FAS Recommendation for Advertising OTC Drugs in Russia

07 March 2019

GMP News

During 2017-2018, the Federal Antimonopoly Service of Russia (“FAS”) paid close attention to advertisements of OTC medicines and considered large number cases of violations of advertising legislation by pharmaceutical companies.

At the end of 2018, FAS in collaboration with the Association of International Pharmaceutical Manufacturers and other market players, established a guideline on recommended advertising of OTC medicines.

This Guideline is based on the analysis of the FAS’s practice and court practice in recent years. The Guideline contains important approaches to controversial issues arising in the advertising of OTC medicines in Russia.

Below you may find the short summary of the most important recommendations that shall be taken into account.

1. Inaccurate advertising

Advertising shall be deemed as inaccurate where information on the therapeutic effect and therapeutic properties does not correlate within:

According to the Guideline, generic words, for instance, “cold, cough, chill, fever, etc.“, can be used in advertisements, provided that their medical terms and synonyms are included in the package leaflet.

2. Guaranteed treatment

Russian law prohibits any guarantee of the efficacy of a medicine. Pharmaceutical companies may use, in advertising, therapeutic properties of a medicine and its effect upon a patient’s organism. FAS recommends the use of words and expressions that indicate the process and impact of a medicine and not the guaranteed result. Moreover, used therapeutic properties should correspond to the package leaflet.

The following phrases are acceptable.

3. Words “fast”, “rapidly”, “instantly”, etc.

The use of such words as “”fast”, “rapidly” and “instantly” characterizing the time of the therapeutic effect and therapeutic properties is unacceptable. With regard to other medicine’s characteristics, the use of these words is permissible, for example: “it dissolves quickly“, “stored for a long time“.

4. Persuading healthy consumers to use a medicine

Russian law prohibits persuading healthy consumers to use a medicine. If a medicine is used for prevention of disease, it should be directly indicated in the advertisement. It is unacceptable to use phrases “everyone should take this medicine“, “many people have these symptoms“.

5. Assumptions that a consumer has a disease

Russian law restricts stating, or suggesting in an advertisement, that a consumer has a disease, or symptoms of diseases. For example, it is not recommended to use the following:

It is allowed to mention the symptoms that are specified in the product leaflet, for example, “when you have a cough”, “in case of a cold”. Advertisements can also refer to indications and usage in package leaflet, or information, on consumers’ intention to relieve a symptom: for treatment of a cough”.

Since the FAS will follow Guideline when considering advertising cases, this document becomes a very important and effective tool for pharmaceutical companies in the production of advertisement of medicines. It helps to avoid the most frequent and gross violations, using recommendations approved by the regulatory body itself.

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