Whistleblowing scheme of the Danish Medicines Agency

01 November 2020

The Danish Medicines Agency’s whistleblowing scheme offers a way to disclose information about serious concerns.

Who can report information?

Any employee of the Danish Medicines Agency can make a disclosure under the whistleblowing scheme. It covers employees in the broad sense, including employees under collective agreement, public servants, part-time and full-time employees, volunteers as well as paid and unpaid interns.

Former employees of the agency can also make a disclosure under the scheme provided the disclosure concerns information that came to their knowledge while they were working for the agency.

Individuals who have not yet taken up employment with the agency can also disclose information under the scheme if the disclosure concerns information that came to their knowledge in connection with the recruitment procedure or other contractual negotiations prior to employment.

Finally, collaboration partners and their employees can make a disclosure under the scheme if the collaboration between the collaboration partner and the Danish Medicines Agency is of a more continuous and formalised nature, e.g. if a collaboration agreement has been entered between the parties. This could be private companies such as contractors and subcontractors.

Others, like members of the public, whose case is being reviewed by the Danish Medicines Agency will generally not be covered by the scheme. If you are not covered by the Danish Medicines Agency's whistleblowing scheme, but wish to report a serious concern within the agency’s area, please do not hesitate to contact us. You can find our contact information here.

What information is covered?

The whistleblowing scheme only deals with information about serious incidents affecting the way in which the agency exercises its duties. It is assessed in each individual case whether the matter at hand is a serious incident.

Serious incidents generally comprise the disclosure of:

  • criminal offences, e.g. breach of professional secrecy, misuse of financial sources, theft, deception, embezzlement, fraud, bribery, etc.
  • gross or repeated violations of the law, e.g. the legislation on the use of force, the Public Administration Act, the Data Protection Act, the Access to Public Administration Files Act, etc.
  • gross or repeated violations of administrative principles, e.g. the inquisitorial principle, requirements for fairness and proportionality, etc.
  • gross or repeated violations of essential internal guidelines, e.g. on official journeys, gifts and financial reporting, etc.
  • severe interpersonal conflicts at work, e.g. serious harassment, including sexual harassment.
  • Deliberate deception of members of the public and collaboration partners.

To make a disclosure under the whistleblowing scheme, the whistleblower must possess information about or have reasonable grounds to suspect that any such serious incident has taken place.

No incorrect or misleading information must deliberately be reported under the whistleblowing scheme. Information reported this way in bad faith may be reported to the police and could have adverse employment law consequences or contractual consequences for the whistleblower.

If we receive a disclosure under the whistleblowing scheme which we consider to fall outside the scope of the scheme, we will advise the whistleblower where to report the concern instead.

How to make a disclosure?

If you wish to make a disclosure under the agency’s whistleblowing scheme, please use the link at the bottom of the page.

Your disclosure will be reviewed by the agency’s Director General’s Office (the Head of Division and a legal officer) and will be decided finally by the Director General. In the event that a disclosure concerns the Head of Division of the Director General's Office, it will be reviewed by the Finance Division (the Head of Division and an appointed employee) and will be decided finally by the Director General. In the event that a disclosure concerns the Director General, it will be processed by the executive management in the Department of the Ministry of Health.

We will review your report as soon as possible.

If you provide your contact details when making a disclosure, we will acknowledge receipt of your report no later than seven days after submission, and we will inform you of the next steps/the review of the case.

We may need to ask follow-up questions to ensure that the case is reviewed on a fully informed basis.

Please note that when you make a disclosure under the agency’s whistleblowing scheme using the link below, your IP address of the computer you use when making a disclosure will be logged. If you want to make an anonymous disclosure, you should either send your report from a public computer, for example from a library where you are not logged in with your identity, or use a VPN connection or TOR. Either method should ensure that the IP address cannot be traced back to you.

The same applies if you make a disclosure from a computer on the network of the Danish Medicines Agency since this activity might be registered as part of the routine logging of user activity on the agency's network.

Also, if you wish to make an anonymous disclosure, you should pay particular attention to the following:

  • Do not provide your name or any personally identifiable data about your identity, such as address or phone number – also not in any attached documents or other files you upload.
  • The content and nature of your disclosure could be such that your identity could be deduced. This could be the case if your report concerns something that only a limited number of persons knows about.
  • We will not be able to communicate with you, which would be helpful in case we need more information to assess the concern that you have reported to us.
  • There is a risk that your case will be closed without us ever getting to the bottom of it. The reason is that anonymous disclosures could be difficult to handle in practice and that authorities must not themselves give weight to anonymous information in connection with a radical decision involving, for example, an authority’s employee.
  • There may be exceptional cases where, for example, the police is seeking information about a person who has made an anonymous report in order to prevent crimes that could put the security of the state of people’s lives or health at risk.

The Danish Medicines Agency encourages you not to make an anonymous disclosure under the whistleblowing scheme if you consider this to be an option.

 

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