Doctors’ relationships with companies

Updated 11 March 2022

Doctors’ relationships with companies comprised by the medicinal cannabis pilot programme

Doctors who want to operate or establish a relationship with a company covered by the medicinal cannabis pilot programme have either an obligation to notify us about relationships or to apply for permission of relationships.

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 have a relationship with a company at the same time.

Important things to know:

1. Some types of relationships only have to be notified to the Danish Medicines Agency

Not all types of relationships 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) with a market value of up to DKK 200,000 at the time of acquisition in each individual company.

2. All other types of relationships require permission from the Danish Medicines Agency

For the types of relationship not covered by the notification obligation, permission from the Danish Medicines Agency is required. It usually takes 4-6 weeks to process an application for the authorisation of a relationship provided the information therein is complete.

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 with a market value of more than DKK 200,000 in a company

If you want to hold securities or other ownership interests in a company with a market value of 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 if it concerns a company comprised by the medicinal cannabis pilot programme. You can notify or apply for permission of a relationship by sending an email.

If the relationship is with a pharmaceutical company, a medical device company, a company manufacturing, producing or distributing products without an intended medical purpose or specialised stores, you must notify us of this relationship or apply for permission of the relationship here.

If the relationship involves specialised information, research, teaching or presentations, your email must include the following details:

  • Your full name and authorisation number
  • Name and address of your workplace (where you perform your clinical duties or hold a managerial position where you have an influence on the choices made by other healthcare professionals in the treatment of patients)
  • 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
    (specialised information/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 and authorisation number
  • Name and address of your workplace (where you perform your clinical duties or hold a managerial position where you have an influence on the choices made by other healthcare professionals in the treatment of patients)
  • 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-date and end-date of the relationship
  • The payment you will personally receive per calendar year from the company for the concerned type of 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 and authorisation number
  • Name and address of your workplace (where you perform your clinical duties or hold a managerial position where you have an influence on the choices made by other healthcare professionals in the treatment of patients)
  •  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 amounts to a market value of 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 obligation or the obligation to apply for permission of a relationship is punishable pursuant to the Act on a Medicinal Cannabis Pilot Programme (Danish title: Lov om forsøgsordning med medicinsk cannabis).

We will assess in each case if a breach should be reported to the police, which could result in a fine. In the specific case, we will pay regard to several factors in our assessment, e.g. the number of breaches and if there are 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 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

You can search this list to see 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 send an email. 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 a Medicinal Cannabis Pilot Programme (section 66).


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