Proprietary pharmacists’ relationships with companies

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

Proprietary pharmacists who want to operate or establish a relationship with a company covered by the medicinal cannabis pilot programme have an obligation to notify us about their relationships.

Important things to know:

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

Before you establish a relationship, you must notify the Danish Medicines Agency thereof, 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

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, you must notify or apply for permission of this relationship here.

Notify or apply for permission before you establish a relationship

You must notify/apply for permission of a relationship from the Danish Medicines Agency before the relationship is established. You can do so by sending an email.

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

• Your full name
• Name and address of your workplace (where you serve as proprietary pharmacist) 
• 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-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

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
• Name and address of your workplace (where you serve as proprietary pharmacist) 
• 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
• Name and address of your workplace (where you serve as proprietary pharmacist) 
•  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
• Any other information you consider relevant for the Danish Medicines Agency’s assessment 

3. Non-compliance with the rules

Failure to comply with the notification obligation 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.

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

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