Pharmaceutical Guide. Law and Practice

The advertising of medicines in the Russian Federation is regulated primarily by the general and special provisions of Federal Law No. 38-FZ dated March 13, 2006 ‘On Advertising’ (the “Law onAdvertising”).

Also, the Association of International Pharmaceutical Manufacturers (“AIPM”) sets out some rules on advertising and methods of promotion to the general public. These requirements are prescribed by the AIPM Code of Practice, which is a self-regulatory code, and applicable only to the pharmaceutical companies that are members of AIPM. 

In particular, the AIPM Code establishes both general provisions on the promotion of medicines and specific features for advertising and other methods of promotion to the general public.

If a violation of the AIPM Code is established, AIPM may impose the following sanctions: 

• oblige employees of the violating company to complete an online training session on the AIPM Code;

• inform the company’s parent company of the violation; 

• in the case of a serious violation, impose a financial fine in an amount not to exceed the current AIPM annual membership fee, which must be used in a manner to be decided by the next general meeting of AIPM;

 

• make the fact of the violation public on the AIPM website, including but not limited to the identity of the offending company, if the violation is serious or repeated. This posting will remain on the AIPM website for three months. A violation is considered repeated if it is committed within 24 months of the initial violation involving the same medicine, or a similar violation but with another medicine; 

• recommend to the general meeting that the firm concerned be expelled from AIPM. Expulsion from the AIPM does not release the expelled or withdrawing member company from its financial obligations, nor does it release the company from the duty to pay a fine imposed on it; or

• a combination of the possibilities mentioned above.

To reiterate, given that the AIPM Code is a self-regulatory code, the above sanctions are purely reputational and do not result in any legal consequences but may affect AIPM membership.

An advertisement is information disseminated by any method, in any form and using any means, addressed to an indefinite range of persons and aimed at attracting attention to the item being advertised, the formation or maintenance of interest in it and the promotion of it on the market.

Information on disease awareness or press releases can be classified as advertising if such information has the features of advertising mentioned above.

Generally, there is a very fine line between advertising and non-advertising content, and whether the features of advertising exist will be decided in each individual case, taking into account the specific circumstances of the case.

Informational and analytical materials such as reviews of internal and external markets, results of scientific research and testing are not usually considered to be advertising.

The Law on advertising stipulates an exhaustive list of restrictions on performing advertising activity with regard to medicines. The legislation also sets restrictions regarding the content and location of an advertisement, national symbols being used, the size of the advertising materials, the duration of TV and radio advertising, etc.

An advertisement may not improperly compare a product to another manufacturers’ products, may not discredit the honour, dignity and business reputation of other market players, and may not create unfair competition in the market.

Legislation prohibits advertising, except in specialised printed publications and in the context of events for pharmaceutical and medical professionals, if such advertising meets the following conditions:

• concerns prescription medicines (for information about prescription medicines that does not have “promotional” features, the legislator establishes a more extensive list of acceptable sources where it can be placed, compared to advertising, including specialised publications intended for medical and pharmaceutical workers, which implies that information on prescription medicines may be placed not only in publications but also in special resources on the Internet);

• concerns narcotic drugs/psychotropic substances, the use of which is permitted for medical purposes and which are included in the list of narcotic drugs and psychotropic substances whose circulation is restricted in the Russian Federation;

• contains references to specific cases of medical treatment in which the health of an individual improved as a result of the application of the medicine; or

• contains an expression of gratitude by individuals in connection with the application of the medicine.

An advertising campaign involving the provision of samples of medicines containing narcotic drugs and psychotropic substances is also prohibited.

Only registered medicines can be circulated within the Russian Federation, so advertising of non-registered medicines is not allowed. The question of the use of off-label medicines is not directly settled in the law; medicines are allowed to be advertised (with respect to their properties and characteristics, and methods of application and use) strictly to the extent of the information that is contained in the instructions for use that was duly approved by the Ministry of Health during the registration procedure for such medicines.

The AIPM Code also states that only registered medicines may be promoted, and only to the extent of their registered indications for use.

It is forbidden for healthcare professionals to issue prescriptions for medicines in the absence of medical indications, or for medicines that are not registered in the Russian Federation.

The law does not expressly stipulate rules for the provision of information (other than advertising) about unauthorised medicines or unauthorised indications among the professional community (eg, specialised publications for HCP, monographs, scientific articles, reports at congresses, conferences, symposia, or scientific councils). However, it is not prohibited to share such information with the professional community, because it is allowed to import and use medicines not registered in Russia to treat patients who need special treatment because they have an intolerance to registered medicines or have specific indications.

The AIPM Code also provides that it is possible to exchange scientific information related to non-registered medicines within the scientific community, provided that the provision of such information is not a way of promoting the medicine.

General rules

It is a general principle that advertising must be true and fair. 

In particular, advertising is considered unfair if it contains inaccurate comparisons with competing products (although a fair comparison is allowed), if it impairs the goodwill of competitors, or if it is considered to constitute unfair competition under the anti-monopoly legislation.

Advertising is considered false if it contains information that is not consistent with the actual facts. The Law on Advertising provides an extensive and exhaustive list of information that needs to be true, covering almost all aspects of advertising instruments.

In addition, advertising must comply with common moral rules: it must not encourage violence or brutality, must not induce abusive practices, must not contain pornographic content, etc. 

Generally, it is not permitted to use a foreign language if this may lead to a misrepresentation of information. Given the harsh approach of the antitrust authorities, it is a common practice for all parts of advertising materials that are stated in a foreign language (eg, a well-known and widely used slogan) to be accompanied with a translation in a footnote or otherwise. 

Advertising of medicines

The advertising of both prescription-only and over-the-counter medicines needs to comply with the exhaustive list of additional requirements indicated in the Law on Advertising. Thus, among other things, advertising must not: be addressed to minors (ie, those under 18 years old); make reference to the particular experience of the treatment or a disease or improvement of health as a result of use of the given medicine; express gratitude to individuals in relation to the usage of the medicine; make reference to the fact of mandatory trials and thus presume the advantages of the medicine; contain any statements or presumptions with regard to consumers’ illnesses or other health problems; create an impression that there is no need to consult a doctor; guarantee the safety or effectiveness of a medicine and the absence of adverse events, etc.

In addition to the above, medicines must not be advertised with the use of images of healthcare professionals, unless such advertising is intended for healthcare professionals, or is made within the framework of medicinal or pharmaceutical exhibitions, seminars, conferences or other similar events, or is made in specialised print media aimed at healthcare professionals.

In advertising, information on the features and characteristics of medicines must be provided within the framework of the instruction for medical use. Such information must be accompanied with the notices on counterindications and the need to read the instructions for medical use or to consult with a specialist. Depending on the method of advertising (radio, TV, printed materials, etc) the Law on Advertising may define specific requirements for the duration/placement of the above information.

Promotional campaigns are not permitted if they presuppose only the distribution of medicine samples.

Prescription-only medicines cannot be advertised to the general public.

Liability

In accordance with Russian legislation, a violation of the legislation applicable to the advertising of medicines may entail a fine of up to RUB500,000 (approx. USD8,500). The fine does not relieve the company of its obligations to terminate the violation and to meet other requirements as may be set in the order of the regulatory authority (eg, to stop using the materials, etc). The company’s failure to duly execute the above order may entail a separate liability, in accordance with legislation.

Advertising in accordance with a self-regulatory code

The AIPM Code of Conduct in its capacity as a self-regulatory code for international pharmaceutical companies contains a list of good practices in the area of advertising which the members of AIPM are supposed to follow. These good practices generally do not contradict Russian legislation, but the code adds more detail to the existing mandatory regulations.

In particular, the AIPM Code sets the basic principles for the promotion of medicines. Thus, advertising of a medicine must clearly identify it as a pharmaceutical product and must encourage its appropriate use by presenting the information objectively. The promotion of medicines must not be disguised, ie it must not be carried out under the guise of post-registration clinical studies or observational studies, epidemiological studies or marketing studies. Any promotional activity by employees of a pharmaceutical company aimed at healthcare specialists (eg, presentations during events, the authoring of a publication, etc) must clearly identify such individuals as employees of the relevant pharmaceutical company.

In addition to provisions of the Russian legislation, the AIPM Code outlines the standards for advertising information. The advertising of medicines should contain objective, accurate and current information that is based on duly approved information regarding the pharmaceutical product and is supported by scientific evidence, which needs to be available upon request. In practice, almost every statement in advertising has a reference to scientific research confirming such statement. Advertising should be clear, exact, balanced, honest, objective and sufficiently complete to enable the recipient to form an objective opinion as to the therapeutic value of the medicine concerned. The advertising should not mislead by distorting, exaggerating or omitting any significant information in any way. Any ambiguity must be avoided. As mentioned above, comparative advertising is allowed, but it should compare identical characteristics of the medicines and should not mislead the consumers through the absence of any significant information.

The AIPM Code also provides for requirements applicable to advertising via the internet (see 7 Internet, below).

Russian legislation does not provide for an exact list of specific pieces of information that must be present in advertising. Advertising is based on the above general principles and is usually evaluated by companies and by the regulatory authorities based on the overall impression on the consumer of such advertising, rather than on whether or not specific pieces of information are present.

For instance, the legislation does not require advertising to mention the price of medicines. However, if the price is mentioned, it should meet the requirements indicated in the applicable regulations (it should be true, fair, complete, etc).

The laws prohibit the distribution of samples of medicinal products among patients if such distribution is made by healthcare professionals or pharmacy employees on the basis of an agreement with a pharmaceutical company or its agents. 

The AIPM Code imposes certain restrictions on interactions between patient organisations and pharmaceutical companies, including that a pharmaceutical company cannot be a founder of or a participant in a patient organisation. In addition, financial support of patient organisations is generally allowed but the main purpose of such support must have a public benefit and must facilitate the performance of the mission pursued by the respective organisation. If such funding is provided for an event organised by a patient organisation, the former must ensure that the place where the event is held and the conditions for holding it meet the corresponding hospitality requirement indicated in the Code (for instance, it is not associated with entertainment, luxury or exclusivity).

No other specific restrictions are imposed on interaction with a patient organisation, provided that companies take into consideration the non-commercial status of the patient organisation and other related general restrictions in accordance with the general provisions of the Russian legislation. 

It is a general rule that healthcare professionals must not be involved in the advertising of medicines to the general public.

All the general requirements applicable to advertising to the general public are applicable to advertising to healthcare professionals, but there are some exceptions for specific requirements to advertising medicinal products. For instance, the advertising of prescription-only medicines is permitted to be directed at healthcare professionals, if carried out within medicinal or pharmaceutical exhibitions, seminars, conferences or other similar events, or in the specialised print media aimed at healthcare professionals. Moreover, if aimed at healthcare professionals, advertising may contain information on a particular experience of the treatment of a disease or an improvement of health as a result of use of the medicine, and may express gratitude to individuals in relation to the use of the medicine.

The legislation imposes certain restrictions on interactions between healthcare professionals and pharmaceutical companies that have the purpose of limiting the involvement of pharmaceutical companies in the process of prescribing medicines (please see 9 Gifts, Hospitality, Congresses and Related Payments for further details). In particular, as far as is applicable to advertising, while interacting with healthcare professionals, pharmaceutical companies are not allowed, among other things, to provide false and/or incomplete information on medicines nor to induce the prescription of medicines on standard forms containing advertising information or on standard prescription forms on which the name of the medicine is pre-printed.

Similar restrictions are applicable to the interaction of pharmaceutical companies with pharmacists and with heads of pharmaceutical organisations, subject to the specifics of their professional activity. Thus, among other things, pharmaceutical companies are not allowed to provide false and/or incomplete information on medicines, including information on medicines that have the same INN.

Advertising may not refer to data on file or other clinical studies whose results have been approved by the Ministry of Health during the initial state registration of a medicinal product or in the course of introducing changes to the registration dossier. Moreover, it is not allowed to advertise medicinal products by underscoring that they have undergone clinical trials when the initial registration is contemplated, because it is prohibited to advertise goods mentioning that there are studies proving their safety, efficacy or other parameters if such studies are required for allowing the goods in question to be released on the market.

Providing healthcare professionals with reprints of articles from journals and other similar materials is permitted. Usually, if such materials are of a purely scientific and informational nature and are not aimed at promoting medicinal products, they will not be considered advertising. However, Russian regulations on the circulation of medicines impose certain requirements on such information, which are to a certain extent similar to those for the advertising of medicinal products. For instance, information on OTC medicines may be provided in the general media, while information on prescription medicines may be placed in specialised printed media for healthcare professionals that is not available to be purchased on the open market and is circulated among healthcare professionals only. Such information can also be delivered to healthcare professionals during visits or meetings, if non-professionals are not allowed to participate in such events.

If such materials contain advertising, then the above restrictions will apply as well. 

The AIPM Code provides for certain limitations on that type of interaction with healthcare professionals:

• such activity must be aimed at the improvement of the professional level of healthcare professionals and should not pursue solely advertising purposes;

• reprints and other similar materials may be provided on electronic devices (CD, USB), provided that such devices are not intended for personal use. Such reprints may be treated as advertising materials and, therefore, should meet the requirements stipulated in the legislation and the AIPM Сode and, in particular, should meet the specific rules applicable to advertising to healthcare professionals.

Generally, the advertising of medicines does not require prior authorisation from or a notification to any Russian regulator. At the same time, where there are doubts as to the content of advertising, a pharmaceutical company may submit a request to the advertising regulator – the Federal Antimonopoly Service of the Russian Federation (FAS Russia) – to obtain an opinion on whether the advertising complies with the applicable legislation. However, depending on the method of advertising (eg, outdoor advertising), additional general procedures (not specific to the advertising of medicines) might be applicable (eg, public tender rules, authorisation of the municipal authority, authorisation of the residents of an apartment building, compliance with technical standards, etc).

Neither Russian legislation nor any self-regulatory body requires SOPs to be adopted or specific personnel to be employed to ensure compliance with the advertising rules; a company is free to decide on how to handle its advertising activity. However, it is common practice for pharmaceutical companies to have a specific internal procedure that needs to be followed to ensure the compliance of medicinal advertising materials. Considering the specifics of advertising, within such procedure an advertising material needs to be approved by the relevant pharmaceutical company’s medical counsel, marketing specialist, regulatory specialist and legal counsel. Depending on the content of the particular advertising material and the intended audience, additional departments of a pharmaceutical company may be involved.

The advertising of medicines on the Internet (eg, the placement of banners, active hyperlinks, postings on websites, in blogs and social media, and on message boards, forums, etc) must comply with the general requirements for advertising and, in particular, with the requirements for the advertising of medicinal products provided by Russian legislation and the AIPM Code. No specific legal rules apply, but the nature of the Internet requires pharmaceutical companies to consider certain technical matters.

Advertising on the Internet must contain an apparent reference that would identify the pharmaceutical company as the source of the information, as well as identifying the intended audience of that advertising information. The information itself needs to be appropriate for the intended audience. 

The promotion of prescription-only medicines on the Internet is prohibited. However, the industry proceeds on the basis that it is possible to advertise them during online events (eg, webinars) for healthcare professionals or by placing such advertising on the webpages of an Internet site which are only accessible by healthcare professionals using their own login and password (eg, in a professional social network for healthcare professionals). 

The advertising of over-the-counter medicines in social media is allowed subject to the general restrictions indicated above. The promotion of prescription medicines is possible by placing ads in closed social networks for healthcare professionals.

Companies need to ensure that certain advertising information is accessible only to healthcare professionals. This could be done by granting a list of specified persons (ie, registered members of a social network) access by entering a login and password.

Federal Law 273-FZ “On Combatting Corruption” dated December 25, 2008 (“Anti-corruption Law” ) defines corruption as an abuse of entrusted power, bribery, abuse of authority, commercial bribery or another unlawful use by the individual of his/her position irrespective of the public interest and that of the state, for the purpose of receiving money, value, other property or services, or property rights for personal benefit or for the benefit of an identified third party, or the unlawful provision of a benefit to identified individuals by other individuals. 

Corruption infringements are considered criminal offences under Russian law.

Importantly, the receipt or provision of bribery is always associated with public officials. At the same time, Russian law also defines commercial bribery as bribery of persons exercising managerial functions in private organisations. Healthcare professionals (“HCP”) are not automatically considered public officials. However, in cases where they are employed by state or municipal medical institutions and possess certain managerial powers (eg, supervision over personnel, or disciplinary responsibilities), administrative functions (eg, having property at their disposal or exercising control over finances), or authority to make legally significant decisions (eg, to issue official certificates or expert opinions), they can be held liable for an abuse of power entrusted to them or for receiving commercial bribery. 

Thus, Russian law prohibits commercial bribery, which is identified as a person responsible for managerial or administrative functions within a commercial or other organisation (including private medical institutions) illegally receiving money, securities, or other valuables, or illegally obtaining services having an economic value, in exchange for committing acts (or omissions) connected with his authority as an officer in the interests of the giver (including a benefit identified by his organisation). 

Please note that the law understands an abuse of entrusted powers to mean the relevant officer using the entrusted powers in a commercial organisation against the interest of the organisation and for the purpose of receiving benefits and advantages for himself/herself or for other persons, or for the purpose of inflicting harm on other persons, if this causes substantial damage to the rights and interest of individuals or organisations, or to the legally protected interests of society or the state. 

Also note that only individuals may be held criminally liable in Russia (Russian law does not recognise the criminal liability of legal entities), but legal entities that have benefited from corruption offences may be subject to administrative liability in the form of considerable fines.

Federal Law 323-FZ “On the Protection of the Public Health in the Russian Federation” dated November 21, 2011 (the "Public Health Law") states that HCPs and heads of Healthcare Organisations are prohibited from receiving gifts or money from companies involved in the process of developing, manufacturing and selling medicines (“Pharmaceutical Companies”) (except fees under agreements for clinical studies or the performance of educational and scientific services by a HCP), including expenses for entertainment, vacations, travel and participating in entertainment events paid for or organised by the above companies. In addition, the Public Health Law prohibits HCPs from entering into written or oral agreements with companies with the aim of prescribing medicines or recommending them to patients. Federal Law 61-FZ “On the Circulation of Medicines” dated April 12, 2010 (the “Circulation of Medicines Law”) contains a corresponding provision of the above benefits, restricting the provision by Pharmaceutical Companies to HCPs and the heads of Healthcare Organisations. These restrictions are also duplicated in the AIPM Code.

The law does not contain any direct restrictions related to the provision of a benefit to Healthcare Organisations; however, if an arrangement/provision leads to an infringement of competition or corruption law requirements, or leads to an infringement by a HCP of the Public Health Law’s requirements, there is a high probability that it will be considered unlawful.

The Public Health Law directly prohibits HCPs from receiving any gifts made by Pharmaceutical Companies.

At the same time, the AIPM Code permits the provision to HCPs of inexpensive stationery (pens, writing pads, and pencils), in the context of scientific events. However, any products so provided must not be labelled with the name of the relevant company or medicine; otherwise, the product may be regarded as a prohibited gift.

The Public Health Law and Circulation of Medicines Law prohibit the provision of samples to HCPs and pharmacists with a view to such samples subsequently being transferred to patients. In addition, the AIPM Code restricts any transfer of samples to HCPs not only for the purpose of their subsequently being provided to patients, but also for personal use. The provision of demo packs and empty secondary or primary packaging is also covered by this restriction.

Generally, the provision of medicines to non-profit organisations is considered possible under a donation agreement. However, taking into account the above restriction as well as the ambiguity of the law (there is no restriction with respect to a Healthcare Organisation), this is not advisable if there is any possibility that the provided medicines will be delivered to patients for their personal use under donation agreements. This recommendation mainly relates to those medicines that may be used by the patients themselves.

Russian law accepts a free-of-charge transfer from a company to a non-profit organisation under a donation agreement if the donation is made with a socially useful purpose. At the same time, the AIPM Code permits Pharmaceutical Companies to provide samples to non-profit Healthcare Organisations with the aim of making them aware of the usage of the medicine and allowing them to gain experience in working with it in accordance with the approved package leaflet. Moreover, for the purpose of a donation, a receipt and a written request from the Healthcare Organisation must be drawn up, and the company must inform the Healthcare Organisation of the remaining shelf lives of the medicines that are planned to be transferred.

The AIPM Code states that such provision may be performed only within the first two years after the medicine is launched on the market of the Russian Federation, and it must be documented in writing with a confirmation that the samples are not intended for sale. Moreover, the number of samples provided should not exceed four per year per HCP of the Healthcare Organisation with the corresponding medical specialisation.

The AIPM Code specifies that samples must not be associated with any incentive to recommend, prescribe, purchase, supply, sell or administer the medicine provided as a sample.

Pharmaceutical companies are allowed to sponsor scientific meetings or congresses and/or the attendance of these events by HCPs, but the sponsorship must not be personalised or direct. In particular, a pharmaceutical company may sponsor an event, but it must not approve the list of HCPs attending the event or it could be considered as a prohibited provision of a gift to an HCP. 

Please note that the Circulation of Medicines Lawstates that Pharmaceutical Companies holding a scientific event are prohibited from preventing other Pharmaceutical Companies or their representatives from producing or selling medicines with a similar mechanism of pharmacological effect, or from participating in the events. It is also not permitted to create discriminatory conditions for certain participants, such as:

• allowing different participants different lengths of time for their presentations, and different spaces for demonstrating samples or advertising materials at exhibition spaces and stands, unless such conditions are envisaged by agreements of these organisations and their representatives for the financing of such events and arise from different expenses of participants for the organisation of the event; and

• establishing a participation fee that exceeds the expenses incurred in relation to the organisation of the event, which results in an unjustified limitation of the participants.

Furthermore, Healthcare Organisations or their representatives that undertake the organisation and/or financing of events in accordance with the Circulation of Medicines Law must provide access to information on the date, place and time of the events, plans, programmes of the events and topics to be discussed, and the composition of the participants, by posting relevant information on their official websites at least two months prior to the holding of such events. Moreover, at least two months prior to the holding of such events, information on the events must be forwarded to the federal executive body performing control and supervision functions in healthcare (known by the Russian abbreviation ‘Roszdravnadzor’) so that the information can subsequently be posted on its official website.

The AIPM Code specifies certain requirements that must be met by Pharmaceutical Companies organising events. In particular, all events must be organised for the purpose of providing HCPs with educational and scientific information in the sphere of healthcare and pharmaceuticals. Moreover, Pharmaceutical Companies must not organise events abroad unless the participating HCPs are from different countries or it is justified by logistics or security, eg, international scientific congresses and symposia.

The AIPM Code prohibits the usage of places/hotels that may be associated with luxury, entertainment or exclusivity, regardless of the class, and recommends using business centres, educational institutions and hotels for events. Moreover, the place of the event must meet the purpose of educational and scientific achievement. In particular, an event may be organised in a public place only if it is held in an isolated room or other premises closed to the public.

Importantly, there is a restriction on organising entertainment or sport events to attract HCPs to participate in a scientific event. Pharmaceutical companies must not organise or pay for entertainment within an event or outside the scope of the event.

Please note that it is permitted to provide information in relation to products that are not registered in the country or that are registered on different terms, provided that the following requirements is met:the provision of such information must be permitted under the law of the country in which the event takes place, the event must be truly international (with many participants from different countries), there must be a clear indication that the product is not registered in the country of the event, and all the materials related to the use of such medicine in other countries must be accompanied by a clear indication that the conditions of registration may differ. 

At the same time, Pharmaceutical Companies are allowed to serve a buffet-style lunch at an event, provided it is justified by the duration of the event and is aimed at keeping the HCPs refreshed but is not a type of entertainment. Such food must be provided within justified limits and must not be available only to participants in the events. 

Within the event, the HCPs may receive some stationery (pens, writing pads and pencils) to make some notes, but such products must be free from the names of companies and medicines, and must be of insignificant value.

The provisions of the AIPM Code apply to events organised abroad by AIPM member companies.

The Public Health Law and the Circulation of Medicines Law directly prohibit HCPs from receiving any gifts or money from Pharmaceutical Companies (except fees under agreements for clinical study, or for the performance by a HCP of educational and scientific services). Consequently, no direct grant or donation to HCPs is allowed.

However, Russian law allows a donation to be made to Healthcare Organisations, scientific organisations or other non-profit organisations (art.582 of the Russian Civil Code). Importantly, non-profit organisations are defined by the law as companies whose basic objective is other than to make a profit and which do not distribute any profit they do generate among their participants. Please note that a donation may be made only for a socially useful purpose. At the same time, Russian law does not distinguish the form of donation as a donation of money, services or equipment; a grant will also be considered as a form of donation. In particular, a Pharmaceutical Company may provide an educational grant to a Healthcare Organisation. Such a donation in the form of educational grants in accordance with the AIPM Code may be made to support medical education and may be solely intended to raise the quality of medical care provided to patients. Furthermore, the AIPM Code prohibits cash donations.

The AIPM Code specifies that a donation may be provided only on the basis of a written request by a non-profit organisation and a subsequent donation agreement. A Pharmaceutical Company that is making a donation must inform the Healthcare Organisation that is receiving the donation of the remaining shelf lives of the donated medicines. Moreover, a donation must not be aimed towards commercial purposes; it must be independent of any commercial interest and must not be tied in with the subsequent recommendation, prescription, purchase, supply or sale of the product, etc. 

Importantly, any form of provision must not be associated with a particular HCP or list of HCPs. For instance, a donation is acceptable, but the same donation made in the name of a specific employee may be considered to amount to an unlawful gift or provision of money to such HCP.

Rebates or discounts to HCPs may not be granted because the purchase is performed by Healthcare Organisations, not individuals. Moreover, the Public Health Law prohibits a HCP from receiving any rebates from Pharmaceutical Companies, except fees under a clinical study agreement or for the performance of scientific or educational activity. 

If Healthcare Organisations are public bodies, the purchase of medicines is performed under the public procurement procedure regulated by Federal Law 44-FZ dated April 5, 2013 “On Public Procurement”. Therefore, the price is formed under a competitive procedure and the parties may not predict it in advance. The infringement of such procedure or the making of prior arrangements regarding the price may lead to significant competition risks. 

If Healthcare Organisations are commercial, a Pharmaceutical Company will provide rebates and bonuses in accordance with its commercial policy. Please note that putting one purchaser in a more advantageous position than others may lead to competition risks. 

The Public Health Law and Circulation of Medicines Law permit a HCP to receive fees from Pharmaceutical Companies under clinical study agreements and for the performance of educational and scientific services.

Importantly, the interaction between a Pharmaceutical Company and a HCP must not result in a conflict of interest for the HCP, particularly a conflict between professional and personal interest. 

The AIPM Code also permits HCPs (apart from pharmaceutical professionals and heads of pharmacies) to provide educational and scientific services and perform services under clinical study agreements.

At the same time, the AIPM Code sets a list of factors by which the parties to the agreement must be guided. Firstly, a written agreement must be concluded between the parties with a description of the services to be provided, and must not lead to the HCP prescribing or recommending the Pharmaceutical Company’s medicine. Moreover, compensation for services must be reasonable and in line with fair market value. Importantly, the Pharmaceutical Company must have a reasonable need for such agreement, and the criteria for appointing the HCP in question must be guided by the purpose of the agreement. In addition, the number of HCPs actually engaged must correspond to the number actually needed for the purpose of receiving the relevant services.

The AIPM Code allows Pharmaceutical Companies to pay a HCP’s expenses incurred in relation to the concluded service agreement (ie travel, accommodation and meal expenses), but such expenses must correspond to a number of characteristics. For instance, it is prohibited to compensate expenses for accommodation in hotels that the public would associate with luxury. Moreover, expenses for meals must be reasonable and it is permitted to pay for only economy class plane tickets unless the flight does not exceed four daylight hours. Importantly, there is a prohibition on offering compensation for any expenses incurred by an accompanying person. Any exceptions must be justified by an objective need and approved by the Pharmaceutical Company’s management.

Generally, the Public Health Law and Circulation of Medicines Law do not require any prior notification norauthorisation to perform educational and/or scientific activity at the request of Pharmaceutical Companies. 

At the same time, if a conflict of interest arises, a HCP must notify the head of the Healthcare Organisation in writing of such conflict. The Public Health Law defines a conflict of interest as a situation in which a HCP, during his/her professional activities, has a personal interest in obtaining a financial or any other benefit that affects or may affect the proper performance of his/her professional duties resulting in a conflict between the personal interest of the HCP and the interests of the patient. Importantly, any failure to perform the obligation to notify the head of a hospital of the occurrence of a conflict of interest may result in an administrative offence (Article 6.29. of the Code of Administrative Offences).

Russian law does not contain a requirement for Pharmaceutical Companies to disclose all transfers of value to HCPs and Healthcare Organisations. However, each Pharmaceutical Company that is a member of AIPM must make a documentary record and must disclose annually information on items of value provided (directly or indirectly) to Healthcare Organisations or HCPs that are connected with research and development activity in accordance with the AIPM Code.

The disclosure requirements are not applicable to a transfer of value related to i) non-prescription medicines; ii) items not listed in the AIPM Code, particularly those items useful for medical practice, meals and drinks, and samples of medicines, if this is permitted by the law and the AIPM Code; or iii) valuables that are a part of the ordinary course of purchases and sales of medicines by and between a Pharmaceutical Company and a Healthcare Organisation or HCP.

Information on a transfer of value must be disclosed by Pharmaceutical Companies on their websites in Russian (it may also be given in English) within 6 months after the end of the year to which the disclosure relates. It must be publicly available for three years after disclosure. There must be documentary proof of each transfer of value, and such proof should be kept for five years. The reporting period covers a full calendar year. If a Pharmaceutical Company became subject to the disclosure obligations during the reporting period, it must disclose information only about the relevant part of the year.

The disclosure of transfers of value to HCPs shall be made on an individual basis, with a HCP’s permission given in compliance with personal data protection rules. Furthermore, the AIPM Code establishes a set structure that must be used for the purpose of disclosure made by Pharmaceutical Companies.

Therefore, each Pharmaceutical Company must disclose, on an individual basis, the amounts attributable to transfers of value in each reporting period in a category identified by the AIPM Code. Please note that the transferred amounts may be aggregated by categories if a detailed report on each type of valuable is available, upon the request of the relevant recipient or authority. The AIPM Code sets three types of transfer of value: those to Healthcare Organisations, those to HCPs and those connected with research and development:

All transfers of value to Healthcare Organisations are categorised as follows: donations and grants made to Healthcare Organisations and organisations supporting healthcare; expenses associated with the events (sponsor agreements with healthcare organisations or third party providers, a registration fee, travel and accommodation expenses); and fees for services and consulting.

Transfers of value to HCPs are categorised as follows: expenses associated with events (registration fee, travel and accommodation expenses); and fees for services and consulting.

If information may not be disclosed on individual basis (mainly owing to personal data protection issues), it must be disclosed on an aggregate basis. The aggregate disclosure must include in each category the number of recipients on an absolute basis and as a percentage of all recipients, as well as the aggregate amount transferred to such recipients.

If a transfer of value is subject to disclosure and made to HCPs through a Healthcare Organisation, this transfer must be disclosed once. If possible, it is advisable to make a disclosure on an individual basis with the particular HCP being identified.

Information about transfers of value for the purpose of research and development activity must be disclosed by each Pharmaceutical Company on an aggregative basis. Expenses incurred for events connected with research and development activity may also be included in the aggregate amount in the category “Research and Development transfer of value”.

Moreover, each Pharmaceutical Company must publish a note outlining the methodologies it used in preparing disclosure for each category. This note must include a general overview or specific considerations of the interactions for a particular country, and methodologies of identifying and covering the following aspects (if applicable): approaches to long-term agreements, VAT and other tax issues, currency aspects and other issues related to the timing and amount of transfers of value for the purposes of disclosure under the AIPM Code.

In accordance with the AIPM Code, disclosure must be governed by the code existing in the state in which the recipient of value has a physical address. If a foreign company does not have a subsidiary or affiliated company and is not represented in any other way in Russia, it must disclose the information in accordance with the code governing disclosure in the country of its registration. If there is no such code, the disclosure will be governed by the code in the company's country of registration that regulates similar relations and is applicable to the company in question.

The Russian Federal Antimonopoly Service (the FAS) is the federal executive authority which controls compliance with legislation in the area of advertising.

Committing an offence in the sphere of the adverting of medicines may result in:

• the FAS issuing an order to the offending person (the advertiser, or a producer or distributor of advertising) to eliminate violation; or

• the imposition of an administrative liability, according to part 5 of article 14.3 of the Administrative Code of the Russian Federation, ranging from RUB2,000 to RUB2,500 for individuals, from RUB10,000 to RUB20,000 for the officers of companies, and from RUB200,000 to RUB500,000 for legal entities.

Also, in accordance with the Law on Advertising, if a party’s rights and interests have been infringed by an improper advertisement, that party may file a claim with the court for compensation to cover losses caused by such advertisement, and for such advertisement to be publicly refuted (counter advertising). If the court establishes that the advertisement has actually caused losses to the claimant, the company will have to refute the advertisement at its own expense at a place, in the manner and within the timeframe prescribed by the court.

If advertising is recognised as an act of unfair competition, the FAS may impose an administrative liability on the offender, according to part 1 of article 14.33 of the Administrative Code of the Russian Federation, ranging from RUB12,000 to RUB20,000 for a company’s officers, and from RUB100,000 to RUB500,000 for legal entities.

The recent enforcement trend is that the FAS is paying more attention to market participants' observance of the specific legislative requirements for the advertising of medicines. In particular, the FAS is overseeing the observance of legislative provisions regarding the prohibition of advertising that:

• guarantees the positive action of a medicine, its safety, effectiveness and the absence of side effects;

• refers to the therapeutic qualities of dietary supplements;

• concerns properties and characteristics – including the methods of the application and usage of a medicine – beyond the indications contained in the instructions for use approved by the Ministry of Health;

• is “surrogate advertising”, ie when a prescription medicine is promoted under the guise of an OTC medicine (the advertising of prescription medicines is strictly allowed only in specialised printed publications and in the context of events for pharmaceutical and medical professionals);

• contains statements or assumptions about the presence of any diseases or health disorders; or

• promotes the creation of an impression that a healthy individual has a need to apply the medicine, etc.

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