False Advertising of Medicinal Products

January 19, 2022

BRACE©

Medicinal products have a direct impact on human health. Advertising for medicinal products has its own specifics, yet it remains subject to the general requirements of advertising legislation.

Specifically, Article 5 of Federal Law No. 38-FZ dated March 13, 2006, On Advertising establishes that advertising must be reliable. This article contains 20 points defining the characteristics of false advertising. Advertising is recognized as false if it contains information that does not correspond to reality regarding:

• advantages of the advertised product over products in circulation manufactured by other producers or sold by other sellers;
• any characteristics of the product, including its nature, composition, method and date of manufacture, purpose, consumer properties, conditions of use, place of origin, presence of a certificate of conformity or declaration of conformity, marks of conformity and market circulation marks, service life, and expiration dates;
• the assortment and configuration of products, as well as the possibility of purchasing them in a specific location or within a specific period;
• the cost or price of the product, the payment procedure, the amount of discounts, tariffs, and other conditions for purchasing the product;
• warranty obligations of the manufacturer or seller;
• exclusive rights to the results of intellectual activity and equivalent means of individualization of a legal entity or a product;
• research and testing results;
• provision of additional rights or advantages to the purchaser of the advertised product;
• the actual volume of demand for the advertised or other product;
• the volume of production or sale of the advertised or other product;
• the manufacturer or seller of the advertised product.

Furthermore, pursuant to Article 24 of the Federal Law On Advertising, advertising of medicinal products must not target minors, guarantee a positive result of use, safety, or effectiveness, or create the impression that a doctor’s consultation is unnecessary, etc. Advertising must warn listeners, viewers, and readers about possible side effects and consequences, which can be reviewed by reading the instructions.

Dietary Supplements (the "Supplements") are related products. When advertising Supplements, it is permissible not to notify consumers about possible contraindications (Resolution of the Plenum of the Supreme Arbitration Court of the Russian Federation No. 58 dated October 8, 2012). Naturally, medicinal product advertising must also comply with general requirements:

• it must not incite violence;
• it must not disparage the honor, dignity, or business reputation of competitors or other persons;
• it must not use profanity; 

The primary purpose of ensuring the reliability of medicinal product advertising is to protect the rights and interests of consumers and comply with competition protection legislation. At the same time, the reliability of certain advertising materials is often evaluative in nature.

Below we consider key examples of law enforcement practice related to the falsity of medicinal product advertising.

When considering one case, a regional branch of FAS Russia established that an advertisement stated the medicinal product should be used with caution during lactation; however, according to the instructions for medical use of the medicinal product, the breastfeeding period is a contraindication. Consequently, the advertisement reported information that did not correspond to reality regarding the characteristics of the medicinal product. Additionally, the same advertising materials stated that the active ingredient was natural micronized progesterone. However, according to the instructions for medical use, the active ingredient is micronized progesterone. In this regard, the authority recognized the advertisement as false.[1]

In some cases, the advertiser succeeds in justifying the reliability of information provided in the advertisement. For example, an advertiser submitted information to FAS Russia stating that Chinese scientists had conducted in vitro studies on the activity of several medicinal products against the new coronavirus, including the advertised product. Considering the research results, the Health Commission of the PRC included the drug in the recommendations for treating COVID-2019 in China ("Program for the Diagnosis and Treatment of Pneumonia Caused by the New 2019-nCoV Coronavirus", published on the website of the National Health Commission of the PRC). Under these circumstances, the FAS Russia commission concluded that the advertisement, which was broadcast on radio stations in January 2020, did not show signs of being false.[2]

Another common mistake made by advertisers is "mixing" the advertising of medicinal products and Supplements, even though Article 25 of the Federal Law On Advertising establishes separate requirements for Supplement advertising. For instance, as reported by the Volgograd UFASe, for almost the entire 25-minute program, consumers were persuaded that the product was medicinal, as the overall semantic content of the advertisement indicated characteristics such as therapeutic properties for eye health. The advertised product was referred to simply as a "remedy", a "unique complex", a "complex of substances", a "complex of natural extracts and substances", a "new product", or an "eye assistant". Thus, information stating that the advertised product was a food product or candy was not conveyed to the consumer in a perceptible form.

This advertisement also included a statement at the end regarding the need to consult a specialist before use, which could also mislead the consumer regarding the nature of the advertised product. This further confirms the importance of clearly distinguishing between medicinal products and Supplements when determining the content of advertising materials and establishing the necessary disclaimers.[3]

Another example of a violation of reliability requirements is a notable case where the UFAS identified a sign of unreliability regarding information about the advantages of the advertised product over products in circulation manufactured by other producers or sold by other sellers. The regulatory authority’s decision notes that the video sequence of the commercial contains an image of a stomach with a circular saw blade with sharp teeth moving inside it, labeled "Al aluminum". Such an image gives reason to believe that aluminum negatively affects the human stomach by damaging its walls. According to the information in the advertisement, the negative impact of aluminum on digestion results in constipation, which may arise as a side effect of aluminum-containing drugs. However, medicinal products containing aluminum are approved for use and are effective in relieving heartburn, and the side effects of these drugs do not indicate harm to the digestive organs. Since the commercial discussed a side effect of aluminum-containing drugs in the form of digestive disorders, the authority found the advertiser in violation of advertising legislation.[4]

Sometimes, when identifying the falsity of medicinal product advertising, the regulatory authority also notes non-compliance with Article 24 of the Federal Law On Advertising, which contains specific requirements for such advertising. Specifically, in one case, FAS Russia noted that an advertisement stated the components of the medicinal product act faster on the cause of venous valve dysfunction and blood stasis. However, the instructions for medical use stated that the duration of treatment could be up to 12 months. Furthermore, the phrase "acts faster on the cause" is meaningless, as no scientific threshold or criteria exist to define the action as fast, since the characteristic "fast" cannot be verified. According to the regulatory authority, in addition to being false, such advertising creates the impression in a healthy person that the advertised object is necessary.[5]

Another example of advertising simultaneously recognized as false and as guaranteeing a positive effect in contradiction to Article 24 of the Federal Law On Advertising involved an advertisement suggesting that a dental gel "will quickly cure dental diseases" and that the components would provide "fast and comprehensive action". This information did not correspond to reality or the instructions for use of the gel. The advertisement also failed to mention that the positive impact on the course of the disease within 3 minutes of use referred only to its analgesic effect, rather than a comprehensive effect.[6]

One of the most common reliability requirements for medicinal product advertising involves the provision of incorrect prices. For example, signs of a violation of advertising legislation were identified in an advertisement stating: "In the pharmacy... autumn price drop! ...Prices from manufacturers...", placed on a banner at the pharmacy entrance. The information in the advertisement contained information that did not correspond to reality regarding the cost or price of the product. According to the protocol to the invoice, the manufacturer's actual selling price without VAT for the medicinal product was "75 rubles 34 kopecks", while the wholesale organization's actual selling price with VAT was "81 rubles 46 kopecks". Meanwhile, the retail organization's actual selling price with VAT was "103 rubles 10 kopecks". Thus, the price established by the manufacturer differed from the price at which the pharmacy sold these products. Consequently, the aforementioned advertisement was false.[7] In another case, the authority established that the advertisement indicated the markup on drugs on the VED List in the pharmacy was "0 rubles". However, according to the submitted price coordination protocols, the price for VED List drugs in pharmacies is formed by adding the distributor's wholesale markup to the manufacturer's actual selling price. Furthermore, a retail markup also exists for certain VED List drugs in several pharmacies. Therefore, the advertisement did not meet the criteria for reliability.[8]

A further example of false advertising involves providing inaccurate characteristics of the advertised object. One advertisement used the following wording: "Nail fungus. Use Oflomil lacquer. Within the first 24 hours, Oflomil lacquer penetrates deep into the nail and kills fungus even under decorative lacquer. One application for 7 days of treatment. From damage to transformation. Oflomil lacquer is a powerful treatment for nail fungus at a more affordable price." Analysis of the advertisement suggests the product can be used with cosmetic decorative lacquer and will penetrate deep into the nail to kill the fungus. However, according to the product instructions: "During treatment, one should avoid using artificial nails and not use cosmetic nail polish." Thus, the possibility of using the product together with decorative lacquer is not provided for by the instructions for its use, and the information regarding the conditions for using this product reported in the advertisement did not correspond to reality.

This article reviews key examples of law enforcement practice where medicinal product advertising may be recognized as false. We remind you that pursuant to Part 5 of Article 14.3 of the CAO RF, a violation of advertising legislation entails an administrative fine on citizens in the amount of 2,000 to 2,500 rubles; on officials — from 10,000 to 20,000 rubles; and on legal entities — from 200,000 to 500,000 rubles.

To avoid these fines, we recommend verifying advertising materials for compliance with the instructions, avoiding comparisons of the advertised object with other products on the pharmaceutical market, and accurately stating the selling price of the medicine to ensure it matches the actual price. It is essential to recognize that any advertising materials must be individually checked for compliance with advertising legislation to minimize the risks of being recognized as false.

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References

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

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

[3] Decision of the Volgograd UFAS Russia in Case No. 17-03-5-02/677.

[4] Decision of FAS Russia dated March 28, 2017, in Case No. 3-5-14/00-08-17.

[5] Order of FAS Russia dated February 28, 2017, in Case No. 3-5-1/00-08-17.

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

[7] Decision of the Vologda UFAS Russia dated January 27, 2017, No. 42/2016,384.

[8] Decision of FAS Russia dated January 17, 2017, in Case No. 3-5-40/00-08-16.