The Danish Pharmacovigilance Council

Updated 05 February 2024

The Council's main tasks

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

The Danish Pharmacovigilance Council’s job is to offer general advice to the DKMA on adverse reactions and other pharmaceutical risks.

Among the tasks of the council are:

To make recommendations to the DKMA 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 DKMA about information for medicine users on medicines and side effects
To make recommendations to the DKMA about information on the prevention of medication errors.

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

It is presumed that the council will actively 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 maximum 11 members.

Term of council members

The members are appointed by the DKMA for four year terms.

Members currently sitting on the council

The DKMA appoints members to the Danish Pharmacovigilance Council upon public notice. The following members have been appointed for the period 2021-2024:

Torben Mogensen, MD, Medical Specialist, BA in Philosophy
Karsten Lollike, Novo Nordisk, Corporate Vice President and QPPV
Birthe Søndergaard, Healthcare Director, Association of Danish Pharmacies
Karin Frøidt, MSc in Chemical Engineering, Group Quality Manager at Dagrofa
Rosemarie Elisabeth Wedell-Wedellsborg, Danish Consumer Council (council member)
Espen Solem, Consultant, Department of Clinical Pharmacology, Bispebjerg and Frederiksberg hospitals, and Leader of the Capital Region of Denmark’s ADR Manager Function
Anna Mette Nathan, Specialist in General Medicine, General Practitioner, Vice-Chair of the Danish Medical Association and Chair of the Danish Medical Association’s Medicine and Medico Committee
Hanne Borgeskov, Consultant responsible for staff training, Clinical Pharmacological Unit, Aalborg University Hospital
Eva Sædder, Senior Consultant, Department of Clinical Pharmacology, Aarhus University Hospital
Thomas Nødvig, Information Consultant, Medicin.dk
Marijke Vittrup, Director at Øjenforeningen (Danish Eye Association)

The Chairman

The DKMA has appointed Torben Morgensen as Chairman of the Danish Pharmacovigilance Council for the period 2021-2024.

Number of meetings

The council meets approximately 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 may decide to convene extraordinary meetings, if necessary.

Composition requirements

It follows from the Danish Medicines Act that 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 DKMA appoints members to the Danish Pharmacovigilance Council upon public notice.

Anyone can nominate members to the council, and self-nomination is 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 out and sign a declaration of interests form. The declaration must be annexed to the meeting minutes.

The members must, of their own accord, fill out and sign a new declaration in the event of changes to previous declarations made. New declarations must be annexed to the minutes of the first-coming 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 their 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 room during the processing of the case concerned. Thus, the member concerned participates in neither the review nor the decision-making process of the case.

Declarations of interest of the members of the Danish Pharmacovigilance Council

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 DKMA serves as secretariat to the Danish Pharmacovigilance Council. The extent of this work is determined by the leadership team of the DKMA.

Meeting procedure

The Chairman summons the meetings in writing, giving at least eight days notice, if possible. The meetings may also be summoned by the secretariat 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. For ordinary meetings, the agenda must at least include the following items:

Approval of minutes from the previous meeting
Chairman's report
Reports 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 may 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 may demand that their position be recorded in the minutes.

In special circumstances and if the Chairman agrees, the secretariat may present a case to the council in writing outside a council meeting. A member may, however, 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, they 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 objections made concern the way in which the subject-matter of a decision is presented.

The approved minutes are published in Danish here on the 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 from the DKMA may 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 DKMA decides who is to act in his place.

Transparency of the council's work

Minutes and meeting dates are posted here on the Danish version of the 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 DKMA 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 (Danish title: 'Bekendtgørelse nr. 1566 af 6. december 2016 om forretningsorden for Rådet for Lægemiddelovervågning')