Bills Digest no. 59 2006–07
Prohibition of Human Cloning for Reproduction and the
Regulation of Human Research Amendment Bill 2006
This replaces the 27 November
2006 version of this Digest so as to remove
ambiguities relating to access to stem cells, the National Health
and Medical Research Council s views on the definition of human
embryo and the US position on
funding stem cell research. This Digest contains some additional
information on new sections 23 and 23A of the Prohibition of
Human Cloning Act 2002 as proposed by Schedule 1, item 7 of
the Bill. It refers to the
definition of precursor cell that is contained in section 8 of the
Prohibition of Human Cloning Act 2002. It also provides
additional information regarding the amendment moved by
Senator Colbeck and the
proposed legislative review to be conducted in three years
time.
WARNING:
This Digest was prepared for debate. It reflects the legislation as
introduced and does not canvass subsequent amendments. This Digest
does not have any official legal status. Other sources should be
consulted to determine the subsequent official status of the
Bill.
CONTENTS
Passage History
Purpose
Structure of the Bills Digest
Historical background
Scientific background
Policy background
International background
Ethical arguments regarding the human
embryo
Financial implications
Main Provisions
Concluding Comments
Endnotes
Contact Officer & Copyright Details
Passage
History
Prohibition of Human Cloning for
Reproduction and the Regulation of Human Research Amendment Bill
2006(1)
Date
introduced: 19 October
2006
House: Senate
Portfolio: Private Member's Bill (Senator Kay
Patterson)
Commencement:
The operative provisions commence on Royal
Assent. The substantive provisions contained in Schedules 1 to 4
commence on the day after six months from Royal
Assent.
The Bill amends the Prohibition of Human
Cloning Act 2002, the Research Involving Human Embryos Act
2002 and the Customs (Prohibited Exports) Regulations
1958 in order to implement most of the
recommendations made by the Legislative Review Committee that had
reviewed the operation of the two Acts in 2005.(2)
This Bills Digest is structured in the following way:
- Background to the Bill, including
- Historical background
- Scientific background
- Policy background
- International background
- International background
- Ethical arguments regarding the human embryo
- Main provisions
- Glossary
Human intervention in the creation and
cessation of human life presents legislators with a vast array of
scientific, moral and ethical concerns with which to grapple.
Debates on issues such as in vitro fertilization (IVF),
abortion and human cloning have always been contentious because of
the precious nature of the subject matter at its core, namely human
life. Advances in scientific research in recent decades have meant
that legislators both domestically and overseas have been asked to
deal with very difficult issues associated with the development of
human clones. The challenges presented by scientific research were
well summarised in the following extract from the Issues
Paper released in August 2005 by the Legislation Review
Committee:
During the 1990s, research in assisted
reproductive technology (ART) and human stem cells raised some new
challenges. New techniques for creating a human embryo became
possible, the creation of Dolly the sheep in 1997 raised the
possibility that cloning a human may become technically feasible,
and research interest in cells taken from inside human embryos
(so-called embryonic stem cells ) increased. These developments
raised significant ethical issues about how human embryos can be
created, what forms of human reproduction are acceptable, and what
research uses of human embryos should be
permitted.(3)
In the 1990s three States, Victoria, South Australia and Western
Australia, enacted legislation purporting to ban human reproductive
cloning and to regulate research on human embryos.(4)
This regulation evolved as part of the regulation of
ART.(5) Under the legislation, the definition of cloning
and human embryo varied in each State and accordingly so did the
research practices that were prohibited and
permitted.(6)
All States and Territories were also governed by the National
Health and Medical Research Council s (NHMRC) Ethical
Guidelines,(7) although it was argued that the NHMRC
Guidelines were only enforceable against institutions receiving
NHMRC funding, and hence, a privately funded body would not need to
comply with the Guidelines.(8) It was also noted that
the prohibition on destructive research on embryos in each of the
States that had legislation, conflicted with the NHMRC Guidelines
which permitted researchers to apply for a licence to conduct such
research on excess ART embryos.(9)
The legislation in Victoria, South Australia and Western
Australia was enacted prior to the cloning of Dolly the sheep by
somatic cell nuclear transfer (SCNT) and it was uncertain whether
the definitions and prohibitions specified in the legislation would
effectively deal with the possibility of
cloning.(10)
Therefore by 1999 there was no nationally consistent legislation
and for those jurisdictions that did have legislation, it was
unclear whether the legislation was adequate for the changes in the
scientific environment.(11) In 1999 the House of
Representatives Standing Committee on Legal and Constitutional
Affairs, chaired by the Hon. Kevin Andrews MP, established an
inquiry to consider the issues.(12)
In 2000, the Commonwealth Gene Technology
Act 2000 was enacted which contained a prohibition on the
cloning of whole human beings. The legislation contained yet
another definition of cloning.(13) It had limited
coverage and applied to, amongst other areas, corporations, things
done in the course of trade and commerce, things done that may
spread the disease or pests, for purposes relating to statistics
and actions by the Commonwealth or Commonwealth
authorities.(14)
In August 2001, the House of Representatives Standing Committee
on Legal and Constitutional Affairs Committee, released its report
(the Andrews Report).(15) The Andrews Report made a
number of recommendations, including that the Commonwealth
legislate to regulate human cloning and stem cell
research.(16) A useful summary of the stance taken by
the Committee members is as follows.
The Andrews Report revealed that its Standing
Committee members were divided on the issue of whether the creation
of embryos via the SCNT process should be permitted in Australia.
It noted that a majority of the Standing Committee supported this
process being legalised, primarily on the basis of the potential
for such research to develop stem cell therapies to treat various
diseases. A minority of the Committee were opposed to such research
due to concerns about the ethics of the destruction of human
embryos for research, particularly as, at that time, the potential
benefits of such research were highly speculative.
[T]he Standing Committee reached a consensus to
recommend a three-year moratorium on the legislation of nuclear
transfer, with the issue to be reviewed at the conclusion of that
period.(17)
The Council of Australian Governments (COAG) considered the
Andrews Report s recommendations and in 2002 agreed that nationally
consistent legislation should be introduced banning human cloning
and some other related practices and regulating research involving
excess ART embryos.(18)
In December 2002 the Federal Parliament enacted the
Prohibition of Human Cloning Act 2002 (PHC Act) and the
Research Involving Human Embryos Act 2002 (RIHE Act).
Together the Acts:
- prohibit human cloning and several other practices considered
unacceptable(19)
- prohibit the creation of human embryos, by any means, for any
purpose other than for attempting to achieve a pregnancy in a
woman[, and]
- allow certain uses of excess human embryos created through ART
under strict regulation and licence.(20)
After the enactment of the PHC Act and the RIHE Act, the States
and Territories passed legislation which reflected these provisions
to ensure that the legislation had national
coverage.(21)
Both the PHC Act and the RIHE Act contain provisions specifying
that an independent review of the operation of each Act needed to
be undertaken two years after the Acts received Royal
Assent.(22) Both Acts also contain provisions requiring
that the reviews be undertaken by persons agreed to by the Minister
with the agreement of each State.(23)
To meet these legislative obligations the Legislative Review
Committee (LRC) was appointed in June 2005 to consider and report
on the scope and operation of each of the Acts. The LRC was chaired
by the Hon. John S Lockhart AO QC. On 19 December 2005 the LRC gave
its report, Legislation Review: Prohibition of Human Cloning
Act 2002 and Research Involving Human Embryos Act
2002(24) (Lockhart Report), to the Federal
Government.(25) The Lockhart Report contained 54
recommendations and suggested that the current legislative
arrangements required significant change.
In a press release dated 23 June 2006, the Prime Minister stated
the following:
The Australian Government has considered the
recommendations of the Lockhart Review. This is a difficult and
complex issue on which many different views are held.
After careful reflection, the Government is not
disposed to make any changes to the existing national legislative
framework for research involving human embryos, agreed in 2002.
Recognising, however, the range of issues and
views, there will be a detailed discussion on this issue within the
Government parties when Parliament resumes for the Spring
sitting.(26)
Thereafter followed the meeting of COAG on 14 July 2006. The
Communique describing COAG s views and course of action
stated that:(27)
COAG noted that agreement had not yet been reached
across jurisdictions on all the 54 recommendations of the Lockhart
Review Committee Report. However, COAG agreed that officials would
continue to work on those Lockhart Review recommendations of an
administrative nature on which there is agreement and report back
to COAG by December 2006.
While COAG restated its preference for nationally
consistent arrangements, in the absence of national agreement some
States and Territories reserved the right to alter the legislation
within their own jurisdictions to the extent that is within their
power. See: http://www.coag.gov.au/meetings/140706/index.htm#Lockhart.
After the 14 July COAG meeting general political debate about
the issue continued. After lobbying by some Coalition backbenchers,
Cabinet level and Coalition party room discussions occurred and the
Prime Minister indicated that if the matter came before Parliament,
Coalition parliamentarians could vote according to their
conscience, as was the case in 2002.(28) The leader of
the opposition indicated that Labor Party members would do the
same.(29)
The subsequent political debate has culminated in the generation
of two Bills dealing with stem cell issues. The first, a joint Bill
sponsored by Senator Stott Despoja (Australian Democrats) and
Senator Webber (Australian Labor Party) Somatic Cell Nuclear
Transfer (SCNT) and Related Research Amendment Bill 2006 was
released as an exposure draft on 14 Septebmer 2006.
(30)The second, a Bill sponsored by Senator Patterson
(Liberal Party) Prohibition of Human Cloning for Reproduction and
the Regulation of Human Embryo Research Amendment Bill 2006
released an exposure draft on 26 September 2006 and was introduced
to the chamber. This Bill was then subsequently introduced into the
Senate on 19 October 2006.
The Prohibition of Human Cloning for Reproduction and the
Regulation of Human Embryo Research Amendment Bill 2006 includes
amendments permitting therapeutic cloning or SCNT for research,
training and clinical application, for both human embryo clones and
animal-human hybrid embryo clones. The following sets out the
scientific, policy and international background to the Bill.
This part of the Digest explains the basic scientific principles
associated with creation of an embryo by natural means and by human
cloning.
The basic steps for natural creation of a human embryo are as
follows and are illustrated in diagrams 1 and 2.
The sperm inseminates the oocyte. Between 12 - 20 hours after
the sperm has inseminated the oocyte two pronuclei are formed in
the cytoplasm of the egg around the maternal and paternal
chromatids and two polar bodies are formed in the perivitelline
space.
Approximately 20 hours after the sperm enters the oocyte, the
pronuclear membranes dissolve and the maternal and paternal
chromosomes combine. Almost immediately (and without reformation of
the nuclear membrane), the chromosomes align for the first cell
division (a process known as syngamy).
Diagram 1: Fertilisation.
Source: Discussion Paper: Human Embryo – A Biological
Definition (NHMRC) 2005.
Diagram 2: Pre-implantation Development.
Source: Discussion Paper: Human Embryo – A Biological
Definition (NHMRC) 2005.
The NHMRC Working Party on the Biological Definition of the
Embryo concluded that syngamy is the most appropriate marker for
the completion of fertilisation because this is when the genome of
the new entity is created.(31) However, as syngamy is
difficult to visualise: the earliest point at which fertilisation
can be visually confirmed is the first mitotic cell division
(cleavage).
During days 2-3, the zygote goes through its first cell division
and its progeny also divide several times thereafter to form a
compact ball of cells called the morula. As the cells continue to
divide, the morula enlarges to form a hollow sphere called a
blastocyst. The cells in the outer layer of the blastocyst give
rise to a placenta and other supporting tissues. The cells in the
centre give rise to the developing body layers of the evolving
embryo and foetus, and ultimately to all the organs and tissues of
the body. The cells of the inner cell mass can be extracted from
the blastocyst and cultured to derive embryonic stem cells.
The following discussion sets out basic scientific information
regarding cloning.
Cloning is a type of asexual reproduction that results in the
production of an organism which is a genetic copy of another
organism. Two types of cloning are important to keep in mind;
reproductive cloning and therapeutic cloning . There seems to be
general societal agreement that reproductive cloning is
unacceptable and it is banned in Australia. There is a far greater
divergence of views, however, in relation to therapeutic cloning.
Although it is currently banned in Australia, a general consensus
has not been reached as to whether it should be permitted in
future.
Embryo clones may be created by a variety of methods
including:
- Somatic cell nuclear transfer (SCNT) which is explained
below
- Parthenogenesis; which has been performed on some mammals and
occurs where egg cells have been stimulated to divide into embryos
without fertilisation by sperm. Researchers have so far been unable
to grow embryos to maturity
- Splitting an embryo at the early cell division stage, similar
to the natural process by which monozygotic ( identical ) twins are
formed, and
- Inserting an embryonic cell nucleus into the oocyte cytoplasm
after removal of the original oocyte nucleus.
Although
embryonic cloning can occur naturally in humans, the scientific
techniques of cloning usually differs from the basic steps that are
gone through in the natural development of a human embryo and the
following discussion deals with cloning by SCNT.
SCNT involves taking an egg cell (oocyte), removing the cell s
nucleus (which contains almost all of the genetic material), and
replacing it with another cell nucleus from another cell, usually a
somatic cell (although other cells such as embryonic stem cells may
be used). Scientists then use certain means (commonly an electric
current), to induce the enucleated egg and its new nucleus to fuse
and develop into an embryo.
Diagram 3: Somatic cell nuclear transfer
Source: Appendix 2 Issues Paper Lockhart Review
Because the nucleus contains most of the DNA of an organism, the
embryo is genetically identical to the person from whom the somatic
cell was taken (hence the term clone is used). (nb except for the
egg mitochondrial DNA which is in any embryo).
If the embryo is transferred back to the uterus of the female
and developed into a foetus, this is reproductive cloning.
Therapeutic cloning
and production of embryonic stem cells
The embryo may, however, be cultured to the blastocyst stage at
which point the embryonic stem cells are removed from the embryo.
These embryonic stem cells can then be used for research or
treatment (hence the term therapeutic cloning is used). The removal
of the embryonic stem cells destroys the capacity of the embryo to
continue to grow and develop. However, recent advances suggest that
it may soon be possible to remove one or two individual cells from
the blastocyst or early morula without destruction of the embryo
(in a technique similar to that used for pre-implantation genetic
diagnosis). The cell or cells removed can be grown up into a
pluripotent embryonic stem cell line. The embryo can continue its
development. There is some speculation over whether the foetus and
ultimately baby developed would be affected by the loss of an early
embryonic cell.(32)
Although the terms therapeutic cloning and SCNT are used
interchangeably, SCNT is considered to be the more accurate of the
two terms and is now in common scientific usage. Professor Alan
Trounson, from the Australian Stem Cell Centre, argues that:
We re not cloning in the sense that people
understand we re cloning Nor, necessarily are we focused on a
therapeutic. So somatic cell nuclear transfer is more descriptive
of what we re trying to do.(33)
For the purposes of this current debate, the reader should focus
on two types of stem cells; embryonic stem cells and adult stem
cells.
Human embryonic stem cells were first isolated in
1998.(34) Embryonic stem cells are pluripotent cells,
which means that they have the capacity to turn into any cell type
in the adult body (note they cannot turn into placental and related
tissue). Technically, totipotent cells can differentiate into any
cell type, including into cells of the placenta and other
supporting tissues. Such cells are only present for the first few
divisions after fertilisation. Cells thereafter are referred to as
pluripotent. Further differentiation results in multipotent stems
cells. A multipotent cell can turn into a defined set of related
cells types, for example different types of blood cell, but not
into any cell type. As noted above, they are extracted from the
human embryo at the blastocyst stage of embryonic development. They
can be extracted from an embryo created either through the
sperm/egg fertilisation process or from an embryo created by
artificial means such as SCNT.(35)
Currently in Australia, embryos that are excess to IVF needs can
be used by researchers to harvest embryonic stem cells. Where
embryos have been created for the purpose of ART such as IVF, but
they are excess to the patients needs, they may be donated to
research. Researchers may apply to the NHMRC for a licence to use
these excess embryos for different purposes such as the harvesting
of embryonic stem cells. Currently the NHMRC had received four
applications and four licences have been granted for research to
derive ES cell lines. Stem cell lines are also imported into
Australia.(36)
Most tissues and organs in the adult human body have some adult
stem cells (adult here means post-birth). Adult tissues in which
stem cells that have been identified include skin, intestine,
liver, brain and bone marrow.(37) Adult stem cells are
multipotent cells as opposed to pluripotent cells and
hence are limited in what they can become and in what they can be
used for. They can only differentiate into a set of defined cell
types but cannot become any type of cell.
Policy arguments and Lockhart
recommendations relating to embryonic stem cells
A range of policy issues have been
canvassed during the debate on whether to permit SCNT/ cloning. The
following is a brief discussion of these issues.
The Issues Paper from the LRC provided the following
explanation of why some scientists are interested in stem
cells:
Stem cells are of great interest to researchers
because of their potential to regenerate damaged or diseased
tissues. The treatment of leukaemia patients with bone marrow
containing blood stem cells from compatible donors has been a
routine procedure since the 1970s. Since that time, scientists have
hoped to develop other stem cell therapies. Stem cells also provide
a good model for research on the development and function of
different cell types and the features of certain cellular disease
states. Embryonic stem cells have attracted particular interest
because they are pluripotent.
Stem cells from human embryo clones have attracted
additional interest because they provide an opportunity to obtain
embryonic stem cells that are a precise match for the person of
whom the human embryo clone is a copy. Treatment of this person
with their own matched stem cells would prevent immune rejection
problem and/or avoid having to wait for a suitable matched donor.
The same would be true of adult stem cells if they were obtained
from a person requiring stem cell treatment. (38)
Therefore the main reasons for supporting stem cell research is
the potential for therapeutic benefits including:
- treatment of serious and currently untreatable
conditions(39)
- studying disease states,(40) and
- screening new drugs.(41)
Currently the use of excess ART embryos under licence has led to
the development of a number of embryonic stem cell lines.
Researchers in the area have, however, advocated for the creation
of embryonic stem cell lines from embryos cloned through SCNT. The
Lockhart Report stated that this would be beneficial because:
further development in this area of research
requires the creation of human embryo clones to generate embryonic
stem cells that are either patient matched for the development of
specific cellular therapies or of known genotype for disease
modelling and other research.(42)
In essence, researchers argue that the development of
individually DNA matched stem cells (which is made possible through
SCNT) will overcome the problems of tissue rejection when treating
patients. It is also argued that the development of SCNT stem cell
carrying genetic disorders will be useful as scientists will be
able to watch the cells grow and, hence, understand the development
of complex diseases. Stem cells from SCNT could also lead to the
identification of drugs and treatment for diseases.(43)
Therefore, there is specific interest in embryonic stem cells that
are derived from SCNT (ie, cloning) because of the benefits of
generating donor matched cells.
Currently the law does not permit SCNT and hence the generation
of stem cell lines from SCNT.(44) The Lockhart Report
examined the issue of whether the law should be changed to permit
SCNT. The following is a summary of some of the arguments
considered in the Lockhart Report.
During the course of the stem cell debate one of the areas of
contention that has arisen has been whether research using
embryonic stem cells will produce outcomes that are different to
research carried out on adult stem cells. If research on each type
of stem cell produced the same result, this would weaken the
argument in favour of using SCNT.
Whilst it is clear that embryonic and adult stem cells have
different characteristics, in 2001 there was no agreement among
scientists about whether research on adult or embryonic stem cells
would produce different or more scientifically successful outcomes,
particularly in relation to organ transplants.(45) The
Lockhart Report noted that in 2001, many researchers considered
that research involving both should continue until their efficacy
became clearer.(46)
The Lockhart Report documented arguments which suggested that
embryonic stem cells could achieve different results to adult stem
cells. It also noted evidence given that using adult stem cells
would achieve similar outcomes.(47) The Lockhart Report
also noted that there had been developments in the use of adult and
embryonic stem cells since 2001. It concluded that the potential
for each of the type of stem cells was unclear, however, that:
based especially on the evidence of experts who
work directly in one or both fields of stem cell research (adult or
embryonic), that further research involving both adult and
embryonic stem cells is required to improve knowledge and to
develop effective disease treatments.(48)
The Lockhart Report considered whether there had been any
changes in the scientific landscape since 2001. If changes in the
scientific state of play had occurred then it could be argued that
the law should be revised so that it stays in step with scientific
developments. Since the release of the Lockhart Report there have
also been additional reports commissioned by Australian governments
which have examined scientific developments, including:
- a report commissioned by the Department of Prime Minister and
Cabinet titled Analysis of advice on developments in assisted
reproductive technology and related medial and scientific
research (mpconsulting report)(49) and
- a report commissioned by the Victorian Department of
Innovation, Industry and Regional Development titled, Key
Recent Advances in Human Embryonic Stem Cell Research, A Review of
Scientific Literature.(50)
The Lockhart Report concluded that research into stem cells has
been extremely active since 2002. (51)It also noted that
there had been developments in research on SCNT.(52)
The mpconsulting report focused on changes in the state of play
in relation to ART and related research since the passage of the
PHC Act and the RIHE Act. The mpconsulting report classified a
change in the state of play as being the raising of new issues (be
they scientific developments, unintended consequences of the
legislation, or new ethical arguments) that were not considered in
2002 but had been raised and considered in the context of the LRC s
review of the legislation in 2005.(53) The report
focused particularly on the definition of human embryo, the
creation and use of embryos for ART research and the creation of
embryos for stem cell research.(54)
The report concluded that on each of these issues it would
appear, based on a consideration of relevant materials, that there
has not been any significant change in the state of play since 2002
.(55) Despite this conclusion, the report did, however,
state in the section on stem cell research that it is clear that
there have been developments since the legislation was introduced
in 2002 . (56)
On 8 September 2006, the Victorian Government released a report
prepared by Dr. Nicholas Gough FTSE for the Victorian Department of
Innovation, Industry and Regional Development , which set out a
scientific summary of key recent advances in human embryonic stem
cell research and key recent advances with respect to [SCNT].
(57) This report documented that there had been relevant
scientific developments both in the fields of embryonic stem cells
and SCNT since 2002.
The Lockhart Report also noted other arguments put forward for
opposing therapeutic cloning including that there are:
- safety concerns, such as whether stem cells derived from SCNT
are sufficiently normal to allow their use as therapeutic agents in
human medicine ,(58) and
- difficulties in monitoring the activities to determine whether
the activities are reproductive cloning or therapeutic
cloning.(59)
The issue of therapeutic cloning raises significant moral and
ethical questions. The Lockhart Report noted that:
the main objection to [embryonic stem] cell
research is because of ethical concerns about the destruction of
human embryos. (60)
Issues relating to the moral and ethical aspects of therapeutic
cloning are discussed in more detail below.
After weighing up the various arguments, the Lockhart Report
recommended that human SCNT should be permitted
(recommendation 23). The Bill implements this
recommendation. This recommendation is limited by the current
provisions in the PHC Act that prohibit:
- development of human embryos created by any means beyond 14
days gestation in any external culture or device, and
- implantation into the reproductive tract of a woman of a human
embryo created by any means other than fertilisation of an egg by a
sperm.
Policy arguments
and Lockhart recommendations relating to the definition of the
human embryo(61)
Many of the provisions in the PHC Act and RIHE Act rely on the
term human embryo. Currently human embryo is defined in section 8
of the PHC Act and section 7 of the RIHE Act as:
A live embryo that has a human genome or an
altered human genome and that has been developing for less than 8
weeks since the appearance of 2 pronuclei or the initiation of its
development by other means.
In the course of considering the adequacy of the current
definition of human embryo, the Legislation Review Committee made
use of a draft NHMRC discussion paper entitled Human Embryo A
Biological Definition.(62) The draft discussion
paper was written by three NHMRC Embryo Research Licensing
Committee members and three other Australian experts (the
Biological Definition of Human Embryo Working Party, hereafter
referred to as the NHMRC Working Party).(63) As the
Lockhart Report noted, This paper addressed issues concerning the
definition of human embryo in the current legislation that have
arisen as a result of the Licensing Committee s work since 2003.
(64) This draft discussion paper noted that problems
with the current definition related to natural fertilisation,
artificial fertilisation and individuals with DNA from more than
one species.(65)
The current definition of human embryo refers to the appearance
of the first two pronuclei. This has been regarded as being too
restrictive for research purposes. The Lockhart Report, for
example, stated the following:
The definition of a human embryo in the Acts (RIHE
Act s7 and PHC Act s8) starts from the appearance of two pronuclei.
This prevents any research requiring experimental fertilisation of
an egg with sperm because, once the two pronuclei are visible (the
earliest biological marker for such research), an embryo has been
created and creation of a human embryo for research contravenes the
PHC Act s14. These provisions prevent a range of research to
improve IVF, including maturation of oocytes, testing of sperm
quality and fertilisation research.(66)
It went on to explain that:
Under the current definition of a human embryo,
researchers are not able to undertake experimental fertilisation
studies because the legislation requires the process to cease
before the two pronuclei are formed thereby preventing the
researcher from confirming that fertilisation has
occurred(67)
As a result, the NHMRC s Working Party s draft discussion paper
recommended moving the point in time in which an embryo, formed
through fertilisation of an oocyte with a sperm, is taken to have
been created, to the first mitotic cell division. The NHMRC Working
Party argued that this should be the point in time where an embryo
is regarded as being created because by that point in time the
genome for the entity has been created and it is the earliest point
after creation of the genome that scientists can actually visualise
this milestone.(68)
The NHMRC s Working Party s draft discussion paper also noted
that there are a number of emerging technologies that produce
embryos that do not involve the contribution of DNA from both sperm
and egg such as SCNT. The draft discussion paper considered that
the current definition of human embryo does not accommodate these
new technologies and hence considered that it should be
amended.(69)
Drafting a definition of a human embryo does raise a large
number of moral and ethical considerations. These are explored in
further detail below.
Lockhart recommendations
The NHMRC Working Party s draft discussion paper suggested that
changes should be made to the definition of human embryo. The
Lockhart Committee recommended that the definition of a human
embryo used in both Acts should be changed to that definition set
out in the draft discussion paper (recommendation
28).(70) In December 2005, after the release of
the Lockhart Report, the NHMRC Working Party finalised its
discussion paper. The definition of human embryo in the final
version of the discussion paper differs slightly to that contained
within the draft version. The Bill proposes to amend the definition
of human embryo and it uses the definition of human embryo that is
used in the final version of the NHMRC Working Party s discussion
paper.
The Explanatory Memorandum to the Bill notes that the definition
proposed in the Bill differs from that recommended by the Lockhart
Committee in its report. (71)It explains that:
- the Lockhart Report used a draft definition devised by the
NHMRC Working Party
- the definition proposed in this Bill is the NHMRC Working Party
s final version, and
- members of the Lockhart Committee have since stated that it was
their intention to use the final definition developed by the
NHMRC.(72)
It is important to note that while the NHMRC Embryo Research
Licensing Committee has endorsed the definition of human embryo in
the final version of the NHMRC Working Party s discussion
paper,(73) the NHMRC itself has not yet endorsed the
definition.(74)
Policy
arguments and Lockhart recommendations relating to the effect
of the RIHE Act and the PHC Act on ART research
The Lockhart Report found that research to improve the success
of ARTs (such as IVF) has been hampered as a result of the RIHE Act
and the PHC Act. The Lockhart Report stated that:
The overwhelming response to the reviews from ART
providers and researchers was that the legislation has impeded
research to improve ART technologies that was active before the
legislation was passed.(75)
Whilst it is beyond the scope of this Digest to explore all of
these issues in depth, the following are examples of some of the
areas identified in the Lockhart Report that have been regarded as
impeding ART research and clinical practice.(76)
The culture, and then maturation, of oocytes under laboratory
conditions in vitro maturation (IVM) is regarded by
researchers as being a process that could produce a variety of
advantageous scientific outcomes.(77) The Lockhart
Report noted that the development of technology to enable IVM is
currently impeded by the legislative arrangements. The Lockhart
Report explains that:
IVM is a complex procedure in which both the
nucleus and the cytoplasm of the oocyte need to be brought to
precisely the right point of maturity to allow fertilisation with a
sperm. (78)
Determining the right point of maturity could happen by
fertilising the oocytes. The Lockhart Report stated the
following:
Dr John McBain, Director, Melbourne IVF, told the
Committee that the biggest effect of the Act has been prevention of
work on in vitro maturation of oocytes from frozen ovarian tissues.
These oocytes cannot be fertilised under the current definition of
embryo because the legislation requires the process to cease just
before the two pronuclei are formed thereby preventing the
researcher from confirming fertilisation.(79)
As noted above, the Lockhart Report proposed changes to the
current definition of human embryo to address this problem.
One other way of determining the right point of maturity for IVM
is through parthenogenesis. The Lockhart Report noted that
currently IVM oocytes cannot be parthenogenetically activated to
test their activation potential because parthenogenetic activation
of oocytes is illegal under the PHC Act.(80) The
Lockhart Report recommended that intentional parthenogenetically
activation of oocytes should be permitted, under licence, for
development up to 14 days. The report also recommended that
implantation of the oocyte into the women s reproductive tract
should continue to be prohibited (recommendations 16, 3 and
4).
The Lockhart Report noted that the prohibition of creation of
human animal hybrid embryos (section 20 of the PHC Act), combined
with the current definition of an embryo, has also prevented
research or testing requiring fertilisation.(81)
The Lockhart Report explained that
For example, ART researchers and practitioners
were previously able to undertake fertilisation studies using human
sperm and animal oocytes (eg hamster) to test sperm
quality.(82)
The report noted that they are no longer able to do this as a
result of section 20 of the PHC Act. The report went on to
recommend that the legislation be changed to permit the creation of
human-animal hybrids up to the point of, but not including, the
first cell division to allow testing of human gamete maturity or
viability (recommendation 17 and recommendation
24).
The Lockhart Report noted that the creation of a human embryo
for any purpose other than to achieve a pregnancy in a woman
prevents the creation and use of fresh embryos for research. The
Lockhart Report noted that:
Some ART researchers indicated that a number of
valuable studies could be done if it were possible to use embryos
created from eggs and sperm specifically for research up to the
stage of implantation. This is prohibited by current legislation
...(83)
The Lockhart Report rejected the idea of permitting the creation
of human embryos specifically for research purposes, apart from
that permitted under recommendation 15.
The Lockhart Report noted that provisions of the RIHE Act for
declaring embryos to be excess ART embryos and giving proper
consent for research has operated to prevent the immediate (fresh)
availability of ART embryos for research. (84)The report
stated that:
The current legislation also prohibits the use of
fresh excess ART embryos through the consent process. The 14 day
cooling-off period that is required after embryo donors give
consent for a specific research project but before the embryo is
used (see Sections 11.1 and 11.2) limits the use of fresh
embryos.(85)
The Lockhart Report recommended that the NHMRC Australian Health
Ethics committee should review its guidelines for consent
(recommendation 29) with a view to easing this
problem.
The Lockhart Report also noted that embryos that are not
suitable for implantation for any reasons are allowed to die and
are not available for research despite the fact that such embryos
would be a useful source of fresh embryos for research, training
and quality assurance activities.(86)
The Lockhart Report recommended that embryos that are unsuitable
for implantation should be permitted to be used for research,
training and improvements in clinical practice. It also recommended
that objective guidelines be drawn up for use in determining when
an embryo is unsuitable for implantation (recommendations
20-22).
Cytoplasmic transfer has been used as a fertility treatment
overseas, particularly for older women. It has also been flagged as
a possible treatment for the prevention of mitochondrial disease.
Research on cytoplasmic transfer in Australia has been prohibited
since 2002 because it would lead to the creation of a human embryo
containing genetic material provided by more than two persons
(currently sections 15 and 18 of the PHC Act).
The Lockhart Report stated that:
It is the Committee s view that cytoplasmic
transfer offers potential for the treatment of mitochondrial
disease and to improve fertilisation for some women. Therefore
consideration should be given to research, under licence, on this
procedure.
Recommendation 19 of the Lockhart Report
reflects this conclusion.
The Lockhart Committee identified three areas of concern in
relation to having prescriptive legislation in relation to these
issues.(87) One of these was a lack of legal protection
for researchers.(88) It noted that a researcher who had
been granted a licence by the NHMRC Licensing Committee would have
no defence if a court subsequently found that the actual licence
contravened the legislation.(89) The other concerns
identified by the Lockhart Committee were related to the
difficulties associated with drafting legislation in relation to
rapidly changing technology and in the interpretation of the
legislation.(90)
Accordingly, the Lockhart Committee made recommendations
50 52. The Explanatory Memorandum explains:
Those recommendations suggest that the NHMRC
Licensing Committee should be given the power to give legally
binding rulings on the interpretation of the legislation and that a
person who conducts research on the basis of a ruling should be
protected from liability under the legislation.(91)
However, the Explanatory Memorandum goes on to explain that this
latter recommendation (recommendation 52) raises
significant constitutional issues relating to the impermissible
exercise of judicial power by a non-judicial body.
(92)
The Lockhart Committee reported that:
The processes that have been put in place for
monitoring compliance with the legislation and facilitating
compliance are generally regarded as suitable, although suggestions
for improvements to the system were also made. It is clear that
there is a major deficiency in the legislation with regard to the
limited powers of the inspectors appointed under the RIHE Act to
monitor activities that are not covered by a licence. As a result
of this deficiency, suspected breaches by non-licence holders
cannot be adequately investigated.(93)
Further, the Lockhart Committee reported that it had heard that
in relation to licensed premises inspectors are not empowered to
make unannounced inspections and this inhibits their ability to
investigate suspected breaches of the legislation.(94)
The Lockhart Committee stated that its view was that inspectors
should have adequate powers under both Acts to investigate
suspected breaches of either Act. (95) It also commented
that [t]here is a legal question whether these powers already
clearly exist .(96)
Accordingly, the Lockhart Committee recommended that:
- the NHMRC Licensing Committee continue to perform its functions
(recommendation 38), and
- NHMRC Licensing Committee inspectors be empowered under both
Acts, if such powers do not clearly exist, to enter and inspect
non-licensed facilities with the same enforcement powers and
pursuant to the same requirements as relate to search warrants
under Commonwealth legislation (recommendation
39).(97)
The Lockhart Committee reported that there was widespread
support of the NHMRC Licensing Committee for its regulatory
oversight of the type of research the subject of
review.(98)
One particular problem identified by the Lockhart Committee was
that:
due to the specific expertise of each Licensing
Committee member, a vacancy on the committee poses a significant
problem, because licensing applications cannot be handled
effectively. As appointment to the committee involves approval by
all States and Territories, there have been lengthy delays in
filling vacancies. The [Lockhart] Committee noted that there is not
scope in the [RIHE] Act as presently framed to address this
problem, which is because the Licensing Committee is a national
committee that oversees research in all States and Territories. The
Committee therefore draws this to the attention of the Australian
Parliament and the [COAG] for consideration and recommends that
they give urgent attention to this problem.(99)
The relevant recommendation is recommendation
36.
At present the exportation from Australia of a human
embryo is prohibited unless permission has been granted by the
Minister for Customs pursuant to regulation 7 of the Customs
(Prohibited Exports) Regulations 1958.(100) This
regulation provides that an application to the Minister for such
permission may only be made in certain limited circumstances,
namely:
- by the prospective mother or, in the event that the prospective
mother has died, the spouse of the prospective mother at the time
that the embryo was created or donated ,(101) and
- for the sole purpose of implantation in the prospective mother
or a relevant woman (as described in the Regulations) to achieve
her pregnancy .(102)
The Lockhart Committee reported that it had:
heard from ART consumers that the current export
prohibitions and custom regulations regarding human embryos have
made it difficult for couples to export their embryos
overseas for their own reproductive use. The Committee s view is
that the current arrangements, which involve personal application
to the Minister for Customs to export embryos for personal
reproductive use, are too cumbersome and stressful for users and
should be streamlined.(103) [Emphasis added]
Accordingly, in recommendation 41, the Lockhart
Committee recommended that the import(104) or
export of a patient s reproductive material for their own
ongoing ART treatment should only be subject to existing quarantine
regulation.(105)
The Report by the Lockhart Committee states:
As the number of human stem cell lines has
increased throughout the world, it has become apparent that there
is a need for the creation of stem cell registries and stem cell
banks to enable researchers to locate cell lines of interest, along
with appropriate information about source and quality. While the
current focus of interest in stem cell banks is on the registration
and storage of embryonic stem cell lines for research, it is
possible that in subsequent years advances in stem cell engineering
and transplant immunology may mean that stem cell banks also come
to fulfil an important clinical function.(106)
The Lockhart Committee reported its view that:
an Australian national stem cell bank would make
stem cells, including embryonic and adult stem cells, more widely
available to researchers and also limit the number of embryos
required for further derivation of stem cell
lines.(107)
Accordingly, the Committee recommended that a national stem cell
bank be established (recommendation 47).
The Committee also recommended that a national register of
donated excess ART embryos be established (recommendation
49).(108) In the Committee s view, the
functions of such a register could be to:
- facilitate embryo donation for research
- provide a transparent record of the number of donated excess
ART embryos held, and,
- possibly, facilitate embryo donation to another
couple.(109)
As mentioned above, the Lockhart Committee had heard a number of
concerns about the capacity of legislation to respond to research
needs in a fast-moving area of technology. (110) In view
of these fast moving developments in the field (111) and
because of the number of amendments proposed by the Lockhart
Committee, recommendation 53 suggested that both
Acts should be subject to further review either six years after
royal assent of the current Acts or three years after royal assent
to any amended legislation. (112)
It is beyond the scope of this Digest to cover the international
state of play in relation to cloning and stem cell development. For
a recent comparative overview of regulatory frameworks for stem
cell and cloning research in 50 countries, refer to Beyond the
Permissibility of Embryonic and Stem Cell Research: Substantive
Requirements and Procedural Safeguards .(113)
Permitting SCNT or the use of excess ART embryos for scientific
purposes raises significant arguments about the moral status of the
human embryo.
Any developments and advances, whether they are societal or
technological, require constant identification, analysis and, if
necessary, regulation. Such regulation most commonly is achieved
through laws either by application of existing laws or through the
creation of new ones. Existing laws can be utilised by expanding
their application as the result of judicial interpretation.
However, where courts are unable to stretch the application of a
particular law far enough to bring the development or advance
within its reach, it can become necessary for lawmakers to provide
new, or modify existing, regulatory frameworks.
In 2002, the Australian Federal Parliament was faced with the
task of reacting to new developments in molecular genetics and
biomedicine. It passed new legislation to regulate human cloning
and provided a regime for research involving human embryos.
With this Bill, Federal Parliament is again concerned with this
issue, proposing to pass amendments that will refine and develop
the existing legislation concerning reproductive and other forms of
cloning, combining countervailing and adaptive regulatory measures
to accommodate the scientific advances that occurred since the last
debates in Parliament.
It is not difficult to predict that the ensuing parliamentary
debate will be passionate and controversial. Vigorous debates
ensued the last time this topic was discussed in
Parliament.(114)
Parliament is regularly confronted with the proposals to
implement complex and/or controversial policies. Controversy is
usually the result of different political ideologies or agendas.
Complexity is often caused by the need to skilfully craft very
complex legal solutions to implement policies; sometimes the legal
complexity of the proposed laws is part of the controversy.
This Bill is very controversial. This is not necessarily due to
different political ideologies; rather the controversy arises
because the proposed changes are founded upon significant moral and
ethical considerations of the genesis and evolution of life.
As these considerations are guided strongly by personal beliefs
and convictions rather than by political views, it seems only
proper that the ensuing debate is not conducted along party lines.
This is not a political, but a personal debate.
The ensuing debate strikes at the heart of humanity and dignity.
The following brief discourse is not an attempt to give conclusive
answers to any of the issues which may influence the debate.
Rather, it is to serve as an overview of the underlying moral and
ethical considerations, their origins and, if possible, as a primer
for further thought. As such it is aimed at avoiding a reduction of
the debate to a battle of beneficial and knowledgeable cleverness
versus ignorant and superstitious anxiety. (115)
At the outset, it is important to identify the core and scope of
the controversy surrounding stem cell research.
There is a sliding scale of controversy depending upon the
source of the stem cells.
The less controversial sources include those that do not require
the destruction of a blastocyst, a form of embryo developed at the
earliest stages of embryogenesis.(116) Examples include
adult stem cells or stem cells derived from the blood of the
umbilical cord.(117) Some jurisdictions have decided
that the use of stem cell lines that are already in existence raise
fewer moral objections. Prominently, the United States (US) and
Germany have decided not to provide federal funding (US), or even
to prohibit outright (Germany), the creation of new stem cell
lines, but both nations permitted research on lines that were
already in existence at the time the prohibition came into force or
was announced.(118) The underlying arguments for this
distinction are discussed further below in the context of
differentiating between the creation and the use
of stem cells.(119)
The more controversial sources include those that require the
harvesting of stem cells from embryos that were:
- created and stored in the context of an assisted reproductive
program for an individual couple for the purpose of procreation or
overcoming childlessness
- created for the purpose of producing stem cells for therapeutic
purposes (therapeutic cloning), or
- the result of procedures resulting in a chimeric or
hybrid embryo.
These sources for stem cells are more controversial because
their harvesting will require the embryo s
destruction.(120) This destruction poses one of the
central ethical quandaries for this debate.
The substance of this controversy relates to the moral
status of the embryo. What will be destroyed when the stem
cells are harvested: a plain cell mass or an early embryo? If it is
an early embryo, is it already human life with the same moral
status as a human being? Or does this early embryo constitute
ante-nascent human life, which has not gained sufficient
personality or personhood ; that is, it has not yet acquired the
same moral status as a born human being? And, finally, is there a
moral difference between an embryo created by sperm and egg and
those created by SCNT, parthenogenesis or other laboratory
means?
The answers are important because born human life is
considered to have the highest moral status that correlates with
the full protection against destruction. This protection stems from
concepts such as inviolable human dignity and human rights. The
intentional destruction of a born human being is generally
considered homicide. Thus, if it is argued that the embryo
possesses the same moral status as a born human being, the logical
consequence is inescapable: the destruction of this embryo equates
to homicide.
If it can be reasoned that the embryo is merely a cell mass or
an early embryo without the same moral status when compared to born
human life, its intentional destruction would not necessarily
equate to homicide. To argue in favour of the destruction of an
embryo without moral status would reduce or even fully eliminate
the moral or ethical dilemma.
These considerations amount to the search for a justification of
why the destruction of an embryo is not homicide which is deemed by
society to be the most reprehensible of all crimes. Two threshold
questions underpin these considerations, including:
- when does life begin to assess whether a blastocyst is
in fact a new life or independent organism,(121)
and
- whether the moment in which a new life begins is also
the moment in which a human being begins that is, to assess the
moral status of the blastocyst.
A further issue discussed in the literature is whether the
purpose for which the embryo was created should be
considered in the context of this debate.
Two immediately obvious moments mark the point in time in which
a new life or the life of a new organism may begin.(122)
The first moment is the conception or cell fusion, that is, the
moment in which oocyte and sperm amalgamate. The second possible
moment is the birth of a human being itself. Neither can be
discredited comprehensively. However, there are also strong
arguments in favour of why one moment is considered too early and
the other too late.
The interim period between conception and birth is marked by a
continuum of evolutionary steps. Examples from the early stages of
this evolution include the:
- fusion of the genetic material of the oocyte and the sperm
- completion of fertilisation with the creation of the zygote, a
genetically unique entity
- end of the first mitotic cell division
- formation of the blastocyst
- development of the primitive streak, or
- the development of blood in the foetus.
At least theoretically, each of the above moments could be the
point in time in which life commences. Indeed, all of them have
been used to define this moment.
The choice of one moment in time over the other is generally
rationalised based on a belief system or conviction, promoting
arguments derived, for example, from science or religion.
However, regardless of the persuasiveness of the supporting
arguments, the fact remains that any point in time within this
continuum of evolution will be an arbitrary point with the
potential to spark considerable disagreement. German philosopher J
rgen Habermas noted that:
The fact that every attempt to draw a definite
line somewhere between fertilization, or the fusion of nuclei, on
the one hand, and birth on the other hand is more or less arbitrary
because of the high degree of continuity prevailing in the
development from the organic origins to, first, life capable of
feeling and, then, to personal life.(123)
For him, the very fact of the continuum between conception and
birth speaks against any attempt to ascertain an absolute beginning
for the purpose of lawmaking.
A separate question is whether the moment in which life begins
is also the moment in which life assumes the qualities of born
human life or a human being. Conceptually, the discussion considers
that even if it is possible to determine exactly when life
commences, further developmental steps are required to form a human
being and the acquisition of a moral status is gradual.
If this proposition is accepted, then it follows that the
protection that correlates with the moral status also increases
gradually during the embryogenesis. The apex of this gradual
acquisition of moral status and protection is reached with the
birth of the human being.
For example, despite accepting that a human embryo is a member
of the human species, not a member of some other species such as
frogs or cows , Harvard Professor D W Brock has noted that:
[ ] this is not sufficient to give it the same
moral status as humans who are incontestably persons. That is
because the moral status of human persons does not derive simply
from their species membership. Rather, it must be some properties
of humans that endow them with personhood and in particular make it
seriously wrong to kill them. (124)
Whilst this distinction seems somewhat artificial, it is quite
common. In her book Stem Cells, Controversy at the Frontiers of
Science, science journalist and biochemist Elizabeth Finkel
has written that the Catholic church is taking the view that the
question when an embryo acquires personhood or the moral status of
a human being is governed by science rather by
theology.(125) Accordingly, this varied throughout
history. According to Finkel, this point is currently reached with
the fusion of female and male genetic material, that is, after
conception.(126)
Other Christian churches and religions apparently also
distinguish between the creation of life and the acquisition of
personhood. Finkel refers to examples from the Anglican Church,
Judaism and Islam, all of which believe in the gradual evolution of
personhood over time. Interestingly, the author reports that
Judaism and Islam consider this evolution to be completed after a
period of forty days the time Catholic cleric and philosopher
Thomas Aquinas assigned to the ensoulment of an
embryo.(127)
Two issues are, however, important to note. First, despite
apparently accepting the acquisition of personhood at a later stage
then conception, the Catholic church deems the protection of human
life to attach from the moment of conception.
Second, the observation that Christian teachings advocated the
gradual acquisition of personhood is controversial. Professor G
Dunstan, who is one of the leading proponents of the gradual
acquisition and claimed that the full protection of even the early
embryo from the point of fertilisation is a result of
late-19th century Christian teachings, has recently been
challenged.(128)
Professor D A Jones argues that Professor Dunstan s work is
based on the omission of important authorities, and is reliant on
flawed sources and the failure to distinguish between divergent
categories.(129) He is particularly critical of
Professor Dunstan s conclusions that the medieval western church
believed in a delay between fertilisation and ensoulment , arguing
that this conclusion is derived from a flawed early translation of
the Bible. In his opinion, throughout Christian history, the
deliberate destruction even of early embryonic life was considered
to be homicide.(130)
Whether a human embryo is a human life with a moral status equal
to that of born human life is also an influential issue during any
abortion debate. American medical doctor and biochemist Leon R
Kass, Chair of the President s Council of Bioethics
between 2002 and 2005, suggested that these debates are analogous,
if not identical .(131) And British Theologist Robin
Gill discussed the re-emergence of the gradualist position in
abortion debates, applying it to the stem cell
debate.(132) However, despite obvious similarities,
questions have been asked whether sound and neutral arguments
differentiating between an early embryo such as a blastomere facing
destruction and a foetus facing abortion can be derived from the
abortion debates.(133) For example, Professor Habermas
observed that although the abortion debates alert society to the
issue of the moral status of the unborn life :
all attempts to describe early human life in terms
that are neutral with respect to world views, that is, not
prejudging, and thus not acceptable for all citizens of a secular
society, have failed.(134)
Divorcing the commencement of life from the moment in which life
acquires the status of a human being offers two advantages to the
proponents of stem cell research and the legislature, including
that it:
- allows arguments in favour of the destruction of the early
embryo without the need to justify further the moral implications
of the destruction of the embryo, and
- creates a new category of prenatal life a human embryo without,
or with only limited, moral status which can be used by the
legislature as the subject matter of a new legal framework.
It is important to realise, however, that the gradual
acquisition of personhood takes place in the same continuum in
which the commencement of life takes place the period between
conception and birth. This gradual acquisition may even continue
after birth. Therefore, it must be stressed that any attempt to
specify individual grades of moral status along the time line
between conception and birth are inevitably arbitrary. Parallels to
the discussion in relation to the genesis of life, referred to
above, are in order. Thus, to mark the line when a human embryo is
deemed to have acquired a moral status sufficient to refute any
justification of its destruction is likewise arbitrary.
Consequently, the criticism that such arbitrariness confounds any
attempt to draw a line as the basis for legal implications in this
period must apply here as well.(135)
A further distinction used to justify the destruction of early
embryos is based on differentiating between the purposes for which
embryos are created. The key issue is to assign a different moral
status to the embryo depending upon the purpose for which it was
created. This approach is often chosen to overcome the apparent
inconsistency between:
- permitting, accepting or tolerating the destruction of embryos
created as the result of ART, and
- opposing the destruction of embryos when they were created for
research.
Embryos created for their use in an ART program are initially
created for the purpose of procreation or, as it is also put, to
overcome childlessness. As soon as one of these embryos is
successfully implanted and continues to develop, the other embryos
become excess material. They are no longer needed for their
intended purpose.
Theoretically, such excess embryos can be kept in cryostorage
over prolonged periods of time.(136) However, whilst
some embryos will not survive the freezing or thawing process, the
majority will later be discarded, that is, destroyed. This
destruction is in some cases permitted, or in many Australian
States even mandated by law, and it seems that it is generally
morally accepted or at least tolerated.(137) On the
other hand, the thought of creating embryos for the sole purpose of
consumption through research is not always met with the same
tolerance or acceptance.(138) For example, Professor
Habermas calls this conditionally created human life that is
instrumentalised by researchers for an ulterior
purpose.(139)
There have been moral concerns against the creation of embryos
with a view to destroying them for research purposes. To discredit
a distinction based upon the purpose for which the embryo was
created, it has been argued that if:
embryos may be used for research into the causes
of treatment infertility, [ ] it is inconsistent to reject research
into the possible treatment of serious invalidating diseases as
being not sufficiently important.(140)
Or, similarly:
once they accept the creation and sacrifice of
embryos to benefit infertile people with a child-wish, they do not
have a sound reason to condemn the creation and sacrifice of
embryos to benefit ill and injured people who could be helped by
stem cell therapies.(141)
As has been noted above, some jurisdictions have based their
legislative framework on the understanding that the use of stem
cell lines that are already in existence raise fewer moral
objections. For example, Germany has decided to prohibit the
creation of stem cell lines, but permitted research on lines which
were already in existence at the time the prohibition came into
force or was announced. One German politician who supported Germany
s ban on stem cell research with newly created stem cell lines
reportedly stated that:
The killing of embryos for research purposes must
remain illegal [ ] But we cannot cancel the fact that embryos were
already killed for existing cell lines.(142)
This view underlies the value judgement that:
An embryo, which has been created in vitro, must
be consumed neither for research nor for therapeutic purposes, but
must in line with its natural telos be given the chance instead of
developing into a human being and of being
born.(143)
The US administration used a similar rationale and value
judgement to justify its decision to make federal funding of stem
cell research dependent upon the cells existence at the moment in
time when the policy was announced.(144)
To permit the use of stem cells whilst prohibiting their
creation allows scientists to research with existing lines without
having to face the moral dilemmas arising from the need to destroy
embryos in order to obtain lines.
It has been noted that this:
Distinction between use and derivation is neither
cynical nor disingenuous for it reflects the basic distinction in
the ethics of complicity between causing an immoral or wrongful act
to occur and benefiting from it once it has
occurred.(145)
Distinguishing between research with stem cells that already
have been created at a particular point in time and research which
would require the destruction of further embryos has been likened
to the use of organs from a murder victim, that is, the gain of a
benefit from a wrongful act.(146)
In addition to the issues discussed above, the justification
debates often invoke the rights or freedoms of a particular class
of stakeholders. A detailed discussion of the arguments comprising
this debate would go beyond the scope of this Digest; however, some
of the key aspects of these debates should be highlighted here,
including:
- a woman s right to choose to donate her eggs is this right
absolute or should it be restricted to protect embryos? In
addition, should it be restricted to protect women from being
exploited for commercial reasons?
- the scientists freedom of research and their entitlement to
explore this avenue can or should this freedom be legitimately
restricted and if so, on what grounds?
- a person s right to optimal treatment for a disease can the
legislature deny a human being the chance of being cured from a
grave illness or is there an overriding concern that society at
large may face dire consequences as the result of the
research?
Generally, these aspects raise issues such as the absoluteness
of a right of freedom, and, if it is found not to be absolute, how
far it may be restricted. This balancing exercise regularly invokes
inquiries into the proportionality of a restricting measure.
There is a fear that permitting therapeutic cloning will
ultimately lead to cloning for reproductive purposes: it is the
first step on the slippery slope towards the cloning of a human
being.
The slippery slope argument is founded on the
prediction that a particular outcome will inevitably occur if a
certain preceding step is taken.(147) Thus, engaging the
slippery slope argument equates to the prediction that the
knowledge gained from therapeutic cloning is the preceding step
that will inevitably lead to research into reproductive cloning.
Pointing out that the slippery slope in relation to stem cell
research is an inevitability, Leon R Kass notes that:
Despite the na ve hopes of many, neither will be
able to defend the boundary between therapy and genetic
enhancement. [ ] the genetic genie, first unbottled to treat
disease, will go its own way, whether we like it or
not.(148)
However, the slippery slope argument has also met with
resistance. For example, some authors argue that appropriate laws
and powerful oversight authorities will provide sufficient
safeguards against sliding down the slope.(149) Others
argue that the presumed automatism of the continued development
towards human cloning is disputable .(150) There are,
however, scientists who already entertain arguments in favour of
human reproductive cloning. It is argued that IVF and reproductive
cloning are, in essence, both reproductive technologies. Thus, the
moral justification using IVF should, by analogy, also apply to
justifying developing human reproductive cloning
research.(151)
A separate issue that is, however, closely linked to the
slippery slope argument, is the phenomenon that society has a
general tendency towards normalisation, that is, people get used to
developments and processes once they are set in motion and become
more common.(152) Thus, it has been argued that once
research into therapeutic cloning yields its first promising
results or, later, even therapeutic successes, society will become
accustomed to the issue and moral concerns subside. In support of
this proposition, comparisons have been drawn between the debates
surrounding other medical developments that were regarded by many,
at least initially, as morally or ethically controversial or plain
wrong. Examples where normalisation occurred include heart
transplantation procedures which were considered wrong, too
dangerous or even to be playing God .(153) Similarly,
IVF was initially extremely controversial. Today, these procedures
are an accepted part of modern medicine (154) and highly
valued by both the scientific and lay communities.
(155)
Especially in the initial stages where new treatments are
available, the clinical application of such treatments is possibly
so costly that it may only be available to those who have the
required financial means. It has been queried whether such
exclusiveness can comply with demands of equality in society, a
concern rebutted by Professor Ronald Dworkin, who argues that the
initially limited availability will, in the long term, result in
developments and discoveries of much more general
application.(156)
It has been suggested that mastering any cloning technique would
allow the human species to gain too much control over nature. In
turn, this control over nature has the potential to blur the line
between choice and chance, a significant dichotomy underlying our
moral framework.(157) Thus, the answers we find based on
values, beliefs and convictions, are critical to our understanding
of our species and our moral underpinnings. As Professor Dworkin
notes:
The crucial boundary between chance and choice is
the backbone of our ethics and our morality, and any serious shift
in that boundary is seriously dislocating. (158)
However, it must also be noted that shifts in moral values
are quite common in society and it has been noted that the
last decades have seen:
Significant revolutions in what counts as an
object of moral concern the civil rights revolution, the women s
liberation movement, the rise of environmentalism and environmental
ethics, and the animal rights movements.(159)
The interference with the genetic integrity of human beings may
also lead to a change in the genetic identity of a person. This new
or altered identity can be used as a reference point for
establishing the otherness of people and therewith an alteration of
the perception of equality. Querying whether a human being is
nature s creation or ours, Habermas has asked whether we:
May [ ] consider the genetic self-transformation
and self-optimisation of the species as a way of increasing the
autonomy of the individual? Or will it undermine our normative
self-understanding as persons leading their own lives and showing
one another equal respect?(160)
That there is the potential for a different normative
self-understanding of humans as a result of genetic medicine has
recently surfaced in relation to persons who are the result of
assisted conception. The ABC reported in its 7:30 Report
that these so-called test-tube babies struggle to come to terms
with their often unknown genetic heritage, feel like a product of
reproductive technology rather then a human being and perceive a
lack of identity .(161)
Both the Explanatory Memorandum and the Revised Explanatory
Memorandum are silent on the issue of financial implications. It is
not evident that there will be a financial impact on the
Commonwealth.
Schedule 1 of the Bill amends
the PHC Act and Schedule 2 amends the RIHE Act.
The Explanatory Memorandum states that the amendments are
consistent with the LRC s recommendations.(162)
Schedule 3 is a saving provision which outlines
the effect the Bill will have, once passed, on applications for
licences not yet decided and on licences already issued (existing
licences are to continue in force). Schedule 4
amends the Customs (Prohibited Exports) Regulations 1958
by repealing regulation 7. This regulation prohibits the export of
human embryos except in certain limited circumstances where
Ministerial permission has been granted. The main provisions of
Schedules 1, 2 and 4 are dealt with thematically rather than
numerically. Schedule 3 is not discussed further.
The current definition of human embryo in both Acts (subsection
8(1) of the PHC Act and subsection 7(1) of the RIHE Act) is
repealed and replaced with the following:
human embryo means a
discrete entity that has arisen from either:
(a) the first mitotic division when fertilisation
of a human oocyte by a human sperm is complete; or
(b) any other process that initiates organised
development of a biological entity with a human nuclear genome or
altered human nuclear genome that has the potential to develop up
to, or beyond, the stage at which the primitive streak appears;
and has not yet reached 8 weeks of development
since the first mitotic division.
As mentioned earlier, the Lockhart Committee recommended that
the current definition of a human embryo be changed
(recommendation 28).(163)
The Explanatory Memorandum states that the key differences
between this new definition and the current definition in the Acts
are:
- the point at which a human embryo is defined
to commence existence. The identification of the first mitotic
division as the time when fertilization is complete and the time at
which the fertilized egg becomes an embryo. This recognises that
fertilization is a process and that an embryo does not arise until
the process is complete; and
- the definition used for embryos created other
than by human egg and sperm. In the new NHMRC [Working Party]
definition, the capacity to develop to the stage of the appearance
of the primitive streak is taken as the marker of an entity that is
an embryo. This is a conservative definition and acknowledges that
entities such as those that have arisen by SCNT are indeed
embryos.(164) [Emphasis added]
New paragraphs 8(8)(a) and (b)(165) of the
PHC Act and new paragraphs 7(5)(a) and (b) of the
RIHE Act clarify that references in each Act to a human
embryo do not include references to a hybrid embryo or a
human embryonic stem cell line.
In working out the length of the period of development of a
human embryo any period when the development of the embryo is
suspended(166) is not included (current subsection 8(3)
of the PHC Act and current subsection 7(2) of the RIHE Act).
Currently, subsection 20(1) of the RIHE Act only
permits a person to apply to the NHMRC Licensing Committee for a
licence authorising use of excess ART embryos.(167)
New subsection 20(1) of the RIHE Act will contain
a similar provision but will also permit persons to apply for
licences in relation to a number of other activities. These
activities are currently prohibited and involve the creation and/or
use of other embryos and the use of human eggs. These changes are
detailed below.
Before discussing the new permitted activities,
it should be noted that new subsection 24(1) of the RIHE
Act provides that such licences will be subject to the
condition that:
- each person donating an embryo or egg must have given proper
consent(168) to the creation or use(169) of
that embryo or egg and
- the licence holder must have reported in writing to the NHMRC
Licensing Committee that such consent has been obtained, and any
restrictions to which the consent is subject.
This reflects recommendation 31
of the Lockhart Report.
As noted above, subsection 8(1) of the PHC Act defines a human
embryo clone as a human embryo that is a genetic copy of another
living or dead human, but does not include a human embryo created
by the fertilisation of a human egg by human sperm.
Currently, section 9 of the PHC Act stipulates that it is a
criminal offence intentionally to create a human embryo clone with
a maximum penalty of 15 years imprisonment.
As there is no equivalent provision in new Part 2 of the
PHC Act, the Bill effectively implements the Lockhart
Committee s recommendations to permit the creation of human embryo
clones in some circumstances (recommendations 23
25). The Explanatory Memorandum explains that the change
will permit human embryo clones to be created for research up to 14
days if the creation is licensed.(170)
New paragraph 20(1)(b) of the RIHE Act provides
that a person may apply for a licence authorising:
- the creation of human embryos other than by fertilisation of a
human egg by a human sperm, and
- use of such embryos.
New subsection 20(1A) of the RIHE
Act confirms that the NHMRC Licensing Committee is not
permitted to authorise any use of the embryo that would result in
development for longer than 14 days (excluding any period when
development is suspended).
It is a criminal offence, with a maximum penalty of:
- 5 years imprisonment, intentionally to engage in use without a
licence authorising the use by that person (new section 10A
of the RIHE Act), and
- 10 years imprisonment, intentionally to engage in creation or
development without a licence authorising the creation or
development by that person (new section 22 of the PHC
Act).
New section 23C of the PHC Act provides that
Regulations are to be made permitting, subject to
appropriate conditions or restrictions, the import or export of
human embryonic stem cell lines which have been derived
from human embryo clones using practices consistent with
Australian legislation. This reflects the Lockhart Committee s
recommendation 42.
It will be a criminal offence, with a maximum penalty of 15
years imprisonment, to:
- develop a human embryo (including a human embryo
clone)(171) outside the body of a woman for more than 14
days (new section 14 of the PHC Act), or
- place a human embryo clone in the human body or the body of an
animal (new section 9 of the PHC Act).
At present, these activities are criminal offences in the PHC
Act (current sections 16 and 10 respectively) but the maximum
penalty is 10 years imprisonment. On 7 November 2006, the
Senate passed an amendment moved by Senator Stott Despoja, also on
behalf of Senator Webber, to increase the maximum penalty from 10
years imprisonment to 15 years imprisonment.
It is, and will remain, a criminal offence, with a maximum
penalty of 15 years imprisonment, intentionally to:
- import a human embryo clone into Australia (current subsection
11(1); new subsection 10(1) of the PHC Act),
or
- export a human embryo clone from Australia (current subsection
11(2); new subsection 10(2) of the PHC
Act).
The Bill also retains the provision that
stipulates that it is not a defence to an offence under new
section 9 or new section 10 of the PHC
Act that the human embryo clone did not survive or could
not have survived (new section 11 of the PHC Act).
This provision is essentially the same as current section 12 of the
PHC Act.
Currently, section 15 of the PHC Act stipulates that it is a
criminal offence, with a maximum penalty of 10 years imprisonment,
for a person intentionally to create or develop a human embryo
containing genetic material provided by more than 2 persons.
The Bill seeks to implement the Lockhart Committee s
recommendations 13 and 26,(172) and
accordingly distinguishes between creation of such a human embryo
by a process:
- of the fertilisation of a human egg by a human sperm outside a
woman s body, and
- other than the fertilisation of a human egg by a human
sperm.
(See the section below which prohibits the
creation of a human embryo by a process of the fertilisation of a
human egg by a human sperm outside a woman s body for a purpose
other than achieving pregnancy in a woman (new section 12
of the PHC Act implementing the Lockhart Committee s
recommendation 13)).
New paragraph 20(1)(c) of the RIHE Act provides
that a person may apply for a licence authorising:
- the creation of human embryos other than by
fertilisation of a human egg by a human sperm that contain genetic
material provided by more than 2 persons, and
- use of such embryos.
The penalty regime devised by
new subsection 20(1A) and
new section 10A of the RIHE Act applies. For details see
discussion above.
It is a criminal offence, with a maximum penalty of 10 years
imprisonment, intentionally to engage in such creation or
development without a licence authorising the creation or
development by that person (new section 23 of the PHC
Act).(173)
It will also be a criminal offence, with a maximum penalty of 15
years imprisonment, intentionally to:
- create or develop a human embryo by a process of the
fertilisation of a human egg by a human sperm outside a woman s
body where the human embryo contains genetic material provided
by more than 2 persons (new section 13 of the PHC
Act)(174)
- develop a human embryo outside the body of a woman for more
than 14 days (new section 14 of the PHC Act)
- place a embryo in a woman s body knowing that, or being
reckless as to whether, the embryo is a human embryo containing
genetic material provided by more than 2 persons
(new subsection 20(3) and
new paragraph 20(4)(c) of the PHC Act)
- import an embryo into Australia knowing that, or being reckless
as to whether, the embryo is a human embryo so created
(new subsection 20(1) and
new paragraph 20(4)(c) of the PHC Act), or
- export an embryo from Australia knowing that, or being reckless
as to whether, the embryo is a human embryo so created
(new subsection 20(2) and
new paragraph 20(4)(c) of the PHC Act).
At present, these activities are criminal offences in the PHC
Act (current section 13;(175) section 16; subsection
22(3) and paragraph 22(4)(c); subsection 22(1) and paragraph
22(4)(c); subsection 22(2) and paragraph 22(4)(c) respectively),
but the maximum penalty is 10 years imprisonment. This
change in maximum penalty is the result of amendments in the Senate
on 7 November 2006.
The retention of the provision in the third bullet point
(disregarding the change in maximum penalty) reflects the Lockhart
Committee s recommendation 8.
Currently section 17 of the PHC Act provides that it is a
criminal offence, with a maximum penalty of 10 years imprisonment,
to:
- use precursor cells taken from a human embryo or a human fetus,
intending to create a human embryo, or
- develop, intentionally, such an embryo.
A precursor cell is defined as a cell that has
the potential to develop into a human egg or human sperm.
(176)
The Bill seeks to implement the Lockhart
Committee s recommendation 27.(177)
New paragraph 20(1)(d) of the RIHE Act provides
that a person may apply for a licence authorising:
- the creation of human embryos using precursor cells from a
human embryo or a human fetus, and
- use of such embryos.
The penalty regime devised by new
subsection 20(1A) and new section 10A of
the RIHE Act applies. For details see discussion
above.
It is a criminal offence, with a maximum penalty of 10 years
imprisonment, to intentionally engage in such creation or
development without a licence authorising the activity and the
person knows or is reckless as to the fact that they are not
authorised to engage in such activities (new section 23A of
the PHC Act).(178)
It will also be a criminal offence, with a maximum penalty of 15
years imprisonment, intentionally to:
- develop a human embryo outside the body of a woman for more
than 14 days (new section 14 of the PHC Act)
- place an embryo in a woman s body knowing that, or being
reckless as to whether, the embryo is a human embryo created using
precursor cells taken from a human embryo or a human fetus
(new subsection 20(3) and
new paragraph 20(4)(e) of the PHC Act)
- import an embryo into Australia knowing that, or being reckless
as to whether, the embryo is a human embryo that was so created
(new subsection 20(1) and
new paragraph 20(4)(e) of the PHC Act), or
- export an embryo from Australia knowing that, or being reckless
as to whether, the embryo is a human embryo that was so created
(new subsection 20(2) and
new paragraph 20(4)(e) of the PHC Act).
At present, the activities outlined in these four bullet points
are criminal offences in the PHC Act (current section 16;
subsection 22(3) and current paragraph 22(4)(e); subsection 22(1)
and paragraph 22(4)(e); subsection 22(2) and paragraph 22(4)(e)
respectively) but the maximum penalty is 10 years
imprisonment. This change in maximum penalty is the result of
amendments in the Senate on 7 November 2006.
The retention of the provision in the second bullet point
(disregarding the change in maximum penalty) reflects the Lockhart
Committee s recommendation 9.
Currently, subsection 20(2) of the PHC Act stipulates that it is
a criminal offence, with a maximum penalty of 10 years
imprisonment, intentionally to create a hybrid
embryo.(179) There is no specific prohibition on the
development of such an embryo.
The Bill seeks to implement the Lockhart Committee s
recommendation 17.(180)
Originally the Bill also sought to implement
recommendation 24.(181) This
recommendation is as follows.
In order to reduce the need for human oocytes,
transfer of human somatic cell nuclei into animal oocytes should be
allowed, under licence, for the creation and use of human embryo
clones for research, training and clinical application, including
the production of human embryonic stem cells, as long as the
activity satisfies all the criteria outlined in the amended Act and
these embryos are not implanted into the body of a woman or allowed
to develop for more than 14 days.(182)
However, the relevant provisions which would have implemented
this recommendation were removed from the Bill in the Senate.
Accordingly, now recommendation 24 is not
accepted.(183) This change is explained further
below.
New paragraph 20(1)(f) of the RIHE Act provides
that a person may apply for a licence authorising:
- the creation of hybrid embryos by the fertilisation of an
animal egg by a human sperm, and
- use of such embryos up to, but not including, the first mitotic
division
provided the creation or use is for the purposes of testing
sperm quality, and the creation or use will occur in an accredited
ART centre.(184)
On 7 November 2006 the Senate passed an amendment moved by
Senator Bartlett to delete new paragraph 20(1)(g) of the
RIHE Act. That paragraph would have provided that a person
may apply for a licence authorising:
- the creation of hybrid embryos by introducing the nucleus of a
human cell into an animal egg, and
- use of such embryos.
New subsection 20(1A) of the RIHE
Act would have confirmed that in this latter mentioned
case the NHMRC Licensing Committee was not permitted to authorise
any use of the embryo that would result in development for longer
than 14 days (excluding any period when development is suspended).
However, as the Senate passed an amendment removing new paragraph
20(1)(g) of the RIHE Act, it also passed an amendment removing the
reference to new paragraph 20(1)(g) in new subsection 20(1A).
It will be a criminal offence, with a maximum penalty of:
- 5 years imprisonment, intentionally to use a hybrid embryo
without a licence authorising the use by that person (new
section 10A of the RIHE Act)
- 10 years imprisonment, intentionally to create or develop a
hybrid embryo without a licence authorising the creation or
development by that person (new section 23B of the PHC
Act), and
- 15(185) years imprisonment, intentionally to develop
a hybrid embryo for a period of more than 14 days, excluding any
period when development is suspended(186) (new
section 18 of the PHC Act).
It will be a criminal offence, with a maximum penalty of 15
years imprisonment, intentionally to:
- place an embryo in the body of a woman knowing that, or being
reckless as to whether, the embryo is a hybrid embryo
(new subsection 20(3) and
new paragraph 20(4)(h) of the PHC Act)
- import an embryo into Australia knowing that, or being reckless
as to whether, the embryo is a hybrid embryo (new
subsection 20(1) of the PHC Act), or
- export an embryo from Australia knowing that, or being reckless
as to whether, the embryo is a hybrid embryo (new
subsection 20(2) and new paragraph
20(4)(h) of the PHC Act).
At present the activities outlined in
these three bullet points are criminal offences in the PHC Act
(current subsection 22(3) and paragraph 22(4)(h); subsection 22(1);
subsection 22(2) and paragraph 22(4)(h) respectively) but the
maximum penalty is 10 years imprisonment. This change in
maximum penalty to 15 years is the result of amendments in the
Senate on 7 November 2006.
The retention of the provision in the first of the above three
bullet points (disregarding the change in maximum penalty) reflects
the Lockhart Committee s recommendation 5.
Subsection 8(1) of the PHC Act states that a chimeric embryo is
a:
- human embryo into which a cell, or any component part of a
cell, of an animal has been introduced, or
- thing declared by the Regulations to be a chimeric embryo.
It will be a criminal offence, with a maximum penalty of 15
years imprisonment, intentionally to:
- create a chimeric embryo (new section
17 of the PHC Act)
- place an embryo in the body of a woman knowing that, or being
reckless as to whether, the embryo is a chimeric embryo
(new subsection 20(3) and
new paragraph 20(4)(h) of the PHC Act)
- import an embryo into Australia knowing that, or being reckless
as to whether, the embryo is a chimeric embryo
(new subsection 20(1) of the PHC
Act), or
- export an embryo from Australia knowing that, or being reckless
as to whether, the embryo is a chimeric embryo
(new subsection 20(2) and
new paragraph 20(4)(h) of the PHC Act).
At present, these activities are criminal offences in the PHC
Act (current subsection 20(1); subsection 22(3) and paragraph
22(4)(h); subsection 22(1); subsection 22(2) and paragraph 22(4)(h)
respectively) but the maximum penalty is 10 years
imprisonment. This change in maximum penalty to 15 years is the
result of amendments in the Senate on 7 November 2006.
The retention of the first provision (disregarding the change in
maximum penalty) reflects the Lockhart Committee s
recommendation 6,(187) and retention of
the second provision (disregarding the change in maximum penalty)
reflects recommendation 5.
It will be a criminal offence, with a maximum penalty of 15
years imprisonment, intentionally to create a human
embryo by a process of the fertilisation of a human egg by
a human sperm outside a woman s body unless the person s
intention in creating the embryo is to attempt to achieve pregnancy
in a particular woman (new subsection 12(1) of the PHC
Act).
At present, this activity is a criminal offence in the PHC Act
(current subsection 14(1)) but the maximum penalty is 10
years imprisonment. This change in maximum penalty to 15 years is
the result of amendments in the Senate on 7 November 2006.
The defendant does not bear the evidential burden (current
subsection 14(2); new subsection 12(2) of the PHC
Act) in relation to the above mentioned offence.
The Explanatory Memorandum states that new
section 12 of the PHC Act reflects the Lockhart
Committee s recommendations 12 and
13.(188)
It is, and will remain, a criminal offence, with a maximum
penalty of 5 years imprisonment, intentionally to use
outside a woman s body a human embryo that was created by a
process of the fertilisation of a human egg by a human sperm
and that is not an excess ART embryo and the use is not for a
purpose relating to the assisted reproductive technology treatment
of a woman carried out by an accredited ART centre and the person
knows or is reckless as to that fact (current section
11;(189) new section 11 of the RIHE
Act).
It will be a criminal offence, with a maximum penalty of 15
years imprisonment, to:
- remove a human embryo from a woman s body with the intention to
collect a viable human embryo (new section 16 of the PHC
Act)
- intentionally place such a removed embryo into a woman s body
knowing that, or being reckless as to whether, the human embryo was
so removed (new subsection 20(3)
and new paragraph 20(4)(g) of the PHC
Act)
- import, intentionally, such a removed embryo into Australia
knowing that, or being reckless as to whether, the human embryo was
so removed (new subsection 20(1)
and new paragraph 20(4)(g) of the PHC Act),
or
- export, intentionally, such a removed embryo from Australia
knowing that, or being reckless as to whether, the human embryo was
so removed (new subsection 20(2)
and new paragraph 20(4)(g) of the PHC Act).
At present, these activities are criminal offences in the PHC
Act (current section 19; subsection 22(3) and paragraph 22(4)(g);
subsection 22(1) and paragraph 22(4)(g); subsection 22(2) and
paragraph 22(4)(g) respectively) but the maximum penalty is
10 years imprisonment. This change in maximum penalty to
15 years is the result of amendments in the Senate on 7 November
2006.
The retention of the first provision (disregarding the change in
maximum penalty) reflects the Lockhart Committee s
recommendation 11.(190)
It will be a criminal offence, with a maximum penalty of 15
years imprisonment, to:
- alter the genome of a human cell (that is, a human embryonal
cell, a human fetal cell, human sperm or a human
egg)(191) in such a way that the alteration is heritable
by descendants of the human whose cell was altered, intending the
alteration to be so heritable (new
subsection 15(1) of the PHC Act)
- place an embryo in a woman s body knowing that, or being
reckless as to whether, the embryo is a human embryo that contains
a human cell with such an altered genome (new subsection
20(3) and new paragraph 20(4)(f) of the PHC
Act)
- import an embryo into Australia knowing that, or being reckless
as to whether, the embryo is a human embryo that contains a human
cell with such an altered genome (new subsection
20(1) and new paragraph 20(4)(f) of the PHC
Act), or
- export an embryo from Australia knowing that, or being reckless
as to whether, the embryo is a human embryo that contains a human
cell with such an altered genome (new subsection
20(2) and new paragraph 20(4)(f) of the
PHC Act).
At present, these activities are criminal offences in the PHC
Act (current subsection 18(1); subsection 22(3) and paragraph
22(4)(f); subsection 22(1) and paragraph 22(4)(f); subsection 22(2)
and paragraph 22(4)(f) respectively) but the maximum penalty is
10 years imprisonment.
The Explanatory Memorandum explains that the provision in the
first bullet point above:
bans what is commonly referred to as germ line
gene therapy. In germ line gene therapy, changes would be made to
the genome of egg or sperm cells, or even to the cells of the early
embryo. The genetic modification would then be passed on to any
offspring born to the person whose cell was genetically modified
and also to subsequent generations.(192)
The retention of the provision in the second bullet point
(disregarding the change in maximum penalty) reflects the Lockhart
Committee s recommendation 10.
The Bill retains the current definition of prohibited embryo
(current subsection 22(4); new subsection 20(4) of the PHC
Act).(193) The provisions concerning some
prohibited embryos have already been addressed.(194)
Other human embryos which come within the definition of a
prohibited embryo include a human embryo:
- created by a process other than the fertilisation of a human
egg by a human sperm (current paragraph 22(4)(a); new
paragraph 20(4)(a) of the PHC Act)
- created outside the body of a woman, unless the intention of
the person who created the embryo was to attempt to achieve
pregnancy in a particular woman (current paragraph 22(4)(b);
new paragraph 20(4)(b) of the PHC Act), and
- that has been developing outside the body of a woman for a
period of more than 14 days, excluding any period when development
is suspended (current paragraph 22(4)(d); new paragraph
20(4)(d) of the PHC Act).
It will be a criminal offence, with a maximum penalty of 15
years imprisonment, intentionally to:
- place an embryo in a woman s body knowing that, or being
reckless as to whether, the embryo is a prohibited embryo
(new subsection 20(3) of the PHC Act)
- import an embryo into Australia knowing that, or being reckless
as to whether, the embryo is a prohibited embryo (new
subsection 20(1) of the PHC Act), or
- export an embryo from Australia knowing that, or being reckless
as to whether, the embryo is a prohibited embryo (new
subsection 20(2) of the PHC Act).
At present, these activities are criminal
offences in the PHC Act (current subsections 22(3), (1) and (2)
respectively) but the maximum penalty is 10 years
imprisonment. This change in maximum penalty to 15 years is the
result of amendments in the Senate on 7 November 2006.
The relevant Lockhart Committee recommendation,
in relation to the first provision, is recommendation
3 which provides that [i]mplantation into the reproductive
tract of a woman of a human embryo created by any means other than
fertilisation of an egg by a sperm should continue to be
prohibited. (195)
It will be a criminal offence, with a maximum penalty of 15
years imprisonment, intentionally to place a human embryo in:
- an animal (new subsection 19(1) of the PHC
Act), or
- the body of a human, other than in a woman s reproductive tract
(new subsection 19(2) of the PHC Act).
At present, these activities are criminal
offences in the PHC Act (current subsections 21(1) and (2)
respectively) but the maximum penalty is 10 years
imprisonment. This change in maximum penalty to 15 years is the
result of amendments in the Senate on 7 November 2006.
The Explanatory Memorandum states that the
retention of these provisions (disregarding the change in maximum
penalties) reflects the Lockhart Committee s recommendation
7.(196)
It will be a criminal offence, with a maximum of 15 years
imprisonment, intentionally to place an animal embryo in a human s
body for any period of gestation (new subsection 19(3) of
the PHC Act).
At present, this activity is a criminal offence in the PHC Act
(current subsection 21(3)) but the maximum penalty is 10
years imprisonment. This change in maximum penalty to 15 years is
the result of amendment in the Senate on 7 November 2006.
The Explanatory Memorandum states that the
retention of this provision (disregarding the change in maximum
penalty) reflects the Lockhart Committee s recommendation
7.(197)
It will be a criminal offence, with a maximum penalty of 15
years imprisonment, intentionally to:
- give or offer valuable consideration to another person for the
supply of a human embryo (new subsection 21(1) of the PHC
Act), or
- receive or offer to receive valuable consideration from another
person for the supply of a human embryo (new subsection
21(2) of the PHC Act).
At present, these activities are criminal offences in the PHC
Act (current subsections 23(1) and (2) respectively) but the
maximum penalty is 10 years imprisonment. This change in
maximum penalty to 15 years is the result of amendment in the
Senate on 7 November 2006.
The Explanatory Memorandum states that the retention of these
provisions (disregarding the change in maximum penalty) reflects
the Lockhart Committee s recommendation
33.(198)
The reimbursement of reasonable expenses will continue to be
permitted (current subsection 23(3); new subsection 21(3)
of the PHC Act). Again this reflects the Lockhart
Committee s recommendation 33.
It will be a criminal offence, with a maximum penalty of 15
years imprisonment, intentionally to:
- give or offer valuable consideration to another person for the
supply of a human egg or human sperm (new subsection 21(1)
of the PHC Act), or
- receive or offer to receive valuable consideration from another
person for the supply of a human egg or human sperm (new
subsection 21(2) of the PHC Act).
At present these activities are criminal offences in the PHC Act
(current subsections 23(1) and (2) respectively) but the maximum
penalty is 10 years imprisonment. This change in maximum
penalty to 15 years is the result of amendments in the Senate on 7
November 2006.
The Explanatory Memorandum states that the retention of these
provisions (disregarding the change in maximum penalty) reflects
the Lockhart Committee s recommendation
33.(199)
The reimbursement of reasonable expenses will continue to be
permitted (current subsection 23(3); new subsection 21(3)
of the PHC Act). Again this reflects the Lockhart
Committee s recommendation 33.
New paragraph 20(1)(e) of the RIHE Act provides
that a person may apply for a licence authorising research and
training involving the fertilisation of a human egg by a human
sperm up to, but not including, the first mitotic division, outside
the body of a woman for the purposes of research or training in
ART. This reflects the Lockhart Committee s recommendation
15.
New section 10B of the RIHE Act stipulates that
it is a criminal offence, with a maximum penalty of 5 years
imprisonment, to engage in such an activity without a licence
authorising the research or training by that person.
As noted above, the Revised Explanatory Memorandum states that
there were possible constitutional problems with implementing the
Lockhart Committee s recommendations 50
52.(200) Instead, new section 12A of
the RIHE Act is proposed in order to avoid the
constitutional issues and address the basic concern of the Lockhart
Committee.(201)
New section 12A of the RIHE Act provides that a
person will not be criminally responsible for an offence against
the RIHE Act in respect of particular conduct if:
- their conduct is purportedly authorised by a provision of a
licence
- the licence or the provision is invalid, and
- the person did not know, and could not reasonably be expected
to have known, of the invalidity of the licence or the
provision.
The Explanatory Memorandum states that this clause is intended
to address the underlying policy objective of the Lockhart
Committee s recommendations 50
52.(202)
Subsection 35(1) of the RIHE Act provides that in order for an
inspector(203) to find out whether there has been
compliance with the RIHE Act or the Regulations,(204) an
inspector may:
- enter any premises, and
- exercise certain monitoring powers set out in section 36.
Subsection 35(2) outlines the grounds upon which an inspector is
authorised to enter premises.
New paragraph 35(2)(c) provides a new ground,
namely pursuant to a warrant made under new section 37A of
the RIHE Act.(205)
The warrant must specify the day on which it ceases to have
effect (new paragraph 37A(4)(c) of the RIHE Act).
The Bill originally provided that this date not be more than
one month after the issue of the warrant. On 7 November
2006 the Senate passed an amendment moved by Senator Stott Despoja,
also on behalf of Senator Webber, to change this to not more than
15 days after the issue of the warrant.
Before entering premises pursuant to a warrant an inspector must
announce that they are authorised to enter (new section 37C
of the RIHE Act). During the execution of a warrant if the
occupier or other representative is present then the inspector
must:
- make a copy of the warrant available to them (new
section 37B of the RIHE Act), and
- permit them observe the conduct of the search (but not if they
impede the search) (new section
37D of the RIHE Act).
Additional powers are exercisable by the inspector in the case
of entry pursuant to a warrant, namely the inspector may require
any person in or on the premises to:
- answer any of the inspector s questions (new
subparagraph 36(1)(g)(i)), and
- produce any book, record or document requested (new
subparagraph 36(1)(g)(ii)).
These changes appear to respond to the LRC s
recommendation 39.
New subsections 16(7) and (8) of the RIHE Act
provide, respectively, that it is Parliament s intention that any
vacancy on the NHMRC Licensing Committee be filled as soon as
possible and if there is a vacancy for three months then the
Minister must table written reasons for the failure to fill the
vacancy.
The Explanatory Memorandum states that this clause is intended
to address the Lockhart Committee s recommendation
36.(206)
Schedule 4 amends the Customs (Prohibited
Exports) Regulations 1958 by repealing regulation 7 which
prohibits the export of human embryos except in certain
limited circumstances, namely where there is the requisite
Ministerial permission. The regulation was to cease to have effect
at the end of 31 July 2007 (current subregulation 7(16)) but
Schedule 4 repeals the entire regulation.
The Explanatory Memorandum states:
This is consistent with Recommendation
41 of the Lockhart Review that states that the import or
export of a patient s reproductive material, including ART embryos,
for the purpose of that person s ongoing ART treatment should not
require any regulation other than that required under existing
quarantine regulation.(207)
New section 47B of the RIHE Act stipulates that
the Minister administering the Act must table a written report in
Parliament about the establishment of a National Stem Cell Centre
and a national register of donated excess ART embryos and, if
applicable, the making of guidelines. This report is to be
completed no later than six months after the commencement of the
amending Act (that is, the Bill) and tabled in each House within 15
sitting days of that House after the day on which the report was
completed. The Lockhart Committee had recommended that a national
stem cell bank be established (recommendation 47)
and that a national register of donated excess ART embryos be
established (recommendation 49).
On 7 November 2006, the Senate passed an amendment moved by
Senator Colbeck to introduce new section
47C of the RIHE Act. This new section stipulates that the
Minister must cause a report to be prepared concerning the
feasibility of establishing a national legislative or regulatory
approach for effective governance of non-blood human tissue based
therapies including stem cell therapies. This report is to be
completed no later than 18 months after the day on which the
amending Act (that is, the Bill) receives Royal Assent, with copies
to be provided to both Houses of Parliament and the Council of
Australian Governments. The report must be tabled in each House
within 15 sitting days of that House after the day on which the
report was completed.
New section 25A of the PHC Act and
new section 47A of the RIHE
Act are in essentially the same terms and provide
for the further independent review of the operation of each Act.
The review will also consider the clinical application of stem cell
therapies. This review is to be commenced within three years from
the date of Royal Assent of the Bill. This reflects the Lockhart
Committee s recommendation 53. The review of each
Act is to be undertaken concurrently and by the same people
(new subsection 47A(2) of the RIHE Act). A number
of considerations are to be taken into account in the review
(new subsection 25A(4) of the PHC Act and
new subsection 47A(4) of the RIHE Act). The
written report must be provided to both Houses of Parliament and
the Council of Australian Governments before the fourth anniversary
of the day on which the amending Act received Royal Assent
(new subsection 25A(3) of the PHC Act; new
subsection 47A(3) of the RHIE Act).
Arguably
this Bill raises more ethical and moral, than legal or
scientific issues.(209)
To address some of the ethical concerns raised in relation to
the proposed changes, Parliament may want to consider whether to
include in the Bill legal measures based on the principles of
subsidiarity and precaution.(210)
These principles include:
- principle of subsidiarity the principle encompasses
the idea that where there is a choice between two things which
serve the same objective, one should choose the subordinate or
lesser of two evils . According to this view, embryos should only
be used if there is no suitable alternative that would serve the
same research goals.(211) In other words, [t]herapeutic
cloning can only be morally acceptable if there are no good
alternatives. (212)
- precautionary principle the principle encompasses the
idea that precaution is relevant where there is scientific
uncertainty.(213) As one academic has noted:
At its heart, precaution is a reminder of the
limitations of scientific knowledge as a guide to decision-making,
and a warning to heed the lessons of the past to prevent the
occurrence of environmental damage in the future. But how this
simple message is interpreted depends on the risk attitude of the
interpreter.(214)
However, it must be acknowledged that both principles may have
their own disadvantages, including that excessive precaution
potentially could prevent important and beneficial future
developments or that it could be difficult to ascertain whether
there is a suitable alternative which achieves the same research
results.
Further, it is important to remember that the resolution of the
debate will not bring the matter to a close. Issues which will
continue to draw attention to any new legislative regime will
include:
- intellectual property it is questionable
whether stem cell research can be patented.(215)
Academic Matthew Rimmer has argued that the Federal Government will
need to reform patent law if it intends to foster the
commercialisation of stem cell research. (216) In sum,
this is because subsection 18(2) of the Patents Act 1990
stipulates that Human beings, and the biological processes for
their generation, are not patentable inventions. Rimmer concludes
that this section is fundamentally ambiguous .(217) In
2004, the Australian Law Reform Commission (ALRC) released its
report on Genes and Ingenuity: Gene Patenting and Human
Health. Part of the report addressed the issue of stem cell
technologies. The ALRC reported that it:
does not favour amendments to the Patents
Act that would expressly address the patentability of
inventions involving stem cell technologies. [This is because] the
requirements for patentability in the Patents Act are
nearly all technology-neutral and are therefore capable of adapting
to new technologies as they arise.(218)
Rather, the ALRC recommended that IP Australia develop
examination guidelines (consistent with existing law) to explain
how the criteria for patentability applies to inventions involving
stem cells and related technologies.(219) The ALRC also
recommended that the issue of the exploitation of intellectual
property rights over stem cells should be considered when the issue
of the establishment of a National Stem Cell Bank is considered as
part of the independent reviews of the PHC Act and the RIHE
Act.(220) As at the date of publication of this Digest
the Government has not released its response to the ALRC s
report.
- regulation/administration of clinical
therapies the regulation/administration of clinical
therapies arising from such research and involving novel human
products will need to be addressed
- review of the legislation the review clause
will ensure that the issue comes before the Parliament in a few
years time. Given the rapid rate of change in the field, it is
fundamental that the law keep abreast with, and respond to, such
change and thereby provide certainty for those working in it no
matter what the actual ethical response is to those advances in
science and technology.
Finally, the legislative measures implemented at Federal level
will have to be reflected in the legislation of the States and
Territories.
|
Excess
ART embryos
|
those human embryos that
were created for assisted reproductive treatments but are no longer
required for that purpose.(221)
|
|
Oocyte
|
An egg cell.
|
|
Primitive
Streak
|
Thickening in the surface
of an embryo that occurs at the gastrulation stage and is the first
clearly recognisable sign of the developing organism itself. It is
formed at about 14 days. It is the primitive streak , from which
the central nervous system develops.
|
|
Reproductive cloning
|
Using
cloning technology (usually somatic cell nuclear transfer) to
create an embryo that is implanted into a woman for gestation and
birth.
|
|
Therapeutic
cloning
|
Term previously used to
describe cloning to generate embryonic stem cells.
|
|
Somatic
cell
|
Any cell from an animal at
any stage of development except for gametes (egg or sperm) or their
precursors.
|
|
Zygote
|
The product of fusion
between oocyte and sperm cell.
|
- The authors are indebted to the following people, without whom
the completion of this Digest would not have been possible:
Professor Loane Skene, University of Melbourne, Professor Peter
Schofield, University of New South Wales; and the following
Parliamentary Library staff members: Dr Jane Romeyn, Jane Grace,
Effi Tomaras and Rosemary Polya.
- The Explanatory Memorandum notes that the Bill amends the Acts
and the Regulations consistent with the recommendations.
Explanatory Memorandum, pp. 1, 29. Revised Explanatory Memorandum,
pp. 1, 28.
The Bill only seeks to implement some of the Lockhart
Review s recommendations. This is illustrated by review of Appendix
1 of the Explanatory Memorandum and Revised Explanatory Memorandum
which summarises the Lockhart Review s recommendations and how they
are addressed in the Bill.
For example, the entries related to recommendations 18,
29, 30 and 32 state that no legislative change is
required, in some instances because the relevant recommendation is
for the National Health and Medical Research Council to
consider.
The entry in relation to recommendation 24 in
the Revised Explanartory Memorandum notes that the recommendation
is not accepted. Originally, the Bill sought to implement this
recommendation (see Explanatory Memorandum, p. 30), but on 7
November 2006, the Senate, upon the movement by Senator Bartlett,
passed amendments deleting provisions that would have permitted the
creation and use of certain hybrid embryos. Explanatory Memorandum,
p. 30. No equivalent in the Revised Explanatory Memorandum.
- Legislation Review Committee, Issues Paper: Outline of
existing legislation and issues for public consultation,
August 2005, p. 1.
- Infertility Treatment Act 1995
(Vic), Reproductive Technology (Code of Ethical Research Practice)
Regulation 1995 made under the Reproductive Technology Act
1988 (SA), and the Human Reproductive Technology Act
1991 (WA). Also refer to J. Norberry, Research Involving
Embryos and Prohibition of Human Cloning Bill 2002 , Bills
Digest, No. 17, Parliamentary Library, Canberra, 2002 03, p.
10.
- House of Representatives Standing Committee on Legal and
Constitutional Affairs, Human cloning: scientific, ethical and
regulatory aspects of human cloning and stem cell research,
August 2001 (The Andrews Report), p. 128.
- D. Cooper, The Lockhart Review: Where now for Australia? ,
Journal of Law and Medicine, Vol. 14, 2006, p. 31.
- The Andrews Report, p. 129.
- The Andrews Report, p. 130.
- Cooper, loc. cit.
- Norberry, loc. cit.
- LRC Issues Paper, p. 1.
- The terms of reference directed the Committee to review the
report of the Australian Health Ethics Committee of the National
Health and Medical Research Council, Scientific, Ethical and
Regulatory Considerations relevant to Cloning of Human Beings
(16 December 1998). The Andrews Report, p. xviii.
- Section 192B of the Gene Technology Act
2000.
- The Andrews Report, p. 133-134.
- ibid.
- ibid., p. xix.
- Cooper, op. cit., p. 30.
- LRC Issues Paper, loc. cit.
- ibid., p. 13. These practices are also discussed in the Main
Provisions section of this Bills Digest.
- ibid., p. 1.
- Cooper, loc. cit.. Footnote 29 of this article details the
various Acts passed by the States and Territories.
- Section 25 of the Prohibition of Human Cloning Act
2002 and section 47 of the Research Involving Human
Embryos Act 2002.
- Section 25 of the Prohibition of Human Cloning Act
2003.
- Legislation Review Committee, Legislation Review: Prohibition
of Human Cloning Act 2002 and Research Involving Human Embryos Act
2002, Reports, Canberra, December 2005.
- The Hon Julie Bishop MP, then Minister for Ageing, Lockhart
review delivered to government , Media Release, 19
December 2005
http://www.health.gov.au/internet/ministers/publishing.nsf/Content/5019A437D5388015CA2570DC0018200A/$File/bis201.pdf.
- The Hon John Howard MP, Prime Minister of Australia Lockhart
Review , Media release, 23 June 2006. See: http://www.pm.gov.au/news/media_releases/media_Release1989.html.
- Council of Australian Governments, Communiqu , July 14 2006.
See: http://www.coag.gov.au/meetings/140706/index.htm#Lockhart.
- The Hon John Howard MP, Prime Minister of Australia Embryonic
Stem Cell Research , Media release, 31 August 2006.
http://www.pm.gov.au/news/media_releases/media_Release2110.html.
- Beazley backs cloning, Daily Telegraph, Thursday 17
August, p. 13. See:
http://parlinfoweb.parl.net/parlinfo/Repository1/Media/npaper_5/ZYKK60.pdf.
- Senate. Community Affairs Committee. Inquiry into the
Legislative responses to Recommendations of the Lockhart Review.
Legislation and documentation relating to the Inquiry. See:
http://www.aph.gov.au/Senate/committee/clac_ctte/leg_response_lockhart_review/legis_doc/leg_doc.htm.
- Legislation Review Committee, Reports, p. 93.
- H. Mertes, G. Pennings, and A. Van Steirteghem, An ethical
analysis of alternative methods to obtain pluripotent stem cells
without destroying embryos Human Reproduction, Vol. 21,
No. 11, 2006, pp. 2749-55. N. Strelchenko et al Morula-derived
Human Embryonic Stem Cells , Reproductive BioMedicine
Online, Vol. 9, No. 6, pp. 623 629.
- R. Beran, The great divide: therapeutic cloning ,
Australian Life Scientist, November/December 2005, p.
31.
- J. A. Thomson et al, Embryonic stem cells derived from human
blastocysts , Science, Vol. 282, 1998, pp. 1145-7.
- This paragraph has been amended to remove ambiguity relating to
pluripotent cells.
- This paragraph has been amended to provide additional
information on the availability of stem cells in Australia.
- G. D. Fischbach and R. L. Fischbach, Stem cells: science,
policy and ethics, The Journal of clinical investigation,
Vol. 114, No. 10, November 2004, p. 1364.
- LRC Issues Paper, op. cit., p. 11.
- Legislation Review Committee, Reports, p. 61.
- ibid., p. 62.
- ibid., p. 62.
- ibid., p. 169.
- ibid., p. 62.
- ibid.
- ibid.
- LRC Issues Paper, op. cit., p. 40.
- ibid., p. 47-52.
- ibid., p. 170.
- Mpconsulting, Analysis of advice on developments in assisted
reproductive technology and related medical and scientific
research, Canberra, June 2006.
- N. Gough,
Key recent advances in human embryonic stem cell research.
A review of scientific literature commissioned by the Department of
Innovation, Industry and Regional Development, Government of
Victoria, Australia. 2006.
- ibid., p. 53.
- ibid., p. 67.
- Mpconsulting, op cit., p. iii.
- ibid.
- ibid.
- ibid., p. 21.
- Gough, loc cit.
- Legislation Review Committee, Reports, p. 61.
- ibid.
- ibid., p. 47.
- This part of the Digest has been revised to clarify the views
of the NHMRC in relation to the definition of human embryo.
- ibid., p. 21.
- National Health and Medical Research Council, Human Embryo
A Biological Definition: Discussion Paper, December 2005, p.
1.
- Legislation Review Committee, Reports, op. cit., p.
21.
- ibid., p. 93.
- ibid., p. 30.
- ibid., p. 31.
- ibid., p. 93.
- ibid.
- ibid., p. xxiv.
- Explanatory Memorandum, p. 5. Revised Explanatory Memorandum,
p. 5.
- Explanatory Memorandum, p. 5. Revised Explanatory Memorandum,
p. 5.
- NHMRC, Discussion Paper, loc. cit.
- NHMRC, Submission to Senate Community Affairs
Committee, Attachment 1, p. 5.
- Legislation Review Committee, Reports, op. cit., p.
29.
- ibid., p. 30.
- ibid., p. 32-33.
- ibid.
- ibid., p. 33.
- ibid., p. 30.
- ibid.
- ibid., p. 33.
- ibid., p. 34.
- ibid., p. 30.
- ibid.
- ibid., p. 168.
- ibid., p. 153.
- ibid., p. 153.
- ibid., p. 154.
- ibid., p. 153.
- Explanatory Memorandum, p. 21. Revised Explanatory Memorandum,
p. 21.
- Explanatory Memorandum, p. 22. Revised Explanatory Memorandum,
p. 21.
- Legislation Review Committee, Reports, op. cit., p.
113.
- ibid., p. 178.
- ibid.
- ibid.
- ibid., p. xxv.
- ibid., p. 176.
- ibid., p. 177.
- Paragraph 7(4)(a) of the Customs (Prohibited Exports)
Regulations 1958.
- Legislation Review Committee, Reports, op. cit., p.
12.
- ibid., p. 12.
- ibid., p. 179.
- The Lockhart Committee reported that human embryos can
be imported for human therapeutic use (including implantation),
artificial insemination or in vitro fertilisation (IVF). It would
appear that there is no current prohibition on the
importation of a human embryo unless it is a type not
permitted to be created in Australia (a so-called prohibited embryo
in the PHC Act). ibid., p. 12.
- ibid., p. xxv.
- ibid., p. 143.
- ibid., p. 181.
- ibid., p. xxvi.
- ibid., p. 181.
- ibid., p. 182.
- ibid., p. 182.
- ibid., p. xxvi.
- R. M. Isasi and B. M. Knoppers, Beyond the Permissibility of
Embryonic and Stem Cell Research: Substantive Requirements and
Procedural Safeguards , Human Reproduction, Vol. 21, No.
10, 2005, pp. 2474 81.
- To a certain degree, these debates are comparable with those
concerning the topics euthanasia and abortion. However, see
comments below, p. 28.
- L. R. Kass, Life, Liberty and the Defence
of Dignity, The Challenge for Bioethics, Encounter Books, San
Francisco, 2002, p. 122.
- For convenience, the term embryo is used subsequently.
- For further examples, see D. W. Brock, Is a consensus possible
on stem cell research? Moral and political obstacles , Journal
of Medical Ethics, Vol.32, 2006, p. 37.
- This part of the Digest has been revised to better highlight
the existing differences between the US and German approach.
- See below, p. 29.
- It is acknowledged that recently media reported about American
scientists that have been able to remove one cell of an embryo at
the eight-cell stage. Claiming that this cell could be used to
derive stem cells, this technology has been hailed a breakthrough
because it would not require the destruction of the early embryo.
Due to the serious questions raised about the technology including
whether the separated cell is in itself an embryo which is
destroyed to harvest stem cells this technology is not further
considered in this context. See further: Mertes et al., loc. cit..
For a critical comment in relation to this research, see P. Singer,
A. Sagan, Choose Life, Bulletin with Newsweek, 5 September
2006, p. 36.
- It should be noted that the term life is not used in a strict
biological sense, but rather in the sense that something is alive
.
- From a biological point of view, there is a distinction between
living tissue, which is unable to support itself independently, and
an independently living organism. A zygote can be understood as a
form of life without being a human being yet.
- J. Habermas, The Future of Human Nature, Polity Press,
Cambridge, 2003, p. 32.
- Brock, op. cit., p. 38.
- E. Finkel, Stem Cells, Controversy at the Frontiers of
Science, ABC Books, Sydney, 2005, p. 33-4. She refers to
interviews conducted with Father Norman Ford, Director of the
Caroline Chisholm Centre for Health Ethics, Melbourne, and Father
Peter Carnley, former Archbishop of Perth and Primate of the
Anglican Church of Australia.
- ibid..
- ibid., pp. 34-6.
- G. R. Dunstan The moral status of the human embryo: a tradition
recalled , Journal of Medical Ethics, Vol. 1, 1988,
p.
- D. A. Jones, The human embryo in the Christian tradition: a
reconsideration, Journal of Medical Ethics, Volume 31, 2005, p.
711.
- ibid., pp. 712-3.
- Kass, op. cit., p. 86.
- R. Gill, Response to: The human embryo in the Christian
tradition, Journal of Medical Ethics, Vol. 31, 2005, p.
713-4.
- Instructive: C. Starck, Embryonic Stem Cell Research according
to German and European Law , German Law Journal, Vol. 7,
No. 7, 2005, p. 651-3.
- Habermas, op. cit., p. 31
- ibid., p. 32.
- The Canadian Victorian Fertility Centre reports that:
Recent reports have described pregnancies that have occurred from
embryos cryopreserved and stored for over ten years. The only
current limiting factor is for these older embryos is the quality
of the cryopreservation protocol in place at the time of storage.
Victorian Fertility Centre, Embryo Freezing and Thawing,
available at: http://www.victoriafertility.com/services/embryo-freezing.htm
(accessed: 26 November 2007).
- Some Australian States have legislation restricting the storage
of excess embryos beyond five years. The Age reported in 2005, that
Victorian IVF clinics destroyed 6642 excess embryos between 1998
and 2005. H. Nader, Legal limit destroys 6642 embryos , The
Age, 26 September 2005, p. 5.
- E. Parens, On the Ethics and Politics of Embryonic Stem Cell
Research , in S. Holland, K. Lebacqz, L. Zoloth (eds), The
Human Embryonic Stem Cell Debate Science, Ethics, and Public
Policy, Bradford Book, MIT Press, Cambridge, 2001, pp.
43-4.
- Habermas, op. cit., p. 30.
- G. de Wert and C. Mummery, Human embryonic stem cells: research
ethics and policies , Human Reproduction, Vol. 18, No. 4,
p. 675.
- K. Devolder, Creating and sacrificing embryos for stem cells ,
Journal of Medical Ethics, Vol. 31, 2005, p. 370.
- Member of the German Bundestag (Federal Parliament) M
B hmer, CDU, cited in G. Vogel, German Researchers get green light,
just , Science, Vol. 295, 8 February 2002, p. 943.
- Starck, op. cit., p. 641.
- Brock, op. cit., p. 36.
- J. A. Robertson, Human embryonic stem cell research: ethical
and legal issues , Nature, Vol. 2, January 2001, p.
76.
- ibid.
- It has been suggested that this argument has two facets,
including, first, the acceptance of the practice X will inevitably
lead to the acceptance of the undesirable practice Y, so that X
must be banned in order to prevent Y, and, second, the
justification of the practice X implies the acceptance of
undesirable practice. de Wert and Mummery, op. cit., p. 675.
- Kass, op. cit., pp. 123-4.
- Fischbach and Fischbach, op. cit, p. 1370.
- de Wert and Mummery, loc. cit..
- D. Elsner, Just another reproductive technology? The ethics of
human reproductive cloning as an experimental medical procedure ,
Journal of Medical Ethics, Vol. 32, No. 10, 2006, p.
596-7.
- Habermas, op. cit., p. 19.
- Fischbach and Fischbach, loc. cit..
- B. Steinbock, Cloning Human Beings: Sorting through Ethical
Issues, in B. MacKinnon (ed.) Human Cloning Science, Ethics,
and Public Policy, Urbana and
Chicago, University of Illinois Press, Chicago, 2000, p.
82.
- Fischbach and Fischbach, loc. cit..
- R. Dworkin, Sovereign Virtue: The Theory and Practice of
Equality, Harvard University Press, Cambridge, 2000, p.
440.
- For example: B. E. Rollin, Ethics and Species Integrity ,
The American Journal of Bioethics, Vol. 3, No. 3, 2003, p.
16, referring to the works of J. S. Roberts and F. Bayliss,
Crossing Species Boundaries , The American Journal of
Bioethics, Vol. 3, No. 3, 2003, pp. 1-13.
- Dworkin, op. cit., p. 444.
- Rollin, loc. cit.
- Habermas, op. cit., p. 29.
- Australian Broadcasting Corporation, Genetic Anger,
7:30 Report, 23 November 2006.
- Explanatory Memorandum, p. 1. Revised Explanatory Memorandum,
p. 1. See Appendix I of the Explanatory Memorandum and the Revised
Explanatory Memorandum for details about how the Bill addresses the
Lockhart Review recommendations.
- Legislation Review Committee, Reports, op. cit., p.
xxiv. This part of the Digest has been revised as the NHMRC s views
on the definition of human embryo are now discussed in an earlier
part of the Digest.
- Explanatory Memorandum, p. 5. Revised Explanatory Memorandum,
p. 5.
- Item 6 of Schedule 1 also inserts new
subsections 8(6) and (7) of the PHC Act which clarify,
respectively, that references in the PHC Act to an embryo mean a
living embryo and references to a human egg mean a human
oocyte.
- For example, when frozen.
- An excess ART embryo is defined in section 9 of the RIHE Act.
Essentially it refers to a human embryo that was created by
assisted reproductive technology ( ART ) for use in the ART
treatment of a woman and is in excess to the needs of that woman or
her (then) spouse. An ART embryo is deemed to be in excess of those
needs if each of those people has given the requisite written
authority or written determination.
- New section 8 of the RIHE Act defines proper
consent as the consent obtained in accordance with guidelines
issued by the CEO of the NHMRC under the National Health and
Medical Research Council Act 1992 and prescribed by the
Regulations. New subsection 24(8) of the
RIHE Act provides that where the excess ART embryos are
unsuitable for implantation (that is, diagnosed by pre-implantation
genetic diagnosis or determined by certain objective guidelines to
be unsuitable: new subsection 7(1) of the RIHE
Act) a licence may provide that those guidelines apply in
a modified form in relation to the use of such embryos. See the
Lockhart Review s recommendations 20 22 for
recommendations regarding use of such fresh ART embryos.
- New subsection 7(1) of the RIHE Act provides that
use includes develop, or development, as the case
requires. Emphasis added.
- Explanatory Memorandum, p. 7. Revised Explanatory Memorandum,
p. 7.
- The Note to new section 9 of the PHC Act
states The development of a human embryo (including a human
embryo clone) outside the body of a woman for more than 14
days is prohibited by section 14. Emphasis added.
- Explanatory Memorandum, p. 14. Revised Explanatory Memorandum,
p. 14.
- This part of the Digest has been revised as this sentence was
omitted earlier in error.
- This provision is narrower than current section 15 of the PHC
Act in order to accommodate the change effected by new
section 23 of the PHC Act.
- Note the offence in current section 15 of the PHC Act is
broader than new section 13 of the PHC Act as the
new offence is confined to the situation where there is
fertilisation of a human egg by a human sperm outside a woman s
body whereas the current offence is not so confined.
- Section 8 of the PHC Act. This part of the Digest has been
revised in order to draw attention to the definition used in the
PHC Act. This was thought advisable as the provisions of the Bill
relating to use of precursor cells were the subject of a proposed
amendment moved by Mr Michael Ferguson, MP, in the House of
Representatives on 6 December 2006. The House did not pass the
amendment.
- Explanatory Memorandum, p. 15. Revised Explanatory Memorandum,
p. 15.
- This part of the Digest has been revised as this sentence was
omitted earlier in error.
- A hybrid embryo is defined in current subsection 8(1) of the
PHC Act.
- Explanatory Memorandum, pp. 15, 30. Revised Explanatory
Memorandum, pp. 15, 30.
- Explanatory Memorandum, p. 11. There is no equivalent in the
Revised Explanatory Memorandum.
- Legislation Review Committee, Reports, op. cit., p.
xxiii.
- Explanatory Memorandum, p. 30. Revised Explanatory Memorandum,
p. 30.
- An accredited ART centre is defined in section 8 of the RIHE
Act.
- On 7 November 2006, the Senate passed an amendment moved by
Senator Stott Despoja, also on behalf of Senator Webber, to
increase the maximum penalty from 10 years imprisonment to 15 years
imprisonment.
- Note that because a hybrid embryo is excluded from the
definition of a human embryo, new section 14
of the PHC Act (offence of developing a human
embryo outside a woman s body for more than 14 days) is not
applicable.
- Explanatory Memorandum, p. 11. Revised Explanatory Memorandum,
p. 11.
- Explanatory Memorandum, p. 9. Revised Explanatory Memorandum,
p. 9.
- Note the current offence is broader than new section 11
of the RIHE Act as the new offence is confined to the
situation where there is fertilisation of a human egg by a human
sperm outside a woman s body whereas the current offence is not so
confined.
- Explanatory Memorandum, p. 10. Revised Explanatory Memorandum,
p. 10.
- Current subsection 18(2); new subsection 15(2) of the
PHC Act.
- Explanatory Memorandum, p. 10. Revised Explanatory Memorandum,
p. 10.
- Subject to the change of definition to human embryo .
- Namely the provisions concerning the following prohibited
embryos : a human embryo that contains genetic material provided by
more than 2 persons (new paragraph 20(4)(c) of the PHC
Act), a human embryo created using precursor cells taken
from a human embryo or a human fetus (new paragraph
20(4)(e) of the PHC Act), a human embryo that contains a
human cell (within the meaning of [new] section 15) whose genome
has been altered in such a way that the alteration is heritable by
human descendants of the human whose cell was altered (new
paragraph 20(4)(f) of the PHC Act), a human embryo that
was removed from the body of a woman by a person intending to
collect a viable human embryo (new paragraph 20(4)(g) of
the PHC Act), and a chimeric embryo or a hybrid embryo
(new paragraph 20(4)(h) of the PHC
Act).
- Legislation Review Committee, Reports, op. cit., p.
xxii.
- Explanatory Memorandum, p. 12. Revised Explanatory Memorandum,
p. 11.
- Explanatory Memorandum, p. 12. Revised Explanatory Memorandum,
p. 12.
- Explanatory Memorandum, p. 13. Revised Explanatory Memorandum,
p. 13.
- Explanatory Memorandum, p. 13. Revised Explanatory Memorandum,
p. 13.
- Explanatory Memorandum, p. 22. Revised Explanatory Memorandum,
p. 21.
- Explanatory Memorandum, p. 22. Revised Explanatory Memorandum,
p. 21.
- Explanatory Memorandum, p. 21. Revised Explanatory Memorandum,
p. 21.
- Subsection 7(1) defines an inspector as a person appointed as
an inspector under subsection 33(1) of the RIHE Act. That is, a
person employed, or appointed, by the Commonwealth or a State who
has been appointed as an inspector by the Chairperson of the NHMRC
Licensing Committee.
- As well as presumably the PHC Act. Section 41 of the RIHE Act
provides that a reference in this Part on Monitoring Powers to this
Act includes a reference to the PHC Act.
- Again, it would appear that this new provision will also apply
in relation to investigating whether the two Acts or the
Regulations have been complied with. See Explanatory Memorandum, p.
27. Revised Explanatory Memorandum, p. 26.
- Explanatory Memorandum, p. 22. Revised Explanatory Memorandum,
p. 22.
- Explanatory Memorandum, p. 28. Revised Explanatory Memorandum,
p. 28. Emphasis added.
- Note that it is beyond the scope of this digest to explore in
detail further issues that therapeutic cloning raises including
issues regarding egg donation and the effective administration of
clinical therapies.
- For example the Hon. Tony Abbott MP has been quoted as saying
the debate will ultimately turn on ethical considerations, not
scientific considerations . J. Bunce, Stem cell report not
commissioned to influence debate , PM, AAP, 1 September 2006, Story
No. 1034.
- de Wert and C. Mummery, op. cit., p. 674.
- ibid., p.675.
- ibid., p.678.
- It has been noted that this principle has its genesis in German
environmental policy. J. Peel, Precaution A Matter of Principle,
Approach or Process? , in Melbourne Journal of
International Law, Vol. 5, No. 2, 2004, pp. 483-5.
- ibid., pp. 484 5.
- Australian Law Reform Commission, Report 99, Genes and
Ingenuity: Gene Patenting and Human Health, 2004, paragraph
15.61. See also M. Rimmer, The Attack of the Clones: Patent Law and
Stem Cell Research , in Journal of Law and Medicine, Vol.
10, May 2003, pp. 488 505.
- Rimmer, ibid., p. 489.
- ibid., p. 504.
- ALRC Report 99, op. cit., paragraph 15.65.
- ALRC Report 99, op. cit., recommendation 15 1.
- ALRC Report 99, op. cit., recommendation 15 2.
- LRC Issues Paper, p. 1.
Susan Dudley, Thomas John and Justine Clarke
6 December 2006
Bills Digest Service
Parliamentary Library
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