Supplementary comments
Senator Brian Harradine
Research Involving Human
Embryos and Prohibition of Human Cloning Bill 2002: Entrenching the
Commercialisation and Commodification of Human Life
This legislation will set the unheard-of
precedent for the statutory creation of a
biological underclass-namely, those unworthy of lifebut worthy of sacrifice on the
commercial slab of experimentation.[624]
Introduction
1.1
The Research Involving Human Embryos and Prohibition of Human Cloning Bill
2002 (the Bill) would, for the first time, permit destructive experiments
on human embryos. The Bill would set a precedent for vivisection of living
human beings at the earliest stage of their development. Should the legislation
pass, the embryonic human being will have been reduced to the status of a
laboratory rat. As a matter of principle, if enacted, the precedent will have
been set by which a certain class of human life is held, according to
Commonwealth legislation, to be expendable for profit. Other classes of human
life could then be added to this list of endangered life.
1.2
Despite the demonstrable
humanity of the embryo and the raft of international treaties and declarations
which prohibit destructive non-therapeutic research on human subjects, the Bill
would open the door to a wide range of destructive and other research on human
embryos and stem cells derived from them.
1.3
The Senate Community Affairs
Legislation Committee was entrusted with the task of examining the Research Involving Human Embryos and
Prohibition of Human Cloning Bill 2002 and to report to the Senate by 24
October 2002. The Bill was subsequently split into the Research Involving Embryos Bill 2002 and the Prohibition of Human Cloning Bill 2002.
1.4
The process of examining the
Bill was rushed to the point that:
- Only three weeks were allocated for
public submissions to the Committee;
- Hearings of the Committee were held,
unusually, on Senate sitting days;
- No hearings took place outside
Canberra; and,
- Less than one day was allowed after
finalisation of the Chair’s Report for dissenting reports to be prepared.
1.5
Despite the process being
rushed, public interest in the Committee’s consideration of the Bill has been
high. Of the 1851 submissions received, 1803 opposed destructive research on
human embryos.
Broad scope of the
legislation
1.6
The Bill under consideration is
commonly understood to relate only to research on embryos to produce embryonic
stem cells. What is not generally understood is that the Bill would facilitate
a wide variety of destructive research on human embryos of which stem cell
research would be but a minor part. In effect, the derivation of stem cells on
the basis of exaggerated claims of impending cures has been the Trojan Horse
used to establish the principle of destructive embryo research.
1.7
The range of embryo research
permitted by the Bill includes using human embryos to examine the effectiveness
of new culture media used in assisted reproductive technology (ART) practice,
to assist in understanding embryonic development and fertilisation, training
clinicians in microsurgical ART techniques, transport, observation and storage
of embryos, micromanipulation, lasering, cutting and dissecting, studies in
genetic makeup and expression, quality assurance testing to ensure that
pre-implantation diagnostic tests give accurate results, drug testing including
toxicology studies on human embryos as well as the destructive extraction of
embryonic stem cells.[625]
1.8
Apart from stem cell research,
nothing in this long list of areas of human embryo research was mentioned in the
COAG Communique dated 5 April 2002.
1.9
This research would entrench
the commercialisation and commodification of human life.
1.10
As one witness told the
Committee:
Where vast sums of money are at stake, it would be impossible to
regulate such research so effectively as to prevent more and more destructive
research, requiring more and more embryos, be they bar-coded, fresh, frozen or
what have you.[626]
1.11
The Committee was also told in
a submission:
Human life is never disposable, at any stage of its development.
It should never be seen as a commodity, as a type of property able to be
exploited for profit. Nor is the value of any human life, or its claim to
protection, reducible to or dependent on age or its utility to others.[627]
Human status of the
embryo
1.12
Weighty evidence was put to the
Committee as to the human status of the embryo.
1.13
Dr Nicholas Tonti-Filippini
provided the Committee with an ontological definition of the human embryo:
From the moment that the first
cell is formed, a human embryo is an individual organism oriented to
development to human adulthood, normally requiring only nutrition and a
favourable environment for that development to occur, and whose inherited
nature is formed by the human genome which carries the inherent radical
capacity for rationality that is distinctive of human beings.
1.14
Dr Tonti-Filippini detailed six
propositions and a conclusion to develop the argument:
1. All members of the human family, (including those who may not
be rational especially the developmentally disabled and the mentally ill,
children, and the elderly), have inherent dignity and equal and inalienable
rights. (ICCPR)
2. The capacity for
rationality morally distinguishes human beings from animals.
3. Being of the kind of
being which has the capacity for rationality is a basis for an individual to be
recognised as having inherent dignity and hence the bearer of equal and
inalienable rights.
4. The human genome
contains information that determines that a living individual who possesses and
is formed according to the human genome is of the kind of being which has the
capacity for rationality.
5. Those living
individuals who possess and are formed according to the human genome have
inherent dignity and are the bearers of rights.
6. Embryonic human beings
are living individuals who possess and are formed according to the human
genome;
Therefore, embryonic human beings have inherent dignity and equal and
inalienable rights.[628]
1.15
In his
submission, Dr Tonti-Filippini also pointed to the implications for other
people of a denial of the humanity of the human embryo:
A fundamental concern I have is that by classifying very immature human
beings as not yet human because of their capacities for specifically human
activities have not yet come to fruition, capacities such as rationality and
thought, we make the status of all human beings dependant upon their capacities
rather than simply on membership of the human family.[629]
1.16
Dr Robert Orr from the
University of Vermont and Dr Christopher Hook from the Mayo Graduate School of
Medicine point to the beginning of life not being determined by where the
embryo is positioned:
The essential nature of humanhood is inherent to the individual,
it is not something that is imputed based on location. These arguments based on
geography are feeble attempts to avoid the basic fact understood and accepted
by scientists for many generations that human life begins with the union of two
human gametes.[630]
1.17
They also refute the argument
that as the embryo will die anyway it should therefore be used for research:
[this] only accepts and supports the erroneous and tragic
approach of the infertility industry which perceives children as products and
embryos as commodities ... A society that chooses to capitalise on this tragedy
acts as opportunists, not as stewards.[631]
1.18
The Queensland Bioethics Centre
clarifies in its submission the difference between killing and allowing to die:
... in the case of the frozen embryo the decision is made to cease
the extraordinary life-support and allow nature to take its course. This
[option is] to discontinue the life-support and allow the embryo to return to
as natural a state as possible - a warm, moist environment. Development will be
restored for a short time, but then nature takes its course. The embryo,
because of its immaturity and inability to sustain itself, dies. The person who
thaws the embryo in this case is not involved in an act of intentionally
killing the embryo anymore than a doctor who does not initiate futile or overly
burdensome life sustaining treatment on a dying neonate or who discontinues
overly burdensome treatment on a dying patient.
On the other hand when someone takes the embryo and extracts its
stem cells, we do not have a case of “nature taking its course”. The embryo is
carefully and slowly thawed to maintain its viability short-term in order that
its stem cells can be harvested. It does not die because it cannot sustain
itself in this environment. The embryo dies because someone has ripped it
apart. The person who so deliberately destroys the embryo might be doing so for
all kind of noble motives, but he/she can’t escape the fact that he/she is
intentionally killing the embryo.
In the former case it is not necessary that the person is
willing the death of the embryo. In the latter case it is necessarily so.[632]
Human Rights Implications
1.19
Dr Katrina Hallen points out
that there is a body of human rights law specifically relating to human
experimentation which states that voluntary consent by the subject of the
research is absolutely essential:
The human rights perspective is that
the rights of the subject must prevail over the interests of science.
Scientific experiments must be designed for the benefit of the subject, not for
the destruction of the subject, even if the destruction of the subject may
benefit another group of human beings. The use of one group of the human family
to serve as experimental subjects, or spare parts resources, for another group
is exploitative and abusive. The use of human embryos to serve as experimental
subjects for the interests of science, creates a group of human individuals
that can be used and destroyed for another group of human individuals. This
violates the ethical principles of doing no harm, benefiting the subject
experimented on, autonomy, justice and the sanctity of human life.[633]
1.20
Stripping the embryo of its
humanity for utilitarian purposes would have frightening implications for other
vulnerable minority groups.
1.21
Dr Robert Orr and Dr
Christopher Hook examine rationales from the historical record used to justify
research abuses on human subjects:
... codes, guidelines, and
regulations have been developed specifically for the purpose of bridling this
research enthusiasm with ethical principles. One such principle is that human
subjects’ research is never to result deliberately in the death of a subject,
regardless of how much supposed good may result from the investigation.[634]
1.22
Denying the humanity of the
human embryo and using it as an experimental tool, would contravene the
principles underpinning a number of international human rights instruments
including:
- The Nuremberg Code (1947)
- UN Declaration on the Rights of the
Child (1959)
- The International Covenant on Civil
and Political Rights (1966)
- Protocol I Additional to the Geneva
Conventions of 12 August 1949, and Relating to the Protection of Victims
of International Armed Conflict (1977)
- Convention on Human Rights and
Biomedicine (1997)
- Universal Declaration on the Human
Genome and Human Rights (1997)
- Declaration of Helsinki (2000)
1.23
Further details of these
instruments are given in the Appendix to this report.
1.24
If this
Bill is passed, the Australian Parliament will have abrogated the foundational principle of law and public policy regarding the
uniform protection of all human life and entrenched in legislation approval for
the deliberate destruction of human life for radically utilitarian, commercial
purposes.
1.25
The Senate Select Committee on
the Human Embryo Experimentation Bill 1985:
sought guidance in the
protective role of the law recognised in the jurisprudence of our legal system
as the minimum and for some the only, justification for interference with the
freedom of others - in this case the freedom to carry out research on human
embryos. It is in this framework that the Committee answers the questions
accepted by all as the correct query: what is the respect due to the human
embryo?
1.26
The Select Committee
recommended “that the principle protecting the embryo from destructive
non-therapeutic experimentation be adopted by the Senate in its consideration
of this matter.”[635]
1.27
The current Bill radically
departs from this principle of protection.
1.28
To enshrine in law the
destruction of the smallest and most vulnerable members of the human family to
obtain marketable human commodities would be inhuman.
The unacceptable
precedent
1.29
The Bill will set a dangerous
precedent in Australian law where human embryos will be defined as disposable
and commodities available for use in research. Dr Warwick Neville for the
Australian Catholic Bishops’ Conference pointed out this legislation would mean
that there would be different levels of respect accorded to the human embryo
under different branches of the law:
This legislation will set the unheard-of precedent for the
statutory creation of a biological underclass-namely, those unworthy of life
but worthy of sacrifice on the commercial slab of experimentation. That is the
precedent that would be set by this legislation. And what of the inchoate
rights of embryos already recognised by the Supreme Court of Tasmania in the
landmark case in 1996 of Re K? The frozen generation will be denied the
ultimate right of having those rights ever crystallised.[636]
1.30
Dr Gregory Pike from the
Southern Cross Bioethics Institute argues that such a precedent as contained in
the Bill may have a significant negative impact on Australians’ ethical approach
to life and death issues:
My ... point is that we have tried to clarify what we see as a
distinction which in one respect we hoped would never have to be made, and that
is the distinction between intentional killing and allowing to die. It is a
difficult one, but one recognised in ethics in several different arenas. What
concerns me most about this particular application of the `they're going to die
anyway, so let's use them' approach is that that line of reasoning has been
used in other arenas in the past and some of those have been quite disturbing.
As often happens in ethics and philosophy, what is a consistent argument in one
arena gets transferred into another arena.[637]
Informed consent
inadequate
1.31
Concern was raised in
submissions that parents of embryos would not be given adequate information or
control over the end uses of their embryos. The Feminist International Network
of Resistance to Reproductive and Genetic Engineering (FINRRAGE), for example,
observed:
Informed consent is a central issue which we believe has yet to
be properly addressed. Will donors be informed of the full implications of the
research and the commercialisation of the research undertaken using the embryos
they donate? Holland (1996) points out that ‘...downstream commercialisation is a
potent and problematic issue. How to safeguard it ethically and how to keep
women from potential exploitation is the rub. The potential profitability of
cell lines derived from donated embryos is huge given the promise of
regenerative medicine.’[638]
1.32
Dr Tonti-Filippini made a
similar observation about this downstream commercialisation:
Once couples have consented to their embryos being used, they
have no further say over what may be done. They do not even have to be informed
about what is done with their embryos or their embryonic stem cells. Their
legal relationship with their embryos ceases when they give consent.
The Cloning Bill incorporates the interests of the researchers
and their corporate supporters so that the embryonic stem cells become the
unencumbered assets of the company. There is no restriction on their use,
export or subsequent trade in them. An IVF couple will have no way of knowing
what research is being done on their embryonic stem cell cultures, or whether
the cell cultures remain identified with the couples and who the end-users
might be.
One would expect that couples would be interested in whether
Genomically related information is obtained which is medically
relevant to them and to their families
The cultures and their DNA are used as a commercial asset and
the couple may have lost an opportunity to profit from that commercial
exploitation
the end-uses of their cultures and products derived from them
are ethically acceptable to them, and whether they should have exercised
greater responsibility in donating their embryos.[639]
Overproduction of
human embryos
1.33
The Chair’s Report fails to
place the current issue of human embryo research into any context. How has it
come to pass that thousands of human embryos - with no chance of ever being
implanted - have been deliberately created? We are on the verge of establishing
a national scheme for capitalising and profiting from a situation which should
never have been allowed to develop: more than 70,000 human embryos stored in a
frozen state, with no questions asked as to why such a massive stockpile of
embryos was allowed to accrue in the first place.
1.34
FINRRAGE argued in its written
submission that:
... this bill will act to cover up for the mistakes of the IVF
industry in creating many thousands of so-called spare embryos in the first
place.[640]
1.35
The number of human embryos in
storage since 1994 has risen from about 22,000 to 72,000[641], a proportion of which are available
for use in research.
1.36
Medical and Managing Director
of Sydney IVF, Professor Robert Jansen, admitted before the last Senate
committee to examine this issue that it was not difficult to manipulate a
“surplus” of human embryos. Professor Jansen told the Senate Select Committee
on the Human Embryo Experimentation Bill 1985:
It is a fallacy to distinguish
between surplus embryos and specifically created embryos in terms of embryo
research. The reason why I say this is that any intelligent administrator of an
IVF program can, by minor changes in his ordinary clinical way of going about
things, change the number of embryos that are fertilised. So in practice there
would be no purpose at all in enshrining in legislation a difference between
surplus and specially created embryos. It would be but a trifle
administratively to make those embryos surplus rather than special.[642]
1.37
Professor Jansen has since
attempted to recant this statement by referring unconvincingly to difficulties
in collecting human ova rather than the issue of creating surplus human
embryos.[643]
Embryonic stem cells
for developing therapies
1.38
The research used to ‘sell’
this legislation in debate has largely been limited to embryonic stem cell
research and claims by some researchers that this may lead to cures for
conditions such as diabetes and Parkinson’s disease.[644] However other scientists were more
cautious and some were dismissive.
1.39
Deputy Vice Chancellor
(Research) at the Australian National University, Professor John Hearn, warned:
it is premature to anticipate therapeutic results that will
treat patients with Alzheimers, Parkinsons, Diabetes and other disorders. The
field is less than five years old. Use of patients in wheelchairs, film stars,
and emotional statements from scientists, industry or the media are
inappropriate and risk damaging the credibility of research.[645]
1.40
Professor Peter Rowe, Director,
Children’s Medical Research Institute, Westmead, Sydney said:
I have an interest in a number of these things that are thrown
around in the press, particularly things like Alzheimer’s, diabetes and
Parkinson’s. These are very complex disorders. To say that you will cure them
by putting in a few cells is a joke. We do not even know the genetic basis.[646]
1.41
Similar views were expressed by
Professors Colin Masters, John Martin, Peter Silburn, Michael Pender and
Michael Good.[647]
1.42
Emeritus Professor of Medicine
at the University of Melbourne, John Martin, pointed out that there was no
‘proof of concept’ for embryonic stem cell research:
All the proponents of human embryonic stem cell research rely
ultimately on the one argument - that cures for serious chronic diseases are
sure to follow. If that were true it would be difficult to be opposed to it,
but there is no evidence to support these claims from appropriate animal
experimentation ...
Why, then, should we not require a substantial body of evidence
to justify destructive research on human embryos? Why do we not have from
animal models of disease, ample proof of the principle that, say in diabetes or
Parkinson’s Disease, prolonged therapeutic benefit can be obtained from the use
of ES cells, and that this can be achieved free of the problems of tumour
development, and overcoming the immunological barriers? Why do we not have laid
out clearly the milestones to be achieved in fulfilling these conditions, and
the time-lines required?[648]
Destroying human
embryos for research
1.43
The broader range of
destructive human embryo research received less attention than embryonic stem
cell research. As outlined earlier, the range of embryo research permitted by
the Bill includes using human embryos:
- to examine the effectiveness of new
culture media used in assisted reproductive technology (ART) practice;
- to assist in understanding embryonic
development and fertilisation;
- training clinicians in microsurgical
ART techniques;
- transport, observation and storage of
embryos;
- micromanipulation, lasering, cutting
and dissecting;
- studies in genetic makeup and
expression;
- quality assurance testing to ensure
that pre-implantation diagnostic tests give accurate results;
- drug testing including toxicology
studies on human embryos as well as the destructive extraction of
embryonic stem cells.[649]
1.44
The Southern Cross Bioethics
Institute noted that the list of research that will be carried out on human
embryos is likely to include “toxicology studies on live human embryos, and
testing new drugs on humans rather than animals”.[650]
1.45
Dr Tonti-Filippini commented on
some of the areas of research which might involve human embryos and human
embryonic stem cells:
We are seeing a whole opening up of this area to unregulated,
unrestricted and unsurveyed research on both the stem cells and the embryos.
You ask questions like these: who stops the stem cells finishing up in
cosmetics and who stops them being sent for biowarfare to one of the less
democratic regimes in the world? Remember, they can be sold off. Alan Trounson was
talking earlier about buying and selling the stem cells. If he has got products here in Australia within the
companies that he is associated with, what stops those companies selling them
to anybody?[651]
1.46
The Committee also heard
evidence from Sydney IVF Medical Director Professor Robert Jansen that
“hundreds” of embryos would be needed “in the development of culture medium for
meaningful results”.[652]
Alternative stem cell
sources
1.47
A number of submissions gave
references to over one hundred articles published in peer reviewed scientific
and medical journals which detail successful therapies now available to
patients using adult stem cells. These include treatments to treat patients
with stroke, cancer, bone defects, and muscle, gut and retina problems. There have
also been promising results published where there have been successful adult
stem cell experiments using animal models to treat conditions such as spinal
injury, Diabetes and Parkinsons.[653]
1.48
Dr Tonti-Filippini noted that
to-date no successful therapies for humans have been published using embryonic
stem cells:
Treatments using a patient’s own stem cells have been achieved
for many diseases. Claims about treatments of disease using embryonic stem
cells are just hype. There just is no such track record for embryonic stem
cells. In these circumstances, it is
ludicrous to be claiming the development of treatments using embryonic stem
cells as a reason for passing a Bill allowing human embryonic experimentation.
There is no such necessity. The truth of the matter is that human embryos and
embryonic stem cells have many research and industrial uses ...[654]
1.49
Adult stem cells have been
compared unfavourably with embryonic stem cells on the basis that they do not
have pluripotentiality - the ability to produce many types of tissue. However
Professor Michael Good, Director of the Queensland Institute of Medical
Research has described this limitation as an advantage:
...the ideal cell that you want in a transplantation situation is
one that does not have great pluripotency, that cannot differentiate into
multiple unwanted tissues, that has a limited tissue differentiating profile
and that you have enough of. Those cells are provided by adult stem cells.
Furthermore, if they are taken from the patient, you will not have this problem
of graft rejection, which to me is the major problem of embryonic stem cell
derived tissue.”[655]
Communities opposed
to destructive embryo research
Aboriginal and Torres
Strait Islanders
1.50
The National Aboriginal
Community Controlled Health Organisation made a submission to the Committee
which drew attention to Aboriginal and Torres Strait Islander people’s concern
with the Bill. The submission referred to “strong cultural beliefs opposed to
the destruction of human life from its earliest stage. Embryonic stem cell
research would violate such beliefs and accordingly we could not support such
research.”[656]
People with
disabilities
1.51
A significant number of
submissions from people with disabilities opposing the destruction of embryos
were received, though none were invited to give evidence before the Committee.
1.52
Diabetics for Ethical Treatment
argued that:
It is unethical, and an insult to the integrity of persons with
diabetes, to pursue research into therapies which involve harming or destroying
human beings, including human embryos ... We firmly believe that an attack on the
dignity and well-being of any group of human beings is an attack on human
dignity itself. It is a profound insult to people with disabilities and
illnesses, including diabetics, to presume that we are willing to accept
therapies developed at the cost of other human lives.[657]
1.53
Some families made submissions
to the Committee, with Olivia and Vicki Dunne drawing attention to their
experience living with Cystic Fibrosis:
As a sufferer and as a carer, we would submit to the members of
the Committee that it is not legitimate to look for those cures at the cost of
another human being. We have seen that in embryonic stem cell research the
donor is always destroyed. If the price of new lungs and new pancreases for the
members of our family is someone else’s life then it is too high a price to
pay.[658]
1.54
The Sadkowsky family drew
attention to the experience of their daughter, who has Rett Syndrome:
We share both happy and sad times with her, along with our other
children, and we are very proud of the progress she has made despite the
difficulties imposed on her by Rett syndrome. In the 23 years of her life she
has made an immeasurable, positive contribution to our family, our friends and
community in general. Over the years, we have met many wonderful people through
association with Veronica ... Adult stem cells are available in the body, without
resorting to the destruction of human embryos ... It is our opinion that the
resources would be better channelled into this form of research.[659]
1.55
The Archdiocese of Melbourne’s
also recorded that in the United States:
... James Kelly, a 45-year-old paraplegic due to spinal cord
injury, wrote to US President Bush asking him to support embryonic stem-cell
research. Since then he has undertaken a great deal of research into the area
himself. He discovered that while adult stem-cells can and have been used
safely in humans for various therapies, and are clearly our “brightest hope”,
the embryo industry has instead promoted embryonic stem-cells. During his US
Senate testimony, Mr Kelly stated: “I think it is highly immoral for
researchers and others to encourage the sick, crippled and dying to cut their
own throats by supporting cloning [and embryonic stem-cell research], a
research avenue whose extremely speculative potential lies somewhere in the
distant, hazy future, to the detriment of proven avenues that offer more than
futile help.[660]
Women
1.56
There were a number of
submissions received from women’s groups concerned about embryo research and cloning
to produce embryos for research or therapies.
1.57
Feminists for Life (ACT)
commented that:
Embryo research raises serious ethical questions about the
exploitation of women - especially in regard to the demand for eggs to produce
what are now deemed to be surplus embryos or, if some science lobbyists get
their way, for the cloning of embryos for research.[661]
1.58
FINRRAGE point out that:
To justify the research goal, women and people with disabilities
are sometimes held up as future beneficiaries of this research. But the debate
is being driven by the immediate beneficiaries, the research and biotechnology
communities, which are determined that this research go ahead. The science
lobbyists are intolerant of voices from other communities and in some cases
have misled Parliamentarians in their determination to get their way.
1.59
Further, they note that:
It is ironic that under the proposed legislation, women would
not be able to sell their ova or embryos, while researchers are later able to
commercialise the results of their experiments and may potentially make
substantial sums of money.[662]
Conscientious
objection not protected
1.60
Another concern expressed was
for the right to conscientious objection of stem cell scientists or students
who are opposed to using embryos as research tools, and protection from
discrimination because of their position. Conscientious objection is also of
concern to potential recipients of drug treatments derived from destructive
research on embryos.
1.61
There is a concerted attempt by
those supporting embryonic stem cell research to promote the integration of
adult stem cell research with embryonic stem cell research either directly or
indirectly.[663]
1.62
The use of human embryos and
human embryonic stem cells in the testing of drugs and toxicology studies for drug
development has major implications for those objecting on ethical grounds.
1.63
Dr David van Gend, representing
Do No Harm, argued that if widespread embryo research is allowed to go ahead,
Australians will have difficulty exercising their right to conscientiously
object or opt out of involvement:
Conscientiously, people can object from certain
practices-abortion, euthanasia, going to war and so on. But if the fabric of
medical knowledge is stained, as it were, by knowledge derived from destruction
of human embryos, then people will be beneficiaries of that knowledge when they
take from their doctor these new drugs. It is a novel predicament. To me, it is
an uncivil predicament, because never before have we faced a situation where
certain members of society who would conscientiously object from using things
like drugs derived from embryos will have no way out. They will not be able to
opt out of standard medical care when, as would happen with embryo research,
the whole body of pharmaceuticals is tainted with that research.[664]
Cloning still an
issue of concern
1.64
The Chair’s report does not
address the ethical issues surrounding one half of the referred Bill, now
called the Prohibition of Human Cloning
Bill 2002. Human cloning is an area of significant concern and, while there
appears to be a very clear Parliamentary majority to support the prohibition of
human reproductive cloning, it is important to state clearly what human cloning
is and the reasons why it is unacceptable.
1.65
Universal opposition to human
cloning cannot be assumed. The Academy of Science, a senior member of the IVF
research community and the science adviser to a Cabinet minister are all on the
record as not opposed to cloning in various forms.
1.66
Dr Thomas Barlow, science
adviser to Education, Science and Training Minister, Dr Brendan Nelson, wrote
in a column in the UK Financial Times
(1 September 2001) that he considers human reproductive cloning to be no more
serious an issue than “having sex”. “Not to beat about the bush, is there any
honest reason why we should treat it more seriously, say, than having sex?” he
wrote.
1.67
Professor Martin Pera from the
Monash Institute of Reproduction and Development, stated that:
... although the scientific case for the clinical application of
therapeutic cloning in man is not compelling at present, basic research on
reprogramming in humans may eventually be very important to successful
development of adult stem cell based therapies. I therefore endorse in
principle the original recommendation of the report of Mr. Kevin Andrews’ committee of inquiry for a moratorium, rather than a ban, on this area of
research.[665]
1.68
In testimony before the
Committee, the Academy of Science reaffirmed its support for cloning embryos so
that they could be destroyed for their stem cells, which could then
theoretically be used in therapies. This would be achieved by somatic cell
nuclear transfer.
1.69
Distinctions are frequently
drawn between cloning for reproduction and cloning where the embryo is
destroyed to produce therapies, there is little difference in the basic
process.
1.70
The House of Representatives
report Human cloning: scientific, ethical
and regulatory aspects of human cloning and stem cell research, employed
this distinction when it summarised the most common arguments against cloning
for reproductive purposes as:
- A lack of any medical need for cloning
for reproductive purposes;
- Cloning for reproductive purposes
would constitute an infringement of human dignity;
- Cloning for reproductive purposes
would have a negative effect on the family and personal relationships;
- Cloning for reproductive purposes
would undermine individuality and identity;
- It would be unsafe;
- Cloning for reproductive purposes
would potentially pose a threat to human diversity and run the risk of
reintroducing notions of eugenics; and
- It would raise the potential for
coercion of women.[666]
1.71
However, when asked whether
somatic cell nuclear transfer was cloning, whether or not the embryo was placed
in a woman’s uterus or in a petri dish for experiments, Professor John White
from the Academy of Science agreed it was the same process:
... I am glad to agree with you. It certainly is cloning, and the
academy has never resiled from that point of view. It is the method, which was
used to produce the sheep “Dolly”, that can actually allow the DNA from any
particular donor to be expressed in embryonic stem cells. The only virtue of it
from the point of view of future science is that that particular potential is
the only way we know to go about the point. So, of course, it is destructive
cloning - I am afraid I have to agree with you.[667]
1.72
One particular danger of
accepting human cloning - the danger of women being exploited - was raised by a
number of groups including FINRRAGE (Australia):
Women’s bodies are central to the hopes and aspirations of scientists
determined to work in the embryonic stem cell area. Without access to women’s
bodies to harvest their ova, scientists would not be able to produce the
surplus of embryos we are being asked to release to scientific research.
Women’s eggs don’t drop out of the ether. They come from a woman’s ovary which
is in a woman’s body. The ovary has to be hyper-stimulated with dangerous drugs
and the egg cells mechanically extracted.[668]
1.73
FINRRAGE notes that:
If therapeutic cloning were to go ahead - and there is no doubt
the pressure for it will only intensify - the scientists would then need to
work out ways to harvest thousands more ova from women. Scientists undertaking
this research therefore need the cooperation of women to produce the embryos
they need for experiments.[669]
1.74
FINRRAGE also pointed out that
one US source estimates that if cloning was allowed to produce compatible
tissue for therapies:
... if embryonic stem cells were to provide up to 1.7 million
therapies per year, this would require a minimum of 5 - 8 million ova each
year. This estimate generously assumes that it would only take between three
and five embryos to produce one embryonic stem cell culture.[670]
1.75
The Australian Catholic
Bishops’ Conference also raised the issue of the quality of frozen embryos and
whether the call of some biotech companies for access to ‘fresh’ embryos, which
may be a future pressure for cloned embryos:
There is growing evidence that children born from IVF suffer
from a range of adverse medical conditions. Presumably IVF practitioners have
selected for implantation those embryos which are deemed the “best of the
crop.” If that is so, it would mean that those embryos now deemed “spare” or
“excess” might well be of a second order in quality. One might ask, from the
prevailing utilitarian perspective, whether researchers would really want, or
should be allowed, to use embryos of perhaps inferior quality? If not, would
there not then be a push for the need for and use of “fresh” embryos? This has
already been suggested in the debate by some of the biotech companies. How
would a pro-research licensing committee resist such an application? [671]
The Bill
1.76
A large range of problems with
the Bill were raised in submissions and in the Senate Committee hearings. This evidence pointed to major flaws and gaps
in the Bill in the areas of regulation, monitoring, reporting requirements,
accountability, absence of guidelines and lack of independence in oversight
bodies.
1.77
In his written submission, Dr
Tonti-Filippini also pointed out that there was no regulation of industrial and
other uses of human embryonic stem cell cultures:
Human embryonic stem cell cultures fall outside existing ethical
guidelines because they are not considered human tissue. They are considered
not to have been removed from a human body but generated in the laboratory from
human embryos. For ethics committees the stem cells do not constitute a human
subject and hence are not within their jurisdiction. The Bill contains no
restriction on the use of human ES cells.[672]
1.78
Clause 10 deals with the
offence of intentionally importing or exporting a human embryo clone. Dr Morris
from the NHMRC advised the Committee that there is nothing to prevent a person
from taking stem cells from a human embryo and then selling them for profit
overseas:
The use of cells derived from any tissue would be permitted to
be sent overseas ... [The legislation] does not prohibit any uses of embryonic
stem cells.[673]
1.79
Among other interesting
omissions in the Chair’s Report is the fact that literature from biotechnology
academics has noted the relevance of other statutory regimes concerning the
regulation of matters relevant to ART. Other relevant regimes include not only
the Trade Practices Act, but matters relating to intellectual property.
1.80
In further evidence before the
Committee, Dr Neville argued that given that the legislation provides for the
concealment of confidential commercial information, other ways of keeping the
embryo research industry accountable to the public might include the Trade
Practices Act and anti-discrimination legislation.[674]
1.81
Concern was expressed that the
Bill was being considered when the new NHMRC guidelines referred to in the Bill
had not yet been sighted:
... those guidelines were published in 1996 and they are the
subject of review at the moment. So, again, it only adds to the speculative
nature and, therefore, also the difficulty of this committee and the parliament
to enact legislation when, as it were, all of the balls are still in the air. [675]
1.82
In relation to clause 28, which
establishes the NHMRC Licensing Committee, there was evidence given to the
Committee that it was inappropriate for the Licensing Committee to be located
within the administration of the NHMRC. The ACF GeneEthics Network commented
that:
The NHMRC is impenetrable and effectively answerable to no-one
outside. GTRAP and AHEC are examples of
NHMRC with whom we have attempted to engage over many years, with very little
success. We propose that this licensing function be vested in the Office of Gene
Technology Regulator who has statutory responsibilities and authority
commensurate with the importance of this licensing work, and has processes and
mechanisms to engage with the interested and general publics.[676]
1.83
Dr Tonti-Filippini drew
attention to inappropriateness of having the National Health and Medical
Research Council as the parent body for the licensing authority:
We do have a culture here with the Human Research Ethics
Committee and the NHMRC, and now the licensing authority ... There is not
openness in reporting or stringent reporting requirements, so you have got no
reporting of, for instance, the Human Research Ethics Committee’s decisions or
anything like that. The public does not
have access to those. So we have got a
fairly secretive culture, a non-consultative culture. In fact, the institutions will defend that in
terms of their own commercial interests and so on and also their interests in
not having public scrutiny.”[677]
Conclusion
- The Bill sets an unacceptable and
profoundly disturbing precedent in permitting for the first time destructive
experiments on human embryos. A certain class of human life will be
considered expendable for profit. The Bill will entrench the
commercialisation and commodification of human life.
- The scope of the legislation is so
broad as to facilitate a wide range of destructive research on human
embryos of which stem cell research will be a minor part. None of these
areas of human embryo research were the subject of the original COAG
agreement.
- The embryonic human being has inherent
dignity and equal and inalienable rights due to membership of the human
family.
- The Bill contravenes the body of human
rights law on human experimentation in using one section of the human
family to serve as experimental subjects or spare parts resources for
another group.
- Stripping the embryo of protection for
utilitarian purposes has frightening implications for other vulnerable
minority groups.
- The consent process for donating
embryos to research is inadequate. The Bill contains no restriction on
embryonic stem cell use, export and subsequent trade. Once couples have
consented to their embryos being used they have no further say in how
their embryos will be used.
- More than 70 000 human embryos are
currently in storage. The Chair’s report fails to address the crucial
question as to why such a massive stockpile of embryos were allowed to
accrue in the first place.
- Prominent scientists have cast
significant doubt on the overblown claims of pro embryonic stem cell
research advocates.
- No successful therapies using
embryonic stem cells have been published. A number of submissions gave
references to more than 100 articles published in peer reviewed scientific
and medical journals detailing successful therapies using adult stem
cells.
- A number of specific communities,
among them indigenous people, people with disabilities, and women
expressed specific concern about destructive embryo experimentation. Some
people with disabilities stated that it was unethical and an insult to
their integrity to pursue research which involved harming other human
beings.
- The right to conscientious objection
is threatened by this Bill.
- The Chair’s report does not properly
address the ethical issues surrounding one half of the Bill. A number of
scientists have publicly expressed their support for cloning embryos so
they could be destroyed for their stem cells. There is no distinction
between cloning for reproduction and so-called therapeutic cloning.
- Regulation and licensing has been
shown to be inadequate. There is no
regulation of industrial and other uses of human embryonic stem cell
cultures.
- If this Bill is not rejected the
Australian Parliament will have abrogated the foundational principle of
law and public policy regarding the uniform protection of all human life
and will entrench in legislation the deliberate destruction of human life
for radically utilitarian, commercial purposes.
__________________________________________
Senator Brian Harradine (Ind, Tas.)
Appendix
International human rights
and medical research
The International
Covenant on Civil and Political Rights (1966)
Every human being has the inherent right to life. This right shall be protected by law. No one shall be arbitrarily deprived of his
life (Article 6(1)).
“sentence of death ... shall not be carried out on pregnant
women” (Article 6 (5)).
UN Declaration on the
Rights of the Child (1959)
Governments are obliged “to provide appropriate legislative
protection for the child, before as well as after birth.” (preamble)
“every child [ie before as well as after birth] has the inherent
right to life” (Article 6)
No one shall be subjected to torture or to cruel, inhuman or
degrading treatment or punishment. In
particular, no one shall be subjected without his free consent to medical or
scientific experimentation (Article 7).
The Nuremberg Code
Principle 1. The
voluntary consent of the human subject is absolutely essential. This
means that the person involved should have legal capacity to give consent;
should be so situated as to be able to exercise free power of choice, without the
intervention of any element of force, fraud, deceit, duress, over-reaching, or
other ulterior form of constraint or coercion; and should have sufficient
knowledge and comprehension of the elements of the subject matter involved as
to enable him to make an understanding and enlightened decision. This latter
element requires that before the acceptance of an affirmative decision by the
experimental subject there should be made known to him the nature, duration,
and purpose of the experiment; the method and means by which it is to be
conducted; all inconveniences and hazards reasonable to be expected; and the
effects upon his health or person which may possibly come from his
participation in the experiment.
The duty and
responsibility for ascertaining the quality of the consent rests upon each
individual who initiates, directs or engages in the experiment. It is a
personal duty and responsibility which may not be delegated to another with
impunity.
Principle 5. No
experiment should be conducted where there is an a priori reason to believe
that death or disabling injury will occur; except, perhaps, in those
experiments where the experimental physicians also serve as subjects.
Protocol I Additional
to the Geneva Conventions of 12 August 1949, and Relating to the Protection of
Victims of International Armed Conflict, 8 June 1977
Article 11 - Protection of persons 1. The physical or mental health and integrity of persons who are in the power of the adverse Party or who are interned, detained or otherwise deprived of liberty as a result of a situation referred to in Article 1 shall not be endangered by any unjustified act or omission. Accordingly, it is prohibited to subject the persons described in this Article to any medical procedure which is not indicated by the state of health of the person concerned and which is not consistent with generally accepted medical standards which would be applied under similar medical circumstances to persons who are nationals of the Party conducting the procedure and who are in no way deprived of liberty. 2. It is, in particular, prohibited to carry out on such persons, even with their consent: (a) physical mutilations; (b) medical or scientific experiments; (c) removal of tissue or organs for transplantation, except where these acts are justified in conformity with the conditions provided for in paragraph 1.
3. Exceptions to the prohibition in paragraph 2 (c) may be
made only in the case of donations of blood for transfusion or of skin for
grafting, provided that they are given voluntarily and without any coercion or
inducement, and then only for therapeutic purposes, under conditions consistent
with generally accepted medical standards and controls designed for the benefit
of both the donor and the recipient.
Convention on Human
Rights and Biomedicine (1997)
The European Convention for the Protection of Human Rights
and Dignity of the Human Being with regard to the Application of Biology and
Medicine, also known as the Convention on Human Rights and Biomedicine of 4
April 1997. Council of Europe.
Article 2 - Primacy
of the human being
The interests and welfare of the human being shall
prevail over the sole interest of society or science.
Article 16 - Protection of persons undergoing research
Research on a person may only be undertaken if all the
following conditions are met:
...
(ii) the risks which may be incurred by that person are not
disproportionate to the potential benefits of the research,
(iii) the research project has been approved by the
competent body after independent examination of its scientific merit, ...
(v) the necessary consent as provided for under Article 5
has been given expressly, specifically and is documented. Such consent may be freely withdrawn at any
time.
Article 17 - Protection of persons not able to consent to
research
Research on a person without the capacity to consent as
stipulated in Article 5 may be undertaken only if all the following conditions
are met:
1...
iii research of comparable effectiveness cannot be carried out on
individuals capable of giving consent;
iv the
necessary authorisation provided for under Article 6 has been given
specifically and in writing; and
v the person concerned does not object.
2 Exceptionally
and under the protective conditions prescribed by law, where the research has
not the potential to produce results of direct benefit to the health of the
person concerned, such research may be authorised subject to the conditions
laid down in paragraph 1, sub-paragraphs i, iii, iv and v above, and to the
following additional conditions:
i the
research has the aim of contributing, through significant improvement in the
scientific understanding of the individual's condition, disease or disorder, to
the ultimate attainment of results capable of conferring benefit to the person
concerned or to other persons in the same age category or afflicted with the
same disease or disorder or having the same condition;
ii the research entails only
minimal risk and minimal burden for the individual concerned.
Article 18 - Research
on embryos in vitro
1 Where the law allows research on embryos in vitro, it shall ensure adequate
protection of the embryo.
2 The creation of human embryos for research
purposes is prohibited.
Declaration of
Helsinki
Ethical Principles for Medical
Research Involving Human Subjects
World
Medical Association
October
2000
5.
In medical research on human subjects, considerations related to the
well-being of the human subject should take precedence over the interests of
science and society.
17.
Physicians should abstain from engaging in research projects involving
human subjects unless they are confident that the risks involved have been
adequately assessed and can be satisfactorily managed. Physicians should cease
any investigation if the risks are found to outweigh the potential benefits or
if there is conclusive proof of positive and beneficial results.
18.
Medical research involving human subjects should only be conducted if
the importance of the objective outweighs the inherent risks and burdens to the
subject. This is especially important when the human subjects are healthy
volunteers.
Universal Declaration
on the Human Genome and Human Rights
This declaration was adopted unanimously and by acclamation
at the twenty-ninth session of UNESCO’s General Conference on 11 November
1997. The following year, the United
Nations General Assembly endorsed the Declaration.
Article 5
e) If according to the law a person does not have the
capacity to consent, research affecting his or her genome may only be carried
out for his or her direct health benefit, subject to the authorization and the
protective conditions prescribed by law. Research which does not have an
expected direct health benefit may only be undertaken by way of exception, with
the utmost restraint, exposing the person only to a minimal risk and minimal
burden and if the research is intended to contribute to the health benefit of
other persons in the same age category or with the same genetic condition,
subject to the conditions prescribed by law, and provided such research is
compatible with the protection of the individual's human rights.
Article 10
No
research or research its applications concerning the human genome, in
particular in the fields of biology, genetics and medicine, should prevail over
respect for the human rights, fundamental freedoms and human dignity of
individuals or, where applicable, of groups of people.
Article 11
Practices which are contrary to human dignity, such as
reproductive cloning of human beings, shall not be permitted. States and competent
international organizations are invited to co-operate in identifying such
practices and in taking, at national or international level, the measures
necessary to ensure that the principles set out in this Declaration are
respected.
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