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Prohibition of Human Cloning for Reproduction and the Regulation of Human Research Amendment Bill 2006
This replaces the 27 November 2006 version of this Digest so as to remove ambiguities relating to access to stem cells, the National Health and Medical Research Council’s views on the definition of human embryo and the US position on funding stem cell research. This Digest contains some additional information on new sections 23 and 23A of the Prohibition of Human Cloning Act 2002 as proposed by Schedule 1, item 7 of the Bill. It refers to the definition of ‘precursor cell’ that is contained in section 8 of the Prohibition of Human Cloning Act 2002. It also provides additional information regarding the amendment moved by Senator Colbeck and the proposed legislative review to be conducted in three years time.
WARNING:
This Digest was prepared for debate. It reflects the legislation as introduced
and does not canvass subsequent amendments. This Digest does not have
any official legal status. Other sources should be consulted to determine
the subsequent official status of the Bill.
CONTENTS
Passage History
Purpose
Structure of the Bills Digest
Historical background
Scientific background
Policy background
International background
Ethical arguments regarding the human embryo
Financial implications
Main Provisions
Concluding Comments
Endnotes
Contact Officer & Copyright Details
Prohibition of Human Cloning for Reproduction and the Regulation of Human Research Amendment Bill 2006(1)
Date introduced: 19 October 2006
House: Senate
Portfolio: Private Member's Bill (Senator Kay Patterson)
Commencement: The operative provisions commence on Royal Assent. The substantive provisions contained in Schedules 1 to 4 commence on the day after six months from Royal Assent.
The Bill amends the Prohibition of Human Cloning Act 2002, the Research Involving Human Embryos Act 2002 and the Customs (Prohibited Exports) Regulations 1958 in order to implement most of the recommendations made by the Legislative Review Committee that had reviewed the operation of the two Acts in 2005.(2)
This Bills Digest is structured in the following way:
During the 1990s, research in assisted reproductive technology (ART) and human stem cells raised some new challenges. New techniques for creating a human embryo became possible, the creation of ‘Dolly’ the sheep in 1997 raised the possibility that cloning a human may become technically feasible, and research interest in cells taken from inside human embryos (so-called ‘embryonic stem cells’) increased. These developments raised significant ethical issues about how human embryos can be created, what forms of human reproduction are acceptable, and what research uses of human embryos should be permitted.(3)
In the 1990s three States, Victoria, South Australia and Western Australia, enacted legislation purporting to ban human reproductive cloning and to regulate research on human embryos.(4) This regulation evolved as part of the regulation of ART.(5) Under the legislation, the definition of ‘cloning’ and ‘human embryo’ varied in each State and accordingly so did the research practices that were prohibited and permitted.(6)
All States and Territories were also governed by the National Health and Medical Research Council’s (NHMRC) Ethical Guidelines,(7) although it was argued that the NHMRC Guidelines were only enforceable against institutions receiving NHMRC funding, and hence, a privately funded body would not need to comply with the Guidelines.(8) It was also noted that the prohibition on destructive research on embryos in each of the States that had legislation, conflicted with the NHMRC Guidelines which permitted researchers to apply for a licence to conduct such research on ‘excess’ ART embryos.(9)
The legislation in Victoria, South Australia and Western Australia was enacted prior to the cloning of ‘Dolly’ the sheep by somatic cell nuclear transfer (SCNT) and it was uncertain whether the definitions and prohibitions specified in the legislation would effectively deal with the possibility of cloning.(10)
Therefore by 1999 there was no nationally consistent legislation and for those jurisdictions that did have legislation, it was unclear whether the legislation was adequate for the changes in the scientific environment.(11) In 1999 the House of Representatives Standing Committee on Legal and Constitutional Affairs, chaired by the Hon. Kevin Andrews MP, established an inquiry to consider the issues.(12)
In 2000, the Commonwealth Gene Technology Act 2000 was enacted which contained a prohibition on the cloning of whole human beings. The legislation contained yet another definition of cloning.(13) It had limited coverage and applied to, amongst other areas, corporations, things done in the course of trade and commerce, things done that may spread the disease or pests, for purposes relating to statistics and actions by the Commonwealth or Commonwealth authorities.(14)
In August 2001, the House of Representatives Standing Committee on Legal and Constitutional Affairs Committee, released its report (the Andrews Report).(15) The Andrews Report made a number of recommendations, including that the Commonwealth legislate to regulate human cloning and stem cell research.(16) A useful summary of the stance taken by the Committee members is as follows.
The Andrews Report revealed that its Standing Committee members were divided on the issue of whether the creation of embryos via the SCNT process should be permitted in Australia. It noted that a majority of the Standing Committee supported this process being legalised, primarily on the basis of the potential for such research to develop stem cell therapies to treat various diseases. A minority of the Committee were opposed to such research due to concerns about the ethics of the destruction of human embryos for research, particularly as, at that time, the potential benefits of such research were highly speculative. …
[T]he Standing Committee reached a consensus to recommend a three-year moratorium on the legislation of nuclear transfer, with the issue to be reviewed at the conclusion of that period.(17)
The Council of Australian Governments (COAG) considered the Andrews Report’s recommendations and in 2002 agreed that nationally consistent legislation should be introduced banning human cloning and some other related practices and regulating research involving excess ART embryos.(18)
In December 2002 the Federal Parliament enacted the Prohibition of Human Cloning Act 2002 (PHC Act) and the Research Involving Human Embryos Act 2002 (RIHE Act). Together the Acts:
After the enactment of the PHC Act and the RIHE Act, the States and Territories passed legislation which reflected these provisions to ensure that the legislation had national coverage.(21)
Both the PHC Act and the RIHE Act contain provisions specifying that an independent review of the operation of each Act needed to be undertaken two years after the Acts received Royal Assent.(22) Both Acts also contain provisions requiring that the reviews be undertaken by persons agreed to by the Minister with the agreement of each State.(23)
To meet these legislative obligations the Legislative Review Committee (LRC) was appointed in June 2005 to consider and report on the scope and operation of each of the Acts. The LRC was chaired by the Hon. John S Lockhart AO QC. On 19 December 2005 the LRC gave its report, Legislation Review: Prohibition of Human Cloning Act 2002 and Research Involving Human Embryos Act 2002(24) (Lockhart Report), to the Federal Government.(25) The Lockhart Report contained 54 recommendations and suggested that the current legislative arrangements required significant change.
In a press release dated 23 June 2006, the Prime Minister stated the following:
The Australian Government has considered the recommendations of the Lockhart Review. This is a difficult and complex issue on which many different views are held.
After careful reflection, the Government is not disposed to make any changes to the existing national legislative framework for research involving human embryos, agreed in 2002.
Recognising, however, the range of issues and views, there will be a detailed discussion on this issue within the Government parties when Parliament resumes for the Spring sitting.(26)
Thereafter followed the meeting of COAG on 14 July 2006. The Communique describing COAG’s views and course of action stated that:(27)
COAG noted that agreement had not yet been reached across jurisdictions on all the 54 recommendations of the Lockhart Review Committee Report. However, COAG agreed that officials would continue to work on those Lockhart Review recommendations of an administrative nature on which there is agreement and report back to COAG by December 2006.
While COAG restated its preference for nationally consistent arrangements, in the absence of national agreement some States and Territories reserved the right to alter the legislation within their own jurisdictions to the extent that is within their power. See: http://www.coag.gov.au/meetings/140706/index.htm#Lockhart.
After the 14 July COAG meeting general political debate about the issue continued. After lobbying by some Coalition backbenchers, Cabinet level and Coalition party room discussions occurred and the Prime Minister indicated that if the matter came before Parliament, Coalition parliamentarians could vote according to their conscience, as was the case in 2002.(28) The leader of the opposition indicated that Labor Party members would do the same.(29)
The subsequent political debate has culminated in the generation of two Bills dealing with stem cell issues. The first, a joint Bill sponsored by Senator Stott Despoja (Australian Democrats) and Senator Webber (Australian Labor Party) Somatic Cell Nuclear Transfer (SCNT) and Related Research Amendment Bill 2006 was released as an exposure draft on 14 Septebmer 2006. (30)The second, a Bill sponsored by Senator Patterson (Liberal Party) Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Bill 2006 released an exposure draft on 26 September 2006 and was introduced to the chamber. This Bill was then subsequently introduced into the Senate on 19 October 2006.
The Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Bill 2006 includes amendments permitting therapeutic cloning or SCNT for research, training and clinical application, for both human embryo clones and animal-human hybrid embryo clones. The following sets out the scientific, policy and international background to the Bill.
This part of the Digest explains the basic scientific principles associated with creation of an embryo by natural means and by human cloning.
The basic steps for natural creation of a human embryo are as follows and are illustrated in diagrams 1 and 2.
The sperm inseminates the oocyte. Between 12 - 20 hours after the sperm has inseminated the oocyte two pronuclei are formed in the cytoplasm of the egg around the maternal and paternal chromatids and two polar bodies are formed in the perivitelline space.
Approximately 20 hours after the sperm enters the oocyte, the pronuclear membranes dissolve and the maternal and paternal chromosomes combine. Almost immediately (and without reformation of the nuclear membrane), the chromosomes align for the first cell division (a process known as syngamy).
Diagram 1: Fertilisation.
Source: Discussion Paper: Human Embryo – A Biological Definition
(NHMRC) 2005.
Diagram 2: Pre-implantation Development.
Source: Discussion Paper: Human Embryo – A Biological Definition
(NHMRC) 2005.
The NHMRC Working Party on the Biological Definition of the Embryo concluded that syngamy is the most appropriate marker for the completion of fertilisation because this is when the genome of the new entity is created.(31) However, as syngamy is difficult to visualise: the earliest point at which fertilisation can be visually confirmed is the first mitotic cell division (cleavage).
During days 2-3, the zygote goes through its first cell division and its progeny also divide several times thereafter to form a compact ball of cells called the morula. As the cells continue to divide, the morula enlarges to form a hollow sphere called a blastocyst. The cells in the outer layer of the blastocyst give rise to a placenta and other supporting tissues. The cells in the centre give rise to the developing body layers of the evolving embryo and foetus, and ultimately to all the organs and tissues of the body. The cells of the inner cell mass can be extracted from the blastocyst and cultured to derive embryonic stem cells.
The following discussion sets out basic scientific information regarding cloning.
Cloning is a type of asexual reproduction that results in the production of an organism which is a genetic copy of another organism. Two types of cloning are important to keep in mind; ‘reproductive cloning’ and ‘therapeutic cloning’. There seems to be general societal agreement that reproductive cloning is unacceptable and it is banned in Australia. There is a far greater divergence of views, however, in relation to therapeutic cloning. Although it is currently banned in Australia, a general consensus has not been reached as to whether it should be permitted in future.
Embryo clones may be created by a variety of methods including:
Although embryonic cloning can occur naturally in humans, the scientific techniques of cloning usually differs from the basic steps that are gone through in the natural development of a human embryo and the following discussion deals with cloning by SCNT.
SCNT involves taking an egg cell (oocyte), removing the cell’s nucleus (which contains almost all of the genetic material), and replacing it with another cell nucleus from another cell, usually a somatic cell (although other cells such as embryonic stem cells may be used). Scientists then use certain means (commonly an electric current), to induce the enucleated egg and its new nucleus to fuse and develop into an embryo.
Diagram 3: Somatic cell nuclear transfer
Source: Appendix 2 Issues Paper Lockhart Review
Because the nucleus contains most of the DNA of an organism, the embryo is genetically identical to the person from whom the somatic cell was taken (hence the term ‘clone’ is used). (nb except for the egg mitochondrial DNA which is in any embryo).
If the embryo is transferred back to the uterus of the female and developed into a foetus, this is reproductive cloning.
The embryo may, however, be cultured to the blastocyst stage at which point the embryonic stem cells are removed from the embryo. These embryonic stem cells can then be used for research or treatment (hence the term ‘therapeutic cloning’ is used). The removal of the embryonic stem cells destroys the capacity of the embryo to continue to grow and develop. However, recent advances suggest that it may soon be possible to remove one or two individual cells from the blastocyst or early morula without destruction of the embryo (in a technique similar to that used for pre-implantation genetic diagnosis). The cell or cells removed can be grown up into a pluripotent embryonic stem cell line. The embryo can continue its development. There is some speculation over whether the foetus and ultimately baby developed would be affected by the loss of an early embryonic cell.(32)
Although the terms therapeutic cloning and SCNT are used interchangeably, SCNT is considered to be the more accurate of the two terms and is now in common scientific usage. Professor Alan Trounson, from the Australian Stem Cell Centre, argues that:
We’re not cloning in the sense that people understand we’re cloning…Nor, necessarily are we focused on a therapeutic. So somatic cell nuclear transfer is more descriptive of what we’re trying to do.(33)
For the purposes of this current debate, the reader should focus on two types of stem cells; embryonic stem cells and adult stem cells.
Human embryonic stem cells were first isolated in 1998.(34) Embryonic stem cells are pluripotent cells, which means that they have the capacity to turn into any cell type in the adult body (note they cannot turn into placental and related tissue). Technically, totipotent cells can differentiate into any cell type, including into cells of the placenta and other supporting tissues. Such cells are only present for the first few divisions after fertilisation. Cells thereafter are referred to as pluripotent. Further differentiation results in multipotent stems cells. A multipotent cell can turn into a defined set of related cells types, for example different types of blood cell, but not into any cell type. As noted above, they are extracted from the human embryo at the blastocyst stage of embryonic development. They can be extracted from an embryo created either through the sperm/egg fertilisation process or from an embryo created by artificial means such as SCNT.(35)
Currently in Australia, embryos that are excess to IVF needs can be used by researchers to harvest embryonic stem cells. Where embryos have been created for the purpose of ART such as IVF, but they are excess to the patients’ needs, they may be donated to research. Researchers may apply to the NHMRC for a licence to use these excess embryos for different purposes such as the harvesting of embryonic stem cells. Currently the NHMRC had received four applications and four licences have been granted for research to derive ES cell lines. Stem cell lines are also imported into Australia.(36)
Most tissues and organs in the adult human body have some adult stem cells (adult here means post-birth). Adult tissues in which stem cells that have been identified include skin, intestine, liver, brain and bone marrow.(37) Adult stem cells are multipotent cells as opposed to pluripotent cells and hence are limited in what they can become and in what they can be used for. They can only differentiate into a set of defined cell types but cannot become any type of cell.
The Issues Paper from the LRC provided the following explanation of why some scientists are interested in stem cells:
Stem cells are of great interest to researchers because of their potential to regenerate damaged or diseased tissues. The treatment of leukaemia patients with bone marrow containing blood stem cells from compatible donors has been a routine procedure since the 1970s. Since that time, scientists have hoped to develop other stem cell therapies. Stem cells also provide a good model for research on the development and function of different cell types and the features of certain cellular disease states. Embryonic stem cells have attracted particular interest because they are pluripotent.
Stem cells from human embryo clones have attracted additional interest because they provide an opportunity to obtain embryonic stem cells that are a precise match for the person of whom the human embryo clone is a copy. Treatment of this person with their own matched stem cells would prevent immune rejection problem and/or avoid having to wait for a suitable matched donor. The same would be true of adult stem cells if they were obtained from a person requiring stem cell treatment. (38)
Therefore the main reasons for supporting stem cell research is the potential for therapeutic benefits including:
Currently the use of excess ART embryos under licence has led to the development of a number of embryonic stem cell lines. Researchers in the area have, however, advocated for the creation of embryonic stem cell lines from embryos cloned through SCNT. The Lockhart Report stated that this would be beneficial because:
further development in this area of research requires the creation of human embryo clones to generate embryonic stem cells that are either patient matched for the development of specific cellular therapies or of known genotype for disease modelling and other research.(42)
In essence, researchers argue that the development of individually DNA matched stem cells (which is made possible through SCNT) will overcome the problems of tissue rejection when treating patients. It is also argued that the development of SCNT stem cell carrying genetic disorders will be useful as scientists will be able to watch the cells grow and, hence, understand the development of complex diseases. Stem cells from SCNT could also lead to the identification of drugs and treatment for diseases.(43) Therefore, there is specific interest in embryonic stem cells that are derived from SCNT (ie, cloning) because of the benefits of generating donor matched cells.
Currently the law does not permit SCNT and hence the generation of stem cell lines from SCNT.(44) The Lockhart Report examined the issue of whether the law should be changed to permit SCNT. The following is a summary of some of the arguments considered in the Lockhart Report.
During the course of the stem cell debate one of the areas of contention that has arisen has been whether research using embryonic stem cells will produce outcomes that are different to research carried out on adult stem cells. If research on each type of stem cell produced the same result, this would weaken the argument in favour of using SCNT.
Whilst it is clear that embryonic and adult stem cells have different characteristics, in 2001 there was no agreement among scientists about whether research on adult or embryonic stem cells would produce different or more scientifically successful outcomes, particularly in relation to organ transplants.(45) The Lockhart Report noted that in 2001, many researchers considered that research involving both should continue until their efficacy became clearer.(46)
The Lockhart Report documented arguments which suggested that embryonic stem cells could achieve different results to adult stem cells. It also noted evidence given that using adult stem cells would achieve similar outcomes.(47) The Lockhart Report also noted that there had been developments in the use of adult and embryonic stem cells since 2001. It concluded that the potential for each of the type of stem cells was unclear, however, that:
based especially on the evidence of experts who work directly in one or both fields of stem cell research (adult or embryonic), that further research involving both adult and embryonic stem cells is required to improve knowledge and to develop effective disease treatments.(48)
The Lockhart Report considered whether there had been any changes in the scientific landscape since 2001. If changes in the scientific state of play had occurred then it could be argued that the law should be revised so that it stays in step with scientific developments. Since the release of the Lockhart Report there have also been additional reports commissioned by Australian governments which have examined scientific developments, including:
The Lockhart Report concluded that research into stem cells has been extremely active since 2002. (51)It also noted that there had been developments in research on SCNT.(52)
The mpconsulting report focused on changes in the ‘state of play’ in relation to ART and related research since the passage of the PHC Act and the RIHE Act. The mpconsulting report classified ‘a change in the state of play’ as being the raising of new issues (be they scientific developments, unintended consequences of the legislation, or new ethical arguments) that were not considered in 2002 but had been raised and considered in the context of the LRC’s review of the legislation in 2005.(53) The report focused particularly on the definition of human embryo, the creation and use of embryos for ART research and the creation of embryos for stem cell research.(54)
The report concluded that ‘on each of these issues it would appear, based on a consideration of relevant materials, that there has not been any significant change in the state of play since 2002’.(55) Despite this conclusion, the report did, however, state in the section on stem cell research that ‘it is clear that there have been developments since the legislation was introduced in 2002’. (56)
On 8 September 2006, the Victorian Government released a report prepared by Dr. Nicholas Gough FTSE for the Victorian Department of Innovation, Industry and Regional Development’, which set out a ‘scientific summary of key recent advances in human embryonic stem cell research and key recent advances with respect to [SCNT].’(57) This report documented that there had been relevant scientific developments both in the fields of embryonic stem cells and SCNT since 2002.
The Lockhart Report also noted other arguments put forward for opposing therapeutic cloning including that there are:
The issue of therapeutic cloning raises significant moral and ethical questions. The Lockhart Report noted that:
the main objection to [embryonic stem] cell research is because of ethical concerns about the destruction of human embryos. (60)
Issues relating to the moral and ethical aspects of therapeutic cloning are discussed in more detail below.
After weighing up the various arguments, the Lockhart Report recommended that human SCNT should be permitted (recommendation 23). The Bill implements this recommendation. This recommendation is limited by the current provisions in the PHC Act that prohibit:
Many of the provisions in the PHC Act and RIHE Act rely on the term human embryo. Currently human embryo is defined in section 8 of the PHC Act and section 7 of the RIHE Act as:
A live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pronuclei or the initiation of its development by other means.
In the course of considering the adequacy of the current definition of human embryo, the Legislation Review Committee made use of a draft NHMRC discussion paper entitled Human Embryo—A Biological Definition.(62) The draft discussion paper was written by three NHMRC Embryo Research Licensing Committee members and three other Australian experts (the Biological Definition of Human Embryo Working Party, hereafter referred to as the NHMRC Working Party).(63) As the Lockhart Report noted, ‘This paper addressed issues concerning the definition of “human embryo” in the current legislation that have arisen as a result of the Licensing Committee’s work since 2003.’(64) This draft discussion paper noted that problems with the current definition related to natural fertilisation, artificial fertilisation and individuals with DNA from more than one species.(65)
The current definition of human embryo refers to the appearance of the first two pronuclei. This has been regarded as being too restrictive for research purposes. The Lockhart Report, for example, stated the following:
The definition of a human embryo in the Acts (RIHE Act s7 and PHC Act s8) starts from the appearance of two pronuclei. This prevents any research requiring experimental fertilisation of an egg with sperm because, once the two pronuclei are visible (the earliest biological marker for such research), an embryo has been created and creation of a human embryo for research contravenes the PHC Act s14. These provisions prevent a range of research to improve IVF, including maturation of oocytes, testing of sperm quality and fertilisation research.(66)
It went on to explain that:
Under the current definition of a human embryo, researchers are not able to undertake experimental fertilisation studies because the legislation requires the process to cease before the two pronuclei are formed – thereby preventing the researcher from confirming that fertilisation has occurred(67)
As a result, the NHMRC’s Working Party’s draft discussion paper recommended moving the point in time in which an embryo, formed through fertilisation of an oocyte with a sperm, is taken to have been created, to the first mitotic cell division. The NHMRC Working Party argued that this should be the point in time where an embryo is regarded as being created because by that point in time the genome for the entity has been created and it is the earliest point after creation of the genome that scientists can actually visualise this milestone.(68)
The NHMRC’s Working Party’s draft discussion paper also noted that there are a number of emerging technologies that produce embryos that do not involve the contribution of DNA from both sperm and egg such as SCNT. The draft discussion paper considered that the current definition of human embryo does not accommodate these new technologies and hence considered that it should be amended.(69)
Drafting a definition of a human embryo does raise a large number of moral and ethical considerations. These are explored in further detail below.
The NHMRC Working Party’s draft discussion paper suggested that changes should be made to the definition of human embryo. The Lockhart Committee recommended that the definition of a ‘human embryo’ used in both Acts should be changed to that definition set out in the draft discussion paper (recommendation 28).(70) In December 2005, after the release of the Lockhart Report, the NHMRC Working Party finalised its discussion paper. The definition of human embryo in the final version of the discussion paper differs slightly to that contained within the draft version. The Bill proposes to amend the definition of human embryo and it uses the definition of human embryo that is used in the final version of the NHMRC Working Party’s discussion paper.
The Explanatory Memorandum to the Bill notes that the definition proposed in the Bill differs from that recommended by the Lockhart Committee in its report. (71)It explains that:
It is important to note that while the NHMRC Embryo Research Licensing Committee has endorsed the definition of human embryo in the final version of the NHMRC Working Party’s discussion paper,(73) the NHMRC itself has not yet endorsed the definition.(74)
The Lockhart Report found that research to improve the success of ARTs (such as IVF) has been hampered as a result of the RIHE Act and the PHC Act. The Lockhart Report stated that:
The overwhelming response to the reviews from ART providers and researchers was that the legislation has impeded research to improve ART technologies that was active before the legislation was passed.(75)
Whilst it is beyond the scope of this Digest to explore all of these issues in depth, the following are examples of some of the areas identified in the Lockhart Report that have been regarded as impeding ART research and clinical practice.(76)
The culture, and then maturation, of oocytes under laboratory conditions – in vitro maturation – (IVM) is regarded by researchers as being a process that could produce a variety of advantageous scientific outcomes.(77) The Lockhart Report noted that the development of technology to enable IVM is currently impeded by the legislative arrangements. The Lockhart Report explains that:
IVM is a complex procedure in which both the nucleus and the cytoplasm of the oocyte need to be brought to precisely the right point of maturity to allow fertilisation with a sperm. (78)
Determining the right point of maturity could happen by fertilising the oocytes. The Lockhart Report stated the following:
Dr John McBain, Director, Melbourne IVF, told the Committee that the biggest effect of the Act has been prevention of work on in vitro maturation of oocytes from frozen ovarian tissues. These oocytes cannot be fertilised under the current definition of embryo because the legislation requires the process to cease just before the two pronuclei are formed – thereby preventing the researcher from confirming fertilisation.(79)
As noted above, the Lockhart Report proposed changes to the current definition of human embryo to address this problem.
One other way of determining the right point of maturity for IVM is through parthenogenesis. The Lockhart Report noted that currently IVM oocytes cannot be parthenogenetically activated to test their activation potential because parthenogenetic activation of oocytes is illegal under the PHC Act.(80) The Lockhart Report recommended that intentional parthenogenetically activation of oocytes should be permitted, under licence, for development up to 14 days. The report also recommended that implantation of the oocyte into the women’s reproductive tract should continue to be prohibited (recommendations 16, 3 and 4).
The Lockhart Report noted that the prohibition of creation of human–animal hybrid embryos (section 20 of the PHC Act), combined with the current definition of an embryo, has also prevented research or testing requiring fertilisation.(81)
The Lockhart Report explained that
For example, ART researchers and practitioners were previously able to undertake fertilisation studies using human sperm and animal oocytes (eg hamster) to test sperm quality.(82)
The report noted that they are no longer able to do this as a result of section 20 of the PHC Act. The report went on to recommend that the legislation be changed to permit the creation of human-animal hybrids up to the point of, but not including, the first cell division to allow testing of human gamete maturity or viability (recommendation 17 and recommendation 24).
The Lockhart Report noted that the creation of a human embryo for any purpose other than to achieve a pregnancy in a woman prevents the creation and use of fresh embryos for research. The Lockhart Report noted that:
Some ART researchers indicated that a number of valuable studies could be done if it were possible to use embryos created from eggs and sperm specifically for research up to the stage of implantation. This is prohibited by current legislation ...(83)
The Lockhart Report rejected the idea of permitting the creation of human embryos specifically for research purposes, apart from that permitted under recommendation 15.
The Lockhart Report noted that provisions of the RIHE Act for declaring embryos to be excess ART embryos and giving proper consent for research has operated to prevent the immediate (fresh) availability of ART embryos for research. (84)The report stated that:
The current legislation also prohibits the use of fresh excess ART embryos through the consent process. The 14 day cooling-off period that is required after embryo donors give consent for a specific research project but before the embryo is used (see Sections 11.1 and 11.2) limits the use of fresh embryos.(85)
The Lockhart Report recommended that the NHMRC Australian Health Ethics committee should review its guidelines for consent (recommendation 29) with a view to easing this problem.
The Lockhart Report also noted that embryos that are not suitable for implantation for any reasons are allowed to die and are not available for research despite the fact that such embryos would be a useful source of fresh embryos for research, training and quality assurance activities.(86)
The Lockhart Report recommended that embryos that are unsuitable for implantation should be permitted to be used for research, training and improvements in clinical practice. It also recommended that objective guidelines be drawn up for use in determining when an embryo is unsuitable for implantation (recommendations 20-22).
Cytoplasmic transfer has been used as a fertility treatment overseas, particularly for older women. It has also been flagged as a possible treatment for the prevention of mitochondrial disease. Research on cytoplasmic transfer in Australia has been prohibited since 2002 because it would lead to the creation of a human embryo containing genetic material provided by more than two persons (currently sections 15 and 18 of the PHC Act).
The Lockhart Report stated that:
It is the Committee’s view that cytoplasmic transfer offers potential for the treatment of mitochondrial disease and to improve fertilisation for some women. Therefore consideration should be given to research, under licence, on this procedure.
Recommendation 19 of the Lockhart Report reflects this conclusion.
The Lockhart Committee identified three areas of concern in relation to having prescriptive legislation in relation to these issues.(87) One of these was a lack of legal protection for researchers.(88) It noted that a researcher who had been granted a licence by the NHMRC Licensing Committee would have no defence if a court subsequently found that the actual licence contravened the legislation.(89) The other concerns identified by the Lockhart Committee were related to the difficulties associated with drafting legislation in relation to rapidly changing technology and in the interpretation of the legislation.(90)
Accordingly, the Lockhart Committee made recommendations 50–52. The Explanatory Memorandum explains:
Those recommendations suggest that the NHMRC Licensing Committee should be given the power to give legally binding rulings on the interpretation of the legislation and that a person who conducts research on the basis of a ruling should be protected from liability under the legislation.(91)
However, the Explanatory Memorandum goes on to explain that this latter recommendation (recommendation 52) ‘raises significant constitutional issues relating to the impermissible exercise of judicial power by a non-judicial body.’(92)
The Lockhart Committee reported that:
The processes that have been put in place for monitoring compliance with the legislation and facilitating compliance are generally regarded as suitable, although suggestions for improvements to the system were also made. It is clear that there is a major deficiency in the legislation with regard to the limited powers of the inspectors appointed under the RIHE Act to monitor activities that are not covered by a licence. As a result of this deficiency, suspected breaches by non-licence holders cannot be adequately investigated.(93)
Further, the Lockhart Committee reported that it had heard that in relation to licensed premises inspectors are not empowered to make unannounced inspections and this inhibits their ability to investigate suspected breaches of the legislation.(94) The Lockhart Committee stated that its view was that ‘inspectors should have adequate powers under both Acts to investigate suspected breaches of either Act.’(95) It also commented that ‘[t]here is a legal question whether these powers already clearly exist’.(96)
Accordingly, the Lockhart Committee recommended that:
The Lockhart Committee reported that there was widespread support of the NHMRC Licensing Committee for its regulatory oversight of the type of research the subject of review.(98)
One particular problem identified by the Lockhart Committee was that:
due to the specific expertise of each Licensing Committee member, a vacancy on the committee poses a significant problem, because licensing applications cannot be handled effectively. As appointment to the committee involves approval by all States and Territories, there have been lengthy delays in filling vacancies. The [Lockhart] Committee noted that there is not scope in the [RIHE] Act as presently framed to address this problem, which is because the Licensing Committee is a national committee that oversees research in all States and Territories. The Committee therefore draws this to the attention of the Australian Parliament and the [COAG] for consideration and recommends that they give urgent attention to this problem.(99)
The relevant recommendation is recommendation 36.
At present the exportation from Australia of a human embryo is prohibited unless permission has been granted by the Minister for Customs pursuant to regulation 7 of the Customs (Prohibited Exports) Regulations 1958.(100) This regulation provides that an application to the Minister for such permission may only be made in certain limited circumstances, namely:
The Lockhart Committee reported that it had:
heard from ART consumers that the current export prohibitions and custom regulations regarding human embryos have made it difficult for couples to export their embryos overseas for their own reproductive use. The Committee’s view is that the current arrangements, which involve personal application to the Minister for Customs to export embryos for personal reproductive use, are too cumbersome and stressful for users and should be streamlined.(103) [Emphasis added]
Accordingly, in recommendation 41, the Lockhart Committee recommended that the import(104) or export of a patient’s reproductive material for their own ongoing ART treatment should only be subject to existing quarantine regulation.(105)
The Report by the Lockhart Committee states:
As the number of human stem cell lines has increased throughout the world, it has become apparent that there is a need for the creation of stem cell registries and stem cell banks to enable researchers to locate cell lines of interest, along with appropriate information about source and quality. While the current focus of interest in stem cell banks is on the registration and storage of embryonic stem cell lines for research, it is possible that in subsequent years advances in stem cell engineering and transplant immunology may mean that stem cell banks also come to fulfil an important clinical function.(106)
The Lockhart Committee reported its view that:
an Australian national stem cell bank would make stem cells, including embryonic and adult stem cells, more widely available to researchers and also limit the number of embryos required for further derivation of stem cell lines.(107)
Accordingly, the Committee recommended that a national stem cell bank be established (recommendation 47).
The Committee also recommended that a national register of donated excess ART embryos be established (recommendation 49).(108) In the Committee’s view, the functions of such a register could be to:
As mentioned above, the Lockhart Committee had ‘heard a number of concerns about the capacity of legislation to respond to research needs in a fast-moving area of technology.’(110) In view of these ‘fast moving developments in the field’(111) and because of the number of amendments proposed by the Lockhart Committee, recommendation 53 suggested that both Acts ‘should be subject to further review either six years after royal assent of the current Acts or three years after royal assent to any amended legislation.’(112)
It is beyond the scope of this Digest to cover the international state of play in relation to cloning and stem cell development. For a recent comparative overview of regulatory frameworks for stem cell and cloning research in 50 countries, refer to ‘Beyond the Permissibility of Embryonic and Stem Cell Research: Substantive Requirements and Procedural Safeguards’.(113)
Permitting SCNT or the use of excess ART embryos for scientific purposes raises significant arguments about the moral status of the human embryo.
Any developments and advances, whether they are societal or technological, require constant identification, analysis and, if necessary, regulation. Such regulation most commonly is achieved through laws – either by application of existing laws or through the creation of new ones. Existing laws can be utilised by expanding their application as the result of judicial interpretation. However, where courts are unable to stretch the application of a particular law far enough to bring the development or advance within its reach, it can become necessary for lawmakers to provide new, or modify existing, regulatory frameworks.
In 2002, the Australian Federal Parliament was faced with the task of reacting to new developments in molecular genetics and biomedicine. It passed new legislation to regulate human cloning and provided a regime for research involving human embryos.
With this Bill, Federal Parliament is again concerned with this issue, proposing to pass amendments that will refine and develop the existing legislation concerning reproductive and other forms of cloning, combining countervailing and adaptive regulatory measures to accommodate the scientific advances that occurred since the last debates in Parliament.
It is not difficult to predict that the ensuing parliamentary debate will be passionate and controversial. Vigorous debates ensued the last time this topic was discussed in Parliament.(114)
Parliament is regularly confronted with the proposals to implement complex and/or controversial policies. Controversy is usually the result of different political ideologies or agendas. Complexity is often caused by the need to skilfully craft very complex legal solutions to implement policies; sometimes the legal complexity of the proposed laws is part of the controversy.
This Bill is very controversial. This is not necessarily due to different political ideologies; rather the controversy arises because the proposed changes are founded upon significant moral and ethical considerations of the genesis and evolution of life.
As these considerations are guided strongly by personal beliefs and convictions rather than by political views, it seems only proper that the ensuing debate is not conducted along party lines. This is not a political, but a personal debate.
The ensuing debate strikes at the heart of humanity and dignity. The following brief discourse is not an attempt to give conclusive answers to any of the issues which may influence the debate. Rather, it is to serve as an overview of the underlying moral and ethical considerations, their origins and, if possible, as a primer for further thought. As such it is aimed at avoiding a reduction of the debate to a ‘battle of beneficial and knowledgeable cleverness versus ignorant and superstitious anxiety.’(115)
At the outset, it is important to identify the core and scope of the controversy surrounding stem cell research.
There is a sliding scale of controversy depending upon the source of the stem cells.
The less controversial sources include those that do not require the destruction of a blastocyst, a form of embryo developed at the earliest stages of embryogenesis.(116) Examples include adult stem cells or stem cells derived from the blood of the umbilical cord.(117) Some jurisdictions have decided that the use of stem cell lines that are already in existence raise fewer moral objections. Prominently, the United States (US) and Germany have decided not to provide federal funding (US), or even to prohibit outright (Germany), the creation of new stem cell lines, but both nations permitted research on lines that were already in existence at the time the prohibition came into force or was announced.(118) The underlying arguments for this distinction are discussed further below in the context of differentiating between the creation and the use of stem cells.(119)
The more controversial sources include those that require the harvesting of stem cells from embryos that were:
These sources for stem cells are more controversial because their harvesting will require the embryo’s destruction.(120) This destruction poses one of the central ethical quandaries for this debate.
The substance of this controversy relates to the moral status of the embryo. What will be destroyed when the stem cells are harvested: a plain cell mass or an early embryo? If it is an early embryo, is it already human life with the same moral status as a human being? Or does this early embryo constitute ante-nascent human life, which has not gained sufficient personality or ‘personhood’; that is, it has not yet acquired the same moral status as a born human being? And, finally, is there a moral difference between an embryo created by sperm and egg and those created by SCNT, parthenogenesis or other laboratory means?
The answers are important because born human life is considered to have the highest moral status that correlates with the full protection against destruction. This protection stems from concepts such as inviolable human dignity and human rights. The intentional destruction of a born human being is generally considered homicide. Thus, if it is argued that the embryo possesses the same moral status as a born human being, the logical consequence is inescapable: the destruction of this embryo equates to homicide.
If it can be reasoned that the embryo is merely a cell mass or an early embryo without the same moral status when compared to born human life, its intentional destruction would not necessarily equate to homicide. To argue in favour of the destruction of an embryo without moral status would reduce or even fully eliminate the moral or ethical dilemma.
These considerations amount to the search for a justification of why the destruction of an embryo is not homicide which is deemed by society to be the most reprehensible of all crimes. Two threshold questions underpin these considerations, including:
A further issue discussed in the literature is whether the purpose for which the embryo was created should be considered in the context of this debate.
Two immediately obvious moments mark the point in time in which a new life or ‘the life of a new organism’ may begin.(122) The first moment is the conception or cell fusion, that is, the moment in which oocyte and sperm amalgamate. The second possible moment is the birth of a human being itself. Neither can be discredited comprehensively. However, there are also strong arguments in favour of why one moment is considered too early and the other too late.
The interim period between conception and birth is marked by a continuum of evolutionary steps. Examples from the early stages of this evolution include the:
At least theoretically, each of the above moments could be the point in time in which life commences. Indeed, all of them have been used to define this moment.
The choice of one moment in time over the other is generally rationalised based on a belief system or conviction, promoting arguments derived, for example, from science or religion.
However, regardless of the persuasiveness of the supporting arguments, the fact remains that any point in time within this continuum of evolution will be an arbitrary point with the potential to spark considerable disagreement. German philosopher Jürgen Habermas noted that:
The fact that every attempt to draw a definite line somewhere between fertilization, or the fusion of nuclei, on the one hand, and birth on the other hand is more or less arbitrary because of the high degree of continuity prevailing in the development from the organic origins to, first, life capable of feeling and, then, to personal life.(123)
For him, the very fact of the continuum between conception and birth speaks against any attempt to ascertain an absolute beginning for the purpose of lawmaking.
A separate question is whether the moment in which life begins is also the moment in which life assumes the qualities of born human life or a human being. Conceptually, the discussion considers that even if it is possible to determine exactly when life commences, further developmental steps are required to form a human being and the acquisition of a moral status is gradual.
If this proposition is accepted, then it follows that the protection that correlates with the moral status also increases gradually during the embryogenesis. The apex of this gradual acquisition of moral status and protection is reached with the birth of the human being.
For example, despite accepting that a human embryo is a member of the human species, ‘not a member of some other species such as frogs or cows’, Harvard Professor D W Brock has noted that:
[…] this is not sufficient to give it the same moral status as humans who are incontestably persons. That is because the moral status of human persons does not derive simply from their species membership. Rather, it must be some properties of humans that endow them with personhood and in particular make it seriously wrong to kill them. (124)
Whilst this distinction seems somewhat artificial, it is quite common. In her book Stem Cells, Controversy at the Frontiers of Science, science journalist and biochemist Elizabeth Finkel has written that the Catholic church is taking the view that the question when an embryo acquires ‘personhood’ or the moral status of a ‘human being’ is governed by science rather by theology.(125) Accordingly, this varied throughout history. According to Finkel, this point is currently reached with the fusion of female and male genetic material, that is, after conception.(126)
Other Christian churches and religions apparently also distinguish between the creation of life and the acquisition of personhood. Finkel refers to examples from the Anglican Church, Judaism and Islam, all of which believe in the gradual evolution of personhood over time. Interestingly, the author reports that Judaism and Islam consider this evolution to be completed after a period of forty days – the time Catholic cleric and philosopher Thomas Aquinas assigned to the ‘ensoulment’ of an embryo.(127)
Two issues are, however, important to note. First, despite apparently accepting the acquisition of personhood at a later stage then conception, the Catholic church deems the protection of human life to attach from the moment of conception.
Second, the observation that Christian teachings advocated the gradual acquisition of personhood is controversial. Professor G Dunstan, who is one of the leading proponents of the gradual acquisition and claimed that the full protection of even the early embryo from the point of fertilisation is a result of late-19th century Christian teachings, has recently been challenged.(128)
Professor D A Jones argues that Professor Dunstan’s work is based on the omission of important authorities, and is reliant on flawed sources and the failure to distinguish between divergent categories.(129) He is particularly critical of Professor Dunstan’s conclusions that the medieval western church believed in a delay between fertilisation and ‘ensoulment’, arguing that this conclusion is derived from a flawed early translation of the Bible. In his opinion, throughout Christian history, the deliberate destruction even of early embryonic life was considered to be homicide.(130)
Whether a human embryo is a human life with a moral status equal to that of born human life is also an influential issue during any abortion debate. American medical doctor and biochemist Leon R Kass, Chair of the President’s Council of Bioethics between 2002 and 2005, suggested that these debates are ‘analogous, if not identical’.(131) And British Theologist Robin Gill discussed the re-emergence of the ‘gradualist position’ in abortion debates, applying it to the stem cell debate.(132) However, despite obvious similarities, questions have been asked whether sound and neutral arguments differentiating between an early embryo such as a blastomere facing destruction and a foetus facing abortion can be derived from the abortion debates.(133) For example, Professor Habermas observed that although the abortion debates alert society to the issue of the ‘moral status of the unborn life’:
all attempts to describe early human life in terms that are neutral with respect to world views, that is, not prejudging, and thus not acceptable for all citizens of a secular society, have failed.(134)
Divorcing the commencement of life from the moment in which life acquires the status of a human being offers two advantages to the proponents of stem cell research and the legislature, including that it:
It is important to realise, however, that the gradual acquisition of personhood takes place in the same continuum in which the commencement of life takes place – the period between conception and birth. This gradual acquisition may even continue after birth. Therefore, it must be stressed that any attempt to specify individual grades of moral status along the time line between conception and birth are inevitably arbitrary. Parallels to the discussion in relation to the genesis of life, referred to above, are in order. Thus, to mark the line when a human embryo is deemed to have acquired a moral status sufficient to refute any justification of its destruction is likewise arbitrary. Consequently, the criticism that such arbitrariness confounds any attempt to draw a line as the basis for legal implications in this period must apply here as well.(135)
A further distinction used to justify the destruction of early embryos is based on differentiating between the purposes for which embryos are created. The key issue is to assign a different moral status to the embryo depending upon the purpose for which it was created. This approach is often chosen to overcome the apparent inconsistency between:
Embryos created for their use in an ART program are initially created for the purpose of procreation or, as it is also put, to overcome childlessness. As soon as one of these embryos is successfully implanted and continues to develop, the other embryos become excess material. They are no longer needed for their intended purpose.
Theoretically, such excess embryos can be kept in cryostorage over prolonged periods of time.(136) However, whilst some embryos will not survive the freezing or thawing process, the majority will later be discarded, that is, destroyed. This destruction is in some cases permitted, or in many Australian States even mandated by law, and it seems that it is generally morally accepted or at least tolerated.(137) On the other hand, the thought of creating embryos for the sole purpose of consumption through research is not always met with the same tolerance or acceptance.(138) For example, Professor Habermas calls this ‘conditionally created human life’ that is instrumentalised by researchers for an ulterior purpose.(139)
There have been moral concerns against the creation of embryos with a view to destroying them for research purposes. To discredit a distinction based upon the purpose for which the embryo was created, it has been argued that if:
embryos may be used for research into the causes of treatment infertility, […] it is inconsistent to reject research into the possible treatment of serious invalidating diseases as being not sufficiently important.(140)
Or, similarly:
once they accept the creation and sacrifice of embryos to benefit infertile people with a child-wish, they do not have a sound reason to condemn the creation and sacrifice of embryos to benefit ill and injured people who could be helped by stem cell therapies.(141)
As has been noted above, some jurisdictions have based their legislative framework on the understanding that the use of stem cell lines that are already in existence raise fewer moral objections. For example, Germany has decided to prohibit the creation of stem cell lines, but permitted research on lines which were already in existence at the time the prohibition came into force or was announced. One German politician who supported Germany’s ban on stem cell research with newly created stem cell lines reportedly stated that:
The “killing of embryos for research purposes must remain illegal” […] But “we cannot cancel” the fact that embryos were already killed for existing cell lines.(142)
This view underlies the value judgement that:
An embryo, which has been created in vitro, must be consumed neither for research nor for therapeutic purposes, but must – in line with its natural “telos” – be given the chance instead of developing into a human being and of being born.(143)
The US administration used a similar rationale and value judgement to justify its decision to make federal funding of stem cell research dependent upon the cells’ existence at the moment in time when the policy was announced.(144)
To permit the use of stem cells whilst prohibiting their creation allows scientists to research with existing lines without having to face the moral dilemmas arising from the need to destroy embryos in order to obtain lines.
It has been noted that this:
Distinction between use and derivation is neither cynical nor disingenuous for it reflects the basic distinction in the ethics of complicity between causing an immoral or wrongful act to occur and benefiting from it once it has occurred.(145)
Distinguishing between research with stem cells that already have been created at a particular point in time and research which would require the destruction of further embryos has been likened to the use of organs from a murder victim, that is, the gain of a benefit from a wrongful act.(146)
In addition to the issues discussed above, the justification debates often invoke the rights or freedoms of a particular class of stakeholders. A detailed discussion of the arguments comprising this debate would go beyond the scope of this Digest; however, some of the key aspects of these debates should be highlighted here, including:
Generally, these aspects raise issues such as the absoluteness of a right of freedom, and, if it is found not to be absolute, how far it may be restricted. This balancing exercise regularly invokes inquiries into the proportionality of a restricting measure.
There is a fear that permitting therapeutic cloning will ultimately lead to cloning for reproductive purposes: it is the first step on the slippery slope towards the cloning of a human being.
The slippery slope argument is founded on the prediction that a particular outcome will inevitably occur if a certain preceding step is taken.(147) Thus, engaging the slippery slope argument equates to the prediction that the knowledge gained from therapeutic cloning is the preceding step that will inevitably lead to research into reproductive cloning. Pointing out that the slippery slope in relation to stem cell research is an inevitability, Leon R Kass notes that:
Despite the naïve hopes of many, neither will be able to defend the boundary between therapy and genetic enhancement. […] the genetic genie, first unbottled to treat disease, will go its own way, whether we like it or not.(148)
However, the slippery slope argument has also met with resistance. For example, some authors argue that appropriate laws and powerful oversight authorities will provide sufficient safeguards against sliding down the slope.(149) Others argue that the ‘presumed automatism’ of the continued development towards human cloning ‘is disputable’.(150) There are, however, scientists who already entertain arguments in favour of human reproductive cloning. It is argued that IVF and reproductive cloning are, in essence, both reproductive technologies. Thus, the moral justification using IVF should, by analogy, also apply to justifying developing human reproductive cloning research.(151)
A separate issue that is, however, closely linked to the slippery slope argument, is the phenomenon that society has a general tendency towards normalisation, that is, people get used to developments and processes once they are set in motion and become more common.(152) Thus, it has been argued that once research into therapeutic cloning yields its first promising results or, later, even therapeutic successes, society will become accustomed to the issue and moral concerns subside. In support of this proposition, comparisons have been drawn between the debates surrounding other medical developments that were regarded by many, at least initially, as morally or ethically controversial or plain wrong. Examples where normalisation occurred include heart transplantation procedures which were considered wrong, too dangerous or even to be ‘playing God’.(153) Similarly, IVF was initially extremely controversial. Today, these procedures are ‘an accepted part of modern medicine’(154) and ‘highly valued by both the scientific and lay communities.’ (155)
Especially in the initial stages where new treatments are available, the clinical application of such treatments is possibly so costly that it may only be available to those who have the required financial means. It has been queried whether such exclusiveness can comply with demands of equality in society, a concern rebutted by Professor Ronald Dworkin, who argues that the initially limited availability will, in the long term, result in developments and discoveries of much more general application.(156)
It has been suggested that mastering any cloning technique would allow the human species to gain too much control over nature. In turn, this control over nature has the potential to blur the line between choice and chance, a significant dichotomy underlying our moral framework.(157) Thus, the answers we find based on values, beliefs and convictions, are critical to our understanding of our species and our moral underpinnings. As Professor Dworkin notes:
The crucial boundary between chance and choice is the backbone of our ethics and our morality, and any serious shift in that boundary is seriously dislocating. (158)
However, it must also be noted that shifts in moral values are quite common in society and it has been noted that the last decades have seen:
Significant revolutions in what counts as an object of moral concern—the civil rights revolution, the women’s liberation movement, the rise of environmentalism and environmental ethics, and the animal rights movements.(159)
The interference with the genetic integrity of human beings may also lead to a change in the genetic identity of a person. This new or altered identity can be used as a reference point for establishing the ‘otherness’ of people and therewith an alteration of the perception of equality. Querying whether a human being is nature’s creation or ours, Habermas has asked whether we:
May […] consider the genetic self-transformation and self-optimisation of the species as a way of increasing the autonomy of the individual? Or will it undermine our normative self-understanding as persons leading their own lives and showing one another equal respect?(160)
That there is the potential for a different normative self-understanding of humans as a result of genetic medicine has recently surfaced in relation to persons who are the result of assisted conception. The ABC reported in its 7:30 Report that these so-called ‘test-tube babies’ struggle to come to terms with their often unknown genetic heritage, feel like a ‘product’ of reproductive technology rather then a human being and perceive ‘a lack of identity’.(161)
Both the Explanatory Memorandum and the Revised Explanatory Memorandum are silent on the issue of financial implications. It is not evident that there will be a financial impact on the Commonwealth.
Schedule 1 of the Bill amends the PHC Act and Schedule 2 amends the RIHE Act. The Explanatory Memorandum states that the amendments are consistent with the LRC’s recommendations.(162) Schedule 3 is a saving provision which outlines the effect the Bill will have, once passed, on applications for licences not yet decided and on licences already issued (existing licences are to continue in force). Schedule 4 amends the Customs (Prohibited Exports) Regulations 1958 by repealing regulation 7. This regulation prohibits the export of human embryos except in certain limited circumstances where Ministerial permission has been granted. The main provisions of Schedules 1, 2 and 4 are dealt with thematically rather than numerically. Schedule 3 is not discussed further.
The current definition of ‘human embryo’ in both Acts (subsection 8(1) of the PHC Act and subsection 7(1) of the RIHE Act) is repealed and replaced with the following:
human embryo means a discrete entity that has arisen from either:
(a) the first mitotic division when fertilisation of a human oocyte by a human sperm is complete; or
(b) any other process that initiates organised development of a biological entity with a human nuclear genome or altered human nuclear genome that has the potential to develop up to, or beyond, the stage at which the primitive streak appears;
and has not yet reached 8 weeks of development since the first mitotic division.
As mentioned earlier, the Lockhart Committee recommended that the current definition of a ‘human embryo’ be changed (recommendation 28).(163)
The Explanatory Memorandum states that the key differences between this new definition and the current definition in the Acts are:
New paragraphs 8(8)(a) and (b)(165) of the PHC Act and new paragraphs 7(5)(a) and (b) of the RIHE Act clarify that references in each Act to a human embryo do not include references to a hybrid embryo or a human embryonic stem cell line.
In working out the length of the period of development of a human embryo any period when the development of the embryo is suspended(166) is not included (current subsection 8(3) of the PHC Act and current subsection 7(2) of the RIHE Act).
Currently, subsection 20(1) of the RIHE Act only permits a person to apply to the NHMRC Licensing Committee for a licence authorising use of excess ART embryos.(167) New subsection 20(1) of the RIHE Act will contain a similar provision but will also permit persons to apply for licences in relation to a number of other activities. These activities are currently prohibited and involve the creation and/or use of other embryos and the use of human eggs. These changes are detailed below.
Before discussing the new permitted activities, it should be noted that new subsection 24(1) of the RIHE Act provides that such licences will be subject to the condition that:
This reflects recommendation 31 of the Lockhart Report.
As noted above, subsection 8(1) of the PHC Act defines a human embryo clone as ‘a human embryo that is a genetic copy of another living or dead human, but does not include a human embryo created by the fertilisation of a human egg by human sperm.’
Currently, section 9 of the PHC Act stipulates that it is a criminal offence intentionally to create a human embryo clone with a maximum penalty of 15 years’ imprisonment.
As there is no equivalent provision in new Part 2 of the PHC Act, the Bill effectively implements the Lockhart Committee’s recommendations to permit the creation of human embryo clones in some circumstances (recommendations 23–25). The Explanatory Memorandum explains that the change will permit human embryo clones to be created for research up to 14 days if the creation is licensed.(170)
New paragraph 20(1)(b) of the RIHE Act provides that a person may apply for a licence authorising:
New subsection 20(1A) of the RIHE Act confirms that the NHMRC Licensing Committee is not permitted to authorise any use of the embryo that would result in development for longer than 14 days (excluding any period when development is suspended).
It is a criminal offence, with a maximum penalty of:
New section 23C of the PHC Act provides that Regulations are to be made permitting, subject to appropriate conditions or restrictions, the import or export of human embryonic stem cell lines which have been derived from human embryo clones using practices consistent with Australian legislation. This reflects the Lockhart Committee’s recommendation 42.
It will be a criminal offence, with a maximum penalty of 15 years’ imprisonment, to:
At present, these activities are criminal offences in the PHC Act (current sections 16 and 10 respectively) but the maximum penalty is 10 years’ imprisonment. On 7 November 2006, the Senate passed an amendment moved by Senator Stott Despoja, also on behalf of Senator Webber, to increase the maximum penalty from 10 years’ imprisonment to 15 years’ imprisonment.
It is, and will remain, a criminal offence, with a maximum penalty of 15 years’ imprisonment, intentionally to:
The Bill also retains the provision that stipulates that it is not a defence to an offence under new section 9 or new section 10 of the PHC Act that the human embryo clone did not survive or could not have survived (new section 11 of the PHC Act). This provision is essentially the same as current section 12 of the PHC Act.
Currently, section 15 of the PHC Act stipulates that it is a criminal offence, with a maximum penalty of 10 years’ imprisonment, for a person intentionally to create or develop a human embryo containing genetic material provided by more than 2 persons.
The Bill seeks to implement the Lockhart Committee’s recommendations 13 and 26,(172) and accordingly distinguishes between creation of such a human embryo by a process:
(See the section below which prohibits the creation of a human embryo by a process of the fertilisation of a human egg by a human sperm outside a woman’s body for a purpose other than achieving pregnancy in a woman (new section 12 of the PHC Act implementing the Lockhart Committee’s recommendation 13)).
New paragraph 20(1)(c) of the RIHE Act provides that a person may apply for a licence authorising:
It is a criminal offence, with a maximum penalty of 10 years’ imprisonment, intentionally to engage in such creation or development without a licence authorising the creation or development by that person (new section 23 of the PHC Act).(173)
It will also be a criminal offence, with a maximum penalty of 15 years’ imprisonment, intentionally to:
At present, these activities are criminal offences in the PHC Act (current section 13;(175) section 16; subsection 22(3) and paragraph 22(4)(c); subsection 22(1) and paragraph 22(4)(c); subsection 22(2) and paragraph 22(4)(c) respectively), but the maximum penalty is 10 years’ imprisonment. This change in maximum penalty is the result of amendments in the Senate on 7 November 2006.
The retention of the provision in the third bullet point (disregarding the change in maximum penalty) reflects the Lockhart Committee’s recommendation 8.
Currently section 17 of the PHC Act provides that it is a criminal offence, with a maximum penalty of 10 years’ imprisonment, to:
A precursor cell is defined as ‘a cell that has the potential to develop into a human egg or human sperm.’(176)
The Bill seeks to implement the Lockhart Committee’s recommendation 27.(177)
New paragraph 20(1)(d) of the RIHE Act provides that a person may apply for a licence authorising:
The penalty regime devised by new subsection 20(1A) and new section 10A of the RIHE Act applies. For details see discussion above.
It is a criminal offence, with a maximum penalty of 10 years’ imprisonment, to intentionally engage in such creation or development without a licence authorising the activity and the person knows or is reckless as to the fact that they are not authorised to engage in such activities (new section 23A of the PHC Act).(178)
It will also be a criminal offence, with a maximum penalty of 15 years’ imprisonment, intentionally to:
At present, the activities outlined in these four bullet points are criminal offences in the PHC Act (current section 16; subsection 22(3) and current paragraph 22(4)(e); subsection 22(1) and paragraph 22(4)(e); subsection 22(2) and paragraph 22(4)(e) respectively) but the maximum penalty is 10 years’ imprisonment. This change in maximum penalty is the result of amendments in the Senate on 7 November 2006.
The retention of the provision in the second bullet point (disregarding the change in maximum penalty) reflects the Lockhart Committee’s recommendation 9.
Currently, subsection 20(2) of the PHC Act stipulates that it is a criminal offence, with a maximum penalty of 10 years’ imprisonment, intentionally to create a hybrid embryo.(179) There is no specific prohibition on the development of such an embryo.
The Bill seeks to implement the Lockhart Committee’s recommendation 17.(180)
Originally the Bill also sought to implement recommendation 24.(181) This recommendation is as follows.
In order to reduce the need for human oocytes, transfer of human somatic cell nuclei into animal oocytes should be allowed, under licence, for the creation and use of human embryo clones for research, training and clinical application, including the production of human embryonic stem cells, as long as the activity satisfies all the criteria outlined in the amended Act and these embryos are not implanted into the body of a woman or allowed to develop for more than 14 days.(182)
However, the relevant provisions which would have implemented this recommendation were removed from the Bill in the Senate. Accordingly, now recommendation 24 is not accepted.(183) This change is explained further below.
New paragraph 20(1)(f) of the RIHE Act provides that a person may apply for a licence authorising:
provided the creation or use is for the purposes of testing sperm quality, and the creation or use will occur in an accredited ART centre.(184)
On 7 November 2006 the Senate passed an amendment moved by Senator Bartlett to delete new paragraph 20(1)(g) of the RIHE Act. That paragraph would have provided that a person may apply for a licence authorising:
New subsection 20(1A) of the RIHE Act would have confirmed that in this latter mentioned case the NHMRC Licensing Committee was not permitted to authorise any use of the embryo that would result in development for longer than 14 days (excluding any period when development is suspended). However, as the Senate passed an amendment removing new paragraph 20(1)(g) of the RIHE Act, it also passed an amendment removing the reference to new paragraph 20(1)(g) in new subsection 20(1A).
It will be a criminal offence, with a maximum penalty of:
It will be a criminal offence, with a maximum penalty of 15 years’ imprisonment, intentionally to:
The retention of the provision in the first of the above three bullet points (disregarding the change in maximum penalty) reflects the Lockhart Committee’s recommendation 5.
Subsection 8(1) of the PHC Act states that a chimeric embryo is a:
It will be a criminal offence, with a maximum penalty of 15 years’ imprisonment, intentionally to:
At present, these activities are criminal offences in the PHC Act (current subsection 20(1); subsection 22(3) and paragraph 22(4)(h); subsection 22(1); subsection 22(2) and paragraph 22(4)(h) respectively) but the maximum penalty is 10 years’ imprisonment. This change in maximum penalty to 15 years is the result of amendments in the Senate on 7 November 2006.
The retention of the first provision (disregarding the change in maximum penalty) reflects the Lockhart Committee’s recommendation 6,(187) and retention of the second provision (disregarding the change in maximum penalty) reflects recommendation 5.
It will be a criminal offence, with a maximum penalty of 15 years’ imprisonment, intentionally to create a human embryo by a process of the fertilisation of a human egg by a human sperm outside a woman’s body unless the person’s intention in creating the embryo is to attempt to achieve pregnancy in a particular woman (new subsection 12(1) of the PHC Act).
At present, this activity is a criminal offence in the PHC Act (current subsection 14(1)) but the maximum penalty is 10 years’ imprisonment. This change in maximum penalty to 15 years is the result of amendments in the Senate on 7 November 2006.
The defendant does not bear the evidential burden (current subsection 14(2); new subsection 12(2) of the PHC Act) in relation to the above mentioned offence.
The Explanatory Memorandum states that new section 12 of the PHC Act reflects the Lockhart Committee’s recommendations 12 and 13.(188)
It is, and will remain, a criminal offence, with a maximum penalty of 5 years’ imprisonment, intentionally to use outside a woman’s body a human embryo that was created by a process of the fertilisation of a human egg by a human sperm and that is not an excess ART embryo and the use is not for a purpose relating to the assisted reproductive technology treatment of a woman carried out by an accredited ART centre and the person knows or is reckless as to that fact (current section 11;(189) new section 11 of the RIHE Act).
It will be a criminal offence, with a maximum penalty of 15 years’ imprisonment, to:
At present, these activities are criminal offences in the PHC Act (current section 19; subsection 22(3) and paragraph 22(4)(g); subsection 22(1) and paragraph 22(4)(g); subsection 22(2) and paragraph 22(4)(g) respectively) but the maximum penalty is 10 years’ imprisonment. This change in maximum penalty to 15 years is the result of amendments in the Senate on 7 November 2006.
The retention of the first provision (disregarding the change in maximum penalty) reflects the Lockhart Committee’s recommendation 11.(190)
It will be a criminal offence, with a maximum penalty of 15 years’ imprisonment, to:
At present, these activities are criminal offences in the PHC Act (current subsection 18(1); subsection 22(3) and paragraph 22(4)(f); subsection 22(1) and paragraph 22(4)(f); subsection 22(2) and paragraph 22(4)(f) respectively) but the maximum penalty is 10 years’ imprisonment.
The Explanatory Memorandum explains that the provision in the first bullet point above:
bans what is commonly referred to as germ line gene therapy. In germ line gene therapy, changes would be made to the genome of egg or sperm cells, or even to the cells of the early embryo. The genetic modification would then be passed on to any offspring born to the person whose cell was genetically modified and also to subsequent generations.(192)
The retention of the provision in the second bullet point (disregarding the change in maximum penalty) reflects the Lockhart Committee’s recommendation 10.
The Bill retains the current definition of ‘prohibited embryo’ (current subsection 22(4); new subsection 20(4) of the PHC Act).(193) The provisions concerning some prohibited embryos have already been addressed.(194) Other human embryos which come within the definition of a ‘prohibited embryo’ include a human embryo:
It will be a criminal offence, with a maximum penalty of 15 years’ imprisonment, intentionally to:
At present, these activities are criminal offences in the PHC Act (current subsections 22(3), (1) and (2) respectively) but the maximum penalty is 10 years’ imprisonment. This change in maximum penalty to 15 years is the result of amendments in the Senate on 7 November 2006.
The relevant Lockhart Committee recommendation, in relation to the first provision, is recommendation 3 which provides that ‘[i]mplantation into the reproductive tract of a woman of a human embryo created by any means other than fertilisation of an egg by a sperm should continue to be prohibited.’(195)
It will be a criminal offence, with a maximum penalty of 15 years’ imprisonment, intentionally to place a human embryo in:
At present, these activities are criminal offences in the PHC Act (current subsections 21(1) and (2) respectively) but the maximum penalty is 10 years’ imprisonment. This change in maximum penalty to 15 years is the result of amendments in the Senate on 7 November 2006.
The Explanatory Memorandum states that the retention of these provisions (disregarding the change in maximum penalties) reflects the Lockhart Committee’s recommendation 7.(196)
It will be a criminal offence, with a maximum of 15 years’ imprisonment, intentionally to place an animal embryo in a human’s body for any period of gestation (new subsection 19(3) of the PHC Act).
At present, this activity is a criminal offence in the PHC Act (current subsection 21(3)) but the maximum penalty is 10 years’ imprisonment. This change in maximum penalty to 15 years is the result of amendment in the Senate on 7 November 2006.
The Explanatory Memorandum states that the retention of this provision (disregarding the change in maximum penalty) reflects the Lockhart Committee’s recommendation 7.(197)
It will be a criminal offence, with a maximum penalty of 15 years’ imprisonment, intentionally to:
At present, these activities are criminal offences in the PHC Act (current subsections 23(1) and (2) respectively) but the maximum penalty is 10 years’ imprisonment. This change in maximum penalty to 15 years is the result of amendment in the Senate on 7 November 2006.
The Explanatory Memorandum states that the retention of these provisions (disregarding the change in maximum penalty) reflects the Lockhart Committee’s recommendation 33.(198)
The reimbursement of reasonable expenses will continue to be permitted (current subsection 23(3); new subsection 21(3) of the PHC Act). Again this reflects the Lockhart Committee’s recommendation 33.
It will be a criminal offence, with a maximum penalty of 15 years’ imprisonment, intentionally to:
At present these activities are criminal offences in the PHC Act (current subsections 23(1) and (2) respectively) but the maximum penalty is 10 years’ imprisonment. This change in maximum penalty to 15 years is the result of amendments in the Senate on 7 November 2006.
The Explanatory Memorandum states that the retention of these provisions (disregarding the change in maximum penalty) reflects the Lockhart Committee’s recommendation 33.(199)
The reimbursement of reasonable expenses will continue to be permitted (current subsection 23(3); new subsection 21(3) of the PHC Act). Again this reflects the Lockhart Committee’s recommendation 33.
New paragraph 20(1)(e) of the RIHE Act provides that a person may apply for a licence authorising research and training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in ART. This reflects the Lockhart Committee’s recommendation 15.
New section 10B of the RIHE Act stipulates that it is a criminal offence, with a maximum penalty of 5 years’ imprisonment, to engage in such an activity without a licence authorising the research or training by that person.
As noted above, the Revised Explanatory Memorandum states that there were possible constitutional problems with implementing the Lockhart Committee’s recommendations 50–52.(200) Instead, new section 12A of the RIHE Act is proposed in order to avoid the constitutional issues and address the basic concern of the Lockhart Committee.(201)
New section 12A of the RIHE Act provides that a person will not be criminally responsible for an offence against the RIHE Act in respect of particular conduct if:
The Explanatory Memorandum states that this clause is intended to address the underlying policy objective of the Lockhart Committee’s recommendations 50–52.(202)
Subsection 35(1) of the RIHE Act provides that in order for an inspector(203) to find out whether there has been compliance with the RIHE Act or the Regulations,(204) an inspector may:
Subsection 35(2) outlines the grounds upon which an inspector is authorised to enter premises.
New paragraph 35(2)(c) provides a new ground, namely pursuant to a warrant made under new section 37A of the RIHE Act.(205)
The warrant must specify the day on which it ceases to have effect (new paragraph 37A(4)(c) of the RIHE Act). The Bill originally provided that this date not be more than one month after the issue of the warrant. On 7 November 2006 the Senate passed an amendment moved by Senator Stott Despoja, also on behalf of Senator Webber, to change this to not more than 15 days after the issue of the warrant.
Before entering premises pursuant to a warrant an inspector must announce that they are authorised to enter (new section 37C of the RIHE Act). During the execution of a warrant if the occupier or other representative is present then the inspector must:
Additional powers are exercisable by the inspector in the case of entry pursuant to a warrant, namely the inspector may require any person in or on the premises to:
These changes appear to respond to the LRC’s recommendation 39.
New subsections 16(7) and (8) of the RIHE Act provide, respectively, that it is Parliament’s intention that any vacancy on the NHMRC Licensing Committee be filled as soon as possible and if there is a vacancy for three months then the Minister must table written reasons for the failure to fill the vacancy.
The Explanatory Memorandum states that this clause is intended to address the Lockhart Committee’s recommendation 36.(206)
Schedule 4 amends the Customs (Prohibited Exports) Regulations 1958 by repealing regulation 7 which prohibits the export of human embryos except in certain limited circumstances, namely where there is the requisite Ministerial permission. The regulation was to cease to have effect at the end of 31 July 2007 (current subregulation 7(16)) but Schedule 4 repeals the entire regulation.
The Explanatory Memorandum states:
This is consistent with Recommendation 41 of the Lockhart Review that states that the import or export of a patient’s reproductive material, including ART embryos, for the purpose of that person’s ongoing ART treatment should not require any regulation other than that required under existing quarantine regulation.(207)
New section 47B of the RIHE Act stipulates that the Minister administering the Act must table a written report in Parliament about the establishment of a National Stem Cell Centre and a national register of donated excess ART embryos and, if applicable, the making of guidelines. This report is to be completed no later than six months after the commencement of the amending Act (that is, the Bill) and tabled in each House within 15 sitting days of that House after the day on which the report was completed. The Lockhart Committee had recommended that a national stem cell bank be established (recommendation 47) and that a national register of donated excess ART embryos be established (recommendation 49).
On 7 November 2006, the Senate passed an amendment moved by Senator Colbeck to introduce new section 47C of the RIHE Act. This new section stipulates that the Minister must cause a report to be prepared concerning the feasibility of establishing a national legislative or regulatory approach for effective governance of non-blood human tissue based therapies including stem cell therapies. This report is to be completed no later than 18 months after the day on which the amending Act (that is, the Bill) receives Royal Assent, with copies to be provided to both Houses of Parliament and the Council of Australian Governments. The report must be tabled in each House within 15 sitting days of that House after the day on which the report was completed.
New section 25A of the PHC Act and new section 47A of the RIHE Act are in essentially the same terms and provide for the further independent review of the operation of each Act. The review will also consider the clinical application of stem cell therapies. This review is to be commenced within three years from the date of Royal Assent of the Bill. This reflects the Lockhart Committee’s recommendation 53. The review of each Act is to be undertaken concurrently and by the same people (new subsection 47A(2) of the RIHE Act). A number of considerations are to be taken into account in the review (new subsection 25A(4) of the PHC Act and new subsection 47A(4) of the RIHE Act). The written report must be provided to both Houses of Parliament and the Council of Australian Governments before the fourth anniversary of the day on which the amending Act received Royal Assent (new subsection 25A(3) of the PHC Act; new subsection 47A(3) of the RHIE Act).
Arguably this Bill raises more ethical and moral, than legal or scientific issues.(209)
To address some of the ethical concerns raised in relation to the proposed changes, Parliament may want to consider whether to include in the Bill legal measures based on the principles of subsidiarity and precaution.(210) These principles include:
At its heart, precaution is a reminder of the limitations of scientific knowledge as a guide to decision-making, and a warning to heed the lessons of the past to prevent the occurrence of environmental damage in the future. But how this simple message is interpreted depends on the risk attitude of the interpreter.(214)
However, it must be acknowledged that both principles may have their own disadvantages, including that excessive precaution potentially could prevent important and beneficial future developments or that it could be difficult to ascertain whether there is a suitable alternative which achieves the same research results.
Further, it is important to remember that the resolution of the debate will not bring the matter to a close. Issues which will continue to draw attention to any new legislative regime will include:
… does not favour amendments to the Patents Act that would expressly address the patentability of inventions involving stem cell technologies. … [This is because] the requirements for patentability in the Patents Act are nearly all technology-neutral and are therefore capable of adapting to new technologies as they arise.(218)
Rather, the ALRC recommended that IP Australia develop examination guidelines (consistent with existing law) to explain how the criteria for patentability applies to inventions involving stem cells and related technologies.(219) The ALRC also recommended that the issue of the exploitation of intellectual property rights over stem cells should be considered when the issue of the establishment of a National Stem Cell Bank is considered as part of the independent reviews of the PHC Act and the RIHE Act.(220) As at the date of publication of this Digest the Government has not released its response to the ALRC’s report.
Finally, the legislative measures implemented at Federal level will have to be reflected in the legislation of the States and Territories.
| Excess ART embryos |
those human embryos that were created for assisted reproductive treatments but are no longer required for that purpose.(221) |
| Oocyte |
An egg cell. |
| Primitive Streak |
Thickening in the surface of an embryo that occurs at the gastrulation stage and is the first clearly recognisable sign of the developing organism itself. It is formed at about 14 days. It is the ‘primitive streak’, from which the central nervous system develops. |
| Reproductive cloning |
Using cloning technology (usually somatic cell nuclear transfer) to create an embryo that is implanted into a woman for gestation and birth. |
| Therapeutic cloning |
Term previously used to describe cloning to generate embryonic stem cells. |
| Somatic cell |
Any cell from an animal at any stage of development except for gametes (egg or sperm) or their precursors. |
| Zygote |
The product of fusion between oocyte and sperm cell. |
The Bill only seeks to implement some of the Lockhart Review’s recommendations. This is illustrated by review of Appendix 1 of the Explanatory Memorandum and Revised Explanatory Memorandum which summarises the Lockhart Review’s recommendations and how they are addressed in the Bill.
For example, the entries related to recommendations 18, 29, 30 and 32 state that no legislative change is required, in some instances because the relevant recommendation is for the National Health and Medical Research Council to consider.
The entry in relation to recommendation 24 in the Revised Explanartory Memorandum notes that the recommendation is not accepted. Originally, the Bill sought to implement this recommendation (see Explanatory Memorandum, p. 30), but on 7 November 2006, the Senate, upon the movement by Senator Bartlett, passed amendments deleting provisions that would have permitted the creation and use of certain hybrid embryos. Explanatory Memorandum, p. 30. No equivalent in the Revised Explanatory Memorandum.
This paper has been prepared to support the work of the Australian Parliament using information available at the time of production. The views expressed do not reflect an official position of the Parliamentary Library, nor do they constitute professional legal opinion.
ISSN 1328-8091
© Commonwealth of Australia 2006
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Published by the Parliamentary Library, 2006.