Chapter 3 - The majority Report - The case for the Lockhart Recommendations
Introduction
3.1
The Committee was divided on acceptance of the two bills, which were
based on the Lockhart Recommendations. However a majority of the committee
agreed emphatically to support, and to recommend that Senators vote for, the Patterson
Bill. The majority of the Committee also acknowledge the excellent contribution
to the deliberations from Senators Stott Despoja and Webber through their draft
exposure bill.
3.2
This chapter provides a brief scientific overview of the issues involved
in the Lockhart Recommendations and the arguments provided in evidence which
supported the Lockhart Recommendations, and the two bills prepared in response
to the recommendations.
Overview of the science relevant to this Bill
A. Assisted Reproductive
Technology:
3.3
Assisted
Reproductive Technology (ART) is the application of laboratory or clinical
technology to gametes and/or embryos for the purposes of reproduction. ART
services are overseen by the NHMRC. Further information about ART and the NHMRC’s role can be found on the
NHMRC website www.nhmrc.gov.au.
3.4
The information given on the NHMRC website
is written in the context of the current legislation.
B. Stem
Cell Science:
3.5
There are many explanations of stem cell science available in scientific
literature, lay press and online. Some sources communicate the science in a
clear non-emotive fashion; others are biased, confusing or simply wrong. Rather
than adding to the array of information already available, the Committee has
decided to write a brief overview and defer to the NHMRC online educational
resource for detailed information on the matter. This can be found in hard copy
in Appendix 4 or online as “Stem Cells, cloning and related issues” at http://www.nhmrc.gov.au/embryos/stemcells/index.htm
3.6
The information given on the NHMRC website is written in the context of
the current legislation.
3.7
The Lockhart Committee also gives a description of the science which can
be found on pages 39 – 40 as 5.1 'Background to Stem Cell Sciences' www.lockhartreview.com.au
3.8
Stem cells are ‘unspecialised’ cells that have the unique
potential to develop into ‘specialised’ cell types in the body (for example
blood cells, muscle cells or nerve cells). This can be either for growth and
development, or for replenishment and repair. They occur at all stages of human
development, from embryo to adult—but their versatility and numbers tend to
decrease with age. Given the right conditions in the body or the laboratory,
stem cells (unlike muscle cells, nerve cells and or blood cells) can replicate
themselves many times over. When a stem cell replicates, the resulting cells
can either remain as stem cells or can become specialised cells.
3.9
Stem cells are commonly described as 'adult' and 'embryonic' because of
the tissue from which they are derived but they can also be defined by their potential
as 'totipotent', 'pluripotent' and 'multipotent'. Totipotent cells are those
stem cells which have the capacity to become any cell of the body as well as
the capacity to form a whole being. These are only found in the first days of
embryo development before the differentiation process begins.
3.10
Pluripotent cells have the potential to become any cell in the body but
have no capacity to form a whole being. Under the current legislation human
embryonic stem cells may only be obtained from donated surplus IVF embryos, and
then only under special licence. These are what we commonly refer to as
embryonic stem cells.
3.11
Multipotent stem cells are those that have entered a more specialised
stage and can only develop into a certain range of cell types. Human adult stem
cells, which generally fall into this category, are donated by people who have
given informed consent for their use in research.
3.12
Another source of human embryonic stem cells could be Somatic Cell
Nuclear Transfer (SCNT). This is a process commonly called cloning. It is
important to remember that the word cloning is used to describe replication of
single cells, genetic material as well as whole beings. It is vital that the
different outcomes are clearly acknowledged. The SCNT process is where the nucleus
of an egg is removed and replaced by one taken from a donor adult cell eg. a
skin cell. This is then stimulated and it behaves like an embryo produced by
sperm and egg. While the basic SCNT technique is the same as that used to clone
whole animals, this cannot happen in humans for several reasons:
- There has been and shall remain, if the Patterson Bill is passed, a
strict prohibition on SCNT embryos being implanted in the body of an animal or
human.
- They are also prohibited from developing beyond 14 days.
- Under the proposed legislation attempting to do either of these things
whether with intent or otherwise will attract a penalty of up to 15 years
imprisonment for the person or persons who tried to do it.
- Scientists
believe that the current indications are that the chances of these SCNT embryos
developing beyond the blastocyst stage are very remote.
3.13
The representatives of Do No Harm tabled at the hearing on Tuesday 25th
November an Editorial from Nature which says 'Whether taken from a fertility
clinic or made through cloning, a blastocyst embryo has the potential to become
a full functional organism'.[1]
This is exactly what the Lockhart Committee addressed in ensuring that an
embryo created by SCNT is encompassed by the definition of embryo.
3.14
This technique is widely used in animal research but is currently
prohibited in Australia using human cells. However it is not illegal in, for
example, the United Kingdom, USA, Singapore, and Sweden. As yet, researchers
have not been able to successfully produce human embryonic stem cells using
SCNT however this technique is less than 10 years old.
3.15
SCNT requires a source of ova. The bills propose these can be donated
human ova or animal ova. Concern has been raised about the potential for
exploitation of women as egg donors and also the ethics of using animal eggs in
the research. It is important to stress that both bills prohibit the
commercialisation of human egg donation and insertion of any cloned human
embryo into the body of an animal or human. The notion of informed consent is
an integral part of any medical procedure.
3.16
There is research that has pointed to the possibility that some
multipotent cells possess plasticity and may be able to develop into more than
one cell type making them more like pluripotent cells.[2]
Other research has recently shown that it is possible to re-program specialised
cells to behave like pluripotent cells.[3]
This is promising new research, as if proven it could remove the need to use
human ova. However SCNT research using ova remains pivotal to advancing this
new research which winds back the cellular clock because we need to understand
what it is in the cytoplasm of the egg that causes the donor nucleus in SCNT to
behave like that of an embryo formed by sperm and egg.
The Lockhart Review Committee
The Lockhart Committee Membership
3.17
The Lockhart Committee was appointed by the then Minister for Ageing, the
Hon. Julie Bishop, and the membership was agreed to by the States and
Territories.
3.18
The membership comprised a group of six eminent Australians. It was
chaired by the late Hon. John Lockhart and included Professor Barry Marshall
whose work, undertaken with Dr Warren, discovering the link between the
bacteria Helicobactor pylori and gastric ulcers, was recognised in October 2005
when they shared the Nobel Prize in Physiology or Medicine.
3.19
The Committee in the Reports and in the Executive Summary detail the
process of the extensive Review they undertook.
3.20
It was of concern to the majority of the Committee that a description
such as 'a poorly outfitted group'[4]
was used by those opposed to the recommendations of the Review to describe the
members of the Lockhart review and their work.
3.21
Professor Sherley's attack on the credibility of the members was rejected
outright by the majority of witnesses appearing before the Committee. The
members of the Lockhart Committee also rejected this unwarranted criticism.
3.22
In his evidence to the Melbourne Inquiry, Professor Graham Jenkin from
Monash Immunology and Stem Cell Laboratories cited an interview with Bob Klein,
Chairman, California Institute for Regenerative Medicine:
The American Medical Association, the California Medical
Association and a group of 80 Nobel Laureates each independently reviewed the
potential stem cell science and reached similar conclusions. What is more,
these independent reviewers fully agreed with the Lockhart Committee's key
position.[5]
What did the Lockhart Committee consider?
3.23
The Terms of Reference for the Lockhart Review were prescribed in the the
Prohibition of Human Cloning Act 2002 and the Research Involving
Human Embryos Act 2002. They were that the persons undertaking the review
must consider and report on the scope and operation of these Acts taking into
account the following:
- developments in technology in
relation to assisted reproductive technology;
- developments in medical research
and scientific research and the potential therapeutic applications of such
research;
- community standards; and
- the applicability of establishing a National Stem
Cell Bank.
3.24
The Acts required that the Lockhart Committee report must contain
recommendations about amendments that should be made to this Act, having regard
to the matters mentioned above.
3.25
They also required that the Lockhart Committee must consult:
- the
Commonwealth and the States; and
- a
broad range of persons with expertise in or experience of relevant disciplines;
and the views of the Commonwealth, the States and the persons mentioned in
paragraph (b) must be set out in the report to the extent that it is reasonably
practicable to do so.
What impact do the Lockhart
recommendations as proposed in the Patterson Bill have on the application of
the existing legislation?
3.26
The Lockhart recommendations and explanations for these can be found on
pages 162-183 of the Lockhart Report and are in Appendix 5.
3.27
In summary, the proposed amendments to the Prohibition of Human
Cloning Act 2002 and the Research Involving Human Embryos Act 2002:
- retain existing prohibitions on activities such as:
- placing
a human embryo clone in the human body or the body of an animal;
- importing
or exporting a human embryo clone;
- creating
a human embryo by fertilisation of a human egg by human sperm, for a purpose
other than achieving pregnancy in a woman;
- creating
or developing a human embryo by fertilisation of human egg by human sperm which
contains genetic material provided by more than 2 persons;
- developing
a human embryo outside the body of a woman for more than 14 days;
- making
heritable alterations to a human genome;
- collecting
a viable human embryo from the body of a woman for the purposes of research;
- creating
or developing a chimeric embryo;
- developing
a hybrid embryo beyond 14 days;
- placing
a human embryo in an animal, a human embryo into the body of a human other than
into the female reproductive tract or an animal embryo in a human; and
- importing,
exporting or placing in the body of a woman, a prohibited embryo.
- enable certain types of research involving embryos to be
permitted provided that the research is approved by the NHMRC Licensing
Committee (in accordance with legislated criteria) and that the activity is
undertaken in accordance with a licence issued by the NHMRC Licensing
Committee. In summary, a person may apply for a licence to:
- use
excess ART embryos;
- create
human embryos other than by fertilisation of a human egg by a human sperm, and
use such embryos;
- create
human embryos (by a process other than fertilisation of human egg by human
sperm) containing genetic material provided by more than 2 persons, and use such
embryos;
- create
human embryos using precursor cells from a human embryo or a human fetus, and
use such embryos;
- undertake
research and training involving the fertilisation of a human egg, up to but not
including the first mitotic division, outside the body of a woman for the
purposes of research or training;
- create
hybrid embryos by the fertilisation of an animal egg by human sperm, and
develop such embryos up to, but not including, the first mitotic division
provided that the creation or use is for the purposes of testing sperm quality
and will occur in an accredited ART centre; and
- create
hybrid embryos by introducing the nucleus of a human cell into an animal egg,
and use of such embryos.
3.28
Unless a shorter time is specified, the uses of embryos that may be
authorised by a licence may only be authorised for development up to 14
days (excluding any period during which development is suspended). In no
circumstances can any embryo be developed, outside the body of a woman, beyond
14 days.
3.29
The Patterson Bill gives effect to the recommendations of the Lockhart
Committee by either maintaining recommended prohibitions or making alterations
to the legislation where needed to reflect the recommendations.
The science
3.30
It is important to note that the main area of controversy is not the
merits or otherwise of embryonic stem cell research. This research has been
legal and widely accepted in Australia since the 2002 using donated surplus human
IVF embryos. The major disagreement is the permitting of SCNT as a potential additional
source of human embryonic stem cells. Many of those who argued against this
aspect of the recommendations object to using any stem cells derived from an
embryo that is destroyed in the process. That is, their objections go beyond
SCNT to procedures that are already lawful.
3.31
Overwhelmingly Lockhart members, contributors and the majority members
of this committee in favour of the Patterson Bill acknowledged that an SCNT embryo
is defined as a human embryo. While respecting the individual’s right to see
the SCNT embryo as equal in status to that of an embryo produced by egg and
sperm, it is intrinsic in the recommendations of Lockhart and the Patterson
Bill that the continued prohibition of the creation of an embryo by egg and sperm
for any purpose other than ART demonstrates the difference in the intrinsic
value of the egg and sperm embryo.
3.32
Those in favour of the Patterson Bill argued that the central issue to
consider is whether the value of the SCNT embryo outweighs the potential that
SCNT research may offer living and future people for the prevention and
treatments of disease.
3.33
Most evidence the committee received in support of the Lockhart Review
and related bills focussed on the need and benefits of permitting somatic cell
nuclear transfer (SCNT) to produce embryonic stem cells. People in favour of
this bill were sensitive to those who believe that the intrinsic value of the SCNT
embryo is equal to that of an embryo created through natural fertilization using
egg and sperm. However they did not think that this belief should outweigh the
potential to help living people with the possible understanding of disease
process, therapies or drug testing the resultant SCNT ES cells may be used in
finding.
3.34
In the lead up and during the course of these hearings some people accused
scientists of 'peddling hope to vulnerable people' and misleading people using
'hype' by promising cures. The majority of the committee found those in favour
of this research to be measured and candid about the uncertainty of the outcome
of the research.
3.35
Interestingly upon perusal of a previous committee report on this same
issue it appears that a simular view point was expressed by one of our
colleagues in the House of Representatives. In 2001 the Standing Committee on
Legal and Constitutional Affairs reported to the House of Representatives
through its chair The Hon Kevin Andrews that:
...the Committee has heard from many people. Scientists have
shared their excitement about the discovery of techniques that could open
future possibilities of cures for life threatening conditions. Families of
people with disabilities have welcomed the prospect that some day relatives
with Parkinson’s or Alzheimer’s disease might be restored to health. Yet
researchers have cautioned also that such treatments remain speculative, and
warned against raising hopes prematurely. In the case of Alzheimer’s, the
disease process has not even been identified.
3.36
It is the opinion of the majority of this committee that the claim that
reputable scientists are hyping the potential of this research is
inappropriate.
3.37
An overwhelming number of scientific contributors stressed that before
we could expect to develop therapies we needed to understand how cells develop
and differentiate and how disease processes occur at a cellular level. They
also argued while this research remained prohibited any hope of finding
therapies would be delayed and that stem cells derived by this technique would
assist in our understanding of cell biology and in developing therapies for
genetic disease. Many also argued that this knowledge would also provide
greater potential for identifying adult stem cell treatments.
3.38
Supporters also suggested variously that:
- Existing legislation was being overtaken by scientific development;
- Legislative differences over SCNT amongst jurisdictions were
causing leading researchers to leave Australia and was hampering collaborative
work with overseas institutions;
- The proposed amendments reflect a plurality of views; and
- The current regulatory framework is inconsistent by allowing
embryos created for ART to be used for stem cell research, but prohibits
creating cloned embryos from being created for the same purpose.
3.39
The Lockhart Review sought to establish the equivalence of these two
activities, saying in their report that:
...the production and destruction of such embryos is not
dissimilar to the production and destruction of excess ART embryos, which is
permitted by the legislation and widely accepted by society. Thus, to permit
one (production and destruction of ART embryos) but not the other (production
and destruction of nuclear transfer and other bioengineered embryos) is
inconsistent and appears to attach more importance to the treatment of
infertility than to the treatment of other serious diseases and conditions that
could be helped as a result of this activity.[6]
3.40
Dr Paul Brock indicated that the implementation of the Lockhart
recommendations would address legislative inconsistencies between the two acts:
The Lockhart Review put the focus on a current anomaly which the
proposed Bill will redress. The 2002 Australian legislation allowed for the
creation of human embryonic stem cell lines from fertilised human eggs that
have become surplus to the needs of IVF implantation – which means that they
would never be implanted into the woman’s uterus. But the 2002 legislation
currently does not allow creation of such human embryonic stem cell lines
derived from an unfertilised human egg in the SCNT process, which would also
never be implanted into the woman’s uterus. This is a logically and ethically
inconsistent situation.[7]
3.41
SpinalCure Australia also emphasised that allowing SCNT would be
comparable with the current treatment of excess ART embryos:
This type of embryo is not intended to be implanted, so the
production and destruction of such an embryo is not dissimilar to the
production and destruction of excess IVF embryos, which is permitted by
legislation and accepted by society. Therefore denying SCNT but allowing IVF
research implicitly values infertility treatment more than potential cures to
chronic diseases.[8]
3.42
Likewise, Professor Melissa Little indicated that, in the context of
already allowing research on excess ART embryos, the Lockhart Review's
recommendation to allow SCNT presented the same ethical questions as those
addressed in 2002. Referring to the current legislative arrangement, she
stated:
This acknowledges that, while not the opinion of all in our
country, our society does not regard the blastocyst as having equivalent rights
to an implanted embryo, fetus or a postnatal human being. A blastocyst is a
ball of undifferentiated cells with no capacity to self-sustain or to
differentiate without successful implantation into a womb. It is a seed. It has
potential and no more. We condone the discard of such tissues as a part of IVF,
hence there is no additional ethical dilemma in using these cells for some
other purpose...
The Lockhart committee reaffirms the acceptability of our
existing legislation with respect to the regulated derivation of new human ES
cell lines.[9]
The case for SCNT Research
3.43
While the obvious argument in favour of allowing human SCNT research to
take place in Australia is the potential medical benefits human embryonic stem
cells in general may bring, we are reminded that as yet no human ES cells been
derived from this process. Scientists point out the catch-22 that until the ban
is lifted research cannot progress in Australia. Many scientists who
contributed to the debate pointed out that SCNT research in animals has shown
that this technique has specific value over and above that of ES cell research
using egg and sperm derived embryos.
Creation of Disease-Specific Embryonic
Stem Cell Lines
3.44
Because SCNT techniques involve cloning of donated adult cells we would have
the opportunity to seek donations of cells from people with identified diseases.
This could allow targeted research into particular diseases.
...if we wish to generate pluripotent cell lines in order to gain
insights into certain complex diseases, there is currently no alternative to
the generation of disease-specific embryonic stem cell line [other than ] via
SCNT.[10]
3.45
These disease-specific stem cells lines would allow scientists in
multiple laboratories to work on cells known to have genetic problems at the
same time. These cloned cells could be used to gain better understanding of
those disease processes at a cellular level, test drugs and hopefully derive
therapies.
3.46
Professor Jack Martin, one of the few respected scientists who objected
to this research, based his argument on the notion that there have been no
therapies derived from ES cells and there was no 'proof of concept' to justify
lifting the prohibition on SCNT. Other scientists disagreed, as well
illustrated by Professor Martin Pera’s comment to the committee where he stated:
...with respect to the statement that there are no [human]
therapies from cloned embryonic stem cells, of course there are not because
research has not been done on a human yet that would enable it. However, there
is proof of concept in animal studies that you can treat disease with such an
approach.[11]
Better understanding of ageing
process and cancer
3.47
It is known that as we age our genetic material deteriorates and SCNT
technology allows exploration of the cellular ageing process which could lead
to a better understanding of conditions such as cancer.
Understanding de-differentiation
3.48
Concern has been raised about the need to use donated human eggs in
order to perform SCNT research. It has been pointed out that promising new
research uses insertion of certain proteins into an adult cell to stimulate it to
regress to a pluripotent stem cell-like state. This could mean that the need
for human eggs may be reduced or even eliminated if this research can be
replicated. However scientists point out that SCNT research is vital in
advancing this new research as de-differentiation of the adult cell is an
intrinsic part of the SCNT process and so SCNT research allows the ideal arena
to further our understanding of de-differentiation.
3.49
Sir Gustav Nossal encapsulated the argument in support of lifting the
prohibition on SCNT. He wrote:
Embryonic stem cell research is rich in promise. It has already
demonstrated its potential in the study of disease causation, in development of
new diagnostic methods and in basic research. In the longer term, the
possibility of new therapies for serious diseases is real, though this will be
the work of decades rather than of years...
Stem cell science has advanced to the point where it is pushing
against the boundaries of current legislation. It is time for the next step.[12]
3.50
The Monash Immunology and Stem Cell Senior Researchers (The Monash
Researchers) supported permitting SCNT on the basis of its potential to treat a
number of incurable diseases:
Access to somatic cell nuclear transfer (SCNT) technology is
critical to study the causation and treatment of many common, yet complex human
diseases, including many types of cancers and neurodegenerative diseases such
as Motor Neurone Disease (Lou Gehrig’s Disease or AML), Parkinson’s Disease,
Alzheimer’s Disease, Multiple Sclerosis, Muscular Dystrophies, and numerous
other debilitating conditions... It is important to emphasise that neither
embryonic nor adult stem cells (as opposed to SCNT derived stem cells) are able
to provide an adequate research platform for study of disease processes such as
those listed above, neither are diseased cells derived from the lesions able to
be expanded sufficiently in vitro for detailed analysis. The advent of SCNT
circumvents these issues and provides a unique opportunity to examine such
disease states.[13]
3.51
A number of disability support groups argued similarly with Kidney
Health Australia submitting that:
Embryonic stem cells offer great hope to patients with kidney
disease, because potentially they can be induced to form any cell type of the
human body, including any type of kidney cell. So if a cell type in the kidney
(of which there are approximately 30 different types) is being lost due to
disease, or parts of the kidney have been damaged or destroyed by disease,
embryonic stem cells offer the promise of replacing these lost cell populations
and/or repairing regions of the kidney.[14]
3.52
Professor Melissa Little, in discussing the potential for therapeutic
applications, suggested that improvements in understanding cell biology and drug
screening would constitute the main benefits. Professor Little is researching
treatments for kidney disease at the University of Queensland and wrote:
While the long-term objective is obviously some advancement in
medical science, it is possibly more likely that research into stem cells will
not lead to the cures that we currently imagine. I would argue that there is
likely to be two often undiscussed outcomes of this research that may well have
far greater implications for human health and a much greater chance of being
delivered. The first of these is increased biological understanding. Our
fundamental understanding of how a cell is directed to become a specific type
of cell remains vague. The fact that there is an ability to change the fate of
a cell such that it takes on another form is only just becoming accepted in
cell biology and this has come out of recent advances in stem cell science. How
and when and why this happens during normal processes of response to injury or
disease can start to be addressed by investigating processes such as how a
nucleus is reprogrammed during somatic cell nuclear transfer. This will have
very broad implications for our understanding of biology and medicine. It may
also ultimately allow us to avoid the derivation of a blastocyst at all, which
would be a position morally acceptable to all. The second outcome of stem cell
research that is often overlooked is the development of such cells as screening
tools. To have a supply of potentially patient-specific human cells to screen
compounds in development for human use is very likely to revolutionise the
pharmaceutical and biotechnology industries and lead to increased safety in new
products.[15]
3.53
The Australian Stem Cell Centre also stated that SCNT would assist in greater
understanding of genetic diseases:
SCNT offers a unique approach to the study of genetic disorders
in humans. The availability of such cell lines would enable the study of the
cellular basis of disease susceptibility, an understanding of the evolution or
trigger for the emergence of a genetic disease in the very early human and the
testing of hypotheses concerning the involvement of specific genes for patients
suffering from a number of serious diseases. [16]
Adult and embryonic stem cell complementarity
3.54
There was no witness or submission where support for embryonic stem cell
research was expressed that was not also in favour of concurrent adult stem
cell research. These supporters spoke of the importance of both arms of stem
cell research.
3.55
Many opponents of SCNT have argued that there is little justification
for crossing ethical barriers to develop embryonic stem cells when adult stem
cells offer greater therapeutic promise. However this is not an argument against
SCNT per se but rather objection to the general notion of embryonic stem cell
research.
3.56
Conversely, submitters supportive of the Lockhart recommendations argued
that research on embryonic and adult stem cells should be undertaken
contemporaneously, thereby improving the overall understanding of stem cell differentiation
and the potential applications of stem cell therapies, from both adult and
embryonic stem cells.[17]
3.57
Senator Stott Despoja emphasised this issue in her tabling speech:
We should be wary of advocating one type of research over the
other. Each has its strengths and weaknesses – such as the pluripotency
(ability to differentiate into any body cell) of embryonic stem cells versus
the more limited multipotency (restricted to certain cell types) of adult stem
cells – although new research is challenging this idea. Embryonic stem cells
also have the unlimited capacity to keep dividing.
Most scientists agree that both forms of research must be
pursued in the quest for knowledge of diseases and conditions and potentially
treatments; that neither area of research can single-handedly provide all
treatments.[18]
3.58
The Monash Researchers noted the complementary nature of research in
this field commenting that: 'Knowledge about one or other cell type will in all
probability enhance the breadth and efficacy of the applications of the other'.[19]
Similarly, Professor Tuch and Dr Sidhu stated: 'only by encouraging research
with all forms of stem cells will benefits result to the community, both of a
scientific and therapeutic nature'.[20]
3.59
The Federation of Australian Scientific and Technological Societies also
suggested that it would be 'premature' to give preference to one aspect of stem
cell research over another:
...the rapidity and intensity of the field means that results in
both adult and embryonic stem cell research in Australia and internationally,
have, in many cases, not been replicated or confirmed (and this is to be
expected given the time frames involved). Thus it is premature to make
definitive statements about the efficacy of different research or potential
clinical techniques. Indeed, the scientific evidence suggests it is highly
desirable that a variety of techniques both within and across adult and
embryonic stem cell research and other tissue regeneration research programs
are supported.[21]
3.60
Professor Barry Rolfe argued that comparisons between the two types are
needed to progress adult stem cell therapy:
The advances being made in research into adult stem cells should
in no way preclude research using embryonic stem cells. I am studying the
concept of stem cell reprogramming and it is clear from the research to date
that we need as many comparisons as possible to work out how to go forward from
a totipotent stem cell to a defined pluripotent stem cell type and how one
might progress “backwards” from a pluripotent cell to a true totipotent cell.
Resolution of this question could help to bypass all the future fuss over
embryonic stem cells. We cannot possibly know what such research may lead to,
so a comparison is very valuable.[22]
3.61
Professor Bob Williamson from the Australian Academy of Science and who
works with adult stem cells explained the need to research both embryonic and
adult stem cells:
We believe that stem cell science represents a real opportunity
for better clinical care. I actually work exclusively with adult stem cells,
and perhaps I will make the point around that: why do I as an adult stem cell
scientist believe that somatic cell nuclear transfer and embryonic stem cell
research is important? Embryonic stem cells have two very important properties
that are positive. One is that they can differentiate; they can give any cell
type in the body. Adult stem cells cannot transdifferentiate in general and, as
you get older, they become less and less likely to transdifferentiate. So,
although it is possible to get liver cells from an adult to form more liver
cells, and bone marrow cells to form bone marrow cells, we cannot get those
cells to form heart muscle, neurones and so on. Only embryonic stem cells can
do that.
Only embryonic stem cells have the capacity to grow and grow and
grow indefinitely—their second important property. Adult stem cells stop
growing after 15, 20 or 25 generations. Because we need to understand these
properties, we need to use research in ES cells to teach us how to use adult
stem cells. Adult stem cells have two great advantages: one is that they are
safe and the second is that they will not be immunologically rejected.
My personal view as an adult stem cell scientist is that we need
to encourage this kind of research.[23]
3.62
Professor Phil Waite from UNSW stated that it was too early to predict
the potential of embryonic stem cells as 'research on human embryonic cells has
been underway for just 8 years, compared with 50 years for adult cells' and emphasised
the need to better understand both types of stem cells:
...it is clear that adult and embryonic stem cells are
fundamentally different. We need to understand the basic science of these cells
and their differences before we can determine which would be most useful for
the many disorders we seek to treat...Clearly we should not shut the door on
any one type before we know its potential.[24]
3.63
Stem Cell Sciences Ltd contended that the focus should be on appropriate
regulation, rather than the merits of adult over embryonic stem cells:
As a Company actively exploring the therapeutic potential of
different stem cell types, including both adult and embryonic stem cells, we
believe that it is not yet clear which stem cell type will be of most value in
certain therapeutic indications and that both must be pursued in order to
deliver the most effective and safest medical outcomes. The debate surrounding
the Lockhart Review recommendations should not be about which type of stem cell
is superior but about how to regulate valuable and necessary research to advance
regenerative medicine in Australia.[25]
3.64
The Australian Stem Cell Centre submitted that allowing SCNT research
could improve adult stem cell therapies such that many of the ethical dilemmas
central to this debate could be overcome:
SCNT should be viewed as an important tool for reprogramming an
adult cell genome in an experimental environment and not as a procedure related
to reproductive biology to achieve a live birth.
Understanding the reprogramming of an adult cell nucleus to
achieve a more flexible or plastic state would have far-reaching beneficial
implications for biology and medicine. Ultimately, SCNT may deliver an
understanding of those unidentified factors within an egg cell that can
reprogram the behaviour of a mature cell, these findings might eventually
obviate the need to use eggs or produce embryos at all, because it could be
applied directly to the reprogramming of adult cells. In addition,
understanding reprogramming would also increase our knowledge of adult tissue
stem cell plasticity (the conversion of one type of tissue stem cell into cells
of another tissue). This important area of SCNT is currently entirely closed to
Australian researchers.[26]
What has changed since 2002
3.65
Opponents of the Lockhart recommendations claim that nothing has changed
to justify relaxing of the current legislation. Some scientists who gave
evidence supported this view for example Professor James Sherley and Emeritus
Professor John Martin. However the overwhelming majority of scientists who
provided evidence to the inquiry refuted this claim. They provided a
significant number of peer reviewed journal articles clearly demonstrating that
the claim is baseless. In addition opponents referred to the report
commissioned by the government by MP consulting. However this document has attracted
controversy over the narrow terms of reference given to the consulting firm. It
has been claimed that the scope was so limited that the findings were
predictably in favour of the premise that there was little change in 'the state
of play':
I have read the MP Consulting document...I genuinely do not
believe that the MP Consulting document has any credibility. I say that first
because the MP Consulting document was prepared in private, without taking any
evidence, without inviting any evidence, without allowing any rebuttal; whereas
Lockhart took evidence in public debate.[27]
I understand that the MP Consulting document had a much narrower
range and brief and they were asked to assess the state of play. I was a little
concerned that the state of play was almost to look at public announcements and
commentary and not necessarily the scientific merit and justification.[28]
Stem cell science is pushing up against the boundaries of the current
legislation.[29]
3.66
Advocates of SCNT described the limitations of what can be achieved
using stem cells derived from ART embryos, which usually do not have specific
disease characteristics. Evidence was provided that there had been advances in
embryonic stem cell research since the passage of the Acts, which give weight
to the contention that the legislation was being overtaken by developments in
the field.
3.67
The Victorian Government provided the Committee with a report titled
'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'. The Australian Academy of
Science also referred to this review and provided a commentary prepared by Sir
Gustav Nossal and Dr Graham Mitchell on technological developments over the
past few years in the field of human stem cells in regenerative medicine. They
concluded:
In the opinion of these reviewers and in the current and
appropriate cautious and regulated environment, a broad SCNT approach is required
for stem-cell based regenerative medicine to achieve its undoubted promise. On
the specific question of whether the field has actually progressed in a
technological sense, we can respond unequivocally in the affirmative.
Formidable challenges confronting the field have been addressed particularly
around the generation of clinically-acceptable human ES cells and
production of medically-relevant tissue cells from human ES cells
(tested in animal systems). SCNT appears to be the best current approach to address
the fundamental issue of rejection by the recipient of transplanted cells.
Finally, very obvious progress has been made in the use of ES cells and their
progeny in cell-based screening for new drugs, for toxicology assays, and for
the identification of molecules involved in ES cell renewal and, conversely,
differentiation into tissue cells.[30]
3.68
A Literature Review 'Human embryos, stem cells and cloning –
developments in research and regulations since 2001' prepared for the
Department of Health and Ageing in August 2005 noted that:
Research on the growth and differentiation of stem cells for
scientific investigations, development of cellular therapies and investigation
of disease development has increased rapidly since 2001. Most work has focused
on rodent, nonhuman primate and human embryonic and adult stem cells. The
literature in this area is vast and we have only been able to include the most
general reviews and summarise the main issues relating to embryonic and adult
cell types.[31]
3.69
Professor Phil Waite, who is comparing embryonic stem cells, adult bone
marrow stem cells and olfactory stem cells in spinal cord injury, listed the
following recent advancements:
...research in the last few years has demonstrated that:
- Human embryonic stem cells can be differentiated into
myelin producing precursor cells and made in sufficient numbers and purity for
human use.
- Human embryonic stem cells can repair
demyelinating lesions in mice.
- Human embryonic stem cells can improve locomotor
function in a rat model of spinal cord injury.
- Adult stem cells migrated less well in the
spinal cord and mature glial cells would not remyelinate.
- Complications such as excessive growth of
teratomas were never seen.[32]
3.70
Advocates of SCNT stressed that the benefits that may occur through SCNT
were not available through excess ART embryos. According to Professor Little,
having access to disease-specific embryonic stem cells is significant:
...the derivation of hES cell lines [by SCNT] will enable us to
increase our understanding of normal development, abnormal development, nuclear
activity and our ability to reprogram one cell type into another. This
understanding will be of great importance to the development of new treatment
techniques and the manipulation of cell type during disease. To be able to
develop a human ES cell from a patient with a disease of development is likely
to give us significant insight into what has gone wrong in embryonic
patterning. Such understanding can never be gained by simply harvesting
existing hES cells from an IVF blastocyst.[33]
3.71
Stem Cell Sciences Pty Ltd state in their submission that 'since 2002
there have been several major publications that demonstrate the advances in
human embryonic stem cell research'.[34]
These include:
- Improvements
in the quality of embryonic stem cell lines towards generation of cells that
could be used for a clinical application;[35]
- Numerous
examples of differentiation and engraftment of cells derived from human and
animal embryonic stem cells in animal models;[36]
- Correction of genetic abnormalities in mouse embryonic
stem cells;[37]
- Value of embryonic stem cells in drug screening and
toxicology;[38]
- Demonstration
that stem cells generated from SCNT share the same characteristics as those
derived from a fertilised blastocyst in animal models;[39]
- Basic proof-of-concept that stem cells generated by
SCNT could partially restore function in animal models;[40] and
- Value of SCNT to investigate epigenetic factors
including cancer characteristics in animal models.[41]
3.72
Monash Immunology submitted that recent advances in stem cell research
provide unparalleled opportunities to explore cell and tissue development, to
enable tissue repair, and to lead to new treatments and drug discoveries that
could limit or ameliorate degenerative diseases. Research involving both adult
and embryonic stem cells should be pursued with rigor and intensity to
determine the efficacy and safety of new medical treatments based on cell
therapy and associated discoveries.[42]
3.73
They cited many of the same publications that Stem Cell Sciences Pty Ltd
did as the key publications on transplantation of human/primate embryonic stem
cells into preclinical animal models of human disease and injury and also:
- Banin
E, et al. 2006. Retinal incorporation and differentiation of neural precursors
derived from human embryonic stem cells. Stem Cells 24(2):246-257; and
- Lund
RD, et al. 2006. Human embryonic stem cell-derived cells rescue visual function
in dystrophic RCS rats. Cloning and Stem Cells 8(3): 189-199, 2006
3.74
At the Melbourne Hearing they tabled another highly relevant article
that had been published since the hearing commenced which highlighted the speed
at which this research is moving forward:
- D’Amour
et al, Production of pancreatic hormone-expressing endocrine cells from human
embryonic stem cells. Nat Biotechnol. 2006 Oct 19; [Epub ahead of print ] Jurisdictional
implications for Australian research.
Jurisdictional discrepancies
3.75
Somatic cell nuclear transfer is currently legal in the following
countries: Belgium, China, Japan, Mexico, New Zealand, South Korea, Singapore, South
Africa, Sweden, Thailand, United Kingdom and United States of America.[43]
3.76
The committee was warned of the implications of legislative differences
on SCNT between Australia and these countries. First, Australian scientists
working in the area of embryonic stem cell research would leave Australia,
usually for the United States, to pursue their research. Secondly, a more
restrictive regime in Australia would adversely affect collaborative projects
being undertaken with overseas institutions operating in jurisdictions where
the practice is legal.
3.77
The Coalition for the Advancement of Medical Research in Australia
(CAMRA) argued that prohibiting SCNT was encouraging leading stem cell
researchers to move overseas:
Australia has been a leader in stem cell research. Earlier this
year we lost our top human embryonic stem cell scientist, A/Professor Martin
Pera, to California. Last month we lost one of our top adult stem cell
scientists, A/Professor Paul Simmons, to Texas. This will continue.[44]
3.78
The Australian Stem Cell Centre confirmed this trend:
Without the ability to perform SCNT, elite researchers remaining
in Australia will always be behind the lead of the top researchers in the United
States, United Kingdom and other countries where SCNT is lawful. Inevitably,
without the ability to perform SCNT and collaborate on SCNT projects, the
strategy and outlook for the Centre will also be hindered. A number of key
senior scientists have this year left Australia for the United States where
SCNT is permitted and considerable funds are available. The length of time the
legislative review has taken to date and the uncertainty in the outcome is a
significant deterrent to the Centre being able to attract leading scientists,
from this field, to come to Australia. It is also a significant risk to the
stability of the Australian scientists working in this field at present.[45]
3.79
Legislative differences between different jurisdictions where stem cell
research is carried out also have implications for collaborative research. The
Australian Stem Cell Centre indicated that unless the Lockhart recommendations
were implemented, it would be impeded in:
...establish[ing] important scientific collaborations with
highly regarded research groups in jurisdictions that allow activities that are
not currently allowed in Australia under Australian law (particularly key
groups in the UK and the US).[46]
Reflecting plurality in legislation
3.80
Another argument in support of the Lockhart Review and the bills was
that a vociferous minority should not be able to force the prohibition of
activities supported by a significant proportion of the community. This view
holds that in a liberal society with a wide diversity of views, the moral and
ethical opinions of one section of the community should not be imposed on
another.
3.81
The Lockhart Committee contended that the arguments used to oppose
embryo research and SCNT did not justify its legal prohibition:
The Committee was acutely aware of the special moral status
attached to embryos and the concerns that many groups, particularly Christian
churches, had regarding their destruction. But the Committee also recognised
that not all communities in Australia attach the same significance to the
embryo, and that other concerns, such as the need to care for the sick and
vulnerable and respect the wishes of individuals, are also morally important.[47]
3.82
Dr Paul Brock, who has motor neurone disease, agreed that in a pluralist
society no one view should dictate ethical standards:
In any multi-cultural, multi-faithed and non-faithed secular
democratic society such as ours, the formulation of principles of ethical
standards cannot be based exclusively upon any or only one religious creed, or
denomination, or sub-denominations.[48]
Evidence supporting other specific Lockhart Recommendations
Amending the definition of an
embryo
3.83
Presently, the Acts define a human embryo 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 pro-nuclei or
the initiation of its development by other means.'[49] The definition proposed in both the Patterson Bill
and Stott Despoja and Webber exposure draft bill is as follows:
human embryo means a discrete entity that has
arisen from either:
- the
first mitotic division when fertilisation of a human oocyte by a human sperm is
complete; or
- 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.
3.84
The Lockhart Committee advised Senators Patterson and Stott Despoja that
it was their intention that this definition be consistent with the NHMRC
discussion paper titled 'Human Embryo – A Biological Definition',[50]
which was being prepared at the same time as the Lockhart Report was being
finalised for publication. This is reflected in both bills.
3.85
The Lockhart Committee noted that while the 2002 legislation enabled
scientists to continue ART research, the choice of definition for a 'human
embryo' in the Acts:
Has had the apparently unintended consequence of impeding
valuable research and clinical practice in ART clinics. In particular, the
legislation has stopped research on culture and maturation of immature eggs
(called ‘in vitro maturation of oocytes’, or IVM), storage of frozen eggs,
various aspects of IVF, and gamete (egg and sperm) development. Research on
maturation of eggs has been further prevented by the prohibition on oocyte
activation (also called ‘parthenogenesis’). The ability to produce mature eggs
in culture provides a way of reducing the treatment of woman with follicle
stimulating hormone, which would benefit many women undergoing ART. It may also
allow production of mature eggs from frozen ovarian tissue, thus allowing women
who have undergone chemotherapy or other treatments that reduce ovarian
function to have their own genetic children.[51]
3.86
Any attempt to define 'human embryo' will always be contentious. In
their report the Lockhart Committee clearly explain their reasons for
recommending change to the existing definition in the Acts. Professor Wendy
Rogers emphasised the importance of achieving legislative clarity by referring
to an observable marker:
As fertilisation is a process which occurs over time, rather
than a discrete event, any definition relating to embryos created by
fertilisation of an egg by a sperm will be somewhat arbitrary in the sense that
it selects one moment in the process as the marker to define when a human
embryo begins to exist. The NHMRC definition uses a biologically observable
feature (first mitotic division) to anchor their definition for an embryo
created for reproductive purposes, thereby clarifying what is and is not a
human embryo in ways that can be verified, as opposed to using syngamy which is
not as easily observable.[52]
3.87
With regard to the definition's treatment of embryos created by means
other than fertilisation of an egg by a sperm, she commented:
For entities created in other ways, the potential to develop to
the point of appearance of the primitive streak indicates that a human being
might ensue from the process, whilst excluding other entities that have no
potential to develop into a human being. Recognition of potential is one of
reasons often cited for giving moral regard to embryos, so that recognising
this in the definition is consistent with widespread moral views.[53]
3.88
Professor Susan Dodds suggested that the legal definition of an embryo
should seek to provide legal clarity, rather than resolve ethical differences.
This, she stated, was achieved by the proposed definition:
The ethical differences that exist in the community regarding
the moral status of embryos cannot be resolved by legal artifice, and laws that
depend on a particular ethical perspective for their interpretation are likely
to be found to be unjustified. For that reason one of the most important
features of both Bills is that they offer a noncircular definition of the human
embryo that uses objective, observable, scientific features of the development
of fertilised oocytes into embryos to establish the scope of the legal
provisions... Researchers ought to be confident (at least so long as the
science supports first mitotic division and development of the primitive streak
as clear identifiers) that they can predict when and whether the laws apply to
their research.[54]
3.89
Support for the proposed definition was provided by the Fertility
Society of Australia which recognised the scientific justification for the
proposed new definition:
The inclusion of the revised definition of an embryo is useful
in acknowledging that fertilisation is a dynamic process and cannot be defined
until a physiological marker is observed.[55]
Obtaining fresh embryos for research
3.90
Lockhart Recommendations 20-22 and Schedule 2, Items 4 and 24 of the
Patterson Bill seek to enable prior consent to be granted for the use of fresh
embryos, regarded as 'unsuitable for implantation', for research. This
unsuitability would be determined by being either diagnosed with a genetic
abnormality prior to implantation, or by being deemed otherwise unsuitable
against objective criteria. Support for allowing these categories of embryos to
be obtained in a fresh state for research purposes focused mainly on the
benefits of studying embryonic stem cells carrying known genetic deficiencies.
3.91
The Australian Stem Cell Centre wrote of the potential advances possible
should this activity be permitted:
Currently, scientists are unable to obtain IVF created embryos
(created for the purpose of reproduction) affected by an inherited genetic
disease, deemed unsuitable for implantation. ... The potential benefits for the
study of disease by developing disease-affected stem cell lines, with
appropriate consent from the donors, could have many uses from understanding
the genetic triggers and processes during the onset of disease to using the
cells for the development of new drugs and treatments for such diseases.
3.92
The Monash Researchers stressed the importance of creating stem cell
lines with known genetic abnormalities:
...new embryonic stem cell lines need to be established from
embryos with diagnosed genetic abnormality and inheritable genetic disease (eg.
Huntington’s Disease, Cystic Fibrosis, Thalassaemia, Muscular Dystrophy),
donated by couples having IVF and preimplantation genetic diagnosis of such
serious genetic disease. Collectively these will generate research tools that
will be a new and unique resource for gaining improved understanding of these
serious disease conditions and for development of potential new treatment
strategies.[56]
3.93
Professor Wendy Rogers, a specialist in medical ethics and health law
from Flinders University, expressed support for Lockhart's recommendation on
unsuitable embryos identified through pre-implantation genetic diagnosis
(PIGD). She wrote:
I believe that couples can give informed consent to research
with these embryos without the 2 week cooling off period on the grounds that
they have spent considerable time and effort in reaching the point of PIGD, and
are aware of the possibility of some of the embryos being unsuitable for
implantation. In these circumstances, it is not wrong to allow discussion of
the fate of the embryos that will not be used for attempting pregnancy prior to
the results of tests which will identify any such embryos. Allowing donation of
unsuitable embryos for research allows the donating couple to retrieve some
good from the process, and also allows them to express agency in ways that we
usually recognise in Australia. Other couples with ART embryos that are not
required for reproductive purposes have the opportunity to donate their embryos
for research if they so wish; making this change in the legislation will accord
couples with PIGD-identified unsuitable embryos the same options.[57]
3.94
Her support for the use of fresh ART embryos was, however, limited to
those identified through PIGD. Professor Rogers submitted that identifying
other embryos as 'unsuitable', by objective criteria, was more problematic:
The process of judging the quality of embryos when choosing
which to implant is a very inexact science, and any embryos judged as “less
vigorous” on clinical grounds alone should not be considered for use in research
when fresh if there is any chance that they might be considered for
implantation at a later stage.[58]
3.95
The Authors of this Chapter noted that recommendation 32 calls for the
NHMRC to develop guidelines for egg donation and considers that Professor Rogers'
comments should be referred to the NHMRC to be considered when developing the
guidelines.
Allowing the international exchange of genetic material
3.96
Lockhart Recommendation 41, Schedule 4 of the Patterson Bill and
division 2, clause 19 of the Stott Despoja and Webber exposure draft bill seek
to enable the import or export of a patient's reproductive material, including ART
embryos, subject to quarantine regulation. ACCESS supported this measure to
remove 'previously burdensome requirements for people needing to import or
export embryos to continue their ART treatment in another country'.[59]
3.97
Also, Recommendation 42 of the Lockhart Review, Clause 23C of the
Patterson Bill, and division 2, clause 18 of the Stott Despoja and Webber
exposure draft bill would enable researchers to access embryonic stem cell
lines from overseas provided they were derived in a manner consistent with
Australian legislative requirements. The Monash Researchers submitted that the
international exchange of stem cell resources should indeed be facilitated:
It is a
global research priority to derive pluripotent stem cells with a broad range of
diseases for scientific study. Collaborations for this endeavour will minimize
the duplication of effort and resources needed to derive these important cell
lines.[60]
3.98
The Australian Stem Cell Centre also supported a relaxation of the
regulations on exchanging such material. It suggested that this would improve
collaboration and enable donated eggs to be used more efficiently:
The Centre supports an amendment to the Customs (Prohibited
Imports) Regulations 1956 to allow Australian researchers access to stem
cells and stem cell lines derived from SCNT embryos developed overseas. If SCNT
becomes lawful in Australia as a result of this inquiry, co-extensive amendments
must be made to allow importation of SCNT-derived cell lines in order for
researchers in Australia to effectively use this technology and collaborate
with other international scientific groups. This would also ensure no
duplication of unnecessary stem cell lines, effectively minimising the number
of nuclear transfer embryos created and the number of human eggs used to create
those cell lines.[61]
National stem cell bank
3.99
The legislation does not expressly deal with the question of
establishing a national stem cell bank, as recommended by the Lockhart Review.
Senator Stott Despoja commented:
In this draft bill, I have not legislated for a national stem
cell bank. This is partly because a stem cell bank does not necessarily require
legislation. In fact, the UK has a national stem cell bank which does not have
a legislative basis. There are options for such a framework including the
possibility of establishing a stem cell bank along similar lines to that of
blood bank.
This bill requires the Attorney-General's Department and the
Department of Health and Ageing to examine in some detail the issues
surrounding a stem cell bank. The terms of reference are more detailed than
those under which the Lockhart Review was operating.[62]
3.100
In the Patterson Bill the proposed clause of 47b of the RIHE Act
requires the Minister to report to Parliament (within 6 months) regarding the
establishment of a National Stem Cell Centre and a national register of donated
excess ART embryos.
3.101
A number of submitters commented on this issue. Professor Tuch and Dr Sidhu
suggested that the new stem cell bank should operate across several cities,
using existing facilities, and perform the following functions:
- Storing
stem cell lines;
- Distributing
stem cell lines; and
- Acting as
an official site to deposit cell lines.
3.102
They further suggested that a central steering committee could be
established to maintain a registry of stem cell lines and make other decisions,
such as on storage and IP issues.[63]
3.103
The Australian Stem Cell Centre suggested that it, in conjunction with
the Major National Research Facility, is 'the logical organisation to oversee a
national stem cell bank as it has an existing cell storage facility and trained
staff'. Its submission outlined the following benefits of such a facility:
The formal implementation of an
Australian stem cell bank would enhance Australia’s reputation as a leading producer of high quality
cell lines. A national stem cell bank would have many positive features
including:
- ensuring regulatory and ethical compliance of
all cell lines deposited;
- standardising the quality of all cell lines;
- providing consistent complementary information
and service advice with all cell lines;
- conserving embryos; the Bank would reduce
duplication of research to produce specific cell lines;
- being a national (and eventually international)
resource by requiring compulsory deposition of all Australian derived cell
lines;
- providing an independent assessment of the
quality and standard of cell lines;
- being a database of historical records of
production and distribution of all cell lines;
- monitoring the import and export of cell lines;
and
- providing a central body for the independent
reporting requirement to licensing bodies.[64]
3.104
Professor Wendy Rogers insisted that stem cell resources remain in
public hands:
...there is a serious ethical issue of equity that arises when
tissues donated by Australians for the benefit of the Australian community
(including both researchers and patients) are then used to develop commercial
products for private enterprise. The products and profits from the research
involving SCNT and the development of stem cell lines including a stem cell
bank (should they proceed in Australia) should remain in public control, and
equally available within the public healthcare system. The current climate of
competition between the states for commercial biotechnology investment raises
concerns that there will not be public ownership of many resources donated by
Australian women for stem cell research. It is appropriate that any legislation
recognises the interest of those groups who provide the basic resources for the
development of potential therapeutic treatments in having access to those
treatments.[65]
Community Standards
3.105
Some of those opposed to the recommendations suggested the Lockhart
Committee had not adequately taken into account community standards in making
their recommendations. The majority of the Senate Committee are of the opinion
that this is not a valid criticism of them. The Lockhart Committee undertook
extensive consultation involving face-to-face meetings with key stakeholders,
public hearings and some private meetings (at stakeholders’ requests),
facilitated stakeholder discussion forums, and selected site visits. In
addition, the Committee reviewed the latest results of focus group and
telephone survey research by the Public Awareness Program of Biotechnology
Australia, and a literature review (commissioned by the NHMRC on behalf of the
Minister for Ageing) of recent scientific and technological advances in human
cloning, human embryo research and related matters, including stem cell
technologies.
3.106
Witnesses referred to the number of surveys relating to community
opinions on this research and questioned the independence of some, noting that
the use of particular wording, without appropriate context or background
information, could provide misleading results. Ms Joanna Knott from the
Coalition for the Advancement of Medical Research in Australia questioned the
independence of these surveys:
I am aware of quite a lot of research that has come out, but I
think that the Roy Morgan and ACNielsen research is truly independent. I am not
convinced that some of the other research is as convincing, because it is not
necessarily as independent.[66]
3.107
The majority of independent polls found consistently strong support for
research. Professor John McNeil also considered that the Morgan and ACNielsen
polls were more indicative of informed community opinion:
Of the four Australian studies that have been published, two of
them—the ACNielsen poll and the Morgan poll—have been conducted to what I would
regard as a good scientific standard through random telephone dialling. They
have come to quite remarkably similar conclusions.
The key issue is that the percentage of individuals who have
expressed opposition to the concept of stem cell research is roughly 11, 12 or
13 per cent—males and females—and the number that support research in these
studies has been in the majority: over 50 and usually 60 per cent. Quite a few
have not been able to offer an opinion.
There have been somewhat contrary results provided by the Sexton
Marketing study. But it is important to point out that it is recognised that in
an area like this, where there is a large degree of community ignorance, the
way a question is asked can have an enormous impact on the response that is
given. For example, a simple bald question like, ‘Do you support or oppose the
cloning of human embryos as a source of stem cells?’ would be regarded by me as
a rather emotive way of putting a question. And it is not surprising that
without a proper lead-in the results were somewhat different. The response to
that poll suggested that 51 per cent opposed cloning.
My attitude here is that without an introductory program that
explains the context in which the word ‘cloning’ was used it is very unlikely
that the majority of respondents actually understood what they were being asked
about. Therefore, I would pay less attention to this result than I would to the
ACNielsen and Morgan studies.[67]
Response to specific comments raised in opposition
3.108
This final section provides a response to some specific issues raised by
those in opposition to the recommendations and bills that are discussed in the
second part of this chapter.
Embryonic Stem cells and cancer
risk
3.109
Concern was raised by some opponents of the bill that embryonic stem cells
may, if injected into people, sometimes cause cancer, in particular teratoma. It
is the opinion of the majority of the Committee that this concern, while
important, does not require legislative change. These are the sorts of risks
taken into consideration before any new clinical trial involving humans is
permitted to proceed in this country. Also this issue applies to existing legal
research and is adequately covered by standard risk benefit analysis for
medical research and the current protocols under NHRMC and Therapeutic Goods
Administration.
Slippery slope argument and future
reviews
3.110
Opponents of the bills referred to the 'slippery slope' argument expressing
scepticism that a line would be drawn at SCNT. The Lockhart Committee rejected
the slippery slope view:
Allowing SCNT under licence will not inevitably lead to
reproductive cloning. The Australian community almost unanimously opposes it
and it should remain prohibited. However, the best safeguard against
reproductive cloning is restricting the degree to which embryos can be matured
and prohibiting them being implanted [sic] into women. It is reassuring that
there have been no instances of non-compliance with legislative and regulatory
requirements in Australia (where embryo research is allowed under licence) or
in the UK (where SCNT is allowed).[68]
3.111
Dr Paul Brock also rejected the proposition:
...the ‘slippery slope’ assertions of those claiming that embryonic
stem cell research would lead to human reproductive cloning are as hollow as
they are improperly alarmist. It’s like saying that fertilizer production and
nuclear medical research should be banned because terrorists can use these
processes and products to make bombs.[69]
3.112
Related to this argument were concerns that a future review of the Acts
would create pressure for further concessions. The Monash researchers supported
continuing legislative review to ensure that research developments were
recognised:
Since this field of research is developing rapidly, the Acts
should remain under review from time to time (eg 3 yearly) to enable new
unforeseen directions of research endeavour and benefits to be pursued for
treatment of otherwise intractable pathologies and injuries. It is not always
possible to predict the outcomes and direction of research and important new
developments which could be severely hampered unintentionally by inflexible
legislation.
3.113
Professor Susan Dodds also supported ongoing review of the Acts, but
suggested the process needs refinement when assessing 'community standards':
It is important that RIHE and PHC Acts and any amendments to
them should be regularly reviewed in light of scientific developments, legal
developments and evolving ethical attitudes (as is seen in the changes in
attitudes towards IVF over the past 25 years), nonetheless any group
responsible for such a review will need a tool or baseline or set of criteria
to be able to assess “community standards”, especially as it is accepted that
the underlying ethical differences in attitude towards human embryos at various
stages of development will very likely continue to exist.[70]
The recommendations of the Review reflect that temporally
compressed process and the critical reflection of the Review Committee on the
expert advice it received, while clearly acknowledging that there does not
exist a single set of community standards obtaining in these areas.[71]
3.114
Dr Megan Munsie from Stem Cell Sciences Ltd rejected the assertion that
proponents of SCNT would seek to incrementally push the legislative boundaries
each time a review occurs and explained that their position had not changed
since the original legislation was passed:
I think we are being consistent: three years ago we were asking
for the same thing. Three years ago we were asking to do somatic cell nuclear
transfer, and we have the bills we currently have. We have not changed our
position.[72]
3.115
The Lockhart Committee submitted that they had sought middle ground in a
highly polarised debate:
The Committee found from its community consultations, conducted
as part of the Review, that the views on this type of research are widely
polarised and that they cannot always be reconciled. Our report and its
recommendations proposed that a middle ground which reflected the values and
priorities of the community would be supported by the majority of Australians,
while recognising that some would consider that the recommendations went too
far, and others would argue that they did not go far enough.[73]
Availability of ova
3.116
The Majority of the Committee was impressed by the high value placed on
human ova by those working in the area of stem cell and ART research. They
referred to the ova as 'precious' and conveyed to the committee a sense of responsibility
in dealing with limited resource and the sensitivities surrounding their
donation. They also indicated their commitment to develop techniques that could
ultimately minimise the number required for research.
3.117
It should not be forgotten that any research must pass the vigorous
scrutiny of an institute ethics committee and NHMRC licensing requirements and
monitoring before it can take place. The Bill recommends guidelines for egg
donation. The Majority of the Committee are comfortable, without minimising the
significance of human ova, that the bill together with existing protocols for
informed consent regarding medical procedures puts this type of donation on a
par with any other human tissue donation.
3.118
There have been some exaggerated claims that thousands of eggs will be
required to develop and provide treatment for disease using SCNT research.
However these inflated figures were put in perspective by statements like those
of Professor Marilyn Renfree from the Australian Academy of Science where she stated
at the Canberra Hearing that it is hard to speculate on how many eggs would be
needed to research Parkinson’s disease, Alzheimer’s disease and Motor Neurone
disease because no-one has yet done it, particularly due to restrictions in
Australia. However, Professor Renfree does state :
...that we can understand stem cell biology and cellular biology
by using the surplus eggs from assisted reproductive technology treatments,
because once you have a few of those you can make a stem cell bank. They are
banks of stem cells that can, as Professor Williams said, be propagated
indefinitely, so you can multiply them into as many as you wish and distribute
them to various laboratories. Relatively few would be required.[74]
3.119
Claims were made that the demand for human eggs for use in SCNT research
could lead to unethical sourcing and possible commodification of human eggs.
Senator Stott Despoja refuted this idea in her tabling speech:
Some opponents of SCNT have warned that legalisation of this
technique may lead to the commodification of human eggs. It is important to
note that this bill maintains the current prohibition of the sale of human
eggs, sperm and embryos and clarifies “reasonable expenses” in relation to
permitting reimbursement of expenses for the supply of human eggs, sperm and
embryos.[75]
3.120
The Majority of the Committee notes that this is dealt with in a
compatible way in the Patterson bill and is comfortable that this bill
continues the strict prohibition of sale of eggs.
3.121
In his submission Emeritus Professor John Martin expresses concern that
by permitting the use of animal eggs to be used in SCNT research as a means to
conserve human eggs could lead to animal human hybrid clones being implanted in
an animal.[76]
This is absolutely not the case. He cites what he alleges as a deficiency in
the bill with regard to the prohibition of implantation of this type of embryo
into an animal or human body. With respect, Professor Martin has misinterpreted
the intent and meaning of this bill. Notwithstanding the preposterous notion
that any proposal for research of this nature would get approval from an
institute ethics committee or be consistent with the stringent guidelines and
protocols of the NHMRC, the bill clearly prohibits implantation of hybrid
embryos into the body of human or animals.
3.122
The definition of a human embryo is defined in the bill under Schedule
1. Clause 3b includes:
any other process that initiates organised development of a
biological entity of a human nuclear genome or altered human genome that has
the potential to develop up to or beyond the stage at which the primitive
streak appears.
3.123
And if the Bill is passed the definition of a human embryo clone will
remain consistent with the PHC Act in part 1 section 8 Definitions Clause (1)(2)
where it states that:
For the purposes of establishing that a human embryo clone is
a genetic copy of a living or dead human: (a) it is sufficient to establish
that the set of genes in the nuclei of the cells of the living or dead human
has been copied; and (b) it is not necessary to establish that the copy is an
identical genetic copy.
3.124
And so it follows that Part 2 division 1, 9 of the Bill applies to
hybrid embryos where it is clearly stated that it is an offence to place 'a
human embryo clone in the human body or body of an animal'. Such activity
would attract a maximum 15 years in prison.
3.125
The majority of the Committee hopes that Emeritus Professor Martin is
comfortable with this explanation as it is certainly the intent of the Committee
that no such embryo clone should be placed in the body of a human or animal.
3.126
Some opponents of the bill have cited Dr Peacock, Chief Scientist of Australia
as calling for the continued ban on using animal eggs in SCNT research. Dr Peacock
made the following statement in a stem cell briefing session on 13 September 2006:
In the Lockhart Review it was suggested that animal eggs could
be used for some of the research so that fewer human eggs would be required.
Many scientists think that using a nucleus and egg cell from different species
complicates the research. Most scientists regard this particular recommendation
to be of little importance.
3.127
Dr Peacock’s statement is not about banning but about safety which is
adequately covered by research and clinical protocols overseen by the NHMRC.
Conclusion
3.128
Australia has always enjoyed a leading role in biotechnology. We have
been at the forefront of in vitro fertilization since the first break throughs
in the 1970’s. Australian researchers were amongst the first to isolate human
embryonic stem cells in the late 1990s and the first to publish
proof-of-principle of somatic cell nuclear transfer (SCNT) in the mouse in
2000.
3.129
The 2002 legislation enacted the three year moratorium on SCNT research
as recommended by the 2001 report of the House of Representatives Standing
Committee on Legal and Constitutional Affairs (Human Cloning: scientific
ethical and regulatory aspects of human cloning and stem cell research) by
prescribing the legislative review which has come to be known as the Lockhart
review. It is the opinion of the majority of this committee that the Lockhart
Committee discharged their duties with sensitivity and honesty as they
carefully considered the risks and benefits to the Australian community as a
whole. They consulted appropriately and were thoughtful and fair in their
recommendation. They clearly explained every decision they made in language
understandable to all.
3.130
Kevin Andrews who chaired the 2001 committee concluded the foreword of
that report stating:
These are not matters to be decided behind closed doors by
scientists or lawyers, however expert and sincere, without widespread community
consultation. Nor are they matters that can be resolved by doing nothing. As a
society we are confronted with profound issues that require ongoing attention
and discussion.
3.131
The new legislation, if enacted will require that a similar review be
undertaken in a further three years in order to maintain appropriate public and
parliamentary scrutiny of this very important and sensitive research area.
3.132
It is the opinion of the majority of this committee that the
overwhelming weight of evidence presented before us must lead to the acceptance
of the recommendations of the Lockhart Committee.
|
Senator the Hon Kay Patterson
LP, Victoria |
|
Senator Natasha Stott Despoja
AD, South Australia |
|
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Senator Ruth Webber
ALP, Western Australia
|
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Senator Claire Moore
ALP, Queensland |
|
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|
Senator Carol Brown
ALP, Tasmania
|
|
Senator Kerry Nettle
AG, New South Wales |
|
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|
Senator Judith Adams
LP, Western
Australia
|
|
Senator Jeannie Ferris
LP, South Australia |
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