The Ministry of Health updates the Guidelines for the advertising of medicinal products directed to the general public

Second edition of the “Guidelines for the advertising of medicinal products for human use directed to the general public" of the Ministry of Health, Consumption and Social Welfare

Juan Suárez

Capsulas Nº 202

In June, the Ministry of Health published the second edition of the “Guidelines for the advertising of medicinal products for human use directed to the general public”. For the drafting of this updated version of the Guidelines, the Ministry of Health has benefited from the collaboration of Autocontrol and Anefp, two Spanish associations for self-regulation in advertising with an important specific weight in the field of the advertising of OTC medicines. The new Guidelines include important updates as summarized below.

Advertising of medicinal products directed to the general public

This new edition of the Guidelines, like the first one, is divided into two main chapters. The first one, named “Advertising of medicinal products directed to the general public” includes the recommendations of the Ministry on this field and, among other changes, updates the legal references, the definitions and the principles, that shall govern this kind of advertising.

The new Guidelines also refer to the requirements that advertisements must comply with. The main update in this area is the removal of the references to prior administrative approval to which advertisements were subject to until 2013. At that year, this prior approval requirement was abrogated.

The updated Guidelines incorporate a list of the different advertising platforms (radio, TV, web pages, apps) classifying them in accordance with the type of means of communication to which they belong (audiovisual, digital, printed…). The new Guidelines also include specific recommendations on matters which are relevant for the industry such as advertising sponsorships, product placement, comparative advertising and reminder advertising. Regarding comparative advertising, it is set out that advertisements must comply, not only with the prohibition to include claims of a “superior effect” of the advertised product, but also with the prohibition of suggesting that competitive products are less safe than the advertised product or that such competitive products lack any particular ingredient. Regarding reminder advertising, the updated Guidelines no longer foresee the option to include a blurred image of the package of the product.

Code of good practice

The updated Guidelines also include a “Code of Good Practice for the advertising of medicinal products directed to the general public”. Such Code of Good Practice incorporates updated recommendations and interpretation criteria concerning the content of the advertising messages, as well as the images and music accompanying them aimed to ensure that advertisements provide accurate and objective information, and to encourage the rational and adequate use of medicinal products. Finally, the Code of Good Practice contains other changes such as the prohibition of advertising that denigrates women, or the limitation of the participation of healthcare professionals in advertising of directed to the public.

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