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Page 1: Regulating stem-cell research and human cloning in an€¦ · 2006). This ‘double reproductive value’ (Franklin 2006) of the embryo, recognises both the inherent specialness of
Page 2: Regulating stem-cell research and human cloning in an€¦ · 2006). This ‘double reproductive value’ (Franklin 2006) of the embryo, recognises both the inherent specialness of

Regulating stem-cell research and human cloning in an Australian context: the Lockhart Review.

Abstract:

In late 2002 the Federal Australian Government developed legislation explicitly intended to govern both stem-cell research and human

cloning. Together, the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002 provided a

comprehensive national framework for the licensed use of excess ART embryos in research and a complete ban on all types of human

cloning. Both pieces of legislation contained review clauses stating that each Act be concurrently and independently reviewed by the same

committee in 2005, three years after receiving royal assent. The years between the initialisation of the legislation and the outcome of the

review process have resulted in some significant transformations in

how stem-cell science and human cloning are viewed in Australia. This paper will discuss those changes and the shift in attitude they

represent.

Dr. Olivia Harvey

Address for correspondence:

Edith Cavell Building University of East Anglia

Norwich, Norfolk NR4 7TJ

UK

Email: [email protected]

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Introduction: The Australian stem cell research and human cloning debate emerged

in the context of increasing global anxieties surrounding developments in stem cell science and cloning technology during the late 1990s. The

stem cell debate has been played out at a national, regional and global level, with regulatory responses to this emerging field of biomedical

research variously addressing the ethical, cultural, political, social and financial implications opened up by human embryonic stem cell

research and the possibility of human cloning (Salter and Salter, 2005). The reactions of nation-states to stem cell research and human

cloning can be understood as both a reflection of national community attitudes and as sound consideration of economic competition in the

international knowledge economy (Salter and Salter 2005; Waldby 2005; Dickins 2007). The discussion about stem cell research and

human cloning in Australia has been no different, with the Federal

Australian government seeking to develop a workable policy position that recognises the scientific, medical and economic potential of stem

cell research and also encompasses the attitudes of the Australian community towards both the use of human embryos in research and

cloning for reproductive purposes.

The Australian stem cell research and human cloning debate has had many parallels with other discussions on the topic around the world

(Harvey 2005). These include: the call for political leadership (Nerisini 2000; Holliman 2004); significant amounts of media coverage (Nerisini

2000; Holliman 2004); the involvement of special interest groups (Downey and Einsiedal, 2003; Ganchoff, 2004); and the agreement

that limits should be placed on research involving embryos (Franklin, 1999; Kirejczyk, 1999; Nerisini, 2000). The final outcome of the

debate in Australia was that excess IVF embryos would be allowed to

be used for research under strict licensing conditions and that a complete ban on all forms of cloning would be imposed

(Commonwealth of Australia, 2002a and b). This result was seen as progressive enough to assure the nation a foothold at the forefront of

a new and exciting avenue of biomedicine, whilst also providing some safeguards against the wanton production and destruction of potential

human subjects (Harvey 2005).

Almost five years later, in late 2006, the same Australian Government announced some quite significant changes to the legislation. The main

point is that it is now legal for researchers to use the technique known as Somatic Cell Nuclear Transfer, or SCNT, to create human embryo

clones for research (O’Neil 2007). The question is: what does this

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mean for the Australian community? Does this shift in Government

policy reflect changing attitudes towards stem cell research and human cloning in Australia?

Background:

After a Federal Parliamentary Review on Human Cloning and Stem Cell Research in 2001 (Commonwealth of Australia), the Council of

Australian Governments (COAG) decided that a Federal regulatory framework was necessary (Harvey, 2005; Dodds and Ankeny 2006).

In the absence of any other national legislation effectively governing the use of human embryonic material - and the presence of quite

disparate state regulation of assisted reproduction that might potentially do so (Nicol, Gogarty and Chalmers, 2001) - the Prohibition

of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002 were concurrently passed by the Parliament of

Australia (Harvey 2005). Under the COAG agreement, Australian

States and Territories were obliged to put into place appropriate legislation that would be consistent with the new national regulations

(Harvey 2005; Dodds and Ankeny 2006). All Australian states and territories have subsequently introduced legislation to this effect, with

the Northern Territory still in the process of drafting some (www.nhmrc.gov.au).

The Australian position is consistent with several other regulatory

regimes internationally (Salter and Salter, 2005) and is modelled on the licensing system used in the UK. The Australian legislation was

designed to actively encourage research whilst minimising the ethical dilemma involved in the use of embryos (Harvey 2005). The

requirements that research be conducted under license and that only excess IVF embryos be used for research are designed to mitigate the

potentially detrimental effects of an unregulated research

environment. Overall, support for stem cell research in Australia is quite strong (Biotechnology Australia 2006a) and is based on the

perception that the therapeutic possibilities of stem cell research will be significant (Hall, 2004).

In general terms, the original debate was universally polarised along

pro/anti positions. Mass media representation overwhelmingly focused on white, middle-class Australians suffering from debilitating diseases

pitched against right-to-life anti-abortion religious zealots (Harvey 2005). Alternative viewpoints were largely either marginalised by the

mainstream media as biased by religious beliefs or simply too crazy to take seriously (eg. the Raelians, a religious group claiming humans

were created by aliens and that they can clone human beings.

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www.rael.org) (Harvey, 2005). Susan Dodds and Rachel Ankeny

(2006) further argue that homogeneity in the Australian debate was achieved through an absence of ‘deliberative democracy’ and a

circumscription of the debate to purely ethical discussion. For Dodds and Ankeny, the development of relevant legislation relied too much

on the testimony of specially selected experts delivered to closed shops of government officials to be truly open to discussion and

reflection (2006: 100-101). The debate, they argue, was always framed as a ‘science versus religion’ contest (Dodds and Ankeny 2006:

107), and in the secular Australian nation-state, rational science wins.

The regulations around the use of embryos mean that Australian embryos have what Sarah Franklin (2006) calls a ‘double reproductive

value’. Under Australian regulations, any embryo not donated to research must either be implanted into the body of a woman for the

purpose of achieving a pregnancy, or allowed to die. Embryos are not

allowed to be sold, altered, experimented with, tested on, imported or exported (except under ministerial consent for an individual’s own

fertility treatment), sustained past 14 days outside of the body of a woman or implanted anywhere other than the body of a woman

(Commonwealth of Australia 2002a). Given this list of uses of embryos, Australian embryos can be considered first and foremost as

reproductive material. Once they cease to be valued for their reproductive potential and become surplus, or excess, to reproduction,

then and only then can embryos be considered for use in research. On becoming research material, the reproductive qualities of embryos are

redeployed into the foundations of regenerative medicine (Franklin 2006). This ‘double reproductive value’ (Franklin 2006) of the embryo,

recognises both the inherent specialness of the embryo as a potential human being, and also separates out the qualities that make it a viable

medical resource (Waldby 2002).

Spare, or surplus embryos move from one end of the spectrum of

reproduction to the other through ‘the IVF-stem cell interface’ (Franklin 2006). IVF and stem cell research are closely interconnected

in Australia, with at least one of the biggest IVF clinics (Sydney IVF) also conducting stem cell research (DTI 2006). The Research Involving

Human Embryos Act carried this caveat: that only embryos created on or before the 5th of April, 2002, could be used for research

(Commonwealth of Australia, 2002b). This restriction was intended to prevent the deliberate construction of more embryos than strictly

necessary for ART purposes, thereby creating a supply for research (Commonwealth of Australia, 2005: 37). The ban was removed exactly

three years later as specified in the original legislation (Commonwealth

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of Australia 2002b). The lifting of this embargo did open up new

sources of embryos that could potentially be used for research, but there is no evidence to suggest that extra embryos have been

deliberately created in order to produce a research supply.

An independent licensing body for research involving embryos was established in 2003 (www.nhmrc.gov.au). The Licensing Committee is

administered by the National Health and Medical Research Council (NHMRC), a peak statutory body of the federal government. The

NHMRC provides health and medical advice to government, funding to researchers and regulatory and ethical oversight of health and

medicine in Australia (www.nhmrc.gov.au). The Licensing Committee is one of the five principle committee’s of the NHMRC. By contrast, the

UK Human Fertilisation and Embryology Authority (HFEA) – the governing body for all UK-based assisted reproduction and embryo

research - is a statutory body in its own right. Burying the Licensing

Committee within the administrative structure of the NHMRC makes it less publicly visible and therefore less politically engaged in discussion

about stem cell research than the HFEA. In this regard then, the Licensing Committee is effectively restricted to purely administrative

implementation of the legislation regarding both stem cell research and human cloning.

The first licenses for human embryo research were awarded in mid

2004, and only 10 licenses to conduct research involving human embryos have been awarded so far (www.nhmrc.gov.au). The small

number of licenses has been largely attributable to misunderstandings about the requirements of the licensing process and interpretation of

the two Acts; the length of time required to obtain a license; a lack of excess ART embryos; and, a perception that researchers were holding

off applying for licenses until the conclusion of the 2005 review

(Australian Government 2005: 99-109). One of the legislative requirements was that information about embryo licenses be made

public at all times: details of the projects that have been issued licenses can be found on the NHMRC web-site (www.nhmrc.gov.au).

The use of excess ART embryos and the licensing conditions were

intended to mollify community concerns about the wanton production and destruction of embryos (Harvey 2005). The introduction of a

Federal regulatory regime for stem cell research in Australia has been quite successful in negotiating the spectre of Frankenstein-like horrors

of meddling with nature and stem cell research has become an increasingly acceptable practice. In implementing such a structure, the

Australian government struck a delicate balance between the needs of

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medical researchers, patient advocate groups, religious organisations

and the broader community. Stem cell science is now a multi-million dollar industry in Australia, with significant government funding, fierce

inter-state competition, several private companies, major international collaborations and an environment that encourages companies to base

their operations in Australia (Biotechnology Australia 2006b; DTI 2006). Australia’s comprehensive and permissive regulations around

stem cell research and sophisticated scientific research culture are cited as reasons for attracting foreign business (DTI 2006). Lack of

venture capital is currently the only real inhibitor for a globally competitive stem-cell industry in Australia (DTI 2006).

The Lockhart Review:

In recognition of the fast paced changes in stem cell science, both the Prohibition of Human Cloning Act (Commonwealth of Australia, 2002a)

and the Research Involving Human Embryos Act (Commonwealth of

Australia, 2002b) included sunset clauses specifying that they be concurrently reviewed by an independent committee three years after

receiving royal assent. A Legislative Review Committee was appointed in mid 2005, chaired by the late John Lockhart AO, QC

(www.lockhartreview.com.au). The original terms of reference for the Legislative Review Committee were: consider developments in cloning,

stem-cell science, and assisted reproduction; take into account community attitudes; and discuss the possibility of establishing a

National Stem Cell Bank (Commonwealth of Australia, 2005: 4-6). Further terms of reference specified for the Committee in 2005

included examining the effectiveness of compliance with national legislation; the role of other bodies in monitoring ART treatment;

issues to do with Customs, import, export and trade of embryonic material and material involved with assisted reproduction and stem-

cell research; and the overall implications for Australian science and

economic activity (Commonwealth of Australia, 2005: 4-6).

Attuned to the sensitive nature of the debate, the Legislative Review Committee engaged in a wide variety of public consultation,

stakeholder discussions and site visits across Australia (Australian Government 2005: 17-21). A discussion paper was released and

submissions invited from the general public. Meetings were held in all of the state capitals with invited stakeholders that were mostly open to

public attendance. Public discussion forums were held in Sydney, Melbourne and Brisbane. Private meetings with government officials

and other stakeholders were also held. In addition, the Committee visited two research clinics in NSW (Sydney IVF) and Victoria (Monash

University). Over 1000 submissions were made through the

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Committee’s web-site (www.lockhartreview.com.au), with more than

900 of these coming from private individuals. To further ensure the breadth and accuracy of the information being collected, the

Committee also consulted the results of the Public Awareness Program of Biotechnology Australia (www.biotechnology.gov.au). Overall, the

Lockhart Review was generally considered to be thoughtful, comprehensive, progressive and significant. Despite disagreement

over the outcomes of the Review, opponents of stem cell research also agree that the Review was wide-ranging and inclusive.

One of the criticisms of the original debate leading up to the

development of legislation governing human cloning and stem cell research in Australia was that it was done amongst a select and

restricted cohort of stakeholders with little public consultation and was, moreover, circumscribed to a wholly ethical debate (Dodds and Ankeny

2006). The same could not necessarily be said of the Lockhart Review,

although there are some conspicuously familiar names and organisations from the 2002 debate appearing in the 2005 legislative

review. What is also missing from the Lockhart Review is a more wide-ranging consideration of public opinion that takes in less scientific or

mainstream religious discussion. In fact, the legislative review seemed unaccompanied by any of the fanfare of the original debate and had

less political impact than the 2002 legislative development. If the 2002 debate was primarily an ethical discussion (Dodds and

Ankeny 2006), the 2005 review could be said to be a technical one instead. The imperative to balance the

protection of embryos with the needs of medical research was reduced to a detailed scientific discussion of what could and couldn’t be

permitted under the scope of the Acts and what should be changed. Consequently, the main issues addressed by the Legislative Review

Committee included: what is an embryo? how should

embryos/embryonic material be obtained? how effective is regulation? And; are the original restrictions still relevant?

One of the first actions of the Committee was to commission the

National Health and Medical Research Council to develop a working definition of ‘human embryo’ (Commonwealth of Australia, 2005: 89-

98). The NHMRC decided that a human embryo arises from ‘…the first mitotic division when the fertilisation of a human oocyte by a human

sperm is complete…’, OR, ‘…any other process that initiates the organised development of a biological entity with a human nuclear

genome or altered human nuclear genomes…’ and the entity in question is not more than 8 weeks old (Australian Government 2006:

27). Although this might seem largely a technical question, it has

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implications for the kinds of research projects that can be legally

conducted in Australia. Misuses of embryos and the creation, use, import, export, sale or supply of prohibited embryos are criminal

activities, punishable by lengthy amounts of gaol time (Commonwealth of Australia 2002a and b). The concern about a coherent definition of

‘human embryo’ emerged in the light of disagreement over terms in the classification of pre-embryos, embryos, embryo clones and

foetuses (Commonwealth of Australia 2005: 89-90). Clarifying the definition of what counts as a human embryo makes it substantially

easier for the Licensing Committee to decide on appropriate research projects using human embryos and gives more strength to the

legislative measures adopted against inappropriate uses of embryos.

The Legislative Review Committee also devoted a considerable amount of time to investigating the informed consent procedures for supplying

embryos for research (Commonwealth of Australia, 2005: 115-120). In

a departure from the more usual global understanding of one-off consent for human tissue donation, the Australian 2002 embryo

research consent procedures required that consent be obtained for each new project under license (Commonwealth of Australia 2002b).

Once embryos were donated to research, they were stored until called upon for use in research, and then all parties responsible for the

production of the embryo would be asked to provide consent for their use, with a 14-day cooling off period after (Commonwealth of Australia

2002b). The effect of this project-based approach to gaining consent meant that couples were continually drawn into discussion about their

embryos, even though they may have finished IVF treatment long before. Some debate during the Lockhart Review focused on possible

emotional distress to couples created by this continual re-contact (Commonwealth of Australia 2005: 117-119).

The Lockhart Review recommended that the donation of excess embryos be addressed at the conclusion of fertility treatment

(Commonwealth of Australia 2005). In other words, the Legislative Review Committee suggested that consent to donate embryos to

research be the significant concern, not consent for specific research projects. Following organ donation protocols, for example, once

embryos are determined to be excess to a couple’s fertility treatment, the couple can decide whether or not to donate them to research, but

will have no further ability to decide which projects they will support (Commonwealth of Australia 2005: 115-121). The ‘double reproductive

value’ (Franklin 2006) of embryos is reinforced by this change in consent procedures and the transition of embryos from one side of the

IVF-Stem Cell Interface to the other.

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Another major concern for the Legislative Review Committee focused on the role of the Licensing Committee. Substantial examination of the

licensing process, the function of the Licensing Committee, and the Licensing Committee’s scope and effectiveness were undertaken

(Commonwealth of Australia 2005: 99-109). The Legislative Review Committee uncovered important problems with the rules and powers

of the Licensing Committee as established under the 2002 legislation, and has recommended an overhaul of the Licensing regulations

(Commonwealth of Australia 2005). Key aspects of the changes recommended for the Licensing Committee included: more efficient

and stream-lined application procedures to speed-up the time taken to issue licenses; broader scope for interpreting legislation and making

decisions in regards to appropriate research projects; more effective monitoring powers over licensees; increased power to conduct

investigations and recommend criminal proceedings over suspected

license breaches; and the capacity to investigate non-licensed activities thought to breach regulatory conditions (Commonwealth of

Australia 2005: 99-113). The overhaul of the Licensing Committee recommended by the Lockhart Review will give more power and

authority to the Australian stem cell research and human cloning legislation.

The final area of concern for the Legislative Review Committee was to

review the changes in the scientific terrain in assisted reproduction, stem cell research and human cloning since the 2001/2002 debate

(Commonwealth of Australia 2005: 25-67). What the Committee found was that, in effect, the science had changed enough by 2005 to

warrant serious investigation of the techniques prohibited by the original legislation. A raft of changes to the legislation was

recommended by the Legislative Review Committee, only some of

which were later adopted (Commonwealth of Australia, 2005: xxiixxvi).

The restrictions in the 2002 legislation are widely argued by scientists

involved in assisted reproduction research and human embryonic stem cell research to have placed major constraints on the conduct of both

kinds of research in Australia (Commonwealth of Australia 2005: 29- 38, 63-64). One of the concerns resulting from the 2002 legislation

was that Australia would lose key stem cell scientists to overseas organisations (Commonwealth of Australia 2005: 137-138)1. Another

concern was that Australian science would fall behind in the

1 Two Australian stem cell researchers have already gone to the US (Riley 2006).

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international arena (Commonwealth of Australia 2005: 138-139). The

Lockhart Review thus recommended that loosening restrictions on stem cell research would have significant benefits for the Australian

community. Apart from the obvious therapeutic potential of a more permissive approach to stem cell research and research in assisted

reproduction, other benefits include increased economic prospects through making Australian stem cell research look like an attractive

proposition for scientific and commercial development. The Victorian, New South Wales and Queensland state governments have taken the

economic aspects of this multi-billion dollar industry seriously and compete with each other to attract stem cell business to their

territories (DTI 2006).

The Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002 specifically banned: the creation of a clone

or chimera of any kind (therefore restricting the use of somatic cell

nuclear transfer or SCNT); the creation of an embryo by any means other than fertilisation of a human egg with a human sperm; the

creation of an embryo for any purpose other than the reproductive treatment of a woman; the development of embryos outside of a

woman’s womb beyond 14 days; the creation of hybrid entities; and the creation of embryos containing genetic material of more or less

than two people (Commonwealth of Australia 2002a and b). The Legislative Review Committee found that all the regulations of the

original legislation were still relevant, but proposed these changes: that fresh ART embryos unsuitable for implantation also be used in

research (subject to license); and that somatic cell nuclear transfer be permitted under license too (Commonwealth of Australia, 2005:

xxiixxvi).

Other recommendations of the Lockhart Review included: that

suitable criteria for determining non-implantation potential of embryos be developed; that chimeras and partial-human embryos be made

available for use in research; that embryos containing genetic material of two or more people be made; and that parthenogenesis and nuclear

transfer be used as an alternative form of fertilisation of embryos for research (Commonwealth of Australia 2005: xxii-xxvi). The Lockhart

Review also recommended that using embryos for research in assisted reproduction be permissible (Commonwealth of Australia 2005:

xxiixxvi).

In sum, the Legislative Review Committee concluded that national legislation governing assisted reproduction, the use of human embryos

in research and the banning of human cloning was necessary, and that

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the existing legislation should be adapted to respond to social, ethical,

and scientific developments in these areas. By 2005, the issue was no longer about whether or not stem cell research should proceed

(Harvey 2005), but exactly how it should be done. Susan Dodds and Rachel Ankeny point out that the Legislative Review Committee took

the earlier 2002 debate as prima facie evidence that the Australian community was happy for human embryonic stem cell research to

proceed (2006: 100-101). The Lockhart Review focused almost exclusively on the procedural aspects of conducting controversial

scientific research in Australia, highlighting and emphasising that scientific knowledge is valued above any other considerations. The

changes recommended by the Lockhart Review reflected a commitment to an expansion of the research agenda that was in

keeping with the Australian stem cell research communities’ profile as cutting-edge and globally competitive. Overall, the Legislative Review

Committee was limited to highlighting the best path for enhancing the

scientific and economic focus of the Australian stem cell industries by suggesting that restrictions be lessoned and regulatory control be

streamlined.

Debating the Lockhart Report: The recommendations of the Lockhart Report were fiercely contested

in the Australian Parliament during 2006, resulting in the development of two separate pieces of legislation and a further parliamentary

inquiry (Commonwealth of Australia 2006b). The continuation of the debate resulted when the Prime Minister rejected the Lockhart

Review’s recommendations with the declaration that nothing needed to be changed about regulations governing stem-cell research or human

cloning. This unilateral decision provoked a parliamentary backlash and produced several attempts to devise legislative amendments

which would reflect the changes suggested by the Lockhart Review.

Political debate over the proposed amendments led to a Parliamentary Review in the upper house of the Australian Parliament. The Senate

Committee for Community Affairs embarked on a similar programme of nation-wide public consultation as the Legislative Review

Committee, although on a much smaller scale and within a comparatively short time-frame. A modified version of the Legislative

Review Committee’s recommendations eventually passed through the Australian Parliament in late 2006. The Prohibition of Human Cloning

for Reproduction andthe Regulation of Human Embryo Research Amendment Act 2006 (Commonwealth of Australia, 2006a) updates

the 2002 laws and makes some minor changes to other relevant Acts.

The Prohibition of Human Cloning for Reproduction and the Regulation

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of Human Embryo Research Amendment Act 2006 represents a much

dampened incorporation of the recommendations of the Legislative Review Committee and shows a far more circumscribed approach to

cloning and human embryonic stem cell research than is contained in the Lockhart Report. Weighing more heavily on the side of ethics and

community concerns rather than advantage for Australian science, the Amendment Act 2006 provides a counter-balance to the enthusiasm

for scientific progress demonstrated by the Legislative Review. Although some of the key changes introduced into the legislation of

human embryonic stem cell research in Australia are significant, the overall limitations still reflect a cautious (Salter and Salter 2005)

regulatory approach to the stem cell industries.

The final outcome of the 2005/2006 debate on stem cell research and human cloning in Australia is that all the previous prohibitions

regarding human cloning or the misuse of embryos continue to stand,

with the exception of the creation of human embryo clones through somatic cell nuclear transfer. Whilst almost all the procedural aspects

of the Legislative Review Committee’s recommendations have been accepted, exceptions were made over some of the suggestions for

lifting restrictions placed around what kinds of research could be conducted. No chimeras or hybrids of any kind are allowed to be

created except under licence, and no human embryo clones or embryos not created by the fertilisation with a human egg with a

human sperm will be allowed to be implanted into the body of a woman or developed beyond 14 days (Commonwealth of Australia

2006a). Parthenogenesis and creating human embryos or human embryo clones containing genetic material from more than two people

or genetic material from non-human sources are also banned (Commonwealth of Australia 2006a). There will also be an overall

increase to 15 years imprisonment for most violations of laws

regarding the creation, use, import and export of human embryos and human embryonic material (Commonwealth of Australia 2006a).

The main concern of the 2006 Parliamentary debate was over the use

of animal eggs and the fears that part-human, part-animal hybrids would be created. While the Legislative Review Committee

recommended that animal eggs be used to minimise demand for human oocytes and consequently potential exploitation of the women

who provide them, the use of animal eggs was ultimately seen to be much too controversial to include in the Amendment Act 2006.

Although there is a significant shortage of oocytes for research, using animal tissues appears to cross a threshold that the Australian

community is not yet ready for.

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Conclusion: The years since the implementation of the Prohibition of Human

Cloning Act 2002 and the Research Involving Human Embryos Act 2002 have seen some subtle transformations in the way human

embryonic stem cell research is considered by the Australian community. Whereas the earlier debate focused on whether or not

stem cell research and human cloning should proceed, the 2005 Legislative Review addressed the more nuanced details about how

stem cell research and human cloning should be regulated. The fundamental concerns at the heart of the debate have shifted from

being a question of when is it appropriate to use potential human subjects as resources for others (Harvey, 2005), to now include

questions like: how do we provide the right level of ethical safeguards and legal protection for the conduct of research? In other words, no

longer simply about the possibilities for the exploitation of potential

human subjects (clones or embryos), the Australian stem cell research and human cloning debate now addresses the more technical

questions of the best way to regulate the research environment without undermining the potential for scientific and commercial

success.

Significant achievements in both assisted reproduction and stem cell research in Australia have provided the groundwork for the

legitimation of research involving human embryonic material. Stem cell research is an established field of scientific endeavour in Australia,

with promising developments in the treatment of conditions like diabetes, Alzheimer’s disease and prostate cancer (DTI 2006;

Anonymous 2007). The final outcome of the debate represents a progressively changing approach to stem cell science within the

Australian community. The steady normalisation of something once

regarded as Frankensteinian science has meant that, by early 2007, the embryo is increasingly being seen as a therapeutic entity, no

longer explicitly associated with an intrinsically inviolable human identity. Given this, a more permissive regime around stem cell

research and human cloning in Australia will result in substantial economic benefits for the Australian community.

References:

Anonymous 2007. Stem cell ban may cause brain drain. The Age, June 20. Available from: http://www.theage.com.au [accessed

20/06/2007]. Australian Government, 2006. ‘Human Embryo’ – A biological

definition, National Health and Medical Research Council

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Discussion Paper 2005, National Health and Medical Research

Council, Canberra. Biotechnology Australia, http://www.biotechnology.gov.au [accessed

19/06/2007]. --------------------------, 2006a. Public support for stem cell research

remains strong, Biotechnology Australia Media Release, 3 May www.biotechnology.gov.au [accessed 18/06/07].

--------------------------, 2006b. Key Issues on Stem Cells. http://www.biotechnology.gov.au/assets/documents/bainternet/

StemCells2006820060502132032.pdf [accessed 18/06/07]. Commonwealth of Australia, 2001. Human Cloning: Scientific, ethical,

and regulatory aspects of human cloning and stem cell research, The Andrews Report, House of Representatives Standing

Committee on Legal and Constitutional Affairs, The Parliament of the Commonwealth of Australia, Canberra.

------------------------------, 2002a. Prohibition of Human Cloning Act,

The Parliament of the Commonwealth of Australia, Canberra. ------------------------------, 2002b. Research Involving Human

Embryos Act, The Parliament of the Commonwealth of Australia, Canberra.

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Embryos Act 2002. The Lockhart Report, Legislative Review Committee Reports, Canberra.

-----------------------------, 2006a. Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research

Amendment Act, The Parliament of the Commonwealth of Australia, Canberra.

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approaches. Journal of Bioethical Inquiry, 3: 95-107. Downey, R. and Einsiedal, E. 2003. Life and death politics: social

movements and stem cell research. Paper presented at Social Studies of Science Society (4S) Annual Meeting, 5-19 October,

Atlanta, Georgia, USA.

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