The Danish Medicines Agency's update to its advertising guideline on medical devices is going out for consultation. The deadline for providing comments is 31 May 2024.
The guideline is being updated now because the existing guideline has not been changed since 2014, while the executive order on advertising, etc., of medical devices has been updated continuously many times - and most recently in 2022.
The guideline will now be extended and more precise. We have highlighted a few examples below:
Employees' use of SoMe
In the same way as for the advertising of medicinal products, the guideline now clarifies that the rules do not just apply to specific senders, and that any affiliation to a manufacturer is included in the assessment of whether a message regarding a medical device is considered advertising. This means that the social media interactions of employees of a medico company can be considered advertising even when the employee is acting on his or her own. An example is if the employee shares or "likes" material containing positive mention of the company's medical devices.
Influences and bloggers can now also be held responsible under the rules on advertising, etc., of medical devices if they engage in the advertising of medical devices.
Serious diseases
The guideline now also says that if it is justified for special health reasons, the Danish Medicines Agency can allow mention of serious diseases in extraordinary cases, but never in the form of advertising on television, videos, in movies or the like. The update to the guideline does not specify when a disease is considered serious, so this would still depend on a specific assessment. This new section was added to the guideline because the executive order on advertising was amended in 2022, leading to the above-mentioned new rule as an exception to the prohibition against mentioning serious diseases in the advertising of medical devices to persons not working with the device in question.
Payment for advertising space
The update also includes a new section on the possibilities of buying advertising spaces, which section corresponds to the existing guideline for medicinal products. In addition to the existing guideline on advertising space in pharmacies, it has now been specified that medico companies are also allowed to buy advertising space at professional events attended only by health professionals. This could for example be annual conferences and similar events organised by professional societies. Moreover, the guidelines states that a price per square metre of DKK 2000, including VAT and administration fee, for advertising space at a full-day event at a rented, external location accommodating about 50-80 participants would be considered proportionate to the service offered.
Advertising of products without an intended medical purpose
The guidelines also contains a section on the advertising of products without an intended medical purpose. The reason being that a 2023 amendment of the medical device regulation ("MDR") entails that similar rules apply regarding advertising, etc., of certain types of products without an intended medical purpose. We have previously sent out an insight on the amendment of the MDR, see here. This section specifies that a few sections of the guideline now also apply to products without an intended medical purpose, including the sections on discounts, gifts and payment for advertising space. In addition to that it refers to the new, separate executive order on advertising, etc., of products without an intended medical purpose (in Danish).
Deadline for providing comments: 31 May 2024.
The address for sending comments is provided in the consultation letter.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.