Hot Topics 64 - Health and the Law - Legal Information Access Centre

HOTTOPICS
2008 > TOpICS 64
L E g A L I S S u E S I N p L A I N L A N g u A g E
This is the sixty-fourth in the series Hot Topics:
legal issues in plain language, published by the Legal
Information Access Centre (LIAC). Hot Topics aims to
give an accessible introduction to an area of law that is
the subject of change or public debate.
AUTHORS: Dr Thomas Faunce and Kathy Shats, ANU;
Carolyn Adams, Australian Law Reform Commission
(Health Privacy in Australia pp 6-10).
EDITOR: Cathy Hammer
DESIGN: Bodoni Studio
Health and the Law
1 Overview of health law in Australia State Library of NSW
PHOTOS: Fairfaxphotos – main cover image
(Louise Kennerley, AFR), pp 2, 4, 11, 13, 17 & 21;
iStockphoto – p 7; The DW Stock Photo Library –
pp 9 & 20; Newspix – p 22.
Role of the Constitution, parliament and courts – regulating doctors Cataloguing-in-publication data
and other health professionals – regulating medicines and medical
Author: Faunce, Thomas
devices – medical negligence – seeking damages for negligence –
consent to medical treatment – When may less information be given? – Carolyn Adams; editor: Cathy Hammer
capacity to consent.
6 Health privacy in Australia
Subjects: Medical laws and legislation – Australia
Privacy legislation regulating the handling of health information –
Other Contributors: Shats, Kathy
health privacy in a federal system – the Privacy Act 1988 (Cth) – state
Adams, Carolyn
and territory regulation of privacy – electronic health records – children
Hammer, Cathy
Legal Information Access Centre
and young people – deceased individuals – law reform and the privacy of
Series: Hot topics (Sydney, N.S.W.); no. 64
personal health information – patient access to their medical records.
Dewey Number: 344.94041
11 Fertility and conception issues
Hot Topics, ISSN 1322-4301, No. 64
Artificial reproductive technology – wrongful birth and wrongful life –
© Library Council of New South Wales 2008. All rights
surrogacy – cloning – abortion.
13 End of life issues State Library of New South Wales). Apart from any use
Voluntary euthanasia – palliative care: pain relief and ‘double effect’ –
withdrawing or withholding treatment and ‘no CPR’ orders – case
without written permission from the Legal Information
study: Messiha – case study: Schiavo – Australian cases on the role of Access Centre.
courts and tribunals in disputes about medical treatment – advantages
and disadvantages of court decisions on futile treatment – organ
donation by brain-dead persons – autopsies – coronial enquiries.
19 Human right to health
Medical ethics and human rights law – nanomedicine and sunscreens –
Australia-US Free Trade Agreement, blood products and the PBS –
23
whistle-blowing in the medical profession.
Further information
Title: Health & the law/authors: Thomas Faunce, Kathy Shats,
Publisher: Sydney, N.S.W.: Legal Information Access Centre,
2008.
reserved. Copyright in Hot Topics is owned by the Library
Council of New South Wales (the governing body of the
permitted by the Copyright Act (including fair dealing for
research or study) this publication may not be reproduced
Hot Topics is intended as an introductory guide
only and should not be interpreted as legal advice.
Whilst the Legal Information Access Centre attempts
to provide up-to-date and accurate information,
it makes no warranty or representation about the
accuracy or currency of the information it provides
and excludes, to the maximum extent permitted by law,
any liability which may arise as a result of the use of this
information. If you are looking for more information on
an area of the law, the Legal Information Access Centre
can help – see back cover for contact details. If you
want legal advice, you will need to consult a lawyer.

Overview of Health
Law in Australia
rOle Of THe cOnsTiTuTiOn,
parliamenT and cOurTs
In Australia, the Commonwealth (Federal) Parliament
and the state and territory parliaments have power to
make laws in relation to health and medical matters. The
Federal Government is restricted to making legislation
on heads of power specifically listed in the Constitution
such as those mentioned in s 51. Section 51 xxiiiA
was inserted after a referendum in the 1940s to allow
federal laws about, among other things, ‘pharmaceutical,
sickness and hospital benefits’ as well as ‘medical and
dental services’. This section forms the basis of the
federal law (the National Health Act 1953 (Cth) which
establishes the Pharmaceutical Benefits Scheme (PBS)
where the federal government pays most of the cost of
medicines and bargains down their price on the basis of
evidence about their cost-effectiveness.
It is not possible to argue that funding and control of
public hospitals comes within the meaning of ‘medical’
services in section 51 xxiiiA, because running hospitals
involves a variety of other services such as nursing
services, administration services, physiotherapy etc.
The legislation passed by parliaments of the states and
territories in relation to health falls into three main
areas:
> public health;
> administration of public hospitals and licensing of
private hospitals and private nursing homes;
> regulation of the medical and other health
professions.
Judges sit on a variety of courts to interpret and apply
legislation and constitutional provisions to the particular
facts of cases heard by the courts. The High Court sits in
Canberra and there are also Federal Courts (interpreting
federal legislation), state and territory Supreme Courts
and then below them in the hierarchy, District Courts,
magistrates courts or local courts.
HOT Tip
In section 51 xxiiiA, the words ‘medical and dental
services, but not so as to authorise any form of civil
conscription’ arose as a result of one of the few
successful constitutional referendums, held on 28
September 1946, after WWII. The Chifley (Labor)
government proposed the Constitution Alteration
(Social Services) Bill 1946 which, among other things,
gave it power to create a scheme of free essential
medicines. This was opposed at the time by the British
Medical Association, the forerunner of the Australian
Medical Association, the trade union of doctors
which opposed what they saw as the beginning of
socialised medicine. 1
regulaTing dOcTOrs and OTHer
HealTH prOfessiOnals
Doctors and other health professionals (such as nurses,
physiotherapists and counsellors) are regulated in what
they do professionally by codes of ethics such as
the updated version of the Hippocratic Oath called
the Geneva Declaration 2 and the Australian Medical
Association Code of Ethics. 3 Some core obligations of
such oaths are that doctors:
> should respect their patients’ rights to confidentiality
> should not deliberately harm or abuse patients
> should not work beyond their level of competence
> should treat patients equally.
Ethics committees considering proposals for research may
also consider principles flowing from the Declaration of
Helsinki 4 such as the need to fully inform subjects of the
risks involved and any conflicts of interest the doctors
might have. Also relevant are institutional guidelines
and policies (many produced by the National Health
and Medical Research Council (NHMRC), contractual
terms of employment of hospital staff, judicial decisions
(‘case law’), laws of the Federal parliament and of state
parliaments. The ACT and Victoria now have legislation
requiring judges to take into account human rights
1. For further discussion, see ‘Devaluation of a Constitutional Guarantee: The History of Section 51(XXIIIA) of the Commonwealth
Constitution’, Danuta Mendelson, Melbourne University Law Review, available at www.austlii.edu.au/au/journals/MULR/1999/14.html
2. Available from the website of the World Medical Association at www.wma.net/e/policy/c8.htm
3. Available online at http://www.ama.com.au/web.nsf/tag/amacodeofethics
4. Available from the website of the World Medical Association at www.wma.net/e/policy/b3.htm
Overview of Health Law in Australia 1

when resolving ambiguities in legislation. International
human rights relevant to health include the ‘right to
life,’ the prohibition of ‘cruel, inhuman or degrading
treatment or punishment’ and of medical or scientific
experimentation without ‘free consent’.
The behaviour of doctors and health professionals is
also regulated by the laws that bind everyone, such as
criminal and civil law, common law and legislation as
discussed earlier. Particularly important is the tort of
negligence under which a plaintiff must prove that the
persons he/she is suing has breached a recognised duty of
care and caused damage of a type that the law recognises
as compensable.
regulaTing medicines and medical
deVices
The Therapeutic Goods Act 1989 (Cth) provides a
framework for regulating medicines and medical devices
to ensure their quality, safety and effectiveness. Medicines
assessed as having a higher level of risk are evaluated
and registered, whereas lower risk consumer medicines
including complementary medicines and vitamins are
assessed for quality and safety. Regulations under the
Act set out requirements for advertising and labelling.
The Therapeutic Goods Administration is responsible
for evaluating prescription medicines to decide which
can be sold in Australia, and which are listed on
the Pharmaceutical Benefits Scheme, a scheme which
subsidises the cost of necessary prescription medicines
for consumers. For information on the Therapeutic
Goods Administration see www.tga.gov.au and for
information on the Pharmaceutical Benefits Scheme see
www.pbs.gov.au
medical negligence
Once a doctor willingly accepts a patient’s request for a
medical opinion, they owe that patient a ‘duty of care’.
The doctor’s duty is to achieve the best outcome for
image u navailable
that patient, but is under no obligation or duty to cure
them. The standard of care in general terms will be
that of a reasonable doctor in the defendant’s position.
Junior doctors do not owe a lower standard of care, as
all doctors who are registered are held out to the public
as reaching a minimal acceptable standard of care. To
make a claim for medical negligence you need to prove
that a duty of care was owed by the professional, that the
standard of care was broken and that damage arose.
HOT Tip
‘Duty of care’ is the obligation owed to anyone who
could be injured by a person’s lack of care. It must be
‘reasonably foreseeable’ that an injury could result from
the lack of care: Donoghue v Stevenson [1932] AC 562.
The duty may be owed to a person in a specific category,
such as a doctor to a patient.
Traditionally, doctors were not said to have breached
their duty of care if they acted in accordance with a
practice accepted by their peers – that is, by a body
of practitioners skilled in that particular field. This is
known as the ‘Bolam’ test, after an English case: Bolam
v Friern Hospital Management Committee (1957) 1 WLR
582. 5 This case was accepted and followed in Australia
for some time.
The law in Australia changed, however, due to the
groundbreaking High Court case Rogers v Whitaker:
see case study, p 3. The essence of the change lay in
who it was that could determine that a practitioner was
negligent. Under the Bolam test, a practitioner’s peers
(i.e. other doctors) set the standard. But under Rogers v
Whitaker, the court replaced this with an objective test
to be determined by the court itself. In other words,
the court had to decide whether a reasonable doctor,
exercising reasonable care and skill, would have acted
in that way given the available material. So if a court
decided that a practitioner was acting unreasonably, the
practitioner would be liable even if he or she followed a
practice accepted as proper at that time by the medical
profession.
In Rogers v Whitaker, the case turned specifically on a
practitioner’s failure to warn of the risks involved in
undertaking treatment. A later case, Naxakis v Western
General Hospital took the objective test even further. 6
Naxakis extended the court-determined objective test
to negligent diagnosis and treatment. This case involved
a schoolboy who had been hit on the head with a
school bag in a fight with another child. The victim
was treated in hospital and sent home, only to collapse
a couple of days later. He was then found to have a
major intracranial bleed from a burst aneurysm. The
bursting of the aneurysm caused permanent impairment.
Gabriele Charotte, Australian Financial Review.
5. Available at http://oxcheps.new.ox.ac.uk/casebook/Resources/BOLAMV_1%20DOC.pdf
6. [1999] HCA 22 available at http://www.austlii.edu.au/au/cases/cth/HCA/1999/22.html
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HOT TOPICS 64 > Health and the Law

There was evidence that, if an angiogram had been
undertaken before the hospital release, the aneurysm
might have been identified and treated.
Justice Gaudron stated:
‘… it was for the jury to form their own conclusion as
to whether it was reasonable for one or more of those
steps to be taken. It was not for the expert medical
witnesses to say whether those steps were or were not
reasonable. Much less was it for them to say, as they
were frequently asked, whether, in their opinion, the
hospital and Mr Jensen were negligent in failing to
take them.’
The Civil Liability Act 2002 (NSW) sets out the
standard of care for professionals (note: it refers to
professionals in general, not just medical practitioners).
Section 50 of the Act states that a professional does not
incur a liability in negligence if they ‘acted in a manner
that (at the time the service was provided) was widely
accepted in Australia by peer professional opinion as
competent professional practice’. The fact that there
are differing peer professional opinions widely accepted
in Australia does not prevent any one or more of those
opinions being relied on. It also states that the peer
professional opinion does not need to be universally
accepted in order to be considered widely accepted.
There is a proviso, however. Peer professional opinion
cannot be relied on if the court considers that the
opinion is irrational. The test is therefore a return to
the Bolam test but with a limitation that leaves it open
for a court to conclude that the opinion relied upon was
irrational.
[Some information in this section was previously published in Hot
Topics 51: Personal Injury by Stella Tarakson, Legal Information
Access Centre.]
seeking damages fOr negligence
To commence litigation proceedings against a doctor
you must have sent the doctor a written notice of claim
(not the actual legal statement of claim) within the
statutory time limit of the event causing damage or when
symptoms of it first appeared, or when you first saw a
lawyer about it. The doctor must respond to that notice
within a prescribed time: see Uniform Civil Procedure
Rules (NSW) rule 6.10. The essence of that response
should be that the notice of claim complies with the
legislation, whether liability is admitted or denied, the
percentage of contributory negligence claimed, whether
any offer is accepted or rejected and what is a reasonable
estimate of damages.
In seeing a solicitor to commence proceedings to recover
damages for medical negligence you are likely to be
asked to sign a costs agreement providing for payment
for legal services at a rate of approximately $300 per
hour. If the case is taken on as ‘no win no fee’ this won’t
be sought until settlement. If you lose a ‘no win no fee’
case sTudY:
ROGERS v WHITAKER
The plaintiff had been blind in her right eye since
sustaining a childhood injury. Nearly 40 years later,
she agreed to surgery with the aim of restoring
some sight to that eye and improving its appearance
by removing scar tissue. The operation was not a
success. It did not result in improved vision to the
right eye. Instead, it caused an inflammation in her
left eye as a result of sympathetic ophthalmia (which
generally has a one in 14,000 chance of occurring).
This ultimately led to loss of sight in her left eye. As
her right eye was not improved, she was left almost
totally blind.
The issue was not that the surgeon had failed to
conduct the operation with the required care and
skill. Rather, the case turned on the failure to warn
the patient of the risk of sympathetic ophthalmia.
The trial judge in the Supreme Court of New South
Wales faced competing evidence from medical
practitioners. One body stated it would not warn of
the risk, another stated it would. The trial judge found
for the plaintiff. The defendants appealed, without
success, to the Court of Appeal and then to the High
Court.
The High Court found that the doctor was in breach
of his duty of care in not warning of the risk of
sympathetic ophthalmia. It stated that the Bolam test
could not be applied to the provision of information,
and noted that a patient’s consent requires that
sufficient information be given.
Rogers v Whitaker (1992) 175 CLR 479; available online at
www.austlii.edu.au/au/cases/cth/HCA/1992/58.html
case, the question of whether you have to pay the costs
of the other side or not will depend on the terms of
your cost agreement and the costs order, if any, made
by the court. Normally if the case is settled prior to
the court hearing, the plaintiff doesn’t have to pay the
costs of the defendant. However, you may have to pay
disbursements, even in ‘no win no fee’ cases.
Many plaintiff firms provide the first hour free of charge
so that the solicitor can determine whether you have a
reasonable claim or not. The solicitor will need to know
the factual chronology, so it is advisable to prepare this
before you meet.
It must be mentioned however, that under the Civil
Liability Act 2002 (NSW) a doctor may give an apology
(an oral or written expression of sympathy or regret)
which cannot be admissible as an express or implied
admission of fault or liability. Another avenue of redress
is to make a complaint to the hospital, the medical board
or Health Complaints Commissioner. The aim here is
generally to achieve an apology, receive information or
prevent the same harm happening to others.
Overview of Health Law in Australia 3

HOT Tip
Disbursements – money expended by a solicitor on
behalf of a client, which can include filing fees, setting
down fee, applications for official records, stamp duty
and barrister’s fees.
Costs order – an order made by a court that the costs of
one party be paid or shared by the other party. usually
the party that has lost a case has to pay, or if the case
is settled (i.e. agreement is reached outside court
proceedings) a costs order may be part of the settlement
agreement.
cOnsenT TO medical TreaTmenT
Doctors need to obtain implied or direct consent
before they touch patients, otherwise their actions could
constitute assault. To avoid legal action for assault or
battery (trespass to the person), doctors and other health
professionals must obtain a patient’s free consent to the
‘nature’ of what is proposed before they undertake any
medical procedure or treatment (Chatterton v Gerson
[1980] 3 WLR 1004). This applies even where the
proposed treatment would clearly benefit the person and
a failure to treat may result in harm that could have been
avoided. The principle applies not only to treatment
but also to diagnostic and investigative procedures.
Convenience to the patient or surgeon (not having to
start the operation again another day after an unusual
finding) is not an exception to this rule (Murray v
McMurchy [1949] 2 DLR 442). Free consent to medical
treatment and experimentation is also a human rights
obligation (see Article 7 International Covenant on Civil
and Political Rights 7 ) (ICCPR).
The rule about prior consent is based on recognising
that the inherent dignity of competent adult patients
entitles them to make their own ‘autonomous’ medical
decisions, even if apparently not in their ‘best interests’.
The law has also increasingly emphasised that a patient
must be given adequate information to make an informed
decision on whether to agree to a medical procedure.
This includes accurate, up-to-date information about the
patient’s medical condition and prognosis; the options
for investigation or treatment and their advantages and
disadvantages, including what is likely to happen if
nothing is done; and the availability of more skilled or
experienced doctors.
Most of the cases have concerned the type and amount
of information that needs to be given about the potential
risks of a proposed procedure. The High Court said in
Rogers v Whitaker 8 that a doctor must warn a patient of
risks that are ‘material’, and that a risk is material if:
in the circumstances of the particular case, a
reasonable [that is, an ‘ordinary’] person in the
patient’s position, if warned of the risk, would be
likely to attach significance to it or if the medical
practitioner is or should reasonably be aware that the
particular patient, if warned of the risk, would be
likely to attach significance to it.
Essentially, this means that a patient should be warned
of risks that are:
> objectively reasonably likely (that is on a statistical
basis) or;
> of particular (subjective) concern to that person that
has been communicated beforehand to the doctor.
image u navailable
Robert Pearce, Sydney Morning Herald.
7. Available online at http://www.unhchr.ch/html/menu3/b/a_ccpr.htm
8. [1992] HCA 58; available online at http://www.austlii.edu.au/au/cases/cth/HCA/1992/58.html
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HOT TOPICS 64 > Health and the Law

Objective risk information is best given with the
assistance of printed materials with adequate time for
the patient to reflect upon it and discuss it with friends
and relatives. More information about material risks is
required for a ‘cosmetic’ procedure than for surgery that
is clinically indicated for preservation the patient’s life
or immediate health and would have been proceeded
with regardless of the answer given. Serious risks, like
death, stroke or paralysis should be mentioned even
if they are remote. Relatively minor injuries – such as
bruising after a doctor has inserted a plastic cannula into
a vein, or damage to the front teeth on intubation by
an anaesthetist – may be material if they are frequent.
Unusually inquisitive patients may need to be given
more risk information: see Chappel v Hart.
9
Patients should ask for the risk information to be given
to them in writing so they are able to take time to
consider it at home. When asked to sign a ‘consent form’
the patient should ensure that they are able to think
clearly; that they have not been given a ‘pre-med’, for
example, or are unable to think clearly for some other
reason. If they have particular concerns, they should
be sure to note these on the form, or have the doctor
record them, as well as any answers given. If language
is a difficulty they should ask for a translator. Even if a
patient signs a consent form, this is not conclusive proof
that all the matters mentioned in the form have been
discussed with the patient or understood by them.
The doctor should mention whether he or she has any
conflict of interest (for example, holding shares or a
managerial position in a company marketing a product
or device that will be used in the procedure). If the
doctor also wants to include you in a research project,
that consent discussion should take place separately.
WHen maY less infOrmaTiOn Be
giVen?
There are several situations in which less information
may be justifiable.
The first is in an emergency. Treatment may be given
without any information or consent if it is necessary
to protect the patient’s life or health (Guardianship
Act 1987 (NSW), s 37(1)). If, for instance, a patient
is unconscious, a health professional may perform
whatever procedures are reasonably necessary in the
circumstances to preserve the patient’s life or health. It is
not necessary to obtain the consent of the patient’s next
of kin, although that is generally done as a courtesy.
The second case in which less information may be
required is when the patient waives the right to be
given information. Ethically, a doctor should confirm
that the reasons behind such a refusal do not involve a
misunderstanding.
The third situation is a doctor’s limited discretion
(therapeutic privilege) not to disclose information where
he or she has reasonable grounds to believe, and is
prepared to document, that disclosure of the information
may itself harm the patient (for example, if the patient
is suicidal or mentally ill). Mere anxiety in the patient is
not a sufficient reason under this ground for a doctor to
withhold information; see Rogers v Whitaker . 10
capaciTY TO cOnsenT
The principles that people may not be given medical
treatment without their consent, and that they are
entitled to adequate information to make an informed
choice, apply to competent adults (that is, to people over
18 who are able to understand their condition and the
options for treatment). The same applies to withholding
consent and refusing treatment.
If the person is a child (under 18), either parent or a
guardian may generally consent to a medical procedure
and the parent or guardian is entitled to the same
information as an adult patient. However, an older
child may also be able to consent if sufficiently mature
to understand the procedure. This will depend on
the child’s age and level of maturity and also on the
particular procedure. Even relatively young children
can consent to simple procedures for their own
good, such as a vaccination. On the other hand,
greater maturity and understanding will be required
for procedures that are risky or contentious, such as
contraception (Gillick’s case [1986] AC 112). In the
cases of abortion, reproductive sterilisation, or medical
procedures concerned with contraception of a mentally
handicapped minor, the parent or appointed guardian
alone cannot consent and the guardianship tribunal
must be involved and possibly a court (Guardianship Act
1987 (NSW) Part 5; Marion’s case 11 ).
People who have an intellectual disability or mental illness
may not be able to consent to medical treatment. Again,
this will depend on the patient’s level of understanding
(which may fluctuate) and the nature of the procedure.
If the impairment is slow to develop, persons may make
an enduring power of attorney allowing a nominated
person to give consent to lawful medical treatment
on their behalf and to its withholding or withdrawal
(Powers of Attorney Act 2003 (NSW) Part 4).
If a person has impaired decision-making capacity due
to permanent or long-term disability, and is over 18,
consent may be given by a person appointed under the
Guardianship Act 1987 (NSW).
9. Chappel v Hart [1998] HCA 55, per Kirby J at [99], available at www.austlii.edu.au/au/cases/cth/HCA/1998/55.htmll
10. Available online at http://www.austlii.edu.au/au/cases/cth/HCA/1992/58.html
11. Secretary, Department of Health and Community Services v JWB and SMB (Marion’s case) [1992] HCA 15;
available at www.austlii.edu.au/au/cases/cth/HCA/1992/15.html
Overview of Health Law in Australia 5

Health privacy
in Australia
‘privacy is a fundamental principle underpinning
quality health care. Without an assurance that
personal health information will remain private,
people may not seek the health care they need
which may in turn increase the risks to their own
health and the health of others.’
Australian Government Department of Health and
Ageing, Submission to the Office of the Privacy
Commissioner – Review of the Private Sector Provisions
of the Privacy Act 1988, December 2004.
Traditionally, a person’s health information was
protected by ethical and legal duties of confidentiality.
Health service providers – such as doctors, dentists,
nurses, physiotherapists and pharmacists – owe a
duty of confidentiality to health consumers. The duty
requires that health service providers only use the health
information they collect from health consumers for
the purpose for which the information was provided.
The duty is intended to foster a relationship of trust
between health service providers and health consumers.
Such duties are not absolute and there are circumstances
in which the law permits, and sometimes requires, the
disclosure of confidential personal health information,
for example, in the case of notifiable diseases. See, for
example, Public Health Act 1991 (NSW) s 14 and Health
Act 1958 (Vic) s 138.
More recently, privacy legislation has also been
introduced in a number of Australian jurisdictions to
regulate the handling of personal information, including
personal health information. The following table sets
out those Acts across Australia that deal specifically with
the privacy of personal health information.
These laws operate alongside the existing duties of
confidentiality. Privacy legislation establishes rules for the
collection, use and disclosure of personal information,
as well as avenues for individuals to access and correct
their own information. Such legislation generally also
priVacY legislaTiOn regulaTing THe
Handling Of HealTH infOrmaTiOn
Jurisdiction public Sector private Sector
Commonwealth Privacy Act 1988 (Cth) Privacy Act 1988 (Cth)
New South Wales Health Records and Information Privacy Act Health Records and Information Privacy Act
2002 (NSW) 2002 (NSW)
Privacy Act 1988 (Cth)
Victoria Health Records Act 2001 (Vic) Health Records Act 2001 (Vic)
Privacy Act 1988 (Cth)
Queensland Administrative scheme Privacy Act 1988 (Cth)
Western Australia Information Privacy Bill before the Western Privacy Act 1988 (Cth)
Australian Parliament
Information Privacy Bill before the Western
Australian Parliament
South Australia Administrative scheme Privacy Act 1988 (Cth)
Tasmania Personal Information Protection Act 2004 (Tas) Privacy Act 1988 (Cth)
ACT Health Records (Privacy and Access) Act 1997 Health Records (Privacy and Access) Act 1997
(ACT)
(ACT)
Privacy Act 1988 (Cth)
Privacy Act 1988 (Cth)
Northern Territory Information Act 2002 (NT) Privacy Act 1988 (Cth)
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HOT TOPICS 64 > Health and the Law

provides for complaints to a statutory official, usually a
privacy commissioner or a health services commissioner,
where personal information may have been handled
inappropriately.
HealTH priVacY in a federal sYsTem
The Australian Constitution establishes a federal
system in which legislative powers are distributed
between the Australian Parliament and the six state
parliaments. As noted in the table (previous page), the
Australian Parliament and a number of the states and
territories have passed legislation relating to privacy and
this has resulted in some overlap and duplication. The
following is a brief description of the privacy legislation,
including specific health privacy legislation, currently
operating in Australia.
THe priVacY acT 1988 (cTH)
The principal piece of federal legislation regulating
privacy in Australia is the Privacy Act 1988 (Cth).
The Preamble to the Privacy Act makes clear that the
legislation was intended to implement, at least in part,
Australia’s obligations relating to privacy under the
United Nations International Covenant on Civil and
Political Rights as well as the Organisation for Economic
Co-operation and Development Guidelines on the
Protection of Privacy and Transborder Flows of Personal
Data. These instruments do not draw a distinction
between the protection of personal information generally
and the protection of personal health information.
The Privacy Act applies to both.
The Act contains a set of 11 Information Privacy
Principles (IPPs) that apply to Australian Government
and ACT Government agencies, and 10 National
Privacy Principles (NPPs) that apply in the private
sector throughout Australia. The Act does not regulate
the handling of personal information by state or
Northern Territory government agencies, except to a
very limited extent.
The Act establishes the Office of the Privacy
Commissioner. The Privacy Commissioner has a
number of functions, including receiving complaints
from individuals who believe their information has
been handled in a way that does not comply with the
requirements under the Act.
For further information see www.privacy.gov.au
New South Wales
The Privacy and Personal Information Protection Act
1998 (NSW) contains a set of Information Protection
Principles that regulate the way NSW Government
agencies handle personal information, but not personal
health information.
The Health Records and Information Privacy Act 2002
(NSW) regulates the handling of health information in
NSW Government agencies and the private sector. The
Act contains 15 Health Privacy Principles that outline
how health information must be collected, used and
disclosed, and allows individuals to make complaints to
the NSW Privacy Commissioner.
The Health Records and Information Privacy Act applies
in the private sector, which means that anyone handling
health information in the private sector in NSW must
comply with that Act as well as the federal Privacy Act.
This also means that health consumers may have a
choice about whether to complain to the federal Privacy
Commissioner or the NSW Privacy Commissioner
where they believe that their health information may
have been handled inappropriately by a private sector
health service provider in NSW.
For further information see www.lawlink.nsw.gov.au/
privacynsw
Victoria
Like NSW, Victoria has an Information Privacy Act
2000 (Vic) which covers the handling of personal
information in the Victorian public sector other than
personal health information. The Health Records Act
2001 (Vic) covers the handling of health information
in the Victorian public and private sectors. Complaints
under this Act are made to the Office of the Health
Services Commissioner. Victorian private sector health
service providers must comply with both the Victorian
Health Records Act and the federal Privacy Act.
For further information see www.health.vic.gov.au/hsc/
image u navailable
sTaTe and TerriTOrY regulaTiOn Of
priVacY
There are also a number of state and territory laws in
relation to privacy, including the privacy of personal
health information. In some states, where there is
no privacy legislation, state government agencies are
required to comply with administrative privacy regimes.
iStockphoto.
Health privacy in Australia 7

In addition, the Charter of Human Rights and
Responsibilities Act 2006 (Vic) introduces a Charter of
Human Rights and Responsibilities for the protection
and promotion of human rights in Victoria. Part 2 of
the Act sets out a number of human rights, including
the right of a person not to have his or her privacy,
family, home or correspondence unlawfully or arbitrarily
interfered with. The Act requires statutory provisions
to be interpreted in a way that is compatible with the
human rights set out in the Act. It also requires public
authorities to act in a way that is compatible with those
human rights.
Queensland
The handling of personal information and personal
health information by Queensland Government
agencies is managed through an administrative scheme.
Information Standard 42A – Information Privacy for
the Queensland Department of Health applies only to
that Department and requires health information and
personal information to be managed in accordance with
National Privacy Principles adapted from the Privacy
Act. The Health Quality and Complaints Commission
Act 2006 (Qld) sets out a number of health privacy
principles that apply in both the public and private
sectors in Queensland. The Commission is developing
a Code of Health Rights and Responsibilities that will
address health privacy and other issues in more detail.
For further information see: www.hqcc.qld.gov.au
Western Australia
Currently, Western Australia does not have specific
privacy legislation. The Information Privacy Bill 2007
(WA) was introduced into the Western Australian
Parliament on 28 March 2007. It proposes to regulate
the handling of personal information by the WA public
sector and the handling of health information by the
public and private sectors in Western Australia. The
Bill proposes to establish the Privacy and Information
Commissioner, replacing the current Information
Commissioner with an expanded role which will include
resolving complaints.
South Australia
There is no specific privacy legislation in South Australia.
PC012 – Information Privacy Principles Instruction, issued
by the South Australian Department of the Premier
and Cabinet, requires South Australian Government
agencies to comply with a set of Information Privacy
Principles based on the IPPs in the federal Privacy Act.
South Australia also has a Code of Fair Information
Practice based on the NPPs in the federal Privacy
Act. The Code applies to the South Australian
Department of Health and the Department for
Families and Communities. For further information see
www.archives.sa.gov.au/privacy/committee.html
Tasmania
The Personal Information Protection Act 2004 (Tas)
regulates the handling of personal information by
Tasmanian public sector bodies. This Act applies to all
personal information, including health information.
Under the Act, the Tasmanian Ombudsman may either
investigate and determine complaints or refer them to
another person, body or authority that the Ombudsman
considers appropriate. For further information see
www.ombudsman.tas.gov.au
In addition, the Health Complaints Act 1995 (Tas) applies
to Tasmanian health service providers in both the public
and private sectors. The Act provides for a Charter of
Health Rights, which includes rights to confidentiality,
privacy and security. For further information see
www.healthcomplaints.tas.gov.au
Australian Capital Territory
ACT Government agencies are required to comply
with an amended version of the federal Privacy Act,
administered by the Office of the Privacy Commissioner.
The Health Records (Privacy and Access) Act 1997 (ACT)
removes health information from the jurisdiction of
the Office of the Privacy Commissioner and covers the
handling of health information in ACT Government
agencies and the private sector. For further information
see www.hrc.act.gov.au
In addition, the Human Rights Act 2004 (ACT) provides
that all individuals have the right not to have their
privacy, family, home or correspondence unlawfully
or arbitrarily interfered with. Under the Act, when
a court is interpreting an ACT law it must adopt an
interpretation ‘consistent with human rights’ as far as
possible.
Northern Territory
The Northern Territory has combined its information
privacy, freedom of information, and public records
laws into a single Act, the Information Act 2002 (NT).
The Act includes 10 Information Privacy Principles,
which regulate the way that the Northern Territory
public sector handles personal information, including
health information. For further information see
www.privacy.nt.gov.au
Although the Northern Territory does not have health
specific privacy legislation, Territory Health Services
issued the Territory Health Services Information Privacy
Code of Conduct in 1997. The Code is enforceable under
the Public Sector Employment and Management Act
(NT). In addition, the Code of Health and Community
Rights and Responsibilities confers a number of rights
and responsibilities on all providers and consumers
of health and community services in the Northern
Territory. Principle 4 of the Code provides that people
have a right to information about their health, care and
8
HOT TOPICS 64 > Health and the Law

treatment, and also that health service providers have a
responsibility to protect the confidentiality and privacy
of health service users. For further information see
www.nt.gov.au/omb_hcscc/hcscc/index.htm
elecTrOnic HealTH recOrds
Traditionally, health information has been collected and
stored in paper-based systems, with information about
one individual held in a number of disparate locations,
such as general practitioners’ records, hospital records,
pathology laboratory records and medical specialists’
records. However, health information is increasingly
collected, stored and transferred in electronic form
and health information about large numbers of health
consumers is collected into central databases, such as the
Medicare database and cancer registers.
Another important trend is the move to integrate health
information systems and to create shared electronic
health records. Sharing and linking of health information
about particular individuals has the potential to achieve
better health outcomes for consumers – by allowing
health service providers, regardless of their location,
better access to health information – but have also given
rise to privacy concerns.
A large number of electronic health information
systems are being developed at the local, regional
and national levels across Australia. Some important
national initiatives are being developed by the National
E-Health Transition Authority (NEHTA). NEHTA is
developing a national approach to Shared Electronic
Health Records (SEHRs) – records that will contain
selected health information about a health consumer,
which can be shared among multiple authorised health
service providers. An important precursor to SEHRs
is the development of Unique Healthcare Identifiers
(UHIs) for individuals and healthcare providers to
ensure that information is attributed to the right patient
and the right provider. For further information see
www.nehta.gov.au
cHildren and YOung peOple
The Privacy Act does not set a minimum age at which
an individual can make decisions regarding his or her
own personal information. Guidelines developed by
the Office of the Privacy Commissioner provide some
assistance in dealing with children and young people.
The Guidelines to the National Privacy Principles suggest
that each case must be considered individually, and give
guidance on when a young person may have the capacity
to make a decision on his or her own behalf:
As a general principle, a young person is able to give
consent when he or she has sufficient understanding
and maturity to understand what is being proposed.
In some circumstances, it may be appropriate for a
parent or guardian to consent on behalf of a young
person; for example if the child is very young or lacks
the maturity or understanding to do so themselves.
The Guidelines on Privacy in the Public Health Sector
stress that where a young person is capable of making
his or her own decisions regarding personal information,
he or she should be allowed to do so. The guidelines
further suggest that, even if the young person is not
competent to make a decision, his or her views should
still be considered.
Generally, state and territory privacy legislation and
administrative schemes adopt the same approach to
children and young people as the Privacy Act. Some state
and territory legislation provides guidance regarding the
capacity of children or young people to make decisions
regarding their own personal information. For example
the Health Records and Information Privacy Act 2002
(NSW) and the Health Records Act 2001 (Vic) both
provide that an individual is incapable of making
such decisions if he or she cannot understand the
general nature and effect of such a decision, or cannot
communicate his or her decisions.
The Health Records (Privacy and Access) Act 1997 (ACT)
links the test of capacity to the individual’s ability to
understand the nature of, and give consent to, a health
service. Some legislation also includes express provisions
on how, and by whom, decisions can be made on behalf
of a child or young person unable to make his or her
own decisions.
deceased indiViduals
DWSPL/A Hampton.
image u navailable
The federal Privacy Act does not protect the personal
information of deceased individuals, except for
special provisions dealing with declared disasters
and emergencies. However, the Privacy and Personal
Information Protection Act 1998 (NSW), the Health
Records and Information Privacy Act 2002 (NSW)
and the Health Records Act 2001 (Vic) cover personal
information about individuals who have been dead for
less than 30 years. This reflects the 30 year period after
Health privacy in Australia 9

which government archival records are generally open to
public access. The Northern Territory Information Act,
which combines privacy, freedom of information and
archives provisions, covers personal information within
the first five years after an individual dies. Tasmanian
privacy legislation extends to the personal information
of individuals who have been dead for less than 25 years,
and the Health Records (Privacy and Access) Act 1997
(ACT) covers deceased individuals without imposing
any time restrictions.
laW refOrm and THe priVacY Of
persOnal HealTH infOrmaTiOn
There have been a number of important recent inquiries
intothelawregulatingtheprivacyofpersonalinformation.
Both the Australian Law Reform Commission (ALRC)
and the NSW Law Reform Commission were tasked
with inquiring into whether existing legislation provides
an effective framework for the protection of the privacy
of the individual. The Commissions were asked to look
at a range of issues including whether a more consistent
approach to privacy across Australia would be desirable.
The ALRC has produced a number of consultation
documents in the course of its inquiry, including
Discussion Paper 72: Review of Australian Privacy Law.
These documents – and in particular the ALRC’s final
report, presented to the Australian Attorney-General in
May 2008 – provide more detailed information on all of
the issues discussed above.
paTienT access TO THeir medical
recOrds
In Breen v Williams ,
12
the High Court of Australia
unanimously held that health consumers do not
have a right of access to their medical records at
common law. This means that health consumers must
rely on legislation, such as privacy and freedom of
information legislation, to provide them with a right of
access to medical records.
The exceptions to IPP 6 include, for example, those
situations in which a record-keeper is required or
authorised to refuse access under the Freedom of
Information Act 1982 (Cth) (the FOI Act) and the
Archives Act 1983 (Cth).
In relation to private sector health service providers,
NPP 6 provides that private sector organisations
must provide individuals with access to their personal
information, including their health information, on
request, subject to a number of exceptions. In the case
of health information, organisations are not required to
provide access if doing so would pose a serious threat to
the life or health of any individual. 13 Health consumers
who apply for access to their medical records and are
refused, may lodge a complaint with the federal Office
of the Privacy Commissioner.
NSW legislation
There is also privacy legislation regulating access
to health information at the state and territory level in
a number of jurisdictions. In NSW, the Health Records
and Information Privacy Act 2002 provides a right
of access to health information held by NSW public
and private sector health service providers. Under that
Act, organisations that hold health information must, at
the request of the individual to whom the information
relates and without excessive delay or expense, provide
the individual with access to the information subject to
a number of exceptions. If a health consumer requests
access to his or her medical records and is refused, the
health consumer may lodge a complaint. In relation
to public sector agencies, the consumer must complain
to that agency and the agency must inform the NSW
Privacy Commissioner. In relation to private sector
organisations, the consumer may complain directly to
the Privacy Commissioner.
Commonwealth legislation
The Privacy Act 1988 (Cth) regulates access to health
information held by Australian Government public
sector agencies and private sector health service providers.
In relation to Australian Government public sector
agencies, IPP 6 provides that:
Where a record-keeper has possession or control
of a record that contains personal information, the
individual concerned shall be entitled to have access
to that record, except to the extent that the recordkeeper
is required or authorised to refuse to provide
the individual with access to that record under the
applicable provisions of any law of the Commonwealth
that provides for access by persons to documents.
12. Breen v Williams [1995] HCA 63; available at www.austlii.edu.au/au/cases/cth/HCA/1995/63.html
13. Privacy Act 1988 (Cth) sch 3, NPP 6.1(b).
10
HOT TOPICS 64 > Health and the Law

Fertility and
conception issues
arTificial reprOducTiVe
TecHnOlOgY
Artificial reproductive technology (ART) centres in
jurisdictions such as NSW and the ACT must be
accredited by the Reproductive Technology Accreditation
Committee (RTAC), of the Fertility Society of Australia.
The RTAC Code of Practice sets and maintains
standards for clinics and centres offering ART. ART
clinics currently rely on ethical guidelines produced
by the National Health and Medical Research Council
(NHMRC) for their chief guidance.
Legislation establishes that where semen donation is
used to produce a pregnancy, the husband of the
pregnant woman shall be presumed to be the father.
Where a pregnancy has arisen from ovum donation,
the woman who underwent the ART procedure shall be
presumed to be the mother. In NSW, see the Status of
Children Act 1996.
Research tends to confirm that in vitro fertilisation (IVF)
that is, impregnation of an ovum with sperm outside the
body prior to re-implantation, drops off markedly as a
successful technique for pregnancy in females over 35
years, to minimal rates in those over 40 years. IVF is
expensive (although a Medicare rebate is available) and
the woman may be exposed to side effects.
Ethical issues
One controversial area in ART involves pre-implantation
genetic testing for sex selection. Some argue that the
embryo is not a legal entity or that parents should have
the right to determine the gender mix in their family
especially in a situation where some selection is taking
place anyway (the embryo growing most vigorously is
implanted). Others believe that discarding embryos on
the basis of sex (rather than the presence of a sex-linked
genetic disease) ‘instrumentalises’ them (i.e. makes them
valuable only for another’s use, not according to their
own intrinsic dignity).
Another area of ethical concern is whether anonymous
sperm donation should be used. Children so conceived
may subsequently have health and personal reasons for
trying to locate their genetic father.
Debate also arises about parents seeking to test a child
for a genetic disease that they do not wish to be tested
for themselves, for example Huntington’s disease: see
note p 12. Such testing might deprive the child of their
human right not to know their genetic predisposition to
disease. All babies in Australia are subjected to a heelprick
test for certain inherited diseases that are easily
treated. The status of the blood taken and stored in
this way is controversial as in the future it may provide
a vast amount of information about the individual to
the State.
image u navailable
Frozen embryos in the laboratory of an IVF clinic in
Melbourne, 2007.
Photo: Jason South, The Age (Melbourne).
14. Cattanach v Melchior [2003] HCA 38; available online at www.austlii.edu.au/au/cases/cth/HCA/2003/38.html
15. [2006] HCA 15 available online at www.austlii.edu.au/au/cases/cth/HCA/2006/15.html; and [2006] HCA 16 available online at
www.austlii.edu.au/au/cases/cth/HCA/2006/16.html
Fertility and conception issues 11

Note: The onset of Huntington’s disease is typically between
the ages of 30 and 45. It is an inherited neurological disorder with
symptoms including abnormal movement and gait, slurred speech
and intellectual impairment. The disease almost always affects an
individual who inherits the gene and there is no known cure.
For more information see: http://www.ahdansw.asn.au/information/
huntingtons.html
WrOngful BirTH and WrOngful life
In 2003 Australian High Court found that the common
law could allow parents to claim damages when medical
negligence was proven to have led to the birth of an
unplanned, but healthy, baby. 14 In 2006, in Harriton
v Stephens and Waller v James; Waller v Hoolahan 15
the High Court of Australia in a six-to-one decision
decided that no such claim could be made by a child
when medical negligence in failing to order an in utero
genetic test caused the child severe disability. In an era
when almost all pregnancies will soon require patented
fetal genetic tests as part of the professional standard of
care, the High Court, by barring so-called ‘wrongful
life’ (better termed ‘wrongful suffering’) claims, may
have created a partial immunity from legal action of this
kind for the corporate manufacturers of such tests and
the doctors who administer them.
surrOgacY
Surrogacy is where a woman agrees to bring to gestation
in her uterus the ovum of another woman fertilised
outside the first woman’s body and introduced artificially.
It is a means by which some women (for example those
without a uterus because of accidents, genetics or
disease) can have children.
The Prohibition of Human Cloning for Reproduction
Act 2002 (Cth) makes it an offence to give or receive
‘valuable consideration to another person for the supply
of a human egg, human sperm or a human embryo’. The
laws in some Australian jurisdictions do not prohibit
surrogacy if it is altruistic (i.e. done for another’s benefit
rather than for financial gain). In NSW, there is no
specific legislation, although the Assisted Reproductive
Technology Act 2007, which, if it is given affect will deal
with surrogacy and ART, received assent in December
2007, but has not yet commenced.
clOning
Human reproductive cloning involves growing a whole
human from DNA inserted into an ovum that is then
brought to gestation in a uterus. It is banned by federal
and state legislation (Prohibition of Human Cloning
for Reproduction Act 2002 (Cth) and related state and
territory legislation). This type of cloning should not
be confused with research cloning which is a routine
practice of cellular laboratories.
aBOrTiOn
Abortion is governed by state and territory law in
Australia, and so the circumstances in which a woman
is able to access termination of pregnancy services varies,
depending upon where she is living and the distance
she is able to travel.
Most state and territory laws have been built upon
the British Offences Against the Person Act 1861. At
Federation, the British Act made abortion in Australia
illegal under all circumstances. Changing social attitudes
to abortion and growing concerns about the health risks
of illegal abortion led to interpretations by the courts
of Australian state laws which deemed that abortions
were not unlawful if they were necessary to preserve a
woman’s health. How this is defined varies between the
states and territories. However, three offences identified
in the 1861 Act continue to underpin the abortion laws
in most Australian jurisdictions, including NSW:
> the attempt to procure an unlawful miscarriage by the
pregnant woman;
> the attempt to procure an unlawful miscarriage by
another person (regardless of whether the woman is
pregnant);
> supplying the means to procure an unlawful abortion,
knowing there is an intention to procure a miscarriage
unlawfully (whether she is pregnant or not). See
Crimes Act 1900 (NSW) sections 82-84.
A court ruling in 1971, known as ‘the Levine ruling’ 16
established that an abortion would be lawful in NSW if
there were ‘any economic, social or medical ground or
reason’ upon which a doctor could base an honest and
reasonable belief that an abortion was required to avoid
possible ‘serious danger to the pregnant woman’s life
or to her physical or mental health’. The Levine ruling
determined that this danger might arise at any time
during the pregnancy. The ruling expanded the grounds
on which a doctor could legally conclude that a pregnant
woman faced a risk to her health, and in this respect
was more liberal than Victoria’s Menhennitt ruling in
1969. 17 Justice Kirby reaffirmed and expanded upon
the Levine ruling in 1995 in a case called Superclinics. 18
He ruled that the service provider could take into
account a woman’s current and future social
circumstances, and the ways a woman’s mental or
physical health might be endangered by the birth of
the child.
Recently the Victorian Law Reform Commission has
provided advice about three options to decriminalise
abortion in Victoria. The report is available from
www.lawreform.vic.gov.au
16. R v Wald (1971) 3 DCR (NSW) 25
17. R v Davidson [1969] VR 667
18. [1995] NSWSC 103; available online at www.austlii.edu.au/au/cases/nsw/NSWSC/1995/103.html
12
HOT TOPICS 64 > Health and the Law

End of
life issues
A major issue in this area is whether elderly people or
those suffering a terminal illness can prepare directives
specifying the point at which they would like medical
treatment not to be initiated or be withdrawn from
them.
Such ‘living wills’ or ‘advance directives’ are rarely
used even though they are encouraged by the NSW
Department of Health. 19 Part of the problem is that
people find it very difficult to second guess what
circumstances they will be in and what medical treatment
they might need. An alternative worth considering is to
include something like the following:
‘I [name] DIRECT that medical treatment [which
is not reasonably likely to return me to the following
situation which I consider to be a minimum acceptable
quality of life…..] be withheld or withdrawn.’
This formulation gives treating doctors the very
important information of what you would consider a
minimal acceptable quality of life. They are then in a
much better position to judge what treatment will be in
your best interests. No specific form is required for an
advance directive in NSW, however some organisations
have produced documents that can be used. 20
These powers can also be conferred under health
care powers of attorney and as a result of legal orders
appointing a guardian over a person who is technically
incompetent to make decisions about their own
health care.
VOlunTarY euTHanasia
Voluntary euthanasia, ‘mercy killing’ or ‘assisted suicide’
involves the deliberate killing of another non-depressed
human being at his or her request in order to reduce
pain or assaults on human dignity related to a terminal
illness. It has been rendered illegal by legislation in all
states and territories in Australia.
Euthanasia and assisted suicide is legal in the Netherlands
and Oregon in the US, and controversy continues about
image u navailable
Voluntary euthanasia supporter Dr Philip Nitschke,
outside Central Local Court at the trial of Shirley Justins
and Caren Jennings over the death of Graeme Wylie.
They were convicted respectively of manslaughter and
of being an accessory to manslaughter in June 2008.
Photo: Adam McLean, SMH.
law reform in this area. Research suggests that many
doctors assist terminally ill patients to die, but do not
publicise the fact. In the Diane Pretty case the European
Court of Human Rights held that the human right
of respect for privacy was engaged where the State
prevented a patient exercising her choice to avoid what
he or she considered to be an undignified and distressing
end to his or her life.
It seems to be settled that doctors following a patient’s
lawful direction to refuse life-saving medical treatment
are not assisting suicide. 21
palliaTiVe care: pain relief and
‘dOuBle effecT’
In the case of Diane Pretty, Lord Bingham in the
House of Lords 22 considered that the human rights
prohibition on ‘cruel, inhuman or degrading treatment’
might be engaged where a public official had forbidden
the provision of pain-killing or palliative drugs to a
terminally-ill patient.
19. Using Advance Care Directives; available online at http://www.health.nsw.gov.au/pubs/2004/pdf/adcare_directive.pdf; see details on p 23 for
ordering free print copies.
20. See for example the detailed form available from Hunter New England Area Health Service
http://www1.hnehealth.nsw.gov.au/docs/advanced_care_directive.pdf; and 4 page form in My Health, My Future, My Choice, see p 24 for details.
21. See Re B (Adult: Refusal of Medical Treatment [2002] EWHC 429 (Fam); available at www.bailii.org/ew/cases/EWHC/Fam/2002/429.rtf
22. [2001] UKHL 61, para 14; available at www.bailii.org/uk/cases/UKHL/2001/61.html
End of life issues 13

The doctrine of medical ethics known as ‘double effect’
allows doctors to continue to relieve pain by incremental
doses of drugs such as opiates (morphine) even if the
unintended effect of such pain relief is death of the
patient (usually from suppression of the neurons in the
brain that drive the patient to breathe).
WiTHdraWing Or WiTHHOlding
TreaTmenT and ‘nO cpr’ Orders
Doctors cannot be forced by relatives of a patient
to commence or continue medical treatment that is
case sTudY: messiHa
On 17 October 2004, Mr Isaac Messiha, aged 75,
was admitted to the Intensive Care unit of the St
george Hospital, New South Wales. Mr Messiha,
suffered from chronic obstructive pulmonary
disease. He had had cardiac surgery ten years
earlier, and had been admitted to hospital after a
previous cardiac arrest three months earlier. Dr
Theresa Jaques, Director of St george’s Intensive
Care unit diagnosed Mr Messiha as having suffered
a cardiac arrest and resultant severe brain damage.
It was estimated that Mr Messiha’s brain had
been deprived of oxygen for 25 minutes before
ambulance officers arrived and commenced CpR.
Over the next few days Dr Jacques and other staff
repeatedly evaluated the patient’s condition. The
glasgow Coma Score never rose above 5 and was
generally 3, the lowest possible reading, consistent
with non-purposeful occasional eye-opening. Dr
Jacques communicated closely with Mr Messiha’s
family and informed them that the results indicated
there was no reasonable prospect that Mr Messiha
would return to a meaningful quality of life.
On 21 October 2004 an electroencephalograph
(‘EEg’) showed the complete absence of cortical
activity. At this stage the patient was being
mechanically ventilated via an endotracheal tube,
was being fed via a naso-gastric tube, had an
indwelling urinary catheter, was incontinent of
faeces and required constant suctioning of saliva by
the nursing staff.
Dr Jacques proposed that it was in the best
interests of the patient that treatment be withheld.
This would involve removal of the tubes for
ventilation and feeding, and the institution of a donot-resuscitate
order covering subsequent cardiac
or respiratory arrest.
The patient’s relatives disagreed with this proposal.
They believed that the patient had spontaneously
opened his eyes to voice and they demanded that
everything possible be done. They arranged for an
eminent independent neurologist to examine the
patient on 27 October. The neurologist agreed with
Dr Jacques’ assessment of Mr Messiha’s condition,
and with her proposal to withdraw active treatment.
technically ‘futile,’ that is, incapable on reasonable
grounds of returning the patient to a meaningful
quality of life. The most difficult task where the patient
is unconscious or otherwise incompetent is to get
good evidence of what the patient would regard as a
‘meaningful quality of life.’ United States courts tend
to try and obtain evidence from relatives and friends
about what the patient would have wished. 23 English
courts focus on what would be in the ‘best interests’ of
the patient. 24
Where conflict exists between the patient’s family and
the patient’s doctors as to whether medical treatment
The relatives sought an order from the Supreme
Court of NSW that medical treatment not be
withdrawn. In the decision handed down on 11
November 2004, Justice Howie found that the
court had the power to make the decision about
Mr Messiha’s treatment under its parens patriae
jurisdiction. This ancient jurisdiction allows
superior courts to oversee the care and treatment
of children and incompetent adults. Justice Howie
clearly stated that the guiding principle under the
parens patriae jurisdiction is the best interests of
the patient and that medical opinion about that
issue would be given great weight:
[I]t seems to me that it would be an unusual
case where the Court would act against what
is unanimously held by medical experts as an
appropriate treatment regime for the patient in
order to preserve the life of a terminally ill patient
in a deep coma where there is no real prospect
of recovery to any significant degree. This is not
to make any value judgment of the life of the
patient in his present situation or to disregard
the wishes of the family and the beliefs that they
genuinely hold for his recovery. But it is simply
an acceptance of the fact that the treatment of
the patient, where, as here, the Court is satisfied
that decision as to the appropriate treatment
is being made in the welfare and interest of the
patient, is principally a matter for the expertise of
professional medical practitioners…
Justice Howie accepted that there was no
reasonable prospect of active treatment offering Mr
Messiha a return to a meaningful quality of life. On
that basis it could not be said that active treatment
was in Mr Messiha’s best interests, and the family’s
application was dismissed.
Isaac Messiha (by his tutor Magdy Messiha) v South East Health
[2004] NSWSC 1061; available at http://www.austlii.edu.au/au/
cases/nsw/supreme_ct/2004/1061.html
23. Cruzan v Director, Missouri Department of Health, 497 US 261 (1990); available online at www.law.cornell.edu/supct/html/88-1503.ZS.html
24. Airedale Hospital Trustees v Bland [1992] UKHL 5; available online at http://www.bailii.org/uk/cases/UKHL/1992/5.html
14
HOT TOPICS 64 > Health and the Law

case sTudY: scHiaVO
On February 25, 1990, Terri Schiavo suffered
brain damage after a myocardial infarction (‘heart
attack’), possibly caused by a chemical imbalance
resulting from an eating disorder. This left her
in what was clinically diagnosed as a ‘persistent
vegetative state’. Her husband, Michael, was
appointed her legal guardian, and in 1993 was
awarded one million dollars in a malpractice
lawsuit against physicians who failed to diagnose
and treat the eating disorder. In 1998, Mr Schiavo
filed a petition with the court to discontinue his
wife’s feeding tube, a request that her parents,
Mr and Mrs Schindler, devout Catholics, opposed.
The parties were involved in more than 25 court
rulings and interventions over a period of ten
years, as a result of which the feeding tube was
twice been removed and reinserted. Contentious
issues concerned whether Terri made an advance
directive and who had the ultimate authority to
withdraw futile treatment from her.
Late in March 2005 her doctor, following the
order of a Florida Supreme Court judge, removed
the feeding tube that had been keeping Schiavo
alive for 15 years, despite the extraordinary,
last-minute efforts of Republican congressional
leaders to extend her life by issuing a subpoena
for her to give testimony before them.
At a midnight sitting in March 2005 the uS
Congress voted to order a federal court to
review the case. The legislation gave the parents
standing in federal court, though it did not compel
a federal judge to take up the case. On 21 March
2005, uS president Bush issued the following
public statement:
‘Today, I signed into law a bill that will allow
Federal courts to hear a claim by or on behalf of
Terri Schiavo for violation of her rights relating
to the withholding or withdrawal of food, fluids,
or medical treatment necessary to sustain her
life. In cases like this one, where there are
serious questions and substantial doubts, our
society, our laws, and our courts should have a
presumption in favor of life. This presumption
is especially critical for those like Terri Schiavo
who live at the mercy of others. I appreciate the
bipartisan action by the Members of Congress
to pass this bill. I will continue to stand on the
side of those defending life for all Americans,
including those with disabilities.’
The uS Supreme Court refused to hear an
emergency appeal by the Schindlers, and Terri
died on 31 March 2005, aged 41, nearly two weeks
after doctors removed her feeding tube.
The Schiavo case represents an unprecedented
legislative involvement in individual end-of-life
clinical decision making. It is difficult to imagine
the professional and social consequences of
making such intervention routine. Criticisms that
the legislative action in this instance is the result
of a broader agenda on the human right to life and
the political role of its religious proponents must
be taken seriously by clinicians.
united States Court of Appeals decision of 23 March
2005 available at http://www.ca11.uscourts.gov/opinions/
ops/200511556.pdf
that is apparently ‘futile’ should be continued, the issue
is best discussed before the Hospital’s Clinical Ethics
Committee. Ultimately, if such disagreement persists,
a declaration to lawfully withdraw treatment may have
to be obtained from a Court. If the relatives continue
to dispute a withdrawal of treatment decision, then
relevant doctors should specify that as a reason for not
signing the death certificate. This will then activate the
jurisdiction of the coroner.
‘No CPR’ (cardio-pulmonary resuscitation) orders may
be written in consultation with a terminally ill patient
and the patient’s family, in accordance with hospital
guidelines, to avoid the indignity of life ending in
the pressure of an emergency attempt at CPR. This
might possibly involve deep chest compressions, cardiac
‘shocks’ with a defibrillator, the insertion of intravenous
cannulae and giving of drugs such as adrenaline.
One important issue that Justice Howie discussed
in the Messiha case was whether resource restriction
(pressure for beds) should ever be mentioned to relatives
in discussions of end of life treatment. Certainly to do
so seems to indicate an erosion of the primacy of the
patient’s reasonable prospects of return to a meaningful
quality of life as the decisive principle. The courts have
preferred not to get involved in cases of resource rationing
because they are not in possession of a political mandate,
nor do they have the professional knowledge to make
such decisions. The only situation where a court might
become involved is where there has been unfairness or
illegality in the decision-making process (for example,
racial discrimination). Yet, pressure of scarce resources
as a result of rationing of government health expenditure
are an inevitable social justice background to such
decisions, that filters down to intensive care specialists
for whom it often reluctantly becomes a matter of
trading lives in pressured clinical deliberations. The
question then arises whether a Schiavo type ‘extreme’
case could arise in Australia.
Futile treatment is a notoriously controversial concept
which has proven almost impossible to define.
Disagreements still arise as to what level of probability
of success one chooses before saying a treatment is
technically ‘futile’ in the sense of, on the best available
End of life issues 15

evidence, not being reasonably likely to return the
patient to a meaningful quality of life.
In Messiha, Justice Howie took obvious comfort in
the unanimity of medical opinion in finding against
authorising treatment. In the Schiavo case, on the other
hand, the legislature intervened to counter both medical
and judicial opinion as to the patient’s prior expressed
intentions and best interests. In doing so it appeared
to contradict established judicial standards clearly
distinguishing withdrawal and withholding of medical
treatment from euthanasia and specifying that, at least
in that jurisdiction, the final test should involve an
assessment of the substituted judgment of the patient.
One practical lesson of the Messiha case may be that the
legal system can provide appropriate solutions to the
problems of futility disputes where there is irresolvable
disagreement between relatives and clinicians as to the
best interests of an incompetent patient.
the orders required the court to be involved in future
decisions about his treatment.
Available at www.austlii.edu.au/au/cases/nsw/supreme_
ct/2000/1241.html
Re RWG [2000] QGAAT 2 – the wife of a 73 year-old
male with an acquired brain injury made an application
for a no-CPR order and for the power to refuse
antibiotics. The GAAT agreed to the no-CPR order but
would not consent to the refusal of antibiotics, given the
patient was not suffering from an infection at the time
of the hearing and, as such, it would be premature to
examine the issue.
Available at www.austlii.edu.au/au/cases/qld/QGAAT/2000/2.html
Re BWV [2003] VSC 173 – the Supreme Court of
Victoria ordered a guardian to be appointed to refuse
artificial feeding for a 68 year-old woman with advanced
Pick’s disease (a form of dementia). The Supreme Court
ausTralian cases On THe rOle Of
cOurTs & TriBunals in dispuTes
aBOuT medical TreaTmenT
Marion’s case – the High Court decided in this case
that all non-therapeutic sterilisations of disabled people
must be approved by a court or tribunal, to safeguard the
assessment of the person’s best interests. Since Marion,
courts have held that gender reassignment surgery for
children, and bone marrow donation by children should
also be approved by the court before it can go ahead.
Secretary, Department of Health and Community Services v JWB and
SMB (Marion’s case) [1992] HCA 15; available at
www.austlii.edu.au/au/cases/cth/HCA/1992/15.html
Re PVM [2000] QGAAT 1 – a 39 year old man with
severe brain and spinal injuries, requested the removal
of artificial ventilation, but there were concerns about
his competence. The Queensland Guardianship and
Administrative Tribunal (GAAT) found the man to be
competent and to have the right to refuse treatment.
Available at www.austlii.edu.au/au/cases/qld/QGAAT/2000/1.html
Northridge v Central Sydney Area Health Service
[2000] NSWSC 1241 – clinicians at Royal Prince Alfred
Hospital had decided to withdraw active treatment from
a patient who had suffered brain damage after a drug
overdose. A decision was made to withdraw feeding and
antibiotics from Mr Thompson after approximately five
days and a no-CPR order was entered on his chart, even
though his Glasgow Coma Score rating had risen to
9, and he was responding to voice. The relatives of the
patient expressed their disagreement with the decision
to withdraw active treatment. On application to the
NSW Supreme Court, it was found that the doctors
had misdiagnosed the patient’s condition and that
their decision to withdraw active treatment had been
premature. Orders were made to continue treatment and
adVanTages and disadVanTages
Of cOurT decisiOns On fuTile
TreaTmenT
Disadvantages
> Costs and delay may be significant for long running
actions. In American states which have mandatory
court review, many patients had died before the action
concerning their treatment has been heard. However,
the Australian experience has so far shown that the
courts and tribunals can act with surprising speed and
efficiency.
> The adversarial process may be inappropriate
especially if it exacerbates the strained relationships
between the relatives and health carers. Realistically, if
legal action has been resorted to one must conclude that
the relationships have already soured to the point where
it has become necessary for third party involvement.
> Publicity brought to the case may lead to clinicians
becoming involved in a public political debate involving
right to life issues.
Advantages
> Legal action provides finality and closure. It also
provides for a forum where all views can be heard and
tested.
> Legal action safeguards the assessment of the best
interests of the patient, by providing an independent
and procedurally fair assessment based on all the
evidence.
> Legal action provides protection. Once the court
has sanctioned the withdrawal of active treatment,
clinicians who act in correspondence with those orders
are immune from suit, or from criminal prosecution.
16
HOT TOPICS 64 > Health and the Law

found that artificial feeding was medical treatment
and not the reasonable provision of food and water,
under the Victorian legislation. Given the feeding was
medical treatment, it could be refused under the Medical
Treatment Act 1988 (Vic).
Available at www.austlii.edu.au/au/cases/vic/VSC/2003/173.html
Organ dOnaTiOn BY Brain-dead
persOns
In all Australian states and territories, legislation states
that a person has died when there has occurred:
> irreversible cessation of all function of the brain of the
person;
> irreversible cessation of circulation of blood in the
body of the person.
See for example, the Human Tissue Act 1983 (NSW),
section 33. Legislation also requires that a medical
certificate must be completed for every death, even
where the death has been reported to the Coroner. See
for example the Births, Deaths and Marriages Registration
Act 1995 (NSW).
If a deceased person is shown, after reasonable inquiries
to have agreed to organ donation during his or her life,
written authorisation may be given by the designated
officer of a hospital, or the senior available next of kin,
for removal of such tissue. This will not apply if the
coroner needs to hold an inquest.
Where a person is being kept alive by artificial ventilation
and circulatory support, authority for organ donation
cannot be given unless the patient has been declared
brain dead independently by two medical practitioners,
each with at least five years’ experience and one of whom
is a specialist neurologist or neurosurgeon. The tests
these doctors perform include checking for absence of
brain stem function through whether the pupils, or the
eyes in general, respond to pain, light or cold water in
the ears; whether the patient has a gag reflex and tries to
breath after being disconnected from the ventilator (the
blood’s rising carbon dioxide level will normally trigger
the respiratory centre in the brain stem).
The law operates on the principle that the views that
a person expressed while alive about organ donation
will be respected once he or she is dead. If the deceased
person’s views are not known, it is left to the next of
image u navailable
A patient is attended to by an emergency medical team after being airlifted from the site of a collision between a passenger train
and a semi-trailer near the country town of Kerang, in north-western Victoria, 5 June 2007.
Wayne Taylor, The Age (Melbourne).
End of life issues 17

kin to decide whether that person should become an
organ donor. If the views of the deceased person are not
known and no relative can be found, the person may be
used as an organ donor.
The most practical way of ensuring that your views
about organ donation are made known to hospital staff
is to always carry a signed written statement in your
wallet indicating whether or not you are prepared to be
an organ or tissue donor, or to register with the central
register.
auTOpsies
The purpose of a post-mortem examination (an autopsy)
performed by a pathologist is to better understand the
factors that may have contributed to the person’s death.
This information may be important for the next of
kin (eg if the person died from an infectious or genetic
disease), or for the community as a whole (in identifying
or tracing outbreaks of disease; in teaching doctors and
nurses; and in checking the quality of the hospital’s
diagnostic and treatment procedures). The report will be
made available to a medical practitioner nominated by
the relatives of the deceased.
Consent is required prior to carrying out a post-mortem
examination unless it is ordered by the Coroner. As is
the case with organ and tissue donation, the law operates
on the principle that the person’s expressed wishes,
while alive, about the use of his or her body when they
are dead, will be respected after their death. Therefore
the law on consent for post-mortem examinations and
for donation of bodies to medical schools is, in most
respects, the same as for organ and tissue donation after
death.
The Coroner may dispense with a post-mortem if
requested by an immediate family member of deceased
or that person’s representative if already satisfied ‘that the
manner and cause of death are sufficiently disclosed’.
> dies during or within 72 hours after a medical,
surgical or dental operation or an invasive medical or
diagnostic procedure;
> dies, and a medical practitioner has not given a
certificate as to the cause of death;
> dies, having not been attended by a medical practitioner
at any time within the period commencing three
months prior to the death;
> dies after an accident where the cause of death appears
to be directly attributable to the accident;
> dies, or is suspected to have died, in circumstances
that should be better ascertained; or
> dies in custody.
The public relies on its Coroners to determine the
identity of deceased persons, the reason for their death
and to refer deaths resulting from an apparent indictable
offence to the Director of Public Prosecutions. The
Coroner cannot make a finding of guilt or innocence,
but rather establishes whether a person has ‘a case to
answer’.
The Coroner may hold an inquest (court hearing) to
assist in determining the manner and cause of death.
These proceedings are generally open to the public and
witnesses are called. An inquest must be held if the death
appears to have arisen after or during administration of
an anaesthetic.
cOrOnial enQuiries
A Coroner has a wide discretion in deciding whether
to hold an inquest into a reported death or whether
to dispense with an inquest and complete an inquiry
without a public hearing. Legislation in all Australian
states and territories permits a Coroner to hold an
inquest into the manner and cause of death when a
person:
> is killed;
> is found drowned;
> dies or is suspected to have died, a sudden death the
cause of which is unknown;
> dies under suspicious circumstances;
18
HOT TOPICS 64 > Health and the Law

Human right
to health
medical eTHics and Human
rigHTs laW
Health law academics (and many of their students)
are accustomed to viewing the fields of bioethics and
international human rights law as distinct areas of
‘standards setting’ or ‘norms’. However, the development
of medical ethics and human rights has many intriguing
parallels. John Locke, a founding father of human rights
jurisprudence, was a physician who studied alongside
Sydenham, a doctor of medicine who used accurate
observation of symptoms to treat and classify illness,
against the beliefs of many of his peers, gaining him the
title of ‘the English Hippocrates’. It seems possible that
the major factor promoting both human rights norms
and those of the Hippocratic Oath, was direct proximity
to the relief of individual human suffering.
International humanitarian law is an aggregation of
customary and treaty based norms, concerned with the
treatment of the wounded, civilians and prisoners in
war. It has many areas of overlap with medical ethics.
Its origins may similarly be traced to the unrelieved
suffering of wounded soldiers directly witnessed by
Henry Dunant on the battlefield after the battle of
Solferino in 1859. Dunant founded the Red Cross in
1863 and was awarded the first Nobel Peace Prize in
1901.
Proving a breach of the Hippocratic Oath’s ethical
obligation to ‘do no harm’ was central to the conviction
of the Nazi doctors at the Nuremberg Trials after
the Second World War for non-consensual, brutal
experimentation, sterilisation and active non-voluntary
euthanasia. Those proceedings spurred creation
of the documents that remain central to medical
ethics: the Declaration of Geneva, (or modernised
the Hippocratic Oath), the Nuremberg Declaration on
Human Experimentation, and the International Code of
Medical Ethics.
Mirroring these international medical ethics documents
are the three instruments that make up the international
Bill of Human Rights:
> Universal Declaration of Human Rights (UDHR);
> International Covenant on Civil and Political Rights
(ICCPR);
> International Covenant on Economic, Cultural and
Social Rights (ICESCR).
These instruments were directed at relationships
between individuals (within the sphere of governmental
responsibility), as well as relations between States.
They contained many principles and obligations that
resembled norms of medical ethics.
Particularly overlapping with medical ethics in the
UDHR were provisions requiring respect for human
dignity and equality (articles 1 and 2), as well as
the human right to life (article 3). Others resembled
components of medical ethics in prohibiting torture or
cruel, inhuman or degrading treatment or punishment
(article 5), requiring non-discrimination (article 7),
freedom from arbitrary interference with privacy (article
12) and progressive realisation of the human right to
a standard of living adequate for health and medical
care (article 25). In the same category was the human
right to share in scientific advancement and its benefits
(article 27).
In considering the intersections between medical
ethics and human rights it is important to take into
account article 38 of the Statute of the International
Court of Justice. This provision identifies international
conventions and customary international law, among
others, as the sources of international law. Thus, as a
declaration, rather than an international convention, the
UDHR did not directly create binding human rights
norms under international law upon signatory states.
Neither did UNESCO’s Universal Declaration on the
Human Genome and Human Rights, which overlaps
with many areas of bioethics and medical ethics and
pronounces that the human genome represents part of
the common heritage of humanity, whilst forbidding
practices contrary to human dignity, such as human
reproductive cloning.
Human right to health 19

It is possible that such declarations may come to be
accepted as representing international customary law
if sufficient states implement them with the sense of
being obliged to do so. A comparison can be made to
the ‘Norms on the Responsibilities of Transnational
Corporations and Other Business Enterprises with
regard to Human Rights’, which was adopted by the
UN Sub-Commission on the Promotion and Protection
of Human Rights in August 2003 after years of effort
and deliberation. The legal status is similar in the
sense that it has not acquired any formal status of
international law. Although the norms have been acting
as a restatement of international legal principles to
companies, questions surrounding the legal status still
form a focal point of controversy. A fundamental
question can also be posed as to whether these types of
norms targeted at individuals and corporations can be
adequately explained within the traditional framework
of international law.
nanOmedicine and sunscreens
Nanotechnology is an expanding field of medical
research. It involves the manufacturing of therapeutic
products from ultra-small particles having one dimension
less than approximately 100nm (0.00001 cm). The
properties of such engineered nanoparticles (ENPs)
differ considerably from their bulk equivalents. Some
ENPs are the diameter or length of large proteins or
viruses (100-300nm).
image u navailable
In sunscreens, the use of ENPs allows broad spectrum
ultraviolet (UV) blocking agents, such as titanium and
zinc oxides which form white pastes at bulk scale, to
be applied with greater cosmetic transparency. Existing
packaging often refers to such ENPs as ‘microfine’,
giving consumers no details of size range. Such ‘clear
zinc’ sunscreens are strongly advocated by the medical
profession and health agencies for daily use to protect
human skin from infancy to old age from UV damage.
Published research, now relied upon by safety regulators
in many nations, suggests no significant adverse health
effects from these new ENP sunscreen preparations,
chiefly because there is minimal absorption below
the outermost layer of the skin, composed mostly of
dead cells. It was on this basis that our Therapeutic
Goods Administration (TGA) approved the marketing
of microfine sunscreens in Australia. However, this
conclusion seems hard to reconcile with increasing
research indicating that ENP patches may provide an
effective route for transcutaneous vaccination. Most
studies indicating lack of ENP dermal penetration
have been done in non-human skin. Also, they appear
not to have systematically considered cuts, abrasions,
dermatological conditions, co-application of insect
repellents, pre-existing UV damage, age or flexure of
skin, despite the impact it is reasonable to expect these
factors are likely to have on ENP sunscreen absorption in
daily life. ENP size is clearly of the utmost importance.
Significant regulatory, public and professional concerns
have arisen about unforeseen and unique toxicities
from ENPs. These are fuelled by consideration of
factors such as their size, high mobility in the body and
unusual reactivities. Also relevant are conflict of interest
problems in industry-funded regulatory agencies under
corporate pressure to achieve ‘fast-track’ approval of
nanotherapeutic products, considered ‘innovative’ (in a
technical and marketing if not an evidence-based sense)
rather than full implementation of the ‘precautionary
principle’.
Internationally, no health technology regulator currently
specifies distinct safety regulations/requirements that
must be met by manufacturers using ENPs in sunscreens
or other health products. Similarly, no regulatory agency
internationally currently possesses effective methods to
monitor ENP exposure risks.
There is clearly a need for further research on dermal
absorption of sunscreen ENPs under a variety of realistic
conditions, focusing on size and exposure limits. In
the interim, regulatory authorities should consider
mandatory packaging warnings, expressing care about
protracted use over cuts and abrasions, particularly
in children. Consideration could also be given to a
requirement that sunscreen packaging clearly specify
the average size or size range of ENPs in sunscreen
DWSPL/Maynard.
20
HOT TOPICS 64 > Health and the Law

formulations. This facilitates citizen choice and patient
informed consent, as many sunscreen products do not
use nanoparticulate formulations.
Use of sunscreen is only one component of sun safety
– along with use of shade and sun protective clothing.
It is important to stress the important message that
repeated application of sunscreen can protect against
the development of sunburn, photoageing of the skin
and squamous cell carcinoma precursors. Nevertheless,
realistic appraisal suggests that sunscreen application is
already not an entirely benign act; it may, for example,
increase the risk of basal cell carcinoma, with conflicting
results on prevention of melanoma. Such effects may be
the result of changed sun exposure behaviour under a
belief of ‘protection’.
ausTralia-us free Trade
agreemenT, BlOOd prOducTs and
THe pBs
Australia currently has strong claims to being regarded as
self-sufficient in supplies of whole blood. Self sufficiency
in this area is desirable, particularly given increasing
threats of emergent infectious diseases and terrorism,
as well as ongoing issues with quality control in remote
locations.
In recent years, increasing imports of plasma-derived
and recombinant (artificially produced) products have
occurred (with limited public debate), yet the majority
continues to be derived from Australian donations and
processed in Australia. Whole blood, plasma and platelets
from volunteer donors are collected by the Australian
Red Cross Blood Service, and tested for HIV, hepatitis B
and C, HTLV-1 and 2, syphilis, and for cytomegalovirus
to protect recipients with immune deficiencies. Blood is
a scarce global commodity; paid donors in developing
countries are becoming an increasingly important source
of the world’s plasma. Reviews have consistently found
that paid blood donors are more at risk of emergent
infectious disease and are more likely to donate in
symptomless ‘window’ periods. In short, blood sourced
from paid ‘donors’ is less safe. CSL Limited is currently
the sole provider of plasma fractionation services in
Australia, enjoying exclusive rights under the PFA
with the Commonwealth Government, due to end in
December 2009. (Plasma fractionation is the separation
of plasma into components.)
Australia’s Free Trade Agreement with the United
States (AUSFTA) came into force on 1 January 2005.
Chapter 15 of the AUSFTA (‘Government Procurement’)
established an obligation that government contracts for
goods and services (such as those involved with blood
supply) must be equally open to suppliers in both
countries. A specific annex, however, excluded from
this obligation ‘the procurement of plasma fractionation
services’ in Australia.
Nevertheless, in May 2004, the United States Trade
Representative and the Australian Minister for Trade
undertook an exchange of side letters (a binding part of
AUSFTA) on blood products and plasma fractionation
services. Central to these obligations is an expiry date
for the present contract – the Plasma Fractionation
Agreement (PFA) with CSL Ltd – and the creation of a
review process to consider opening up blood services to
competitive overseas tender. Fortunately the Australian
government decided, after consulting with the State
governments not to proceed in this direction.
If a large overseas company used its economies of scale
and legal expertise with complex procurement documents
to undercut local providers in a tendering process there
could be serious consequences, for example:
> plasma donated in Australia could be shipped
overseas for fractionation and then returned. In
such circumstances, thorough cleaning of equipment
between batch runs – though specified in written
guidelines – could not be as rigorously monitored as it
is locally;
> a proportion of Australia’s cheap and comparatively
safe blood supply could be siphoned off into overseas
markets, where it would be highly valued as a low risk
product.
Annex 2C of the AUSFTA included provisions
establishing a Medicines Working Group comprising high
level officials from both countries. US negotiators to the
AUSFTA wanted to restrict the evidence-based processes
that Australia’s Pharmaceutical Benefits Scheme (PBS)
system used to bargain down the cost of new, innovative
image u navailable
Blood donation at the Australian Red Cross.
Tamara Dean, Sydney Morning Herald.
Human right to health 21

drugs on cost-effectiveness grounds. Concern exists that
this body was involved in driving legislative changes
to the PBS in the middle of 2007 that divided it into
separate categories for innovative medicines and generic
drugs with reduced cost-effectiveness processes between
these categories. If this controversial assumption is true
then it could be seen as diminishing sovereignty of the
Australian people over their health policy. This area
suggests that in a globalised economy, trade agreements
have become a type of ‘supra-national’ legislation.
WHisTle-BlOWing in THe medical
prOfessiOn
‘Whistleblowing’ refers to the disclosure to the public of
information from within an organisation that suggests
a significant danger to public safety or well-being.
There is considerable anecdotal evidence of the power
of large organisations to place substantial financial and
psychological burdens on whistleblowers. The perceived
likelihood of reprisals or retaliation occurring (often in
the guise of performance reviews) has been found to be a
strong determinant of whether employees and colleagues
will report wrongdoing. Similarly, there is a widespread
belief that those who report corruption or misconduct
are likely to suffer for it. People are more likely to report
wrongdoing if they believe it will result in few personal
costs. Exposing deception or misconduct in scientific
research is obviously for the public good, yet this
often is countered, regardless of what legal protections
are technically available, by the fear of receiving lessfavourable
treatment, retribution or even the end of a
chosen career and income security for a family.
There is little, in terms of institutional governance
guidelines, on how best to implement or fund the
legislative protections afforded to whistleblowers. Few
academic institutions seem interested in teaching
whistleblowing seriously in any formal sense, for example
as an accepted (if last resort) component of governance
structures.
In the context of whistleblowing about scientific
misconduct, complete instruction in and recall of
image u navailable
Whistleblower Toni Hoffman, Senior ICU nurse, outside
Bundaberg Hospital, Qld after hearing news of Jayant
Patel’s arrest, March 2008.
Photo: John Wilson.
relevant bioethical, legal and international human
rights principles will not themselves motivate action.
Motivation, involving the generation of emotion
to encourage performance of an act, also requires
convictions, or a sense of conscience, derived from
previously established virtue. One suggestion is that such
conscience arises most readily from direct proximity to
individual patient suffering.
Finding a virtue-based justification for whistleblowing in
relation to misconduct concerning scientific research is
conceptually difficult. One potential source of standards
for such concepts is the UNESCO Universal Declaration
on Bioethics and Human Rights and its associated
database. Article 18 of this declaration provides:
‘1. Professionalism, honesty, integrity and transparency
in decision-making should be promoted, in particular
declarations of all conflicts of interest and appropriate
sharing of knowledge.’
Article 14 provides:
‘2. Taking into account that the enjoyment of the
highest attainable standard of health is one of the
fundamental rights of every human being without
distinction of race, religion, political belief and
economic, or social condition, progress in science and
technology should advance:
(a) access to quality health care and essential
medicines, especially for the health of women and
children, because health is essential to life itself
and must be considered to be a social and human
good;
(b) access to adequate nutrition and water;
(c) improvement of living conditions and the
environment;
(d) elimination of the marginalisation and the
exclusion of persons on the basis of any grounds;
(e) reduction of poverty and illiteracy’.
Whistle blowing, by its very nature, generally is an
external manifestation of poor internal procedures
through which potentially unethical, dangerous,
unprofessional, unsafe or illegal behaviour may be
reported and dealt with. A timely recent example of this
has concerned the US Food and Drug Administration
(FDA), where whistleblowers such as Dr David Graham
have indicated that FDA scientists have been discouraged
by supervisors from raising questions about drug safety
and sometimes have been prevented from sharing their
concern with FDA advisory committees.
Most states in Australia (including NSW) have legislation
that is designed to protect whistleblowers from unjust
reprisals. Nonetheless, managers may disguise such
activities as performance reviews. Whistleblowers,
despite their courage and desire to apply principles of
the public good in the face of obstacles, continue to
be persecuted by the organisations they are trying to
improve.
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HOT TOPICS 64 > Health and the Law

Further information
The Legal Information Access Centre (LIAC)
located in the State Library can help if you need
more information about the law, including cases and
legislation or see www.liac.sl.nsw.gov.au/legislation/.
The service is free and confidential. Contact details on
back cover.
The Health Information Service, located in the
State Library, is a free confidential service to help you
find accurate up-to-date information about health and
well-being. Resources include recent consumer health
publication, health-related databases and journals.
www.sl.nsw.gov.au/services/health
Tel: (02) 9273 1684
Email: health@sl.nsw.gov.au
Australian Law Reform Commission
www.alrc.gov.au
Website has many speeches and papers relating to
human genetic material and privacy including ‘Genes
and ingenuity: gene patenting and human health’
(ALRC 99) and ‘Essentially yours: the protection of
human genetic information in Australia’ (ALRC 96).
Australian Medical Association (NSW) Ltd
www.nswama.com.au
Click on the tab ‘Policy and issues’ to find position
papers and a section on medical ethics which includes
the AMA’s Code of conduct and declarations of the
World Medical Association.
guardianship Tribunal (NSW)
www.gt.nsw.gov.au
The Tribunal makes guardianship and financial
management orders for people aged 16 years and
over with decision-making disabilities. The website
has information and forms relating to medical
consent, clinical trials, powers of attorney, enduring
guardianship and substitute consent.
Tel: (02) 9555 8500
Toll free: 1800 463928
TTY: (02) 9552 8534
Fax: (02) 9555-9049
Email: gt@gt.nsw.gov.au
Health Care Complaints Commission
www.hccc.nsw.gov.au
The Commission investigates and prosecutes
complaints about health care. Website contains
information on making a health care complaint.
Tel: (02) 9219 7444
Toll Free in NSW 1800 043 159
TTY service for the hearing impaired: (02) 9219 7555
Fax: (02) 9281 4585
Email: hccc@hccc.nsw.gov.au
Interpreter service
People who prefer a language other than English should
contact us through Telephone Interpreter Service
(TIS) on 131 450. Interpreters can be arranged by the
Commission to discuss a complaint.
National Health and Medical Research Council
www.nhmrc.gov.au
The NHMRC provides independent advice on funding
health and medical research; ethical guidance on health
and medical research issues; and develops health advice.
They publish guidelines, information papers and
pamphlets on a range of health issues.
NSW Department of Ageing, Disability and Home
Care (DADHC)
www.dadhc.nsw.gov.au
Tel: 02 8270 2000
TTY: 02 8270 2167
Website includes:
Planning Ahead Kit: resources for managing financial,
health and lifestyle decisions into the future, 2005, which
provides information about enduring power of attorney,
enduring guardianship and advance care directives.
Your Future Starts Now: A Guide for Over 50s
(March 2008)
A booklet about taking steps to protect your interests
and making sure things are done the way you want.
NSW Health
www.health.nsw.gov.au
A wide range of resources under the ‘Publications and
resources’ tab, including Using Advance Care Directives:
NSW, www.health.nsw.gov.au/pubs/2004/pdf/adcare_
directive.pdf
For a free print copy contact:
Better Health Centre – Publications Warehouse
Tel: (02) 9816 0452
Fax: (02) 9816 0492
Further information 23

NSW Law Reform Commission
www.lawlink.nsw.gov.au/lrc
Office of the privacy Commissioner (Federal)
www.privacy.gov.au
Tel: 1300 363 992
TTY: 1800 620 241
Email: privacy@privacy.gov.au
Non-English Speakers
If you need assistance with other languages call the
Translating and Interpreting Service on 131 450 and
ask for the Office of the Privacy Commissioner on 1300
363 992. This is a free service.
privacy NSW
www.lawlink.nsw.gov.au/privacynsw
The Office administers and accepts complaints under
NSW privacy legislation.
Tel: (02) 8688 8585
privacy_nsw@agd.nsw.gov.au
public Interest Advocacy Centre (pIAC)
www.piac.asn.au
See the health subject index under ‘publications’.
Tel: (02) 8898 6500
Fax: (02) 8898 6555
Email: piac@piac.asn.au
puBlicaTiOns
*The law handbook, Redfern Legal Centre
Publishing, 10th ed, 2007. See Chapter 28: Health law.
*Sex and the law, FPA Health and C Read, 2006.
Chapters on medical treatment & the law, consent to
medical treatment, and reproduction.
+Elder law in Australia, R Lewis, LexisNexis
Butterworths, 2004. Sections on duty of care, trespass
to the person, end of life decisions, delegation and
capacity.
+public health law and regulation, C Reynolds,
Federation Press, 2004. Covers main public health
areas: sanitation, disease, food and drugs; looks at
emerging trends and risk-based approach to public
health.
+Law and medical practice: rights, duties,
claims and defences, L Skene, LexisNexis
Butterworths, 2nd ed., 2004. Sections on legal duties
of doctors, consent to medical procedures, doctor’s
duty to provide information, injuries caused by medical
treatment, access to medical records, privacy &
confidentiality, withdrawal of treatment & euthanasia,
abortion & wrongful birth.
Australian health and medical law reporter,
CCH Australia (loose-leaf service). Covers aspects
of clinical care such as medical negligence, consent,
drug use, medical litigation, patients’ rights, forensic
medicine, dying with dignity and palliative care, public
health, ethics of practice. Available at LIAC in the State
Library of NSW.
Australian medico-legal handbook, C Stewart, I
Kerridge & M Parker, Elsevier, 2008. Available at LIAC
in the State Library of NSW.
Disputes and dilemmas in health law, I
Freckelton & K Petersen (eds), Federation Press, 2006.
Available at LIAC in the State Library of NSW.
Who owns our health? Medical professionalism,
law and leadership beyond the age of the
market state, T Faunce, UNSW Press, 2007.
My health, my future, my choice: an advance
care directive for New South Wales is published
by the Advance Care Directive Association Inc with
assistance from the Benevolent Society. It explains
what advance care directives are, how they can be
useful and includes a form designed to make it as
simple as possible for people to record their wishes.
It costs $14. Download an order form or go to
www.advancecaredirectives.org.au.
Mental Health Rights Manual
Published by the Mental Health Coordinating Council
– 2008 edition soon to be available at www.mhcc.
org.au/rightsmanual/mhrm.html Covers areas such as
mental health care & treatment, guardianship, access to
information & privacy, carers rights & responsibilities.
Working with young people: ethical and legal
responsibilities for health workers, 2005, NSW
Association for Adolescent Health Inc (NAAH).
Covers duty of care, confidentiality, consent to
treatment, sexual health. Available online at
www.naah.org.au/download_files/ACFF391.pdf
‘Refusing Advance Refusals: advance
directives and life-sustaining medical
treatment’ by L Willmott, B White & M Howard,
Melbourne University Law Review [2006] MULR 7.
Available online at www.austlii.edu.au/au/journals/
MULR/2006/7.html
* A Find Legal Answers Tool kit book available in all NSW
public libraries.
+ A Lawbooks for Libraries title, available in many public
libraries – check the Find Legal Answers website www.
legalanswers.sl.nsw.gov.au for your nearest LIAC library.
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HOT TOPICS 64 > Health and the Law