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ATTACHMENT 1
On 5 April 2002 the Council of Australian Governments (COAG) agreed that
the Commonwealth, States and Territories would introduce nationally consistent
legislation banning human cloning and other unacceptable practices and
establishing a national regulatory framework for the use of excess assisted
reproductive technology (ART) embryos. It was agreed that the National Health
and Medical Research Council (NHMRC) would be the licensing and regulatory body.
In response to the COAG agreement the Research Involving Embryos and
Prohibition of Human Cloning Bill 2002 was introduced into the Commonwealth
Parliament on 27 June 2002. The Research Involving Embryos and Prohibition of
Human Cloning Bill 2002 was amended in the House of Representatives by division
into two bills, the Prohibition of Human Cloning Bill 2002 and the Research
Involving Embryos Bill 2002.
This Regulation Impact Statement (RIS)
focuses on the costs and benefits of prohibiting cloning and other practices
relating to reproductive technology.
The problems that currently exist in relation to the prohibition of
cloning and certain unacceptable practices associated with reproductive
technology include:
• lack of consistency in regulatory coverage of
human cloning and other unacceptable practices through the existence of
legislation in three States (Victoria, South Australia and Western Australia),
the Commonwealth Gene Technology Act 2000 and the absence of regulation
in other jurisdictions;
• the impact that the current lack of
certainty or national consistency in the regulatory environment may have on
Australia’s international competitiveness.
On 5 April 2002 COAG agreed that the Commonwealth, States and Territories
would introduce nationally consistent legislation banning human cloning and
other unacceptable practices and that the legislation would establish a national
regulatory framework for the use of excess ART embryos, to be administered by
the NHMRC as the national regulatory and licensing body.
The groups likely to be affected by legislated prohibited practices are
ART service providers, consumers of ART services, researchers, Government and
the community.
ART service providers
The Australian
Institute of Health and Welfare’s National Perinatal Statistics unit
reported that there were 34 IVF units in Australia in 2000.
Consumers
of ART services
Data available from the National Perinatal
Statistics Unit for the year 2000 showed that women underwent 27,067 treatment
cycles with oocyte retrieval or embryo transfer for all techniques of assisted
conception in Australia’s 34 IVF
units.
Researchers
In general, most of the prohibited
practices cannot currently be carried out by researchers, as they are contained
in NHMRC guidelines, the RTAC code of practice or existing state legislation.
It is, however, possible that if the legislation is reviewed there will be
researchers who may wish to undertake research that would involve some of the
prohibited practices.
Government
This includes the
Commonwealth Government, State and Territory Governments and existing regulatory
authorities in Victoria, South Australia and Western
Australia.
Community
There is debate within the community about
the moral and ethical considerations related to certain applications of
reproductive technology, and the lack of national consistency in their
regulation.
On 5 April 2002 COAG agreed that certain unacceptable practices should be
prohibited in nationally consistent legislation.
In making their
decision, COAG considered the recommendations of a report entitled the
“Report on Human Cloning, Assisted Reproductive Technology and Related
Matters”. This Report included a list of all of the unacceptable
practices and was accompanied by a detailed RIS exploring the impacts of bans on
the unacceptable practices.
The two options outlined in the report
were:
Option 1: Voluntary compliance with unacceptable practices
as detailed in revised NHMRC/AHEC
Guidelines[1]. In order to
achieve national consistency, this option would mean that the three States with
legislation would need to repeal such legislation (at present there are some
differences between the practices banned in legislation in three States and the
unacceptable practices detailed in the NHMRC/AHEC Ethical Guidelines on
ART – refer Attachment A of this RIS). All people would be expected
to voluntarily comply with the nationally consistent unacceptable practices
detailed in revised NHMRC/AHEC Ethical Guidelines on ART. This would
essentially reflect a national adoption of the position that currently occurs in
the five jurisdictions without legislation; or
Option 2:
Nationally consistent legislated bans on the unacceptable practices. This
option would involve each jurisdiction enacting legislation, or amending
existing legislation, to ban the unacceptable practices as detailed in
Table 1. The unacceptable practices banned in the legislation would be
reviewed within three years. The purpose of the review would be to determine
whether each of the practices are still considered unacceptable and whether they
should continue to be banned in legislation. This review would be undertaken
with broad consultation to assess the acceptability of each of these practices
at that time.
Following is a table that is based on the table included in
the RIS accompanying the Report to COAG, detailing the potential impacts of
banning the various unacceptable practices in nationally consistent legislation.
Table 1: Summary of the impacts of banning certain unacceptable
practices in nationally consistent legislation
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Proposed Prohibition
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Impacts of banning certain unacceptable practices
|
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Creating a human clone.
|
No attempts at cloning a human being (commonly referred to as
“reproductive cloning”) are currently evident in Australia.
Prohibition therefore unlikely to have an impact on researchers or ART
clinics.
|
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Creation of an embryo for purposes other than assisted reproduction or by a
process other than the fertilisation of a human ovum by human sperm.
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Will prevent the creation of embryonic stem (ES) cells via the
process of somatic cell nuclear transfer (SCNT), for potential therapeutic uses.
On the basis of early research in this area, it appears that there may be
potential to create ES cells that are compatible with individual patients or
patient groups and could therefore be used in therapeutic applications, reducing
the chance of rejection problems after transplantation. ES cells have been
reported to have potential to treat cancer, Alzheimer’s disease,
Parkinson’s disease, paraplegia, and other diseases.
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|
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Prohibiting the creation of embryos by SCNT will also limit potential use
of ES cells in drug screening. SCNT could be used to create libraries of stem
cells representative of specific disease states to test how a drug acts in the
human body.
|
|
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Researchers in Israel and the UK, and private-sector researchers in
the USA are currently permitted to create embryos by SCNT. Relative to these
more permissive countries, Australia may lose international competitiveness,
overseas and local investment, and access to intellectual property. Such
negative effects may result even if the ban is only maintained in Australia for
three years.
|
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Whilst there is unconfirmed evidence that researchers overseas have created
embryos via SCNT for the purposes of research, there are no confirmed reports
that such embryos have been able to be developed to the point that stem cells
can be obtained and used in human treatments. The potential benefits detailed
above are based on preliminary research. To date, there is no evidence of any
attempts being made in Australia to create a human embryo via SCNT as this
practice has been considered unacceptable under NHMRC/AHEC Guidelines and banned
in Victoria, SA and WA.
Work is continuing in relation to embryonic stem cell based nuclear
programming which involves replacing the nucleus of an embryonic stem cell with
the nucleus of an adult cell. This technique does not involve the creation of
an embryo (and is therefore not prohibited) but also has the potential to lead
to genetically compatible cells for transplantation and tissue engineering.
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|
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This prohibition would also ban the creation of embryos, by fertilisation
of an egg by sperm, purely for research purposes. This may limit some
researchers access to embryos for research. This may impact on the capacity of
researchers to undertake certain work exploring the process of embryonic
development, where embryos are created specifically for this research purpose.
However it would not impact on research involving excess ART embryos.
|
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Creation or development of an embryo for assisted reproduction that
contains genetic material from more than 2 people.
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Prevents the use of a relatively new technique that involves the transfer
of the cytoplasm from a healthy egg (generally donated by a younger woman) to
the egg of another woman who has had fertility problems (often older women).
This has the potential to increase the chances of successful conception via IVF
for some older women. Currently this technique is not in use in Australia as it
is thought to be unsafe, due to possible impacts of the existence of a third
party’s genetic material, but has been used overseas. There are also
ethical concerns associated with the creation of embryos with genetic material
from three people.
|
|
Creation or development of an embryo for assisted reproduction that uses
any precursor cells of eggs or sperm from an embryo or fetus.
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Currently no evidence of this technique being used in Australia nor any
intention to utilise this practice for clinical or research purposes in the near
future.
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Maintaining an embryo outside the body of a woman after the 14th
day of its development excluding any time in which its development is
suspended.
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Currently no evidence of this practice occurring in Australia nor any
intention to utilise this practice for clinical or research purposes in the near
future.
|
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Altering the genome of a cell of a human being or in vitro embryo such that
the alteration is heritable.
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Removes the possibility of using germ line gene therapy to permanently cure
inherited diseases such as sickle cell anaemia, haemophilia and cystic fibrosis
in subsequent generations. Currently, there are concerns regarding unintended
consequences and the safety of using germ line gene therapy – as such it
is not clear if Australian scientists appear to be contemplating using germ line
gene therapy.
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Embryo flushing.
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Currently no evidence of this practice occurring in Australia nor any
intention to utilise this practice for clinical or research purposes in the near
future.
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Creating or developing a hybrid or chimeric embryo or placing such an
embryo in the body of a human or animal for any period of gestation.
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Currently no evidence of this practice occurring in Australia. Anecdotal
evidence suggests that, should this practice not be prohibited, some researchers
may wish to use some types of hybrid or chimeric embryos particularly for drug
screening applications.
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Placing a human embryo in an animal or in any human body cavity other than
the female human reproductive tract or placing an animal embryo in a human for
any period of gestation.
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Currently no evidence of this practice occurring in Australia nor any
intention to utilise this practice for clinical or research purposes in the near
future.
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Giving or offering valuable consideration to any person for donation of
gametes or embryos of that person or of any other person. Note that it is not
intended to exclude the disbursement of reasonable expenses incurred by a person
in connection with a donation of their genetic material.
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Currently no evidence of this practice occurring in Australia.
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Consultations on an exposure draft of the Research Involving Embryos and
Prohibition of Human Cloning Bill 2002 and RIS, including the proposed
prohibited practices, were conducted with a range of people in the fields of
ART, medical research, consumer issues, ethics and law, in each capital city
between 24 May and 6 June 2002.
During consultations, there was general
support for the inclusion of unacceptable practices in legislation. However two
prohibitions in particular gave rise to considerable comment and debate
regarding the costs and benefits of banning such practices:
• the
ban on the creation of embryos by a process other than the fertilisation of a
human egg by human sperm by somatic cell nuclear transfer (or so called
“therapeutic cloning”) to create embryonic stem cells.
Those who did not support prohibiting “therapeutic cloning”
expressed concern that:
Ø the ban would put Australian research
behind other countries where such a ban does not exist which may in turn impact
on the Australian research community’s international competitiveness and
the broader community’s access to potential cell therapies;
and
Ø the
intended review of the legislation within three years that may result in a
lifting of this ban may be too late to alleviate these possible
impacts.
Others considered that:
Ø the need for “therapeutic
cloning” is questionable as there may be alternative avenues to achieve
the outcomes desired; and
Ø discussion within the broader community of
the benefits of “therapeutic cloning” may be premature as there are
currently no confirmed reports that a human embryo created by SCNT has developed
to the stage that stem cells could be derived.
• creation or
development of an embryo for assisted reproduction that contains genetic
material from more than 2 people, particularly as it effectively bans the use of
cytoplasmic transfer in ART clinical practice.
Those that did not
support a provision that effectively banned cytoplasmic transfer expressed
concern that women who might otherwise be able to achieve a pregnancy following
the use of cytoplasmic transfer on their eggs will be disadvantaged compared to
women in other countries where this technique is permitted.
Others
considered that:
Ø cytoplasmic transfer is a very new
technique and its safety with respect to babies created using the technique is
yet to be established; and
Ø any live born child may have DNA from
three separate people (posing ethical questions) and the impact of the third
party mitochondrial DNA on normal development is not totally clear at this
stage.
It was, however, noted that if the technique can be refined to the
point where it is both safe and there is no additional genetic material
contained in the transferred cytoplasm then the ban on the technique may no
longer be applicable, subject to approval of the use of the techniques under the
RTAC accreditation guidelines and approval by the relevant ART licensing bodies
in Victoria, South Australia and Western Australia.
It is desirable that governments have the ability to apply appropriate
sanctions for non-compliance, with regard to certain unacceptable practices, to
both publicly and privately funded organisations (at present there is
non-equivalent regulatory environments for private and public institutions in
Australia). Consumer and community confidence would also be likely to be
improved with the introduction of legislative sanctions.
A legislative
approach provides a clear basis of operation for ART service providers and
researchers. As the practices proposed to be banned in legislation are broadly
consistent with those that are deemed unacceptable under the NHMRC/AHEC
Guidelines and existing legislation in three States, the fact that the bans will
be included in legislation in all jurisdictions is likely to have minimal
practical impact in terms of compliance.
A prohibition on the creation
of embryos via somatic cell nuclear transfer (so-called “therapeutic
cloning”) for any period of time may, however, impact on Australia’s
competitiveness with other more liberal countries particularly with respect to
intellectual property ownership, level of research expertise and industry
investment.
In relation to this point governments have decided, that at
this time there is insufficient evidence to prove the efficacy of
“therapeutic cloning” and that it also continues to pose significant
ethical and safety issues. Therefore COAG decided to include it as a prohibited
practice to be banned in nationally consistent legislation. The same
consideration by COAG was given in relation to the technique of cytoplasmic
transfer.
The review of the legislative prohibitions within three years
will enable reconsideration of scientific developments and associated benefits
as well as any changes in community views on all the practices (including
“therapeutic cloning” and cytoplasmic transfer) that may
result.
As recommended in the COAG communique, the regulatory system will be
reviewed within three years. The review will be carried out on all aspects of
the legislation, which will take into account changes in technology, the
potential therapeutic uses for such technology, and any changes in community
standards.
Specifically, the Prohibition of Human Cloning Bill 2002
provides for the Minister to ensure that an independent review of the
legislation be undertaken 2 years after the legislation in enacted. In summary,
the review must:
• be undertaken by people chosen by the Minister
with the agreement of the States;
• include a consideration of the
scope of the legislation, particularly taking into account developments in ART
(such as refinement of cytoplasmic transfer), scientific and research
developments, the potential therapeutic applications of any research (including
for “therapeutic cloning”) and community
standards;
• contain recommendations about any amendments that should
be made to the legislation;
• be informed by consultation with the
Commonwealth, States, Territories and a broad range of stakeholders;
• include information about the views of the Commonwealth, States and
Territories (to the extent that it is reasonably practicable to do so);
and
• be completed and provided to the Council of Australian
Governments within 12 months (by the third anniversary of the
legislation).
The following table is based on one that was included in the Regulation
Impact Statement that accompanied the “Report on Human Cloning, Assisted
Reproductive Technology and Related Matters”, the recommendations of which
were considered by COAG at their meeting on 5 April 2002.
A
comparison of the practices to be banned in proposed nationally consistent
legislation and those practices that are currently considered unacceptable.
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Proposed Prohibition
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Related unacceptable practice in NHMRC/AHEC Guidelines and inclusion in
current legislation (Vic, SA and WA)
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Reasons for inclusion of prohibition as proposed
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Cloning of a human being.
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Guideline 11.3 and prohibited in all three Acts. There is also a
prohibition in the Gene Technology Act 2000.
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Scientific developments have occurred that have caused reconsideration of
the wording used in the current bans on human cloning. Revised wording is
proposed that ensures that regardless of the means used for the development of a
human clone, human cloning is banned.
|
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Creation of an embryo for purposes other than assisted reproduction or by a
process other than the fertilisation of a human ovum by human sperm.
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Guideline 11.1 and effectively prohibited in all three Acts.
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Reflects the current prohibition but clarifies that an embryo can only be
created for assisted reproduction through fertilisation.
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Creation or development of an embryo for assisted reproduction that
contains genetic material from more than 2 people.
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Not included in Guidelines. Prohibited in Vic. Not explicitly prohibited
in WA and SA but any procedure leading to this outcome would require approval by
licensing body.
Prohibited under RTAC guidelines for the accreditation of ART
clinics.
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Not currently practiced in Australia due to concerns that procedures
leading to this outcome may not be completely safe. Inclusion of this
prohibition brings it into line with the more recent RTAC Guidelines.
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Creation or development of an embryo for assisted reproduction that uses
any precursor cells of eggs or sperm from an embryo or fetus.
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Guideline 11.4 and effectively prohibited in Vic and WA.
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Prohibition re-worded to clarify potentially inaccurate terminology.
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Maintaining an embryo outside the body of a woman after the 14th
day of its development excluding any time in which its development is
suspended.
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Guideline 11.2 and specifically prohibited in SA and WA.
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Prohibition re-worded to clarify that development excludes periods of
storage.
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Altering the genome of a cell of a human being or in vitro embryo such that
the alteration is inheritable.
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Effectively prohibited in all three Acts and considered ethically
unacceptable by NHMRC (“Guidelines for Ethical Review of Research
Proposals for Human Somatic Cell Gene Therapy and Related
Therapies”).
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Concerns that, despite potential benefits, the effects of inheritable
changes to the genome are too poorly understood to allow practice to be carried
out.
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Embryo flushing.
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Guideline 11.8, specifically prohibited in SA and WA and effectively
prohibited in Vic.
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While it is intended that this prohibition continue, it is recommended that
the wording be changed so as to reflect the outcome rather than the technique
which is the intentional removal of a viable embryo from a woman.
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Creating or developing a hybrid embryo or placing a hybrid embryo in the
body of a human or animal for any period of gestation.
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Guideline 11.5 and effectively prohibited in all 3 Acts. There is also a
prohibition in the Gene Technology Act 2000.
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Reflects the current prohibition but clarifies that a hybrid embryo must
not be implanted in the body of a human or animal.
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Placing a human embryo in an animal or in any human body cavity other than
the female human reproductive tract or placing an animal embryo in a human for
any period of gestation.
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Guideline 11.7 and effectively prohibited in all 3 Acts.
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NHMRC/AHEC prohibition expanded to be brought more in line with State
prohibitions and to expressly ban putting an animal embryo in a human.
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Giving or offering valuable consideration to any person for donation of
gametes or embryos of that person or of any other person. Note that it is not
intended to exclude the disbursement of reasonable expenses incurred by a person
in connection with a donation of their genetic material.
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Guidelines 11.9 and 11.10 effectively prohibited in all 3 Acts.
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Combination of NHMRC/AHEC prohibitions relying on the wording of
prohibitions included in SA and WA Acts.
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[1] It should be noted that the NHMRC/AHEC Ethical Guidelines on ART are currently subject to review and will be reissued in early 2003. Information on the nature of the revisions is not yet available.