Whistleblowing scheme of the Danish Medicines Agency
Introduction and purpose
This page describes what the purpose of the whistleblower mechanism is, how it works, who can use it, and the types of concerns that can be raised through the mechanism.
The whistleblower mechanism aims to ensure that whistleblowers (as defined below) have a special independent and autonomous channel through which to quickly and confidentially report actual or potential breaches covered by the Danish Whistleblower Act for the purpose of having an independent and autonomous whistleblower unit assess which measures may be required.
If you intend to report a concern, we advise and encourage you to start by reading the following important information about the whistleblower mechanism of the Danish Medicines Agency.
Who can raise a concern?
You can submit a report to the agency's whistleblower mechanism if you have acquired information on actual or potential breaches in a work-related context and if you belong to at least one of the following groups of people:
- You are an employee of the Danish Medicines Agency.
- You have previously been employed with the Danish Medicines Agency and wish to report information that came to your knowledge while working for the agency.
- You were a candidate for a position at the Danish Medicines Agency and wish to report information that you acquired during the recruitment process or other pre-contractual negotiations.
- You are a business partner (includes self-employed persons) of the Danish Medicines Agency, and the business relationship existing between you and the agency is of a more continuous and formalised nature. This could be persons working under the supervision and direction of, for example, one of the agency’s contractors, subcontractors or suppliers, including their employees.
- You are or have been a member of the management, or you fill another role in relation to the management body of the Danish Medicines Agency.
The term employee/worker is broad and also covers employees under collective agreement, public servants, part-time and full-time employees, volunteers and paid and unpaid interns.
Other persons, such as members of the public, whose case is being reviewed by the Danish Medicines Agency generally do not fall under the whistleblower mechanism. If you are not covered by the agency's whistleblower mechanism but wish to inform us of unacceptable conditions within the agency’s area, we ask you to use the usual channels of communication. Contact information of the Danish Medicines Agency.
If you do not fall under the above-mentioned group of people and specifically wish to report a suspicion of illegal circumstances regarding medicinal products, you can – also anonymously – read more about how to do this on the Danish Medicines Agency's website: Report suspected illegal activities with medicines.
Instead of using the Danish Medicines Agency’s whistleblower mechanism, you can use the Danish Data Protection Agency’s external whistleblower channel at whistleblower.dk.
You also have the option of raising concerns to an external whistleblower channel established in an EU institution, etc. for the handling of breaches under the scope of Directive (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who report breaches of Union law (the “Whistleblower Directive”). This could be channels established by the European Commission or the European Medicines Agency (EMA).
Please be aware that if you report information on breaches under the scope of the Whistleblower Directive to such external whistleblower channels established in an EU institution, etc., you must fulfil at least one of the conditions to obtain protection under the Danish Whistleblower Act.
It is important that you know that you are free to choose whether to use the Danish Medicines Agency’s whistleblower mechanism or an external whistleblower channel referred to above.
We would also like to point out that neither internal nor external whistleblower systems limit the freedom of expression of public employees. In other words, freedom of expression and the right to disclosure prevail in accordance with the provisions relating thereto.
What information is covered?
You can report information on actual or potential breaches of Union law within the following areas:
- Public procurement
- Financial services, products and markets, and prevention of money laundering and terrorist financing
- Product safety and compliance
- Transport safety
- Protection of the environment
- Radiation protection and nuclear safety
- Food and feed safety
- Animal health and welfare
- Public health
- Consumer protection
- Protection of privacy and personal data
- Security of network and information systems
In addition to the above areas, actual or potential breaches affecting the financial interests of the EU as well as actual or potential breaches relating to the internal market, including, for example, breaches of Union competition and State aid rules, are also covered.
For concerns raised in the above areas, it is not required that the breach has a certain degree of seriousness.
You can also report information on actual or potential breaches that constitute a serious breach of Danish and/or Union law or any other serious wrongdoing. This could be:
- Criminal offences, e.g. breach of confidentiality, misuse of financial funds, theft, deceit, embezzlement, fraud, bribery, etc.
- Serious or repeated breaches of the law, e.g. the legislation on the use of force, the Public Administration Act, the data protection legislation, the Access to Public Administration Files Act and, where applicable, any legislation the purpose of which is to safeguard public health, etc.
- Serious or repeated breaches of administrative principles, e.g. the inquisitorial principle, the requirement for impartiality, the doctrine of abuse of powers and the principle of proportionality, etc.
- Serious or repeated breaches of substantial internal guidelines, e.g. on official journeys, gifts and financial reporting, etc.
- Serious interpersonal conflicts at work, e.g. serious harassment such as bullying or harassment due to race or political or religious beliefs, etc.
- Sexual harassment
- Deliberate deception of members of the public and business partners
It is assessed in each individual case whether the matter raised is a serious wrongdoing.
The following matters fall outside the scope of the whistleblower mechanism.
- Other breaches, e.g. breaches of a workplace smoking policy. This kind of information is something you would report to your immediate manager, trade union representative or HR.
- Classified information, falling within the scope of Ministry of Justice Circular No. 10338 of 17 December 2014 on protection of classified information of common interest to NATO or EU Member States, other classified information and information subject to protection in the interests of security generally (the “Safety Circular”), which at the same time is confidential, cf. section 152(3) of the Danish Penal Code. This is because it is illegal to make a disclosure involving classified material.
- Information covered by the obligation of professional secrecy of healthcare professionals pursuant to section 40 of the Danish Health Act. Link to the Danish Health Act (in Danish only).
If you report information to the whistleblower mechanism, you must have reasonable grounds to believe that at the time of reporting the matters reported by you are true and that the information fall within the scope of the Danish Whistleblower Act (reported in good faith).
You must not report inaccurate information under the whistleblower mechanism deliberately. Such disclosure of information made in bad faith is punishable by a fine.
What to include in the report?
To facilitate the investigation of the concern being reported, we ask you to provide as many details as possible.
It is important that you provide us with the following information if you can:
- The person(s) involved
- If anyone else knows about the (suspected) concern
- If the management knows about the concern
- If there is documentation to support the concern
- If further information about the concern exists and where to find it
- How long it has been going on for
- If you know of attempts to conceal the concern
It will usually not be possible for us to investigate a report if the concern is not sufficiently specified or solely makes very broad allegations with no further clarification or evidence. Usually, no further investigations are carried out if reports are clearly unfounded.
How is your reported concern dealt with?
The Danish Medicines Agency has a designated whistleblower unit. The whistleblower unit:
- receives reports and maintains contact with the whistleblower;
- follows up on reports;
- gives feedback to the whistleblower.
The whistleblower unit treats the report as confidential and must keep the information included in the report confidential.
The whistleblower unit is based in the Director General’s Office and consists of the Head of the Director General's Office and a legal officer. The outcome of an investigation is decided finally by the Director General.
If a report concerns the Head of Division of the Director General's Office, that report will be dealt with by Finance & Processes (the Head of Division and an appointed employee) and decided finally by the Director General. If a report concerns the agency’s Director General, that report will be dealt with by the management in the Department of the Ministry of Health.
If the whistleblower unit considers that a report falls outside the scope of the whistleblower mechanism, they will advise the whistleblower about alternative channels for raising the concern. The proper handling of the reported concern is based on an individual assessment of the content and nature of the concern. For example, the whistleblower may be advised to discuss the matter with their trade union representative or HR instead. Moreover, the whistleblower unit is not required to forward the concern to another relevant authority, cf. section 12(3) of the Danish Whistleblower Act.
If the whistleblower unit finds that the report can be considered on its merits, it will initiate an investigation into the reported concern taking into account relevant information obtainable within the agency and as required with the involvement of external authorities and public supervisory bodies.
If the investigation conducted by the whistleblower unit identifies unacceptable conditions, there are different courses of action:
- If the matter raised is a criminal offence, it may be reported to the police.
- If the matter raised involves serious mistakes and/or neglect by an employee of the Danish Medicines Agency, this may have adverse employment consequences for the employee, including disciplinary action, e.g. in the form of a warning or, in the worst-case scenario, dismissal.
- If the matter raised involves serious mistakes and/or neglect by a business partner of the Danish Medicines Agency, this may have contractual consequences for the business partner, e.g. termination for breach.
Timeframe
We will acknowledge receipt within seven days after receiving a whistleblower report. We will as soon as possible and no later than three months after the receipt date give whistleblowers feedback on the progress of the investigation and the outcome if possible.
We may need to extend the timeframe for giving feedback if the particular circumstances of the matter raised, particularly the nature and complexity of the report, require a longer investigation. We will keep you informed about this and tell you if you can expect to receive any further feedback.
“Feedback” means a notification on the actions taken by the Danish Medicines Agency to assess the accuracy of the allegations made and, as relevant, to address the reported actual or potential breach. The feedback that whistleblowers receive from our whistleblower unit may be limited as a result of our compliance with relevant law, including for example rules about data privacy and the confidentiality provisions of the Public Administration Act.
How to send your information?
If you wish to report a concern under the whistleblower mechanism of the Danish Medicines Agency, you must send this to the Danish Medicines Agency by letter. It must be clearly stated on the envelope that the letter is for the Whistleblowing scheme of the Danish Medicines Agency – please also state "CONFIDENTIAL" on the envelope.
Letters must be sent to:
The Danish Medicines Agency
Att.: Whistleblowing scheme of the Danish Medicines Agency
Axel Heides Gade 1
2300 Copenhagen S
This is a temporary solution, until a permanent IT solution is implemented.
If you wish to report a concern anonymously
If you wish to report a concern to the Whistleblowing scheme of the Danish Medicines Agency anonymously, there are a few things to pay attention to:
- Do not provide your name or any other personally identifiable data that could reveal your identity such as your address or phone number – this includes any appendix.
- It might be possible to deduce your identity based on the content and nature of your disclosure. This could be the case if your report concerns something that only a few people know about.
- We will not be able to communicate with you, which would be helpful in case we need more information to assess the matter 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. It happens because anonymous disclosures can be difficult to handle in practice, and because authorities per se must not base their decisions on anonymous information in cases that could have serious consequences for a public employee for example.
- It is possible, in very exceptional cases, that the police, or other authority, will try to obtain information about the person who reported a concern anonymously to prevent the commission of a crime that could put the security of the state or people’s lives or health at risk.
In continuation of the above, we encourage you not to make an anonymous disclosure under the whistleblower mechanism if you consider it possible.
In this connection, it should be noted that only the whistleblower unit mentioned above has access to the inquiries sent to the Danish Medicines Agency. All incoming inquiries are placed on a confidential file in the agency's case processing system.
Whistleblower protection
Conditions for protection of whistleblowers
Pursuant to the Danish Whistleblower Act, a whistleblower is protected against retaliation if the whistleblower has reported information under the Danish Medicines Agency’s whistleblower mechanism. The whistleblower protection applies only if all of the following conditions are met:
- The person submitting the report meets the criteria for being a whistleblower.
- The whistleblower had reasonable grounds to believe that the reported information was true at the time of reporting.
- The reported information falls within the scope of this Danish Whistleblower Act.
Retaliation means any disadvantageous treatment or disadvantageous effect in response to a reported disclosure. This may include suspension, dismissal or demotion.
Whistleblowers who report information in bad faith and knowing that the reported information is inaccurate are not protected against retaliation. Depending on the circumstances, a whistleblower who deliberately reports false information may be fined. If the whistleblower is employed with the Danish Medicines Agency, it may also have employment consequences for this person.
The protection described in this section also extends to the following persons:
- Facilitators, i.e. a natural person who assists the whistleblower in reporting a concern, e.g. a trade union representative;
- Third persons who are connected with the whistleblower and who could suffer retaliation in a work-related context, such as a colleague;
- Businesses and authorities that the whistleblower owns, works for or is otherwise connected with in a work-related context.
The Danish Whistleblower Act, including the provisions on the protection of whistleblowers, also applies to the public disclosure of information made by the whistleblower, but only if the whistleblower meets the following criteria:
- The whistleblower first reported the concern internally and externally or directly externally, but the relevant whistleblower unit took no appropriate action in response to the report within the timeframe laid down in the Danish Whistleblower Act.
- The whistleblower has reasonable grounds to believe that the breach may constitute an imminent or manifest danger to the public interest, including, for example, the lives and safety of individuals.
- The whistleblower has reasonable grounds to believe that if the report is made to an external whistleblower mechanism, there is a risk of retaliation, or there is a low prospect of the breach being effectively addressed, due to the particular circumstances of the case.
In this context “public disclosure” refers in particular to the public disclosure of information on actual or potential breaches via news media, social media or similar platforms.
The other requirements of the Danish Whistleblower Act, e.g. for whistleblowers to act in good faith, also apply to the whistleblower’s public disclosure of information on actual or potential breaches.
Disclosure of personal data
Information about the whistleblower’s identity or other information based on which the whistleblower’s identity may be directly or indirectly deduced may only be disclosed to persons beyond the members of the Danish Medicines Agency’s whistleblower unit after obtaining the whistleblower’s explicit consent.
However, information about the whistleblower’s identity may without their consent be disclosed to other public authorities for the purpose of addressing breaches, e.g. a criminal offence that is likely to occur, or for the purpose of safeguarding the rights of defence of the persons concerned. If the identity of a whistleblower is disclosed without their consent, the whistleblower will be informed, and an explanation will be provided. However, they will not be informed if this would jeopardise any related investigations or judicial proceedings.
The identity of the whistleblower could also be disclosed in case of judicial proceedings related to the reported concern.
Details from the report that do not reveal the identity of the whistleblower will only be disclosed to persons beyond the members of the agency’s whistleblower unit for the purpose of following up on the report or to address a potential breach of matters falling under the whistleblower mechanism.
Notification and protection of the person(s) concerned
After a preliminary investigation has been made and all evidence of relevance has been secured, the person(s) concerned, i.e. the person(s) affected by the report, will receive the following information:
- the names of the persons responsible for handling the report (the whistleblower unit);
- the concerns raised by the report.
Under the Danish Whistleblower Act, the person(s) concerned are entitled to have their identity protected while the case is being processed and have the right to an effective defence. Under the Danish Whistleblower Act, these rights may not be waived by an agreement to the detriment of the person(s) concerned.
The Danish Medicines Agency’s whistleblower unit will at all times safeguard the data privacy rights of the person(s) concerned in compliance with the law.
Data security and data storage
Reports made to the Danish Medicines Agency’s whistleblower mechanism are stored in compliance with the Danish Whistleblower Act to the extent necessary and proportionate for the purpose of complying with the requirements of the act.
The Danish Medicines Agency’s whistleblower unit processes all information reported under the whistleblower mechanism, including information about persons reported through the mechanism, in compliance with the legislation in force.
All reports will be stored securely, and it will only be possible for the relevant persons to access the information.
If the matter is reported to the police or other authority, the Danish Medicines Agency’s whistleblower unit will close the report immediately after the relevant authority(ies) has/have closed the procedure.
If the information obtained should lead to disciplinary actions against the person(s) concerned, or there are other reasons why it would be sensible and necessary to retain the information about the person(s) concerned, the information will, if relating to an employee of the Danish Medicines Agency, be kept in that person’s personnel file.
Other links
Ministry of Justice’s guidelines on freedom of expression for public employees (in Danish only)