Responsibilities and Expectations of the
Medicines Adverse Reactions Committee (MARC)
Roles of Medsafe in relation to the MARC
Composition and Membership
The Medicines Adverse Reactions Committee (MARC) comprises up to 11 members who are appointed for a term of three years (renewable for a further three years).
The Chair and other members of the Committee are drawn from experts in various fields of clinical medicine, pharmacy, pharmacovigilance, epidemiology and biostatistics and medicines regulation. The MARC also holds a position for a layperson (non-healthcare professional) to represent consumer interests.
Members have an expert knowledge of medicines or consumer interests, and an interest in adverse reactions to medicines.
The composition of the MARC is as follows:
- An epidemiologist
- A general practitioner
- A clinical pharmacist
- A clinical pharmacologist
- Four specialist clinicians (e.g. from fields such as psychiatry, paediatrics, cardiology, geriatrics, dermatology)
- A layperson
- The Medical Director of the New Zealand Pharmacovigilance Centre
- A Medsafe representative
Medsafe may obtain further expert advice from other specialists where such expertise is not available within the Committee.
The MARC meets in Wellington four times per year (normally on the second Thursday of March, June, September, and December). Meetings usually commence at 9:00am and finish by 5:00pm; however, these times are flexible depending on the length of the agenda. The meetings are held in Wellington with lunch and morning/afternoon tea provided.
An agenda and accompanying meeting dossier is sent to members at least one week before each meeting to allow members time to prepare for the meeting. However, information on urgent medicine safety issues may be emailed to members up to two days prior to the meeting.
On rare occasions, an ad hoc meeting or teleconference may be convened to consider an urgent medicine safety issue.
Responsibilities of the MARC
The MARC provides expert advice on medical and scientific evaluations of medicines safety issues, referred to the Committee by Medsafe. Based on these evaluations, the MARC may recommend strategies to improve the risk-benefit profiles of medicines.
MARC members are expected to carefully read the information provided before the meeting, giving consideration to the clinical significance of each item and options for action. At the meeting, MARC members are expected to provide Medsafe with their expert opinion on the issues discussed. Members then recommend what, if any, further action should be taken by Medsafe.
Following each meeting, MARC members review the minutes to confirm that they accurately reflect the discussion and recommendations made during the meeting.
Any media or other queries directed to MARC members are usually referred to the Chair or to Medsafe.
Roles of Medsafe in relation to the MARC
The Secretariat for the MARC is provided by Medsafe.
The Secretariat prepares the agenda and dossier for each meeting, which includes writing reports and risk-benefit reviews.
After each meeting, the Secretariat prepares the minutes and implements the recommendations of the Committee in a timely manner. Where necessary, the Secretariat seeks approval from the Minister of Health, Director-General of Health, or relevant delegates with regard to the recommendations of the Committee.
The Secretariat also ensures that members are reimbursed for their time and travel.
Travel, Expenses and Fees
Committee members usually make their own travel arrangements through the Ministry’s approved travel agents, paid for by the Ministry of Health.
In addition, members are entitled to meeting preparation and attendance fees and may be entitled to claim for other expenses incurred.
Conflicts of Interest
A conflict of interest arises when a Committee member is involved in matters that could potentially affect their ability to be (or be perceived as being) neutral or impartial.
Committee members, or prospective members, must disclose whether they have
any financial, professional, or personal interests that might create a
conflict of interest. These may include:
- Directorships or other employment;
- Interests in business enterprises or professional practices;
- Share ownership;
- Beneficial interests in trusts;
- Existing professional or personal associations with the Crown body concerned;
- Professional associations or relationships with other organisations;
- Personal associations with other groups or organisations;
- Family relationships (including family members with relevant shares/benefits in trusts).
In appointing Committee members with knowledge and expertise in specialised areas, the potential for conflicts of interest may be unavoidable. It would be impractical to exclude members from offering advice where they simply have an interest per se. However, to protect the decision-making integrity of the bodies concerned (and public confidence in them), systems are in place to ensure potential conflicts of interest are identified and managed.
Members are required to complete a conflict of interest declaration form before each meeting to disclose any conflicts arising at that particular meeting. It is the Chair's responsibility to decide whether a member's interest constitutes a material (significant) direct or indirect interest, and, if so, how this conflict should be managed.
Further Information
For further information please contact Medsafe on (04) 819 6800 and ask to be put through to the MARC Secretary.