Nurses' notification of and application for permission to establish relations with companies
Below you can read about the notification duty and the obligation to apply for permission if you are a nurse and treat patients or assist in patient treatment and want to establish a relationship with or operate a medical device company.
The notification duty and the obligation to apply for permission only apply to nurses undertaking clinical duties in Denmark. You undertake clinical duties if you treat patients or have a managerial position, in which you have a significant influence on choices made by other doctors, nurses or dentists in relation to patient treatment.
The rules do not apply to a relationship with a medical device company if the nurse’s specific relationship only concerns medical devices in class I. Nor do the rules apply to a company engaging in both medicinal products and medical devices if the nurse’s specific relationship only concerns medicinal products.
Here are eight important things you need to know about relationships:
1. Some types of relationship only need to be notified to the Danish Medicines Agency
Not all types of relationship require permission from the Danish Medicines Agency. In the following cases, you only need to notify the Danish Medicines Agency of a relationship:
- research (participation in clinical investigations and tests of medical devices). As a nurse, you only need to notify us of research activities if you have the overall responsibility for the completion of a project (primary investigator or similar responsibility) or if you receive payments.
- ownership (e.g. of shares) of up to DKK 200,000 at the time of purchase in a medical device company.
Rules on relationships in connection with participation in panel debates
Generally, the Danish Medicines Agency does not assess your notification of a relationship. We publish the information you submit and use the exact wording of your notification. We publish the information shortly after you submitted the notification.
2. All other types of relationship require permission from the Danish Medicines Agency
The types of relationship that are not covered by the notification duty require prior permission from the Danish Medicines Agency. The assessment time is usually 4-6 weeks if the information stated in the application is comprehensive.
If you want to carry out professional tasks, for example participation in advisory boards (group of experts), consultancy services or the writing of articles or other material for a company, you need to apply for permission from the Danish Medicines Agency. This also applies to positions of trust in a medical device company.
Ownership of more than DKK 200,000 in a company
If you want to hold securities or have ownership of more than DKK 200,000 at the time of purchase in a medical device company, you also need to obtain permission from the Danish Medicines Agency.
3. Notify or apply for permission before you establish a relationship
Before you establish a relationship, you must notify the Danish Medicines Agency or apply for permission to establish a relationship. Please use this form for all types of relationship:
Notify or apply for permission to establish a relationship (e-form) (in Danish only)
Please use this form to notify us about financial support to attend a professionally relevant activity abroad: Notify us about financial support from a company (e-form) (in Danish only)
In the guidelines, you can read more about the notification duty and the obligation to apply for permission, the definition of a relationship, when nurses and companies are covered by the rules on relationships, companies’ duty to inform and reporting obligation as well as the Danish Medicines Agency’s practice in relation to notifications and permissions:
4. Non-compliance with the rules
Non-compliance with the notification duty or the obligation to apply for permission may lead to a fine, see section 272 of the Danish Health Act and section 19 of the Danish executive order no. 1154 of 22 October 2014 on healthcare professionals’ relationships with pharmaceutical and medical device companies and stores specialised in the sale of medical devices, which came into force on 1 November 2014.
It is not regular practice for the Danish Medicines Agency to report matters to the police in case a healthcare professional repeatedly fails to notify us or apply for permission to establish a relationship with a company. After more than a year with the Danish Health Act’s rules on relationships, we have changed our practice with effect from 1 February 2016.
We will always make a specific assessment in each case to determine whether a violation should be reported to the police, which may result in a fine. The specific assessment will be based on a number of considerations. We will consider the number of violations and any mitigating circumstances, for example if the company has neglected its duty to inform the healthcare professional.
5. Publication of information
We publish information about any relationship that we have been notified of and any relationship for which we have granted permission. The information is deleted two years after the relationship ended.
We also publish nurses’ payments from a company. If a nurse has more than one relationship with the same company, we publish the total payment from the relevant company per calendar year.
6. Search the list of nurses who have a relationship with a companyThe Danish Medicines Agency publishes information about nurses who have a relationship with a company:
7. Search the list of companies involved
In this list, you can search for medical device companies covered by the rules on relationships.
Please note that the list may not show all companies covered by the rules.
8. Report changes
You need to inform the Danish Medicines Agency about any changes to your relationship.
Report change to collaboration with a company (e-form) (in Danish only)
The Danish Health Act, Part 61 a: Industrial collaboration provides the legal framework for nurses’ relationships with medical device companies.
The specific rules on relationships are laid down in the Danish executive order no. 1154 of 22 October 2014 on healthcare professionals’ relationships with pharmaceutical and medical device companies and stores specialised in the sale of medical devices (in Danish only).