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.

 

Previous positions

  • 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.

 

Shareholdings

  • Employees who own shares or the like worth up to DKK 100,000 in a pharmaceutical or medical device company may not participate in the processing of cases 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.
  • Employees who own shares or the like worth more than DKK 100,000 in a pharmaceutical or medical device company will be considered to have a conflicting interest and will therefore not be allowed to work with cases or make decisions in cases that may impact the company concerned.
  • If an employee’s spouse/cohabitant or a close family member owns shares worth up to DKK 100,000 in a pharmaceutical or medical device company, the employee will generally not be considered to have a conflicting interest. However, it will be assessed in the individual case if there are special circumstances that could disqualify the employee.
  • If the employee’s spouse/cohabitant or a close family member owns shares worth more than DKK 100,000 in a pharmaceutical or medical device company, the employee will generally be considered to have a conflicting interest and will therefore not be allowed to work with cases or make decisions in cases that may impact the company concerned. It will be assessed in the individual case if there are special circumstances that could disqualify the employee.
  • Stricter rules apply to employees whose role is to inspect pharmaceutical companies. This means that medicine inspectors may not inspect companies in which their spouse/cohabitant owns shareholdings – no matter the size thereof.

 

Other circumstances

  • 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.

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