding the absence of gratitude in advertising in connection with the use of the object of advertising, which occurs when advertising certain medical services (for example, by leaving patient reviews on social networks or posting corresponding reviews on the websites of pharmaceutical or medical organizations).

Thus, in one of the decisions, the control body considered the placement of patient thanks in a magazine to be a violation of advertising legislation.

At the same time, the legal entity's arguments that the thanks concerned the organization's specialists directly were not accepted, since the thanks contained references to specific services provided to patients^[17].

It is important to note that the indicated assessments of the control body are applicable not only to services but also to medicinal products.

In addition, when placing advertising, one should remember references to specific studies of a medicinal product or medical device.

Thus, one printed publication disseminated an advertisement with the wording “A large-scale study of the usefulness of magnetotherapy using the ALMAG-01 apparatus showed that the use of ALMAG contributes to a significant reduction in pain and discomfort”.

The control body concluded that the above advertising creates an idea of the advantages of the ALMAG-01 apparatus by referring to the fact of conducting a large-scale study, in the absence of documents confirming the conduct of such, and has signs of a violation^[18].

Another key requirement for the advertising of medicinal products is the requirement that advertising must not contain assertions or suppositions about the presence of certain diseases or health disorders in advertising consumers.

In this regard, wordings suggesting the presence of a certain disease in consumers will be recognized as unlawful.

For example, FAS Russia recognized advertising with the wording: “Approximately one in thirty-three newborns has congenital developmental defects.

Start taking Elevit as soon as you decide to get pregnant” as violating the requirements indicated above^[19]. Also, it is not recommended to refer to morbidity statistics data in the advertising of medicinal products.

In particular, the wording was recognized as not complying with the Law on Advertising: “According to statistics, 80–90% of the working-age population suffers from spinal osteochondrosis.

Moreover, osteochondrosis is often found already after 20 years of age. It is diagnosed even in schoolchildren“.

Advertising of medicinal products must not contribute to creating an impression in a healthy person of the necessity of using the object of advertising.

Thus, the advertising of the medicinal product “Magne B6 Forte” was recognized as not complying with the indicated requirement, as the video sequence and audio sequence of the advertisement collectively create the impression that it is necessary to fight stress and take the medicinal product even in the case of ordinary fatigue after work.

Specifically, the advertisement showed a woman who had no signs of health problems.

At the same time, the advertisement lacked any information indicating diseases or their symptoms for which the use of the medicinal product is necessary.

In this regard, the control body decided that the advertisement creates the impression that a healthy person needs to take the medicinal product “Magne B6 Forte” to fight stress, including to cope with the loss of strength caused by a busy working day^[20].

It is important to note that the indicated requirement does not apply to the advertising of medicinal products used for disease prevention.

Simultaneously with the requirement indicated above, advertising of medicines must not create an impression of the unnecessariness of consulting a doctor.

Often, guarantees of the safety and efficacy of medicinal products and/or medical devices are regarded by FAS Russia as creating impressions of the unnecessariness of consulting a doctor^[21].

The prohibition to guarantee the positive action of the object of advertising, its safety, efficacy, and the absence of side effects stems from the indicated requirement.

For example, advertising of the medicinal product “Utrogestan” was recognized as illegal due to the wording: “Women of different ages between onconegligence and oncophobia: how to prevent cancer?“.

In the opinion of the control body, such advertising implies positioning the medicinal product as effective and safe^[22].

FAS Russia also considered the presence of guarantees of efficacy in the advertising of the medicinal product “Canephron N“, as the advertisement assured consumers that the preparation effectively reduces the severity of symptoms of lower urinary tract infection^[23].

A fairly large number of violations of the requirements regarding the absence of guarantees of the positive action of the medicine were previously identified by the control body in the advertising of the medicinal product “Duphaston“.

Thus, FAS Russia established that consumer attention is fixed on the statements “effectively eliminates pelvic pain, dyspareunia, and dysmenorrhea“ “pregnancy rate reaches 50% after treatment of endometriosis” “pregnancy rate reaches 50% with postoperative dydrogesterone treatment of endometriosis” “The preparation Duphaston effectively reduces pain in endometriosis” “leads to regression of endometriotic foci by reducing cell proliferation and activating apoptosis in them”  “there are no side effects associated with the stimulation of estrogen and other receptors”^[24].

A separate requirement for medicine advertising is the prohibition to represent the medicinal product as a biologically active supplement, food supplement, or other product that is not a medicine.

In fact, the legislator has established special requirements for the advertising of Biologically Active Supplements (BAS), in connection with which it is necessary to clearly distinguish the objects of advertising.

Also, advertising of medicinal products must not contain assertions that the safety and/or efficacy of the object of advertising are guaranteed by its natural origin.

In this regard, it is recommended to avoid such wordings as: “The preparation is made based on natural ingredients” and other similar wordings^[25].

An important requirement for the advertising of medicinal products is the requirement that such advertising must be accompanied by a warning about the presence of contraindications to their use and application, the necessity of familiarization with the instructions for use, or obtaining consultation from specialists.

At the same time, a fairly common question is the necessity of indicating in the advertisement simultaneously the presence of contraindications, the necessity of familiarization with the instructions, and consultation with a specialist, or whether it is possible to indicate one of such wordings.

FAS Russia has provided clarification that it is permissible to include one of the types of warnings in the content of advertising of medicinal products:

• about the presence of contraindications to their use and application;
• about the necessity of familiarization with the instructions for use of the object of advertising;
• about the necessity of obtaining consultation from specialists.

In this case, depending on the type of object of advertising, the advertiser has the right to independently determine which of these types of warning to use in the advertisement^[26].

In practice, the advertiser most often resorts to indicating two of the warnings given above.

For example: “there are contraindications, it is necessary to familiarize yourself with the instructions“ or “there are contraindications, it is necessary to obtain consultation from specialists”.

However, from the literal interpretation of FAS Russia's clarifications, it follows that one can indicate one of the three types of warning given above.

Nevertheless, the control body does not establish criteria for determining the “sufficiency” of applying an indication of one or another type of warning.

In this regard, disputed issues may arise in practice as to whether the advertiser correctly determined the necessary type of warning.

Currently, law enforcement practice within the framework of the indicated clarifications has not been formed, in connection with which it is recommended to adhere to standardly applied wordings that were used in advertising materials that passed the FAS Russia check without detecting violations regarding the indication of this warning.

The Law on Advertising also establishes requirements for the duration of the warning in advertising:

• in advertising disseminated in radio programs, the duration of such warning must be at least 3 seconds;
• in advertising disseminated in television programs and during cinema and video services – at least 5 seconds, and at least 7 percent of the frame area must be allocated;
• in advertising disseminated by other methods – at least 5 percent of the advertising area (advertising space).

FAS Russia additionally explains that the Law on Advertising does not contain norms determining exactly how the text should be placed in the advertisement; therefore, the area of the warning should be calculated based on the ratio of the area of the entire advertising layout (advertisement) and the area of space occupied by the warning text.

The calculation of the area of such a warning (inscription) is carried out by analogy with the so-called “font size” accepted in publishing.

It is also important to pay attention to the fact that requirements stating that communication in advertising about properties and characteristics, including methods of use and application, of medicinal products and medical devices is permitted only within the limits of indications contained in the instructions for use and application of such objects of advertising approved in the established procedure are somewhat contradictory.

Whereas in accordance with Part 2, Article 67 of the Law on Circulation of Medicinal Products, advertising materials about a medicinal product dispensed without a prescription must correspond to the instructions for use of the medicinal product.

That is, the wording that the advertising of medicinal products must be “within the limits of indications contained in the instructions” somewhat narrows the circle of possible advertising wordings and does not fully comply with the general legal requirements indicated in the Law on Circulation of Medicinal Products.

At the same time, in practice, the control body is guided precisely by the norm on advertising the medicine within the limits of indications for use designated in the instructions.

Cases of bringing advertisers to liability began to occur especially frequently during the pandemic, as some advertising materials contained information about the use of medicines in the treatment of coronavirus infection, which contradicted the indications for use of a particular medicine^[27].

At the same time, FAS Russia often does not accept arguments that the characteristics of the medicinal product not corresponding to the indications for use are presented in accordance with clinical studies.

For example, the instructions for use of the medicinal product “Broncho-munal” lack such properties and characteristics of the preparation as reducing the risk of complications by three times, including complications in the form of otitis media.

In the indicated case, the advertiser explained that the reduction of the risk of complications by three times, including in the form of otitis media, was proven by the clinical study “Jara-Perez J.V. et al.

Primary prevention of acute respiratory tract infections in children using a bacterial immunostimulant: a double-masked, placebo-controlled clinical trial // Clinical Therapeutics, 200. Vol. 22 P. 748 – 759”. However, in the opinion of FAS Russia, the study cannot be accepted as evidence of reducing the risk of complications, since the advertiser did not provide documentary confirmation that this study was approved by the Ministry of Health of the Russian Federation, and the result of this study is not reflected in the instructions for use of the medicinal product^[28].

It is important to note that the non-compliance of advertising materials with the indications for use specified in the instructions for use of the medicinal product is one of the most common violations identified by the control body.

In addition to the requirements indicated above, in accordance with Article 13 of the Law on Advertising, the advertiser, at the request of the advertising distributor, is obliged to provide documentarily confirmed information about the compliance of the advertising with the requirements of the specified law, including information about the presence of a license, mandatory certification, and state registration.

However, the Law on Advertising does not contain provisions obliging the indication of information about the license directly in the advertising of activities subject to licensing.

Consequently, indicating information about the license directly in the advertising of activities subject to licensing is not required^[29].

Thus, when designing advertising materials, it is extremely important to conduct an analysis of the compliance of their content and presentation methods with the requirements of legislation on advertising.

Also currently, a bill proposing to ban the advertising of medicines in television programs and radio programs is under consideration by the State Duma of the Russian Federation.

The explanatory note to the bill reports that despite the fact that advertising of medicinal products is accompanied by a warning about the presence of contraindications to their use and application, the necessity of familiarization with the instructions for use, or obtaining consultation from specialists, citizens often do not pay attention to these messages when urgent elimination of pain with the help of medicines is needed.

This happens because intrusive advertising of medicinal products contains messages about instant healing and contributes to creating an impression in a person that the medicine is capable of curing the manifestation of ailments even without consulting a doctor.

The result of such advertising is the acquisition of medicines by consumers not by the prescription or advice of a doctor, but by the advice of the advertiser.

It seems that, having drawn attention precisely to the increase in mortality due to self-medication, many foreign countries have adopted restrictive measures on the dissemination of information about medicinal products in the media.

In view of the stated, it is proposed to apply this ban in Russian legislation^[30].

We believe that the introduction of such a restriction will lead to the elimination of such an important channel for promoting medicinal products as the media.

At the same time, such an innovation can hardly limit citizens' decisions on self-medication; however, it will significantly limit patients' access to information about existing and newly released medicinal products.

Often, the assessment of the compliance of certain advertising materials with the requirements of legislation on advertising is highly subjective.

An important document allowing the determination of criteria for the admissibility of using certain wordings in advertising is the Recommendations of FAS Russia on compliance with legislation on advertising of over-the-counter medicinal products published on November 22, 2018.

Let us consider their main provisions in more detail. It is important to pay attention that when preparing the Recommendations, the practice of AIPM in considering ethical disputes on advertising between its members based on the AIPM Code of Good Practice was also taken into account.

The most important component of the indicated recommendations is the list of examples of permissible and inadmissible wordings in advertising^[31].

Thus, verbs and verb forms (participles, gerunds) of the perfective aspect indicating the onset of the final result and allowing no other interpretation are inadmissible.

For example: “will rid, will cure, will defeat, will solve (the problem), will destroy, will eliminate, will remove (pain, spasm, etc.), will restore, it will become easier, will heal, helps (to heal, cure, defeat, destroy)”.

It is also not recommended to use nouns indicating the onset of the final result and allowing no other interpretation, as well as phrases with these words (including with the verbs “contributes“ “helps” etc.).

For example: “victory, cure, complete riddance, solution to the problem, contributes to cure, helps healing, etc.“

Instead, verbs indicating a process rather than a result are permissible.

For example: “treats, contributes to treatment, helping, helps to solve, protects, helps to remove, helps to restore, renders”.

It is recommended to use nouns and phrases with them that do not indicate the inevitable onset of the result (for example: “cause, disease, symptoms (including specific types of symptoms), problem, process, treatment, action, helps liberation, helps (contributes to) treatment, protection, helps (contributes to) restoration, etc. ”).

For example, advertising with the wording: “No-Shpa“ removes the spasm, and the pain goes away!” was recognized as illegal^[32].

Also, according to the recommendations, the use of adverbs indicating the achievement of a result or the speed of action of the medicine is inadmissible in advertising.

For example: “definitely, certainly, inevitably, guaranteed, forever, never, quickly (with the exception of phrases given in the 'Permissible' column), slowly, continuously, rapidly, instantly, long, etc.“

Instead, it is recommended to include adverbs in advertising indicating the characteristic of the action of the advertised medicinal product, including adverbs in a figurative sense.

For example: “simultaneously, gently, significantly, insignificantly, conveniently, tenderly, affectionately, softly, etc.“, as well as indications of the time of absorption, distribution, elimination, and other similar characteristics of the preparation in seconds, minutes, hours, and other similar units of time.

Examples of inadmissible adverbs in advertising can serve wordings: “Destroy pain and remove inflammation in a minute” “It kills germs in the throat”.

FAS Russia also draws attention to the fact that the guarantee of cure when using the indicated wordings is reinforced by the video sequence of the commercial, demonstrating how a singer hits green clouds with the inscriptions “inflammation” and “pain” and they instantly disappear^[33].

Additionally, the recommendations note that commercials about medicinal products may use a typical advertising technique in the form of demonstrating possible symptoms of the disease, methods of using the preparation, and the process of achieving the therapeutic effect, provided that the audiovisual sequence of the commercial does not guarantee the positive action of the object of advertising, its safety, and efficacy.

It is important to recall that the beginning of the pandemic in 2020 was marked by an increase in the number of violations of advertising legislation when advertising antiviral medicinal products.

For example, FAS Russia recognized the advertising of the medicinal product “Arbidol” with an indication of its efficacy against the coronavirus infection COVID-19 as illegal^[34].

Specifics of Advertising Over-the-Counter (OTC) Medicinal Products and Prescription (Rx) Medicinal Products

According to the general rule of Part 2, Article 67 of the Law on Circulation of Medicinal Products, information about medicinal products dispensed without a prescription may be contained:

• in publications and announcements of the mass media;
• specialized and general printed publications;
• instructions for use of medicinal products;
• other publications of subjects of circulation of medicinal products.

Advertising materials regarding a medicinal product dispensed without a prescription must correspond to the instructions for use of the medicinal product.

Let us consider in more detail the main issues arising in law enforcement practice when advertising prescription medicinal products.

As noted above, according to Clause 1, Article 67 of the Law on Circulation of Medicinal Products, information about medicinal products dispensed by prescription may be contained only:

• specialized publications intended for medical and pharmaceutical workers, veterinary specialists (may be contained in monographs, reference books, scientific articles;
• reports at congresses, conferences, symposia, scientific councils;
• as well as in instructions for the use of medicinal products.

At the same time, the indicated requirements relate to any information about prescription medicines, including that relating to advertising.

Simultaneously, by virtue of Article 24 of the Law on Advertising, advertising of medicinal products in forms and dosages dispensed by prescription is not permitted otherwise than:

• at places of medical or pharmaceutical exhibitions, seminars, conferences, and other similar events;
• in specialized printed publications intended for medical and pharmaceutical workers.

It should be noted that the Law on Circulation of Medicinal Products provides for such wording as “specialists in the field of circulation of medicinal products”.

However, Russian legislation contains definitions of the concepts “pharmaceutical worker“ and “medical worker“ but lacks information on what is understood by”.

Decision of the Board of the Eurasian Economic Commission No. 206 of November 26, 2019, approved the classifier of positions of employees (in the part of positions related to the production and circulation of medicinal products)^[35].

In fact, it includes all possible positions of pharmaceutical workers.

Federal Law No. 323-FZ of November 21, 2011, “On the Fundamentals of Protecting the Health of Citizens in the Russian Federation“ (hereinafter – “The Law on Fundamentals of Health Protection“, “Law No. 323-FZ”) stipulates that a pharmaceutical worker is “an individual who has a pharmaceutical education, works in a pharmaceutical organization, and whose job duties include wholesale trade in medicinal products, their storage, transportation and/or retail trade in medicinal products for medical use, their manufacture, dispensing, storage, and transportation”.

Currently, there are no clarifications regarding the terminology cited.

It is important that advertising of prescription medicinal products is not disseminated outside the venues of events held for pharmaceutical and medical workers and in non-specialized printed publications.

Thus, one cannot place advertising of prescription drugs in public access, including on open pages of the Internet.

Otherwise, the advertising will be recognized as improper^[36]. Within the framework of the indicated ban, questions often arise about methods of limiting the audience of listeners when conducting events for pharmaceutical and medical workers in the form of webinars and other online meetings.

In practice, pharmaceutical companies are recommended to introduce registration of event participants with a request for confirmation that the participant is a medical or pharmaceutical worker.

Also, bans on references to specific cases of cure from diseases, improvement of human health as a result of using the object of advertising, as well as expressions of gratitude by individuals in connection with the use of the object of advertising, do not apply to the advertising of prescription medicinal products.

At the same time, advertisers quite often resort to so-called “surrogate“ advertising, in which prescription medicinal products are actually promoted through the advertising of over-the-counter medicines or BAS, as the subject of advertising turns out to be confusingly similar (appearance, packaging, etc.) to the prescription medicine.

The indicated violations are actively identified by FAS Russia, and such advertising is recognized as violating the requirements of legislation on advertising^[37].

Overall, the ban on advertising prescription medicinal products is characteristic of the overwhelming majority of countries in the world. For example, according to Art. 88 of Directive 2001/83/EC of the European Parliament and of the Council of November 6, 2001, on the Community code relating to medicinal products for human use, advertising of medicinal products subject to medical prescription is prohibited, with the exception of vaccination campaigns carried out with the approval of the competent authorities^[38].

To date, only two states lack a ban on advertising prescription MPs to consumers (“direct-to-consumer advertisement”), namely, the USA and New Zealand^[39].

The website of the US Food and Drug Administration (FDA) explains that: “the law does not prohibit drug companies from advertising any prescription drug, even those that can cause severe injury, addiction, or withdrawal effects”^[40].

It is important to note that an initiative to lift the ban on advertising prescription medicinal products was announced in Russia in 2015.

The indicated initiative came from the Ministry of Communications and Mass Media of Russia to apply anti-crisis measures in the media industry.

However, the Department for Control of the Social Sphere and Trade of FAS Russia declared disagreement with the project.

In this regard, this project did not pass further consideration^[41].

Nevertheless, the discussion about the reasonableness of banning the advertising of prescription medicinal products continues to this day.

The main argument in favor of allowing the advertising of prescription preparations is the formation of an additional source of information for patients about certain medicines and methods of treating diseases.

Also, allowing advertising may increase demand for prescription medicinal products, which will increase the income of pharmaceutical companies and allow for more active development of new and more effective medicinal products.

On the other hand, such advertising may give rise to an increase in cases of patient self-medication, as cases of dispensing prescription medicines without a prescription continue to exist in practice.

At the same time, risks of the unreliability of information presented in advertising can potentially harm the patient.

Thus, to date, there are no prerequisites in Russian legislation for lifting restrictions on the advertising of prescription medicinal products.

Advertising of BAS (Dietary Supplements)

Despite the fact that biologically active supplements (BAS) are natural and/or identical to natural biologically active substances, as well as probiotic microorganisms intended for consumption simultaneously with food or incorporation into the composition of food products^[42], their advertising is also directly related to the sphere of medicine circulation, although it has its own prohibitions and restrictions.

Advertising of BAS in each case must be accompanied by a warning that the object of advertising is not a medicinal product.

Requirements for such a warning have also been established:

• in advertising disseminated in radio programs, the duration of such warning must be at least 3 seconds;
• in advertising disseminated in television programs, during cinema and video services – at least 5 seconds, and at least 7 percent of the frame area must be allocated to such warning;
• in advertising disseminated by other methods – at least 10 percent of the advertising area (space).

It is important to remember that in the case of placing BAS advertising containing several objects of advertising, the size of the warning is calculated based on the total area of the advertisement.

Thus, FAS Russia recognized the placement of advertising for several BAS highlighted in one advertising block on a newspaper page as a violation.

In this case, the mandatory warning indicated above was placed at the bottom of the page of the specified printed publication and referred to the entire advertising block^[43].

In practice, questions often arise as to how the area of the warning is calculated.

FAS Russia provides clarifications that when calculating the duration or area of the warning, one should take into account the entire expression containing the direct indication of the object of advertising (including in generalized form), as well as the warning itself.

For example, the phrases: “The object of advertising is not a medicinal product” “BAS/Biologically active supplement is not a medicinal product” “Chernika-Forte is not a medicinal product” corresponding to the requirements for the duration and area of the warning, indicate compliance with the requirements of the Law on Advertising^[44].

Another important prohibition in BAS advertising is that such advertising must not create the impression that they are medicinal products and/or possess therapeutic properties.

In practice, there are cases where BAS are passed off as medicinal products during sale.

And buyers subsequently go to court demanding the return of funds paid for the purchase of BAS due to the fact that they were sold under the guise of medicines.

However, when considering this category of cases, providing evidence that the seller passed off BAS as medicines can be very difficult^[45].

BAS advertising must not contain references to specific cases of cure of people, improvement of their condition as a result of using such supplements;

Thus, advertising accompanied by consumer reviews and comments about cases of cure, improvement of condition, or positive result of using BAS will be recognized as illegal^[46].

Also, when advertising BAS, a ban is established on the expression of gratitude by individuals in connection with the use of such supplements^[47].

For example, the control body recognized as a violation the content in advertising of information that a certain person (Orsk) “thanks for the creation of the balsam 'Stozhilnik'“^[48].

In addition to the indicated restrictions, BAS advertising must not induce refusal of healthy nutrition and create an impression of the advantages of BAS by referring to the fact of conducting studies required for their state registration, nor use the results of other studies in the form of a direct recommendation for the use of such supplements.

It is also important to remember that in case of violations of requirements for BAS advertising, liability may be imposed not only on the advertiser but also on the advertising distributor.

Thus, at the beginning of 2020, FAS Russia revealed that Google and Yandex disseminated advertising for a biologically active supplement that contained a component prohibited in Russia.

Specifically, the check was carried out regarding the advertising of the BAS “Gaia Herbs” which was sold in the “iHerb“ online store.

The composition of “Gaia Herbs” includes “Kava pepper (piper methysticum)“ which belongs to the list of potent substances; its manufacture and distribution are prohibited in the territory of Russia.

In this regard, LLC “Yandex” and Google LLC were issued an order demanding the removal of the advertisement.

If the order were ignored, the indicated companies could have been assigned a fine of 100,000 to 500,000 rubles^[49].

Thus, when advertising BAS, first of all, it is necessary to take into account the restrictions cited above and observe the requirements for the warning that BAS is not a medicine.

It is also important to remember the ban on passing off BAS as medicines and positioning BAS as a substitute for ordinary food products.

Violations of Legislation on Advertising of Medicinal Products and Liability for Its Violation

Article 38 of the Law on Advertising establishes that violation of the legislation of the Russian Federation on advertising by individuals or legal entities entails liability in accordance with civil legislation.

Persons whose rights and interests are violated as a result of the dissemination of improper advertising have the right to apply in the established procedure to a court or arbitration court, including with claims for compensation for damages, including lost profits, compensation for harm caused to the health of individuals and/or property of individuals and legal entities, compensation for moral harm, and public refutation of unreliable advertising (counter-advertising).

Also, the control body itself has the right to apply to the court with a demand for counter-advertising.

Civil liability is understood as adverse property consequences for a person who committed a civil offense, expressed in the loss by such person (offender) of part of the property.

Thus, civil liability, as a rule, is of a property nature. It can take the form of compensation for damages, harm (including moral), payment of a penalty, etc.

The legislator differentiates the liability of subjects of advertising activity:

• The advertiser bears liability for violations of legislation on advertising regarding the content of information provided for the creation of advertising.
• The advertising producer bears liability for violations of legislation on advertising regarding the design, production, and preparation of advertising for dissemination.
• The advertising distributor bears liability for violations of legislation concerning the time, place, and means of advertising placement.

If a person who violated a right received income as a result, the person whose right was violated is entitled to demand compensation for lost profits along with other damages in an amount not less than such income.

An example of lost income can be the unlawful depiction of a famous person in advertising without their consent^[50].

In particular, for violation, the advertiser bears liability for violating the requirements of the legislation of the Russian Federation on advertising regarding the communication in advertising of properties and characteristics, including methods of application and use, of medicinal products outside the limits of indications contained in instructions for the use and application of such objects of advertising approved in the established procedure^[51].

An example of the advertising distributor's liability is liability for advertising goods, the production and/or sale of which requires obtaining licenses or other special permits, in the absence of such permits.

Thus, advertising distributors are recommended to mandatorily check the availability of relevant licenses from advertisers^[52].

In addition to liability provided for by civil legislation, the Code of Administrative Offenses of the Russian Federation (CAO RF) provides for a special composition of an administrative offense – “Violation of legislation on advertising of medicinal products” (Part 5, Article 14.3 of the CAO RF).

For such a violation, the imposition of an administrative fine is provided:

• on citizens in the amount of 2,000 to 2,500 rubles;
• on officials – from 10,000 to 20,000 rubles;
• on legal entities – from 200,000 to 500,000 rubles.

This norm establishes an increased amount of administrative liability for violations of legislation on advertising regarding requirements for advertising medicinal products, medical devices, medical services, and biologically active supplements^[53].

In addition to imposing fines, the control body issues an order to cease the dissemination of advertising materials contradicting legislation on advertising.

There is also a practice of replacing the fines indicated above with administrative warnings.

Thus, Part 2 of Article 3.4 of the CAO RF provides that a warning is established for administrative offenses committed for the first time in the absence of harm or the emergence of a threat of harm to the life and health of people, objects of the animal and plant world, the environment, cultural heritage sites (monuments of history and culture) of the peoples of the Russian Federation, state security, the threat of natural and man-made emergencies, as well as in the absence of property damage.

The control body applies the specified norm based on the actual circumstances of the case.

For example, when considering one of the cases on violation of legislation on advertising, the control body concluded that the actions of the medical rehabilitation center to disseminate advertising constitute an administrative offense event.

The specified legal entity had the opportunity to comply with all requirements of the current legislation on advertising but treated its duty with disdain.

However, a circumstance mitigating administrative liability is the termination of the violation by the legal entity.

In view of this, taking into account the commission of the offense for the first time, a decision was made to replace the fine with a warning^[54]. Also, in practice, the control body takes into account the fact whether the person violating the legislation on advertising is a small and medium-sized enterprise (SME) subject, as the imposition of a fine on the specified persons may entail serious economic losses for them^[55].

It is important to pay attention that the subject of the offense can be both the advertiser and the advertising distributor.

According to the conclusions of judicial practice, the advertiser bears liability for violation of legislation on advertising regarding its content, unless it is proven that the specified violation occurred through the fault of the advertising distributor or advertising producer^[56].

At the same time, each instance of improper advertising is specific information about a specific object of advertising, the dissemination of which is carried out in violation of legislative requirements.

Accordingly, administrative liability arises for each fact of violation of the legislation of the Russian Federation on advertising (dissemination of improper advertising)^[57].

Also, advertising may contain signs of unfair competition, liability for which is provided by Article 14.33 of the CAO RF.

The indicated article provides for liability in the form of imposing an administrative fine:

• on officials in the amount of 12,000 to 20,000 rubles;
• on legal entities – from 100,000 to 500,000 rubles.

Unfair competition represents a violation of generally accepted rules and norms of competition:

• illegal receipt, use, and disclosure of confidential information;
• dissemination of false information;
• concealment of information important to consumers, and the like^[58].

In fact, the main sign of unfair competition is the focus on preventing the dissemination of objective and reliable information about competitors.

Clarifications on the application of the above Articles 14.3 and 14.33 of the CAO RF were given back by the Supreme Arbitration Court of the RF, according to which, if acts of unfair competition manifest in advertising, the rules of Art. 14.3 of the CAO RF (violation of legislation on advertising) should be applied^[59].

The Federal Antimonopoly Service and its territorial divisions are authorized to initiate cases on signs of violation of legislation on advertising (Article 33 of the Law on Advertising).

In particular, the antimonopoly authority has the right to:

• issue mandatory orders to advertisers, advertising producers, and advertising distributors to cease violations of the legislation of the Russian Federation on advertising;
• issue mandatory orders to federal executive bodies, executive bodies of constituent entities of the Russian Federation, and local self-government bodies to cancel or change acts issued by them that contradict the legislation of the Russian Federation on advertising;
• file lawsuits in a court or arbitration court to ban the dissemination of advertising carried out in violation of the legislation of the Russian Federation on advertising, as well as lawsuits for public refutation of unreliable advertising (counter-advertising);
• apply to the arbitration court with statements on declaring invalid, in whole or in part, non-normative acts and normative legal acts contradicting the legislation of the Russian Federation on advertising;
• apply liability measures in accordance with the legislation of the Russian Federation on administrative offenses;
• apply to the arbitration court with statements on declaring invalid a permit for the installation of an advertising structure and issue mandatory orders to local self-government bodies of a municipal district or local self-government bodies of an urban district to annul a permit for the installation of an advertising structure;
• organize and conduct checks on compliance with the requirements of the legislation of the Russian Federation on advertising.

Officials of the antimonopoly authority exercising state supervision in the sphere of advertising, in accordance with the powers entrusted to them, have the right to freely visit buildings and premises used by legal entities and individual entrepreneurs upon presentation of a service certificate and a copy of the order (instruction) of the head (deputy head) of the antimonopoly authority on conducting a check, for the purpose of conducting control measures and obtaining documents and information necessary during the check.

In addition, the antimonopoly authority is granted the right to request documents without any restrictions on the composition and volume of information necessary for the implementation of its tasks and functions by the antimonopoly authority.

In this case, the antimonopoly authority may request only documents related to the violation of legislation on advertising and concerning the activities of certain persons^[60].

Under Art. 19.8 of the CAO RF, failure to submit to the federal antimonopoly authority or its territorial body information (data) provided for by legislation on advertising, as well as the submission of such information (data) in an incomplete volume or in a distorted form, or the submission of unreliable information (data), entails the imposition of an administrative fine:

• on officials from 2,000 to 10,000 rubles;
• on legal entities from 20,000 to 200,000 rubles.

It is also important to note that Part 2, Article 35 of the Law on Advertising establishes that the disclosure by employees of the antimonopoly authority of information constituting a commercial, official, and other secret protected by law entails liability in accordance with the legislation of the Russian Federation on administrative offenses or the criminal legislation of the Russian Federation.

Damages caused by such disclosure are subject to compensation in accordance with civil legislation. Also, according to Part 2, Art. 6 of Federal Law No. 59-FZ of May 2, 2006, “On the Procedure for Considering Appeals of Citizens of the Russian Federation” when considering an appeal, the disclosure of information contained in the appeal, as well as information concerning the private life of a citizen, is not permitted without their consent.

It is not a disclosure of information contained in the appeal to send a written appeal to a state body, local self-government body, or an official whose competence includes resolving the issues raised in the appeal.

According to Article 7 of Federal Law No. 152-FZ of July 27, 2006, “On Personal Data“ operators and other persons who have gained access to personal data are obliged not to disclose to third parties and not to disseminate personal data without the consent of the subject of personal data, unless otherwise provided by federal law.

Based on the indicated norms, the antimonopoly authority has the right to hide the personal data of applicants who reported information about a violation of legislation on advertising if the applicants did not give consent to the processing of their personal data in their applications^[61].

When conducting checks on violations of legislation on advertising, the period for conducting the check cannot exceed 20 business days.

In exceptional cases related to the necessity of conducting complex and/or lengthy special examinations and investigations based on motivated proposals of officials conducting the check, the indicated period may be extended by the head of the antimonopoly authority, but by no more than 10 business days.

If violations of legislation on advertising were identified based on the results of the check, the antimonopoly authority issues an order to cease the violation of the legislation of the Russian Federation, which must be executed within the period indicated in the order (but not exceeding 5 days from the date of receipt of the order).

The order of the antimonopoly authority may be challenged in court within 3 months from the date of the decision or issuance of the order.

However, filing an application to challenge the order does not suspend its execution, except for the case where the court imposes corresponding interim measures in the form of suspension.

To date, it should be noted that according to the statistical observation of FAS Russia for 2020, the number of violations in the advertising of medicinal products, medical services, and biologically active supplements has decreased compared to the previous year^[62].

The control body also notes an increase in the effectiveness of the regulation of medicine advertising based on the developed detailed recommendations.

Promotion of Medicinal Products on the Internet

Currently, an increasing amount of material about medicinal products is disseminated on the Internet.

At the same time, the promotion of medicines on the Internet is not always carried out through advertising.

For example, FAS Russia has provided clarifications that the issuance by a search engine of a list of hyperlinks to various sources of information (websites, forums, etc.) is not advertising, since the issuance of such a list is the result of processing a user's search query.

However, when information aimed at attracting attention to a specific product and distinguishing it from other goods (for example, a pop-up banner, information marked “advertising“ placed via a contextual advertising system) is also placed on the search results page in addition to search results, such information constitutes advertising^[63].

In this case, the materials must contain the signs of advertising established by law.

FAS Russia also reports that: “information about produced or sold goods posted on the website of the manufacturer or seller of these goods or on pages in social networks of the manufacturer or seller of these goods is not advertising if the specified information is intended to inform visitors of the website or page in the social network about the sold goods and assortment”.

However, these clarifications also indicate that if the content of such materials boils down to attracting attention to a certain product, then such information can be recognized as advertising^[64].

Thus, the indicated clarifications do not provide unambiguous criteria for assessing whether certain materials about medicinal products posted online constitute advertising.

Let us recall that in 2020, the Rules for issuing a permit for the retail trade of medicinal products for medical use by remote means were approved, according to which the issuance of a permit for retail trade of medicinal products by remote means is carried out by Roszdravnadzor.

Obtaining a Permit is possible if the pharmacy organization has:

• at least 10 places of carrying out pharmaceutical activity in the territory of the Russian Federation;
• equipped premises (places) for storing formed orders; a website in the information and telecommunication network “Internet“;
• its own courier service possessing equipment ensuring the maintenance of the necessary temperature regime for the delivery of thermolabile medicinal products, or a contract with a courier delivery service possessing such equipment;
• an electronic payment system and/or mobile payment terminals^[65].

The specified resolution refers to the remote sale of over-the-counter medicines only.

Online sale of medicines dispensed by prescription, narcotic, psychotropic, and alcohol-containing medicinal products with an ethyl alcohol volume fraction of more than 25% is still not permitted.

The website of an online pharmacy must mandatorily contain information about medicinal products available in stock from its own inventory and subject to retail sale by remote means, containing information about medicinal products in accordance with the state register of medicinal products for medical use available for order, manufacturers of medicinal products, expiration dates of medicinal products, quantity, retail prices, and storage conditions, as well as instructions for the medical use of medicinal products.

Overall, when promoting OTC (over-the-counter) medicinal products, including through advertising, requirements for advertising materials must also comply with both the general requirements of Article 5 and the special requirements of Art. 24 of the Law on Advertising. However, questions and difficulties regarding the procedure for limiting free access on the Internet to advertising of prescription medicinal products still arise.

To date, pharmaceutical companies working online introduce various restrictions on access to advertising of prescription medicines.

For example, by warning that the site information is intended only for medical and pharmaceutical workers with an offer to confirm that the specified person is such.

However, this does not always fully protect advertising materials from access by persons to whom they are not addressed.

Thus, the issue of clear measures to restrict advertising of medicinal products on the Internet is currently not regulated at the legislative level.

Furthermore, many specialists note the question of how, given the international nature of the Internet, to determine the focus of medicines on promotion specifically in the Russian Federation and how to ensure the identification of the advertiser and advertising distributor if the hosting is located outside Russia and the site has a foreign domain name.

Based on the foregoing, it is important to note that the adoption of the Decree of the Government of the Russian Federation regulating online trade in medicines has significantly increased the attractiveness of distributing medicines on the Internet.

Nevertheless, a number of questions regarding the control of advertising and other methods of promoting medicinal products online (especially prescription ones) remain unregulated, which creates risks of an increase in the number of possible violations.

Promotion of Biomedical Cell Products

Federal Law No. 180-FZ of June 23, 2016, “On Biomedical Cell Products“ (hereinafter – “The Law on Biomedical Cell Products”) establishes that a Biomedical Cell Product (hereinafter – “BMCP”) is “a complex consisting of a cell line (cell lines) and excipients or of a cell line (cell lines) and excipients in combination with registered medicinal products for medical use and (or) pharmaceutical substances included in the state register of medicinal products, and (or) medical devices.“

In accordance with Article 40 of the Law on Biomedical Cell Products, “information about biomedical cell products must be contained only in specialized publications, including monographs, reference books, scientific articles, reports at congresses, conferences, symposia, scientific councils, on specialized websites in the 'Internet' network, as well as in instructions for the use of biomedical cell products and other information materials intended for medical workers”.

Thus, the legal regime for information about BMCPs is similar to the requirements for promoting prescription medicines.

At the same time, it is important to note that the Rules for the Sale of Biomedical Cell Products, approved by Decree of the Government of Russia No. 49 of January 23, 2018, limit the circle of persons to whom BMCP manufacturers sell them.

Such persons include:

• other BMCP manufacturers (for the production of BMCP);
• scientific organizations;
• educational organizations (for conducting scientific research);
• organizations carrying out medical activity.

Medical assistance using BMCPs can be provided by medical workers who have undergone training under an additional professional program (advanced training program) on issues of BMCP application.

Independent use of biomedical cell products by a patient is not permitted. When considering and assessing violations of the quality of released BMCP batches, as well as when making decisions on withdrawing released BMCP batches from circulation, corrective and preventive actions, and other measures to reduce risk, the organization must apply risk management principles to ensure BMCP quality^[66].

Based on the foregoing, it can be concluded that the dissemination of information about BMCPs is possible only within the professional environment without the possibility of advertising them in open access.

Consequently, the regulation of BMCP promotion is even stricter than the regulation of the promotion of prescription medicines, the advertising of which is still possible, as is the communication of information about the medicinal product from doctor to patient.

However, regarding BMCP promotion, the legislation regulates precisely the specifics of interaction between doctors and BMCP manufacturers.

Other Channels for Promoting Medicinal Products by Pharmaceutical Manufacturers

One of the key tools for promoting medicinal products is working with doctors and pharmacists.

On the one hand, which medicinal product will be purchased largely depends on their prescriptions and recommendations.

On the other hand, it is important to observe the principle of reasonableness and not violate the principle of free competition when distributing medicinal products.

At the same time, it is important that the medical community and pharmacists receive timely information about the development of the pharmaceutical industry, the appearance of new medicines, and their efficacy, excluding any corruption component and possible conflicts of interest.

Restrictions on the interaction of medical manufacturers with pharmaceutical and medical workers are established by Art. 74 of the Law on Fundamentals of Health Protection and Articles 67.1 and 67.2 of the Law on Circulation of Medicinal Products.

The established bans apply to pharmaceutical and medical workers, as well as to heads of pharmacy organizations and medical organizations.

In particular, medical workers and heads of medical organizations are not entitled to accept from organizations engaged in the development, production, and/or sale of medicinal products, medical devices, organizations possessing rights to use the trade name of a medicinal product, organizations for wholesale trade in medicinal products, pharmacy organizations (their representatives, other individuals and legal entities carrying out their activities on behalf of these organizations) gifts, funds (with the exception of remuneration under contracts when conducting clinical studies of medicinal products, clinical trials of medical devices, remuneration associated with the implementation by a medical worker of pedagogical and/or scientific activity), including for payment of entertainment, recreation, travel to a place of recreation, as well as to participate in entertainment events held at the expense of companies or company representatives.

A ban is also established on receiving samples of preparations and medical devices from a company or its representative for handing over to patients; and in certain cases, on receiving company representatives. In addition, a doctor is prohibited from prescribing medicines on forms containing information of an advertising nature.

Pharmaceutical workers and heads of pharmacy organizations are not entitled to accept gifts, funds, including for payment of entertainment, recreation, travel to a place of recreation, and to participate in entertainment events held at the expense of a company or company representative.

Similar (corresponding) bans are also established for pharmaceutical manufacturers and their representatives.

In addition, pharmaceutical manufacturers and their representatives are not entitled to visit medical workers during working hours at workplaces, except for cases related to conducting clinical studies of medicinal products for medical use, participation in meetings of medical workers and other events aimed at improving their professional level or providing information related to monitoring the safety of medicinal products, in the manner established by the head of the medical organization.

To date, quite a few questions arise when applying the bans indicated above in practice.

For example, which of the events held by a pharmaceutical company can be classified as scientific and which as entertaining?

Clear criteria for distinguishing such events are absent at the legislative level. Is it permissible for pharmaceutical manufacturers to pay for a buffet when holding scientific events with the participation of pharmaceutical and medical workers?

There is also a question of whether it is possible to organize meetings of medical workers with pharmaceutical manufacturers or their representatives outside working hours and on what conditions.

All indicated questions are currently effectively left to the discretion of the pharmaceutical manufacturers themselves, who independently assess the risks of holding a particular event.

The indicated legal uncertainty contributes to the emergence of a whole range of difficulties in organizing effective information interaction between pharmaceutical manufacturers and medical or pharmaceutical workers.

For example, Directive 2001/83/EC of the European Parliament and of the Council of November 6, 2001, “On the Community code relating to medicinal products for human use” indicates that doctors should not be influenced by direct or indirect financial incentives from medical representatives and other persons.

At the same time, it provides for the possibility, within certain limiting conditions, to provide samples of medicinal products free of charge to persons authorized to prescribe medicines or to supply them so that they can familiarize themselves with new preparations and gain experience in handling them.

It is important to note that by the restrictions established above (both in Russian and foreign legislation), the legislator did not pursue the goal of completely excluding the possibility of any interaction between representatives of the medical and pharmaceutical communities.

These bans are established directly in the interests of patients in order to exclude a biased approach by a doctor or pharmacy employee when providing a patient with information about a particular medicinal product.

The most detailed criteria, which pharmaceutical representatives are actually currently guided by when organizing cooperation with doctors and pharmacy organizations, are given in the Code of Good Practice of the Association of International Pharmaceutical Manufacturers (AIPM).

According to Clauses 3.4.3 and 3.4.4 of the Code of Good Practice of the Association of International Pharmaceutical Manufacturers (AIPM), it is permissible to pay for or reimburse the expenses of healthcare specialists directly related to the services provided, including expenses related to the travel of healthcare specialists to the place of service provision, accommodation, and meals.

When paying for or reimbursing expenses, the following requirements must be observed:

• it is prohibited to use hotels or facilities that are associated in the eyes of the public with luxury or exclusivity, regardless of their class;
• meals are permitted within reasonable limits;
• for trips of healthcare specialists not exceeding 4 hours in the daytime, economy class air tickets should be purchased;
• reimbursement of any expenses of accompanying persons is not permitted.

Exceptions must be justified by objective necessity and agreed upon with the company management^[67].

Regarding the issue of distributing promotional materials and printed products during events, there is no ban in the AIPM Code.

However, the criterion for distributing materials is improving the professional level of healthcare specialists and not pursuing exclusively the goal of advertising.

Information provided by medical representatives must be complete, objective, reliable, and up-to-date.

The pharmaceutical company bears liability for the content and form of information provision (Articles 3.6.3, 3.6.4 of the AIPM Code).

It is important to note that the specified document uses the term “medical representative“ which is absent in current Russian legislation.

Nevertheless, medical representatives in Russia are by default understood as representatives of developers and manufacturers of medicinal products.

Thus, we believe that when assessing the legality of holding a particular event, it is important to be guided by the criteria indicated above.

From the literal interpretation of the established restrictions, organizing a meeting of a medical representative with a medical worker outside working hours will not be a violation provided that the doctor did not accept gifts (in particular, payment for lunch, travel, entertainment) within the framework of the indicated meeting.

At the same time, the Law on Circulation of Medicinal Products does not limit the exact places for holding meetings and events.

For example, it can be assumed that a business meeting can be organized in a restaurant on the condition that the doctor independently pays for the dishes purchased in the restaurant during the event.

However, it is also no less important to pay attention to the format of the event itself and its content to avoid it being of an entertaining nature.

The content of the meeting should be directly related to the provision of scientific information, training, and conducting clinical studies.

Also, doctors can be involved as speakers at such events provided that they do not advertise medicinal products and observe the scientific format of the report.

In addition, currently, the Law on Fundamentals of Health Protection establishes that a conflict of interest for a medical or pharmaceutical worker is “a situation in which, when carrying out professional activities by the indicated workers, a personal interest arises in obtaining personally or through a company representative material benefit or other advantage that affects or may affect the proper performance of their professional duties, as well as other duties, including those related to the development and consideration of clinical guidelines, due to a contradiction between the personal interest of the indicated persons and the interests of patients”.

It is important to pay attention to the fact that the legislation does not establish exact criteria for determining the presence/absence of a conflict of interest.

This can cause many disputes regarding the presence of a conflict of interest. For example, a doctor, after examining a patient at their main place of work in a state polyclinic, recommended additionally undergoing magnetic resonance imaging of the spine in a private clinic (at their place of part-time work).

Having considered such a dispute, the Orenburg Regional Court (Decision of November 11, 2016, in Case No. 21-578-2016) did not find confirmation of the worker's personal interest in referring the patient to a private clinic, since it is important to establish the fact of the worker's real interest in obtaining profit from the patient^[68].

Additionally, it is important to note that to date, liability for violating the bans cited above has not been established.

Previously, a bill was in the State Duma of the Russian Federation on introducing new articles into the CAO RF regulating, inter alia, liability in this area.

The bill proposed establishing fines for pharmaceutical manufacturers from 300,000 to 500,000 rubles, and for medical workers, a warning or a fine from 5,000 to 7,000 rubles. However, the indicated bill was rejected in 2018^[69].

Nevertheless, when giving gifts to medical or pharmaceutical workers, there is a risk of qualifying these actions as commercial bribery (Article 204.2 of the Criminal Code of the RF), since currently, petty commercial bribery in an amount not exceeding 10,000 rubles is criminally punishable, in addition to the corpus delicti of commercial bribery (Article 204 of the Criminal Code of the RF), where liability begins with bribery in an amount exceeding 25,000 rubles.

In this case, to qualify acts under the articles indicated above, it is necessary to prove that the “gift” was conditioned by the commission by the “donee” of actions in the interests of the “donor”.

Thus, issues of promoting medicinal products within the framework of interaction between pharmaceutical manufacturers (developers of medicinal products) and their representatives with pharmaceutical or medical workers currently remain not fully regulated.

When determining the limits of what is permitted, it is recommended to be guided by the literal interpretation of the restrictions established by Russian legislation and the norms of the AIPM Code in the order of independent assessment by pharmaceutical manufacturers of the legality of committing certain actions/holding events.

There are various forms of promoting medicinal products subject to legal regulation. At the same time, with the development of information technologies, new forms of promotion appear, which gradually prompt the legislator to adopt new legal acts for their regulation.

At the same time, the indicated legal acts are not always adopted promptly, and sometimes regulate already actually established promotion practices.

Legislation on advertising in the Russian Federation imposes various requirements on the advertising of prescription and over-the-counter medicinal products, as well as BAS.

At the same time, one cannot fail to note the significant number of committed violations identified by the control body.

We believe that the issuance by FAS Russia of detailed recommendations and criteria for assessing advertising materials contributes to reducing the number of offenses.

Violations of legislation on advertising are far from always associated with a purposeful desire of pharmaceutical companies to promote medicinal products in an unfair manner.

Often, the assessment of advertising materials and their content is highly subjective.

In this regard, it is recommended to conduct an additional legal analysis of advertising materials by lawyers practicing in the field of pharmaceutical law.

Also problematic is the issue of limiting access to advertising of prescription medicinal products on the Internet, as legislatively established mechanisms for protecting such information are absent.

In fact, such mechanisms are independently developed by pharmaceutical manufacturers.

Issues of interaction between pharmaceutical companies and medical and pharmaceutical workers remain regulated to a much lesser extent.

To date, the issue of more detailed legislative regulation of restrictions on interaction between pharmaceutical companies and medical workers remains relevant, taking into account various methods of such interaction already established in practice but causing disputes and doubts regarding the possibility/impossibility of their application.

We believe that a number of important provisions on issues of promoting medicinal products not regulated by Russian legislation can be proposed to be borrowed from the AIPM Code.

_____________________

^[1] Kotler P., Gary A. Principles of Marketing. 5th European ed. Moscow: Williams, 2015. P. 33.

^[2] Letter of the Federal Antimonopoly Service No. AK/92163/17 dated December 27, 2017, “On the Differentiation of the Concepts of 'Signboard' and 'Advertising”.

^[3] Decision of the Kemerovo OFAS Russia dated February 28, 2020, in Case No. 042/05/28-82/2020.

^[4] Letter of FAS Russia No. DF/82787/20 dated September 24, 2020, “On Classifying Information Stands as Advertising Structures”

^[5] Letter of FAS Russia No. AK/52901/19 dated June 24, 2019, “On Clarification Regarding Advertising in Messengers (Viber, Whatsapp), Classification of Information as Advertising, Methods of Identifying Advertisers”.

^[6] Letter of FAS Russia No. AK/41745/21 dated May 24, 2021, “On Qualification of Information on Free Services Rendered by a Non-Profit Organization as Advertising”.

^[7] Resolution of the Plenum of the Supreme Arbitration Court of the RF No. 58 dated October 8, 2012, “On Certain Issues of the Practice of Application of the Federal Law 'On Advertising' by Arbitration Courts.

^[8] FAS in the Media: Representatives of a Medical Center and Pharmacy Were Explained How a Signboard Differs from Advertising. September 25, 2018.

^[9] Letter of the Federal Tax Service No. ShT-6-03/348@ dated April 25, 2007.

^[10] Decision of FAS Russia dated September 3, 2020, in Case No. 08/05/5-44/2020.

^[11] Ruling of FAS Russia dated January 30, 2019, in Case No. 3-24-5/00-08-19.

^[12] Recommendations of FAS Russia on Compliance with Legislation on Advertising of Over-the-Counter Medicinal Products dated November 22, 2018.

^[13] Resolution of FAS Russia dated March 19, 2020, in Case No. 08/04/14.3-7/2020.

^[14] Decision of the Volgograd OFAS Russia dated January 30, 2017, in Case No. 16-03-5-02/743.

^[15] Clarification on Amendments to the Federal Law “On Advertising Related to the Adoption of the Federal Law “On Protection of Children from Information Causing Harm to Their Health and Development”.

^[16] FAS Will Punish the Publisher of a Periodical for “Nurofen” Advertising. March 22, 2016.

^[17] Decision of the Volgograd OFAS Russia dated March 20, 2017, in Case No. 17-03-24-02/101.

^[18] Decision of the Tatarstan OFAS Russia No. IP-08/5047 dated April 11, 2016, in Case No. 08-35/2016.

^[19] Decision of FAS Russia dated November 29, 2016, in Case No. 3-24-52/00-08-16.

^[20] Decision of the Tatarstan OFAS Russia No. IP-08/5047 dated April 11, 2016, in Case No. 08-35/2016.

^[21] Resolution of FAS Russia dated October 17, 2017, in Case No. 4-14.3-1670/00-08-17.

^[22] Resolution of FAS Russia dated September 24, 2015, in Case No. 4-14.3-875/00-08-15.

^[23] Decision of FAS Russia dated November 26, 2020, in Case No. 08/05/24-79/2020.

^[24] Resolution of FAS Russia dated September 7, 2020, in Case No. 08/04/14.3-62/2020.

^[25] Decision of FAS Russia dated September 10, 2019, in Case No. 08/05/24-72/2019.

^[26] Gorshkova L.L. Question-Answer // Financial Herald: Finance, Taxes, Insurance, Accounting. 2012. No. 3. P. 86 – 88.

^[27] Letter of the Federal Antimonopoly Service No. DF/52241/20 dated June 22, 2020, “On Advertising of Medicinal Products, Medical Devices and Medical Services, Methods of Prevention, Diagnosis, Treatment and Medical Rehabilitation, Methods of Traditional Medicine”.

^[28] Decision of FAS Russia dated November 26, 2020, in Case No. 08/05/24-80/2020.

^[29] Resolution of FAS Russia dated March 19, 2020, in Case No. 08/04/14.3-7/2020.

^[30] Letter of the Federal Antimonopoly Service No. DF/52241/20 dated June 22, 2020, “On Advertising of Medicinal Products, Medical Devices and Medical Services, Methods of Prevention, Diagnosis, Treatment and Medical Rehabilitation, Methods of Traditional Medicine”

^[31] Bill No. 1180509-7 “On Amendments to Article 24 of the Federal Law 'On Advertising' and Article 67 of the Federal Law 'On Circulation of Medicinal Products'”.

^[32] Recommendations on Compliance with Legislation on Advertising of Over-the-Counter Medicinal Products (prepared with the support of FAS Russia) dated November 22, 2018.

^[33] Resolution of FAS Russia dated October 17, 2017, in Case No. 4-14.3-1672/00-08-17.

^[34] Decision of FAS Russia dated June 15, 2017, in Case No. 3-24-26/00-08-17.

^[35] “Arbidol" Madam Against Competitors? E. Nekrasova // Rossiyskaya Gazeta – Federal Issue No. 130(8184).

^[36] Decision of the Board of the Eurasian Economic Commission No. 206 dated November 26, 2019, “On the Classifier of Employee Positions (in the Part of Positions Related to the Production and Circulation of Medicinal Products)”.

^[37] Decision of FAS Russia dated June 2, 2016, in Case No. 3-24-30/00-08-15.

^[38] FAS Recognized Advertising of an Over-the-Counter Medicine or BAS as Illegal. Pylaeva Ya. // Portal “Zakon”. November 18, 2015.

^[39] Directive 2001/83/EC of the European Parliament and of the Council of November 6, 2001, on the Community Code Relating to Medicinal Products for Human Use.

^[40] U.S. doctor group calls for ban on drug advertising to consumers // Site: Reuters.

^[41] Prescription Drug Advertising / Questions and Answers. FDA.

^[42] FAS Russia: Restrictions on Advertising of Prescription Drugs Cannot Be Lifted. Zaezdina P. // Pharmvestnik-TV. April 12, 2015.

^[43] Decision of the Commission of the Customs Union No. 880 dated December 9, 2011, “On Adoption of the Technical Regulation of the Customs Union 'On Food Safety'”.

^[44] Letter of FAS Russia No. AK/10443/16 dated February 19, 2016, “On Warning in BAS Advertising”.

^[45] Letter of FAS Russia No. AD/15051/14 dated April 17, 2014, “On Clarification of Certain Provisions of the Federal Law 'On Advertising'”.

^[46] Review of Judicial Practice of the Supreme Court of the Russian Federation No. 3 (2018), approved by the Presidium of the Supreme Court of the RF on November 14, 2018.

^[47] Resolution of the OFAS of the Ulyanovsk Region on Imposition of Administrative Punishment No. 123 dated April 26, 2019, in Case No. 15497-K/05-2019.

^[48] Decision of the Tatarstan OFAS Russia No. IP-08/6994 dated May 18, 2016, in Case No. 08-48/2016.

^[49] FAS Recognized iHerb BAS Advertising in Google and Yandex as Illegal // Portal “Sostav". October 23, 2020.

^[50] Grishaev S.P. Advertising: Legal Regulation. Moscow: Editorial Office of “Rossiyskaya Gazeta", 2015. Issue 10. 172 p.

^[51] Decision of FAS Russia dated November 26, 2020, in Case No. 08/05/24-80/2020.

^[52] Decision of the Pskov OFAS Russia dated October 28, 2020, in Case No. 060/05/7-568/2020.

^[53] Letter of FAS Russia No. AD/41673/17 dated June 21, 2017, “On Application of Art. 14.3 of the CAO RF”.

^[54] Resolution of the Kurgan OFAS Russia No. 297 dated November 7, 2018.

^[55] Resolution of the Arkhangelsk OFAS Russia dated October 16, 2017, in Case No. 03-06/14-17.

^[56] Information Letter of the Presidium of the Supreme Arbitration Court of the RF No. 37 dated December 25, 1998, “Review of Practice of Consideration of Disputes Related to Application of Legislation on Advertising”.

^[57] Letter of FAS RF No. AK/34209 dated October 1, 2009, “On Clarification of Certain Provisions of the Federal Law 'On Advertising'”.

^[58] Order of Rosstat No. 410 dated July 24, 2020, “On Approval of Federal Statistical Observation Forms for Organization of Federal Statistical Observation of Domestic and Foreign Trade, Tourism, Paid Services to the Population, Transport and Administrative Offenses in the Economic Sphere”.

^[59] Resolution of the Plenum of the Supreme Arbitration Court of the RF No. 58 dated October 8, 2012, “On Certain Issues of the Practice of Application of the Federal Law 'On Advertising' by Arbitration Courts”.

^[60] Letter of FAS Russia No. AK/45747/15 dated August 28, 2015, “On the Resolution of the Supreme Court of the RF on Bringing Communication Operators to Liability for Failure to Provide Information”.

^[61] Decision of the Kemerovo OFAS Russia dated June 1, 2016, in Case No. 54/R-2016.

^[62] The Antimonopoly Authority Published the Results of State Supervision over Compliance with Legislation on Advertising in 2019. Korobka E. // Advokatskaya Gazeta. April 14, 2020.

^[63] Letter of the Federal Antimonopoly Service No. AK/83509/19 dated September 25, 2019, “On Clarification Regarding Advertising in the Information and Telecommunication Network 'Internet'”.

^[64] Letter of FAS Russia No. AK/45828/15 dated August 28, 2015, “On Advertising in the 'Internet' Network”.

^[65] Rules for Issuing a Permit for Retail Trade of Medicinal Products for Medical Use by Remote Means, Carrying Out Such Trade and Delivery of said Medicinal Products to Citizens, approved by Decree of the Government of the Russian Federation No. 697 dated May 16, 2020.

^[66] Order of the Ministry of Health of Russia No. 512n dated August 8, 2018, “On Approval of Rules of Good Practice for Work with Biomedical Cell Products”.

^[67] Code of Good Practice of the Association of International Pharmaceutical Manufacturers (AIPM).

^[68] Zaitseva G.G. Professional Conflict of Interest: Who Falls into the Risk Zone? // Head of Autonomous Institution. 2019. No. 2. P. 39 – 47.

^[69] Bill No. 1093620-6 “On Amendments to the Code of the Russian Federation on Administrative Offenses Regarding the Improvement of Administrative Liability in the Healthcare Sphere”.