Management of conflicts of interest
The Danish Medicines Agency is governed by a clear set of impartiality rules in its daily processing and review of cases. The rules aim to avoid conflicts of interest and to ensure the licensing, control and monitoring of medicines take place on factual grounds. The impartiality rules are rooted firmly in both the Danish Public Administration Act and the Danish Medicines Act. Read on to learn what it means in practice for the employees of the Danish Medicines Agency.
Financing of the Danish Medicines Agency
The Danish Medicines Agency is a public authority financed primarily by fees and charges from the pharmaceutical industry. The fees and charges finance the Danish Medicines Agency’s administrative procedures in relation to e.g. applications for authorisation of medicines, laboratory controls, inspections and monitoring of adverse reactions (pharmacovigilance) – all in an effort to ensure safe, effective and available medicines for the benefit of society.
The Danish Medicines Agency’s work with medicines is regulated by a detailed medicines act, among other things to avoid conflicts of interest.
All charges and annual fees received from the pharmaceutical industry are related to the tasks the Danish Medicines Agency undertakes according to the medicines act in force. The income is used to finance the expenses incurred by the Danish Medicines Agency in relation to e.g.:
- Review of applications for authorisation of medicines
- Monitoring and supervision of authorised medicines and pharmaceutical companies
- Notification of medicine prices
- Licensing and control of clinical trials of medicines.
The Danish Medicines Agency also generates income from other areas – including from the medical device industry related to medical device cases.
The impartiality rules in practice
- Employees who will be working with licensing decisions, supervision and monitoring of adverse reactions of medicines (pharmacovigilance) cannot have a financial interest or any other interest in the pharmaceutical and medical device industries that could affect their impartiality. This applies equally to employees of the Danish Medicines Agency and to members of committees and councils who offer advice to the Danish Medicines Agency.
- Employees who in any way or form have a significant relationship with a specific pharmaceutical or medical device company may not work with cases involving that particular company.
- In supplement to our own impartiality rules, the Danish Medicines Agency also follows the rules of the European Medicines Agency (EMA) when working with EMA tasks.
- If an employee whose role is to inspect pharmaceutical companies has previously been employed with a pharmaceutical company, he or she is not allowed to inspect that company in the first five years after leaving that company.
- On 4 July 2019, new rules were introduced in the Danish Medicines Agency, which mean that new members of staff are not allowed to own shares or the like in pharmaceutical and medical device companies. Currently employed staff must divest any shares or the like within two years after they have been given notice. If an employee inherits shares in a pharmaceutical and/or medical device company, he or she must, as a rule, divest any such holdings within one year. The individual in question cannot participate in the review of or make decisions in cases related to the concerned pharmaceutical and/or medical device company before the holdings have been divested.
- Employees of the Danish Medicines Agency who own shares worth more than DKK 100,000 in companies other than pharmaceutical and/or medical device companies will be considered to have a conflicting interest towards these companies. Consequently, they cannot participate in the review of or make decisions in cases related to these companies. Employees who own shares worth less than DKK 100,000 cannot participate in the review of or make decisions in cases that may have a significant financial impact on the company concerned. In cases with no significant financial impact on the company, it will be decided on a case-by-case basis if the employee has a conflicting interest.
- If an employee’s close family member of other closely related person owns shares worth more than DKK 100,000 in a company, the employee will generally be considered to have a conflicting interest towards the company and therefore cannot participate in the review of or make decisions in cases related to that company. If a close family member of the employee owns shares worth less than DKK 100,000 in a company, he or she will generally not be considered to have a conflicting interest. However, an assessment must always be made in the specific case to see if there are other circumstances leading to a different outcome.
- Employees are allowed to undertake secondary employment alongside their principal job at the Danish Medicines Agency. However, secondary employment must not cause a potential conflict of interest with the duties performed for the Danish Medicines Agency. Employees are generally not required to tell us about their secondary employment, unless there is a risk that the secondary employment collides with the duties at the Danish Medicines Agency.
- Doctors, veterinarians, nurses or other authorised healthcare professionals employed with the Danish Medicines Agency who undertake a second job in the pharmaceutical or medical device industries must always inform their manager of the secondary employment.
- If a manager has a conflicting interest in relation to a certain company, the employees working on cases specific to that company must not report to that manager but should instead report to the next superior.