DRAFT – NOT GOVERNMENT POLICY

Background information on organ

donation and transplantation in New
Zealand
Contents
Purpose.........................................................................................................................3
An overview of New Zealand’s deceased organ donation and transplantation system
and practices in clinical settings...................................................................................4
Institutional Arrangements........................................................................................4
Society awareness....................................................................................................4
Donation....................................................................................................................5
Procurement..............................................................................................................7
Transplantation and post-transplant care.................................................................8
A brief history of organ donation and transplantation in New Zealand......................11
Key legislative and policy changes in New Zealand...............................................11
The Human Tissue Act 2008......................................................................................15
Consenting or objecting to the collection and use of human tissue.......................15
Registering as a donor............................................................................................17
Selling, trading and advertising tissue....................................................................18
Using human tissue for non-therapeutic purposes.................................................18
The services and organisations involved and their responsibilities...........................19

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Purpose
The purpose of this report is to provide background information on New Zealand’s current
and historical policy, legislation and service settings for deceased solid organ donation and
transplantation. This includes the roles and responsibilities for institutional arrangements,
public awareness, donation, procurement, transplantation and post-transplant care.

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An overview of New Zealand’s deceased organ donation and

transplantation system and practices in clinical settings
This section provides an overview of the deceased solid organ donation and transplantation
system, and describes each part of the process and who carries it out. Detail about the
different organisations and services in organ donation and transplantation and their
responsibilities are provided in the last section on page 19. Figure 1 shows a system
overview of the deceased solid organ donation and transplantation process. Each area is
then discussed in turn.

Figure 1: Organ donation and transplantation process

Institutional arrangements

Identified need Waiting list

(recipient) (recipient)
Eligibility &
Allocation

Society Donation Procurement Transplantation Post-transplant

awareness (donor) (donor) (recipient) care (recipient)

Institutional Arrangements

Institutional arrangements refer to the cooperative structures needed to ensure sustainability

of the organ donation and transplantation processes. There are a variety of different
organisations involved in organ donation and transplantation in New Zealand, for example:

 the Ministry of Health is responsible for the overall regulation and policy for organ
donation and transplantation
 district health boards (DHBs) have an important role in the funding and provision of
services
 Organ Donation New Zealand (ODNZ) is the national coordination service for
deceased organ donation and is responsible for the retrieval and transport of organs
 the National Renal Transplant Services leads and implements an agreed work
programme to improve the volume of live donor kidney transplants in NZ
 the New Zealand Blood Service provides cross-matching services.

Society awareness

Society’s awareness refers to people’s awareness and knowledge about organ donation and
transplantation. There are a variety of organisations and services involved in raising people’s
awareness about organ donation and transplantation.

Awareness raising events and initiatives

 ODNZ have organised different awareness raising events over the years, including a
campaign in October 2014, Have the conversation today 2014 awareness day,
involving information on coffee cups to encourage people to have the conversation
about donation with their families

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 transplant units, on behalf of ODNZ, encourage people (mostly organ recipients) to

distribute resources about organ donation
 Kidney Health New Zealand (KHNZ), a non-profit organisation, promotes awareness
about kidney donation by providing pamphlets and information about kidney disease,
donation and transplantation
 GiveLife.org, an initiative led by Andy Tookey, aims to generate awareness of New
Zealand’s organ donor shortage.

Awareness through school education

 ODNZ developed and launched a NCEA accredited school education programme in
2013, with information about organ donation for students in Years 9, 10, 11 and 13
 KHNZ also provides information and teaching resources for schools, including
information about kidney disease and the treatments available.

Donation

In New Zealand, the following solid organs can be donated following death (in the
appropriate circumstances): kidneys, livers, hearts, lungs, and pancreases. Tissue donation
is not in the scope of the review, but includes eyes, skin, bone marrow, and heart valves.

People of all ages can now be considered for donation. At the time of death the age and
medical condition of the person will determine the organs and tissues that can be donated.
Very few medical conditions prevent a person from being able to donate. For example, a
person with severe chronic obstructive pulmonary disease may not be able to donate lungs
for transplantation but may be able to donate heart, liver, and kidneys.

Only a small number of people (less than 1%), however, will die in circumstances that make
it possible for organs to be donated for transplantation. People who die at the scene of a
crash, for example, cannot donate organs for transplantation. This is because once the heart
stops and there is a period of time when the organs have no blood and oxygen supply, the
organs will not be suitable for donation.

Circumstances where donation is possible

The two main circumstances where deceased donation is possible are following: brain death
and cardiac death (otherwise referred to as circulatory death). Brain death occurs when
there is irreversible and complete loss of vital brain functions and the ventilator is all that
keeps the bodily organs alive. Two separate assessments are required to be carried out by
two doctors to confirm that the patient's brain has died.

Some people with non-survivable injuries to the brain never become brain dead because
they retain some brain stem function. In these circumstances donation after cardiac death
might be an option when it is clear that the individual is dependent on ventilator support and
cannot survive. A decision to withdraw treatment is made by the medical team and the
family, independent from any discussion about donation.

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Discussing donation
The donation process takes place in each of the 24 intensive care units (ICU) in New
Zealand. Potential donors are sometimes identified in the emergency department, when the
patient is unlikely to survive. If the family supports the possibility of donation, the patient is
admitted to ICU.

Each ICU in New Zealand has a LINK team, which is a liaison team comprising of an ICU
nurse, ICU doctor (intensivist), and an operating theatre nurse. These teams play a key role
as local leaders, experts and liaison persons for organ and tissue donation in all donor
hospitals in New Zealand. They provide the link between donating hospitals and ODNZ
donor coordinators, who support the LINK teams in the donation process and are
responsible for coordinating the retrieval of organs and some tissues from deceased donors
to transplant units and tissue banks.

Once a patient has been identified as a potential donor, an ICU staff member will discuss
donation with the family. This is usually an intensive care doctor, but can sometimes be
another doctor (physician/anaesthetist) or ODNZ donor coordinator. In 2014, intensive care
clinicians were the predominant people discussing donation (80%, 37 people). Two donor
coordinators and one other clinician discussed donation. In five instances, the families
volunteered consent rather than being approached1.

The family is provided information about donation and what is involved. The information
provided depends on the family and what they require. Clinical guidelines2 for ICUs make
recommendations about what the discussion should cover. This includes ensuring that the
family understands:

1. donation is an option, not an obligation

2. organ and tissue transplantation is an effective treatment for patients with a variety
of diseases
3. the whole process of organ donation is done with respect and dignity.

If the family agrees to donation, they are required to sign an “Authority for Organ and Tissue
Removal” form. Consent is required for every organ and tissue donated.

ODNZ provides 24 hours advice, support and follow-up to LINK teams and other health-care
professionals caring for potential deceased donors.

Resources and guidelines for intensive care staff

All intensive care staff and operation room staff have access to the ODNZ App, launched in
2014, which provides them with all the necessary resources for organ and tissue donation.
This includes ODNZ Best Practice Guidelines for NZ ICUs and NZ operating theatres,
including the documents and forms required for donation and a direct contact line to an
ODNZ donor coordinator.
Key clinical guidelines for organ and tissue donation and transplantation are published by
the Australian and New Zealand Intensive Care Society (ANZICS). The ANZICS statement

1
Australia and New Zealand Organ Donation (ANZOD) Registry. 2015. The 2015 ANZOD annual
report. Adelaide: ANZOD.
2
Australian and New Zealand Intensive Care Society (ANZICS), 2013. The ANZICS statement on
death and organ donation (edition 3.2). Melbourne: ANZICS.

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on death and organ donation3 outlines: the processes for the determination of death; the
responsibilities of intensive care staff in organ and tissue donation; and guidelines for
donation after cardiac death to organ donation.

Workforce training
The College of Intensive Care Medicine (CICM) is the body responsible for intensive care
medicine specialist training and education in Australia and New Zealand.

ODNZ is also responsible for providing educational programmes to health professionals

involved with organ donation. ODNZ organises various educational courses and workshops,
including the Australasian Donor Awareness Programme (ADAPT). ADAPT entails one-day
workshops once or twice a year for intensive care staff on how to manage clinical situations
involving death, understanding grief and bereavement, and caring for the family of the
deceased patient.

New Zealand clinicians have also recently been attending a new two-day core Family
Donation Conversation (cFDC) workshop in Australia, provided by the Organ and Tissue
Authority (OTA). The cFDC focusses on providing health professionals with training to
conduct conversations with families about the opportunity of organ and tissue donation and
the skills to support a family to make an informed and enduring decision about donation.

This year, CICM facilitated OTA to present cFDC in Auckland, New Zealand in early
November. New Zealand clinicians are evaluating the content of the workshop to consider
whether it is suitable for the New Zealand context and replacing the ADAPT workshop.

Monitoring the donation process

ODNZ collects information on all deaths in ICUs and key aspects of the donation practice.
This includes information about consultation with ODNZ, determination of death, formal
discussion with families of potential organ donors and the number of actual organ and tissue
donors.

This information allows ODNZ to assess the donation practice to ensure nationally
consistent processes for deceased donation and identify areas for improvement. ODNZ uses
the information to provide feedback to ICU staff.

Procurement

ODNZ is responsible for the coordination of the retrieval of organs from deceased donors
and transport to transplant centres in New Zealand. ODNZ also sometimes coordinates the
transport of organs to Australia (where a suitable New Zealand recipient is not identified) and
tissues to tissue banks in New Zealand (eg, the New Zealand National Eye Bank).
During the donation discussion process, a donor co-ordinator from ODNZ is contacted by
either an intensivist or LINK nurse. The donor co-ordinator may sometimes meet the family
prior to the donation to provide any information and support needed and help complete the
3
Ibid.

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details of consent. Donor coordinators are responsible for obtaining the necessary
information about the donor’s medical and social history.
Once the donor coordinator has ensured that all the necessary documentation is complete
(including any legal or administrative requirements), they organise the organ and tissue
retrieval operation. Donor coordinators liaise with the ICU staff, coroner, transplant services
and organ removal teams, operating room, transport and sometimes tissue banks. Donor
coordinators are available 24 hours a day, seven days a week, to receive referrals of
potential donors.
The New Zealand Blood Service carries out the blood matching tests and tissue typing tests
of solid organ transplants. Tissue typing is the matching of the donor to a potential recipient,
who requires a solid organ, to ensure they are compatible.

Transplant surgical teams travel from transplant centres to the donating hospital where the
patient is being cared for. The operation to remove organs is carried out as it would be for
any other surgical operation, including the suturing and dressing of the incision(s) at the end
of the operation. Donor coordinators then coordinate the transport of organs to transplant
centres.

Support for whānau

Families of deceased donors have the opportunity to be with the patient both before and
after the organ retrieval. Information can be provided about the outcome of the donation, if
the family wants it.

Donor coordinators provide ongoing support and care for the family. They also provide the
opportunity for families to anonymously communicate with the recipients, if they wish to.
Communication between the donor coordinator and families is continued for many months,
or years for some families.

Each year, two or three services are held in Auckland and another major city (Wellington or
Christchurch) in recognition of those who have donated organs, including their families.
Donor families, recipients and their families, and health professionals from both donation and
transplantation are invited to these services.

Transplantation and post-transplant care

Three transplantation centres perform kidney transplants in New Zealand: Auckland Renal
Transplant Group4 in Auckland DHB, Wellington Renal Transplant Unit in Capital and Coast
DHB, and Christchurch Kidney Transplant Unit in Canterbury DHB. Livers, hearts and lungs
are all transplanted in Auckland DHB at the New Zealand Liver Transplant Unit and the New
Zealand Heart and Lung Transplant Service, respectively.

4
Auckland Renal Transplant Group additionally performs simultaneous kidney and pancreas transplants where
the recipient has a condition that results in a non-functioning pancreas eg, type 1 diabetes.

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Organ recipient pathway

Prior to the transplantation, organ recipients will have followed their own pathway. In order to
be considered for an organ transplant (involving either a deceased or living donor), the
patients need to be referred by their GP to a consultant, who then makes a referral to the
transplant unit. All patients are required to undergo medical and psychosocial tests to assess
their suitability for transplant.

Once assessed, patients may be placed on the relevant deceased donor national waiting
list5, depending on which organ(s) they need. National waiting lists for kidneys, hearts and
lungs are managed by the New Zealand Blood Service, but the National Renal Transplant
Service and the New Zealand Heart and Lung Transplant Service have responsibility for
deciding who can go on the waiting lists, respectively. For liver transplants, the waiting list is
both managed and run by the New Zealand Liver Transplant Unit.

The criterion for being placed on a waiting list differs for each organ. When deciding whether
to list a patient, criteria6 include:

 age: Although for most organs, age is not by itself an exclusion criterion, the
presence of multiple comorbidities in patients over 65–70 years of age would be
expected to exclude the majority of such patients from consideration
 comorbidities: Exclusion criteria are likely to include conditions or combinations of
conditions that result in an unacceptably high mortality or morbidity risk from
transplantation (eg active malignancy, infection)
 lifestyle: Substance abuse, including excessive alcohol consumption, cigarette
smoking and illicit drug taking, are generally considered contraindications to
transplantation. These lifestyle factors can result in poorer outcomes
 inability to comply with complex medical therapy: For example chronic cognitive or
neuropsychiatric deficits in the absence of a carer capable of taking on this role.

Guidelines for determining the organ recipient

When a deceased donor organ becomes available, a range of criteria are taken into account
in deciding who on the waiting list receives the organ, for example, blood type, size of the
organ relative to the size of the patient being transplanted, Human Leukocyte Antigen (HLA)
matching (kidneys only)7. The criteria are set out in different guidelines:
 heart, liver, and pancreas transplantations follow the Transplantation Society of
Australia and New Zealand (TSANZ) Organ Transplantation from Deceased Donors:
Consensus Statement on Eligibility Criteria and Allocation Protocols
 kidney transplantations follow the National Renal Transplant Service National
Kidney Allocation Scheme Protocol
 lung transplantations follow the International Society for Heart and Lung
Transplantation (ISHLT) guidelines.

5
Organs from non-directed living donors (donors who do not donate to a specific person) are also allocated to
patients on the deceased donor list.
6
The Transplantation Society of Australia and New Zealand (TSANZ). 2015. Organ Transplantation from
Deceased Donors – Eligibility Guidelines and Allocation Protocols Vs 1.4. Sydney: TSANZ
7
Where there is a patient who is closely matched to an available deceased donor organ, they receive additional
priority (due to better outcomes). Approximately 30% of deceased donor kidneys are allocated to patients with a
close match. However, this process has recently been questioned by the National Ethics Advisory Committee.

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The decisions for getting on the waiting list or receiving an organ when one is available are
made by the medical specialist.
The National Ethics Advisory Committee (NEAC) has previously identified potential ethical
issues relating to the process for referrals and allocation. NEAC provided a report on the
ethical issues to the Associate Minister of Health in early 2015. The report identified
indicative issues associated with equity of access to transplantation, application of ethical
principles to the processes for listing patients and allocating deceased donor organs, and
number of people waiting for deceased donor kidney transplants.
Currently, NEAC is waiting for the Australian National Health and Medical Research
Council’s (NHMRC) work on Ethical Guidelines for Eligibility Criteria and Allocation Protocols
for Organ Transplantation from Deceased Donors to be finalised. NEAC will then conduct an
assessment of the finalised Australian ethical guidelines, with advice concerning what further
work is needed, including consideration of whether it is possible to endorse the guidelines as
they stand for use in New Zealand.

Transplanting organ(s) and post-transplant care

For kidneys, the transplant operation occurs at the transplant centre where the recipient has
been assessed. All other organs are transplanted in Auckland. Where a recipient doesn’t live
at the location of the transplant centre, their DHB provides pre-transplantation services
(work-up services), and refers them to the transplanting centre for final assessment. Pending
satisfactory outcome of the final assessment, the transplant centre then performs the
surgical procedure itself.

Early post-transplant care is provided by the transplanting centre before the patient is
referred back to their local specialist consultation centre within a few weeks or months
depending on the organ transplanted and the patient’s clinical condition.

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A brief history of organ donation and transplantation in New Zealand

The first organ to be transplanted in New Zealand was the kidney at Auckland Hospital on 28
May 1965. The first heart transplant occurred on 2 December 1987. The 1990s saw the
commencement of lung transplantation in 1993, and liver and pancreas transplantation in
1998.

Key legislative and policy changes in New Zealand

The following table provides a snapshot of the key legislative actions and policies that have
been considered and implemented in New Zealand. Each box highlights the key years and a
summary of what happened.

1964  Human Tissue Act 1964 passed. This was eventually repealed and replaced by the
Human Tissue Act 2008.

1989  Human Tissue Act 1964 amended to allow for the establishment of a database of
potential organ and tissue donors through Land Transport New Zealand (now New
Zealand Transport Agency). At the time people first apply or renew their driver’s
license, they must answer ‘yes’ or ‘no’ to a question asking them to indicate whether
they would be willing to donate organs in the event of their death.

2002  Andrew Tookey presents a petition to the Health Select Committee requesting
Parliament to address the organ donor shortage. The petition called for wide-ranging
initiatives to increase the organ donation rate from deceased people, including
establishing an organ donor register for potential deceased donors.

 Government (Labour) agrees to the recommendations in Tookey’s petition in principle

2004 and agreed to provide additional resources to deceased organ donation by extending
the services of the National Transplant Donor Coordination Office in 2005. However,
the proposal for a donor register was rejected.
 Ministry of Health begins review of the regulatory framework of human tissue and
tissue-based therapies, which previously spanned a number of acts and regulations
including the Human Tissue Act 1964.

2005  The National Transplant Donor Coordination Office is expanded and renamed Organ
Donation New Zealand (ODNZ), with an increase in funding to:
- become the national deceased organ donation agency
- provide additional education, training and advisory activities
- develop nationally consistent processes to ensure that all families of potential
deceased donors are given the option to donate.
 Financial assistance to living organ donors introduced under the Social Security Act
(1964). Living donors can receive support for lost income up to the level of Jobseeker
Support (previously called the Sickness Benefit) and childcare assistance. The payment
is administered by the Ministry of Social Development (MSD) and provided for up to 12
weeks from the surgery date. Accommodation and travel assistance is made available
for live donors through the Ministry of Health’s National Travel Assistance Policy.

2006  National (opposition) MP Jackie Blue introduces Member’s Bill “Human Tissue (Organ
Donation) Amendment Bill” to establish a legally-binding organ donor register, which

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would not allow family members to override the deceased individual’s wishes. This was
initially supported by Government and in Budget 2006 funding was allocated to the
establishment and on-going costs of a national organ donor register pending the
Minister's final allocation decisions. Eventually this funding was made available for
other priority health capital projects.
 Government's Human Tissue Bill is introduced and passes 1st reading.
 National Renal Advisory Board (NRAB), an independent board partially supported by
the Ministry of Health, develops a scoping paper for a National Strategic Plan for Renal
Services.

 Member’s Bill “Human Tissue (Organ Donation) Amendment Bill” by Jackie Blue
2007 considered with Government’s Human Tissue Bill. However, the proposal for a donor
register was rejected on its second reading due to strong opposition in public
submissions. The Ministry of Health’s view was that a register alone was unlikely to
increase donation rates.

2008  The Human Tissue Act 2008 was passed (and replaces Human Tissue Act 1964). It
contains a provision to facilitate the establishment of a donor register if the
Government wishes to do so.

2009  The Auckland Renal Transplant Group establishes a national Kidney Paired Exchange
scheme (now NZ Kidney Exchange), which “matches” pairs of potential recipients and
their live donors who are not a suitable match for each other, with pairs in a similar
position. Each paired exchange results in two transplants and two patients who will no
longer require dialysis. The scheme may also facilitate exchange chains involving more
than two pairs, and/or non-directed donors 8 with a patient from the deceased donor
waiting list.

2010  National MP Michael Woodhouse drafts a Member’s Bill "Financial Assistance for Live
Organ Donors" to increase support to living organ donors to 80% of lost income. This
Bill eventually passed on to National MP Chris Bishop.

2011  National Renal Advisory Board (NRAB) requests a review of the funding model for renal
transplantation and submits a proposal to ensure adequate capacity for the transplant
service. Following this, NRAB submits “Five Point Plan to Increase Live Donor Renal
Transplantation in New Zealand” to the Minister of Health, which includes:
- piloting increased support at transplant units
- implementing proposals to meet 80% of live donor’s lost income as a health
programme
- funding the development of a feasibility study for the development of a national
kidney exchange programme
- funding live renal transplantation as a national service
- make increasing live renal transplantation one of the Government’s health priorities
for the next three years.
In response, the National Health Board (Ministry of Health) establishes a Renal
Transplantation Technical Advisory Group to review services and funding for kidney
transplant services. This lead to the establishment of the National Renal Transplant
Service in 2014 and changes to allow fund transfers of inter-district kidney transplant

8
Non-directed living donors are donors who have volunteered to donate their organ to anyone who
needs it, not a specific person.

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services.

2012  Budget 2012 includes a total of $4 million for three initiatives to increase both live and
deceased donation rates.
1) $2 million funding over four years for Organ Donation New Zealand to increase
deceased donation rates, including:
- further education and training for staff in relation to deceased organ and tissue
donation
- increased feedback to intensive care staff around the auditing process
- enhanced reporting for the death audit.
2) $1.75 million over three years to the “Live Kidney Donation Aotearoa” project at
Counties Manukau District Health Board to help overcome barriers to live donor
kidney transplantations in Pasifika and Māori patients. The project has eight
objectives with a range of initiatives, including:
- education resources and programmes for patients, their families, and health-
care providers
- community engagement activities
- a peer support programme.
3) $250K to formalise the kidney exchange programme at Auckland District Health
Board.
 The Minister of Health releases a notice in the New Zealand Gazette to allow the kidney
exchange programme and its participants to be exempt from sections 56, 58, 59 and 61
of the Human Tissue Act to ensure that the exchange of kidneys in the context of the
programme is legal.

2013  National Ethics Advisory Committee (NEAC) begins work looking at ethical issues
associated with access to organ transplantation (involving organs from both living and
deceased donors), including:
- the processes for referrals
- being placed on the deceased donor waiting list
- deciding who receives an organ when one becomes available.
NEAC will do further work after the Australian National Health and Medical Research
Council’s releases their ethical guidelines in early 2016.
2014  Budget 2014 includes $4 million funding over four years for three initiatives to increase
living organ transplantation.
1) Establishment of a National Renal Transplant Service. The purpose of the service is
to implement the National Plan for Renal Transplant Services 9, which aims to:
- improve access to live renal transplantation for patients with end-stage renal
disease
- increase live donations by 10 each year over a four-year period
- improve the quality, consistency, and timeliness of the donor and patient
pathways.
A new National Renal Transplant Leadership Team was established to support the
service, comprising of a strategy group to provide strategic guidance and review the
performance of the service, and an operational group to develop and implement

9
The National Plan for Renal Transplant Services were developed by a technical advisory group
supported by the Ministry of Health.

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the work programme. The Ministry of Health funds the Clinical Director of the
National Renal Transplant Service (1 day/week), as well as a business analyst and
secretariat to support the services.
2) More donor liaison coordinators in 11 District Health Boards (three renal transplant
centres and eight renal service providers). Donor liaison coordinators provide
support for both existing and new renal patients who are eligible for
transplantation, with a primary focus on increasing the number of people who
would be willing to become living donors. This includes education to potential
donors as well as support for timely assessments as dictated by the needs of the
DHB’s Renal Service.
3) Continuation of the NZ Kidney Exchange programme (NZKX), including the
formation of a kidney exchange coordinator role. There have been 6 exchanges to
date, all of which have included a non-directed donor. NZKX is now part of the
National Renal Transplant Service.
 Ministry of Health agrees for the New Zealand Kidney Exchange (NZKX) programme to
propose collaborating with the equivalent Australian Kidney Exchange (AKX)
programme, to increase the number of matched pairs suitable for exchanging kidneys.
Discussions are currently underway.
 ODNZ launches smartphone application with the necessary resources for health
professionals in organ and tissue donation, including ODNZ Best Practice Guidelines
and other resources for intensive care units (such as how to approach families about
discussing donation).

2015  Minister of Health requests advice on how to increase organ donation and
transplantation rates in New Zealand. The Ministry of Health is leading a review of
organ donation and transplantation, primarily focused on deceased organ donation
rates due to the number of initiatives already underway to improve live donation that
require time to embed and be evaluated. Initial advice is due to the Minister in March
2016.
 On 25 June, Chris Bishop’s private Member's Bill “Financial Assistance to Live Organ
Donors” is introduced to Parliament. The Bill has passed its first reading and is
currently under consideration by the Health Committee. The Ministry of Health is
providing advice to the Health Committee in evaluating the Bill.

The Human Tissue Act 2008

The Human Tissue Act 2008 regulates the collection and use of tissue, primarily from dead
human bodies, and sets up a framework requiring informed consent for human tissue
collection and use.

Although the collection and use of tissue from living people is covered by the Code of Health
and Disability Services Consumers’ Rights and common law, the Human Tissue Act requires
informed consent from living people to:

 analyse information about a condition of a person outside of a health care procedure

 use tissue collected from a living person for a secondary purpose, after the donor’s
death (ie, for a purpose other than one that the donor consented to while alive).

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The Human Tissue Act (the Act) also regulates trading, importing and exporting tissue,
advertising tissue, and the use of tissue for non-therapeutic purposes.

Consenting or objecting to the collection and use of human tissue

For the purposes of this report, informed consent is interpreted as agreement, and informed
objection as disagreement to, as the Act states, “the collection or use of human tissue […]
given by a person who is entitled to give it […] and given freely in the light of all information
that a reasonable person […] needed in order to give informed consent” (s9).

A definition for what is required to make an informed decision is not provided in the Act.
However, the Act makes informed consent the fundamental principle underpinning the lawful
collection and use of human tissue from deceased people. The Act specifies who may give
consent and raise an objection for the collection and use of human tissue, and creates
penalties for collecting and using tissue without informed consent (s22).

The consent framework gives primary consent or objection to the deceased, where this has
been given while the individual was alive, or from someone nominated by the deceased who
can decide on their behalf. A nomination must be made with the nominee’s written consent
and can be ended at any time by the nominee giving written notice to the individual.

In the absence of consent or objection by the individual, or their nominee, the decision is
made by the immediate family by reaching general agreement. If the immediate family is
unable to reach a decision, the Act allows for a decision to be made by the next close
available relative. Figure 1 provides an overview of the hierarchy for consent or objection for
using or collecting human tissue from a deceased person.

Figure 1: Consent framework for using or collecting human tissue from a deceased
person

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Did individual before death

give informed consent or
raise an informed
Object objection? (s31) Consent

No

Did nominee(s) give

informed consent or raise
an informed objection?
Object (s31, 35, and 39) Consent

No

Did immediate family give

informed consent or raise
an informed objection?
Object (s31, 36, and 40) Consent

No

Did a close available relative

give informed consent that
is not overridden by an
overriding objection? (ss 10,
No Yes
31, and 41)

Use is prohibited (ss Decide whether to proceed

19(1)(a) and 22) with use (ss 16 and 17)

Immediate family is defined in the Act as a person who has one or more of the following
relationships with the deceased individual:

 a spouse, civil union partner, or de facto partner of the individual

 child, parent, guardian, grandparent, brother, or sister of the individual
 stepchild, step-parent, stepbrother, or stepsister of the individual.

A close available relative is defined in the Act as someone older than 16 years of age who:

 was a spouse, civil union partner, or de facto partner of the individual immediately
before their death
 or a son or daughter, if the above is not available
 or a parent or guardian, if neither of the above is available
 or a brother or sister, if none of the above are available.

Both informed consent and informed objection have legal standing and prevent lower-ranked
decision-makers in the hierarchy from consenting or objecting. However, a close available
relative may raise an overriding objection where another close available relative has given
informed consent. Overriding objection is a disagreement to any kind of collection or use of
human tissue after a close available relative has given consent. The disagreement is given
priority and seen as overriding the consent primarily given.

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Any informed consent, informed objection, or overriding objection must be in writing or given
verbally in the presence of two or more witnesses. The Act requires decision-makers and the
person collecting or using human tissue to take into account the cultural and spiritual needs,
values and beliefs of the immediate family of the individual whose tissue is collected.

In practice, potential donors are unlikely to have met the legal requirements for consenting or
objecting to the use or collection of their organ(s). If a person has made a decision in their
will, this is seldom accessible in the ICU. Families are always asked to make the decision,
and are expected to agree by general consensus.

The Act allows for a number of reasons why donation should not proceed. For example, the
individual’s organs/tissues may be unsuitable for donation, or the family are unable to make
a decision. If the family cannot agree, the Act allows for collection and use of tissue not to
proceed in these circumstances (s17).

Registering as a donor
The Act does not establish an organ and tissue donor register for potential deceased donors
but does include a clause that permits the establishment of a register by regulation at a later
date (s78). An opt-in register is a register where only people willing to donate are listed, as
opposed to an opt-out register where only people unwilling to donate are listed. Some
registers are combined opt-in and opt-out, and some registers include a question about
whether the family should be asked to make the decision.

When applying for a driver license in New Zealand, people are asked to indicate whether
they would be willing to donate organs in the event of their death. The information is stored
electronically by the New Zealand Transport Agency on the driver license database. People
can request that the database be updated if they change their minds before renewing their
license every ten years.

Although individuals can indicate their willingness to donate in the event of their death, this
does not constitute as informed or binding consent to be a donor. It does not meet the
requirements for consent in the Act. There is a common public misperception in relation to
the donor status on the driver license register – many people think that the register records
consent when in fact it is only an indication of intent.

The driver’s license can provide guidance for families about the patient’s views towards
organ donation. However, driver license information is not routinely accessed when
discussing donation with the family of a potential donor. The information can be accessed by
ODNZ staff through the police, if the family requests it.

Over 1 million people in New Zealand have indicated their wish to donate organs on their
driver’s license. In 2013, 3% (one) of New Zealand organ donors had indicated their
intention to be an organ donor on their driver license10.

10
Australia and New Zealand Organ Donation (ANZOD) Registry. 2014. The 2014 ANZOD annual
report. Adelaide: ANZOD.

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Selling, trading and advertising tissue

The Act regulates any trading, importing, and exporting of human tissue, by prohibiting the
exchange of organs for financial or other consideration (s56, 58, and 59). The current
Government policy of providing income support for live organ donors is consistent with this
provision, as the Act permits reimbursement of actual and reasonable costs incurred in
donation.

The Act also prohibits any advertising relating to the purchase or sale in New Zealand of
human tissue. There are exceptions to these regulations referring to research, wigs from
living people’s hair, and human tissue that is or is part of a controlled drug or medicine (s61).

In October 2012, the Minister of Health released a notice in the New Zealand Gazette to
exempt the kidney exchange programme and its participants from sections 56, 58, 59 and 61
of the Human Tissue Act. The notice was made with respect only to the donation and receipt
of human kidneys, which ensured the programme was legal.

Using human tissue for non-therapeutic purposes

The Act provides regulations for the use of human tissue for non-therapeutic purposes,
including audit, anatomical examination, research and post mortem. The Ministry of Health
has guidelines for the use of human tissue for future unspecified research purposes11.

The Act contains a range of penalties for any offences, such as the above, that vary
according to the seriousness of the offence. The proposed penalties for the most serious
offences are up to 1 year in prison or a fine of $50,000.

Ministry of Health. 2007. Guidelines for the Use of Human Tissue for Future Unspecified Research
11

Purposes. Wellington: Ministry of Health.

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The services and organisations involved and their responsibilities

Auckland Renal Transplant Group (includes pancreases)

The name Auckland Renal Transplant Group refers to a group of clinicians at Auckland City
Hospital who provide renal (and pancreas) services to patients at Auckland District Health
Board.

Australasian Donor Awareness Programme (ADAPT)

ADAPT was established in 1994 to provide training and education for health professionals
who are involved in the care and management of dying patients, and their families, including
those patients who may become potential organ and tissue donors. ADAPT in New Zealand
is currently provided by Organ Donation New Zealand, and entails one-day workshops once
or twice a year for intensive care staff on how to manage clinical situations involving death,
understanding grief and bereavement, and caring for the family of the deceased patient.

The ADAPT programme in Australia is currently being revised and replaced under the Organ
and Tissue Authority’s (OTA) Professional Education Package by the end of 2015. The
College of Intensive Care Medicine have suggested that New Zealand adopt this new
programme and facilitated OTA to present the core Family Donation Conversation unit in
Auckland, New Zealand in early November 2015. New Zealand clinicians are evaluating the
content of the workshop to consider whether it is suitable for replacing the ADAPT workshop
for the New Zealand context.

Australasian Transplant Coordinators Association (ATCA)

In the mid-1980s transplant and donor coordinators established the Australasian Transplant
Coordinators Association (ATCA). ATCA is a representative organisation for health
professionals directly involved in organ donation. It publishes national standards for
transplant coordinators (also called recipient coordinators) and national guidelines for
intensive care units in conjunction with TSANZ (see below).

Australian and New Zealand Dialysis and Transplant Registry (ANZDATA) and
Australia and New Zealand Organ Donation Registry (ANZOD)
ANZDATA records the incidence, prevalence and outcome of dialysis and transplant
treatment for patients with end-stage renal failure. ANZDATA is located at The Royal
Adelaide Hospital, South Australia. The registry is a project responsible jointly to the
Australian and New Zealand Society of Nephrology (see below) and to Kidney Health
Australia.

ANZOD is a collaborative effort of ATCA (see above) and ANZDATA and collects and
records data on all organ donors after death. This information is provided by donor hospitals
and some Organ Donation Agencies. While the provision of this data is voluntary, the
Registry believes that coverage is close to 100 percent.

Both ANZDATA and ANZOD are funded by the Ministry of Health, the Australian
Government Department of Health, and Kidney Health Australia.

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Australia and New Zealand Society of Nephrology (ANZSN)

ANZSN is the professional association for nephrologists with a special interest in renal
diseases. The Society aims to promote and support research in kidney health and disease,
and to ensure the highest professional standards for the practice of nephrology in New
Zealand and Australia. ANZSN also jointly established and operates the Australian and New
Zealand Dialysis and Transplant Registry (ANZDATA) with Kidney Health Australia. ANZSN
has created national evidence-based guidelines for practice within many areas of renal
disease, including renal transplantation.

The Australian and New Zealand Intensive Care Society (ANZICS)

ANZICS is the peak professional and advocacy body for medical practitioners specialising in
the treatment and management of critically ill patients in public and private hospitals.
ANZICS supports all aspects of intensive care medical practice through ongoing professional
education, the provision of leadership in medical settings, clinical research and analysis of
critical care resources, including the development of the ANZICS statement on brain death
and organ donation.

Australian and New Zealand Liver Transplant Registry (ANZLTR)

ANZLTR is a collaborative effort of the liver transplant units in New Zealand and Australia
and is coordinated through the Princess Alexandra Hospitals in Brisbane, Queensland.
ANZLTR aims to collect, collate and report data relating to activity of outcomes of liver
transplantation in the region. Data on all patients listed for liver transplantation and their
subsequent outcomes is supplied by all the participating units. The coordinating centre is
responsible for all monitoring of data quality and the preparation and publication of the
ANZLTR annual report.

ANZLTR is partially funded by the Australian Government Department of Health and is also
sponsored by Novartis and Janssen-Cilag.

The College of Intensive Care Medicine (CICM)

CICM is the body responsible for intensive care medicine specialist training and education in
Australia and New Zealand. The College offers a minimum six year training program, in both
general and paediatric intensive care, with a number of assessments, culminating in
Fellowship of the College of Intensive Care Medicine (FCICM). The College has over 900
Fellows throughout the world. The main office is located in Melbourne, with regional
committees throughout Australia, and national committees in New Zealand and Hong Kong.

District Health Boards (DHBs)

DHBs are funded by the Ministry of Health and are responsible for the funding and provision
of intensive care, transplantation and renal services.

GiveLife.org
GiveLife.org is an initiative led by Andy Tookey which aims to generate awareness of New
Zealand’s organ donor shortage and campaign for changes to increase deceased organ
donations. The website states that the initiative is “not a charity asking for money […] all we
are asking you is to consider giving 'The Gift of Life'”.

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Kidney Health NZ (KHNZ)

KHNZ is a non-profit organisation, which relies on public contributions for support. KHNZ
promotes live kidney donation for transplantation and provides information and education
services relating to renal disease. It also funds research on kidney disease.

Kidney Kids NZ
Kidney Kids NZ is a parent driven non-for-profit organisation founded in 1990 to provide
emotional support and to help parents of children with kidney disorders. They assist parents
to obtain the best services possible for their kids. Their services include support group
meetings, coffee mornings, educational evenings, and special events.  They also hold two
annual camps each year for kidney kids who are at, or near, end stage renal failure (ESRF)
and kidney kids who are experiencing social distress. 

Live Kidney Donation Aotearoa (LKDA)

A provider in Counties Manukau DHB, Clinical Research and Effective Practice (now
Middlemore Clinical Trials) received funding in Budget 2012 over three years to deliver the
programme Live Kidney Donation Aotearoa (LDKA).

LKDA’s main roles are to inform, promote and facilitate in the area of live kidney donation in
New Zealand so that donors, recipients and health practitioners can make the best choices.

LKDA is coordinated by kidney health practitioners and scientists with strong links to
community and other stakeholders in the field of kidney disease. LDKA works directly with
patients and their whānau, community groups, health practitioners (including GPs) and
Counties Manukau DHB.

National Ethics Advisory Committee (NEAC)

NEAC is a committee set up under New Zealand legislation to advise the Minister of Health
on ethical issues in health services and research, and determine national ethical standards
for the health sector.

NEAC acts as an independent advisor to the Minister of Health. The Ministry of Health
provides policy staff and other resources to support NEAC but the Committee remains
independent of the Ministry and its work.

National Pancreas Transplant Registry (NPTR)

NPTR collects data on all Australian and New Zealand recipients of pancreas and islets
transplants. The Registry monitors the progress of pancreas transplantation activity and
provides a tool to analyse the causes for success and failures. NPTR is based in Sydney,
New South Wales and collects data from the two pancreas transplant units in Australia and
the one in Auckland in New Zealand.

NPTR is funded by the Australian Government Department of Health.

National Renal Advisory Board (NRAB)

NRAB is an independent board, working in partnership and partially funded by the Ministry of
Health to support the provision of renal services to patients. They provide expert advice on

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all aspects of renal services, including identified priorities, renal care standards, and
monitoring and auditing of activities.

NRAB reports to renal departments, District Health Boards and the Ministry of Health.
Representatives on NRAB are key stakeholders, clinical and managerial leaders, and
consumer groups, including the New Zealand Nephrology Group, the Renal Society of
Australasia (New Zealand branch), the New Zealand Board of Dialysis Practice and Kidney
Health New Zealand.

NRAB has of one subcommittee ‘Audit and Standards’. The Renal Society of Australasia
Nursing Advisory Group and the New Zealand Board of Dialysis Practice (NZBDP) also
report to NRAB (see details below).

National Renal Transplant Leadership Team (NRTLT)

In 2014, a new NRTLT was established to support the National Renal Transplant Service, comprising
of:
 a strategy group to provide strategic guidance and review the performance of the service
 an operational group to develop and implement the work programme.
The Ministry of Health funds the Clinical Director of the National Renal Transplant Service, as well
as a business analyst and secretariat to support the services. NRTLT’s role is to provide strategic
direction and drive the implementation of the National Plan for Renal Transplantation.
Their purpose is to provide expert advice to the Ministry of Health on:
 specific areas relating to renal transplantation
 improve clinical outcomes for patients with end-stage renal disease where this is
linked to transplantation
 consider services / initiatives for prioritisation, as part of a strategic planning and
prioritisation process, that link to the longer term view of national renal
transplantation services.

New Zealand Blood Service (NZBS)

NZBS is the Crown agent that ensures the supply of safe blood products. NZBS takes
responsibility for the development of an integrated national blood transfusion process, from
the collection of blood from volunteer donors to provision of blood products within the
hospital environment.

NZBS helps the organ donation process by managing the national waiting lists for organs.
NZBS also facilitates transplantations by carrying out the blood tests, tissue typing tests and
cross-matching tests to ensure potential donor and recipient organ(s) are compatible.

New Zealand Board of Dialysis Practice (NZBDP)

NZBDP is a professional society that sets goals and standards related to certification of
clinical physiologists (Dialysis). NZBDP supports and maintains the education programme
for quality patient care dialysis specialty.

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New Zealand National Eye Bank

New Zealand National Eye Bank is a non-profit organisation dedicated to the prevention of
blindness by the provision of donated corneal and other tissues.

New Zealand Kidney Exchange programme (NZKX)

NZKX is a project that ‘matches’ pairs of potential kidney recipients and their live donors,
who are not a suitable match for each other, with pairs in a similar position. The Ministry of
Health funds NZKX, and Auckland District Health Board is responsible for the planning,
coordination and overall provision of the NZKX services, which fall under the National Renal
Transplant Services.

New Zealand Transport Agency (NZTA)

NZTA is a crown entity governed by a statutory board. NZTA administers the Driver
Licensing Register, which asks people to indicate whether or not they would like to be a
donor.

Organ and Tissue Authority (OTA)

OTA was established in 2009 and operates under the Australian Organ and Tissue Donation
and Transplantation Authority Act 2008, as part of the Australian Government's national
reform programme. The OTA is an independent statutory agency within the Australian
Government Health portfolio.

The Organ and Tissue Authority (OTA) works with Australian states and territories, clinicians
and the community sector to deliver the Australian Government’s national reform programme
to improve organ and tissue donation and transplantation outcomes in Australia.

Organ Donation NZ (ODNZ)

ODNZ is a national service that reports to the Ministry of Health, and is hosted by Auckland
DHB on behalf of all DHBs, to coordinate organ donation and some tissue donation from
deceased donors in intensive care units. ODNZ also refers livers and cardiothoracic organs
to and from Australia. ODNZ is contracted to carry out the following:

 educating and training health professionals involved in organ and tissue donation
 providing information and ongoing support for families who have donated
 providing information to the public and advice to health professionals about organ
and tissue donation in New Zealand
 auditing organ donation practices in New Zealand
 working with health professionals to ensure nationally consistent processes
 assisting the Kidney Exchange programme (by packing and transporting kidneys).
ODNZ has an Advisory Group, which provides guidance and oversight of ODNZ. Advisory
Committee members include representatives from intensive care medicine and nursing,
transplantation, Māori/Pacific health, consumers.

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Funding for ODNZ is received through DHB top slice funding. The additional funding
received in Budget 2012 is through a direct contract between the Ministry of Health and
Auckland DHB.

The Renal Society of Australasia Nursing Advisory Group (RSA NAG)

RSA is the professional body for nephrology nurses within Australia and New Zealand. The
purpose of the RSA is to share knowledge in renal replacement therapies throughout New
Zealand and Australia.

The branch’s Nursing Advisory Group in New Zealand provides leadership and a primary
focus on the establishment of national standards of practice and a professional development
model for nephrology nursing in New Zealand.

Transplantation Society of Australia and New Zealand (TSANZ)

TSANZ is the professional academic association of physicians, surgeons and scientists
interested in all forms of transplantation. TSANZ was formed in the 1970s to undertake
education, promotion of scientific understanding and determining protocols and procedures
for managing transplant organ quality and allocation.

Members of TSANZ include scientists, doctors, recipient coordinators and research

students. TSANZ has a standing committee responsible for each area of organ
transplantation (heart/lung, kidney, liver, pancreas and cornea), including the national
allocation guidelines.

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