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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