Proprietary pharmacists’ relationships with companies

Updated 01 March 2018
Temabillede om medicinsk cannabis med tekst

Proprietary pharmacists’ relationships with companies comprised by the medicinal cannabis pilot programme

Here you can read about your duty of notification if you are a proprietary pharmacist and want to operate or establish a relationship with a company covered by the medicinal cannabis pilot programme.

Seven important things to know:

1. Any type of relationship must be notified to the Danish Medicines Agency

You must notify the Danish Medicines Agency of a relationship before the relationship is established, regardless of the type of relationship you are establishing with the company.

A professional relationship could involve teaching/presentations, advisory boards, consultancy services, directorships, part-time or full-time employment. It could also involve research activities 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.

A relationship could also involve ownership such as shareholdings in a company.

2. Send your notification before you establish a relationship

You must notify the Danish Medicines Agency of the relationship before it begins. Your notification must be sent by email to tilknytning@dkma.dk.

If the relationship involves a professional relationship, 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,

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.

3. Non-compliance with the rules

Failure to comply with the notification duty 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.

4. Publication of information

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

5. 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.

6. 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.

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.