Bills Digest no. 59 2008–09
Australian Organ and Tissue Donation and Transplantation Authority
Bill 2008
WARNING:
This Digest was prepared for debate. It reflects the legislation as introduced
and does not canvass subsequent amendments. This Digest does not have
any official legal status. Other sources should be consulted to determine
the subsequent official status of the Bill.
CONTENTS
Passage history
Purpose
Background
Financial implications
Main provisions
Concluding comments
Contact officer & copyright details
Passage history
Australian Organ and Tissue Donation
and Transplantation Authority Bill 2008
Date introduced: 18
September 2008
House: House
of Representatives
Portfolio: Health
and Ageing
Commencement: 1
January 2009
Links: The relevant
links to the Bill, Explanatory Memorandum and second reading speech
can be accessed via BillsNet, which is at http://www.aph.gov.au/bills/. When Bills
have been passed they can be found at ComLaw, which is at http://www.comlaw.gov.au/.
The primary purpose of this Bill is to establish the
Australian Organ and Tissue Donation and Transplantation Authority (the
Authority). This Authority is to implement the Government’s proposed package
of reforms to institute a nationally consistent and coordinated system
of organ and tissue donation for transplantation. The Bill also establishes
the Australian Organ and Tissue Donation and Transplantation Advisory
Council, which is to advise the Chief Executive Officer (CEO) of the Authority
on relevant matters.
The creation of a national organ donation scheme as a means to improve
rates of donation in Australia was one of the key ideas discussed at the
2020 Summit in May this year. Following the 2020 Summit, on 2 July 2008
the Rudd Labor Government announced a proposed national reform package
intended to ‘establish Australia as a world leader in organ donation for
transplantation’.[1] One of the key features of this
reform package was the establishment of a new independent national organ
donation and transplantation authority to coordinate national organ donation
reform initiatives and programs. This Authority, to be set up by 1 January
2009, was to drive and oversee the set of reforms that was endorsed by
the Council of Australian Governments on 3 July 2008.[2] Key features of the reform package
are outlined in a series of fact sheets available at the Department of
Health and Ageing website.[3]
The Senate Standing Committee for the Scrutiny of Bills raised concerns
about the powers of delegation given to the CEO of the Authority. These
concerns were addressed to the satisfaction of the Committee by an advice
from the Minister for Health and Ageing, Nicola Roxon.[4]
The following background and analysis is effectively a summary of the
material provided in the Parliamentary Library research paper, ‘The future
of organ donation in Australia: moving beyond the “gift of life”’. For
a more detailed account of the organ donation sector in Australia, please
consult the paper at: http://www.aph.gov.au/Library/pubs/rp/2008-09/09rp11.pdf.
While a majority of Australians support organ donation, comparatively
few actually donate their organs. At 10 donors per million members of
population, Australia performs poorly relative to comparable industrialised
nations.
At present, around 1,800 Australians are on waiting lists for an organ
donation.[5] Without an
increase in the rate of organ donation, waiting lists are expected to
grow in the future, as the demand for organ transplantation is anticipated
to rise with an ageing population and the increased incidence of lifestyle
diseases such as obesity and Type 2 diabetes. Not only are waiting lists
for organ donation expected to increase in the future but so, too, are
the numbers of Australians dying whilst waiting for an organ transplant.
In this context, there is substantial interest in finding ways of translating
Australians’ stated commitment to organ donation into improved actual
organ donation rates.
In response to the need to improve rates of organ donation and transplantation,
all Australian governments signed up to a 10-point National Reform Agenda
in July 2006. This Agenda has as its primary goal an increase in safe,
effective and ethical organ and tissue donation for transplantation. The
Howard Government committed $28 million for national initiatives towards
achieving this goal and, in October 2006, commissioned the National Clinical
Taskforce on Organ and Tissue Donation (the Taskforce) to provide it with
evidence-based advice on ways to improve the rate of organ, eye and tissue
donation for transplantation in Australia.[6]
In its final report, submitted in January 2008, the Taskforce noted that,
despite a long list of reports, reviews and organisations that have been
created in an attempt to increase the nation’s organ donation rate over
time, no significant inroads have yet been made. The Taskforce attributed
Australia’s inability to increase organ donation rates to a number of
factors, chief of which was the fragmented nature of the organ donation
and transplantation sector. Unlike other comparable nations, Australia
does not have a national organ donor coordination network or single coordinating
agency. Instead, the system is state- and territory-based, with each jurisdiction
operating under its own organ and tissue donation-related legislation,
procedures and practices. Indeed, not only is there variation between
jurisdictions, but also within them, with individual hospitals and clinics
operating according to their own different practices.[7]
Essentially, the Taskforce highlighted
the need for national coordination of all major aspects of Australia’s
organ donation and transplantation system. These include: communications
with the public about donation; clinical triggers and notification protocols
to identify potential donors; waiting list criteria and organ allocation
protocols; and, data collection and dissemination on Australia’s organ
donation and transplantation performance. The Taskforce recommended the
establishment of a national donation and transplantation authority, comprising
clinicians and governments, to coordinate the above activities and any
future organ donation-related reforms on a national basis.[8]
A number of the Taskforce’s recommendations—including the establishment
of a National Authority—are reflected in the Government’s national reform
package.
Should the Bill be passed, and the Government’s reforms implemented,
this would represent a significant departure from, and improvement over,
existing arrangements. While specific aspects of Australia’s system have
in the past been conducted on a national basis, these have not, on the
whole, been successful. This is undoubtedly because they were not part
of a broader and more consistent program of national coordination.
The establishment of a National Authority could be the first step on
the road to bringing Australia’s system into closer alignment with world’s
best practice nationally coordinated organ donation and transplantation
systems, such as Spain’s. Spain currently has the highest rate of organ
donation in the world (34.3 donors per million population in 2007)—largely
due to its commitment to improving organ donation rates throughout the
country’s entire health care system. Organ transplantation has a specific
budget allocation in Spain, and all aspects of organ donation and transplantation
activities are nationally coordinated and consistent. Perhaps most importantly,
a standardised donation process and proactive donor detection program
is run by designated organ transplant coordinators in the nation’s hospitals.[9]
Each of these features is more-or-less mirrored in the Government’s proposed
national reform package.
One feature of Spain’s system, however, that is not to be introduced
to Australia as a part of the proposed reforms is that nation’s presumed
consent, or opt-out, system of legal consent for donation. Under an opt-out
system of consent, people are assumed to wish to donate their organs after
death, unless they officially register their objections beforehand. This
system differs from Australia’s opt-in arrangements, wherein a person
must explicitly give their consent to become an organ donor after death.
The question of whether or not Australia should introduce an opt-out
system of consent has provided the main point of discussion in recent
debates over reform of the nation’s organ donation sector.
Several commentators have expressed their support for the introduction
of an opt-out system to Australia, on the basis that this could lead to
an increase in the number of organs available for transplantation.[10] However, the Government chose
not to change Australia’s framework of legal consent for donation as a
part of its reform measures, in keeping with the recommendation of the
Taskforce.[11]
In considering changes to the legislative basis of consent for organ
donation in Australia, the Taskforce recommended against the introduction
of an opt-out system by any Australian state or territory.[12] It did so primarily on the grounds
that ‘when international comparisons in donor rates according to consent
laws (and actual practice) are considered, there is no clear correlation
between opt-out systems and better performance in organ donation’.[13]
However, there is some evidence to suggest that opt-out systems do indeed
help to increase the number of donated organs available for transplantation.
For example, a recent study of opt-in and opt-out systems, conducted over
a ten-year period for 22 countries, concluded that, when other determinant
factors affecting donor numbers were accounted for, those countries with
opt-out legislation in place had deceased organ donor rates that were
25 to 30 per cent higher than those with opt-in legislation.[14]
Under current Constitutional
arrangements, legislative responsibility for organ donation lies with
the states and territories. Until Parliament does legislate for an opt-out
(or opt-in) system, organ donation and transplantation activities will
continue to be undertaken largely through regulation and administration.
While the Authority could require compliance with a policy or protocol,
standard or code of practice (as determined by the Authority) as a term
or condition of financial assistance, under clause 57 of the Bill, it
could not compel the states and territories to comply. As a result, were
any of the states or territories to choose to introduce an opt-out system
of consent—as some have indicated they are considering—they would be free
to do so.
For example, a Queensland Parliamentary
Committee is currently exploring the option of introducing an opt-out
system to that state. Among other things, the Committee is seeking crown
law advice on whether or not the state could adopt an opt-out system independent
of the other states and territories. The Committee tabled its report on
28 October 2008.[15]
Various other possible options for boosting organ donation rates in Australia
were not considered by the Taskforce, and do not form a part of the Government’s
proposed package of reforms. These options are discussed in the Parliamentary
Library paper, ‘The future of organ donation in Australia: moving beyond
“the gift of life”’, along with a proposed alternative basis and approach
to organ donation in Australia.
To date, there has been no significant public comment on the Bill, and
what little comment there has been has been strongly supportive. For example,
Dr Tim Mathew, Medical Director of Kidney Health Australia, has welcomed
the Bill on the grounds that it should enable reforms that would significantly
improve Australia’s organ donation rate.[16]
Earlier, Chris Thomas, CEO of Transplant Australia, provided his support
for the Government’s proposed package of reforms. Mr Thomas thought it
likely that the reforms would increase the number of organs available
for transplantation.[17] In speaking on the Bill, Leader
of the Opposition, Malcolm Turnbull indicated that the Coalition strongly
supports the objectives of the Bill and expressed his support for the
legislation and for other future measures calculated to promote organ
donation. Mr Turnbull stated, ‘if this legislation proves to be inadequate,
we will continue to work in a genuine bipartisan fashion to promote organ
donation’.[18]
The reform package enabled by the Bill provides for total Australian
Government funding of $151.1 million over four years. This figure consists
of $136.4 million in new funding and $14.7 million in transfers and offsets
from existing organ and tissue program funding.
Clause 4 of the Bill provides definitions for expressions used
throughout the Bill. These include:
- ‘organ’ means an organ of a human body (within the ordinary meaning
of that expression). According to the Wikipedia entry on organ
transplantation ‘organs that can be transplanted are the heart, kidneys,
liver, lungs, pancreas, penis and intestine’. The Explanatory Memorandum
also details the intentions of the Bill and provides a list which is
not intended to be exclusive.[19]
The point is made in the Explanatory Memorandum that the definition
is based on existing state and territory legislation and is intended
to be broad and general.
- ‘tissue’ means a part of a human body (other than an organ), or a
part of an organ, or a substance extracted from an organ or part of
a body. Once again, according to the Wikipedia entry on organ transplantation,
‘tissues include bones, tendons, cornea, heart valves, veins, arms and
skin’.
- ‘partner’ is defined as a spouse or de facto partner and ‘de facto
partner’ will have the meaning that is in the Acts Interpretation
Act 190I (the AIA). Currently the AIA does not have a definition
of ‘de facto partner’ but the Same- Sex Relationships (Equal Treatment
in Commonwealth Laws – General law Reform) Bill 2008 before the Parliament
will provide, if passed, that a person will be a de facto partner of
another person (whether of the same sex or a different sex) if the relationship
is registered under a state or territory, or they have a relationship
as a couple living together on a genuine domestic basis. If passed,
this new definition will commence on the day of Royal Assent of that
Bill, which is likely to be before the commencement date of this Bill.
Clause 8 establishes the Australian Organ and Tissue Donation
and Transplantation Authority (the Authority) which will consist of the
Chief Executive Officer (the CEO) and staff. The function of the Authority
is to assist the CEO in the exercise of his or her functions (clause
9).
The Note to the clause makes clear that the Authority will not have a
legal identity separate from the Commonwealth and the Explanatory Memorandum
states:
It is intended that the Authority will be a prescribed
agency for the purposes of the Financial Management and Accountability
Act 1997. This means that the Authority will be subject to that
Act.
The Review of the Corporate Governance of Statutory Authorities and Office
Holders (the Uhrig review) was released on 12 August 2004. [20] One of the recommendations of
the Uhrig review was that the legislative basis for statutory agencies
should be simplified—the Financial Management and Accountability Act
1997 should be applied to budget funded statutory authorities; the
Commonwealth Authorities and Companies Act 1997 should be applied
to authorities that are legally and financially separate from the Commonwealth.
The CEO’s functions are set out in clause 11 of the Bill and include,
in part, such functions as:
- Formulating, in writing, policies and protocols relating to organ
or tissue donation and transplantation matters (hereafter referred to
as ‘organ donations’) (paragraph 11(1)(a))
- Declaring, in writing, standards and codes of practice relation to
organ donations (paragraph 11(1)(b))
- Carrying out educational, promotional and community awareness programs
relevant to organ donations (paragraph 11(1)(f))
- Making financial grants on behalf of the Commonwealth in relation
to organ donations (paragraph 11(1)(g)), and
- Advising the Minister about organ donations (paragraph 11(1)(j))
- Performing such other functions as specified in a written instrument
by the Minister.
In performing the functions, the CEO must have regard to the objectives
and other matters outlined in clause 12, and must also comply with
any written policy principles that the Minister gives under clause
13. The Minister’s instructions and policy principles are not legislative
instruments (subclause 11(6) and subclause 13(4)) which
has the effect that they will not be disallowable by Parliament.
The CEO is appointed by the Minister, and for a term not to exceed 5
years (clauses 14 and 15). The CEO may not engage in any
other employment without the Minister’s approval (clause 20) and
must make full disclosure to the Minister to avoid any conflicts of interest.
The Minister may terminate the appointment for the standard reasons such
as misbehaviour, incapacity, bankruptcy and so on (clause 22).
The Minister may also give written directions of a ‘general nature’ to
the CEO by way of legislative instrument (which are also not disallowable
and not subject to the ‘sunset arrangements’ in the Legislative Instruments
Act 2003, see notes one and two to clause 30).
Part 4 of the Bill establishes the Australian Organ and Tissue
Donation and Transplantation Advisory Council (the Council) which will
consist of a Chair and at least 9, and no more than 15, members (clauses
31 and 33).[21]
The Council’s function is to advise the CEO ‘about organ or tissue donation
and transplantation matters’ (clause 34).
Members are appointed by the Minister, who must consult State and Territory
counterparts and any other persons the Minister considers appropriate
(paragraphs 34(2)(a)-(d)). Appointments are for a period not exceeding
3 years and (subclause 34(4).
To be eligible for appointment to the Council, members must have expertise
in certain areas of endeavour, such as public administration, organ or
tissue donation and transplantation matters, business, management, finance,
health consumer issues or other appropriate fields of expertise (subclause
34(6)).
In terms of accountability and transparency, Council members must make
disclosures to the Minister and to each other (clauses 42 and 43)
and hold office subject to any terms and conditions determined by
the Minister (clause 43).
There will also be Expert Advisory Committees (the Committee/s) which
will be appointed by the CEO to advise the CEO ‘about organ or tissue
donation and transplantation matters’ referred to it by the CEO (clauses
44 and 45). Members will be part-time and for a period not
exceeding 3 years, and appointments can be terminated by the CEO (clause
46).
The Bill provides similar regulation regarding the establishment of committees,
while not specifying details such as how many members comprise a committee
or how many committees may be established by the CEO.
The Explanatory Memorandum[22] explains the rationale for the
two tier structure:
This two tier advisory structure will allow the CEO
to receive advice from a range of appropriate expert sources to assist
him or her in the effective performance of his or her functions.
All of the persons appointed under the Bill will have their remuneration
determined by the Remuneration Tribunal (clauses 17, 38 and 48)
apart from the staff of the Authority who will be engaged under the Public
Service Act 1999 (clause 25). It should be noted that the CEO
can also engage suitably qualified persons as consultants on terms and
conditions determined by the CEO (clause 26).
On behalf of the Commonwealth, the CEO can enter into agreements with
the states, territories or a person to make a grant of financial assistance
which relates to one or more organ or tissue donation and transplantation
matters (clauses 54-56).
Clause 57 deals with compliance with policies, protocols, standards
and codes formulated or declared by the CEO under paragraphs 11(a) and
(b). Under subclause 57(1), compliance with these is voluntary
– presumably on the basis that the Commonwealth does not currently have
the constitutional power to require compliance on organ donation matters
by non-Commonwealth bodies or persons.[23]
However, as previously noted in this Digest, the Commonwealth can make
compliance a condition of any grant of financial assistance, contract
etc: subclause 57(2).
The Privacy Act 1988 does not apply to deceased people. However,
the Privacy Act does have some relevance to the matters dealt with in
the Bill. Clause 58 specifies that the deceased person’s partner,
or other authorised person yet to be established by regulation, must give
consent for the release of information that might identify a donor or
recipient.
Clause 58 seeks to preserve patient confidentiality by preventing
the CEO from publishing or disseminating information that might identify
a donor or recipient without consent from the person or a person who is
authorised to consent on the person’s behalf.
Clause 59 preserves the operation of state and territory laws
that can operate concurrently (that is, laws that are not inconsistent
with the Bill), and subclause 59(2) specifically provides that
the provisions of the Bill do not affect any laws (statutory or common
law) relating to the giving of consent to the removal or an organ or tissue
(from a living or a dead person). It is worth noting in this context,
that the Bill goes to issues of governance and establishing the Authority,
the Council and the Committees, but does not deal with issues or details
such as consent and administration of organ transfer procedures in general,
areas that are a state or territory responsibility.
Concluding comments
It is likely that the establishment of an Australian Organ and Tissue
Donation and Transplantation Authority would, along with other elements
of the Government’s national reform package, help to improve the rate
of organ donation and transplantation in Australia—at least in the short-
to medium-term. While the reform package has been welcomed by a range
of commentators, it is debatable whether or not the proposed changes will
meet Australia’s existing demand for organs, or provide for a sustainable
supply of organs into the future.
Matthew Thomas and Diane Spooner
13 November 2008
Bills Digest Service
Parliamentary Library
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