Richard has recently returned from a series of conferences and meetings with bioethicists in the US. We are grateful to him for letting us post this clear summary of the key points of the recent Legislative Review.
Human cloning: on the way out?
A recent review of the law permitting human cloning for research is less than enthusiastic about cloning and admits the law may soon be outdated.
In 2002 both Houses of the Commonwealth Parliament voted unanimously to prohibit all forms of human cloning, including cloning for research. The overwhelming consensus was that it was ethically wrong to create a human embryo for the purpose of destroying it in research, including research involving the extraction of embryonic stem cells.
A majority of both Houses did, however, support legislation which permitted the use of so-called “excess” human embryos, fertilised in vitro for reproductive purposes but never implanted, to be used for research, including the extraction of embryonic stem cells.
In 2005 a review of this legislation by the Lockhart committee coincided with the six month period between the much celebrated claim by Korean scientist Hwang Woo Suk to have successfully created several human embryonic stem cell lines from cloned human embryos and the revelation that this claim was fraudulent.
Based largely on the perceived need for Australia to catch up with the (fraudulent) Korean developments the Lockhart committee recommended changing the law to permit human cloning for research.
Despite the setback of Hwang’s fraud being exposed proponents of human cloning successfully hyped the possible results from such research to persuade a bare majority of one in the Australian Senate that legislation permitting human cloning for research was the best hope that the lame would soon walk, the blind see and the diabetic discard his or her insulin supplies.
The new law permitting cloning was assented to on 12 December 2006 and came into effect six months later in July 2007.
The report of the review of the new legislation by a committee chaired by former Federal Court judge the Hon Peter Heerey QC was released by the Gillard government on 7 July 2011.
The past four years has not favoured the proponents of human cloning.
The report observes:
Attempts to generate human ES cells by SCNT have been pursued for over seven years and, with the notable exception of work reported from Korea and subsequently admitted to be fraudulent, are yet to produce a claim to development of a human ES cell line, though development of embryos to the eight cell stage has been achieved.
A majority of the committee did recommend that the scheme permitting human cloning for research under license continue while commenting:
However, in reaching this recommendation, the Review Committee notes the lack of progress in SCNT [somatic cell nuclear transfer – the main cloning technique] research in animals and humans.
The Review Committee believes that this must impact on the Licensing Committee’s interpretation of its statutory obligation, when it is considering any future application for a licence to undertake research involving SCNT, to take into account ‘the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs, or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means’ when it is considering any future application for a licence to undertake research involving SCNT.
Committee member the Rev Fr Kevin McGovern strongly dissented from this recommendation noting:
the approach recommended by the Lockhart Review, which stated that ‘the greater the potential benefits of an activity, the greater the need for ethical objections to be of a high level and widely accepted in order to prevent that activity. Conversely, where benefits are not yet established, or where there is widespread and deeply held community objection, then total prohibition through the legal system may be justified.’
Reverend McGovern believes that in 2011 the latter standard has been reached for SCNT. In 2006, SCNT seemed the only way to seek the benefits of regenerative medicine. With the advent of induced pluripotent stem cells, this is no longer the case. It is hard to see what SCNT now contributes to the progress of regenerative medicine. What would be lost if Australia’s regulatory regime permitted the harvesting of embryonic stem cells from excess embryos along with research with adult stem cells and induced pluripotent stem cells, but did not permit SCNT?
Some scientists have proposed some possible benefits of SCNT, but their arguments are not entirely convincing. Dr Megan Munsie argues that SCNT-ES cells might more closely resemble ES cells than iPS cells. However, the evidence from animal work is that SCNT generally produces damaged or abnormal embryos. This strongly suggests that even if SCNT-ES cells more closely resemble ES cells, these SCNT-ES cells will still be genetically abnormal and inferior to ES cells.
Professor Bob Williamson advocates SCNT to generate stem cell lines as disease models to study late-onset conditions. It is not clear, however, why SCNT-derived lines would be more useful than iPSClines.
Beyond that, there is only the possibility of what ‘might’ be learnt if research into SCNT continues. The proposed benefits of SCNT research therefore seem not entirely convincing, sometimes rather small, and largely theoretical. On the other hand, SCNT involves the most profound of ethical concerns. It is the creation of human life which will be used in research and then destroyed. When people understand this, many people within the community are troubled by SCNT.
For all this, however, this most serious of ethical concerns has been judged less significant than the mostly theoretical benefits which might come if research into SCNT is allowed to continue. With this outcome, Reverend McGovern wonders whether the ethical concerns about SCNT research are ultimately being given anything more than lip-service.
The report noted that fellow committee member Dr Faye Thompson “shares Reverend McGovern’s concerns about SCNT”. So only three of the committee’s five members fully endorsed the recommendation – including known cloning advocates Professors Loane Skene and Ian Frazer who had each played a key role in the 2006 hype for cloning.
The report notes that of the total number of 264 submissions, 188 were from the general community. Of these, 112 specifically commented that they did not support human cloning, while all 188 stated that they did not support the use of human embryos for research.
In its final recommendation the report calls for a further review of the legislation each five years commenting that:
The Review Committee thinks it highly desirable that in this rapidly changing field of science there be periodic reviews. For example, it may be that by the time of the next review it has become accepted that SCNT is no longer appropriate.
The Heerey committee unanimously recommended that there be no change to the legislation which prohibits payment for eggs or sperm. This was noteworthy given the very public campaign of committee member Professor Loane Skene for such a change.
The committee also rejected a proposal to change the legislation to allow the creation by fertilisation of human embryos with genetic inheritance from more than two people. Proponents claim this could help women with mitochondrial disease have children unaffected by the disease.
The majority of the committee also recommended allowing experimental research in creating human embryos using sperm or eggs derived by manipulating body cells or embryonic stem cells [in vitro derived or IVD gametes] . This technique could ultimately be used to create a child from sperm and an egg derived from a single individual or from two persons of the same sex.
Fr McGovern again dissented observing that:
the development of knowledge about human IVD gametes will lead almost inevitably to their use in human reproduction, even if many in our society are opposed to this.
The committee rejected calls from the Coalition for the Defence of Human Life and other community organisations to repeal the provisions in the law permitting the use of eggs from aborted baby girls to make human embryos for research.
In what can only be described as a lack of moral imagination the committee could not see anything to distinguish this abhorrent practice from other forms of making human embryos for research (such as cloning) or from the donation of tissue from aborted babies for other purposes. While these practices are all unethical surely there is something particularly repulsive to human and moral sensibility in making an aborted baby girl a mother only to cannibalise her offspring for speculative research.
Fr McGovern is to be commended for his forthright dissent and astute comments throughout the report. On the fundamental question of using any human embryos as a source for stem cells, including those “excess” to IVF requirements he states:
Section 8 of the NHMRC Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research requires that embryos which must be disposed of should be disposed of respectfully.
He does not believe that the evisceration of these embryos to extract their stem cells is respectful disposal. As we would be concerned if this was done to a human being at any other stage of human development, he believes that we should be concerned about this.
The Coalition for the Defence of Human life will continue to work for an end to all legislation that permits destructive research of any kind on any human embryo.