On 17 April 2023, the Ministry of Health, through the so-called prior public consultation, kicks off the process to review the regulation on advertising of medicinal products. Until 1 May 2023, anyone interested may send their opinions on the first ideas of the new regulation (still without a draft text) through the email publimed@sanidad.gob.es.

The current legal framework on advertising of medicinal products is mainly made up by Medicinal Products and Medical Devices Act 2015 and Medicinal Products Advertising Regulation 1994, in addition to general provisions on advertising. Particular note should be made to guidelines on advertising of medicinal products, some of them at a regional level, which have traditionally had a great influence on the regulation in this field.

The current legal framework has now become outdated. Not only does it not incorporate new rules that have been introduced in recent years, but it also needs to be updated to more current times.  Thus, the new regulation on advertising of medicinal products aims to:

• undertake a comprehensive regulation on advertising of medicinal products in its dual dimension of advertising directed to the public and to healthcare professionals;
• update the current regulations, incorporating the legal developments that have taken place in recent years, in particular, the removal of prior control by the health authorities in the advertising of medicinal products to the public;
• adapt the regulations to the requirements of today's world, in which digital media are clearly predominant;
• defining the powers at national and regional levels; and
• establish mechanisms that make it possible for people with sensory disabilities to have access to advertising actions without reducing the safety and truthfulness of the messages.

This is only a first step in the process to adopt the new regulation on advertising of medicinal products. As the process moves forward, stakeholders will have a second opportunity to contribute with their suggestions, now with a draft text already in place.

For more details, please contact the author or the Hogan Lovells lawyers with whom you regularly work.

Authored by Álvaro Abad.