Is drug advertising harmful?

The project primarily envisages changes to the content and manner of presentation of warnings regarding the safety of the medicinal product in the advertisement of a drug to the public. In the opinion of the authors of the new regulation, in accordance with its rationale, the current regulations insufficiently attract the attention of the recipients of advertisements, so that the content of displayed or read messages in the advertisement does not reach patients properly. In the justification there was even a controversial thesis that "the phenomenon of a constant increase in the number of advertisements of medicinal products containing the warning, and thus its repetition, directed to the public via radio TV stations and other media" leads to "excessive and reckless consumption of medicinal products used in self-medication ”(although no studies have been cited to support this claim).

What solution to this problem is proposed by the legislator? First of all, the draft regulation includes three alternative versions of the special warning in the advertisement of an open-label medicine, from which it will be possible to choose the one that the MAH will include in the advertisement. In this way, the content of the warnings in advertisements broadcast on radio or television will differ from each other, which is supposed to prevent the recipients of the advertisement from ignoring their content - they would focus more on the warning, the content of which will be variable. The draft amendments to the regulation on advertising of medicinal products also provide for an increase in the minimum space to be occupied by a warning addressed to patients in the visual advertisement of a medicine; Currently, it is not less than 10% of the advertising space, after the change of regulations it would be 20%.

On the other hand, it is more difficult to understand the reasons why it is planned to require that the wording of the warning in audiovisual (e.g. television) or visual advertising (posters or leaflets) for a medicine should be displayed in black on a white background. Currently, the provisions of the Regulation on advertising of medicinal products only require that the wording of the warning should be placed in the advertisement in such a way that "the text stands out from the background of the plane, is visible, legible, stationary, horizontally placed", which is a sufficient guarantee of legibility/visibility of the warning .

The requirement for the warning to be in the form of a black text on a white background, provided for in the draft amendment to the regulation, seems to be an excessive solution, inadequate for the purpose (which is to ensure that the warning is visible in the content of the advertisement), and at the same time may evoke undesirable associations. Why? Currently, the requirement to place warnings in this form (black font on a white background), although not in the advertisement (because it is not allowed), but on the packaging, applies to ... cigarettes. It is hard not to resist the impression that, after the introduction of the obligation to include warnings in advertisements for medicines similar to those commonly associated with tobacco products, at least some patients will raise serious doubts as to the safety of medicinal products.

However, the biggest reservations are raised by the fact that the regulation does not provide for a proper vacatio legis for advertisers. Although the draft provides that an advertisement whose dissemination started before the date of entry into force of the regulation, which does not meet the new requirements, may be disseminated for no longer than 6 months from the date of entry into force of the regulation, this does not apply to advertisements prepared for broadcast or dissemination, and yet not widespread. All advertising materials, especially those prepared for broadcast on television, must be prepared and ready well before their first display or dissemination. It can therefore be assumed that on the date of entry into force of the new regulations (which may occur at any time - the regulation only requires publication and does not have to go through the legislative process like the act), a number of advertising materials that will be consistent with the existing, not new regulations, will be ready - recorded or printed. Destroying them and preparing them anew will be very costly for the duty holders.

Therefore, it would be rational to adopt a solution according to which each advertisement, not only the one that is already on the market, may be disseminated in the current form for 6 months after the date of entry into force of the new regulations.

Katarzyna Czyżewska advocate

Czyżewscy law office