Revised: 10 November 2021

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.

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Current members

Chair

Dr Christina (Chris) Cameron (MClinPharm, FRACP)
Dr Cameron is a Consultant in General Medicine at Capital and Coast DHB, Consultant in Clinical Pharmacology at Capital and Coast DHB, Senior Lecturer in clinical pharmacology at the Wellington School of Medicine, University of Otago, Chair of the Medicines Review Committee at Capital and Coast DHB, committee member of the Named Patient Prescribing Authority, PHARMAC, committee member of RUPAG and Schedule Rules, PHARMAC, and Secretary for the Australasian Society for Clinical and Experimental Pharmacologists and Toxicologists. Dr Cameron provides expertise in the fields of general medicine and clinical pharmacology.

Members

Dr Alex Romain (BSc (Hons), MBBS, MRes, MRNZCGP)
Dr Romain is a General Practitioner in Northland working predominantly with Māori patients. He has editorial experience in medical publishing at the British Medical Journal and Journal of Primary Health Care, and an academic background in molecular and translational medicine. Dr Romain was a Clinical Lead in Canterbury’s Covid-19 response. Dr Romain provides expertise in the field of rural general practice.

Dr Sean Hanna (MBChB, PGDipGP(Dist), PGDipClinEd(Dist), FRNZCGP, FRACGP)
Dr Hanna is currently a General Practitioner and primary health organisation (PHO) clinical lead at high needs urban iwi provider, Ora Toa PHO in Porirua, General Practitioner at Evolve Youth One Stop Shop (Wellington), Lead Medical Educator (GPEP1 Wellington) and GPEP1 Teacher Royal New Zealand College of General Practitioners (RNZCGP), Wellington Medical School Clinical Education Advisor, University of Otago Rural Medical Immersion Programme Clinical Education Advisor. Dr Hanna is currently a member of PHARMAC’s Pharmacology & Therapeutics Advisory Committee (PTAC), Chair of PTAC’s Diabetes, Anti-infective, Immunisation and Mental Health subcommittees, member of MoH Technical Advisory Group Immunisation and member of the Professional Conduct Committee (Medical Council of New Zealand). Dr Hanna provides expertise in urban general practice.

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.

Associate Professor Lianne Parkin (MB ChB, DipObst, DPH, PhD, FAFPHM)
Associate 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. Associate Professor Parkin provides expertise in the field of epidemiology.

Honorary Associate Professor Marius Rademaker (BM FRACP FRCP(Edin) DM FNZDSi)
Hon Assoc Prof Rademaker is a dermatologist currently working as Honorary Associate Professor of Medicine at the University of Auckland, Research Director for the Waikato Skin Research Association, Consultant for MoleMap and Director Dermatology Clinical Trials for Clinical Trials New Zealand. Hon Assoc Prof Rademaker currently sits on PHARMAC’s PTAC as deputy chair and has previously been 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. Hon Assoc Prof Rademaker provides expertise in the field of dermatology.

Mr Zaffer Khan Cusi Malik (BScN, MNSc, PG Cert in Advanced Nursing Practice)
Mr Malik is a Nurse Practitioner with a focus on acute medicine and the health of older people at Capital and Coast District Health Board. Mr Malik’s unique role allows him to work at the secondary and primary care interface where he assists general practitioners in managing complex patients. Mr Malik also has experience in acute nursing, emergency nursing and general medicine where he has held roles such as Charge Nurse Manager and Clinical Nurse Educator in these areas. Mr Malik provides expertise in the field of nursing.

Ms Leasa Carlyon (J.P., 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 in restorative justice, elder mediation and project management.

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 Michael Tatley(MBChB, BBusSci(Hon), FFCH(SA), FAFPHM, FNZCPHM)
Dr Tatley is Director of the New Zealand Pharmacovigilance Centre (NZPhvC) at the University of Otago. The NZPhvC provides pharmacovigilance services on contract to Medsafe. His experience is in the area of drug safety surveillance and the evaluation of adverse events attributed to medicines. He has a particular interest in vaccine adverse events and vaccinology.

Ms Leanne Te KaruMuaūpoko/ Te Āti Haunui-a-Pāpārangi (DipPharm, PGCertHerbalMeds, PGDipClinPharm, MHSc(Hons), PGCert(Prescribing), MMPA, MCAPA, FPSNZ, NZRegPharm)
Ms Te Karu is a Pharmacist Prescriber at Pihanga Health Medical Centre and Papakura Marae Clinic Medical Centre. Ms Te Karu is also the Associate Dean (Māori) at the University of Otago School of Pharmacy, a presenter/contractor to PHARMAC, an advisor to the Health Quality Safety Commission, an honorary lecturer at the University of Auckland School of Pharmacy, and the Director of Tu Kapua Limited. Ms Te Karu is also currently a Doctor of Philosophy candidate at the Department of General Practice, University of Auckland. Ms Te Karu provides expertise in the field of clinical pharmacy (primary care).

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.

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.

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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

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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.

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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.

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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.

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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.

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