Checks and controls on medicinal product advertising for the general public
In accordance with its legal mandate to protect the safety of patients in this area, Swissmedic performs regular and targeted control of advertisements promoting medicinal products in print media, TV spots and in electronic media.
We have noticed that the mandatory statement in the advertising of medicinal products to the general public is very often not presented in the legally required manner. Advertising to the public must provide the target audience with certain minimum/mandatory information. This mandatory information includes the statement to read the package leaflet or, if applicable, the information on the outer packaging (box).
Importance of mandatory information in medicinal product advertising
Every use of medicinal product is associated with potential health risks. The inclusion of mandatory statement in an advertisement for a medicinal product should ensure that, before using an advertised medicinal product, patients read the information needed for its correct and safe use (package leaflet). This information/leaflet is designed to help patients to use a given medicinal product according to its intended purpose. The mandatory statement also makes it clear that the promoted product is not just another consumer good, but rather an authorised medicinal product. As such, the mandatory statement is provided to ensure the safe use of of medicinal products. Thus, the requirements regarding the presentation of this mandatory statement are one of the key elements in medicinal product advertising.
The correct presentation of the mandatory statement in the advertising of medicinal products to the general public is regulated by law (wording, font size, etc. – with regard both to advertising in print and in electronic media). Authoritative regulations/rules regarding the appearance of the mandatory statement in advertising aimed at the general public are defined in Art. 16, para. 5 let. c and Art. 17 and 17a of the Regulation for Advertising of Medicinal Products.
For some years now, and in various publications (e.g. SMJ 08/2008), Swissmedic has described in detail its practice concerning the specific requirements on how mandatory statement in the individual advertising formats (print media, TV/cinema, radio and Internet) should be structured.
The corresponding details about the precise wording, font size and placement of the mandatory statement can be also found in the following checklist (in German and French), which can be downloaded from the Swissmedic website: