Collaboration with healthcare professionals
When collaborating with healthcare professionals, it is important to be aware of the rules for advertising, presents and financial benefits:
- A company must not give or offer healthcare professionals presents, prizes or financial benefits to promote the sale of a medical device. However, this prohibition does not extend to discounts on medical devices, presents of an insignificant value when such presents can be used in the recipient’s business (a maximum of DKK 300 in a calendar year) or the lending of devices for demonstration purposes for up to two months.
- A company is allowed to pay for services offered by a healthcare professional or a pharmacy if the payment is proportionate with the services offered. Companies can also pay for travel and accommodation and provide professional information and training.
- Collaboration and relationships must be notified to the Danish Medicines Agency, and the company must inform the healthcare professional of the notification duty. The Danish Medicines Agency publishes the information
- On its website, a patient association must publish all financial benefits it has received from a medical device company.
Danish medical device companies must notify the Danish Medicines Agency of the names of doctors, dentists, nurses and proprietary pharmacists, who have a professional or financial relationship with the company.
The notification duty applies to manufacturers that market medical devices in classes IIa, IIb or III, in vitro diagnostic medical devices or active implantable medical devices, representatives of manufacturers of this type of products as well as importers and distributors of this type of products that are established in Denmark.
Stores specialised in the sale of medical devices that are established in Denmark must notify the Danish Medicines Agency of the names of doctors who have a relationship with the company.
The notification duty applies to owners of stores specialised in the sale of medical devices in classes IIa, IIb or III, in vitro diagnostic medical devices or active implantable medical devices, and representatives of owners of stores specialised in the sale of this type of products that are established in Denmark.
Report relationships with healthcare professionals (in Danish only)
When establishing a relationship with a doctor, dentist, nurse or proprietary pharmacist, the company or store specialised in the sale of medical devices must inform the healthcare professional of the rules
Professional and financial relationships
A professional relationship may cover consultancy services (for example research, teaching or the writing of articles), full-time or part-time employment. Generally, all types of relationship are covered by the rules, even if the healthcare professional does not receive payments from the company.
Financial relationships cover healthcare professionals who own or hold securities in a pharmaceutical or medical device company or a store specialised in the sale of medical devices.
Financial support to specialists and healthcare professionals
If a specialist or healthcare professional receives financial support from a pharmaceutical or medical device company to attend professionally relevant activities abroad, the person must inform the Danish Medicines Agency. In this connection, the company has a duty to inform the specialist or healthcare professional
Openness about collaboration
The rules are intended to ensure that healthcare professionals have no conflicts of interest. The rules will ensure that healthcare professionals have no financial or other interests in the industry that may influence their clinical duties, and the purpose is to promote public confidence in the health sector.