The Reimbursement Committee
The tasks of the Reimbursement Committee
The Reimbursement Committee advises the Danish Medicines Agency in cases regarding reimbursement from the Danish regions - both general reimbursement and individual reimbursements for medicines.
The Reimbursement Committee's tasks especially involve:
- advising the Danish Medicines Agency in cases concerning application for general reimbursement of medicines
- giving advice about general reimbursement at periodic and ad hoc reassessments of status for reimbursement of medicines
- advising the Danish Medicines Agency about individual reimbursement of medicines (single reimbursement, increased reimbursement and reimbursement for the terminally ill)
- participating in ad hoc groups of experts under the Reimbursement Committee.
Number of members
The Reimbursement Committee has up to seven members of which two must be general practitioners. The members are appointed by the Danish Minister of Health and Prevention upon recommendation by the Danish Medicines Agency.
One member is appointed by the Minister upon recommendation by the Regions' Board for Wages and Tariffs. The Reimbursement Committee members are appointed for four years, and together they have a wide-ranging expertise.
Until 30 June 2021, the following members serve on the Reimbursement Committee:
- Janne Unkerskov, general practice specialist
- Kristian Karstoft, specialist in clinical pharmacology (Danish Regions)
- Lone Baandrup, specialist in psychiatry
- Michael Røder, special in internal medicine and medical endocrinology
- Nina Hannover Bjarnason, specialist in pulmonary medicine and clinical pharmacology
- Palle Mark Christensen, Chairman, specialist in general medicine and clinical pharmacology
- Søren Boesgaard, specialist in cardiology
From 1 September 2020 to 31 August 2024, patient and consumer interests will be handled by the following member:
- Thorkil Clement Kjær, Former Managing Director
Term of committee members
The Reimbursement Committee members are appointed for four year terms.
Number of meetings
The Committee is expected to convene once a month. The meetings are usually held at the Danish Medicines Agency.
The Chairman can decide to hold extraordinary meetings, if necessary.
The rationale behind the Committee's composition of professional groups/interests
The Committee is composed of six physicians and one representative from Danish Regions.
The composition of the Reimbursement Committee members is to join a wide-ranging medical and pharmaceutical expertise to provide the best possible medical advice to the Danish Medicines Agency in questions of reimbursement of medicines. The representative from Danish Regions serves to protect the Danish regions' interests in the Committee work.
Pursuant to the Danish Health Act, two members of the Reimbursement Committee must be general practitioners.
Appointment of members
The Danish Medicines Agency invites interested parties to nominate members to the Reimbursement Committee.
Everyone can nominate members to the Reimbursement Committee, and self-nomination is also possible.
The Danish Minister of Health and Prevention appoints one member upon the recommendation of the Regions' Board for Wages and Tariffs. The Minister appoints the remaining six members upon the recommendation of the Danish Medicines Agency. The Minister also appoints a Chairman from among the members of the Committee.
Requirements of committee members
When committee members are appointed, importance is attached to their knowledge of, practical experience with and interest in rational use of medicine in general and the reimbursement area in particular.
The members are appointed based on their medical skills and relevant experience in order to ensure a wide-ranging expertise in the Committee.
Furthermore, it is also emphasised that the members must not have any financial interests or other interests in the pharmaceutical industry which could make them biased.
Declaration of interests
The members must fill out and sign a declaration of interest form before the first meeting after appointment. These declarations 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 declarations must be attached to the minutes of the first-coming meeting.
A Committee 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 Committee of any potentially conflicting interests before the processing of a case begins. The Committee decides whether the member may participate in the processing of the case. The Committee's decision must be recorded in the minutes.
If a member has a conflicting interest, he or she must must leave the room during the processing of the case concerned. Thus, the member concerned neither participates in the review nor the decision-making process of the the case.
You can download the member's declaration of interest forms in the box to the right (in Danish only).
Confidentiality
The committee members are bound by professional secrecy regarding the confidential information they gain knowledge of as members of the Committee.
It is the responsibility of the individual member to ensure that the material the member receives as part of serving on the Committee is not disclosed to third parties. When a member resigns from the Committee, the member concerned must return all the confidential material received while serving on the Committee.
The secretariat of the Reimbursement Committee
The Danish Medicines Agency provides a secretariat for the work of the Committee. It is the Danish Medicines Agency's CEO who decides the extent to which the secretariat must assist the Committee.
Meeting procedure
The Chairman and the secretariat plan the meetings by presenting the cases to the Committee.
By the authority of the Chairman, the secretariat summons the Committee meetings in writing by at least 12 days notice if possible.
Notices of meetings must include an agenda. Moreover, the members must to the extent possible receive any documents regarding the individual items.
It is the Chairman who sets the agenda. For ordinary meetings, the agenda must include the following items:
- approval of minutes from the previous meeting
- Chairman's report
- Secretariat's report
- Any other business.
It is the Chairman who presides over the meetings.
Minutes
Draft minutes are sent out in Danish as soon as possible after the meeting and at the latest when the next ordinary meeting is summoned.
Any objections to the minutes must be submitted no later than at the next ordinary Committee meeting. However, the Chairman and secretariat must be informed immediately if objections are made to the way in which the content of a decision has been presented.
The Chairman signs the approved minutes. Subsequently, the minutes are published on the Danish Medicines Agency's website in Danish.
Decision-making process
In general, the Committee can only make a decision when the Chairman and at least four of the committee members are present. If there are fewer members present, the Committee can still make a decision. To do so, the attending members must find that postponing the case would be of significant inconvenience to the individual or individuals of the case, or would jeopardize important health considerations.
Generally, the Committee can only make a decision in a case if such decision is scheduled in the agenda. However, the Committee can still make a decision in a case which is not on the agenda if all members agree to do so.
The Committee decides by simple majority. In the event of a tie, the Chairman has the casting vote.
In agreement with the Chairman, the secretariat can in special circumstances present a case to the Committee in writing outside a committee meeting. However, a member can demand that the case be processed at a meeting before a decision is made.
If a committee member disagrees with a decision, the member can demand that this be recorded in the minutes.
Participants at the committee meetings
The Reimbursement Committee meetings are not open to the public. The Committee can only hold meetings with outside parties if agreed with the Danish Medicines Agency beforehand.
Employees from the secretariat and other employees of the Danish Medicines Agency can attend the meetings to the extent the Chairman decides.
Absence
The committee members must as far as possible inform the secretariat if they are unable to attend a committee meeting.
The Committee decides by simple majority who must function as Chairman if the Chairman is expected to be absent for a longer period.
Transparency of the Committee's work
It is possible to follow the Committee's work here on the Danish Medicines Agency's website. We publish:
- the committee members' names and their declaration of interest forms (on this page, the latter of which in Danish only)
- recommendations regarding general reimbursement applications from companies and recommendations in connection with the reassessment of the reimbursement status for medicinal products
- reassessment of reimbursement status for medicinal products (in Danish only)
- annual reports
- meeting minutes.
Minutes must be taken at each committee meeting. The minutes must at least include information about:
- the time and place of the meeting
- the names of meeting attendants, including the name of the minute-taker
- agenda of the meeting
- the decisions made
- time and place of the forthcoming ordinary meeting.
Remuneration
The medical members and the member representing patient and consumer interests receive remuneration in accordance with the Danish Government regulations.