Advertising and promotion of medicines and biologically active food supplements in Kazakhstan

Advertising and promotion of medicines and biologically active food supplements (hereinafter referred to as – Advertising of Medicines and BAFS) on the territory of the Republic of Kazakhstan are regulated by the following regulatory legal acts:

• Code of the Republic of Kazakhstan dated July 7, 2020 No. 360-VI ЗРК on public health and healthcare system (Healthcare Code);
• Law of the Republic of Kazakhstan dated December 19, 2003, № 508 on Advertising (Advertising Law);
• Rules for advertising of medicines and medical products, approved by Order of the Minister of Healthcare of the Republic of Kazakhstan dated December 20, 2020, No. ҚР ДСМ-288/2020 (Rules for Advertising Medicines);
• Rules for advertising biologically active food supplements, approved by the Order of acting Minister of Healthcare of the Republic of Kazakhstan dated October 27, 2020, No. ҚР ДСМ-160/2020 (Rules for Advertising BAFS);
• Rules for the ethics of promoting pharmaceuticals and medical devices, approved by Order of the Minister of Healthcare of the Republic of Kazakhstan dated December 21, 2020, No. ҚР ДСМ-294/2020 (Ethics Rules);
• Rules for labeling online advertising, approved by Order of the Minister of Culture and Information of the Republic of Kazakhstan dated February 16, 2024, № 59-НҚ.

Advertising means information disseminated and (or) placed in any form, by any means, intended for an indefinite number of persons and designed to create or maintain interest in an individual or legal entity, goods, trademarks, works, services, and facilitate their implementation.

Advertising of medicines means information disseminated and (or) placed in any form, using any means, intended for an indefinite group of persons, containing individual information or a set of information about medicines and medical products, contributing to their promotion and implementation.

Considering that according to the Rules for Advertising BAFS, advertising of BAFS is carried out subject to its compliance with legislation in the fields of healthcare and advertising, in particular the requirements of the Healthcare Code, then the requirements established for advertising of medicines apply by analogy to advertising of BAFS.

Forms of advertising of medicines

Even though the definition of medicine advertising states that information can be distributed and posted in any form, by any means, and is intended for an indefinite number of people, there are several restrictions on medicine advertising, which are listed in paragraph 3 of Article 56 of the Healthcare Code.

Thus, by subparagraph 2) of paragraph 3 of Article 56 of the Healthcare Code, advertising of prescription medicines in the media is prohibited. The media, according to the Law on the Mass Media, means a printed periodical, television, radio channel, documentary film, audiovisual recording, and other forms of periodic or continuous public dissemination of mass information, including Internet resources.

At the same time, the Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare of the Republic of Kazakhstan does not limit the distribution and placement of advertising of prescription medicines, which does not violate the Ethics Rules, the Rules for Advertising Medicines and the requirements of the Healthcare Code - in specialized printed publications intended for medical and pharmaceutical workers, as well as on specialized events such as medical and pharmaceutical conferences, symposia, meetings, etc.

Rules For Labeling Online Advertising

From March 1, 2024, the Rules for Labeling Online Advertising are in effect, according to which online advertising placed by influencers (bloggers) on a commercial and/or contractual basis is subject to labeling.

Labeling of online advertising is carried out in a text format with the possibility of its identification and contains a text indication that the posted material is an advertisement. The text indication contains one of the following wordings: “advertising”, “promotional material”, “affiliate material”, “sponsored material”, “advertising”, “paid for by the sponsor” or “PR”.

Thus, we understand that advertising of medicines and BAFS can be carried out on online platforms with mandatory text labeling only, like advertising in other media - if there is a conclusion from the Center on the compliance of medicine advertising with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare.

Advertising permission 

To distribute and place advertising for prescription and (or) over-the-counter medicines, it is necessary to undergo an assessment of medicine advertising materials and obtain a conclusion on the compliance of advertising with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare from the RSE on the REU “National Scientific Center for Health Development named after Salidat Kairbekova” of the Ministry of Healthcare of the Republic of Kazakhstan (hereinafter - the “Center”) for which, according to the Rules for Advertising Medicines, the applicant must enter into an agreement with the Center. The list of necessary documents and materials that must be submitted to the Center to receive the service, as well as the procedure for the Center’s actions, are specified in paragraphs 11 to 19 of the Rules for Advertising Medicines.

Despite the fact that the Rules for Advertising Medicines contain a procedure for issuing a conclusion on the compliance of medicine advertising with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare, in practice a dilemma arises when the Center refuses to accept documents and materials from applicants for the assessment and issuance of permission to advertise prescription medicines, justifying this by the fact that they do not have guidelines (instructions) for providing this service, and there is also no approved price list for the provision of services. As a result, we see that the Center cannot provide the service due to the lack of protocol procedures in its commercial policy, and the applicants cannot take advantage of the opportunity to promote their products by the law. 

Also, the Rules for Advertising Medicines do not establish a period for which a conclusion is issued on the compliance of advertising with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare. It is noteworthy that until February 20, 2015, the Rules for issuing permission to advertise medicines, medical products, and medical equipment in the Republic of Kazakhstan were in force, approved by order of the Minister of Healthcare of the Republic of Kazakhstan dated March 20, 2013 No. 167, which in terms of the algorithm of actions did not differ from those as specified in the Rules for Advertising Medicines. The Rules 2013 also did not have a price list for services, but the validity period of the permit was established and issued for the period of validity of the registration certificate of medicines, medical devices, and medical equipment.

 

Authors: Aliya Zhumekenova, Aidana Baitimova.