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Australasian Biotechnology (backfiles)
AusBiotech
ISSN: 1036-7128
Vol. 12, Num. 1, 2002, pp. 26-30
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BIOTECHNOLOGY LEGISLATION
Australasian Biotechnology, Vol. 12 No. 1, 2002, pp. 26-30
BIOTECHNOLOGY LEGISLATION
CLONING AND EMBRYONIC RESEARCH IN AUSTRALIA: A REVIEW OF
THE LEGISLATIVE POSITION
Sangeeta Puran
Solicitor, Freehills, GPO Box 4227, Sydney, NSW 2001, email: sangeetapuran@freehills.com.au
Summary
Controversy over the use of cloning technology
in humans has once again arisen with Advanced Cell Technology (ACT) reporting
that it has cloned the first early human embryo in Massachusetts, United States.
This paper:
- discusses some of the issues specific to ACTs research - i.e. the cloning of an early human embryo as opposed to the cloning
of a living human being; and
- reviews the current legislative framework in Australia, both at the Commonwealth
and State levels, regulating the use of cloning techniques in humans, and
discusses the basis upon which such a framework may permit ACTs research
to be undertaken in Australia.
Background
Concurrent with the human genome project, which started in 1990, scientists
worldwide have been experimenting with cloning technology in a number of species
other than humans. In February 1997, the first adult mammal, a sheep named
Dolly, was successfully cloned. Since then, scientists have continued undertaking
such cloning research, even experimenting with human genes in species other
than humans2. ACTs claim of cloning the first early human embryos
has signalled to many the move to experimentation with cloning technology in
human species. Further, while others have previously claimed similar success3,
this is the first time that such work will be reported in a popular scientific
journal4.
Human Cloning Versus Embryonic Cloning
Much attention has focused on what ACTs research, i.e. the cloning of human
embryos (which this paper refers to as embryonic cloning), means for
the prospect of cloning technology being applied to clone living duplicates
of human beings (which this paper refers to as human cloning). A common tendency
has been to consider issues relating to embryonic cloning as a subset of the
issues relating to human cloning. It is important that the distinct issues relating
to embryonic cloning compared to those relating to human cloning are maintained
in any debate or legislative proposal on whether embryonic cloning is to be
permitted. These distinctions include:
- Therapeutic purposes versus reproductive purposes - Human cloning
is generally regarded as cloning undertaken for reproductive purposes. While
a successfully cloned embryo is the first step to cloning a human being, there
is also interest in the distinct potential use of embryonic cloning for therapeutic
purposes. Spinal cord damage, diabetes, Parkinsons and Alzheimers are amongst
the medical conditions characterised by irreversible damage to non-regenerative
cells. An area of investigation is the implantation of stem cells in diseased
tissues. Stem cells are the precursor cell type from which all cell types
found in humans differentiate and develop from. Stem cells possess the ability
to divide and transform into a range of cells, including those cells irreversibly
damaged in Parkinsons crc, and are predominantly extracted from embryos.
Preventing rejection of implanted stem cells is a major consideration in the
successful employment of stem cell therapy. Embryonic cloning is considered
a means of obtaining compatible stem cell lines necessary to treat disease
or disability in a particular individual.
- Ethical issues Such destruction, and in the case of embryonic cloning,
the creation of an embryo, including for the purpose of subjecting the embryo
to a procedure resulting in its destruction, raises ethical issues. This is
not a subject on which there is the same level of clear general consensus
as exists in relation to human cloning. The view that experimentation even
on extracted stem cells is unethical (largely because of the derivation from
embryos) has also been expressed.
Current Legislative Framework In Australia
The current legislative framework in Australia is characterised by provisions
dealing specifically with cloning, and separate provisions dealing generally
with research in respect of embryos. The relevant legislation, and key provisions
of such, are summarised as follows:
- Commonwealth - At the Commonwealth level, the Gene Technology Act
(Commonwealth) 2000 prohibits the cloning of whole human beings.5 Cloning
is described as follows:
Cloning of a whole human being means the use of technology for the purposes
of producing, from one original, a duplicate or descendant that is, or duplicates
or descendants that are, genetically identical to the original.6
- Victoria - In Victoria, amongst the procedures prohibited under the
Infertility Treatment Act (Victoria) 1995,~ are cloning8 and attempting
to form an embryo outside the body of a woman except for the purposes of a
treatment procedure to be carried out in accordance with this Act9.
Cloning means to form outside the human body, a human embryo that is genetically
identical to another human embryo or personiO. Further, under the provisions
dealing with research11 - research which may result in an embryo
being unfit for implantation (i.e. destructive research) is prohibited and
cannot be approved by the relevant Victorian authority, the Infertility Treatment
Authority, under this Act.2
- Western Australia - in Western Australia, under the Human Reproductive
Technology Act (Western Australia) 1991, it is an offence to carry out any
procedure directed at human cloning13. Cloning is defined as the
use of reproductive technology for the purposes of producing, from one original,
a duplicate or descendant that is, or duplicates or descendants that are,
genetically identical, live born and viable. 14
- Research5 on an embryo may be undertaken pursuant to a licence
authorised by this Act16. Approval by the relevant Western Australian
authority, the Western Australian Reproductive Technology Council, cannot
be provided if the proposed research is likely to harm the embryo17.
- South Australia in South Australia, the Reproductive Technology Act
(South Australia) 1988 provides that, except in accordance with a licence,
research involving experimentation with human reproductive material (meaning
a human embryo, human semen or a human ovum) is prohibitedl8. Any
licence issued under this Act by the South Australian Council on Reproductive
Technology, is subject to a condition prohibiting research that may be detrimental
to an embryo9. The Reproductive Technology (Code of Ethical Research
Practice) Regulations 1995 made under the Reproductive Technology Act provides
that a licensee must not carry out, or cause, suffer or permit to be carried
out, the procedure of cloning0. Cloning is defined as .....any
procedure directed at producing two or more genetically identical embryos
from the division of one embryo.2
- New South Wales, Queensland, the Australian Capital Territory
and the Northern Territory - in New South Wales, Queensland,
the Australian Capital Territory and the Northern Territory, there is no legislation
regulating embryonic cloning or the wider field of embryonic research.
Complications in the Current Legislative Framework
Based on the above overview of the current legislative framework in Australia,
the following comments are made in respect of the regulation of embryonic cloning:
- Legislation governing IVF vs legislation governing research -
Each of the Victorian, South Australian and Western Australian legislation
has been enacted primarily to govern artificial fertilisation procedures,
eg IVF treatments. Regulating embryonic cloning undertaken for stem cell research
purposes in the context of such procedures is intertwined with conditions
relevant to maximising the development and integrity of embryos for implantation.
The common thread of such legislation in prohibiting procedures which destroy
or harm an embryo is irreconcilable with embryonic cloning (and for that matter
any embryonic research) involving stem cell extraction, as embryo destruction
is an unavoidable consequence of stem cell extraction. Further, the focus
on fertilisation (i.e. the inclusion of sperm into an egg) also presents definitional
difficulties (discussed below) when such legislation is applied to cloning
an embryo for research purposes.
- Complications with the definitions of cloning and embryo -
Further, as the prohibitions on cloning are drafted in different terms, this
gives rise to a greater opportunity for speculation as to the extent to which
embryonic cloning is prohibited under each statute. For example, in Victoria,
it is considered that cloning an embryo for any purpose is prohibited, whereas
in Western Australia, embryonic cloning is prohibited only if it is undertaken
for reproductive purposes. This difference is considered to arise because
the Western Australian definition refers to the formation of duplicates or
descendants that are, live born and viable, whereas the Victorian definition
refers simply to the formation of a human embryo without any reference to
the embryo being live, born etc.24
The South Australian definition of cloning is considered to differ
from both of these definitions on the basis that it focuses on the particular
cloning technique used to clone an embryo.25 In particular, the
reference to the division of one embryo has been described as referring
to the technique of embryo splitting. Accordingly, it is unclear whether
the South Australian prohibition applies to cloning by other techniques such
as nuclear cell transfer, which involves removing the nucleus of an egg, followed
by injecting donor cells into the egg (i.e. the technique used to clone Dolly,
the sheep, and referred to as somatic cell nuclear transfer), without necessarily
involving any division of the embryo as occurs in embryo splitting. While
the Victorian legislation appears to prohibit embryonic cloning, whether undertaken
for therapeutic or reproductive purposes, an uncertainty arises in relation
to the definition of embryo as used in the definition of cloning. Embryo
means any stage of human embryonic development at and from syngamy, which
in turn refers to the alignment of chromosomes derived from the male and
female pronuclei. How such a definition sits with embryos created other than
from eggs being fertilised by sperm or injected with cells from a male donor
- for instance, embryos created from eggs injected only with cells from a
female donor - is unclear. The Victorian legislation also deals with embryos
resulting from the process known as parthenogenesis, which is seen as a technique
of creating embryos separate from cloning. While creating embryos by parthenogenesis
is not completely prohibited, such research cannot be undertaken without the
prior approval of the Infertility Treatment Authority.26
- No legislation in majority of Australia As there is no legislation
in New South Wales, Queensland, the Australian Capital Territory and the Northern
Territory, there is no legislative prohibition on scientists undertaking embryonic
cloning research in these jurisdictions.
The above overview is restricted to the current legislative framework in Australia.
Any research involving embryonic cloning should also consider the applicability
of other non-statutory guidelines such as the National Health and Medical Research
Commission (NHMRC) guidelines, the Reproductive Technology Accreditation Committee
Code of Practice and conditions of approval of institutional ethics committees.
A consideration of such guidelines is not undertaken in this paper.
Recommendations of a Federal Parliamentary
Inquiry
In August 2001, the House of Representatives
Standing Committee on Legal and Constitutional Affairs released its report Human
cloning: scientific, ethical and regulatory aspects of human cloning
and stem cell research27 after a two-year parliamentary inquiry.
The Committee recommended that national uniform legislation be established to
purely regulate research involving cloning technology, separate from the legislation
governing artificial fertilisation programs and also separate from any legislation
governing any clinical application of cloning research. The Committee recommended
a complete prohibition of research directed at human cloning. The Committee
did not, however, recommend a complete prohibition of research involving the
use of human embryos. The prohibition in this regard was limited to the deliberate
creation of embryos for research purposes. The Committee considered that the
potential for treatment of human disease presented by stem cell research outweighed
the need for a complete prohibition on research involving the use of human embryos,
and that the embryos surplus from artificial fertilisation programs obviated
the need to create embryos. In relation to research involving surplus embryos,
the Committee recommended that such research should only be permitted in limited
circumstances, including:
- any use be subject to the full and informed consent of the donor parents
of the embryo;
- there should be no commercial incentive to the donor;
- the minimum number of embryos be used;
- an application be made on a case-by-case basis to a regulatory body; and
- a criteria for approval include a requirement that the research cannot be
achieved by any other means.28
The Committee did not clearly identify who ultimately controls the surplus
embryos. While the consent of donor parents is referred to, it is unclear what
rights these individuals actually have ith an embryo, given the reluctance of
the law to grant property rights in such subject matter. This uncertainty, together
with the limited circumstances under which research is to be permitted, suggests
that access to surplus embryos for the purpose of undertaking stem cell research
may not be as simple an exercise as presented.
The Committee noted the importance of a clear definition of cloning, and also
urged that the definitions of cloning in the existing legislation be replaced
by broader and more effective definitions. In addition to the definitional problems
identified above, the Committee also discussed the fact that the current definitions
refer to a requirement of genetic identicality29, and that such
a reference may exclude non identical clones generated as a result of mutations
occurring during development.
Does Australian Legislation Permit the Cloning of Early Human Embryos in
the Manner Undertaken by ACT?
In basic terms, ACTs research consisted of injecting eggs donated by women
specifically for ACTs research, with cells (fibroblast and ovarian cells) from
individuals to be cloned. Both nuclear cell transfer and parthenogenesis techniques
were used to create embryos. The most successful outcome as reported by ACT
was that from the 71 injected eggs, one of these progressed to form a six-cell
embryo before it stopped any further development.30
Cloning
Whether Australian legislation would permit
the cloning activities of ACT may be answered as follows:
- Commonwealth -The prohibition on cloning under the Gene Technology
Act does not govern ACTs research because the relevant prohibition applies
to the cloning of a whole human being. Cloning a human embryo as reported
by ACT, while an essential step in die process is not the cloning of a whole human being, and
hence not governed at the Commonwealth level.
- Victoria - Possibly - ACT undertook to clone embryos using nuclear
cell transfer, including injecting eggs with female donor cells. It is unclear
whether the prohibition under the Victorian legislation extends to embryos
cloned by injecting eggs with female donor cells. This is due to the fact
that it is unclear whether the description of embryo, which in effect refers
to embryos containing chromosomes derived from the male and female pronuclei,
captures embryos resulting from an egg injected only with cells donated from
a female. Therefore cloning of such embryos may not be prohibited in Victoria.
Further, creating embryos by parthenogenesis may also be permitted if such
research has received the prior approval of the Infertility Treatment Authority.
- Western Australia - Possibly - on the basis that the prohibition on cloning, due to
the definition of cloning, is restricted to cloning undertaken for reproductive
purposes. ACT has insisted that its research has been undertaken for therapeutic,
and not reproductive, purposes. In this regard, ACT stated:
We are eager for the day when we will be able to offer therapeutic cloning
or cell therapy arising from parthenogenesis to sick patients. Currently our
efforts focused on diseases of the nervous and cardiovascular systems and
on diabetes, autoimmune disorders and diseases involving the blood and bone
marrow.31
- South Australia - Possibly - while research involving experimentation
with human reproductive material can be only undertaken if a licence is issued
by the South Australian Council on Reproductive Technology, it is arguable
that due to the definition of cloning, the prohibition on licencees in respect
of cloning is limited to embryos created using embryo-splitting techniques,
which is not necessarily the same as the nuclear cell transfer technique used
by ACT.
- New South Wales, Queensland, Australian Capital Territory and the Northern Territory - Yes - as there is no legislation
in these states regulating embryonic cloning, scientists are not prohibited
by legislation from undertaking such research.
- Parliamentary Committees recommendations - No - since ACTs cloned
embryo is a deliberately created embryo, such research would be prohibited
in Australia if the Committees recommendations were enacted as legislation.
Of course, the effectiveness of any such prohibition will depend on what exactly
is specified as the deliberate creation of embryos, i.e. creation for any
purpose, by any technique, whether the resulting embryo is identical or non
identical to its descendant etc.
While the Committee acknowledged that the deliberate creation of embryos in
order to obtain compatible stem cell lines to treat disease or disability in
a particular individual may be an issue in the future, it commented that any
such techniques of treatment remain at best speculative32. In this
regard, the embryos cloned by ACT did not reach the stage of embryonic development
required for stem cell extraction. The Committee recommended a three-year moratorium
on the creation of embryos after which the issue can be reviewed by the Australian
Health and Ethics Committee of the NHMRC33.
Embryonic cloning vs research on
an embryo or an egg
As cloning was not the only element of
ACTs research, it is important that the Victorian, Western Australian and South
Australian legislative provisions governing cloning be examined together with
the provisions governing:
- research involving the embryos, during and subsequent to their development;
and
- research involving the donated eggs. Comments in relation to research involving
the embryos are as follows:
- The Victorian legislation provides in effect that research involving the
formation of an embryo cannot be carried out outside the body of a woman unless
the research has been approved34 by the Infertility Treatment Authority.
Further, as already outlined, the legislation prohibits destructive research
on an embryo. Based on earlier comments
- The Western Australian legislation provides that any procedure related
to the storage of ... an embryo35 requires a licence from the
Western Australian Reproductive Technology Council. The following observations
suggest that it is uncertain whether ACTs research would require such a licence:
- the provision refers to procedures related to the storage of an embryo
and not simply any procedures related to an embryo. It is unlikely that
ACTs research can be described only as procedures related to the storage
of an embryo; and
- the definition of embryo refers to a live human embryo which occurs
from ... the completion of the fertilisation of the egg...36.
Importantly, as fertilisation refers to the inclusion of a sperm into
an egg, this may mean, as in the case of the Victorian legislation, that
ACTs embryos are not captured, as the relevant eggs do not appear to
have been injected with sperm.
- Under the South Australian legislation, while research involving experimentation
with human embryos is prohibited without a licence37, embryo
is not defined. Given that the primary purpose of the South Australian legislation
is to regulate artificial fertilisation procedures involving the creation
of an embryo from male and female donor parents, it is unclear whether the
legislation and hence the prohibition is intended to extend to research involving
the embryos cloned by ACT using only the cells of a female donor.
Comments in relation to research involving
the eggs are as follows:
- The Victorian legislation permits research involving the use of an oocyte
(i.e. egg), provided the consent of the donor is obtained in the requisite
form38. Accordingly, as long as the relevant consent is obtained,
ACTs manipulation of the donated eggs in the first place using nuclear cell
transfer techniques may be undertaken in Victoria.
- The Western Australian legislation requires researchers to obtain a licence
from the Western Australia Reproductive Technology Council in respect of:
- again, procedures related to the storage of an egg39 -
It is unlikely that ACTs manipulation of the eggs can be described as
such; and
- research in respect of eggs in the process of fertilisation4O
- The definition of fertilisation, as discussed above, may exclude the
manipulation of eggs by ACT as these eggs were not injected with sperm.
Accordingly, it is unclear whether ACTs
manipulation of the eggs requires a licence from the Western Australian Reproductive
Technology Council.
- The South Australian legislation prohibits any research involving experimentation
of a human ovum4i except in accordance with a licence issued by
the South Australian Council on Reproductive Technology. Such a broad provision
will most likely capture ACTs experimentation with the eggs in the first
place. Therefore ACT would require a licence from the South Australian Council
on Reproductive
Technology to undertake its experimentation with the eggs in South Australia.
it is noteworthy that experimentation is not defined. This is unlike the position
under the Victorian and Western Australian legislation where the term research
is used instead, and defined42.
Conclusion
From the outset, the advances in cloning
technology have been met with a mixture of ethical concerns and scientific excitement.
Calls for stricter regulation in this area have also been met by calls that
onerous regulation in Australia will hinder international competitiveness of
Australian scientists in this area, with wider consequences including Australia
missing out on commercialisation and patenting opportunities presented by applications
of cloning technology. For regulators in Australia the challenge is to establish
a legislative framework which encourages the pursuit of potential therapeutic
benefits presented by cloning technology while effectively preventing such technology
from being taken too far.
Drawing the relevant line will no doubt
generate numerous controversies, however, it is essential that any debate or
legislative decision:
- maintain the distinction between the issues specific to human cloning and
those specific to embryonic cloning; and
- understand the importance of achieving uniformity and consistency in any
proposed legislative regime in Australia.
The author would like to thank Adam
Liberman and Amalia Stone, of Freehills, for their assistance in preparing
this paper.
- July 1998 researchers at the University of Hawaii cloned 50 mice
in three generations from a single mouse. April 1999 geneticists at Tufts
University in Massachusetts cloned three goats, altering the goats genetic
code to produce a protein in their milk to treat heart attack and strokes.
2000 Oregon researchers produce a rhesus monkey named Tetra by splitting early
stage embryos and then implanting the pieces into the mother. November 2001
Massachusetts research company reports it has cloned the first human embryo,
a development it said was aimed at producing genetically matched replacement
cells for patients with a wide range of diseases (as reported in the Sydney
Morning Herald, Vital stem cell work held in check 27 November 2001,
page 7).
- July 1997 Scottish scientists cloned Polly, a lamb, from skin cells grown
in a lamb and genetically altered to contain a human gene (as reported in
the Sydney Morning Herald, 27 November 2001, page 7)
- The Australian, The great stem cell hard sell 27 November 2001,
page 13, reported that researchers at Kyunghee University in South Korea
claimed back in December 1998 to have produced the first human embryo clone
which they hurriedly destroyed after it divided several times.
- Proposed to be reported in the January 2002 edition of ScientificAmerican.
- Section 192B.
- Section l92B.
- Part S.
- Section 47.
- Section 49.
- Section 3.
- research includes:
(a) An experimental procedure or clinical trial; and
(b) The activities referred to in sections 22(2)(a) and (b). (section 3)
The activities referred to in sections 22(2)(a) and (b) are parthenogenesis
related research
- Sections 24 and 25.
- Section 7(i)(d)(i).
- Section 3.
- research means systematic investigations carried out for the primary purpose
of adding to general knowledge but includes the carrying out of an experiment,
and project of research shall be construed accordingly. (section 3)
- Section 7(1)(a)
- Section 14(2).
- Section 14(1).
- Section 14(2)(b)
- Regulation 6.
- Regulation 2.
- New South Wales Health Minister Craig Knowles will introduce to Cabinet
next month a plan to regulate cloning but Knowlesspokesman declines to say
exactly what the draft legislation will mean (as reported in The Australian,
Calls/or uniform national laws on human cloning. 27 November
2001. page 13).
- The Queensland government will this week become the fourth State to introduce
new laws into State parliament to make human cloning a crimnal act punishable
with ten years jail - but stem cell research will not be hanned (as reported
in The Australian Vallsforuniform nationalaus on Pu mar cloning, 27
No ember 2001, pagc 13).
- Page 134 of the report by the House of Representatives Standing Committee
on Legal and Constitutional Affairs referred to in footnote 27.
- Page 134 of the report by the House of Representatives Standing Committee
on Legal and Constitutional Affairs referred to in footnote 27.
- Sections 22(2)(a) to (c)
- The report Human cloning: scientifiL ethical and regulatory aspects
n/human cloning and stern cell research can be accessed from http://wwwaph.gov.au
house/committee aca preving.htm
- Page 124 of the repor by the Ilouse of Representatives Standing Coin tsittce
on Legal and Constitti ional Affairs referred to n footnote 27.
- Page 137 of the report by the House of Representatives Standing Committee
on Legal and Constitutional Affairs referred to in footnote 27.
- As reported by ACT in the report entitled The First Human Cloned Embryo,
accessed from http://www.sciam.com/explorations/200l/l124O1ezzell/.
- Page 4 of the report by ACT referred to in footnote 30.
- Page 122 of the report by the House of Representatives Standing Committee
on Legal and Constitutional Affairs referred to in footnote 27.
- Page 122 of the report by the House of Representatives Standing Committee
on Legal and Constitutional Affairs referred to in footnote 27.
- Section 22(1) a
- Section 6(1)(a)(iii)
- Section 3
- Section 14(1)
- Section 22(3)
- Section 6(1)(a) (i) and (ii)
- Sections 7(1)(a), 7(1)(b), 7(1)(e), 7(l)(g), 7(1)(h) and 7(i)(j)
- Section 14(1)
- Refer to footnotes 11 and 1
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