The Australian Policy Debate
About Human Embryonic Stem
Cell Research
Wayne Hall
1. Introduction
Australia is a pluralistic liberal democracy in which no ethical theory commands universal assent, so contentious ethical issues must be resolved by the political process. The
usual outcome is a policy that is the most acceptable, or the
least objectionable, to the most citizens.1
The major competing ethical theories in the Australian stem
cell debate have been utilitarianism and deontological theories. Utilitarianism is a consequentialist theory in which
individual acts or moral rules are assessed by their net effect
for good and ill on all who are affected by them.2
Deontological or duty-based theories derive obligatory rules
for moral conduct from general ethical principles, such as,
the rule that it is wrong to take innocent human life.3 These
ethical theories do not exhaust the possibilities4 but they
have dominated the Australian debate about human embryonic stem (hES) cells.
2. Embryonic Stem Cells
Embryonic stem cells are self-renewing, undifferentiated
cells that are extracted from the inner cell mass of a 5-6 day
old embryo or blastocyst.5 The embryo is destroyed in the
process of extracting the stem cells.6 Embryonic stem cells
are pluripotent, that is, they can differentiate into many different cell types but they cannot give rise to an embryo.
Adult stem cells which are found in small numbers in bone
marrow, brain and lining of the gut are multipotent, that is,
they can give rise to a limited number of cell types.
Volume 12, Number 2
A number of potential uses can be made of hES cells. The
first use has been undervalued in public debate: this is the
contribution they may make to improve our understanding
of the processes of cell differentiation and development in
human beings.7 The second potential use is to expedite drug
development by testing the efficacy and toxicity of new
drugs in target human tissues in the test tube.8 A third potential use of stem cells is to provide a vehicle for somatic gene
therapy in genetic disorders, such as, cystic fibrosis, haemophilia, haemochromatosis etc.9 The fourth possible use has
dominated the public debate because of the potential benefits it may provide for people with serious illnesses and disabilities. This is their use in “cellular” or “regenerative
medicine” to generate replacement tissues and organs that
could be transplanted into persons with genetic, congenital
or acquired diseases and disabilities.10
3. Somatic Cell Nuclear Transfer
and Therapeutic Cloning
A major technical problem in using hES cells for regenerative medicine is that they are unlikely to be immunologically
compatible with the recipient and so will provoke an
immune reaction that will lead (in the absence of
immunosuppressant drugs) to their rejection.11
One solution to this problem would be to create a hES cell
tissue bank, that is, a large number of different hES cell
types that would allow matching between donor and recipient.12 A major disadvantage with the hES cell tissue bank is
that this would require a huge number of hES cell lines (the
27
number required being a matter of debate). Such a hES cell
bank would be technically difficult and expensive to generate and the number of human embryos that would be
required to produce such a stem cell bank would test public
support for hES cell research.
A second solution is “therapeutic cloning” which involves
generating hES cells from the recipient of the transplant by
means of Somatic Cell Nuclear Transfer (SCNT) or
“nuclear transfer”.13 SCNT creates an embryonic clone of
the patient by inserting a nucleus from one of the patient’s
cells into an oocyte or egg from which the nucleus has been
removed (i.e. an enucleated oocyte). The new composite cell
is then induced to develop into an embryo.14 After 5-6 days
hES cells are “harvested” from the inner cell mass of the
blastocyst. These cells are used to generate new tissue that is
immunologically identical to the patient and hence can be
transplanted without tissue rejection.
The hope is that SCNT could produce: pancreatic islet cells
for diabetes; dopaminergic neurones for Parkinson’s disease; cardiomyocytes for heart disease; and neurones for
spinal cord injuries.15 These hopes are inspired by studies,
which demonstrate that SCNT is feasible in mice.16 SCNT
technology has not yet been used in humans, with no human
embryos having reached the blastocyst stage.
There are a number of other technical challenges. First, hES
cells need to be grown on human tissues rather than on the
mouse feeder cells to avoid xenotransplantation. Second,
researchers also need to better control cell differentiation so
that they can direct hES cells to develop into the required
type of cell. Third, they also need to purify the regenerated
tissue of hES cells in order to eliminate the risk of producing
teratomas. This occurs in mice when undifferentiated ES
cells are implanted into normal tissue.
4. Adult Stem Cells
Adult stem (AS) cells in the bone marrow (haematopoietic
cells) have been shown to be multipotent, that is, capable of
differentiating into a number of different cell types, e.g. different types of blood cells, muscle and neurones.17 So far
they have not been shown to be pluripotent like hES cells.
AS cells potentially provide a direct way to generate
immunocompatible tissue and organs18 that does not require
the creation of new embryos via SCNT or the destruction of
surplus IVF embryos.
28
There are also a number of technical obstacles to the use of
AS cells for regenerative medicine. AS cells are found in
very small numbers in adult tissue (though they are much
more plentiful in umbilical cord blood). They have so far
proven difficult to identify, isolate and culture, and so cannot yet be used to produce therapeutically useful numbers of
cells for tissue replacement, with the exception of bone marrow transplants which are used to treat cancers of the lymphatic system. As with hES cells, these may not prove to be
insuperable obstacles to therapeutic use of human AS
cells.19
5. Ethical Concerns with
hES Cell Research
5.1 The Moral Status of Embryos
Many who oppose hES cell research and SCNT on moral
grounds believe that from the time of fertilization the
embryo is deserving of the same moral respect and protection as a child or an adult.20 For these critics, all hES cell
research is unethical because the extraction of hES cells
destroys an early human embryo.21
Many of these opponents also argue that hES cell research is
unnecessary because the same therapeutic ends can be
achieved by research on adult stem cells that does not pose
any of the ethical issues raised by hES cell research.22 In
public debate some opponents make the superiority of adult
stem cells their leading argument when in fact they primarily object to hES cell research on moral grounds. The latter
fact only becomes apparent when they are asked why they
would not allow research to proceed on both hES cell and
AS cells.
The view that human moral status begins at conception is
inconsistent with other public policies in Australia. These
include: in vitro fertilization which typically involves the
creation and destruction of surplus embryos; the use of
post-conceptional forms of contraception such as, IUDs and
the “morning-after-pills”; and policies that allow abortion
up to 12 weeks.23
These policies implicitly accept a more developmental view
of moral status24 in which the moral status of a foetus grows
as it develops in utero. On this view, an early embryo, prior
to implantation, does not have same moral status as person
because it lacks morally relevant capacities, such as, the
capacity to think and feel.25 Some bio-ethicists cite the high
Health Law Review
rate of foetal loss in early embryos (as high as 73% before
implantation according to Boklage)26 as a reason for not
according pre-implantation embryos the same moral status
embryos at a later stage of development (say 14 days after
fertilization).27
as result of confusion about social relationships with one’s
parental twin and other first degree relatives, the possibility
of social ostracism by peers, and the effects of depriving a
child of two biological parents.
It is not clear that allowing SCNT for therapeutic purposes
Those who support a developmental view of the moral status
will inevitably lead to its reproductive use or that it is necesof a foetus differ on the point in development at which the
sary to ban any use of SCNT in order to avoid reproductive
moral interests of a foetus precloning. In the UK, expert comclude its destruction.28 Some
mittees have argued that it is
would regard this as occurring
sufficient to make it a criminal
The major competing ethical theories
14 days post-fertilization29
offence to implant SCNT
while in Judaism this occurs at
embryos in a uterus.40
in the Australian stem cell debate
the time of “ensoulment” 40
have been utilitarianism and
days after fertilization.30 How5.3 Access, Equity and
deontological theories.
ever, all agree that a 5-6 day old
Commercialisation
blastocyst does not warrant the
same moral status as a child or
A third a cluster of ethical conadult and so they would regard
cerns about hES cell research
the extraction of hES cells from a blastocyst as morally
has received much less attention in the Australian policy
acceptable.31
debate. These include the commercial motivations for
developing hES cell technology and the implications of
commercialisation for public access to the benefits of these
5.2 Slippery Slopes: Reproductive Cloning
technologies.41 The future economic benefits of hES cell
Opponents of hES cell research point out that SCNT can
research and technology have been cited as a strong reason
also be used for reproductive purposes.32 If a SCNT embryo
for allowing such research.42 Economic benefits of commerwas implanted into the uterus of a surrogate mother, and
cialising hES research do not impress those who oppose hES
allowed to develop to full term, the result would be a baby
cell research on moral grounds. Indeed commercialisation
that was a genomic copy of the adult who supplied the cell
compounds the offence by profiting from a moral evil.43
nucleus (except for mitochondrial DNA from the oocyte
donor). The use of SCNT technology for reproductive purConcerns about social justice and equity underlie other critiposes would allow the asexual reproduction of one member
cisms of commercialisation of hES cell research. Their fear
of an infertile couple, or a homosexual couple or a single
is that commercialisation will restrict community access to
adult to reproduce him or herself.
its benefits by making therapies too expensive for many of
those who are in need of them.44 Proponents of hES cell
In Australia a majority of the public opposes reproductive
research argue that all novel technologies are expensive
cloning.33 The opponents of reproductive cloning include
when first developed because of the need to recoup developrepresentatives of the major Christian and non-Christian
34
35
ment costs. With time, they argue, the procedures become
religions, scientists , and politicians from both parties.
36
37
routine, the manufacturing process more efficient, and patThe same is true in the UK and the USA .
ents expire, allowing more patients to be treated more
cheaply.45
There is less agreement on why reproductive cloning should
be banned. Scientific opponents in Australia, like those in
the UK38, have stressed the high failure rate in animals and
Access to stem cell technology may also be reduced by
the high risk of producing birth abnormalities, miscarriages
restrictive regulations on hES cell research. For example,
and premature aging. Religious opponents have argued that
restricting research to existing hES cells lines confers a
reproductive cloning violates “human dignity”, the sanctity
monopoly on hES cell technology to those researchers and
of marriage, and the natural process of human generation.39
companies that already have extracted hES stem cell lines.
Opponents have also expressed serious concerns about
For those who do not object to hES cell technology on moral
adverse effects on the psychological health of a cloned child
grounds, a concern about equity and access provide good
Volume 12, Number 2
29
reasons for supporting public investment and oversight of
hES cell research.
5.4 Critical Perspectives from Disability Groups
hES cell research under strict oversight on surplus IVF
embryos that existed prior to 5 April 2002 and whose parents give informed consent to their use for research. The
date was intended to avoid any incentive for IVF clinics to
create surplus embryos for research purposes.
Persons with acquired disabilities, such as, spinal cord injuries and juvenile onset diabetes, have been strong public
The legislation is to be independently reviewed two years
advocates of hES cell research.46 Not all disability groups
after it receives Royal assent. The Commonwealth legislashare these views. For example, Newell has objected to the
tion has been passed by the House of Representatives after a
use of disability in justifying
conscience vote (99:33) and
hES cell research, arguing that
was passed by the Senate in
the resources devoted to such
November 2002 (60:40). State
research would be better spent
It is not clear that allowing SCNT for
parliaments in new South
addressing the needs of people
Wales, Queensland, Victoria
therapeutic purposes will inevitably
with serious disability.47 Reeve
and Western Australia have
lead to its reproductive use or that it is
has argued in reply that there is
passed complementary legislano need to choose between care
necessary to ban any use of SCNT in
tion to regulate those areas not
and cure; both are required and
covered by Commonwealth
order to avoid reproductive cloning.
both can and should be suplaw.
ported.
6. The Australian Policy Process
The Australian policy debate about hES cell research has
developed over three years.48 A House of Representatives
Inquiry that was set up in August 1999 under the Chairmanship of Mr. Kevin Andrews reported in September 2001.49 It
recommended a ban on reproductive cloning and a
three-year moratorium on SCNT or therapeutic cloning. The
majority (6:4) supported hES research on surplus IVF
embryos but the minority wanted to restrict research to
existing hES cell lines.50
This outcome allows some hES
cell research while banning reproductive cloning of which
the community strongly disapproves and imposing a moratorium on SCNT, about which the community is still
divided. In so far as can be judged from opinion polls, the
legislation is consistent with public opinion. The majority of
Australians oppose reproductive cloning and the creation of
embryos for research purposes but most support hES cell
research on surplus IVF embryos52(72% in a Bulletin poll in
2001)53. Opinion is more divided about therapeutic cloning.
7. How Good has the Policy
Process Been?
In March 2002, Andrews attempted to persuade Federal
Cabinet to implement the minority recommendations of the
House of Representatives Committee. This prompted a public debate between the Prime Minister, leading hES
researchers and State Premiers from NSW, Queensland and
Victoria, all of who rejected the restrictions proposed in the
HR minority report.51 On 5 April 2002, the Council of Australian Government (COAG) (consisting of the Prime Minister and Premiers) agreed on a framework for nationally
consistent legislation to regulate hES cell research. This
compromise largely enacted the recommendations of the
majority report of the HR Committee.
Opportunities for public involvement and consultation in
the development of the legislation have been limited to making submissions to parliamentary inquiries, commenting on
draft legislation, and lobbying parliamentarians to vote on
the legislation. Public consultation could potentially be
improved by the use of novel methods of consultation and
deliberation.54 Parliamentary “summits” have recently been
used to involve the public in the formulation of drug policy
in a number of Australian states (e.g. New South Wales,
Victoria, South Australia and Western Australia).
The Research Involving Embryos and Prohibition of Human
Cloning Bill 2002 bans (among other things) reproductive
cloning (penalty 15 years jail), SCNT (penalty 10 years jail)
and germ-line gene therapy (penalty 10 years jail). It allows
In Europe, consensus conferences and citizen juries have
been used to help formulate policy in ethically contentious
areas in genetics and biotechnology.55 There has been one
consensus conference in Australia on genetically modified
30
Health Law Review
organisms56 and an exercise in “deliberative polling”57 in
1999 in the lead up to a national referendum on whether
Australia should become a republic instead of a monarchy58.
All of these consultative options involve resources and
costs. Policy makers often fear that they may delay a decision or allow the policy process to be captured by partisans.59
is likely to become a de facto prohibition because of the
political difficulty in repealing a law that prohibits it on pain
of criminal penalties.
What should be the standard in appraising the quality of the
policy process on hES cells? Should we compare the quality
of the process of formulating policy on stem cells with the
quality of processes used to formulate economic policy,
employment, immigration, crime, drug policy, child welfare, social welfare, and health care funding? In all of these
areas, there is much less public consultation on policy. In
some there is more opportunity for policy processes to be
influenced by unrepresentative special interest groups who
can secure the ear and the tongue of unelected and unaccountable media personalities. By these standards, the formulation of policy on hES cell research has been an
exemplar of public consultation. The deliberative process on
stem cell legislation by parliamentarians has also taken
place over three years. Allowing a conscience vote in the
Federal Parliament has also had the desirable effect of freeing politicians from party discipline and encouraging them
to educate themselves about the issues. This is evident in the
quality of the parliamentary speeches made on the bill in the
House of Representatives.
Notes
8. Conclusions
Ethical issues have been critical to the Australian policy
debate about hES cells and therapeutic cloning. The deliberative process and the political negotiation between state premiers and the Prime Minister have produced compromise
legislation that bans reproductive and therapeutic cloning
while allowing limited research on hES cells extracted from
surplus IVF embryos. Despite conflicting views on the
morality of hES cell research, there appears to be majority
support for hES cell research on IVF surplus embryos. The
community seems to have been persuaded that it should be
allowed because of the possibility it holds of developing
effective treatments for hitherto untreatable conditions.
There is as near as one gets to a consensus in favour of a ban
on reproductive cloning in Australia. This is in the absence
of agreement on the reasons why reproductive cloning
should be prohibited. Opinion is much more divided on
SCNT and therapeutic cloning. A moratorium on SCNT
seems a reasonable compromise in the circumstances but it
Volume 12, Number 2
Wayne Hall, Office of Public Policy and Ethics, Institute for Molecular Bioscience, University of Queensland, Brisbane, Australia.
1.
2.
3.
4.
5.
6.
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31
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32
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Anderson, ibid.; Pyne, ibid.; Juengst & Fossel, supra
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Lanza et al., supra note 6; E. Parens, “On the ethics
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C.E. Boklage, “Survival probability of human
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E.N. Dorff, “Stem cell research – a Jewish
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Roy Morgan International, “Most Approve Use Of
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Anderson, supra note 22; Austl., Commonwealth,
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37.
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Austl., House of Representatives, Standing
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U.K., Department of Health, supra note 36; Nuffield
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5.
Peter Lachmann, “Stem cell research – why is it
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Christopher Reeve, “Christopher Reeve responds to
Dr Newell” (2002) June/July Access 6.
Christopher
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Jennifer Norberry, Commonwealth (Austl.), Research
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August 2002).
Ibid.
Austl., House of Representatives, Standing
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Norberry, supra note 48.
J. Oakley, “Democracy, embryonic stem cell
research, and the Roman Catholic church” (2002) 28
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Roy Morgan International, supra note 33.
P. Bishop & Glynn Davis, “Developing consent:
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Davis & Patrick Weller, eds., Are You being Served?
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55.
State, Citizens and Governance (Sydney: Allen and
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S. Joss, “Danish consensus conferences as a model of
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56.
57.
58.
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James S. Fishkin, The Voice of the People: Public
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E. Papadakis, “Social movements: the citizens in
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Bishop & Davis, supra note 53.
Upcoming Events
•
American Society of Law, Medicine & Ethics. The Public’s Health and Law in the
21st Century. June 14, 2004, Atlanta, Georgia. www.aslme.org
•
International ELSAGEN conference. Ethical, Legal and Social Aspects of Human
Genetic Databases, held jointly with the XVIII European Conference on
Philosophy of Medicine and Health Care. August 25-28, 2004, Reykjavik, Iceland.
Information: [email protected].
•
Canadian Bioethics Society. Home Care: The New Frontier of Health Care Ethics.
October 28-31, 2004, Calgary, Alberta. www.bioethics.ca
•
International Association of Bioethics. Deep Listening: bridging divides in local
and global ethics. November 9 - 12, 2004, Sydney, Australia.
www.bioethicsworldcongress.com
Volume 12, Number 2
33