Advertising activity in our country is regulated. However, this is the case throughout the civilized world. There is such a normative act as Federal Law 38 of the Federal Law "On Advertising". We are talking about document No. 38-FZ, adopted on March 13, 2006. Its last revision is from 03/08/2015.
What's the point?
Federal Law 38 "On Advertising" aims to eliminate unfair competition in this area. Its meaning is to protect consumers from harmful effects. Such advertising is recognized as being capable of misleading, causing quite tangible damage to property or health. In addition, such intellectual property is capable of undermining reputation or dignity.
Which areas the law on advertising does not apply
These include its political variety (including election campaigning and related to the referendum), information that the law obliges to disclose or bring to the consumer without fail, analytical and reference material (market reviews, scientific research). All this is not intended to promote the product.
Further, the information of the authorities, state, local self-government should be mentioned, which is not of a commercial nature and does not relate to social advertising. The same kind of signs and signs also belong to this category of intellectual property. Mention should be made of the announcements of various entities, both legal entities and individuals, that are not related to income generation.
What else?
The law also does not include the information that is posted on the packaging (data about the manufacturer, etc.) and any design elements related specifically to this product, and not to an outsider.
The information about the object, which is naturally "inscribed" in an artistic or scientific work, mentions the manufacturer or seller and does not carry a commercial purpose, also belongs to this category.
Federal Law "On Advertising" N 38 FZ - basic concepts
Let's define the terms. Advertising is understood as any information, regardless of the type and method of placement, the addressee of which is a wide range of people. Its purpose is to draw attention to the mentioned product (service) for sale or promotion on the market.
Another concept is the object of advertising. It can be a product, its manufacturer or seller, an event (concert, festival, competition, competition), an intellectual achievement. In a word, this includes everything that requires attention.
A product is a product of activity (including works and services) intended for sale, exchange and other types of circulation.
Other concepts
What other terms does the federal law "On Advertising" use? There are not so many of them. For example, under the so-called inappropriate advertising is understood as one that contradicts the requirements of Russian legislation. But what are the subjects, that is, the actors, called here?
Advertisers, manufacturers and distributors are those who are engaged, respectively, in the manufacture or sale of goods, bringing information into a commercial format and communicating to the consumer in any way. These three categories of subjects are closely related to each other and serve as links in the same chain.
As you know, whoever pays calls the tune. Sponsored advertising is one where a prerequisite is to mention a certain person as a “benefactor”.
In addition, there is also a social variety. Under it, the federal law "On Advertising" means information of a non-commercial nature to achieve the goals of charity, etc.
The solution of all the above issues is within the competence of the federal antimonopoly body, as well as its local representatives.
What is required from Russian advertising?
What kind can they be?
- any of its characteristics, consumer qualities, service life and shelf life, assortment and configuration;
- place of origin and availability of certificates, the possibility of purchasing in a specific place or for a specific time;
- cost or price, payment procedure, discounts, tariffs and other monetary matters;
- the conditions under which the delivery, repair, exchange, service of this product are made, and its warranty conditions.
What other information can be unreliable?
Information about a variety of rules and timing of events, the number of prizes / winnings and the procedure for receiving them is unreliable.
This also includes any information about the persons who are manufacturers or sellers of this product.
What advertising shouldn't be doing?
There are certain actions that are not allowed. Their advertising law is strictly prohibited. This is, first of all, a call for illegal actions, cruelty and violence. Next, mention should be made of the creation of a threat to the safety of transport by the similarity of some symbols to road signs. Another - the formation of condemnation of those who do not use the advertised product, or the use of pornographic information.
Advertising, as you know, is the engine of trade, but not all goods and services can be advertised on the territory of the Russian Federation. There is a section of the law that clearly spells out all the restrictions and prohibitions on advertising a particular product or service. The implementation of this law is strictly monitored by the Federal Antimonopoly Service. This service operates in accordance with the Federal Law on Advertising. In this article, we will touch on some sections of this law, which explains which goods are prohibited from advertising in Russia.
What shouldn't be advertised?
Any services requiring mandatory certification must have documents confirming the fact of certification.
Some types of goods are subject to partial restrictions, which in turn must also be enforced. So, for example, advertising is allowed, but with certain restrictions on the following goods: alcoholic beverages, medicines, tobacco products, dietary supplements, financial services, securities, lotteries, etc. Such advertising should not contain information about the benefits of these types of goods and services, should not encourage a person to buy this product. A person should not see in such an advertisement an incentive to improve his health with the help of these products, improve well-being, promote the harmlessness of these products and an unhealthy lifestyle. In addition, advertising of this category of goods should not contain in the text of appeals to minors under 18 years old, and also contain photographs of these persons in the images. When advertising alcoholic beverages and tobacco products, the organizer is obliged to point out the fact that excessive consumption is harmful to human health.
When organizing advertising campaigns, for example, tasting samples of alcoholic beverages, it is also prohibited to involve minors in this, to offer them tasting alcohol. Such promotions can only be held in places where retail sale of these types of alcohol is organized and subject to certain conditions.
It is planned to ban advertising of harmful products
Another ban is imposed on advertising of dietary supplements. In particular, when advertising them, it is forbidden to use words such as treatment, cure, etc. All expressions should be replaced by synonyms without using these words. It is not allowed to advertise the services of traditional healers, representatives of occult organizations, if they do not have special permissions.
Samvel Grigoryan
Moscow city
Graduated with honors from the Faculty of Pharmacy of the Moscow Medical Academy (now the First Moscow State Medical University) named after I. I.M.Sechenov. More than ten years working in the industry media.
"I'm not a gold piece to please everyone." Who just did not like to repeat this phrase, including Ivan Bunin, Vladimir Mayakovsky and Faina Ranevskaya. Advertising is also not a gold piece. It can be different: successful and not very successful, unforgettable and quickly erased from memory, bright and inexpressive, witty and primitive. Advertising does not always evoke positive emotions in us, especially if it interrupts watching an exciting film.
The paradox is that advertising material that causes contradictory feelings can be perfectly remembered, thereby achieving the desired effect. For example, many with whom I had a chance to talk on this topic still have in their ears the heart-rending scream of a woman who opened the door of her apartment and found a ginger cat at the doorway. As you remember, he stood on his hind legs with a bouquet of flowers and a string bag of citrus fruits. However, something suggests that this masterful video is a successful video for antiallergic drug advertising. And, in my opinion, one of the most unforgettable.
You won't forget this
Our experts
Veronika Kazakevich
director of Civil Law Department of the Law Firm "Cliff" (Moscow
Andrey Kolebtsev
head of Ipsos Healthcare projects (Moscow)
Medicines are advertised in the media (including the Internet), in specialized publications for doctors and pharmacists / pharmacists, as well as directly in pharmacies. That is, advertising of drugs can be directed not only at the consumer, but also at medical and pharmaceutical workers who prescribe or recommend these drugs. The object of advertising in federal, regional, local media and the Internet can also be pharmaceutical and pharmacy organizations, for example, drug manufacturing companies, pharmacy chains, individual pharmacies.
Recently, two opposite trends have been observed in this area.
What is better for society as a whole, the pharmaceutical industry, the pharmacy system: to implement one of these ideas or to keep the status quo?
Status quo: pharmaceutical advertising law
The topic of advertising of medicines and medical devices is regulated by Article 24 of the Federal Law of 13.03.2006 No. 38-FZ "On Advertising". Part 8 of this article states that advertising of prescription drugs, as well as medical devices, for the use of which special training is required, is allowed only in places of pharmaceutical and medical exhibitions, conferences, other similar events, as well as in professional pharmaceutical and medical publications. In other words, wide advertising of prescription drugs addressed to the consumer is prohibited.
The next indisputable requirement is that advertising of drugs and medical devices must be accompanied by a warning about the presence of contraindications to their use, the need to read the instructions or obtain specialist advice (part 7). If the advertisement informs about the properties or characteristics of the drug, then this is allowed only within the limits of the indications contained in the instructions (part 6).
Part 1 of Art. 24 also contains a number of limitations. In particular, advertising should not guarantee the positive effect of the medicinal product, its effectiveness, safety, absence of side effects (clause 8). It is forbidden to claim that the safety and effectiveness of a medicine is guaranteed by its natural origin (clause 10). It is impossible, through advertising material, to create the impression that it is unnecessary to consult a doctor (clause 7), persuade a healthy person to take the advertised medicine (clause 6), unless we are talking about preventive measures, and also inspire the advertising consumer that he is unwell, has something or another disease or disorder (item 5).
According to paragraph 2 of Part 1 of Art. 24 of the Law "On Advertising", it is prohibited to mention specific cases of cure for diseases, improvement of health as a result of the use of the advertised drug in advertising of medicines. Advertising should also not contain expressions of gratitude to people in connection with the fact that they have used this drug (paragraph 3). Let's make a reservation that the requirements of paragraphs 2 and 3 of h. 1 of Art. 24 does not apply to advertisements directed exclusively to pharmaceutical and medical professionals (specialized publications, exhibitions, seminars, conferences, etc.).
It is also forbidden to create the impression of the advantages of the advertised drug by reference to the fact of conducting research that is mandatory for state registration of the drug (clause 4). Of course, the advertising material should not contain references to minors (clause 1). We add that the requirements of paragraphs 1-8 also apply to advertising of medical devices.
The expert pays attention
Advertising of dietary supplements is regulated by Article 25 of the same law. Veronika Kazakevich, director of the civil law department of the law firm "Cliff", draws attention, in particular, to the following. If an advertisement announces that a dietary supplement can be purchased in a pharmacy that helps with any diseases, this will be qualified as a violation of paragraph 1. of part 1 of this article, because advertising of dietary supplements should not create the impression that they are drugs and have medicinal properties. For example, Veronika Kazakevich explains,
Veronika Kazakevich also notes that the legislation does not impose any special requirements on the advertising of pharmacies as such. However, since consumers, first of all, are not interested in the pharmacy organization itself, but in those goods that are sold in it, then such an organization is often advertised by mentioning the goods being sold. In this case, drugs and other pharmaceutical products.
Of course, when advertising pharmacies, the general requirements for fairness and reliability must be observed (Article 5 of the Law "On Advertising"). “This means,” emphasizes Veronika Kazakevich, Director of the Civil Law Department of the Cliff Law Firm, “that advertising should not mislead consumers, contain inaccurate information, incorrect comparisons with competitors, etc.”.
Real or perceived violations of advertising legislation sometimes turn into claims from the regulatory and supervisory authorities. Already not only pharmaceutical specialists, but also the majority of residents of large cities are familiar with the slogan "wholesale price pharmacy". Veronika Kazakevich recalls that the Federal Antimonopoly Service of the Russian Federation initiated a number of cases in connection with its use in advertising, which, according to the FAS, misled consumers about the cost of medicines. “Indeed, in accordance with Art. 4 of the Federal Law of 12.04.2010 No. 61-FZ "On the Circulation of Medicines", a pharmacy organization is an organization that carries out retail trade in medicinal products, and the wholesale price is the price of goods sold in bulk (wholesale), which is lower than the retail price due to with savings in retail trade costs ", - comments on the arguments of the FAS Veronika Kazakevich. Accordingly, misleading consumers in this case consists in the fact that the price of a retail organization - no matter how small it may be - is passed off as a wholesale one.
From TV to small plates
In many segments of the economy, advertising budgets are falling or stagnating in 2015. The pharmaceutical segment is showing significant growth.
According to Vi, the largest operator of the Russian media advertising market, the share of the “medicine and pharmaceuticals” product category in the total budgets for federal placement of television advertising in 1–3 sq. M. 2015 was 26% (1st place), having increased compared to the same period in 2014 by 5%. In second place is food (18%), in third place is perfumery and cosmetics (also, by the way, partly a pharmacy assortment). According to the data of the same company, the most active advertising category in newspapers in January-June 2015 was also the category "Medicine, drugs and dietary supplements" (market share - 24%).
As for the trade press, the picture is somewhat different. Andrey Kolebtsev, Project Manager of Ipsos Healthcare, cites the following statistics: “The market for pharmaceutical advertising placed in specialized print media, according to the results of three quarters of 2015, decreased by 7% in terms of advertising costs (in rubles) and by 16% in terms of number advertising modules compared to the same period in 2014 ”. Andrey Kolebtsev also notes that a significant decrease in promotion indicators (advertising costs, the number of advertising modules) was recorded for foreign companies; domestic ones show a slight increase in costs, without an increase in the number of modules.
Among the leaders in terms of efficiency are also handouts for buyers (23.8%), plates for small change with advertising of drugs (21.7%), advertising packaging (20.3%), information stands (18.7%), posters and posters (17.5%), shelf signs (17.3%), pens with advertisements (16.4%). Since the first table and the cash register are the meeting place between the visitor and the first-person, which “cannot be changed,” advertising plates with small change are, according to the same research, the most frequently used advertising material in pharmacies (54.9%).
Advertising bike
When the bicycle has already been invented, it is very important not to waste time and energy trying to reinvent it. The system of legislative regulation of drug advertising that has now developed in the Russian Federation is close to the generally accepted one.
In almost all countries of the world - the EU states, Australia, Canada, Israel, Switzerland, Japan, etc. - the following scheme operates: advertising of non-prescription drugs is allowed to be addressed to both pharmaceutical and medical professionals and consumers; prescription - only for specialists. Variations are possible: in particular, in Australia, advertisements for part of the so-called "Schedule 3" names - drugs that, although they are over-the-counter, but require professional advice from a pharmacist or doctor for safe use - also cannot be directed directly to consumers. The USA stands apart in this case. In this country, advertisements of prescription drugs directed to the consumer are allowed.
Abroad, in contrast to the CIS countries, professional discipline is strictly observed - it is impossible to purchase prescription drugs without a prescription. And if so, then what is the point of targeting the advertisement of prescription drugs to the consumer, after all, not he, but the doctor in this case makes a choice between one or another name.
The choice of a specific OTC drug - for example, from a number of similar ones - can be made by the consumer himself as part of responsible self-medication. In this case, it is logical that he himself could be the addressee of advertising that would offer him one of the options of choice (of course, this does not at all exclude consulting a pharmacist or doctor, but only supplements it). After all, we are not talking about dubious drugs, but about drugs that have state registration, with officially approved indications and proven effectiveness. The benefits of advertising to the consumer consist in offering the opportunity to choose one or another over-the-counter drug.
Well, in conclusion, let's return to the ginger cat mentioned at the beginning of the article. A specific advertising material may or may not be liked, annoying or even frightening, but if it is made in compliance with all legal requirements, there can be no complaints about it. But our wishes as advertising consumers are also of great importance. I will express my own. I am quite loyal to ginger cats, but not very much to heart-rending cries. I doubt that "shock is our way."
In the Russian Federation, there is no special law that establishes regulatory and legal relationships in advertising activities regarding the provision and circulation of medical services and pharmaceutical products.
The general legislative acts are:
- Federal Law No. 86 "On Medicines";
- Federal Law of 13.03.2006 No. 38 "On Advertising";
- Federal document "On narcotic drugs and psychotropic substances";
- Federal Law "On the Circulation of Medicines";
- Resolution of the Government of the Russian Federation No. 970 “On Approval of the Regulation on Municipal Supervision over the Circulation of Medical Devices”.
The main document is considered to be the Federal Law "On Advertising" No. 38, which was adopted by the participants of the State Duma on June 14, 1995. Article 24 is devoted to the regulation of medical services, it is on it that the advertiser should rely on when distributing an advertisement in this area.
In June 2014, the Federal Law of June 28, 2014 No. 190-FZ "On Amendments to Article 24 of the Federal Law" On Advertising "was approved, according to which it was allowed to advertise medical services in all mass media.
According to Article 24 of the Federal Law "On Advertising", the promotion of medical services must be accompanied by a special message that warns of possible restrictions on their use. And also be accompanied by a recommendation on the need to familiarize yourself with the prescription for their use or obtain qualified advice from specialists. The duration of advertising in radio broadcasts should not be more than 3 seconds, and distribution in television, cinema and video services can be extended up to 5 seconds.
It should be noted that the norms and requirements of Part 7 of Article 24 do not apply to advertising that is placed in the venues of medical and pharmaceutical exhibition congresses, classes and seminars. And also in specialty printing publications, whose clients are exclusively medical and pharmaceutical employees.
Changes in the law on advertising
The main changes in the law regarding the advertising of the relevant services are to clarify some medical terms. This is due to the fact that advertisers and distributors of advertising often misunderstood concepts such as medical services and medical activities. Medical services - medical intervention or a complex of medical care, which are aimed at the implementation of preventive, diagnostic and therapeutic actions. And the concept of "medical activity" is much broader.
According to the changes in the law, the exact names of medical services cannot be used, namely:
- x-ray;
- cardiogram;
- prosthetics;
- all subtypes of analyzes, procedures and therapies, as well as the issuance of medical documentation.
It is forbidden to use phrases that directly relate to the provision of health care, as well as certain actions of doctors or medical institutions, for example:
- counseling;
- reception;
- body check;
- examination;
- medical assistance;
- treatment;
- operation, etc.
Mention of specific medical equipment is not allowed - fluoroscope, tomograph, electrophoresis and others, only if the sale of this equipment is not advertised.
The text of part 8 was published in a new edition: "The promotion of pharmaceutical products in prescription forms and dosages for medicinal products, appropriate treatment, including methods of diagnosis and prophylaxis using new technologies, is allowed on the territory of exhibitions and seminars intended only for pharmaceutical and medical personnel."
Find out what is offered to those who decide to relocate to the Far East.
Requirements for advertising drugs
The General Federal Code of March 13, 2006 No. 38-FZ "On Advertising" is divided into 2 main groups of requirements regarding advertising of medical services and drugs:
- basic norms. These requirements apply to advertising in general, including the promotion of medical services. The main requirements are the integrity and reliability of information;
- special norms.
- directly contact persons who have not reached the age of majority;
- contain imaginary ideas about the advantages of the subject of advertising by referring to the fact of carrying out research that is mandatory for the general municipal registration of the subject of the advertisement;
- promote the formation of a potential healthy buyer a sense of the need to use the subject of advertising;
- contribute to the formation of a feeling of unnecessary referral to doctors;
- guarantee a 100% result from the use of the drug, as well as its safety, performance and the absence of side effects;
- to provide the subject of advertising as a positive dietary supplement;
- to assert that the safety and (or) effectiveness of the medicinal subject is guaranteed by its natural origin.
The legislation of the Russian Federation strongly recommends that all of the above rules be followed. For non-observance, article 14.3 of the Administrative Code establishes impressive penalties. The size of the administrative penalty: for Russian citizens - from 2,000 to 2,500 rubles; for civil servants - from 10,000 to 20,000 thousand rubles; for legal entities - from 200,000 to 500,000 rubles.
Time allowed for advertising
The advertising distributor bears responsibility for non-compliance with Russian regulations on advertising concerning the time, place and means of advertising distribution. This Federal Law does not regulate the specifically allowed time for advertising medical supplies and medicines.
In accordance with the changes that came into force on 01.01.2015, the allowed time was set only for the promotion of alcoholic beverages.
Download the latest version of the law on advertising
The distribution of the advertisement is complicated by the lack of judicial practice and official explanatory notes of the highest judicial institutions. That is, on the one hand, advertising of medical services has many restrictions, and on the other hand, the Federal Law "On Protection of Consumer Rights" defines the obligation to provide the consumer with the necessary and truthful information.
