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Summary of international examples of
organ donation reform programmes
Contents
Purpose ...................................................................................................................... 2
Executive Summary ................................................................................................... 2
Implications for New Zealand’s review ....................................................................... 7
Key elements of successful reform in leading countries – Spain, Croatia, and
Portugal ...................................................................................................................... 9
Key lessons ............................................................................................................ 9
Key elements of reform........................................................................................... 9
More recent reform – Australia, the United Kingdom, and the European Union ....... 13
Australia................................................................................................................ 14
National Organ Donation Collaborative (NODC) ............................................... 14
National Clinical Taskforce on Organ Donation and Tissue Donation Taskforce
.......................................................................................................................... 14
National Reform Package ................................................................................. 17
Results .............................................................................................................. 19
United Kingdom (UK) ............................................................................................... 20
Organ Donation Taskforce Recommendations (First report) ............................. 20
Consideration of an opt-out system (Second report) ......................................... 25
Implementation of the Taskforce’s recommendations ....................................... 25
Wales specific action – Introduction of a “soft” opt-out system ......................... 27
Results .............................................................................................................. 27
European Union ....................................................................................................... 28
Directive on standards of quality and safety of human organs intended for
transplantation................................................................................................... 28
The Action Plan on Organ Donation and Transplantation (2009-2015)............. 29
Appendix A: Full list of the Australian taskforce’s recommended actions ................. 30
Appendix B: Full list of Actions in the European Union’s ‘Action Plan on Organ
Donation and Transplantation (2009-2015)’ ............................................................. 35
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Purpose
This paper summarises the main organ donation reform programmes successfully
undertaken by other countries in order to provide guidance on the types of issues and
actions New Zealand should consider to increase its deceased donation rates.
Executive Summary
The countries with the highest performing organ donation systems (Spain, Croatia, and
Portugal) initiated reform programmes 15-25 years ago. The key elements of these reform
models (as identified by the Australian Organ and Tissue Authority) were:
a.
an appropriate legal and ethical framework
b.
a national coordinating body
c.
hospital-based clinical donation specialists
d.
specialist training for clinical staff in management of deceased donation process and
family donation conversations
e.
implementation of a clinical governance framework that supports quality assurance and
audit of hospital clinical practice and governance of donation process
f.
financial support to donor hospitals to ensure that costs related to management are not
a barrier to donation
g.
media engagement and national community awareness and education
h.
international cooperation to share best practice.
More recently, Australia and the United Kingdom have implemented successful reforms
based on the key elements outlined above, contextualised to suit their health care systems
and social, ethical, economic and ethical environments. The reform undertaken by these
countries can provide guidance for New Zealand, as Australia and the United Kingdom were
in similar positions to New Zealand before their reform. The Australian experience is
particularly relevant given it has many similarities with New Zealand.
Both Australia’s and United Kingdom’s reform included the establishment of a national
coordinating body to lead, promote, and manage the organ donation system. The Organ and
Tissue Authority was established in Australia and the role of the NHS Blood and Transplant
was expanded in the United Kingdom. Both countries increased their network of donation
specialists and clinical training, improved their quality assurance, changed their funding
arrangements, and increased their professional and public awareness and education
activities.
Neither country made any changes to its consent system, with the United Kingdom
specifically considering and rejecting moving to an opt-out system at that time. Five of the
eight jurisdictions in Australia (Victoria, New South Wales, Western Australia, Queensland
and Tasmania) have previously undertaken reviews into alternative consent models. They
have all retained an opt-in model and decided against adopting a presumed consent opt-out
model or a first person consent model (where the donor’s decision is binding).
Following reform, Australia increased its deceased donor rate per million of population (pmp)
from 11.4 in 2009 to 16.1 in 2014 (a 41% increase) and the United Kingdom increased its
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rate from 15.0 to 20.4 (a 36% increase) (refer figure 1). Both countries reported a slight
decrease in their donation rates between 2013 and 2014.
Figure 1: Deceased donation rates (pmp) for New Zealand compared to
Australia and the United Kingdom
25
Pre reform
Post reform
20
15
New Zealand
10
Australia
5
United Kingdon
0
Year
Source: International Registry in Organ Donation and Transplantation
While the United Kingdom decided not to change its consent legislation, the Welsh
Government decided to introduce a “soft” opt-out system for organ donation in 2013 that will
come into effect 1 December 2015. Under a “soft” opt-out system, consent is deemed unless
the person has, while alive, registered his/her wish not to become an organ donor after
death. However, the next of kin will in practice always be consulted and donation will not
proceed if the next of kin objects. Ireland is also considering a similar change. As these
changes have not come into force there is no evidence on the impact on donation rates at
this time.
At the same time as Australia and the United Kingdom were undertaking their reviews, the
European Union was also focused on the issue of how to raise donation and transplantation
rates in its Member States. In December 2008, the European Commission adopted a
proposal for:
1.
a Directive defining quality and safety requirements for human organs intended for
transplantation
2.
an action plan for improving co-operation between Member States in this field.
The Action Plan on Organ Donation outlines the priority actions that the European Union
considers its member states should focus on to improve organ donation and transplantation.
These are consistent with the key elements of reform outlined above. In particular, in order
to increase organ availability the Action Plan recommends member states: promote
transplant donor coordinators, promote quality improvements programmes, and improve the
knowledge and communication skills of health professionals and patients support groups on
organ transplantation.
Refer to Table 1 for a summary of the actions undertaken by these countries grouped
against the eight key elements of reform identified above. Figure 2 demonstrates the
comparative performance of these countries in terms of their donation rate per million of
population in 2014.
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Table 1: Summary of the key elements of reform
Key elements of
reform
An appropriate legal and
ethical framework
Spain
Croatia
Portugal
Australia
United Kingdom
Spain introduced organ
donor legislation in 1979,
which established presumed
consent
Croatia implement a
presumed consent system
in 1988 and a new
Transplant Act in 2013
Portugal introduced
transplant legislation
in 1993 and revised it
in 2007
Guidance on non-heartbeating donation was
published for each country
and an UK Donation Ethics
Committee was established
in 2010
A national coordinating body
A national coordinating body
was established in 1989
A national
coordinating body
was introduced in
2007 and amended
in 2012
Hospital-based clinical
donation specialists
Dedicated clinical staff were
introduced in 1995
A National Transplant
Coordinator was appointed
in 2001 and the Ministry of
Health employs staff
responsible for manage
reform initiatives and a
coordination office
Hospital based teams of
Transplant Coordinators
were initially established
from 1998-2000
The Australian system of organ
donation is based on an informed
consent (‘opt in’) model. Individuals
have the option to record intent to
donate their organs after death on
the Australian Organ Donor
Register. Transplantation
guidelines for ethical practice for
health professionals were
developed by the National Health
and Medical Research Council
(NHMRC) in 2007
A national coordinating body was
officially established in 2009 and is
responsible for implementing the
reform programme
Hospital Donor
Coordinators were
appointed in 2007
and 2008.
A network of donation specialists –
the DonateLife Network - was
established across Australia
Specialist training for clinical
staff in management of
deceased donation process
and family donation
conversations
Training on organ donation
was first made available in
1991 and is mandatory for
all doctors specialising in
intensive care
Professional training to
clinicians was first made
available in 2003 and
remains an ongoing priority
Professional training
was first made
available in 2008 and
all staff employed as
Hospital Donor
Coordinator receive
specific training
Specialist training for clinical staff
in management of the deceased
donation process and family
donation conversations are
available as part of the
Professional Education Package
Clinical leads for organ
donation were appointed
and the Specialist Nurse for
Organ Donating network
was reconfigured and
expected to increase by
146% (as at 2011)
The taskforce
recommended all clinical
staff likely to be involved in
the treatment of potential
organ donors receive
mandatory training in the
principle of donation
The role of the NHS Blood
and Transplant was
expanded to be the organ
donation organisation for
the whole of the United
Kingdom
European Union (EU)
The EU issued a directive
requiring member states to
identity a Competent
Authority with responsible to
ensure compliance with
various quality and safety
requirements
The action plan included an
action to promote transplant
donor coordinators
The action plan included an
action to improve the
knowledge and
communication skill of
health professionals and
patient support groups on
organ transplantation
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Table 1 Continued: Summary of the key elements of reform
Key elements of
reform
Implementation of a clinical
governance framework that
supports quality assurance
and audit of hospital clinical
practice and governance of
donation process
Spain
Croatia
Portugal
Australia
United Kingdom
European Union
Quality assurance
programme is based on a
continuous clinical chart
review of all deaths
occurring in critical care
units. It includes both an
internal and external audit
Hospital audits were
initially commenced in
2002 and have been
gradually refined into a
clinical practice
improvement programme
and quality assurance
process by 2010
As of 2013, Portugal
was planning its
method for
conducting hospital
audits
Data on donation activity
is issued to the national
body every six months
and used to monitor
performance
The EU issued a Directive
requiring member states to
establish and maintain a
framework for quality and
safety. The action plan
included an action to promote
quality improvement
programmes
Financial support to donor
hospitals to ensure that
costs related to
management are not a
barrier to donation
A specific budget is
allocated to fund the
donation management at
every hospital
In 2006 a funding model
was introduced to ensure
hospitals are funded for all
additional costs associated
with organ and tissue
donation
Financial support for
organ donation
activity was
introduced in 2006
and revised in 2011
Reporting and auditing of organ and
tissue donation practice has been
enhanced and embedded across
hospitals in the DonateLife
Network. In March 2012, the
DonateLife leadership the Clinical
Governance Framework (CGF) and
Clinical Practice Improvement
Program (CPIP) was established to
support and guide DonateLife
Network (DLN) staff in achieving
the national objective of increasing
organ and tissue donation rates
across Australia
Organ Donation Hospital Support
Funding (ODHSF) provides a
contribution towards the costs
associated with organ donation
activity
Media engagement and
national community
awareness and education
The national coordinating
body utilises media to
promote organ donation
through the dissemination
of positive news
Coordinated public
awareness campaigns
have been progressively
introduced since 1998
Since 2009, the
national body has
organised joint
community events
and has worked with
the media on general
awareness
International cooperation to
share best practice
Joined the Eurotransplant
in 2007
National community awareness and
education campaigns were
implemented, including
engagement with culturally and
linguistically diverse communities
Australia has based its reform on
international best practice through
engagement with high performing
countries
An analysis of the costs
involved in the
management of potential
organ donation was
undertaken and
additional funding
provided to cover these
costs
A high-prolife, multimedia campaign to
promote organ donation
was launched in 2009,
followed by targeted
campaigns in early
2010.
The action plan included an
action to improve the
knowledge and
communication skill of health
professionals and patient
support groups on organ
transplantation
The action plan included an
action to facilitate the
identification of organ donors
across Europe and crossborder donation
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Figure 2: Worldwide Actual Deceased Organ Donors 2014 (pmp)
0
5
10
15
20
25
30
35
40
Spain
Croatia
Malta
Portugal
USA
Belgium
Austria
Italy
Slovenia
Norway
Finland
Uruguay
UK
Hungary
Belarus
Sweden
Australia
Poland
Latvia
Netherlands
Estonia
Brazil
Switzerland
Denmark
Ireland
Argentina
Romania
Germany
Lithuania
New Zealand
Iceland
South Korea
Iran
Kuwait
Israel
Colombia
Lexembourg
Cyprus
Bulgaria
Hong Kong
Turkey
Costa Rica
Trinidad & Tob.
Saudi Arabia
Russia
Dom. Rep.
Japan
Canada
Chile
Czech Rep.
Eduador
France
Greece
Lebanon
Malaysia
Mexico
Panama
Paraguay
Peru
Slovak Rep
Tunisia
Venezuela
Note: some countries have not yet submitted their data for 2014
Source: International Registry in Organ Donation and Transplantation
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Implications for New Zealand’s review
1.
The main area countries focused on to successfully increase their organ donation and
transplantation rates is the practices in clinical settings that occur when a potential
donation opportunity occurs. These countries have focused on the full range of levers
available to influence practices in clinical settings, including: national leadership,
workforce capability and capacity, training and funding approaches. This suggests that
New Zealand’s current review needs to focus specifically on the practices in clinical
settings and the levers that influence these.
2.
Successful reform programmes have also included a focus on improving public
awareness and understanding of organ donation and transplantation, but to a lesser
degree than they have focused on practices in clinical settings. The approach to
improving public awareness and understanding varies. Some countries (in particular,
Spain) have focused on working with the media to ensure organ donation and
transplantation is reported appropriately and positively. While other countries (eg, the
United Kingdom and Australia) have focused on public awareness campaigns. This
suggests that package of options recommended by the New Zealand review should
include an option or options focused on improving public awareness and understanding.
Further analysis of available evidence is required to identify and assess potential
options.
3.
While countries with the highest deceased donation rates have opt-out consent system,
analysis and comment from experts (particularly in Spain) suggest this is not the main
driver of their high donation rates. Following their 2008 review, both Australia and the
United Kingdom managed to increase their donation rates without changing their
consent system. While international experience does not suggest this is an area the
New Zealand review should focus on, changing the consent systems is often proposed
by stakeholders and the media as an option for improving deceased donation rates. It
would be advisable to review the evidence base relating to consent systems in more
depth, particularly given the Welsh Government’s recent decision to change its consent
system.
4.
The reviews conducted by Australia and the United Kingdom do not provide any
guidance on the potential impact of introducing an organ donation register as both
countries already had a register in place when they completed their review. As a result
their reviews, and subsequent reform, focused on how to increase the number of people
on the registers and did not include any consideration of the cost effectiveness of
establishing a register. The OTA’s analysis of the international approaches to reform did
not include registers as a key element of successful reform. The Australian Taskforce’s
review did include concerns about its system where a willingness to donate is included
on drivers’ licenses (which also occurs in New Zealand). It found a higher proportion of
objections to donate recorded on Australian driver’s licenses and considered this was
due to the lack of information available, and/or time to consider the issue, when
completing the drivers’ licensing process. They recommended against avenues for
registration that require an instantaneous decision in isolation from information about
donation. To reduce objections in the current system, they recommended another option
of ‘undecided at this time / leave decision to family member’. Given the limited guidance
provided by the reviews of Australian and United Kingdom, and the focus this topic
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receives from stakeholders and the media, it would be advisable to review the evidence
base relating to registers in more depth. Based on the concerns raised by Australia, this
analysis should include an assessment of how well the current system where people
can register an ‘intention to donate’ on their drivers’ license is working.
5.
The reform undertaken by other countries has not included the use of incentives to
encourage donation (for example, providing funding towards funeral costs or giving
priority to people registered to be a donor if they require an organ). However, as this
option is often raised by stakeholders it would be sensible for New Zealand’s review to
identify which countries have introduced incentive schemes and whether there is any
evidence of their effectiveness.
6.
In their reviews, both Australia and the United Kingdom expressed concerns about low
donation rates among non-European populations and recommended targeted
promotional and education activities be developed for these populations. The
New Zealand review will need to assess whether this issue is also occurring in
New Zealand and if so, which actions would be appropriate to help address it.
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Key elements of successful reform in leading countries – Spain,
Croatia, and Portugal
Spain, Croatia and Portugal are three of the leading countries for organ and tissue donation.
In 2014, Spain had the highest deceased donation rate per million population (36.0),
Croatian the second highest (35.0) and Portugal the fourth highest (27.7)1. All three
countries previously had much lower rates and have successfully increased their donation
rates following reform. Portugal’s reform (which began in 2008) is more recent compared to
Spain (which began in 1991) and Croatia (which began in 2001)2.
Key lessons
The Australian Organ and Tissue Authority analysed the reform undertaken by these three
countries and identified the following key lessons3:
1.
foundation effort prior to the national reform model
All three countries had an established network of donation specialists for some years
before a concerted effort was made to change clinical practice across intensive care
units (ICUs), critical care, and hospital governance.
2.
a methodical and sustained approach to clinical practice
The three countries all demonstrated a sustained increase in donation outcomes over a
number of years, due to the cumulative impact of organisational reform and professional
training to change end of life care and donation practice at the hospital level. The OTA
concluded that a central role was played by the national coordinating authority to drive
consistency of practice and address variation in practice. The national coordinating
bodies in these countries have stated a coherent suit of measures was required to
achieve a sustained increase.
3.
growth is progressive and cumulative
While the change is revolutionary, the growth is progressive.
Key elements of reform
Working with the relevant national authority or ministry in Spain, Croatia and Portugal, the
OTA identified the following eight key elements usually seen in successful reform4:
1.
an appropriate legal and ethical framework
Organ donation must be supported by appropriate legislation which defines when organ
donation can occur, how consent is to be obtained and how organ donation can be
carried out in a legally and ethically acceptable manner.
Spain introduced organ donation legislation in 1979, which established a presumed
consent system. Although Dr Rafael Matesanz, president of the Spanish National
Transplant Organization (ONT), has stated on a number of occasions that the presumed
1
International Registry in Organ Donation and Transplantation. 2015. URL: www.irodat.org (last accessed November 2015)
Organ and Tissue Authority. 2013. International approaches to organ donation reform.
3 Organ and Tissue Authority. 2013. International approaches to organ donation reform.
4 Organ and Tissue Authority. 2013. International approaches to organ donation reform.
2
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consent system was not the reason for the success of the Spanish system5. It wasn’t
until 1989 when Spain’s national transplant organisation was founded that donor rates
began to rise. During visits to Australia in August and September 2015, both Dr Mirela
Busic (Head of the Croatian Institute for Transplantation and Biomedicine) and
Professor Rafael Matesanz (Director of the Spanish National Transplant Organisation)
confirmed that the consent models adopted in practice in Croatia and Spain involve
establishing the potential donor’s wishes by asking the family and always seeking family
agreement to proceed with donation.
Croatia implemented a presumed consent system in 1988 and a non donor register in
2004. Regardless of the law the family is always approached to discuss the possibility of
organ donation. In 2012, a new Transplant Act was published. This describes in detail
the ethical, professional and organisational standard for organ donation and
transplantation in accordance with the European Union requirements (as set out in the
European Directive on Quality and Safety of Organ for Transplantation).
Portugal first enacted the Transplantation Law in 1993, which was later revised in 2007
to coincide with the new national coordinating body established the same year.
2.
a national coordinating body
The Spanish Model of Organ Donation and Transplantation is coordinated at three
different levels: at national level with the ONT, at the regional level with 17 autonomous
regional coordinators, and at the hospital level. The ONT was established in 1989 as the
responsible agency of the Ministry of Health to oversee donation and transplantation
activities. The ONT and regional coordinators provide the link between policy and
technical processes and all national policy initiatives require inter-regional consensus.
In Croatia, a National Transplant Coordinator was appointed in 2001 following the
announcement of a programme for increasing organ donations in 1998. The Ministry of
Health employs six full time staff responsible for managing the implement of the reform
initiatives, plus six contracted medical students maintaining a 24 hour duty coordination
office (as at 2013).
The Portuguese Transplant Organisation was established in 1993, which created a
regional structure of five coordination offices. It was replaced in 2007 by the Autoridade
para os Servicos de Sangue e da Transplantacāo (ASST), run by the Ministry of Health.
In 2012, due to organisational changes in Portugal, the Instituto Portuguēs do Sangue e
da Transplantacāo (IPST) was created by law and assumed the former ASST’s role, as
well as the European Projects and training programmes.
3.
hospital-based clinical donation specialists
Dedicated clinical staff were introduced in Spain in 1985. Spain has very specific
requirements for its Transplant Coordinators. The role of Transplant Coordinator is
unique in that is was conceived to facilitate early identification and referral of possible
donors. They are appointed by, and report to, the medical executive of the hospital,
rather than the transplantation team. The majority of Transplant Coordinators are
Intensivists, who are supported in their role by nurses. The appointment of Transplant
Coordinators at each procurement hospital is seen as a key element of the Spanish
model which has been progressively replicated in other countries.
In Croatia, hospital based teams of Transplant Coordinators were initially established in
1998-2000. There are 33 hospital (local) coordination teams that are responsible for
5
Organ Donation Taskforce. 2008. The potential impact of an opt out system for organ donation in the UK: An independent
report from the Organ Donation Taskforce.
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donation identification, management and realisation of organ and tissue donation, in
addition to their regular job duties. They are supported in their work by the coordination
staff from the Ministry of Health (as the national coordinating body). The Transplant Act
2004 confirms the appointment of the National Transplant Coordinator and the hospital
based Transplant Coordinators as a legal requirement with clear roles and
responsibilities.
In Portugal, Hospital Donor Coordinators were appointed in 2007 and 2008. There are
45 doctor employed as Hospital Donor Coordinators, with backup staff, in 45 active
donor hospitals. These specialist staff are responsible for creating a ‘donor culture’ in
donor hospitals.
4.
specialist training for clinical staff in management of deceased donation process and
family donation conversations
In Spain a specific emphasis is placed on the staff directly involved with organ donation
to ensure they are appropriately trained in all steps of the donation process. This
training was first made available in 1991 and it is mandatory for all Spanish doctors
specialised in intensive care to attend specific deceased organ donation for
transplantation training. Spain is also considered a world leader in training delivery.
In Croatia professional training was first made available to clinical staff in 2003 and
remains an ongoing priority.
In Portugal professional training was first made available in 2008. All staff employed as
Hospital Donor Coordinators have received the internationally recognised Transplant
Procurement management training.
5.
implementation of a clinical governance framework that supports quality assurance and
audit of hospital clinical practice and governance of donation process
Spain’s quality assurance programme is based on a continuous clinical chart review of
all deaths occurring in critical care units. The programme includes an internal audit
performed by Transplant Coordinators within their hospital and an external audit
conducted by expert Transplant Coordinators from other regions.
Croatia commenced hospital audits initially as an external quality assurance inspection
process in 2002, which was gradually refined into a clinical practice improvement
programme and quality assurance process by 2010.
As of 2013, Portugal was planning its method for conducting hospital audits as part of a
national quality assurance process.
6.
financial support to donor hospitals to ensure that costs related to management are not
a barrier to donation
In Spain, the authorities allocate a specific budget to fund the human and material
resources needed for donation management at every hospital.
Croatia introduced a funding model to ensure the hospital is funded for all the additional
costs associated with organ and tissue donation in 2006.
Portugal introduced financial support for organ donation activity in 2006 and revised the
funding model in 2011.
7.
media engagement and national community awareness and education
In Spain there is no convincing data demonstrating a relationship between advertising
campaigns and a sustained increase in donor rates. It has been observed to be episodic
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and without continuity and at a high cost to benefit ratio. Rather than investing in
significant advertising campaigns, ONT utilises media to promote organ donation
through the dissemination of positive news. For instance, each year Spain conducts a
training seminar in organ donation which is aimed at journalists to provide first-hand
information to ensure media handle information about organ donation and
transplantation appropriately.
In Croatia, coordinated public awareness campaigns have been progressively
introduced since 1998 and include the establishment of an inaugural National Donor day
in 2006.
Portugal has not previously implemented national awareness campaigns. The ASST
national body has organised joint community events with the Catholic Church and
patient organisation since 2009, and has worked with the media on general awareness
of organ and tissue donation and transplantation.
8.
international cooperation to share best practice
Croatia established international cooperation in 2007 when it joined the Eurotransplant
which positively influenced the organ allocation process and the overall Croatian
transplant program.
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More recent reform – Australia, the United Kingdom, and the
European Union
During 2006 – 2008, both Australia and the United Kingdom established taskforces to
undertake comprehensive reviews of their organ donation and transplantation system.
These countries were in similar positions to New Zealand before their reform. For instance,
both had previously made a number of unsuccessful attempts to increase organ donation
rates. Deceased donation rates per million of population were similar in Australia (11.4 in
2009) to New Zealand’s current rates (10.2 in 2014); however, the United Kingdom had
higher rates (15 in 2009). Both countries had a national body responsible for some, but not
all, aspects of organ donation and transplantation and already funded donation coordinators
in hospitals. Australia is particularly relevant from a clinical perspective as many health
professional bodies are Trans-Tasman and we operate a Trans-Tasman organ sharing
agreement (where organs donated that do not have an appropriate recipient in that country
are shared with the other country). One area of difference is that both Australia and the
United Kingdom had a donor registration in place. Therefore, their reviews focused on how
to increase registration rather than consideration of the costs and benefits of establishing a
register.
At the same time as Australia and the United Kingdom were undertaking their reviews, the
European Union was also considering what further action it could undertake to improve
organ donation and transplantation within its Member States.
The reviews in Australia and the United Kingdom, and the European Union’s consideration,
all drew heavily from the successful reform elements of the leading countries, particularly the
Spanish model.
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Australia
Prior to 2006, Australia had undertaken a number of reviews which had been unsuccessful
in improving its donation rates. In 2006 three significant steps were made:
1.
2.
3.
All governments signed up to a 10-point National Reform Agenda that had as its primary
goal an increase in safe, effective, and ethical organ and tissue donation for
transplantation
The Commonwealth Government signalled its support for reform by committing
$28 million for national initiative’s towards achieving this goal
The National Clinical Taskforce on Organ and Tissue Donation (the Taskforce) was
established in October 2006 to consider expert advice and widely consult clinicians and
other stakeholders in order to recommend practical initiatives for reform6.
National Organ Donation Collaborative (NODC)
One of the initiatives funded in 2006 was a National Organ Donation collaborative (NODC)7.
This saw 28 hospitals (22 joined in phase one and a further six joined in phase 2) from most
States and Territories (excepting Queensland and Tasmania) participating in a structural
clinical practice improvement program from 2006 to 2008 to increase organ donation rates.
This was considered to have a positive impact on donation rates and the Taskforce
subsequently recommended it continued to be funded.
National Clinical Taskforce on Organ Donation and Tissue Donation Taskforce
The Taskforce made its final report in January 2008. It recommended a comprehensive set
of 51 recommendations (refer appendix A for the full set of recommendations) and proposed
six critical areas of action to set the direction for reform. The six critical areas of action were:
1.
Funding of a national communications campaign to simplify measures to the public,
dispel myths, educate and better promote the way Australians can commit to donation
based on robust social marketing methodologies
The Taskforce was concerned that the involvement of a number of groups and
individuals to promote donation and transplantation could be creating confusion. It
considered media campaigns and promotional activities needed to be harmonised to
ensure a nationally agreed consistent message was provided. The Taskforce was also
concerned about the low rate of organ and tissue donation among Australia’s Aboriginal
and Torres Strait Islander population and recommended the Government develop
targeted promotional and educational activities for these populations. It also
recommended that the national communications strategy, and professional education,
relating to donation should encompass eye and tissue donation messages.
When considering how to increase consent rates other options commonly considered
include changing the legal system (ie, moving to a presumed consent, or opt-out, model)
and introducing donation registers. When the Taskforce compared international donor
rates according to consent laws (and actual practice) they found no clear correlation
6
Department of Health and Ageing, Australian Government. 2008. National Clinical Taskforce on Organ and Tissue Donation
Final Report: Think Nationally, Act Locally
7 Australian Healthcare Associates. 2011. Organ and Tissue Donation Reform Package: Mind-Point Review Report July 2011.
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between opt-out systems and better performance in donation systems, so decided not to
include this as an area of focus for the review.
As Australia already has a national register (established as a registration of ‘intent’ in
2000 and changed to a registration of ‘consent’ in 2005), the focus of the review was on
how to improve the current registration system. For example, the Taskforce
recommended an online registration process without the need for follow-up signed
document be considered (in jurisdictions where electronic recording of consent alone
satisfied legal requirements). It also recommended that where a potential donor is
identified, the register should be accessed before the family is approached for consent.
Similar to New Zealand, Australians are able to indicate a willingness to donate on their
driver’s license. The Taskforce found a higher proportion of objections to donate
recorded via driver’s licenses and was concerned this may be because of the lack of
information available, or time to consider the issue, when completing the driver’s license
process. It considered avenues for registration that require an instantaneous decision in
isolation from information about donation should not be pursued. To reduce objections
within the current driver’s licensing system the Taskforce suggested another option of
‘undecided at this time / leave decision to family member’ be added (although this was
not included as a formal recommendation).
2. Adoption of national clinical triggers and notifications protocols to identify potential
donors in all emergency departments and ICUs across Australia
The Taskforce recommended the development of a set of simple clinical triggers to be
used for patients where withdrawal of treatment or death is imminent to ensure the early
identification of potential donors. The taskforce developed a set of clinical triggers to be
used for the identification of potential organ donations in emergency departments8. In
these circumstances the emergency department should contact the intensive care unit
to discuss the potential of the ICU providing support to allow time for end-of life
decisions, including donation decisions, to be made. A second set of clinical triggers
were developed for ICUs9. When these indicators are present the ICU should contact
the Organ Donor Coordinator or State-Based Organ Donation agency for clinical
guidance for donation practices. The Taskforce recommended that the clinical triggers
be endorsed by the relevant professional bodies and supported by local protocols within
hospitals to ensure they are effectively implemented.
3. Development and publication of nationally consistent organ transplant waiting list criteria
and organ allocation protocols between jurisdictions and hospitals to ensure utility,
equity and transparency
The Taskforce identified significant variations in the waiting list models and allocation
processes used for eyes, tissues, and organs, as well as differences between states
and territories. It recommended that the Transplantation Society of Australian and New
Zealand develop national processes and protocols.
8
A patient under 75 years of age is intubated and the patient has suffered irrecoverable injury and extubation is being
considered.
9 A patient has severe irreversible injury or several absent brain-stem reflexes; and/or advance in disease trajectory to the point
where withdrawal of life-sustaining therapy is appropriate.
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4. Resourcing of training opportunities and projects that aim to improve clinical practice,
such as the National Organ Donation Collaborative
The Taskforce recommended continuing education should be required for all clinicians
who may be involved in identifying potential donors, particularly staff in ICUs and
emergency departments.
The Taskforce considered designated officers play an integral role in the donation
process and recommended that states and territories develop and implement nationally
consistent duty descriptions and training.
The National Organ Donation Collaborative was established in 2006 to bring together
teams of health professionals from 28 hospitals across Australia to identify best practice
where high donation rates have been achieved. The Taskforce supported the
achievements of the National Organ Donation Collaborative and recommended it be
continued. It also recommended it consider expanding to include eye and tissue
donation.
5. Establishment of a world-class national data system and publication of a National
Organ, Eye and Tissue Donation and Transplant Report to report on Australia’s
performance, to enable benchmarking and to measure the impact of new initiatives
The Taskforce considered that potential organ donors were missed because of variable
practices at key points of the pathway from actual or imminent brain death to raising
organ donation with family. The Taskforce recognised further work was required to test
and improve the proposed clinical triggers, develop national notification steps, and
assess the most cost effective data collection methods, so recommended a national
pilot be funded to trial a system for identification, notification, management, and audit of
potential donors.
The Taskforce recommended a shift from Organ Donor Coordinators providing donor
data to transplant centres by phone to a real-time, electronically based system to reduce
the potential for human error, improve the speed of communication and decision
making, and improve efficiency.
The Taskforce proposed an indicative minimum dataset to provide the basis for the
development of a National Organ, Eye and Tissue Donation and Transplantation Report.
It proposed the establishment of a clinical registries umbrella body to produce the
annual report and drive reforms in data collection.
6. Establishment of a national donation and transplantation authority, comprising clinicians
and governments, to coordinate activity on a national basis and oversee reform or
organ, eye, and tissue donation for transplantation
A separate review of the peak body Australians Donate was undertaken by Australian
Healthcare Associations in 2006-07. The review concluded that amendments made to
the governance and management arrangements of the peak body alone would not lead
to significant improvements in performance of the peak body or the rate of organ
donation due to the seemingly large structural impediments within the sector, including:

the fragmented nature of the sector
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

the jurisdiction-based nature of organ and tissue donation and allocation services
the absence of any effective, powerful central coordinating body to effect change.
Based on this review, the Taskforce concluded that to best support the national reform
agenda a new governance structure for the Australian organ, eye, and tissue donation
and transplantation sector be established. It recommended a national governance
authority, potentially called the Australian Organ and Tissue Authority, be established.
Within the Authority’s structure, the Taskforce recommended separate and specific
reporting lines for:





the field of organ donation / retrieval
the field of organ transplantation
the fields of eye and tissue donation and transplantation
community awareness and education activities
national data reporting and quality and assurance.
The Taskforce recommended that if the Government implemented the proposed
national governance authority, then the funding model should combine core-based
funding with performance based funding.
National Reform Package
In December 2007, following consideration of the draft final report of the Taskforce,
Australian Health Ministers agreed to establish a governance structure to oversee the policy
and programme reforms recommended by the Taskforce10.
In July 2008, the Australian Government announced a Commonwealth funding package of
$151.1million, including new funding of $136.4 million over four years, to significantly
improve Australians’ access to organ transplant. The key features of the reform package
included:
1. $67 million to fund dedicated organ donation specialist doctors and other staff in public
and private hospitals
2. $46 million to establish the national authority (this includes funds held by the national
authority for its administered programs)
3. $17 million in new funding for hospitals to meet additional costs associated with organ
donation
4. $13.4 million to national public awareness and education
5. $1.9 million for counselling for potential donor families.
6. Other significant elements, including enhanced professional education programmes,
consistent clinical protocols, clinical trigger checklists and data collection for organ
transplants in hospitals.
The Australian OTA was officially established on 1 January 2009 through the Australian
Organ and Tissue Donation and Transplantation Authority Act 200811. The OTA assumed full
responsibility for implementing the national reform agenda on 9 March 2009. In
10
11
Australian Healthcare Associates. 2011. Organ and Tissue Donation Reform Package: Mid-Point Review Report July 2011.
Australian Healthcare Associates. 2011. Organ and Tissue Donation Reform Package: Mind-Point Review Report July 2011.
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implementing the measures of the national reform package, the OTA’s responsibilities
include:
1.
2.
3.
4.
coordinating a national network of clinical and other hospital staff dedicated to organ
and tissue donation in hospitals
overseeing a new national network of state and territory organ and donation agencies
formulating national policies and protocols relating to organ and tissue donation and
transplantation matters, including close collaboration with peak clinical and professional
organisations to develop consistent clinical practice protocols and standards
leading an ongoing community awareness and education program.
Key achievements of the reform programme to date include the:
1.
2.
3.
4.
5.
6.
7.
embedding of dedicated medical and nursing donation specialist staff in organ and
tissue donation in key hospitals across Australia, who work collaboratively with staff
from eight DonateLife Agencies and their clinical colleagues
introduction of the Professional Education Package
introduction of the DonateLife Audit of potential donation opportunities
introduction of Organ Donation Hospital Support Funding to assist towards the costs
associated with donation activity
introduction of a National Donor Family Support Service
implementation of the Australian Paired Kidney Exchange programme
development of the Consensus Statement on Eligibility Criteria and Allocation Protocol
for Organ Transplantation from Deceased Donors.
The OTA continues to be the agency responsible for implementing the national organ
donation reform. From 2009 to 2014, the OTA developed strategic priorities to focus
implementation of the national reform programme on an annual basis. In 2014, they
produced a strategic plan that outlines the visions and priorities for 2014-1812. The following
key objectives and strategies have been identified:
1.
2.
increase the number of potential organ and tissue donors
a. implement end of life prompts for donor identification and referral
b. provide professional education and training for clinicians
c. optimise the update of Donation after Circulatory Death donation (DCD) pathway in
hospitals
d. establish processes to optimise the transplantation of organs from extended criteria
donors13 (ECD)
e. support living organ donation
improve organ and tissue donor conversation rates
a. continue to develop an Australian best practice request and consent model for
organ and tissue donation for transplantation
b. increase education of professionals involved in conversations about organ and
tissue donation
12
Australian Organ Tissue Donation and Transplantation Authority. 2014. Organ and tissue donation for transplantation in
Australia. 2014-2015 Strategic Plan.
13 In order to increase the availability of donor organs, expanded eligibility criteria have been developed that include extended
criteria for donation. These are donor characteristics that are associated with increased short and/or long-term morbidity and
mortality after transplantation. (TSANZ. 2015. Consensus statement on eligibility criteria and allocation protocols)
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continue to build public support and confidence in Australian’s donation and
transplantation system
d. support informed family discussion and Australian Organ Donor Register
registration within culturally and linguistically diverse and Aboriginal and Torres
Strait Islander communities
e. optimise physiological management of potential organ donors
enhance systems to support organ and tissue donation and transplantation
a. continue to develop the Electronic Donor Record
b. deliver a national vigilance and surveillance system for deceased organ donation
and transplantation
c. support the delivery of ethical guidelines and clinical protocols for organ
transplantation from deceased donors
d. provide organ donation hospital support funding
e. continue to develop system and processes to capture, analyse and report on
donation and transplantation data and research
f. continue to support the ongoing development of the eye and tissue sector in
collaboration with professional bodies
g. support the development of an Australian Organ Matching System to improve organ
allocation and matching processes
h. continue to support the evolution of the DonateLife Network in response to changes
in the requirements of the organ and tissue donation and transplantation service
model
i. provide national Donor Family Support Services to ensure that donor families have
access to quality bereavement care and support
j. maintaining the OTA as an agency of excellence.
c.
3.
Results
Australia in now in its sixth year of implementing its national reform programme. From 2009
to 2014, the number of deceased organ donors increased from 247 to 378 (an increase of
53%) and its deceased donation rate per million of population (pmp) increased from 11.4 to
16.1 (an increase of 41%) (refer figure 3). Although between 2013 and 2014 the rates
deceased by 5% (from 16.9 to 16.1 pmp).
Figure 3: Deceased donor rates per million population - Australia
20
Pre reform
15
Post reform
10
5
0
Year
Source: International Registry in Organ Donation and Transplantation
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United Kingdom (UK)
In December 2006, the UK Government set up the Organ Donation Taskforce to identify
barriers to organ donation and recommend actions needed to increase organ donation and
procurement within the current legal framework. The taskforce produced an initial report in
January 2008 (Organs for Transplants: A report from the Organ Donation Taskforce), which
made 14 recommendations to the Government. At that time the UK Prime Minister asked for
a review of the legislation for consent for organ donation. In response, the taskforce provided
a second report in November 2008 (The potential impact of an opt out system for organ
donation in the UK).
Organ Donation Taskforce Recommendations (First report)
In its first report, the Taskforce identified three key issues that were barriers to organ
donation: donor identification and referral; donor co-ordination, and organ retrieval
arrangements14. It made 14 recommendations, grouped under 10 topics.
1.
A UK-wide service
The Taskforce concluded that while donation is a ‘local’ activity, transplantation can only
be successfully undertaken as a UK-wide integrated service, to ensure suitable organs
are identified and allocated in a timely manner to meet the needs of patients; many of
whom would die within a very short period unless they receive a transplant. The
Taskforce recommended that a UK-wide Donation Organisation be established
(recommendation 1) and the current National Body, the NHS Blood and Transplant
(NHSBT), should have responsibility for its establishment (recommendation 2). The
NHSBT already had responsibility for managing waiting lists, allocating organs,
analysing transplant data, promoting organ donation, the National Blood Service and
providing professional leadership to Donor Transplant Co-ordinators (DTC). However,
the NHSBT did have responsibility for oversight of the entire donation pathway. For
example it did not employ or manage DTCs, making them vulnerable to local pressures
and decisions.
2.
Legal and ethical issues
The taskforce identified several legal and ethical issues affecting the healthcare
professionals willing to actively participate in organ donation. In particular, the Taskforce
found the legal position with regard to donation after cardiac death (DCD) was unclear.
Concerns were expressed about the conflict of interest that may be felt to arise between
the duty of care of a doctor to a dying patient who is a potential donor after cardiac
death and the steps needed to facilitate donation. The Taskforce recommended urgent
attention was required to resolve outstanding legal, ethical and professional issues in
order to ensure all clinicians are supported and able to work within a clear and
unambiguous framework for good practice (recommendation 3). As part of this
14
Department of Health. 2008. Organs for Transplants: A report from the Organ Donation Taskforce
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recommendation, it also recommendation an independent UK-wide Donation Ethics
Group should be established.
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3.
Making donation usual, not unusual
Organ donation was not found to feature highly amongst many health care
professionals. The taskforce recommended that all parts of the NHS embrace organ
donation as a usual, not an unusual event (recommendation 4). Local policies,
constructed around national guidelines, should be put in place and discussion about
donation should be part of all end-of-life care (eg, emergency medicines, high
dependency units and other areas, as well as intensive care) when appropriate. The
Spanish model demonstrated the importance of clinical champions, typically consultantlevel clinicians, so the taskforce recommended each Trust should appoint an identified
clinical donation champion and establish a donation committee.
4.
Monitoring
The Taskforce considered improving the monitoring the keys steps along the donation
pathway would help increase donation. It considered recommending clinical indicators
as a trigger for notification to the DTCs, based on advice they received that a trigger
point referral systems underpins the success of the American programme. However,
Intensivists expressed concerns that the introduction of clinical triggers at that time
would be counterproductive. Instead the Taskforce endorsed proposals for a national
protocol for the notification of potential organ donations15, developed at their request by
the Donation Advisory Group of UKT, in consultation with the Intensive Care Society.
These establish minimum notification criteria for potential organ donation, which the
taskforce recommended be introduced on a UK-wide basis (recommendation 5) and that
detailed criteria should be considered subsequently.
The Taskforce also recommended that donation activity (including rates of potential
donor identification, referral, and approaches to the family and consent to donation) in
all Trusts should be monitored to encourage a greater focus from Chief Executives and
encourage donation (recommendation 6).
Data from the potential donor audit suggested that a significant number of patients for
whom brain stem death was a possible diagnosis were not undergoing formal tests, for
reasons unknown. The Taskforce recommended that brain steam death testing should
be carried out in all patients where brain steam death is a likely diagnosis even if organ
donation is an unlikely outcome (recommendation 7).
5.
Costs of donor management
The costs of donor management fall on the donor hospital and may be incurred even if
donation is not eventually possible. The Taskforce did not consider financial incentives
15
1) When no further treatment options are available or appropriate, and there is a plan to confirm death by neurological
criteria, the DTC should be notified as soon as sedation/analgesia. This notification should take place even if the attending
clinical staff believe that donation (after death has been confirmed by neurological criteria) might be contra-indicated or
inappropriate
2) In the context of a catastrophic neurological injury, when no further treatment options are available or appropriate and there
is no intention to confirm death by neurological criteria, the DTC should be notified when a decision has been made to withdraw
active treatment and this has been recorded in a dated, timed and signed entry in the case notes. This notification should take
place even if the attending clinical staff believe that death cannot be diagnosed by neurological criteria, or that donation after
cardiac death might be contra-indicated or inappropriate.
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desirable, but that current financial disincentives should be removed through the
development and introduction of appropriate reimbursement (recommendation 8).
6.
Donor transplant co-ordinators
The coordination system in the UK developed in an ad hoc and unsystematic way over
many years. The Taskforce was concerned by the fragmented DTCs arrangements and
that under current arrangements a single DTC could end up working 24 hours or more
without a break. The Taskforce recommended a significant increase in the number of
DTCs was required (recommendation 9). The Taskforce identified three distinct roles
that need to be fulfilled when a potential donor is identified:
a.
b.
c.
the approach to, and assent process with, the potential donor’s family, together with
the support of the family
the process of obtaining and recording all the clinical information required for the
organs to be allocated, and liaison with UK Transplant and individual transplant
centres in order to achieve this
the organ retrieval process itself and the last offices.
The Taskforce recommended that the national Organ Donation Organisation should be
responsible for the employment, training and management of DTCs. Coordinators
should be integrated within a designated critical care group, whilst being part of a local
co-ordinator team, having a central office from which the team was co-ordinated. The
embedded co-coordinators would work closely and collaborate with the Trust donation
champions to ensure appropriate policies were in place and any local obstacles are
identified and resolved.
The process of donor registration should also be improved by the introduction of a realtime IT system.
7.
Organ retrieval teams
The Taskforce identified that current organ retrieval arrangements were already
stretched, relied significantly on help from the donor hospital, and would not be able to
respond to an increase in donation rates. The Taskforce was also concerned by
circumstances where more than one retrieval team were involved in donation. In
Scotland a single multi-organ Scottish Organ Retrieval Team was funded for a year
(2004/05), with positive clinical and cost-effective results. The British Transplantation
Society working party (2006/07) and Taskforce both considered the key principles that
organ retrieval teams should be:
a.
b.
c.
d.
virtually self-sufficient and not require anaesthetic, theatre or surgical staff from the
donor hospital (other than the minimum needed for local liaison)
available 24 hours a day, without elective commitments during their time on call for
retrieval
able to respond appropriately if there is more than one donor in the same region on
the same day
able to provide opportunities for training.
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Based on these principles, the Taskforce recommended a UK-wide network of
dedicated organ retrieval teams should be established to ensure timely, high-quality
organ removal and that the Organ Donation Organisation be responsible for
commissioning the retrieval teams (recommendation 10).
The resourcing of transplant units was outside of the Taskforces remit. However, it
expressed concerns that transplant units may not have adequate resources to perform
the increased number of transplants expected, both in terms of staffing, infrastructure
(beds, operating theatres etc) and support services. It recommended consideration be
given to a national basis for the commission of all transplant services.
8.
Training, education and continuing educational support
The Taskforce was concerned that many critical care staff may go through their training
without ever having been involved with a single potential organ donor. The Taskforce
recommended that all clinical staff likely to be involved in the treatment of potential
organ donors should receive mandatory training in the principles of donation and should
receive regular training updates (recommendation 11).
9.
Honouring the gift of donation
The Taskforce identified there was no formal mechanism to recognise and thank the
families who have supported their loved ones in becoming organ donors. The taskforce
recommended the identification of appropriate to personally and publically recognise
individual organ donors, where desired (by the families) (recommendation 12). These
approaches could include national memoirs, local initiatives, and personal follow-up to
donor families.
10. Promoting donation
The Taskforce supported continued promotion of organ donation to the general public.
The Taskforce was particularly concerned about the under-representation of black and
minority ethnic (BME) groups in actual organ donor numbers, particularly given people
from Asian or African-Caribbean backgrounds are three to four time more likely to need
a kidney transplant than are white people and refusal rates were higher for potential
donors from a BME background. The taskforce considered there was an urgent
requirement to identify and implement the most effective methods though which organ
donation and the ‘gift of life’ could be promoted to the general public, and especially to
the BME population (recommendation 13).
Where a post mortem is required the Coroner (or Procurator Fiscal in Scotland) may
refuse permission for organ retrieval. The Taskforce was made aware of considerable
variation in the practice of individual coroners. The Taskforce recommended the
Department of Health and Ministry of Justice should develop formal guidelines for
coroners concerning organ donation (recommendation 14).
The Taskforce requested that the recommendations be considered and acted on as a whole
as piecemeal solutions had been attempted in the past and not worked.
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Consideration of an opt-out system (Second report)
Following the request to separately consider the consent system, the Taskforce did not
recommend shifting to an opt-out system, as it considered while an opt-out system may
deliver benefits it carried the risk of making the current situation worse16.
The systematic review of research evidence revealed an apparent correlation between high
donation rates and opt-out systems in countries around the world. However, the reviewers
found that presumed consent alone did not explain the variation in organ donation rates
between different countries.
The Taskforce found around 60% of the public would support a change to an opt out system,
as long as it was properly implement to ensure the rights of vulnerable groups were
protected and there was sufficient information to back it up. The Taskforce did not find any
fundamental legal or ethical barriers to introducing a “soft” opt-out system, in which, as a
safeguard, family members would be consulted about donation.
On the other hand, the Clinical working group heard persuasive arguments from health
professionals about the potentially negative implications for clinical practice, especially the
potential to damage the vital relationship of trust between clinicians for people at the end of
life, their patients and their families. Some Intensivists were concerned a change to a opt out
system would lead to some Intensivists opting out of participation in donation programmes,
which would be counter-productive given many of the Taskforce’s other recommendations
were dependent on the active support of Intensivists. The Clinical working group also heard
evidence from recipients of organs who stressed their need to know that the organ had been
freely given by donors and their families and from donor families who often find great comfort
in being an active part of the decision to donate. Some members of public and patients’
groups also felt an opt out system could be ‘dehumanising’ and some faith leaders warned
about the potential for provoking anti-donation feelings.
The Taskforce recommended the United Kingdom focus its efforts on implementing the
recommendations in its first report and only reconsider the potential of introducing an opt-out
system if the intended increase in organ donation rates was not achieved.
Implementation of the Taskforce’s recommendations
The four health administrations in the UK all accepted the recommendations of the
Taskforce in full and came together in a co-ordinated programme17. Working with all the key
relevant professional, NHS, and Government organisations, a Programme Delivery Board
was established to oversee the implementation of the Taskforce recommendations.
A 2011 implementation review reported that all the recommendations had been implemented
and were embedded as business as usual18. For instance, as recommended:
16
Organ Donation Taskforce. 2008. The potential impact of an opt out system for organ donation in the UK: An independent
report from the Organ Donation Taskforce.
17 Department of Health (in conjunction with Department of Health, Social Services, and Public Safety, Healthier Scotland
Scottish Government, Welsh Government). 2011. Report Working together to save lives: The Organ Donation Taskforce
Implementation Programme’s Final Report
18 Department of Health (in conjunction with Department of Health, Social Services, and Public Safety, Healthier Scotland
Scottish Government, Welsh Government). 2011. Report Working together to save lives: The Organ Donation Taskforce
Implementation Programme’s Final Report.
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1.
the role of the NHSBT was expanded to be the organ donation organisation for the
whole of the United Kingdom (note, it is only responsible for blood services in England
and North Wales)
2. guidance for non-heartbeating donation (also termed DCD) was published in England
and Wales, Scotland, and North Ireland
3. An UK Donation Ethics Committee was established
4. by 2011 96% of acute trust/health boards had established a Trust Donation Committee
and appointed Donation Committee Chairs
5. by 2011 98% of Clinical Leads for organ donation (referred to as clinical donation
champions in the original recommendation) were appointed
6. NHSBT had undertaken an analysis of the costs involved in the management of
potential organ donors and as a result Trusts became entitled to claim in the region of
£2,000 to cover the cost of management a potential donor
7. the Specialist Nurse for Organ Donation (SN-OD) (previously called ‘Donor Transplant
Co-Coordinator) network was reconfigured into 12 regional teams and was expected to
increase by 146%
8. a new Electronic Offering System was deployed
9. the National Organ Retrieval Service went live on April 2010 with 6 dedicated
cardiothoracic retrieval teams and 7 dedicated abdominal retrieval teams
10. the NHSBT launched a high profile, multi-media campaign to promote organ donation in
November 2009. This was followed by targeted campaigns between January and March
2010.
While not directly linked to the reform implementation, two potentially useful guidance
documents of note were also produced by United Kingdom organisations in 2011:
1.
2.
the National Institute for Health and Clinical Excellence produced best practice clinical
guidelines for improving donor identification and consent rates for deceased donation
within England and Wales19
the Nuffield Council on Bioethics produced a report covering the ethical, legal and social
implications of transactions involving human bodies and bodily material in medical
treatment and research. The report considers the role of payment and any other form or
remuneration or exchange, the role of consent, the question of subsequent use,
ownership and control of donated materials, the role of those acting as intermediaries
between donors and recipients, and the cultural and international perspectives
(including regulatory differences)20.
While the recommendations of the Taskforce are now complete, the UK Governments and
NHSBT continue to have a focus on increasing organ donation and transplantation rates. In
2013 they launched Taking Organ Transplantation to 2020: A UK Strategy. The Strategy
builds on the lessons learnt while implementing the Taskforce recommendations and
outlines a number of outcomes and actions to enable the UK to match world-class
performance in organ donation and transplantation21.
19
National Institute for Health and Clinical Excellence. 2011. Organ donation for transplantation: improving donor identification
and consent rates for deceased organ donation. NICE clinical guidelines 135.
20
Nuffield Council on Bioethics. 2011. Human bodies: donation for medicine and research.
21 NHS Blood and Transplant, Scottish Government, Welsh Government, Department of Health, and Department of Health,
Social Services and Public Safety. 2013. Taking Organ Transplantation to 2020: A UK Strategy
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Wales specific action – Introduction of a “soft” opt-out system
While the United Kingdom Taskforce decided against the introduction of an opt-out system,
the Welsh Government approved legislation to introduce a “soft” opt-out system for organ
donation in 201322. Under a “soft” opt-out system, consent is deemed unless the person has,
while alive, registered his/her wish not to become an organ donor after death. However, the
next of kin will in practice always be consulted and donation will not proceed if the next of kin
objects. The decision to shift to a “soft” opt-out system was based on:
1.
international evidence suggesting an association between presumed consent legislation
and increased donation rates
surveys indicating significant support for the introduction of an opt-out system for organ
donation in Wales
experimental literature providing evidence for a mechanism through which presumed
consent might increase organ donation, through the influence of the default position23.
2.
3.
The new system will come into force on 1 December 2015. Ireland is also considering a
similar change24.
Results
From 2009 to 2014, the number of deceased organ donors increased from 931 to 1,309 (an
increase of 41%) and its deceased donation rate pmp increased from 15.0 to 20.4 (an
increase of 36%) (refer figure 4).
Although between 2013 and 2014 donation rates deceased by 1.5% (from 20.7 to 20.4
pmp). The NHSBT reported that the fall was due to fewer people dying in circumstances
where they could donate and a lack of improvement in the consent/authorisation rates
(which remains below 60%)25. In response to this decrease the NHSBT has called for
everyone in the UK to discuss organ donation with their families.
Figure 4: Deceased donor rates per million population United Kingdom
25
Pre reform
Post reform
20
15
10
5
0
Year
22
http://gov.wales/topics/health/nhswales/organ/?lang=en
Welsh Government Social research. 2012. Opt-out system of organ donation: International evidence review.
24 In 2013, the Joint Committee on Health and Children in Ireland recommended a transition to a soft out-out policy
25 http:///www.nhsbt.nhs.uk/news-and-media/news-articles/news_2015_07_20.asp
23
27
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Source: International Registry in Organ Donation and Transplantation
European Union
In May 2007, the European Commission adopted a communication outlining actions to
respond to the main policy challenges in relation to organ donation and transplantation:



ensure quality and safety or organs
increase organ availability
and fight organ trafficking26.
In December 2008, the European Commission adopted a proposal for:
1.
2.
a Directive that defines quality and safety requirements for human organs intended for
transplantation
an action plan for improving co-operation between member states in this field.
Directive on standards of quality and safety of human organs intended for
transplantation
The Directive sets out the basic quality and safety requirements needed in every transplant
system. A sound infrastructure and responsible institutions for organ procurement and
transplantation were identified as the main features of a successful transplantation system27.
The Directive requires member states to establish and maintain a framework for quality and
safety that covers all stages of the chain from donation to transplantation and identify a
Competent Authority with responsibility to ensure compliance with the various Articles of the
Directive28. The stages covered by the various Articles are:
1.
2.
3.
4.
5.
6.
verification of donor identity
verification of the details of the donor’s or the donor’s family consent
verification of the completion of organ and donor characterisation in accordance with
specified criteria
the procurement, preservation, packaging and labelling of organ
the transplantation of organs
the reporting serious adverse events and reactions at any stage of the pathway.
The Directive was adopted by the European Parliament and the Council on 7 July 201029
and requires implementation by all member states by August 201230.
26
Commission of the European Communities. 2007. Communication from the Commission to the European parliament and the
council. Organ Donation and Transplantation: Policy Actions at EU level {SEC(2007) 704} {SEC(2007) 705}.
27 Commission of the European Communities. 2008. Proposal for a Directive of the European Parliament and of the Council on
standards of quality and safety of human organs intended for transplantation. {Com(2008)
final}{SEC(2008)2956}{SEC(20082957}.
28 Rudge, C., Matesanz, R., Delmonico, F . L., and Chapman, J. 2012. International practices of organ donation. British Journal
of Anaesthesia, 108 (S1): i48-i55.
29 http://ec.europa.eu/health/blood_tissues_organs/organs/index_en.htm
30 Rudge, C., Matesanz, R., Delmonico, F . L., and Chapman, J. 2012. International practices of organ donation. British Journal
of Anaesthesia, 108 (S1): i48-i55.
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The Action Plan on Organ Donation and Transplantation (2009-2015)
The Action Plan encourages member states to develop their own sets of National Priority
Actions, based on the 10 priority actions outlined in the plan31. Five of the priority actions
were focused on increasing organ availability. These are to:
1.
2.
3.
4.
5.
promote transplant donor coordinators
promote quality improvements programmes
promote the exchange of best practice in living donation programmes
improve the knowledge and communication skills of health professionals and patient
support groups on organ transplantation
facilitate the identification of organ donors across Europe and cross-border donation in
Europe.
A mid-term review of the Action Plan was conducted in 201432. The review was a factual
progress report taking stock of the progress made between 2009 and 2012 at national and
EU level. It identified where the emphasis of EU activities has been in the past and where
the emphasis is intended for the remaining period of the plan. Overall the review reported
good progress had been made by Member States in the first half of the Action Plan. For the
five actions focused on increasing the organ availability the review found:
1.
2.
3.
4.
5.
the appointment and training of transplant donor coordinators had received a lot of
attention in the first years of the Action Plan – given the essential role of transplant
donor coordinators, the review recommended these efforts be maintained, but the
emphasis should lie on national roll-out rather than new EU-funding projects
quality improvement programmes had only been partly taken up by members states –
the review recommended full implementation by members states in the remaining period
of the Action Plan would be key to improving donation quality and rates
many member states were developing programmes in relation to living donation with the
support of several EU projects – the review considered this focus area required more
attention for the remaining period of the plan
member states implemented various measures to improve the knowledge and
communication skills of health professionals and patient support groups (eg, training
courses for staff, workshops for journalists, leaflets etc), supported at the EU level via
the European Donation Days project and Journalist Workshops organised by the
European Commissions – the review recommended these efforts should be further
developed
member states have different consent schemes and tools to identify potential donors –
Instruments are in the process of being developed to improve knowledge about national
consent systems and the identification of potential donors.
31
Commission of the European. 2008. Communication from the Commission: Action plan on Organ Donation an
Transplantations (2009-2015): Strengthened Cooperation between Member State {SEC(2008) 2956}{SEC(2008)2957}..
32 European Commission. 2014. Commission Staff Working Document on the mid-term review of the ‘Action Plan Action Plan
on Organ Donation and Transplantation (2009- 2015):Strengthened Cooperation between Member States” SWD(2014) 147
Final.
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Appendix A: Full list of the Australian taskforce’s recommended
actions
Overarching recommendation
1.
That all Australian governments commit to implementing these recommendations, which
provide a road map for organ, eye and tissue donation for transplantation in Australia.
The six critical areas for action are:
a. Funding of a national communications campaign to simplify measures to the public,
dispel myths, educate and better promote the way Australians can commit to
donation based on robust social marketing methodologies
b. Adoption of national clinical triggers and notifications protocols to identify potential
donors in all emergency departments and ICUs across Australia
c. Development and publication of nationally consistent organ transplant waiting list
criteria and organ allocation protocols between jurisdictions and hospitals to ensure
utility, equity and transparency.
d. Resourcing of training opportunities and projects that aim to improve clinical
practice, such as the National Organ Donation Collaborative
e. Establishment of a world-class national data system and publication of a National
Organ, Eye and Tissue Donation and Transplant Report to report on Australia’s
performance, to enable benchmarking and to measure the impact of new initiatives
f. Establishment of a national donation and transplantation authority, comprising
clinicians and governments, to coordinate activity on a national basis and oversee
reform or organ, eye, and tissue donation for transplantation.
Community awareness and donor registration
2.
3.
4.
5.
6.
7.
8.
That governments fund and conduct a national community awareness and education
campaign, underpinned by a social research and evidence-based national
communications strategy, that raises awareness, promotes donor registration and offers
a pathway to action for increased donation and family discussion.
That governments provide resources to develop and implement targeted promotional
and educational activities on organ, eye, and tissue donation to engage Aboriginal and
Torres Strait Islander peoples and culturally and linguistically diverse communities.
That a community awareness charter for the organ, eye and tissue sector to be
developed to express stakeholder commitment to social research and evidence-based
national communications strategy.
That the AODR remains the single, national and consistent database for individuals to
register their decisions on organ, eye and tissue donation with multiple registration entry
points, and that this message is integrated into the communications strategy.
That a donor card continues to be provided to people who have registered their wish to
be an organ, eye, and tissue donation on the AODR.
That consideration is given to an online AODR registration process without the need for
a follow-up signed document in jurisdictions where electronic recording of consent alone
satisfies legal requirements.
That NSW investigated the conversation of the RTA Register into a mechanism for
direct registration to the AORD.
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9.
That an AORD User Group be established as a priority by Medicare Australia to enable
continuous improvement of the AORD for users.
Donation sector
10. That a national clinical trigger for the early identification of potential organ donors be
introduced into all emergency departments, comprising the following three elements:
a. A patient under 75 years of age is intubated; and
b. The patient has suffered irrecoverable injury and extubation is being considered;
then
c. The intensive care unit is to be contacted about potential support to permit end-oflife decision-making, including decisions about organ and tissue donation.
11. That a national clinical trigger for the early identification of potential organ donors be
introduced into all intensive care units comprising the following elements:
a. A patient has severe irreversible injury or several absent brain-stem reflexes; and/or
b. Advance in disease trajectory to the point where withdrawal of life-sustaining
therapy is appropriate; then
c. The Organ Donor Coordinator or State-Based Organ Donation Agency is to be
notified to provide clinical guidance for donation practices.
12. That states and territories endorse, and adequately resource, the introduction of clinical
triggers into all hospital with emergency departments and/or intensive care units within
their jurisdictions.
13. That where a potential donor is identified, the AORD should be accessed before
approaching the family and the AORD information should be made available to the next
of kin.
14. That the ANZICS33 Brain Death and Organ Donation Working Party be recognised, by
all governments, as the professional body responsible for the development and review
of guidelines for clinical practice in the confirmation of death and the care and
management of potential and actual donors.
15. That the professional bodies endorse national clinical triggers for the early identification
of potential organ donors in emergency departments and/or intensive care units prior to
local adoption in hospitals.
16. That hospitals develop local protocols to support effective implementation of the clinical
triggers in emergency departments and intensive care units.
17. That states and territories support and adequately resource bereavement counselling
and ongoing specialist support for all families of potential organ, eye, and tissue donors
18. That designated officers are recognised as playing an integral role in the donation
process and that states and territories develop and implement nationally consistent duty
descriptions and training that reflect the evolving role of designated officers.
19. That a national pilot project, funded by governments, is established to trial a system for
identification, notification, management and audit of potential donors and is evaluated
for potential national implementation.
20. That governments consider the introduction of a real-time, nationally consistent system
of electronic transmission of donor data between Organ Donor Coordinators and
transplant teams.
33
Australian and New Zealand Intensive Care Society
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21. That government funding for the National Organ Donation Collaborative be continued in
2008-09.
22. That the National Organ Donation Collaborative considers potential expansion to include
eye and tissue donation.
23. That any transition of the management of the National Organ Donation Collaborative to
a new project manager, as a result of proposed governance reforms to the organ, eye
and tissue sector, preserves existing resource commitments and ensure that local
activity can continue without disruption.
24. That governments develop and announce seamless transition arrangements for
Australians Donate to transfer the management of the National Organ Donation
Collaborative as soon as possible in order to minimise uncertainty and assist in retaining
local staff.
25. That the National Organ Donation Collaborative publishes quarterly summaries on a
dedicated website that includes performance data against the outcome measures of the
Collaborative’s Measurements Strategy.
26. That the outcomes of the National Organ Donation Collaborative are published as part
of an annual National Organ, Eye and Tissue Donation and Transplantation Report.
27. That donor identification be included in continuing education and training programmes
funded by the governments for emergency department, intensive care unit and
neurosurgical staff, provided by ADAPT34 or alternative training providers and also
included in medical and nursing education and training curricula.
28. That ADAPT be recognised, by all governments, as a national provider of specialised
education and training programmes on organ and tissue donation.
Eye and tissue sectors
29. That a social research and evidence-based national communications strategy and
professional education relating to donation should also encompass eye and tissue
donation messages.
30. That state and territory health departments, in consultation with attorney generals’
departments, develop and implement automated real-time notification of deaths in
hospitals and coroners’ mortuaries that link to a single contact to approach families
regarding consent for organ, eye and tissue donation. The system for determining the
single point of contact with each potential donor family should be agreed within each
jurisdiction.
31. That eye and tissue donation training programmes are developed and funded by
governments and made available and accessible to staff through ADAPT or alternative
training providers. These programmes should include technical courses on the following:
a. identification of donors
b. consent and bereavement
c. procurement
d. regulatory requirements under the TGA’s code of Good Manufacturing Practice
(cGMP), including the standards for processing and storage.
32. That a national donor database for tissues be developed and funded by the
Commonwealth Government, with consideration given to tissue, eye and organ donor
data being integrated into a single database in the longer term.
34
Australasian Donor Awareness Programme
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33. That explicit eye and tissue allocation protocols should be developed, published and
adopted by jurisdictions.
34. That a national tissue outcomes registry should be established and appropriately
resourced by the Commonwealth Government.
35. That a national eye and tissue banking network be established and funded by
governments to better integrate the eye and tissue banks and progress reform in the
sectors.
Transplant sector
36. That explicit national waiting list criteria for each type of organ should be developed and
published.
37. That the TSANZ35 Standing Committees should be the coordinating groups tasked to
develop the national waiting list entry criteria for each organ, tissue and cornea and, in
conjunction with ATCA36, ASEATTA37, and State-based Organ Donation Agencies,
develop national organ allocation and acceptance protocols that reflect state-specific
requirements.
38. That the development of national waiting list entry criteria and organ allocation an
acceptance protocols be informed by community attitudes on the non-clinical aspects of
the criteria and protocols, such as utility, equity and transparency.
39. That following the development of national waiting list entry criteria and organ allocation
and acceptance protocols, audits and undertaken to monitor their implementation.
40. That a consensus conference be held in 2008 to provide a national forum for clinical and
community review of national waiting list entry criteria and organ acceptance and
allocation protocols.
National data collection and reporting
41. That a National Organ, Eye and Tissue Donation and transplant Report be developed
and published both as an annual compendium and monthly web-based summary, to
report on the success of the National Reform Agenda on Organ and Tissue Donation,
and to provide uniform national data and a clear set of performance indicators to inform
policy and public accountability.
42. That the indicative minimum dataset proposed by the Taskforce become the basis for
the development of the national Organ, Eye and Tissue Donation and Transplant
Report.
43. That national donor disease transmission and surveillance data collection and clinical
reporting mechanisms be developed.
44. That a clinical registries umbrella body be established to produce the annual National
Organ, Eye and Tissue Donation and Transplant Report and to drive reforms in data
collection.
35
Transplantation Society of Australia and New Zealand
Australasian Transplant Coordinators Association
37 Australasian and South East Asian Tissue Typing Association
36
33
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Governance structure
45. That in order to best support the National Reform Agenda on Organ and Tissue
Donation, a new governance structure for the Australian organ, eye and tissue donation
and transplantation sector be established.
46. That a national governance authority be established, with the reporting structure
proposed by the Taskforce, and authorised to undertake the roles and responsibilities
proposed by the Taskforce.
47. That one of the primary functions of the national governance authority for the sector
should be to further support cohesion and collaboration between State-Based Organ
Donation Agencies into a cohesive and collaborative consortium.
48. That membership of the board of the national governance authority be consistent with
that proposed by the Taskforce.
49. That if governments implement a national governance authority for the organ, eye and
tissue sector, then the funding model should combine core-based funding with
performance-based funding.
50. That the Terms of Reference and work plan of the new AHMAC Cognate Committee on
Organ and Tissue Donation and Transplantation is informed by the governance issues
identified by the taskforce.
51. That the Terms of Reference and work plan of the new AHMAC Cognate Committee on
Organ and Tissue Donation and Transplantation include a review of the feasibility, costs
and benefits of establishing a national governance authority to drive reform in the organ,
eye and tissue sector.
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Appendix B: Full list of Actions in the European Union’s ‘Action Plan
on Organ Donation and Transplantation (2009-2015)’
The Action Plan identified 10 priority actions for member states, grouped under three
challenges and 5 objectives:
Challenge 1: Increasing organ availability
Objective 1: Member states should reach the full potential of deceased donation
1.
2.
Promote the role of Transplant Donor Coordinators in every hospital where there is
potential for organ donation – the presence of a key donation person at hospital level
(transplant donor coordinator), whose main responsibility is to develop a proactive donor
detection programme, was identified as the most important step towards optimising
organ donation. This action includes the establishment of internationally recognised
standards for transplant coordinator programmes, the implementation of effective
training programmes and the establishment of national or international accreditation
schemes.
Promote Quality Improvement Programmes Coordinators in every hospital where there
is potential for organ donation – primarily a self-evaluation of the whole process of organ
donation according to the characteristics of the hospital and health system, with the
purpose of allowing results to be compared and areas for improvement identified.
Objective 2: Member States should promote living donation programmes following best
practices
3.
Exchange of best practices on living donation programmes among EU member states;
Support registries of living donation – with the aim to promoting altruistic donation
programmes and developing registration practices regarding living donors in order to
assess and guarantee their safety.
Objective 3: Increase public awareness of organ donation
4.
5.
Improve the knowledge and communication skills of health professionals and patient
support groups on organ transplantation – in addition to promoting training programmes
geared towards health professionals and patient support groups, this action encourages
member states to recognise the important role of mass media and the need to improve
the level of information to the public on these topics and organise periodic meetings at
national level with journalists and opinion leaders and mange adverse publicity.
Facilitate the identification of organ donors across Europe and cross-border donation in
Europe – the Commission will help member states develop identification mechanisms.
Challenge 2: Enhancing the efficiency and accessibility of transplantation systems
Objective 4: Support and guide transplantation systems to be more efficient and accessible
6.
Enhance the organisation models of organ donation and transplantation in EU member
states – this includes the European Commission leading action to promote twinning
projects and peer reviews, assess the use of structural funds and other Community
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7.
8.
instrument for the development of transplantation systems and promote networks of
centres of reference.
Promote EU-wide agreements on various aspects of transplant medicine – in particular:
basic rules for internal EU patient mobility and transplantation, all issues concerning
transplant medicine for extra-Community patients, monitoring organ trafficking, and
common priorities and strategies for future research programmes
Facilitate the interchange of organs between national authorities – by evaluating
procedures for offering surplus organs to other countries, putting procedures in place for
the exchange of organs for urgent or difficult-to-treat patients, and designing IT tools to
support these.
Challenge 3: Improving quality and safety
Objective 5: Improve the quality and safety of organ donation and transplantation
Evaluation of post-transplant results – evaluating post-transplant results though
common definitions of terms and methodology could help promote EU-wide registers or
create a methodology to compare results of existing post-transplant follow-up registers.
The use of expanded donors should also be considered as part of the efforts to increase
the pool of available organs. Since, in practice published experience is not enough to
establish safety limits, the Action Plan recommends common definitions of terms and a
methodology to help determine acceptable levels of risk in the use of expanded donors.
10. Promote a common accreditation system for organ donation/procurement and
transplantation programmes – to provide support for centres of excellence.
9.
On the basis of these actions, Member States were encouraged to develop their own Sets of
National Priority Actions.
36