Guidelines on advertising of over-the-counter (OTC) medicines

Guidelines on advertising of over-the-counter (OTC) medicines

14 January 2019

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 (“Guideline”).

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.

The Guideline will be followed by FAS when considering advertising cases and can help pharmaceutical companies in the production of advertisement of medicines.

For your convenience, we have prepared a 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:

  • Approved summary of product characteristics and package leaflet;
  • Standards of medical care approved by the Ministry of Health;
  • Other documents approved by the Ministry of Health.

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.

  • Verbs / verbs, indicating the process of treatment (treats, promotes treatment, affects symptoms, helps to relieve symptoms, etc.);
  • Nouns / phrases that do not indicate the inevitable onset of the result (illness, symptoms (including specific types of symptoms), helps (contributes) to treatment, facilitates rehabilitation);
  • Phrases indicating time of absorption (within two minutes, a medicine begins to be absorbed);
  • Indications for use and therapeutic properties (for pain relief, aimed at treatment, has an antispasmodic effect).

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:

  • Do you have cough? Sneeze? Headache?
  • It seems you are getting sick ...
  • What's this? Are you ill?
  • You have flu.

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”.

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Practices: Healthcare and Pharmaceutical Industry

Note: Please be aware that all information provided in this letter was taken from open sources. Neither ALRUD Law Firm, nor the author of this letter bear any liability for consequences of any decisions made in reliance upon this information.

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