Tasks of the Licensing Committee
The Licensing Committee's is responsible for:
- giving advice to the Danish Health and Medicines Authority on matters concerning applications for, changes to and withdrawals of marketing authorisations for medicine and clinical trials of medicine.
- participating in the processing of any complaints.
The overall task of the Licensing Committee is to participate in a general cooperation with the Danish Health and Medicines Authority on the requirements to be fulfilled in order for the Danish Health and Medicines Authority to be able to approve new medicines.
The Licensing Committee members are also expected to participate in scientific knowledge sharing with the Danish Health and Medicines Authority's employees.
The Minister for Health may assign new tasks to the Committee.
Number of members
The Licensing Committee consists of maximum 13 members.
The Licensing Committee has the following members for the current term:
- Chairman: Consultant, MD Bjarne Ørskov Lindhardt
- Vice-Chairman: Staff Physician, MD, PhD Mark Ainsworth
- Specialist, PhD, MD Niels Henrik Buus
- Consultant, PhD Hanne Rolighed Christensen
- Professor, MD and licentiate, Else Marie Damsgaard
- Professor, PhD Christian Friis
- Professor, PhD Sven Frøkjær
- Medical Director, MD Steen Werner Hansen
- Consultant, MD Gorm Jensen
- Professor, MD Steffen Loft
- Consultant, MD Lars Kristian Munck
- Senior Scientist, DVM Jens Nielsen
- Professor, MD Søren Sindrup.
Term of committee members
The Licensing Committee members are appointed for four year terms.
Number of meetings
The Committee is expected to convene once or twice a month. See the dates of meetings to the left.
The committee members decide which dates the meetings are to be held. The meetings are normally held at the Danish Health and Medicines Authority, but the assessment of applications can also take place electronically between members.
The Chairman can decide to hold extraordinary meetings, if necessary.
Rationale behind the Committee's composition of professional groups/interests
The Danish Health and Medicines Authority recommends people to be members based on the criteria that the proposed members must have a combined specialist expertise that can enable them to provide the best advice possible to the Danish Health and Medicines Authority.
Appointment of members
The Danish Health and Medicines Authority invites interested parties to nominate members to the Licensing Committee via a public notice. Anyone can nominate members to the Licensing Committee, and self-nomination is also possible.
The Danish Minister for Health appoints members upon the recommendation of the Danish Health and Medicines Authority. The Minister appoints a Chairman and a Vice-Chairman independently of the received nominations.
With the approval of the Minister for Health, the Danish Health and Medicines Authority can set up standing committees to look into specific areas. The Minister for Health may appoint persons for the standing committees that are not members of the Licensing Committee.
Requirements of committee members
The members are appointed based on personal competencies and relevant experience. The selection of members takes into consideration both professional background and documented scientific expertise, as well as association to research institutions and clinical practice. Knowledge of or experience with the regulatory system is also emphasised.
The members must not have economic or other interests in any companies that manufacture, import or sell medicine if these interests could affect the impartiality of the members.
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. The declarations of interest are published on the Danish Health and Medicines Authority's website – see the box to the right.
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 conflicting interests, he or she must 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.
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 any third parties. When a member resigns from the Committee, the member concerned must return all confidential material received while serving on the Committee.
Secretariat of the Licensing Committee
The Danish Health and Medicines Authority provides a secretariat for the work of the Committee. The Danish Health and Medicines Authority's CEO decides the extent to which the secretariat may assist the Committee.
Meeting procedure
The Chairman summons the committee meetings in writing with at least eight days notice if possible.
The secretariat may also summon meetings if the Chairman authorises it to do so.
Notices of meetings must include an agenda. Moreover, the members must, if possible, be sent any documents regarding individual items on 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.
- Secretariat's report.
- Cases for discussion and decision.
- Any other business.
The Chairman presides over the meetings.
Decision-making process
In general, the Committee can only make a decision when the Chairman or the Vice-Chairman and at least half 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 jeopardise 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. The Vice-Chairman has the casting vote if the Chairman is absent. If a committee member disagrees with a decision, the member can demand that this be recorded in the minutes.
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 required and if it has been agreed with the Danish Health and Medicines Authority in advance, the Licensing Committee may obtain expert opinions.
Minutes
Minutes must be taken at each committee meeting. The minutes must as a minimum include information about:
- 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 next ordinary meeting.
Draft minutes are sent out 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 made 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 is presented.
Minutes of Licensing Committee meetings are published in Danish on the Danish Health and Medicines Authority's website.
Participants at the committee meetings
The Licensing Committee meetings are not open to the public. The Committee can only hold meetings with third parties if agreed with the Danish Health and Medicines Authority beforehand.
Employees from the secretariat and other employees from the Danish Health and Medicines Authority can attend the meetings to the extent the Chairman decides.
Absence
Committee members must to the extent possible inform the secretariat if they are unable to attend a committee meeting.
The Vice-Chairman attends to the Chairman's duties if the Chairman is absent.
The Committee decides by simple majority who must function as Chairman if the Chairman and Vice-Chairman are expected to be absent for a long period of time.
Transparency of the Committee's work
Agendas and minutes of the Licensing Committee's meetings are available on the Danish Health and Medicines Authority's website (in Danish only).
The Danish Health and Medicines Authority must not publish confidential information from agendas and minutes of meetings. Therefore, the name of medicines is replaced by the so-called ATC code at the 2nd level. It refers to the place in the body that the medicine acts on. The ATC code is removed once a decision is made concerning a given application.
When the minutes of a meeting are published on the website, the agenda of the same meeting is deleted. Published minutes remain on the Danish Health and Medicines Authority's website for at least three years.
Remuneration
The Chairman and all other members receive remuneration in accordance with Danish Government regulations.
