Public consultation on the guidelines on the advertising of medicinal products

The reason for drafting new guidelines on the advertising of medicinal products for humans and animals is partly due to the new January 2022 regulation about the advertising of veterinary medicinal products, and partly due to the need for an update to the existing advertising guidelines. Whereas the guidelines on the advertising of medicinal products for both humans and animals currently exist as joint guidelines, the new drafts would split these areas into two, so that there would be two sets of guidelines; one for medicinal products for human use and one for veterinary medicinal products.

The guidelines on the advertising of medicinal products for human use

There are no material changes in the new draft guidelines regarding medicinal products for human use, but they contain specifications e.g. within the following areas:

Digital media/SoMe

The draft specifies when employees' behaviour on social media can be characterised as advertising. For instance, the guidelines stress that if a pharmaceutical company's employee "likes" or shares content commending a medicinal product, then this action could be considered as advertising for said medicinal product, even though the employee was acting on its own initiative. 

However, the new guidelines also outline how pharmaceutical company employees might promote the company or highlight their own competences without it being considered advertising. 

The new specifications reflect the focus that there has been on the advertising of medicinal products on social media in recent years, and they once again stress that a pharmaceutical company should pay attention to its employees' use of social media, for instance through internal company guidelines.

Vaccination campaigns

Something new in the draft is an independent section on vaccination campaigns in point 4.3, highlighting what the Danish Medicines Agency will place emphasis on when deciding whether to approve a vaccination campaign. 

Additionally, the new guidelines e.g. contain specifications within the following areas: 

• Advertising at international conferences and conferences in Denmark
• Distributing medicinal product samples to the public 
• Reporting financial support to healthcare professionals
• Payments for advertising space
• Information material and documentation requirements
• Financial benefits for patient associations

The guidelines on the advertising of veterinary medicinal products

A new executive order on the advertising of veterinary medicinal products entered into force on 28 January 2022. On the same date, Regulation (EU) 2019/1 on veterinary medicinal products entered into force, with articles 119-121 containing rules on the advertising of veterinary medicinal products. The new draft guidelines on the advertising of veterinary medicinal products mention the requirements stemming from the above legislation.

There are several amendments in the new draft compared to the text of the current guidelines on the advertising of medicinal products, and many of these amendments reflect the new legislation in Regulation 2019/1. The guidelines also elaborate on what is considered when assessing whether a communication is deemed as advertising. In addition to this, the guidelines also contain information on the use of social media, financial benefits for healthcare professionals and certain specialists, as well as the storing of advertising material.

The consultation deadline is 1 March 2022 for both these guidelines.

Read more about the new guidelines here:

• The consultation portal (in Danish)
• The consultation letter (in Danish)
• The draft guidelines on the advertising of medicinal products for human use (in Danish)
• The draft guidelines on the advertising of veterinary medicinal products (in Danish)
• The executive order on the advertising of veterinary medicinal products (in Danish)
• Regulation 2019/1 on veterinary medicinal products