Advertising of drugs and dietary supplements in Belarus

I. RULES OF ADVERTISING

Key regulations, definitions

Belarusian Legislation sets specific requirements for medical and healthcare advertising, including advertising of drugs and dietary supplements.

Advertising of drugs and dietary supplements is mainly regulated by

• Law of the Republic of Belarus of May 10, 2007 No. 225-Z ‘On advertising' (hereinafter - Law on advertising);
• Resolution of the Ministry of Health of the Republic of Belarus (hereinafter - Ministry of Health) of July 23, 2013 No.63 ‘On implementation of Law of the Republic of Belarus of May 10, 2007 No. 225-Z ‘On advertising’ (hereinafter – Resolution No.63).

‘Advertisement’ means information about an advertised product, placed (disseminated) in any form by any means, to bring attention to the advertised product, formation or maintenance of interest, and (or) promotion in the market (Art. 2 of the Law on Advertising).

‘Drug’ means a medicinal product in a dosage form (Art. 1 of the Law of the Republic of Belarus of July 20, 2006 No. 161-Z ‘On Circulation of Drugs’).

‘Medicinal product’ means a product that either consists of or contains a substance or a combination of substances, that comes into contact with the human body and is used for treatment, medical prevention of human diseases or restoring, correcting, or modifying physiological functions of the human body through pharmacological, immunological or metabolic action or to making a medical diagnosis of human diseases and conditions (Art. 1 of the Law of the Republic of Belarus of July 20, 2006 No. 161-Z ‘On Circulation of Drugs’).

‘Dietary supplements’ means natural, identical to natural food and (or) biologically active substances, as well as probiotic microorganisms, used for direct human consumption or incorporated into food products to enrich the diet and which are not meant to be the only source of nutrition (Art. 1 of the Law of the Republic of Belarus of June 29, 2003 No. 217-Z ‘On the quality and safety of food raw materials and food products for human life and health’).

Approval of the Ministry of Health 

An important requirement for the advertising of drugs and dietary supplements is the approval of the Ministry of Health. The republican unitary enterprise ‘Center for Examinations and Tests in Health Service’ is a specially authorized body for advertisement approval.

There are several exceptions when approval by the authorized body is not required. For example, advertising of drugs carried out within the clinical trials of these drugs, conducted for their subsequent state registration, is not subject to approval only if advertising aims to attract volunteers (patients) to participate in clinical trials.

NB! Starting from July 12, 2024, the requirements for advertising will become stricter due to the changes to the Law on Advertising coming into force. Thus, outdoor advertising and advertising on vehicles of drugs and dietary supplements will be subject to the approval of the Ministry of Health.

Disseminating channels 

It is allowed to advertise OTC drugs and dietary supplements through all possible sources (mass media, social networks, radio, television, outdoor advertising, advertising on vehicles, etc.).

Advertising of prescription-only drugs is permitted:

- through specialized press, a list of which is approved by the Ministry of Health (see Resolution No.63);

- in places of medical or pharmaceutical exhibitions, seminars, conferences, and other similar events.

It should be noted that the legislation separately regulates the procedure for informing healthcare professionals and pharmacists about drugs. Thus, the allowed forms of informing healthcare professionals and pharmacists are:

- oral presentation with/without displaying printed and other informational materials about a drug during meetings, conferences, seminars, symposiums, and other events approved by the Ministry of Health;

- placement of informational materials as part of the aforesaid events;

- providing informational materials to healthcare organizations in electronic form or on paper without personal interaction with healthcare professionals and pharmacists.

II. PRACTICAL ISSUES

А. The most common violations are:

- failure to comply with the requirements for disclaimers;

- non-compliance with the requirements for the speed and sound of the voiceover;

- discrepancy between information given in the drug registration documents and the content of the advertisement.

B. Difficulties in the distinction between advertising and informing, allowing to freely interpret specific cases of providing information about drugs.

III. ADMINISTRATIVE PRACTICES

State authorities closely monitor compliance with legislation on advertising in the fields of pharmaceuticals and healthcare.

The following example is given to illustrate this point.

The Internet advertisement for the drug contained the following information:

- a statement that the therapeutic effect is guaranteed.

Citation: ‘Will lower your blood pressure to age-appropriate levels without chemistry and side effects! Bring your blood pressure back to normal in minutes without harming your health!’;

- a statement that the use of the drug is safe, in particular, due to its natural origin, and is not followed by the development of undesirable or adverse reactions.

Citation: ’No addiction and withdrawal syndrome because of its purely natural formula’.

- a recommendation of state authorities used to enhance the advertising effect;

- an information creating an impression of high speed of development of the therapeutic effect;

- an information creating a feeling of fear and apprehension about the possibility of deterioration of the state of health in case of termination of use of the drug.

Citation: ‘Complete loss of capacity, and life without movement are terrible consequences of neglected hypertension. It is up to you to live a full life or spend the rest of it in fear of becoming disabled!’

The drug was not registered by the Ministry of Health.

The advertisement was recognized as inappropriate and banned from being placed (disseminated).

Link to the source: https://www.mart.gov.by/news/novost/mart-preduprezhdaet-gipertonium-uretramol-mnimye-lekarstva/?sphrase_id=208258 

 

Authors: Dmitry Viltovsky, Aliaksandra Vasilyeva.