Specifics of regulating the advertising of medicines and medical devices in the Republic of Kazakhstan

In recent years, due to the expansion of the Kazakhstani market for medical products, the regulation of the advertising market in this area has significantly transformed. In this regard, we would like to discuss some features of the current regulation in the field of advertising of medicines and medical devices.

As is known, in general, the general requirements for advertising of goods are set out in the Law of the Republic of Kazakhstan “On Advertising” No. 508-II of December 19, 2003. Depending on the specific product, such advertising may be subject to the requirements of other acts that must be observed before the promotion of the product begins. In particular, advertising of medicines and medical devices in the Republic of Kazakhstan (“Pharmaceutical advertising”) has its own regulatory features.

However, in our practice, advertisers are often faced with the need to spend unnecessary time and money due to the fact that they do not take into account these features at the stage of preparing advertising materials.

Below we would like to briefly highlight certain aspects of regulation in this area that you should pay attention totobegan promoting medical products and medicines.

1. Features of the examination of advertising materials.

The legislation prohibits any placement of Pharmaceutical advertising without a positive opinion from the National Center for Expertise of Medicines and Medical Devices (“NCELS”). As part of the assessment, NCELS experts check advertising materials for compliance with the law and provide a positive conclusion or a reasoned refusal.

To conduct an examination, you need an agreement with NCELS, a full package of documents and payment for the cost of the expert assessment (varies depending on the type of advertising material).

At the same time, obtaining an examination has a number of practical features related to the conclusion of contracts, the provision of materials and the peculiarities of the interpretation of certain legal requirements. Ignorance or ignoring such features in practice can lead to loss of time and money.

In this regard, we would like to draw attention to a number of legal requirements for Pharmaceutical advertising and related practical aspects:

• The law prohibits the indication in pharmaceutical advertising of any guarantees of the effectiveness of a medicine or medical device.
• In practice, the placement in Pharmaceutical advertising of information about the process or mode of action of a medicinal product or medical device can be regarded as information that raises the assumption of guaranteed effectiveness;
• According to the requirements for Pharmaceutical advertising, it should not lead to erroneous self-diagnosis. In practice, a description of the symptoms for which the drug is used may be assessed as information leading to erroneous self-diagnosis;
• The requirements for Pharmaceutical Advertising do not allow the indication of characteristics of changes in the human body, organs before and after the use of medicines and medical devices. In practice, a schematic depiction of the disappearance of bacteria (even without depicting changes in the human body) can potentially be accepted as such information.

In connection with the above, it is recommended to pay significant attention to the preparation of advertising materials, taking into account not only legal requirements, but also the practical aspects of their application.

2. A wide range of prohibitions on the distribution and placement of certain types of Pharmaceutical advertising.

The legislation of Kazakhstan also contains a fairly wide list of prohibitions and restrictions regarding pharmaceutical advertising, which includes:

• a ban on advertising of prescription drugs in the media;
• ban on the placement of outdoor and visual Pharmaceutical advertising;
• prohibition of references to the recommendations of scientists, healthcare professionals, as well as government officials who may encourage the use and (or) prescription of medicines and medical devices;
• prohibition on the distribution and placement of Pharmaceutical advertising in public transport, organizations not related to their purpose, use and dispensing.

3. Special requirements for the content of advertising materials.

Depending on the location of placement of Pharmaceutical advertising (radio, television, Internet resources, printed publications, etc.), advertising material must contain mandatory information, without which it cannot be allowed for distribution.

In this regard, we would like to note a number of requirements that advertisers often miss when preparing such materials. In particular, Pharmaceutical advertising must contain:

• information about the main indications for use, side effects and contraindications;
• special instructions for use by children, pregnant women, and during breastfeeding (if any);
• A clear and understandable recommendation before prescribing and using it is to carefully read the instructions for medical use and the warning text with the following content: “Self-medication can be harmful to your health.”

It is important to note that in order to properly comply with content requirements, the legislation also establishes special conditions regarding the duration of the recommendation in advertising, as well as regarding the size of the text in relation to the frame area.

Summarizing the above, I would like to note that today advertising of medicines and medical devices in Kazakhstan is one of those areas where thorough compliance with the provisions of the law does not ensure the absence of any difficulties. It is also necessary to understand in advance the approach of authorized organizations to the interpretation of certain provisions of the law and take these features into account at the stage of preparing advertising materials.

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Author: Maxim Burak, partner and Shyngys Oralbaev, senior lawyer at GRATA International, Nur-Sultan.