Revised: 15 July 2024
Committees
Medicines Adverse Reactions Committee - Committee Process
Composition and membership
Current members
Meetings
Responsibilities of the MARC
Role of Medsafe in relation to MARC
Travel, expenses and fees
Conflicts of interest
Composition and membership
The Medicines Adverse Reactions Committee (MARC) comprises up to 13 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, nursing, pharmacovigilance, epidemiology and biostatistics.
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 and medicines regulation.
The composition of the MARC is as follows:
- an epidemiologist
- two general practitioners (one in urban practice, one in rural practice)
- a clinical pharmacologist
- two clinical pharmacists (one hospital based, one community based)
- four specialist clinicians (eg, from fields such as psychiatry, paediatrics, cardiology etc)
- a nurse
- a layperson
- the Director of the New Zealand Pharmacovigilance Centre
Medsafe may obtain further expert advice from other specialists where such expertise is not available within the Committee.
Current members
Chair
Associate Professor Matt Doogue (FRACP)
Associate Professor Doogue is a clinical pharmacologist at Canterbury District Health Board and also a member of the Department of Medicine at the University of Otago in Christchurch. His research interests include adverse drug reactions, clinical decision support, therapeutic drug monitoring, drug interactions, pharmacogenetics and pharmacokinetics. Associate Professor Doogue provides expertise in the fields of clinical pharmacology, endocrinology, and general medicine.
Members
Dr Chris Kenedi (MD, MPH, FRACP, FACP)
Dr Kenedi is a psychiatrist and internal medicine physician working at Hawkes Bay DHB and in private nationwide. Dr Kenedi is also currently a content expert for the United Nations/ICAO Aviation Mental Health Working Group and on the faculty of Duke University Medical Center in the United States. Dr Kenedi provides expertise in the fields of internal medicine and psychiatry.
Professor Lianne Parkin (MB ChB, DipObst, DPH, PhD, FAFPHM)
Professor Parkin is an academic public health physician and epidemiologist at the University of Otago. Her research interests include the use of routinely collected electronic health and pharmaceutical dispensing data to study the utilisation and safety of medicines and medical devices, and she is the Lead Investigator of the Pharmacoepidemiology Research Network Core Academic Group. Professor Parkin provides expertise in the field of epidemiology.
Dr Marius Rademaker (BM FRACP FRCP(Edin) DM FNZDSi FACD)
Dr Rademaker is a dermatologist currently working as Director of Dermatology Clinical Trials for Clinical Trials New Zealand and as Consultant for MoleMap NZ. Dr Rademaker has previously been deputy chair of PHARMAC’s Pharmacology and Therapeutics Advisory Committee, as well as previously being a member of the Medicines Adverse Reactions Committee, Inter-governmental (Australia/New Zealand) Kava Evaluation Group and Ministerial Working Party on Bee Venom, Propolis and Royal Jelly. Dr Rademaker provides expertise in the field of dermatology, critical analysis of clinical trials and adverse drug reactions.
Mrs Amanda-Biggs-Hume (NP, MN, PGCert, RN, BSc(Hons))
Mrs Amanda Biggs-Hume is a registered Nurse Practitioner working across primary and secondary care in Whanganui. Mrs Biggs-Hume has been a previous executive committee member of Nurse Practitioners New Zealand and previous member of the College of Emergency Nurses committee. Mrs Biggs-Hume provides expertise in nursing, specialising in emergency and acute/urgent care.
Ms Leasa Carlyon (JP, NZ Dip Business Management, NZ Institute of Directors)
Ms Carlyon has extensive experience in governance as a lay member for the Health Practitioners Disciplinary Tribunal, the Ministry for Primary Industries National Animal Ethics Advisory Committee and the Dietitians Board of New Zealand, among other directorships and boards. She is a Justice of the Peace and also served as a Judicial Justice of the Peace in the Wellington Courts. Ms Carlyon provides a consumer lens and represents public interests, drawing on her experience of restorative justice, elder mediation and project management. She is currently working at the Reserve Bank of New Zealand on data projects.
Ms Louise McDermott (MClinPharm, DipTching, RegPharmNZ (prescriber))
Ms McDermott is a Paediatric Pharmacist Prescriber and Pharmacy Team Leader for the Whānau Ora Team at Christchurch Hospital. Ms McDermott has extensive experience in paediatric pharmacy where she works collaboratively with the wider paediatric team at Christchurch Hospital. Ms McDermott is the Chair of the Pharmacist and Therapeutics Special Interest Group of the Paediatric Society of New Zealand and is a member of the Health Quality & Safety Commission Extemporaneous Compounding Group, which works to standardise compounding liquids across New Zealand to reduce errors. Ms McDermott provides expertise in the field of hospital clinical pharmacy.
Dr Leanne Te Karu Muaūpoko/Ngāti Rangi/Te Āti Haunui-a-Pāpārangi (DipPharm (Dist), PGCertHerbalMeds (Dist), PGDipClinPharm (Dist), MHSc(Hons), PGCert(Prescribing), PhD, MMPA, MCAPA, FPSNZ, NZRegPharm)
Dr Te Karu has broad experience across Aotearoa, New Zealand’s health and disability system, including clinical settings, governance, research, strategy, and iwi development. Clinically, she works as a prescribing pharmacist in general practice, focusing on complex multimorbidity and unmet needs, predominantly in Māori and rural populations. Dr Te Karu has completed a PhD in optimal medicines therapy in indigenous populations at the Department of General Practice, University of Auckland, and provides expertise in the field of applied clinical pharmacy (primary care).
Dr Adam Pomerleau (MD, FAACT, FACEM)
Dr Pomerleau is a medical/clinical toxicologist and the Director of the National Poisons Centre at the University of Otago, Dunedin. As the Director of the National Poisons Centre, Dr Pomerleau leads the Centre’s strategic direction and clinical governance, and provides consultations on the management of harms related to exposure of substances to healthcare providers and the public. Dr Pomerleau also works as an emergency medicine physician at Dunedin Hospital. Dr Pomerleau provides expertise in the fields of clinical toxicology and emergency medicine.
Dr Sharon Leitch (MBChB, DCH, FRNZCGP, PGDipGP, PhD)
Dr Sharon Leitch is a general practitioner at the Dunedin Urgent Doctors and Accident Centre and holds an academic position as a Senior Lecturer at the Department of General Practice and Rural Health, University of Otago. Dr Leitch is currently working in a committee establishing the Southern Primary Care Research Network, which will link routinely collected primary care data with other health data sets for research purposes. Dr Leitch provides expertise in the field of general practice.
Dr Howard Wilson (BSc (Pharmacology), PhD (Pharmacology), MBBS) (all University of London)
Dr Howard Wilson has over 30 years’ experience as a rural general practitioner and Medical Officer at Akaroa Health Centre, Akaroa Hospital and now the new integrated Akaroa health care facility. Dr Wilson is currently a locum general practitioner at Akaroa Health and Methven Medical Centre. Dr Wilson has extensive committee/board experience as a past member of PHARMAC’s Pharmacology and Therapeutics Advisory Committee, current member of the New Zealand Formulary Editorial Advisory Board, a board member of Akaroa Health Ltd and has been clinical advisor with local Primary Health Organisations and Canterbury DHB. Dr Wilson provides expertise in the field of general practice.
Dr Alison Barrett (BSc, MD, FRANZCOG, LLB (Honours))
Dr Alison Barrett is a Consultant Obstetrician and Gynaecologist at Health New Zealand | Te Whatu Ora Counties Manukau. In a previous role, she was the Clinical Director of Maternity Services at Waikato Hospital. Dr Barrett attained her Doctor of Medicine at the University of Toronto and is a fellow of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Dr Barrett has extensive experience in women’s health, working both in community and secondary care settings. Dr Barrett provides expertise in the field of obstetrics and gynaecology.
Meetings
The Medicines Adverse Reactions Committee (MARC) meets in Wellington four times per year (normally on the second Thursday of March, June, September, and December). Meetings usually commence at 9:00 am and finish by 5:00 pm. 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 Medicines Adverse Reactions Committee (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 Medsafe.
Role of Medsafe in relation to MARC
The Secretariat for the Medicines Adverse Reactions Committee (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.
Conflicts relevant to any agenda item are included in the minutes of each meeting.
