Advertising of medicinal products - Do’s and don’ts in time of Covid-19

At the moment, there is a naturally raised interest in medicinal products and vaccines – both existing pharmaceuticals as well emerging new pharmaceuticals – which potentially can prove to be effective in the fight against the Covid-19.

Pharmaceutical companies must therefore, especially in these times, be aware of the rules on advertising, including the ban on the advertising of off-label use as well as pre-launch, which remains unchanged and in force. The Danish Ethical Committee for the Pharmaceutical Industry (ENLI) has just exhorted this in their latest newsletter.

In the Danish Medicines Act, an absolute ban applies against advertising to the general public of medicinal products subject to prescription. When advertising to health professionals, it stems from the regulation on advertising and from ENLI´s general code for advertising (which the company is bound by if being a member of LIF) that various requirements need to be met, including a general objectivity and factuality requirement and requirements for certain compulsory information.

It should be noted in this connection that the definition of advertising is interpreted very broadly and covers “any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products” cf. section 1 of the regulation on advertising.

Advertising for off-label use

In these times, it is particularly relevant to be aware that advertising of existing medicinal products must be in accordance with the marketing authorisation of the medicinal product in question. Publicity of non-authorised indications/use of an existing medicinal product, may therefore constitute as prohibited advertising for so-called off-label use. This ban includes not only the companies’ own references and statements but may also include the mere communicating of the references or statements of others.

Pre-launch

In addition to this, there is also a ban on advertising for medicinal products etc. which cannot lawfully be marketed in Denmark. In relation to new medicinal products under development – and in particularly in these times where vaccines are being developed – publicity of such pharmaceuticals may constitute as prohibited advertising in terms of “pre-launch”.

As a starting point, it is not prohibited to refer to the early stage clinical trials relating to medicinal products, but the closer a company is to obtaining a marketing authorisation, the greater the risk of the publicity of the pharmaceutical in question will constitute an unlawful pre-launch and thereby be considered as prohibited advertising.