The Danish Pharmacovigilance Council

Updated 08 December 2016

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.

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 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. We expect to appoint new members early in 2017.

The Chairman

The Danish Medicines Agency appoints the Chairman of the Danish Pharmacovigilance Council among the council members.

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 can decide to hold 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 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 out and sign a declaration of interests form. The declaration must be attached to the meeting minutes.

On their own initiative, the members must fill out and sign a new declaration if what they have previously declared changes. Any new declaration must be attached 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 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 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 Interests for the members of the Danish Pharmacovigilance Council (in Danish only).

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 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:

  1. Approval of minutes from the previous meeting
  2. Chairman's report
  3. Report from the Danish Medicines Agency
  4. 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 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 Danish Medicines Agency can attend the meetings as decided by the Chairman.

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 here on the Danish version of the website.

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

  1. the time and place of the meeting
  2. names of meeting attendants, including the name of the minute-taker
  3. agenda of the meeting
  4. decisions made
  5. 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:
Danish executive order no. 830 of 1 August 2012 on the rules of procedure of the Danish Pharmacovigilance Council

The Danish Pharmacovigilance Council replaces the Council for Adverse Drug Reactions

By the Danish Parliament's adoption of act no. 605 of 18 June 2012 amending the Danish Medicines Act , the rules governing the Danish Pharmacovigilance Council were established. The legislative changes have been written into the English version of the Danish Medicines Act.

The amendment discontinued the Council for Adverse Drug Reactions and replaced it by the Danish Pharmacovigilance Council.

Link to the discontinued Council for Adverse Drug Reactions

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