Content Requirements for Pharmaceutical Company Websites

 

Anna Ivanova, Lawyer at BRACE ©

Roman Shabrov, Partner, Attorney at BRACE ©

December 24, 2021

 

With the development of business on the Internet, legal issues related to the regulation of activities of organizations that have created official websites to distribute information about themselves and position themselves in the market for goods, works, and services arise more frequently. Some companies also create websites not to promote their products, but for information and educational purposes. This also applies to organizations operating in the pharmaceutical market. In addition to the general legally established requirements for the content of official websites, pharmaceutical companies face specific requirements related directly to the regulation of pharmaceutical activities.

In this article, we briefly consider the general requirements for websites that any pharmaceutical company will need to comply with, and touch upon the requirements for the content of websites of organizations whose business profile is the pharmaceutical industry in more detail.

Collection of Personal Data on a Website

Any website effectively provides access to its content to an unlimited number of users. Often, to purchase a particular product, work, or service, as well as for feedback, a user leaves personal data with the organization on the website.

According to Article 3 of Federal Law No. 152-FZ dated July 27, 2006, On Personal Data, personal data includes any information relating to a directly or indirectly identified or identifiable individual (the subject of personal data) to whom the information is provided. A person who collects and processes personal data effectively acquires the status of a personal data operator, since, by law, the processing of personal data means any action (operation) or set of actions (operations) performed with or without the use of automation tools with personal data, including collection, recording, systematization, accumulation, storage, clarification (updating, changing), extraction, use, transfer (distribution, provision, access), depersonalization, blocking, deletion, or destruction of personal data. Moreover, any processing of personal data is carried out with the consent of the subject of personal data. Effectively, a website owner, upon receiving personal data (surname, name, patronymic, phone number, e-mail address, passport data, etc.) from any user, acts as a personal data operator.

Processing personal data without the consent of the personal data subject entails administrative liability in the form of a fine on citizens from 3,000 to 5,000 rubles; on officials from 10,000 to 20,000 rubles; and on legal entities from 15,000 to 70,000 rubles (Article 13.11 of the CAO RF). At the same time, it is also possible for a personal data subject to appeal to a court with a demand to terminate the processing of personal data and pay compensation for moral damages. Despite the fact that currently the law enforcement practice regarding claims by personal data subjects boils down to the need to prove that the personal data operator violated the rules for processing personal data [1] (which may present difficulties if consent for processing was obtained), measures must be taken to minimize such risks. As such measures, it is recommended to publish a personal data processing policy (procedure) on the official website, which will provide for the procedure for withdrawing consent to the processing of personal data. It is also necessary to ensure that before personal data is sent by the personal data subject, automatic confirmation of consent to its processing is provided, with the possibility of ensuring access to review the personal data processing policy.

In addition to this policy, it is necessary to comply with the requirements for obtaining consent to process cookies. As a reminder, cookies are small text documents that a web server (website) saves on a user's computer using a browser. This data collection is generally carried out to optimize the website. However, unfair use of such data may lead to sending intrusive advertising to the user, as well as the leakage of other personal data [2]. In practice, on Russian websites, the rules for collecting cookies are included in the section on the personal data processing procedure. These actions are not prohibited. At the same time, the question of the need to obtain consent for the use of cookies originally arose in the General Data Protection Regulation (GDPR) of the European Union. According to Article 7 of the specified document: "Where processing is based on consent, the controller shall be able to demonstrate that the data subject has consented to processing of his or her personal data" [3]. Notably, this document effectively extends its effect not only to websites of EU countries, but also to websites of other countries visited by users located in the EU. Thus, no website owner is insured against the application of the requirements of the specified regulation to a Russian website. In this regard, it is necessary to post cookie collection rules on the website (including the possibility of establishing such a procedure within the personal data processing policy), as well as to obtain a separate consent from the website user for the website owner to use cookies.

Requirements for Website Advertising and Providing Information to Consumers³⁴

In turn, websites promoting goods, works, and services must comply with the requirements of consumer protection legislation and advertising legislation.

In particular, according to Article 3 of Federal Law No. 38-FZ dated March 13, 2006, On Advertising (the "Law on Advertising"), advertising is "information distributed 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, forming or maintaining interest in it, and its promotion on the market". General requirements for advertising materials are established by Article 5 of the Law on Advertising, which provides that advertising must not be unfair or unreliable.

In particular, in the practice of pharmaceutical companies, there are precedents of being held liable due to the presence of incorrect comparisons with other medicinal products in advertising. For example, in the Decision of FAS Russia dated September 3, 2020, in Case No. 08/05/5-44/2020, advertising with the wording "Supradyn – vitamins with the strongest formula. The dosage in it is 3 times higher than in many" was recognized as incorrect, as it contains incorrect comparisons of the advertised product with products in circulation that are produced by other manufacturers or sold by other sellers [4].

One of the decisions of a regional UFAS points out that: "...the use of a comparative characteristic of the object of advertising with other goods in advertising, for example, by using the words 'best', 'first', 'number one', must be carried out with an indication of the specific criterion by which the comparison is made and which has objective confirmation" [5].

Also, at present, the practice of FAS Russia to recognize advertising as unreliable due to the content of information that a medicinal product helps in the treatment of COVID-19 has become especially frequent and widespread [6].

Regarding the compliance of the goods presented on the website with consumer protection legislation, according to Article 10 of Law of the RF No. 2300-1 dated February 7, 1992, On Protection of Consumer Rights, information about goods (works, services) must mandatory contain the following basic information:

• the name of the technical regulation or other designation established by the legislation on technical regulation and testifying to the mandatory confirmation of the product's compliance;
• information on the main consumer properties of the goods (works, services);
• the price in rubles and terms for the purchase of goods (works, services);
• the warranty period, if one is established;
• rules and conditions for the effective and safe use of goods (works, services);
• the service life or expiration date of the goods;
• the address (location), company name (name) of the manufacturer (performer, seller), authorized organization, or authorized individual entrepreneur, or importer;
• information on the mandatory confirmation of the compliance of goods (works, services);
• information on the rules for the sale of goods (performance of works, provision of services).

Thus, such information about medicinal products, during their online sales, must be posted on the website of retail sellers (pharmacies).

From July 1, 2021, to February 28, 2022, the Regulations on Federal State Control (Supervision) in the Sphere of Circulation of Medicinal Products, approved by Decree of the Government of the RF No. 1049 dated June 29, 2021, are in effect, according to Clause 67 of which, during an experiment (a control action during a test purchase), an inspector requests documents and (or) information about a medicinal product, the provision of which to the consumer is provided for by the legislation of the Russian Federation on consumer protection. Also, posting information about goods on the official website that does not meet the requirements for the information specified above may serve as a basis for recovering losses from the seller associated with such non-provision.

The above requirements are general for all organizations operating on the Internet and having official websites. Next, we will consider the specifics of maintaining websites of pharmaceutical companies regarding information on medicinal products.

Requirements for Advertising Medicinal Products on a Website

The work of pharmaceutical companies is regulated by a large number of regulatory legal acts, and depending on the company's activity profile (manufacturing, distribution, retail or wholesale sales, etc.), a number of specific legislative requirements must also be taken into account when filling the official website of an organization operating in the pharmaceutical market.

Special requirements for advertising medicinal products are established by Article 24 of the Law on Advertising. Thus, advertising of medicinal products must not:

• address minors;
• contain references to specific cases of cure from diseases or 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 impression of the advantages of the object of advertising by referring to the fact of conducting research mandatory for the state registration of the object of advertising;
• contain statements or assumptions about the presence of certain diseases or health disorders in advertising consumers;
• contribute to creating an impression in a healthy person of the need to use the object of advertising;
• create an impression of the uselessness of consulting a doctor;
• guarantee the positive action of the object of advertising, its safety, effectiveness, and the absence of side effects;
• present the object of advertising as a dietary supplement and food supplement or other product that is not a medicinal product;
• contain statements that the safety and (or) effectiveness of the object of advertising are guaranteed by its natural origin.

Notably, when posting advertising materials on the Internet, the probability of detecting the above violations by the control body is significantly higher due to open access to the advertising materials.

For example, on one of the websites, the control body found information that a medicinal product would have a fast and complex effect on diseases of the oral cavity organs, the product would take effect in 3 minutes and help relieve inflammation and pain. In fact, this information did not correspond to the instructions for the medicinal product, and the control body also stated: "the advertisement reports information about the mechanism of action of the drug during treatment and the speed of the onset of a positive effect on the course of the disease, that is, the speed of the treatment process as a whole, which does not correspond to reality and the instructions for use of the drug. At the same time, the phrase 'fast and complex effect' is generally meaningless, since the threshold and criteria allowing the treatment process to be considered fast have not been scientifically defined" [7].

Another important requirement for drug advertising is that the advertising of medicinal products must be accompanied by a warning about the presence of contraindications for their use, the need to read the instructions for use, or to consult with specialists. At least 5% of the advertising area (advertising space) must be allocated for such a warning (and in advertising in television programs and during cinema and video services, at least 7%).

The calculation of the area of such a warning is carried out based on the "font size" established by OST 29.130-97 "Editions. Terms. Definitions", adopted in the publishing business, according to which "font size" means the font size corresponding to the distance between the top and bottom faces of the type. The type is a metal block with a convex image of a printed character used in typographic composition [8].

It is important to remember that these requirements do not apply to advertising distributed in places where medical or pharmaceutical exhibitions, seminars, conferences, and other similar events are held, as well as in specialized print media intended for medical and pharmaceutical workers, and to other advertising whose consumers are exclusively medical and pharmaceutical workers.

In addition, as noted by FAS Russia, this norm requires the inclusion of warnings: about the presence of contraindications for their use; about the need to read the instructions for use of the object of advertising; and about the need to consult with specialists. At the same time, depending on the type of advertising object, the advertiser itself has the right to determine which of these types of warnings to use in the advertisement [9].

Thus, any advertising materials about medicinal products posted on a pharmaceutical company's website must comply with both the general requirements for advertising and the special requirements established directly for medicinal products.

As a reminder, for violation of the requirements for the advertising of medicinal products, Part 5 of Article 14.3 of the CAO RF provides for liability in the form of a fine on officials from 10,000 to 20,000 rubles, and on legal entities from 200,000 to 500,000 rubles.

Information on Prescription Medicinal Products on a Website

Prescription medicinal products (Rx) occupy a special place in the legal regulation of circulation and promotion; therefore, the possibility of posting information about such medicinal products on an official website has significant limitations.

In accordance with Part 8 of Article 24 of the Law on Advertising, advertising of medicinal products in forms and dosages dispensed by prescription is not allowed except in places where medical or pharmaceutical exhibitions, seminars, conferences, and other similar events are held, and in specialized print media intended for medical and pharmaceutical workers.

Thus, advertising prescription medicinal products on the official website of a pharmaceutical company is directly prohibited. However, the legislation leaves many ambiguities regarding how the conduct of online conferences for medical and pharmaceutical workers, which can be held on the official website of a pharmaceutical company, is regulated. Also, the issue of classifying information about prescription medicinal products as advertising is not fully resolved.

According to Article 3 of the Law on Advertising, advertising is "information distributed 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, forming or maintaining interest in it, and its promotion on the market".

At the same time, information, according to Federal Law No. 149-FZ dated July 27, 2006, On Information, Information Technologies, and Information Protection, means information (messages, data) regardless of the form of their presentation.

In accordance with Part 1 of Article 67 of Federal Law No. 61-FZ dated April 12, 2010, On Circulation of Medicinal Products, information about medicinal products dispensed by prescription must be contained only in specialized publications intended for medical, pharmaceutical workers, and specialists in the field of veterinary medicine. Information on medicinal products for specialists in the field of the circulation of medicinal products may be contained in monographs, reference books, scientific articles, reports at congresses, conferences, symposiums, scientific councils, as well as in instructions for the use of medicinal products.

According to the specialists of FAS Russia, information about manufactured or sold goods (services provided) posted on the website of the manufacturer or seller of these goods (the person providing these services) is not advertising if the specified information is intended to inform website visitors about the assortment of goods (services), rules of use, as well as directly about the seller, manufacturer of the goods, or the person providing the services, etc.; therefore, the provisions of the Federal Law On Advertising do not apply to such information [10].

At the same time, it is important to remember that information about prescription medicinal products, including the assortment and rules of use, is also intended only for pharmaceutical and/or medical workers.

Also, in accordance with Article 2.5.2 of the Code of Practice of the Association of International Pharmaceutical Manufacturers (AIPM) (the "AIPM Code"), it is permissible to provide information about pharmaceutical products dispensed by prescription within the framework of online events (webinars) for healthcare professionals, as well as in sections of Internet resources access to which is open exclusively to healthcare professionals [11].

However, the assessment of whether information on a website is advertising is often made by the control body individually and subjectively.

Thus, FAS Russia notes that in some cases, 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 at attracting attention to a specific product and distinguishing it from similar products (for example, a pop-up banner), such information may be recognized as advertising [12].

In this regard, it is necessary to limit access to information about prescription medicinal products posted on the website to pharmaceutical and/or medical workers, and also, if the information is not of an advertising nature, to indicate that the information is for informational purposes and is not advertising.

Information about medicinal products containing narcotic substances occupies a special place and receives special attention from control bodies. As a general rule, Part 9 of Article 24 of the Law on Advertising prohibits the advertising of medicinal products containing narcotic drugs or psychotropic substances authorized for use for medical purposes, included in the list of narcotic drugs and psychotropic substances whose circulation in the Russian Federation is restricted (except for advertising of such medicinal products in places where medical or pharmaceutical exhibitions, seminars, conferences, and other similar events are held and in specialized print media intended for medical and pharmaceutical workers).

Thus, if seminars, conferences, and other events for medical and/or pharmaceutical workers are held via a website, the inclusion of advertising for such medicinal products in these events is possible only if restrictions are established in the registration of participants for such an event (for example, by presenting information confirming that the participant is a medical and/or pharmaceutical worker). When posting information about narcotic medicinal products on the company's website, access to it must also be restricted by confirming that the person receiving the information is a medical/pharmaceutical worker and that the information is for informational purposes and is not advertising.

In addition, besides the risks of liability for violation of advertising legislation, when posting information about narcotic medicinal products in the open domain, the website may be blocked by Roszdravnadzor. For Roszdravnadzor to make a decision that serves as a basis for including domain names and (or) website page pointers, as well as network addresses, in the unified automated information system "Unified Register of Domain Names, Website Page Pointers in the 'Internet' Information and Telecommunication Network, and Network Addresses Allowing for the Identification of Websites in the 'Internet' Information and Telecommunication Network Containing Information, the Distribution of Which is Prohibited in the Russian Federation", regarding information containing an offer for the retail trade of medicinal products, the information must meet such a criterion as the presence of an offer for the retail trade of narcotic medicinal products and psychotropic medicinal products for medical use by remote method. Such criteria also include an offer for the sale of prescription medicinal products and alcohol-containing medicinal products (with an ethyl alcohol content of over 25%) [13].

Thus, for the posting of any information about prescription medicinal products, as well as medicinal products containing narcotic substances, on a pharmaceutical company's website, a mandatory preliminary legal analysis of the content of the posted materials is required.

Sale of Drugs on a Website (Online Sales)

By Federal Law No. 105-FZ dated April 3, 2020, Article 55 of the Federal Law On Circulation of Medicinal Products was supplemented with Clause 1.1, according to which the retail trade of medicinal products for medical use may be carried out by pharmacy organizations by remote method, with the exception of the following medicinal products: those dispensed by prescription, with an ethyl alcohol content of more than 25%, and narcotic and psychotropic medicinal products. Also, a draft law prepared by the Ministry of Health of Russia is currently under consideration, proposing to prohibit the remote sale of potent medicinal products containing small amounts of narcotic drugs, psychotropic substances and their precursors, radiopharmaceutical medicinal products, and immunobiological medicinal products.

According to the Rules for the Sale of Goods under a Retail Purchase and Sale Agreement, the sale of medicinal products is not allowed by trading at the consumer's location outside of retail facilities by direct familiarization of the consumer with the product (at home, at the place of work and study, in transport, on the street, and in other places).

Decree of the Government of the RF No. 697 dated May 16, 2020, On Approval of the Rules for Issuing a Permit to Carry Out Retail Trade of Medicinal Products for Medical Use by Remote Method, Carrying Out Such Trade and Delivery of Specified Medicinal Products to Citizens, and Amending Certain Acts of the Government of the Russian Federation on the Issue of Retail Trade of Medicinal Products for Medical Use by Remote Method established that pharmacies may post offers and conduct trade with the help of aggregator websites.

When accepting orders for the retail sale of medicinal products by remote method through a buyer's appeal to a pharmacy organization or to the owner of an aggregator via a website (mobile application), informing the buyer about indications for use of the medicinal product, dispensing conditions, storage rules for the medicinal product, and interaction with other medicinal products is carried out by posting in the offer for sale of the medicinal product the full text of the latest current instructions for medical use of the medicinal product, including by addressing to a website containing data from the state register of medicinal products for medical use, or a graphic image of the instructions for medical use (package leaflet) of the medicinal product.

At the same time, pharmacy organizations that have concluded an agreement with other persons for the delivery of an order bear liability to the buyer in case of violation of the storage conditions of medicinal products by the specified persons during their delivery, or damage to medicinal products. Pharmacy organizations and persons carrying out the delivery of an order bear liability for the sale of falsified, counterfeit, substandard, and unregistered medicinal products in the Russian Federation [14].

Thus, the following must be indicated on the official website of a pharmaceutical company carrying out online sales of medicinal products:

• delivery conditions for the medicinal product;
• indications for use of the medicinal product;
• dispensing conditions;
• storage rules for the medicinal product;
• data on interaction with other medicinal products (by posting the full text of the latest current instructions for medical use in the offer for sale of the medicinal product), as well as by addressing to a website containing data from the state register of medicinal products for medical use, or a graphic image of the instructions for medical use (package leaflet) of the medicinal product.

Also, one must not forget that the remote sale of drugs is subject to the requirements of Article 497 of the Civil Code: a retail purchase and sale agreement may be concluded based on the buyer's familiarization with the description of the product offered by the seller through catalogs, prospectuses, booklets, photographs, means of communication (television, mail, radio, and others) or other ways that exclude the possibility of direct familiarization of the consumer with the product or a sample of the product upon conclusion of such an agreement (remote method of product sale), as well as the requirements of the Law on Protection of Consumer Rights No. 2300-1 dated February 7, 1992, which establishes that before concluding a agreement, the seller must present to the buyer information about the product, its consumer properties, place of manufacture, name and location of the seller, price and terms of purchase of the product, payment procedure, its delivery, service life, expiration date, and warranty period, as well as the period during which the offer to conclude the agreement is valid.

In this regard, it is possible to include the terms of a public offer on the website for carrying out sales with the establishment of an option for the user to confirm consent to the terms of the public offer when placing an order on the website.

Also, public discussions are currently being held regarding a legislative initiative of the Ministry of Economic Development of Russia, in accordance with which it is proposed to introduce digital innovation in terms of the remote sale of prescription medicinal products within the framework of an experimental legal regime program in the field of digital innovation. In this regard, there is a probability of making corresponding amendments regarding the prohibition on the remote sale of drugs. On the one hand, this initiative, taking into account the introduction of electronic prescriptions, is quite promising. On the other hand, the future application of preventive measures against the forgery of electronic prescriptions is important [15].

Thus, during the remote sale of medicinal products, it is important to comply with both the general requirements for remote sales and the special requirements for the online sale of medicinal products.

Age Restrictions on Access to Information on a Website

Federal Law No. 436-FZ dated December 29, 2010, On Protection of Children from Information Harmful to Their Health and Development establishes requirements for the distribution of information among children, including requirements for the classification of information products, its examination, state supervision, and control over compliance with the legislation of the Russian Federation on the protection of children from information harmful to their health and (or) development.

No direct prohibition on viewing information websites of pharmaceutical companies and their content is established by the specified federal law. At the same time, information containing the following, justified by its genre and (or) plot, may be allowed for circulation only for children in the age category of over 16:

• an image or description of an accident, crash, disaster, disease, or death without a naturalistic display of their consequences, which may cause fear, horror, or panic in children;
• an image or description of cruelty and (or) violence (except for sexual violence) without a naturalistic display of the process of deprivation of life or infliction of injury, provided that compassion is expressed for the victim and (or) a negative, condemning attitude towards cruelty, violence (except for violence used in cases of protecting the rights of citizens and the interests of society or the state protected by law);
• information about narcotic drugs or about psychotropic and (or) intoxicating substances (without their demonstration), about the dangerous consequences of their consumption with a demonstration of such cases, provided that a negative or condemning attitude towards the consumption of such drugs or substances is expressed and there is an indication of the danger of their consumption;
• individual swear words and (or) expressions not related to obscene language;
• an image or description of sexual relations between a man and a woman that do not exploit interest in sex and are not of an insulting nature, except for the image or description of sexual actions.

Thus, for the posting on an official website of any information that directly or indirectly may relate to the above restrictions, it is necessary to introduce access restrictions to the website for children of a particular age category. Special attention to such a restriction should be paid by companies posting information on their websites about medicinal products containing narcotic and psychotropic substances.

Also, as a reminder, according to Article 24 of the Law on Advertising, advertising of medicinal products must not address minors.

Information on Events Held for Medical Workers

According to Article 67.2 of Federal Law No. 61-FZ dated April 12, 2010, On Circulation of Medicinal Products, organizations and their representatives carrying out the organization and (or) financing of events aimed at increasing the professional level of medical workers or providing information related to the monitoring of the safety of medicinal products are obliged to provide access to information about the date, place, and time of these events, plans, programs for these events and topics planned for consideration, and the composition of their participants by posting relevant information on their official websites on the Internet no later than 2 months before the start of these events.

To gain access to the system, it is necessary to send information in the appropriate form to the e-mail address of Roszdravnadzor [16]. The form for notification of events is provided in the letter of Roszdravnadzor No. 16I-1595/13 dated December 25, 2013 [17].

Based on the above, it is necessary to publish information about the events being held on the official websites of pharmaceutical companies that organize and sponsor such events. It is recommended to post information on the website in the form of the notification sent to Roszdravnadzor.

Other Requirements

As a reminder, although the AIPM Code is not a regulatory legal act, its application is extremely important for Russian practice as a self-regulating tool. Roszdravnadzor emphasizes the important role of the AIPM Code, which is designed to ensure, within the framework of self-regulation, high ethical standards for the activities of pharmaceutical companies and professional interaction between the medical community and the pharmaceutical industry in the interests of Russian patients in strict accordance with the legislation of the Russian Federation [18].

In accordance with Articles 7.1.1, 7.2.4, and 7.2.7 of the AIPM Code, each pharmaceutical company is obliged to document and disclose information on the transfer of values that it produces, directly or indirectly, in favor of a healthcare professional or healthcare organization that are the recipients of the specified values. Disclosure of information is carried out on the relevant website of the pharmaceutical company.

Each pharmaceutical company is obliged to document all transfers of values, information about which must be disclosed in accordance with Subclause 7.1.1, and store the relevant documentation on the disclosure carried out according to the AIPM Code for at least 5 (five) years after the end of the relevant reporting period, unless a shorter period is provided for by the current legislation of the Russian Federation.

Categories of transfers of values carried out in favor of healthcare organizations include:

• donations and grants made in favor of healthcare organizations and supporting healthcare, including donations and grants whose employees are healthcare professionals and (or) which provide medical care;
• coverage of expenses related to holding events, carried out through healthcare organizations or third parties, such as: registration fees; sponsorship agreements with healthcare organizations or with third parties engaged by the healthcare organization for the purposes of organizing the event; travel and accommodation;
• payments for the provision of services and consulting. Transfers of values under agreements or related to agreements between pharmaceutical companies and healthcare organizations, in accordance with the terms of which healthcare organizations provide various types of services in favor of the pharmaceutical company, or other types of financing not related to the above categories. Payments for the provision of services and consulting on the one hand, and transfers of values related to expenses agreed upon in accordance with the agreement in writing regulating the relevant activity on the other hand, must be disclosed as two separate amounts.

Thus, this information is subject to disclosure on the official websites of pharmaceutical companies that carry out the transfer of values that they produce, directly or indirectly, in favor of a healthcare professional or healthcare organization, in compliance with the conditions on the confidentiality of personal data.

Also, additional requirements for a website may be established if a pharmaceutical company occupies a dominant position in the market.

In accordance with Article 5 of Federal Law No. 135-FZ dated July 26, 2006, On Protection of Competition, a dominant position is recognized as the position of an economic entity (group of persons) or several economic entities (groups of persons) in the market of a certain product, giving such economic entity (group of persons) or such economic entities (groups of persons) the possibility to exert a decisive influence on the general conditions of the product's circulation on the relevant product market, and (or) to eliminate other economic entities from this product market, and (or) to hinder access to this product market for other economic entities.

According to the Recommendation of FAS Russia dated June 30, 2015, on the development and application of commercial policies by economic entities occupying a dominant position in the markets for medicinal products and markets for medical devices:

"FAS Russia draws attention to the importance of not only the presence of the trade policy itself, but also its content (the presence of a clear conceptual apparatus and transparent non-discriminatory criteria for the selection of counterparties and cooperation with them in such a policy), the availability of the policy for an unlimited circle of persons, as well as the practice of execution of this policy by the dominant economic entity".

"FAS Russia draws attention to the fact that the document (trade policy) of an economic entity occupying a dominant position, as well as a standard agreement and an application for cooperation, must be in the current version, published and available in open access for an indefinite circle of persons in the Internet telecommunication network" [19].

Therefore, if signs of a dominant position in the market are found, it is necessary to post the company's trade policy on the official website.

Indirectly, the content of the website may also be influenced by the Good Manufacturing Practice (GMP) rules and Good Distribution Practice (GDP) rules developed in the EAEU.

Thus, according to Clause 11.60 of the GMP Rules: "If intermediate products are intended for transfer outside the scope of control of the manufacturer's material management system and an expiration date or a date for repeat tests has been defined for them, information confirming the stability of the intermediate products (for example, published data, test results) must be obtained" [20]. At the same time, the source of the published data that can be taken as a basis is not specified. We believe that data that is in open access on the official websites of pharmaceutical companies can be used in this case.

Good Distribution Practice (GDP) establishes that a distributor is obliged to ensure that the supply of medicinal products is carried out only to organizations having a permit (license) or other legal grounds for carrying out activities related to the circulation of medicinal products. To carry out the relevant assessment, it is permissible to assess the authenticity of information contained in documents published on the websites of the relevant state authorities [21]. At the same time, the exact sources from which information can be taken to assess the authenticity of particular information about the buyer are not specified. We believe that such an assessment can be carried out, among other things, on the basis of data about the buyer contained on its official website.

This article lists the main requirements for the official websites of pharmaceutical companies. It is important to note that currently there is no single regulatory legal act establishing such requirements. At the same time, the activities of any pharmaceutical company have their own specific features, which must also be taken into account on an individual basis when analyzing the content of a website.

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References

[1] Ruling of the Supreme Court of the Russian Federation dated September 11, 2020, No. 305-ES20-11672 in Case No. A40-79044/2019.

[2] What are cookies? // RBC Tenders.

[3] General Data Protection Regulation (GDPR) of the European Union. https://gdpr-text.com/ru/.

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

[5] Decision of the Omsk UFAS Russia dated July 8, 2021, in Case No. 055/05/24-652/2021.

[6] Decision of FAS Russia dated March 10, 2020, in Case No. 08/05/24-10/2020.

[7] Decision of FAS Russia dated March 30, 2017, in Case No. 3-5-6/00-08-17.

[8] OST 29.130-97 "Editions. Terms. Definitions", approved by Order of the State Committee for Printing of Russia dated April 7, 1997, No. 39.

[9] Letter of FAS Russia dated June 22, 2020, No. DF/52241/20 On Advertising of Medicinal Products, Medical Devices and Medical Services, Methods of Prevention, Diagnosis, Treatment and Medical Rehabilitation, Methods of Traditional Medicine.

[10] Letter of FAS Russia dated September 25, 2019, No. AK/83509/19.

[11] Code of Practice of the Association of International Pharmaceutical Manufacturers (AIPM).

[12] Letter of FAS Russia dated August 28, 2015, No. AK/45828/15.

[13] Order of Roszdravnadzor dated June 29, 2020, No. 5527 On Approval of the Criteria for Assessing Information Necessary for the Federal Service for Surveillance in Healthcare to Make Decisions That Are Grounds for Including Domain Names and (or) Website Page Pointers in the 'Internet' Information and Telecommunication Network, as well as Network Addresses Allowing for the Identification of Websites in the 'Internet' Information and Telecommunication Network Containing Prohibited Information, in the Unified Automated Information System 'Unified Register of Domain Names, Website Page Pointers in the 'Internet' Information and Telecommunication Network, and Network Addresses Allowing for the Identification of Websites in the 'Internet' Information and Telecommunication Network Containing Information, the Distribution of Which is Prohibited in the Russian Federation'.

[14] Letter of Roszdravnadzor dated June 23, 2021, No. 02i-802/21.

[15] Draft Federal Law On Amending the Federal Law On Circulation of Medicinal Products in Connection with the Adoption of the Federal Law On Experimental Legal Regimes in the Sphere of Digital Innovations in the Russian Federation (Project ID 01/05/06-21/00117151 dated June 21, 2021).

[16] Letter of Roszdravnadzor dated December 16, 2014, No. 01I-2001/14.

[17] Letter of the Federal Service for Surveillance in Healthcare dated December 25, 2013, No. 16I-1595/13.

[18] The New AIPM Code of Practice. Stogova N. M. June 7, 2021 // Moscow Pharmacies. Pharmaceutical Newspaper.

[19] Recommendations of FAS Russia dated June 30, 2015, on the development and application of commercial policies by economic entities occupying a dominant position in the markets for medicinal products and markets for medical devices.

[20] Rules of Good Manufacturing Practice of the Eurasian Economic Union, approved by Decision of the EEC Council No. 77 dated November 3, 2016.

[21] Rules of Good Distribution Practice of the Eurasian Economic Union, approved by Decision of the EEC Council No. 80 dated November 3, 2016.