Changes in the rules for advertising drugs. There is a draft regulation

Currently, messages and warnings appearing in advertisements of medicinal products are often incomprehensible and unclear for the recipient. According to the Ministry of Health, the direction of changes should be to ensure better reception by patients of the content of advertisements for medicinal products, which will contribute to a more wise use of medicinal products.

The proposed regulation provides for the following changes:

1) change of the content of warnings regarding the safety of medicinal products - the current warning does not show the potential to build the desired attitudes among recipients who ensure the safe use of medicinal products in accordance with the leaflet. The above situation adversely affects the recipient of the advertising message, who reacts very poorly to the warning read, which may result in unreasonable and irresponsible consumption of drugs. The proposed new wording of warnings builds the desired habit of the recipient to read the information leaflet attached to the package, which contains information on safe dosing, use in accordance with the indications and any contraindications to the use of the medicinal product. It should be emphasized that the warning has not been changed since the entry into force of the regulation (ie from 28 November 2008). At the same time, the phenomenon of a steady increase in the number of advertisements of medicinal products containing the warning, and thus its repetition, addressed to the public via radio TV stations and other media, causes the addressee of the advertisement to wear out with its content and negatively refer to its content, which may result in excessive and the reckless consumption of self-medicated medicinal products, and therefore without the supervision of a physician. The introduction of the warning in three different versions, but keeping the main message, will draw the recipient's attention to the new element of the advertisement and the message it contains. The recipient of the advertisement, as it was before - with one version of the warning, could ignore its content, because he heard or read the warning many times. It is assumed that the introduction of three versions of the warnings will result in different advertisements for medicinal products, which will focus the public's attention on the content of the warning;

2) waiver of the obligation to indicate contraindications to the use of a medicinal product in an advertisement addressed to the public - it should be noted that the text referring to contraindications contained in the advertisement is incomprehensible to the recipient, is often read quickly and contains a lot of data that they will not be remembered by the recipient anyway; the source of information about the use of the drug, its effects, indications and contraindications for the patient should be the information leaflet attached to the package, read with concentration before taking the drug;

3) as an ordering change, the nomenclature was updated due to the entry into force (after the entry into force of the amended regulation) of the Act of 15 April 2011 on medical activity (Journal of Laws of 2022, item 633 and 655).

Project: HERE

Source: RCL