Russia adopts recommendations on drug advertising

Russia

The Federal Antimonopoly Service of Russia (FAS) together with leading industry associations (AIPM, ARFP and others) issued Recommendations for advertising over-the-counter medicines*, which cover the most common violations in the field of drug advertising, such as performance guarantees, incorrect comparisons and surrogate advertising among others.

The adoption of these recommendations is considered a positive development for the pharmaceutical industry since:

  • They enable market participants to better evaluate their advertising materials in order to avoid violation;
  • They leave less room to subjectivity by the FAS when reviewing advertisements.

Performance guarantees

Guaranteeing a drug’s effectiveness is one of the most common violations in pharmaceutical advertising. At present, a variety of slogans of a positive nature can be deemed to guarantee the performance of a drug, often due to the subjective perception of the FAS.

The recommendations draw a clear line between claims actually guaranteeing performance (that are in violation) and acceptable slogans advertisers are entitled to use. According to these recommendations, advertisements can contain statements related to the therapeutic effect of a drug, provided that such statements focus on the treatment process, and not on results.

The recommendations also allow ads featuring the use of Russian verbs in the imperfective grammatical form, which refers to a process (e.g. “is helping”, “is healing”, “is affecting”). Such use in the past was often recognised as a violation (see FAS decision on case No.3-24-55/00-08-17*). Adverbs that characterise such a process (e.g. “carefully”, “conveniently”, “substantially”) and nouns that do not indicate the inevitability of the result (e.g. “symptoms”, “causes”, “treatment”) can also be used. In addition, ads are allowed to describe the drug’s characteristics as specified in the instructions (e.g. “pain relief”, “it has an antispasmodic effect”), including descriptions of the effectiveness of the drug (e.g. “absorbed within 15 minutes”). Previously, this was recognised as a violation (see FAS decision on case No. 3-5-6/00-08-17*).

As before, words and phrases that promise a positive result in treatment cannot be used (e.g. “will cure”, “will defeat”, “will relieve pain”, “a problem solution”, “helps healing”).

The final legal assessment will be considered after reviewing an advertisement in its entirety, taking into account the full content and context of the phrases used.

Comparative advertising

Russian advertising legislation does not set clear rules for comparative advertising, which is a problem for pharmaceutical businesses. Comparisons in drug advertising are often used in practice, but they can be incorrect or discredit the business reputation of a competitor.

The recommendations approve some basic rules for comparative drug advertising. Comparisons are allowed provided that they include the comparable characteristics of the drugs (i.e. similar composition, mode of action, method of administration) and do not tarnish the business reputation of a competitor. It is also permitted to compare drugs with different international non-proprietary names provided that the drugs are used in the same way, and the criteria for comparing them are clear and reliable.

Surrogate advertising

According to the recommendations, surrogate advertising – the advertising of prescription drugs under the guise of over-the-counter drugs by promoting their external characteristics (i.e. name, packaging) – is not permitted.

In order to avoid being qualified as surrogate, advertising should contain either a direct reference to the fact the drug is available over the counter or focus the consumer’s attention on the characteristics that distinguish the drug from the prescription drug (i.e. its international non-proprietary name, dosage or release form).

Using footnotes and references

In drug advertising, footnotes and references to various studies and scientific literature are often used. The conditions of such use have been clarified to some extent.

The recommendations permit advertisers to confirm information on the therapeutic effect of a drug by making references to sources other than the instructions for use, provided that these sources do not contradict the instructions. This is good news for companies since it provides an opportunity to refer to research articles whose results and conclusions match the instructions for use, but are not fully reflected in them.

The recommendations state the number of footnotes should be kept to a reasonable minimum. They must be short, understandable for the consumer, formatted in a contrasting font, and the duration of their display cannot be less than the display time of a specific sequence.

Assumption of illness

The recommendations clarify which expressions can be considered an assumption that a consumer has a specific disease, which is a violation of the Law on Advertising. Hence, interrogative appeals to the viewer should be avoided in advertising if they contain the names of diseases or symptoms (“Are you sneezing?”, “Do you have a headache?”). These questions, however, can be used in advertising through the dialogue of characters (e.g. “Mum, are you sneezing?”).

Images of medical and pharmaceutical professionals

The Law on Advertising prohibits the use of images of medical professionals in advertisements. The recommendations concur by reflecting the FAS’s broad interpretation of the concept of an “image of a medical professional”. Ads must avoid not only the literal image of a “person in a white coat”, but also any verbal and visual references to the image of a doctor, including fairy-tale or animated characters.

Conclusion

Pharmaceutical companies should review advertising materials already in place and consider carefully the recommendations when developing new advertising.

If you have any questions on the matters referred to in this eAlert, please do not hesitate to contact CMS Russia experts Vsevolod Tyupa and Alexey Shadrin or your regular contact at CMS Russia.

* In Russian