1. General - Medicinal Products
1.1 What laws and codes of practice govern the advertising of medicinal products in Russia?
Only the law is binding, as observance of the rules of the other two is voluntarily.
1.2 How is “advertising” defined?
Advertising is information distributed in any way, in any form and by any means, addressed to the general public, aimed at drawing attention to, forming and supporting interest in the advertised item and promoting it on the market.
1.3 What arrangements are companies required to have in place to ensure compliance with the various laws and Codes of Practice on advertising, such as “sign off” of promotional copy requirements?
The advertised medicines must be properly registered and authorised for use on the territory of the Russian Federation. Medicine production and trade also requires a licence.
1.4 Must advertising be approved in advance by a regulatory or industry authority before use? If so, what is the procedure for approval? Even if there is no requirement for prior approval in all cases, can the authorities require this in some circumstances?
No approval is required or may be required by the authorities.
1.5 If the authorities consider that an advertisement which has been issued is in breach of the law and/or code of practice, do they have powers to stop the further publication of that advertisement? Can they insist on the issue of a corrective statement? Are there any rights of appeal?
The advertising legislation is enforced by the Federal Antimonopoly Service and its regional bodies (hereinafter “the Antimonopoly Service”). If the Antimonopoly Service considers an advertisement to be an offence, i.e., considers it to be improper advertising, it is empowered to stop further publication of the advertisement. Failure to fulfil the obligation to stop is also recognised as an offence and may entail a fine.
If the advertiser considers a decision of the Antimonopoly Service to be incorrect, it may appeal such a decision in court and the subsequent court decisions may also be appealed to a higher court.
Codes of practice are enforced only by the self-regulatory bodies that adopt them. Issue of a corrective statement may be ordered only by a court.
1.6 What are the penalties for failing to comply with the rules governing the advertising of medicines? Who has responsibility for enforcement and how strictly are the rules enforced? Are there any important examples where action has been taken against pharmaceutical companies? To what extent may competitors take direct action through the courts?
Improper advertising is an administrative offence entailing a fine of 40,000 to 500,000 Russian Roubles for legal entities and 2,000 to 2,500 Russian Roubles for entrepreneurs and individuals. The fine is imposed by the Antimonopoly Service.
Moreover, improper advertisements must be withdrawn by decision of the Antimonopoly Service.
Courts may order corrective statements and award damages to the persons affected, including competitors. Such a court action may be brought by both antimonopoly authorities and competitors.
Pharmaceutical advertising is under the constant close attention of the authorities.
Most frequently, pharmaceutical advertisers are fined for not placing a warning of contraindications to using the medicine and the need to seek a physician’s opinion.
1.7 What is the relationship between any self regulatory process and the supervisory and enforcement function of the competent authorities? Can, and, in practice, do, the competent authorities investigate matters drawn to their attention that may constitute a breach of both the law and any relevant code and are already being assessed by any self- regulatory body? Do the authorities take up matters based on an adverse finding of any self-regulatory body?
In practice, we are not aware of any cases initiated by the Antimonopoly Service involving violation of both legislative requirements and rules of the Codes adopted by self-regulatory bodies. This is explained by the non-binding nature of the Codes and, as a result, their unenforceability.
At the same time, should a self-regulatory organisation detect a violation in the advertising legislation, it may notify the Antimonopoly Service to that effect and the latter, in turn, will have to perform an inspection and make a decision on the basis of the inspection results as to whether the advertising may be regarded as improper.
1.8 In addition to any action based specifically upon the rules relating to advertising, what actions, if any, can be taken on the basis of unfair competition? Who may bring such an action?
Under the Law on Advertising, an advertisement is illegal if it constitutes an act of unfair competition, so, actions are usually based on the advertising rules.
If, however, the advertisement amounts to a form of unfair competition that is not covered by the advertising legislation, an action may brought by the antimonopoly authorities or competitors on the basis of the competition law rules.
2. Providing Information Prior to Authorisation of Medicinal Product
2.1 To what extent is it possible to make information available to health professionals about a medicine before that product is authorised? For example, may information on such medicines be discussed, or made available, at scientific meetings? Does it make a difference if the meeting is sponsored by the company responsible for the product?
Russian law does not establish restrictions on sharing information about a medicinal product until its registration, unless it is treated as an advertisement. If the product is intended as a prescription medicine, the information about it may be released to and distributed among only health professionals. It may be discussed or made available at scientific meetings, provided that there is no promotion of the product itself. There are no explicit restrictions under Russian law on the company responsible for the product sponsoring such meetings. There is a certain risk, however, that such sponsorship might be treated as indirect indication of advertising activities.
2.2 May information on unauthorised medicines be published? If so, in what circumstances?
In general, information on unauthorised medicines may be published unless it is treated as an advertisement. In addition, information on prescription medicines may be published only in press or media orientated on health professionals.
2.3 Is it possible for companies to issue press releases about medicinal products which are not yet authorised? If so, what limitations apply?
If the press release is not qualified as advertisement, it may be issued with respect to products that are not yet authorised. A press release about prescription medicines may be published only in the press or media orientated on health professionals.
2.4 May such information be sent to health professionals by the company? If so, must the health professional request the information?
Yes, such information may be sent to health professionals by the company. It is not necessary for the information to be requested by health professionals. The only requirement is that this information should not contain elements of an advertisement.
2.5 May information be sent to institutions to enable them to plan ahead in their budgets for products to be authorised in the future?
There are no prohibitions or specific rules on this. The same rules apply as indicated in question 2.4 above.
2.6 Is it possible for companies to involve health professionals in market research exercises concerning possible launch materials for medicinal products as yet unauthorised? If so, what limitations apply? Has any guideline been issued on market research of medicinal products?
There are no any prohibitions or restrictions on involving health professionals in market research. If the health professionals are doctors, they should act in accordance with the Code of Professional Ethics. According to said Code, doctors should not take part in advertising activities aimed at promoting of medicinal products.
3. Advertisements to Health Professionals
3.1 What information must appear in advertisements directed to health professionals?
No information must appear.
In fact, some requirements specific to pharmaceutical advertising do not apply in such advertisements.
3.2 Is it a requirement that there be data from any or a particular number of “head to head” clinical trials before comparative claims are made?
Comparative claims, if used in advertising, must be supported by reliable documented information, for example, by clinical trial results. No specific number of trials is required.
3.3 What rules govern comparator advertisements? Is it possible to use another company’s brand name as part of that comparison? Would it be possible to refer to a competitor’s product which had not yet been authorised in Russia?
Comparative statements must be accurate and valid, i.e., should an advertisement include comparative statements, they must be true and correct and not distort the facts.
Use of a competitor’s trade mark or brand name is allowed as long as it does not constitute an infringement under the intellectual property law. Mentioning a competitor’s product that has not yet been authorised is legal as long as this does not amount to advertising of it.
3.4 What rules govern the distribution of scientific papers and/or proceedings of congresses to doctors?
There are no specific rules.
It should be noted, however, that if, in addition to research conclusions, scientific papers contain appeals to acquire a certain medicine, the antimonopoly authorities might treat them as advertising. In this case, all the specific regulations will apply. Moreover, the published paper should be marked as an “Advertisement”.
3.5 Are “teaser” advertisements permitted, which alert a reader to the fact that information on something new will follow (without specifying the nature of what will follow)?
Yes, but if the advertised medicine is mentioned, all the specific regulations apply (see question 6.1).
4. Gifts and Financial Incentives
4.1 It is possible to provide health professionals with samples of products? If so, what restrictions apply?
Samples of products may be provided to hospitals, scientific research medical institutions, entrepreneurs, producers and distributors of medicines that have a relevant licence to carry out pharmaceutical activities.
4.2 Is it possible to give gifts or donations of money to medical practitioners? If so, what restrictions apply?
Medical practitioners may not accept gifts or donations from patients or their relatives amounting to more than 3000 Roubles. If the medical practitioner holds a management position in a medical institution, any acceptance of gifts or donations by him may be treated as a criminal offence (i.e., bribery if, in exchange for this, he provides the donor with certain benefits connected with performance of his management functions. If the purpose of the gift or donation has socially useful objectives, they may not be qualified as bribery.
4.3 Is it possible to give gifts or donations of money to institutions such as hospitals? Is it possible to donate equipment, or to fund the cost of medical or technical services (such as the cost of a nurse, or the cost of laboratory analyses)? If so, what restrictions would apply?
Yes, it is possible to give gifts or donations of money to institutions, to donate equipment, or to fund the cost of medical or technical services on the condition that these gifts and donations have socially useful objectives and they are voluntary and gratuitous.
4.4 Is it possible to provide medical or educational goods and services to doctors that could lead to changes in prescribing patterns? For example, would there be any objection to the provision of such goods or services if they could lead either to the expansion of the market for or an increased market share for the products of the provider of the goods or services?
There is no explicit Russian law prohibition on such activities, unless they are qualified as bribery (please refer to our comments in question 4.2). Doctors should, however, act in the best interest of their patients when prescribing specific medicines.
4.5 Do the rules on advertising and inducements permit the offer of a volume related discount to institutions purchasing medicinal products? If so, what types of arrangements are permitted?
Volume-related discounts are not prohibited in the event of sale to institutions purchasing medical products. There are, however, certain tax consequences connected with inducements that should be observed.
4.6 Is it possible to offer to provide, or to pay for, additional medical or technical services or equipment where this is contingent on the purchase of medicinal products? If so, what conditions would need to be observed?
There are no prohibitions or special regulations on this matter. Such arrangements should, however, be reviewed in terms of their compliance with Russian civil law since conditional transactions require a very careful drafting in order to be valid and enforceable.
4.7 Is it possible to offer a refund scheme if the product does not work? If so, what conditions would need to be observed? Does it make a difference whether the product is a prescription-only medicine, or an over-the-counter medicine?
It is very unusual to offer a refund scheme for a product that does not work. If it did not work in the situations indicated in the instructions to the relevant medicines, it would not be registered and allowed for distribution and sale in the Russian Federation. From said point of view, there is no difference whether the product is a prescription or OTC medicine.
4.8 May pharmaceutical companies sponsor continuing medical education? If so, what rules apply?
Yes, they may. In this case, the rules concerning charity mentioned in question 4.2. apply. It should be voluntary and gratitude.
5. Hospitality and Related Payments
5.1 What rules govern the offering of hospitality to health professionals? Does it make a difference if the hospitality offered to those health professionals will take place in another country?
The same rules as for making gifts or donations (please see s. 4.2 above) apply to offering hospitality to health professionals.
5.2 Is it possible to pay for a doctor in connection with attending a scientific meeting? If so, what may be paid for? Is it possible to pay for his expenses (travel, accommodation, enrolment fees)? Is it possible to pay him for his time?
It is possible to pay a doctor for attending a scientific meeting provided that this is not treated as bribery (please see question 4.2 above). It should be noted, however, that, under the Code of Professional Ethics, doctors cannot participate in advertising campaigns, accept any payments from medical companies, enjoy any benefits in other forms if this might undermine their independence or be of detriment to patients. So, if doctors participate in such meetings as independent experts, it is possible to pay them for this or reimburse related expenses.
5.3 To what extent will a pharmaceutical company be held responsible by the regulatory authorities for the contents of and the hospitality arrangements for scientific meetings, either meetings directly sponsored or organised by the company or independent meetings in respect of which a pharmaceutical company may provide sponsorship to individual doctors to attend?
here are no legal sanctions for a pharmaceutical company’s involvement in hospitality arrangements with doctors, unless they are qualified as bribery, which is a criminal offence. Only individuals can be held liable for a criminal offence.
5.4 Is it possible to pay doctors to provide expert services (e.g. participating in focus groups)? If so, what restrictions apply?
The same comments as for question 5.2 above. In addition, certain types of expert examinations, such as forensic psychiatric examinations, military medical examinations and medical social examinations, can only be carried out in medical institutes.
5.5 Is it possible to pay doctors to take part in post marketing surveillance studies? What rules govern such studies?
There are no legal prohibitions or special rules for this. Such payments to doctors undermine their independence, so they are prohibited by the Code of Professional Ethics (please refer to question 5.2 above for more comments).
5.6 Is it possible to pay doctors to take part in market research involving promotional materials?
The same comments as to question 5.5 above.
6. Advertising to the General Public
6.1 Is it possible to advertise non-prescription medicines to the general public? If so, what restrictions apply?
Yes it is.
Advertisements must contain warnings of contraindications and the need to follow the directions for use. Furthermore, advertising of non-prescription medicines shall not:
1) be addressed to minors;
2) guarantee or refer to certain instances of recovery;
3) express thanks to certain persons for taking the medicine;
4) refer to tests required for state registration of the medicine as a benefit;
5) create the impression that the medicine is essential to the consumer’s health or that a doctor’s advice is unnecessary;
6) contain assumptions concerning the consumer’s health problems;
7) persuade a healthy person to use the medicine;
8) create the impression that there is no need to visit a doctor;
9) disguise the medicine as a dietary supplement; or
10) state that the medicine is safe and effective just because it is natural in origin.
Furthermore, use of images of medical and pharmaceutical personnel in advertising materials is prohibited. This is a general rule applying to advertising of all types of good and all medicine advertisers should remember this. There is a limited list of exceptions to this rule applying to 1) advertising of medical services and personal-care products addressed specifically to medical and/or pharmaceutical staff, 2) advertising of goods at venues of medical and/or pharmaceutical exhibitions, seminars, conferences and other events, and 3) advertising in publications intended solely for medical/pharmaceutical staff.
6.2 Is it possible to advertise prescription-only medicines to the general public? If so, what restrictions apply?
Prescription-only medicines cannot be advertised to the general public, only to medical and/or pharmaceutical staff.
6.3 If it is not possible to advertise prescription only medicines to the general public, are disease awareness campaigns permitted, encouraging those with a particular medical condition to consult their doctor, but mentioning no medicines? What restrictions apply?
Yes, disease awareness campaigns are permitted. Such advertisements must not mention any trade marks, trade names, persons or legal entities. Mention of sponsors and government authorities is allowed.
6.4 Is it possible to issue press releases concerning prescription only medicines to non-scientific journals? If so, what conditions apply?
No, press releases concerning prescription-only medicines should be published in special media intended for medical and/or pharmaceutical staff.
6.5 What restrictions apply to describing products and research initiatives as background information in corporate brochures/Annual Reports?
If a description is of an advertising nature and corresponds to the legal definition in the Law on Advertising (see question 1.2), it is subject to the general restrictions (see question 6.1). No extra restrictions are applicable.
6.6 What, if any, rules apply to meetings with and funding of patient support groups, including any transparency requirement as regards the recording of donations and other support in corporate reports?
No special legislative rules apply.
7. The Internet
7.1 How is Internet advertising regulated? What rules apply? How successfully has this been controlled?
Generally, Internet advertising is also regulated by the Law on Advertising and all general rules (see question 6.1) apply.
Nevertheless, the Internet is rather hard to control and legal restrictions are commonly ignored by advertisers on the Internet. Therefore the main cases concerning unfair advertising on websites are initiated by consumers or competitors rather than the Antimonopoly Service.
7.2 What, if any, level of website security is required to ensure that members of the general public do not have access to sites intended for health professionals?
There are no special requirements. Usually a website owner defines the access level at their own choice.
7.3 What rules apply to the content of independent websites that may be accessed by link from a company sponsored site? What rules apply to the reverse linking of independent websites to a company’s website? Will the company be held responsible for the content of the independent site in either case?
A website owner is responsible only for the information it places on the website, namely for the texts, images, banners, etc. It cannot be held responsible for the content of websites that are linked even if it is a sponsor website.
7.4 What information may a pharmaceutical company place on its website that may be accessed by members of the public?
The general rule is that a website accessible by the public may contain any information not running counter to the Law on Advertising and any other information at the discretion of the website owner as far as it does not violate the Russian legislation.
8. General - Medical Devices
8.1 What laws and codes of practice govern the advertising of medical devices in Russia?
The rules are all the same as mentioned in question 1.1.
8.2 Are there any restrictions on payments or hospitality offered to doctors in connection with the promotion of a medical device?
Under the Code of Medical Ethics, doctors shall not take part in any activities that have advertising purposes. Therefore, the mentioned payments or hospitality are prohibited.
9. Developments in Pharmaceutical Advertising
9.1 What have been the significant developments in relation to the rules relating to pharmaceutical advertising in the last year?
Over the last couple of years, no significant developments with regard to pharmaceutical advertising have been observed in Russia.
At the same time, we should mention the legislative initiatives discussed last year for prohibiting advertising of pharmaceuticals. The main purpose of the proposed draft legislation was to limit pharmaceutical advertising by medical and similar health care professionals, specialised editions, medical symposia and conferences. It also suggested that TV advertising of medicines be totally banned. Even though said initiative was not supported, we believe that it clearly reflects the development trend in this sphere of the advertising legislation.
9.2 Are any significant developments in the field of pharmaceutical advertising expected in the next year?
The main developments expected in the next year refer mostly to the general provisions of the advertising legislation. For instance, today any violation of the advertising legislation is punished by a fine of 40,000 to 500,000 roubles, which is deemed incorrect as violations may vary in gravity. In this connection, draft amendments are being considered to introduce differential fines for various types of offence. As for pharmaceutical advertising itself, no significant developments are planned at the moment.
9.3 Are there any general practice or enforcement trends that have become apparent in Russia over the last year or so?
Over recent years, the practice of medical product advertising has proved to be remarkably stable. This type of advertising attracts the particular attention of the Antimonopoly Service, which checks whether said advertising complies, to the best possible extent, with the legislative requirements, as accuracy and reliability of advertising relating to this particular type of good is critical for consumers.
We often come across nutritional supplements advertised as medicines. The Antimonopoly Service takes active steps to avoid the risk of such confusion in the minds of consumers and imposes serious punishments on offenders.
Notable in this respect is Resolution of the Supreme Arbitration Court No. 867/08 of 20 May 2008 concerning radio advertising of “Lamidan”, a product made from brown seaweeds. In the interview, an expert representing the advertiser spoke of positive effect of the product in treating various diseases. At the same time, it was established during court proceedings that “Lamidan” had been registered as a food product made from brown seaweeds and was produced for the food industry and sale to consumers for consumption purposes. It was, therefore, concluded that “Lamidan” constituted a food rather than a medicine. In this connection, the Supreme Arbitration Court stressed that advertising of biological supplements must not create the impression that they have medicinal properties in order to avoid the risk of them begin confused by consumers with medicines.
9.4 Has your national code been amended in order to implement the current version of the EFPIA Code of October 2007?
No, there is no national code in Russia.