Doctors’ relationships with companies

Updated 01 March 2018
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Doctors’ relationships with companies comprised by the medicinal cannabis pilot programme

Here you can read about the notification duty and the obligation to apply for permission if you are a doctor and want to operate or establish a relationship with a company covered by the medicinal cannabis pilot programme.

The rules apply only to doctors 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 the treatment choices that others make.

The rules also apply to doctors who only treat patients as part of voluntary, charitable work and who also have a relationship with a company.

Eight important things to know:

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, it is sufficient that you notify the Danish Medicines Agency before the relationship is established:

  • research such as participation in clinical trials and non-interventional trials. You only need to notify us of research activities if you have the overall responsibility for the completion of a project (if you are the primary investigator or have similar responsibility), or if the company pays you for your participation.
  • teaching
  • presentations
  • ownership (e.g. of shares) worth up to DKK 200,000 at the time of acquisition in each individual company.

 

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. It usually takes 4-6 weeks to process applications if the information provided therein is comprehensive.

Professional tasks

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 company, or part-time or full-time employment in a company.

Ownership worth more than DKK 200,000 in a company

If you want to hold securities or other ownership interests in a company worth more than DKK 200,000 at the time of acquisition, 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 thereof or receive permission from the Danish Medicines Agency. To notify or apply for permission of a relationship, please send an email to tilknytning@dkma.dk.

If the relationship inolves research, teaching or presentations, your email must include the following details:

  • Your full name, private address and authorisation number,
  • Name and address of your workplace (where you perform your clinical duties),
  • Name and preferably also the CVR number (Central Business Registration Number) of the company you want to establish a relationship with,
  • The type of relationship you want to establish with the company (research/teaching/presentations),
  • Start- and end-date of the relationship,
  • The payment you will personally receive per calendar year from the company for the concerned type of relationship.

If the relationship involves other professional tasks (such as advisory boards, consultancy services, directorships, part-time or full-time employment), your email must include the following details:

  • Your full name, private address and authorisation number,
  • Name and address of your workplace (where you perform your clinical duties),
  • Name and preferably also the CVR number (Central Business Registration Number) of the company you want to establish a relationship with,
  • The type of relationship you want to establish with the company,
  • Start- and end-date of the relationship,
  • The payment you will personally receive per calendar year from the company for the concerned relationship,
  • Information about the task. You must state the purpose of the task, the topic addressed by your relationship, as well as the function you will be performing/tasks you will be undertaking,
  • The estimated time used per week/month/year,
  • Any other information you consider relevant for the Danish Medicines Agency’s assessment.

If the relationship involves ownership, your email must include the following details:

  • Your full name, private address and authorisation number,
  • Name and address of your workplace (where you perform your clinical duties),
  • Name and preferably also the CVR number (Central Business Registration Number) of the company you want to establish a relationship with,
  • The number of securities (e.g. shares) you wish to acquire in the company,
  • The market value of the securities at the time of acquisition,
  • If the requested ownership interest is worth more than DKK 200,000 at the time of acquisition, you must inform us if it is likely that you may have to prescribe or recommend the company’s products as part of your clinical duties, and, if so, to what extent.
  • Any other information you consider relevant for the Danish Medicines Agency’s assessment.

4. Non-compliance with the rules

Failure to comply with the notification duty or the obligation to apply for permission is punishable pursuant to the act on the medicinal cannabis pilot programme.

We will assess in each case if an infringement should be reported to the police, which could result in a fine. Our assessment will be based on a number of considerations, such as the number of infringements, any mitigating circumstances, for example if the company has neglected its duty to inform you as a healthcare professional.

5. Publication of information

We publish information about doctors’ relationships with the companies comprised by the pilot programme. The information is deleted two years after the termination of a relationship.

6. List of companies comprised by the medicinal cannabis pilot programme

In this list, you can find out if a company is covered by the medicinal cannabis pilot programme and thus the rules on relationships.

7 . Report relationship changes

You are required to inform the Danish Medicines Agency about any changes to a relationship. Changes should be emailed to tilknytning@dkma.dk. If, for example, the payment you receive or an end-date has changed, that is something you must report to us. Please be aware that some changes require a new permission from the Danish Medicines Agency.

Legislation

The specific rules on relationships with companies comprised by the medicinal cannabis pilot programme are laid down in the act on the medicinal cannabis pilot programme (section 66). The act is in Danish only.

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