The Danish Pharmacovigilance Council

Updated 30 September 2022

The council's main tasks

The Danish Pharmacovigilance Council gives advice to the Danish Medicines Agency in questions of adverse reactions and other risks associated with medicines.

The Danish Pharmacovigilance Council gives general advice to the Danish Medicines Agency in questions of adverse reactions and other risks associated with medicines.

Among the tasks of the council are:

to make recommendations to the Danish Medicines Agency on how to organise the process of collecting adverse reaction reports and use available knowledge about adverse reactions (side effects)
to make recommendations to the Danish Medicines Agency about information for medicine users on medicines and side effects
to make recommendations to the Danish Medicines Agency about information on the prevention of medication errors.

The council may also recommend the Danish Medicines Agency to launch specific initiatives to counter the spread of falsified medicinal products.

The council is expected to contribute to:

improving the quality of pharmacovigilance
fostering dialogue between medicine users, healthcare professionals and authorities
preventing side effects from medicines and
promoting the safe use of medicines.

Members

The Danish Pharmacovigilance Council consists of a maximum of 11 members.

Term of council members

The members are appointed by the Danish Medicines Agency for four year terms.

Members of the council

The Danish Medicines Agency appoints members to the Danish Pharmacovigilance Council upon public notice. For the period from 2021 to 2024, we have appointed the following members:

Torben Mogensen, Specialist, MD, BA in philosophy
Karsten Lollike, Novo Nordisk, Corporate Vice President and QPPV
Birthe Søndergaard, Healthcare Director, Association of Danish Pharmacies
Karin Frøidt, Chemical Engineer, Group Quality Manager at Dagrofa
Sine Jensen, Danish Consumer Council, Senior Health Adviser
Espen Solem, Chief Medical Officer, Bispebjerg and Frederiksberg Hospitals, Department of Clinical Pharmacology and Head of Capital Region of Denmark’s ADR Manager
Anna Mette Nathan, Specialist in general medicine, Vice Chairman of the Danish Medical Association
Birgitte Klindt Poulsen, Chief Medical Officer, Unit of Clinical Pharmacology, Aalborg University Hospital
Eva Sædder, Chief Medical Officer, Department of Clinical Pharmacology, Aarhus University Hospital
Thomas Nødvig, Information Consultant, Medicin.dk

The Chairman

The Danish Medicines Agency has appointed Torben Mogensen Chairman of the Danish Pharmacovigilance Council for the period from 2021 to 2024.

Number of meetings

The council meets around four times a year, but it is up to the council to decide how often and when it will meet. The meetings are usually held at the Danish Medicines Agency.

The Chairman can decide to hold extraordinary meetings, if necessary.

Composition requirements

According to the Danish Medicines Act, the members must include representatives of healthcare professionals, pharmaceutical companies, proprietary pharmacists and other retail distributors of medicinal products, patients and consumers.

Appointment of members

The Danish Medicines Agency appoints members to the Danish Pharmacovigilance Council upon public notice.

Anyone can nominate members to the council, and self-nomination is also possible.

Qualifications of council members

When council members are appointed, importance is attached to their knowledge of, practical experience with and interest in medicine safety and the pharmacovigilance area.

Declaration of interests

After being appointed and before the first meeting, the members must fill in and sign a declaration of interests form. The declaration must be attached to the meeting minutes.

On their own initiative, the members must fill in and sign a new declaration if what they have previously declared changes. Any new declaration must be attached to the minutes of the next meeting.

A council member must not participate in the processing of a case if he or she has a personal interest in the outcome of the case, or if there are any other circumstances which could question his or her impartiality.

Members must inform the council of any potentially conflicting interests before the processing of a case begins. The council then decides whether the member should be allowed to participate in the processing of the case.

The council's decision must be recorded in the minutes.

A member with conflicting interests must leave the meeting room during the processing of the case concerned. The member concerned participates in neither the review nor the decision-making process of the case.

Declarations of interests for the members of the Danish Pharmacovigilance Council (in Danish)

Confidentiality

The members are bound by professional secrecy in relation to confidential information they may acquire as council members.

It is the responsibility of the individual member to ensure that the material the member receives as part of serving on the council is not disclosed to any third parties and remains confidential.

When a member resigns from the council, he or she must return any confidential information acquired while serving on the council.

Secretariat

The Danish Medicines Agency serves as secretariat to the Danish Pharmacovigilance Council. The extent of this work is determined by the Board of Directors of the Danish Medicines Agency.

Meeting procedure

The Chairman summons the meetings in writing, giving at least eight days notice, if possible. The secretariat may also summon meetings by order of the Chairman.

Notices of meetings must include an agenda. Whenever possible, any documents related to individual agenda items should be enclosed with the agenda.

The Chairman sets the agenda. The agenda for ordinary meetings must at least include the following items:

Approval of minutes from the previous meeting
Chairman's report
Report from the Danish Medicines Agency
Any other business.

The Chairman presides over the meetings.

Decision-making process

The presence of the Chairman and at least half of the members is necessary to constitute a quorum.

The council decides by simple majority. In the event of a tie, the Chairman's vote is decisive.

The council can only make decisions on topics that have been put on the agenda for decision-making, unless the entire council agrees to do otherwise.

If a member disagrees with a decision, the member can demand that his or her position be recorded in the minutes.

In special circumstances and if the Chairman agrees, the secretariat can present a case to the council in writing outside a council meeting. A member may nonetheless demand that the case be processed at a meeting before any decision is made.

Minutes

Minutes are taken for each meeting.

Draft minutes are sent out to the members as soon as possible and no later than three weeks after every meeting.

If a member objects to the minutes, he or she must inform the Chairman and the secretariat as soon as possible and no later than three weeks after the draft minutes have been sent out.

In any event, the Chairman and secretariat must be informed immediately if the objections concern the way in which the subject-matter of a decision is presented.

The approved minutes are published in Danish on this website.

Participants at the meetings

The meetings are closed to the public, but the council may decide to call in third parties to discuss specific topics.

Employees from the secretariat and other employees of the Danish Medicines Agency can attend the meetings to the extent the Chairman decides.

Absence

Council members should to the extent possible send their apologies to the secretariat.

If the Chairman is expected to be absent for an extended period of time, the Danish Medicines Agency decides who is to act in his place.

Transparency of the council's work

Minutes and meeting dates are posted on the Danish version of this website.

Minutes must be taken at each meeting. The minutes must as a minimum include information about:

the time and place of the meeting
names of meeting attendants, including the name of the minute-taker
agenda of the meeting
decisions made
time and place of the forthcoming ordinary meeting.

Rules of procedure

Pursuant to the Danish Medicines Act, the Danish Medicines Agency lays down rules of procedure for the Danish Pharmacovigilance Council.

The rules of procedure appear from the following Danish executive order:
Executive order no. 1566 of 6 December 2016 on the rules of procedure of the Danish Pharmacovigilance Council (in Danish)