Advertising of medicines and dietary supplements in the Republic of Uzbekistan

In modern society, advertising of medicines plays a significant role, having a direct impact on the health of each of us. This is not only a means of informing about new products in the world of medicine, but also a factor that has a considerable impact on the production and distribution of medicines and dietary supplements.

In Uzbekistan, there is a rapid increase in attention to improving regulations governing the advertising of medical products. This reflects a serious attitude towards ensuring the safety and quality of the products offered. In this article, we have highlighted the main requirements of advertising legislation that pharmaceutical companies need to be aware of. This area of regulation is designed to ensure transparency and reliability of information provided to consumers, and also emphasize the importance of maintaining ethical standards in the process of promoting medical products. In Uzbekistan, advertising medicines is regulated by several legal acts, primarily by the following:

• Law “On Advertising” No.ЗРУ-776 dated June 7, 2022 (the “Law on Advertising”);
• Order of the Ministry of Health of the Republic of Uzbekistan “On advertising of medical products intended for medical institutions and medical workers of the system of the Ministry of Health and control over execution” No.442 dated December 27, 2013 (the “Order of the Ministry of Health No.442”);
• Decree of the Cabinet of Ministers of the Republic of Uzbekistan “Regulations on the procedure for issuing permission to advertise medical products for minors” No.341 dated December 15, 2014 (the “Decree No.ПКМ-341”), and others.

The State Authorities in the field of regulating medicines advertising are the Consumer Rights Protection Agency under the Antimonopoly Committee of the Republic of Uzbekistan (the "Agency") and the Ministry of Health of the Republic of Uzbekistan (the "Ministry of Health").

In accordance with Article 34 of the Law on Advertising, medicines advertising must contain the full (including international pharmacological) name of the medicine and the name of the manufacturer, as well as information on the use or application of the medicine.

At the same time, advertising of medicines is prohibited if it is:

• distributed only by prescription;
• containing narcotic drugs or psychotropic and (or) potent substances;
• not allowed for medical use in Uzbekistan;
• not passed the State registration in the Ministry of Health.

Also, it is necessary to highlight that advertising of non-prescription medicines must not:

• present the medicine as unique, the most effective, and the safest in terms of the absence of side effects;
• to mislead about the composition, origin, novelty, or patentability of the medical product;
• state that the medical product is a biologically active food supplement, cosmetic or hygiene product, or any other type of product;
• allow incorrect comparisons with other medical products to enhance the advertising effect;
• contain statements that the effect of this medicine is guaranteed;
• suggest that a person's health may be worsened by not using the medicine.

Additionally, advertising non-prescription medicines must be accompanied in each case by a warning about the presence of contraindications to their use, the need to familiarize oneself with the medicine instructions, or obtain expert advice.

In accordance with Article 35 of the Law on Advertising, advertising of biologically active food supplements and nutritional supplements must not:

• create the impression that they are medicines and (or) have therapeutic properties;
• contain references to specific cases of curing people or improving their condition as a result of their use;
• contain an expression of gratitude by individuals in connection with their use;
• encourage people to give up healthy eating habits;
• create an impression of the advantages of biologically active food supplements and nutritional supplements over medicines by referring to the facts of research, state registration, as well as the use of the results of other studies in the form of a direct recommendation for their use;
• use images of children in advertising of biologically active food supplements and nutritional supplements prohibited for purchase or consumption by minors.

In addition to the above, advertising of biologically active food supplements and nutritional supplements in each case must be accompanied by a warning that the object of advertising is not a medicinal product.

It is also important to emphasize that the legislation strictly prohibits stimulating actions in the field of advertising medicines and biologically active supplements, as this prevents possible negative consequences and impacts on making informed decisions on the use of medical products.

Besides, it was also established that the procedure for medicines advertising intended for medical institutions and medical workers is determined by the Ministry of Health.

It should be noted that the above-mentioned Article 34 of the Law on Advertising also provides restrictions on advertising intended for medical institutions and medical professionals, which must fully comply with the list of scientific data on medicines and contain the following information:

• the name of the active substance;
• the content of the active substance per dosage (a form of release);
• side effects and major adverse reactions;
• information on contraindications, warnings, and cases when this medical product should be used with caution;
• interaction with other drugs;
• reference to relevant scientific sources, as well as the possibility and source of additional information;
• information that the users of this advertisement are exclusively medical and pharmaceutical workers.

Moreover, the Agency representatives also confirm that professional information for physicians and advertising of prescription medicines should be placed only in specialized publications that are distributed among physicians.

It should also be taken into account that according to Uzbek legislation, advertising of medicines is carried out by providing references and distributing advertisements, organizing and holding special wall visualizations, educational seminars, and conferences on the territory of the building of a medical institution.

Also, it should be noted that in accordance with requirements established by Order of the Ministry of Health No. 442, it is strictly prohibited for healthcare officials to receive free samples of medicines from medical representatives, as well as distributing or selling free of charge to patients and visitors to a medical institution.

When analyzing the market of advertising medicines and biologically active supplements in mass media, a number of violations that do not comply with the current legislation in the field of advertising are revealed. Often, we come across a situation when advertising materials provided by pharmaceutical companies do not comply with the approved instructions for use established by the competent authorities. For example, in several cases, regulatory authorities find that the manufacturer's instructions indicate the effectiveness of a drug in treating hypertension, while advertising campaigns for the same drug speak of its effectiveness in combating other diseases. Such inconsistencies mislead consumers, which in turn can lead to serious consequences for their health. It is important to identify and prevent such violations, emphasizing the need for transparency and accuracy in the advertising of medical products.

In addition to the above, despite the fact that there are restrictions on the advertising of prescription medicines, for example on promotional products - pens, notepads, calendars, key chains, badges, and souvenirs, prescription medicines continue to be “advertised” in such a way thereby violating the requirements of the law.

Currently, the website of the Committee for the Development of Competition and Consumer Protection of the Republic of Uzbekistan has published an official appeal on the application of the legislation on advertising in relation to biologically active supplements (Official appeal No. 01-06/3339 dated November 11, 2020 from the Director of the Agency for Consumer Protection under the Antimonopoly Committee of the Republic of Uzbekistan – https://consumer.uz/wp-content/uploads/2021/01/3339-01-06-ot-11-11-2020g-proizvoditelyam-bad.pdf). This appeal emphasizes that advertising promises about the therapeutic properties of biologically active supplements can mislead consumers, leading them to refuse to take medicines and, consequently, harming their health. It is also noted that during the pandemic, there has been an increase in the number of advertisements for dietary supplements that give the impression of therapeutic properties.

Legislation requires a clear distinction between biologically active supplements and medicines, so advertising of biologically active supplements should not create an impression of therapeutic effect or cure of diseases.

Returning to the topic of liability, we note that in accordance with Article 47 of the Law on Advertising, financial sanctions for violation of the legislation on advertising are applied in the form of monetary penalties (fines) in the following amounts:

• dissemination of advertisements about products the production, sale or advertising of which is prohibited or restricted by law - shall entail a fine of 100 (one hundred) basic calculated value[1] (BCV), i.e., UZS 34,000,000 (approximately USD 2,720);
• inappropriate advertising, refusal to counter-advertise - entails a fine of 70 (seventy) BCV, i.e., UZS 23,800,000 (approximately USD 1,905);
• violation of the requirements for advertising energy drinks, alcoholic beverages, tobacco products and devices for the use of tobacco and nicotine, pyrotechnics, weapons and ammunition, military products, as well as violation of the procedure for placing external advertising and information - shall entail a fine in the amount of 50 (fifty) BCV, i.e., UZS 17,000,000 (approximately USD 1,360);
• violation of requirements for advertising to minors, medicines, biologically active and nutritional supplements, and children's food products - shall entail a fine in the amount of 30 (thirty) BCV, i.e., UZS 10,200,000 (approximately USD 820).

In case when a legal entity is recognized as guilty in revealed offenses in the field of legislation on advertising, the application of financial sanctions shall be carried out by the authorized state body, and if there is a dispute - the issue of application of financial sanctions shall be resolved in court. 

At the same time, application of financial sanctions does not release subjects of advertising activity - legal entities from the obligation to execute the decision or order of the authorized state body or to perform other actions provided by the legislation on advertising.

It should also be noted that in accordance with part 2 of Article 178 (1) of the Code of Administrative Responsibility of the Republic of Uzbekistan, false advertising, non-compliance with the procedure for placing outdoor advertising or refusing to counter-advertise, as well as advertising products whose advertising is prohibited by law, citizens, and officials - entails a fine in the amount of 5 (five) to 15 (fifteen) BCV, that is, from UZS 1,500,000 to UZS 4,500,000 (approximately equivalent to USD 140 to USD 410).

Due to recent changes in the country's legislation and increased monitoring by regulatory authorities, there has been a development aimed at protecting the rights and interests of consumers. However, it is important to note that there are still instances of unfair advertising of medicines and biologically active supplements, which target both doctors and patients. The legal regulation of advertising in the pharmaceutical industry may benefit from additional clarification on several issues. In order to ensure compliance with legal requirements and avoid any potential negative consequences, it is recommended that pharmaceutical companies establish a process to verify the compliance of their advertising materials with the legislation.

 

Authors: Olmoskhon Khamidova, Mukarramkhon Abdullaeva.

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[1] 1 BCV for March 2024 is UZS 340,000 (approximately USD 28)