In brief
The Government of Catalonia has recently published a guide on the advertising of medicinal products for human use. This guide provides new and updated advice on the understanding of the regulations on advertising on medicinal products. In particular, it focuses on advertising in the digital environment, analyzing the use of digital platforms and tools and providing recommendations for responsible advertising in accordance with the current sectorial regulatory framework.
Introduction
Last February, the Health Department of the Catalonia Government (“Catalan Government“) published its updated Guide on the Advertising of Medicinal Products for Human Use (“Catalan Guide“). This version is the fifth edition of the Catalan Guide, which serves as a reference for sectorial advertising compliance professionals in Spain, interpreting the national regulation on this field, in particular the provisions of the Royal Decree 1416/1994, of 25 June, which regulates the advertising of medicinal products for human use (“RD 1416/1994“).
In this new version of the Catalan Guide, unlike past ones, the Catalan Government has decided to limit its content to the advertising and the promotion aimed at healthcare professionals since, as they point out, there are already other guides in Spain that deal with the advertising of medicinal products for human use aimed at the general public.
The main novelty of the new edition of the Catalan Guide is the incorporation of an entire new section dealing with the advertising of medicinal products in the digital environment. The Guide distinguishes between inserted advertising, targeted advertising and other different digital tools. The inclusion of this section is of great relevance due to the fact that technology is increasingly present in the field of pharmaceutical advertising and because the RD 1416/1994 has not been updated since its approval and does not include provisions relating to the use of digital tools.
Main novelties on advertising in the digital environment
The basic criteria applied by the Catalonia Government in the digital environment is that everything that is not allowed in the analog environment should not be allowed in the digital environment. The Catalan Guide distinguishes between inserted advertising (such as social networks) and targeted advertising (advertising sent directly to a specific healthcare professional).
Digital platforms include the set of technologies, tools and services used to create and run applications or other technology-related products. The Catalan Guide requires pharmaceutical companies to internally review and take responsibility for the actions of their employees in the digital environment. Companies must assess the risk-benefit ratio of using each digital platform by:
- Identifying the nature of the potential audience.
- Examining the objective of the communication.
- Understanding the characteristics of the digital channel.
Regarding inserted advertising, the new Catalan Guide also highlights that digital platforms that do not allow restricted access to their publications will be assumed to be aimed at the general public and therefore they may not include advertising content regarding prescription medicinal products. The Catalan Guide identifies and lists some of the digital platforms that do not allow restricted access to their publications:
The Catalan Guide also reviews digital platforms that allow to limit the access to their publications. In these cases, the creation of closed groups of people has to be analyzed as valid support and, therefore, must be communicated to the competent authorities and its scientific content should prevail over the promotional content. Some of those digital platforms are identified and listed in the Catalan Guide:
With regard to targeted advertising, the Catalan Guide requires the consent in writing of the healthcare professional who is going to receive the advertising communication. Pharmaceutical companies must keep a record of those healthcare professionals who have given their consent. Among the different tools for targeted advertising, the Catalan Guide focuses on the use of:
Finally, the Catalan Guide includes some useful tables summarizing their position regarding advertising in the digital environment. You can access the tables here and here.
The full content of the Catalan Guide is available by clicking on the following link. For more information or in case you need individual advice for your company, please contact our team of experts.
