AUSTRALIAN CATHOLIC BISHOPS CONFERENCE

							13th September 2002

Mr Elton Humphery
Secretary to the
Senate Community Affairs Legislation Committee
Parliament House
Canberra   ACT   2601

Dear Mr Humphrey,

Research Involving Embryos and Prohibition of Human Cloning Bill 2002

	Thank you for your invitation to comment on the above Bill.  

	Please permit me three preliminary comments.  First, the recent vote in the House of Representatives to split the Bill confirms what has been readily apparent for some time, namely that there are two distinct issues addressed by the Bill - cloning and destructive embryo research.  The overwhelming parliamentary and community support to ban cloning in all of its proposed forms should be supported by the Senate.  Senate Committee members would be aware that such a ban is also supported by large sections of the medical research community.  It is the view of the Church at an international level, and at the national level in this country, that cloning, in all of its forms, should be banned. 

	Secondly, in view of the above regarding the ban on cloning, the comments below address, primarily, the most contentious aspect of the legislation - destructive embryo research and issues relating thereto.

	Thirdly, there is already a significant amount of material in the public arena from the  Church (at international and local levels) concerning cloning, embryo research, ethics and law so as to make it otiose to repeat what is readily available elsewhere.  Accordingly, I note summarily the following for the consideration of the Committee and refer, at the end of this letter, to where these previously published materials may be accessed.  I particularly draw attention to the submission to this inquiry from our Conference Research Department.  That submission addresses issues pertaining directly to the Bills now before the Committee, as well as amplifying matters noted below.  My remarks are directed to four areas: the human embryo, the exploitation of women, the shifting claims of science, and the difficulties of effective regulation.

The Human Embryo

1.	The Church has consistently taught, for the consideration of all, that no member of the human family should ever be excluded from being treated with the utmost dignity and respect.  To admit of any exception to the human dignity of all, especially those who are completely vulnerable and without voice, opens the door to admit further exceptions.  Such a principle also accords with medical research codes of long-standing, such as the World Medical Association’s Declaration of Helsinki (1964-2000), the UNESCO Declaration on the Human Genome and Human Rights (1997), and the Council of Europe’s Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (1997) and its additional (1998) Protocol.  These codes confirm that respect for the research subject must take precedence over the interests of society, and over respect for academic or scientific freedom.  Congruent with these codes, the Church upholds and encourages medical research which conforms to the most stringent of ethical standards (e.g. Charter for Health Care Workers, 1995 from the Pontifical Council for Pastoral Assistance to Health Care Workers, par.82; Code of Ethical Standards for Catholic Health and Aged Care Services in Australia (2001), Catholic Health Australia, pars. 2.15-2.17 & 6.13-6.14).

2.	The human embryo is no less a member of the human family simply because it is extremely small.  Embryologists and other medical researchers confirm that human life begins at fertilisation (e.g. “Your destiny, from day one” Nature Vol.418, 4 July 2002 pp.14-15; “Individual life begins with conception by the union of gametes or sex cells....  Growth and development continue thereafter until a sexually mature adult is formed.”  Brookes & Zeitman, Clinical Embryology, 1998, p.2).  This is to say that frozen human embryos are not from some species other than human.  It is utterly discriminatory to select “smallness” as the criterion for their destruction in the utilitarian hope of some potential cure.  It is equally discriminatory to select any other criteria (e.g. those with a terminal illness, baldness, etc) so as to make available for research any member of the human family.  Just because nascent human life does not immediately look like `the rest of us’ (although we all once looked like “them”), is no reason for using them as human “guinea pigs.”  Indeed, Professor Trounson has stated that were young embryos to look like us he would not dissect them for their cells (The Weekend Australian -Magazine, 22nd June 2002, “The Man Who Plays God.”  “When we are talking about dissecting two- or three-month embryos and they have a body form, I couldn’t actually do it.  ... from my own point of view I couldn’t dissect those fully developed embryos or foetuses.”)

3.	One of the reasons advanced for the use of frozen embryos is the utilitarian proposition that there are so many of them deemed “surplus.”  However, this is quite misleading given that there is evidence of long-standing that the number of embryos produced by IVF clinics is easily manipulated (see Report, Human Embryo Experimentation in Australia: Senate Select Committee on the Human Embryo Experimentation Bill 1985, paras: 3.30-31).  The latest statistics from the Australian Institute of Health and Welfare confirm that there has been a more than threefold increase in the number of embryos frozen between 1994 (22,280) and 2000 (71,176).  To so manipulate the production of human life is an affront to human dignity and fosters a view of  life which is more akin to the embryo as “property”, able to be bought and sold as a commodity, than as a member of the human family (e.g. B. Bennett, “The Human Embryo as Property? Cryopreservation and the Challenges for Law,” (2000) 7 Journal of Law and Medicine 434 cf. L Knowles, “Property, Progeny and Patents,” (1999) 29 Hastings Center Report 38).  In short, the dominant paradigm promoted by the destructive, but commercially profitable, use of the “frozen generation” is that of `production - manufacture - commodification - commercialisation of life.’  This paradigm ought be rejected for the extreme utilitarianism that it is.

4.	Embryos (frozen or otherwise) are not completely devoid of rights.  For example, the Tasmanian Supreme Court has held that frozen embryos possess rights (in the instant case, rights of succession) contingent only upon them being born (In re the Estate of the Late K (1966) 5 Tas R 365; D. Chalmers, “Frozen assets: The inheritance rights of embryos,” (1996) 31 Australian Lawyer 19).  The “frozen generation” have been deliberately created to relieve the childlessness of couples.  Now, under government fiat, researchers are to be licensed to destroy them for the cause of financially lucrative but medically and ethically flawed research, thus ensuring that their legally recognised, inchoate rights can never materialise.

5.	Access to the “frozen generation” was “sold” to the Australian public on the basis that its members were needed from which ES cells could be extracted.  We now know that, to a significant degree, this was misleading.  Why?  Because the secretive consultation conducted by the NHMRC regarding an exposure draft of the legislation, and from answers to Senate Committee questions, documented that researchers want access to these embryos for many other purposes including drug testing and toxicology studies, and for the refinement of artificial reproductive technology techniques.

Exploitation of Women

6.	There is some evidence, so far largely un-remarked, that the proposals to use frozen embryos will inevitably require the production of further embryos, which, in turn, will lead to the need for more and more eggs to be harvested from women.  Given the invasiveness of laparoscopic procedures, and the use of super-ovulants, required for such “harvesting”, perhaps it is understandable that there has been so little attention paid in the debate thus far to the exploitation of women (cf. “Donating eggs for IVF fraught with problems, say experts” AAP, 18th June 2002, www.smh.com.au/ ;  “Cloning for Cures Only Possible With Exploitation of Women,” Cloning Fact - May 13,2002, www.cloninginformation.org; E. Blacksher, “On Ova Commerce,” (2000) 30 Hastings Center Report 29). 

Shifting Claims of Science

7.	Given the regular and prominent reporting in the press and other media of the flawed attempts to promote embryonic stem (“ES”) cell research by those who have the most to gain financially from it, few comments are necessary here.  One should note, however, that, increasingly, researchers with medical qualifications are questioning the claims made by those from non-medical backgrounds (e.g. animal husbandry) about the advantages of ES cells versus the peer-reviewed, documented advances made by those engaged in adult stem cell research.  This inevitably leads to questions as to how such persons can know, and make any relevant claims, about cures for any medical condition, such as Parkinsonism.  It will suffice to note that Emeritus Professor of Medicine at Melbourne University, T. John Martin, has stated publicly that “It is the repeated publication of these false claims that is largely responsible for the misinformation provided to the community.  ...there is no evidence for long-term efficacy of embryonic stem cells as treatments in animal models of Parkinson’s or diabetes.   ...Because these and so many other questions are unanswered, no case has been made for the urgency of human embryonic stem-cell research now, before there is even a single “proof of concept” achieved in animal research, and before the many safety issues are resolved.”  (Letter to the Editor, The Australian, 14th August 2002, p.10).  Neuroscientist, Professor Colin Masters of Melbourne University, has commented similarly in relation to the absurdity of claims of cures for Alzheimer’s using stem cells - adult or embryonic.  (“Alzheimer’s stem-cell cure `a joke’”, The Weekend Australian 20-30 June, p.3;  “No scientific imperative for destructive research on human embryos”, Open Letter to Australian Parliaments regarding Stem Cell Science, 28th August 2002)

Regulation - the Slippery Slope

8.	In 1994, the House of Lords Select Committee on Medical Ethics reported on euthanasia.  It said (par.238): “... to create an exception to the general prohibition of intentional killing would inevitably open the way to its further erosion whether by design, by inadvertence, or by the human tendency to test the limits of any regulation.” (Emphasis added)  To a significant degree, the Commonwealth Parliament in 1997 agreed with this, and other opinions, in the Report.  Human nature’s `tendency to test the limits of any regulation’ has not changed discernibly since 1997.  Moreover, in the euthanasia debate, there were no readily apparent financial interests at stake; here there are vast sums of money (in taxpayer funds and via patents) and kudos at risk.  If this Parliament decided that euthanasia could not adequately be regulated when financial pressures were absent, by what measure can it fairly be said that embryo experimentation can be `strictly regulated’ when significant financial incentives are on offer?

Conclusion

	Through their regulative, educative, protective and symbolic effect, our laws will reflect the parliament’s regard for the inherent dignity of all human life, both in its generation and in its existence.  It will reflect on and influence our community as to how we think about and act towards all members of the human family.  Will we seek to be a society protective of all human life, or will we cross a line by which some lives will be regarded as expendable?  Will we adopt, as a principle of public policy and legislative intent, that the ends are justified by any means, including the destruction of nascent human life?  It is on this extreme principle of utilitarianism that the Research Involving Embryos Bill 2002 is founded.

	Human life is never disposable, at any stage of its development.  It should never be seen as a commodity, as a type of property able to be exploited for profit.  Nor is the value of any human life, or its claim to protection, reducible to or dependent on age or its utility to others.

	On the published evidence to date, there is growing scientific agreement that research using adult stem cells is, ethically, a more prudent course and, medically, a more advantageous one.  Moreover, from a resource allocation perspective, given the contested claims surrounding ES cell research, to divert scarce medical research funds into this extremely problematic area, and thereby deprive adult stem cell research of these funds, a cogent argument could be mounted that such a course would at least be imprudent, if not genuinely unjust.

	One final point: as a matter of due process and of principle, one ought seriously question the granting of  significant taxpayer funds for the `biotechnology centre of excellence’ prior to parliamentary scrutiny of all relevant matters, and prior to the enactment of appropriate legislation to regulate an “industry” into the manufacture and exploitation of human life.

	Attached is a list of web sites at which the previously mentioned submissions and other relevant materials from Church sources can be accessed.

						Yours sincerely,

						a Francis P Carroll
						President
						Australian Catholic Bishops Conference

Catholic Materials Relevant to the Research involving embryos Bill 2002 &
the Prohibition of Human Cloning Bill 2002

1.	Catechism of the Catholic Church 1994: “Respect for the person and scientific research” pars.2292-2296

2.	The Gospel of Life (Evangelium Vitae): Encyclical Letter 1995, passim and especially par.63

3.	Pontifical Academy for Life, Reflections on Cloning, 1997

4.	Pontifical Academy for Life, Declaration on the Production and the Scientific and Therapeutic use of Human Embryonic Stem Cells, 2000

All of the above documents are available on the Vatican web site: www.vatican.va.

5.	Australian Catholic Bishops Conference Opening Statement, House of Representatives Standing Committee on Legal and Constitutional Affairs, Inquiry into scientific, ethical and regulatory aspects of human cloning: 29th March 2000 (Archbishop Barry Hickey)

6.	Submission to House of Representatives Standing Committee on Legal and Constitutional Affairs, Inquiry into scientific, ethical and regulatory aspects of human cloning: 14th March 2000 (Research Department: Australian Catholic Bishops Conference)

7.	Discussion Paper on Ethics, Law & Medical Research - Cloning & Stem Cells: A Contribution to the National Debate: 20th September 2001 (Research Department: ACBC)

8.	Submission to the NHMRC Consultation in the Human Cloning and Research Involving Embryos Bill 2002: 5th June 2002 (Research Department: ACBC)

All of the above documents are available on the web site of the Australian Catholic Bishops Conference: www.catholic.org.au.

A similar range of materials is available from the United States Conference of Catholic Bishops: www.nccbuscc.org/prolife.

AUSTRALIAN CATHOLIC BISHOPS CONFERENCE

Submission to the

Senate Community Affairs Legislation Committee

Inquiry into

the Research Involving Embryos Bill 2002

and the Prohibition of Human Cloning Bill 2002

								13th September 2002

Introduction

The following remarks on the Research Involving Embryos Bill 2002 (“the Embryo Bill”) and the Prohibition of Human Cloning Bill 2002 (“the Cloning Bill”) ought be read subject to the contents of the letter to the Senate Community Affairs Legislation Committee (“the Committee”) from the President of the Australian Catholic Bishops Conference, Archbishop Francis Carroll, dated 13th September 2002.

	The Committee will be aware that nearly all of the issues raised by the Bills before it have been addressed most recently by the United States Presidential Council on Bioethics in its first report, Human Cloning and Human Dignity: An Ethical Inquiry (10th July 2002).1  Other issues, such as the definition of “embryo” under the United Kingdom Human Fertilisation and Embryology Act 1990, have been the subject of recent judicial decision.2  There the Court of Appeal held that, in order to determine the question in issue, it was essential to look to the intention of Parliament regarding the Act which was (a) to provide a comprehensive regime of regulation and (b) to ensure that embryos, created by whatever means, would always come within the definition of “embryo” under the legislation even though it was enacted in 1990.

	The Council of Europe addressed many of these same complex issues in its 1997 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine and the 1998 anti-cloning Additional Protocol to the Convention.

	Australia, at a national and State level, has, of course, had a number of inquiries into, and papers have been published on, the creation of children, a subject perhaps most thoroughly treated in the Family Law Council’s Creating Children: A Uniform Approach to the Law and Practice of Reproductive Technology in Australia.3   To these reports ought now be added the first tastes of judicial spices in relation to rulings on access to artificial reproductive technology4 as well as the Senate Legal and Constitutional Legislation Committee’s 2001 Report on its Inquiry into the Provisions of the Sex Discrimination Amendment Bill (No.1) 2000.

	All of this is to confirm a number of things.  First, the matters currently before the Parliament concerning the on-going challenges posed by artificial reproductive technology are being addressed world-wide.  Invariably, the response of legislators is to proceed slowly, indeed, with extreme caution.  As the US experience indicates, there is great wisdom in taking as much time as possible to gather experts from diverse, relevant disciplines to examine and to test the unverified, extravagant and sometimes deliberately deceptive claims made by those who have the most to gain, financially and otherwise, from the new sciences.5  Secondly, it is also clear that there is a significant appreciation among parliamentarians that how we address, at a legislative level, our treatment of human life will impact significantly upon not only the legal ecology of our nation but also upon its ethical landscape.  Put another way, to make an exception, as the Embryo Bill proposes, of one member of the human family - in this case certain kinds of embryos - so as to become research guinea pigs, admits of both the possibility, if not the likelihood, of further exceptions in due course.  Indeed, once the door to one type of embryo is opened, it can only be forced further ajar - never closed.

	This submission proceeds in three parts: first, there is discussion of questions relating to parliamentary sovereignty and process.  Secondly, there follows comment on matters of principle relating to law and ethics.  Thirdly, there are particular comments on certain parts of the Bills with special emphasis on the Embryo Bill.

Parliamentary Sovereignty & Due Process

1.	Both pieces of legislation before the Committee purport to represent the Council of Australian Government’s (“COAG) decision of 5th April.  That legislation, but not the COAG decision, is only now the subject of parliamentary scrutiny.  Critically, the decision created, for the first time in Australian political and legal history, a class of human life which is to be statutorily expendable.  It transgresses, indeed it completely overturns, medical research protocols of long standing, such as the Nuremburg Code (1948) and the Declaration of Helsinki (1964-2000).  In these codes, the interests of the research subject are to take precedence over the interests of research and that of the wider community.  The COAG decision establishes a class of human guinea pigs who are to be made available for destructive, but commercially lucrative, research.

2.	Between the COAG decision, and prior to the introduction of the legislation into Parliament, it was announced that a `Biotechnology Centre of Excellence’ had been established to which $46.5 million of taxpayer funds was committed.  This decision effectively pre-empted any examination by Parliament of the merits of such a Centre and of appropriate regulation being in place before it begins operation.  The well-documented flaws in claims made by those announced to run it, and the now public linking of funds from the collapsed HIH Insurance Company to, and a prominent member of that company on the Advisory Board of, the Monash Institute of Reproduction and Development, suggests that Parliament ought have a more thorough-going opportunity to exercise its scrutiny of all matters pertaining to decisions already taken on these matters.

3.	Frozen embryos have been manufactured, in deliberately excessive quantities, to provide children to childless couples.  The financial cost of their creation is borne by the Australian taxpayer and by the couples involved.6 The COAG decision proposes that legislation be enacted to sanction, under licence, that these same innocent embryos, created for one purpose, be handed over to researchers from diverse scientific backgrounds who will be legally permitted to destroy them on the basis that “there is some likelihood of significant advance in knowledge, or improvement in technologies ... which could not reasonably be achieved by other means.”7

4.	The Explanatory Guide to the Exposure Draft of the Bill (p.10), and the draft Regulation Impact Statement (pp.13-14), detail a large range of matters for which a licence can be granted, none of which were ever the subject of the COAG communique, most of which were never disclosed to the Australian public, and certainly few of which (e.g. “to train clinicians in micro-surgical ART techniques” or “for improving ART techniques”) fall within the parameters of “treatment” as required under the COAG communique.  Presumably these “agendas” remain.  It is also a matter of record that human embryos are sought by researchers for drug testing and toxicology studies.  In short, there is a serious conflict between, on the one hand, the purposes advanced by the NHMRC and researchers for access to frozen embryos and, on the other, COAG’s express decision to allow destruction of surplus IVF embryos only for the purpose of deriving embryonic stem-cells.  Such a conflict also impacts on the transparency and speed of the process by which the legislation comes before this Parliament, the lack of respect paid to the origins of human life, and the deception of the general public because the members of COAG ‘sold’ human embryo experimentation under this guise when other, less attractive, uses are already envisaged.  

5.	As already noted, the course of the US has been fundamentally different to that which is train in Australia.  In the United States, President Bush has established a Presidential Council of experts to examine in detail, inter alia, the competing claims regarding stem cell research, both adult and ES.  The approach there is to proceed with great caution, specifically, as the First Report states at the outset, “...with the aim of advancing public understanding and informing public policy on the matter.  We have attempted to consider human cloning (both for producing children and for biomedical research) within its larger human, technological, and ethical contexts, rather than to view it as an isolated technical development.”8  The majority recommendation of the President’s Council is to ban `cloning-to-produce-children’ combined with a four year moratorium on cloning-for-biomedical-research.’  This is supported by many reasons one of which is that “all stem cell research is at a very early stage, and it is too soon to tell which approaches will prove most useful, and for which purpose.”  The Committee will recall that when another ethically significant matter (euthanasia) came before this Parliament, a length of time much more conducive to `advancing public understanding and informing public policy’ was taken to allow extensive, open consultation both in the community and in the Parliament.  Unfortunately, the current debate is progressing at  such a pace, with only four days of hearings for evidence to be presented and evaluated by Senators regarding matters of great controversy and importance, that one ought be concerned that speed to resolve matters at a legislative level is the principal goal.  It seems most apt to adopt the old adage of `more haste, less speed.’  The approach of the US Presidential Council on Bioethics has much to commend it.

6.	For the reasons just mentioned, and those noted below, one must not be taken as approving any of the abhorrent practices, such as embryo destruction, contemplated by the Bill, nor as implying any confidence that its prohibitions will for long be implemented.  Indeed, notwithstanding the recitation by the Prime Minister and others that a `strict regulatory regime will be in place’, given that money has already been granted to researchers without there being in place any regulation, and that, for example, the UK equivalent of the proposed NHMRC Licensing Committee - the Human Embryology and Fertilisation Authority - has become a “rubber stamp” for whatever researchers deem their latest desire (including the cloning of embryos for research purposes), one would be extremely “courageous” to suggest that there will be genuinely strict regulation as proposed.  

7.	To reinforce the ceding of parliamentary authority and scrutiny to COAG and other such bodies, cl.61 of the Embryo Bill provides that the NHMRC, not the Minister as in cl.25 of the Cloning Bill, must cause an independent review of the operation of the Act.  Both Bills provide that the report on the review is to be given, not to the Minister, or to the Parliament, but to COAG.   Parliament, and relevant Ministers, must resume its and their rightful authority and responsibility and require transparency and accountability in relation to all aspects of an industry which has, as its central and most significant feature, the destructive use of human life.

Law & Ethics
8.	As a general proposition, it is the role of law to educate, to protect and to regulate.  While the Cloning Bill admirably prohibits cloning (subject to a few exceptions), the Embryo Bill educates Australian society to the effect that a certain class of human life is expendable, it regulates so as to allow, for a fee, the destruction of human life, and it fails to protect either embryos or women who donate eggs.  Its principal protections are reserved, under the guise of “confidential commercial information”, to those who will make money (e.g. via patents) from the destruction of human life.  The Bill is singularly lacking in reference to ethical parameters.

9.	The Embryo Bill does not reflect, nor does the Explanatory Memorandum refer relevantly to, international instruments, such as the Convention on the Rights of the Child, or significant national documentation, such as the (Commonwealth) National Statement on Ethical Conduct in Research Involving Humans.  The former refers to the requirement that the child, due to his or her `physical and mental immaturity’, needs special safeguards and care, including appropriate legal protection, before as well as after birth; the latter refers (cl.1.16 ff.) to`the results of research (whether publicly or privately funded) and that the methods used should normally be published in ways which permit scrutiny and contribute to public knowledge.’  The COAG communique similarly calls for “public reporting of research involving embryos so as to improve transparency and accountability to the public” (Attachment 6.4).  To date, this has not occurred, nor does the Embryo Bill do much to ensure that it will do so.  For example, in the course of granting a licence, the legislation should at least require that there be published, refereed evidence from the applicant (cl.35) upon which the Licensing Committee could “reasonably” base its decision.

10.	The Victorian Infertility Treatment Act 1995 provides “Guiding Principles” (s.5) with respect to administering and carrying out functions under that Act.  Those “Guiding Principles” state, inter alia: “(a) the welfare and interests of any person born or to be born as a result of a treatment procedure are paramount; (b) human life should be preserved and protected ....”  It is unclear whether COAG intended, and if so how, these principles should be treated in the light of the COAG decision to allow destructive research on embryos.  Presumably they are simply to be abrogated.  Similar questions arise with respect to the Western Australian Human Reproductive Technology Act 1991 which provides in its preambular section, inter alia, as follows:

	Parliament considers that the primary purpose and only justification for the creation of a human egg in the process of fertilisation or embryo in vitro is to assist these couples to have children, and this legislation should respect the life created by this process by giving an egg in the process of fertilisation or an embryo all reasonable opportunities for implanting.

11.	Note should also be made of the Declaration of Helsinki (2000), in particular, cl.5 which states that “in medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society.”  It is not clear how the Bill might justify the deliberate extinguishment of life with the principles set out in this Declaration and others like it, such as the Council of Europe’s Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine (1997) and relevant provisions of the UNESCO Universal Declaration on the Human Genome and Human Rights (1997). 

12.	All of this is to say that the Embryo Bill proposes that Australia should cross a line which has never been crossed before.  Its cornerstone is the destruction of human life, under licence, and that the group or individual will be financially rewarded for such action.  The Embryo Bill abolishes the foundational element of the Hippocratic tradition - primum non nocere.9

13.	The COAG decision was predicated upon access to alleged surplus frozen embryos solely to extract ES cells.  To be faithful to that decision, the Bill ought be limited only to this expediency.

D.	The Bills - General

14.	There ought be basic, preambular provisions which at least refer to some ethical parameters, such as found in the Victorian and WA legislation, and/or taken from the Declaration of Helsinki.  This may assist some members of the licensing committee to focus on appropriate ethical considerations and provide a source for further ethical reflection.

15.	Neither Bill maximises its constitutional coverage.  Clause 4 of each Bill should be expanded to reflect constitutional heads of power to embrace taxation (Constitution s.51 (ii)) so as to encourage adult stem cell research; (s.51 (xviii)) to deal with copyright, patents, designs and trade marks; and (s.51 (xx)) concerning foreign corporations.  The Bills are deficient with respect to the lack of regulation of un-incorporated entities and individuals.

16.	The definition of “embryo” in both Bills is circular.  It ought read, “embryo means a human entity (or organism) that has been developing for less than 8 weeks, with development beginning at the commencement of fertilisation, or at the initiation of development of a human entity by any other means.”  An alternative definition would be that which is proposed in the submission from the Archdiocese of Melbourne.

The Cloning Bill
17.	Each of the offences in Part 2 of the Cloning Bill - Prohibited Practices - ought include, as does cl.22 (1), (2), and (3) already, reference to acts or omissions done “recklessly.”  The export of “products” from human embryos is not specifically outlawed; it should be.

18.	The Bill is silent on the question of surrogacy.  Notwithstanding cl.22, presumably the Bill, and the COAG decision, are predicated upon banning the commercial trafficking in human eggs, human sperm and human embryos, except in those circumstances which otherwise comply with the licensing system provided by the Bill.10

The Embryo Bill & `the licence to kill’
19.	`Confidential commercial information’, as defined (cl.23), is so broad, and so subjective, as to defy any relevant  meaning (e.g. “Or other value” - to whom?).  “Whistle-blowers” are not protected under the legislation.  As the legislation presently stands, they are likely to be the principal source of information to the public.  Accordingly, they should be protected.  Combined with the effect of cl.45, there is abundant protection for commercial interests but precious little either for embryos or whistle-blowers.

20.	The Bill provides nothing with respect to `conflict of interest.’  Only in the Explanatory Memorandum is one referred to certain sections of the National Health and Medical Research Council Act 1992 (Cth) which summarily states (s.38 (b)(vi)) that it is the Council which determines “the disclosure of members’ interests in matters being considered by the Committee.”  Given the vast sums of money at stake in embryo research, conflict of interest of researchers, decision-makers and commercial interests with respect to licences must be dealt with comprehensively in the legislation.11  Transparency and accountability to parliament, and the general public, must take precedence over confidential commercial information.

21.	Cl.25(2)(d)(ii) refers to “diagnostic investigations.”  Any number of matters might be embraced by or under such an imprecise term.  It would allow a wide range of experiments on embryos which otherwise would be prohibited under the legislation.

22.	Cl.31 provides for the composition of the Committee that is to grant licences to destroy embryos.  It is readily conceivable that most of the members of the Licensing Committee could all come from the IVF or ART industry.  It would be clearly inappropriate for this to occur.  Some mechanism or procedure ought be in place to ensure some balance.  In this regard, it is instructive to note comments from the UK which, to date, has the most laissez-faire regime in relation to embryo experimentation.  A recent editorial comment in the Bulletin of Medical Ethics, on a recent debate in the UK Parliament and a report of a Select Committee, is apposite for the current debate in our Parliament.  The editorial states:
Those invited to give oral evidence to the Committee, rather than those who submitted written evidence, were strongly biassed towards the sole importance of ES cells while playing down the value of adult stem cells.

... So it is all the more worrying that Parliament is encouraging scientists to rush ahead with research on ES cells, that is repellant to many in society because it involves the inevitable destruction of potential human life [sic].  Surely the full potential of adult stem cells should be researched first.
There is a larger issue also.  Many of the bodies set up to regulate aspects of medical advance are populated only by those in favour of advance, preferably as unfettered as possible.  Bodies such as the Human Fertilisation and Embryo Authority and the Gene Therapy Advisory Committee have never had as members anyone who seriously questions the value of some of the `advances’, let alone is opposed to them for ethical, religious or social reasons.  The Department of Health appoints to many of these bodies, and advises parliamentary committees whom to talk to.  Its gung-ho policy is building a serious democratic deficit.12

23.	Cl.35 must be expanded so as to require the applicant for a licence to provide to the Committee (a) formal disclosure of the commercial relationship (if any) between his or her corporate sponsors and the proposed research, (b) published, peer-reviewed research, and (c) verified details of experience which the applicant has, with respect to embryonic stem cell research.  It must be a term of acceptance of any licence granted that the applicant will not contravene the provisions of the Cloning Bill.

24.	Despite reference to `proper consent to donation’ in cl.36 (3) (a) (i), the Bill inadequately addresses the need for detailed information-giving with respect to proposed research, for explanation to the donor(s) of sperm, eggs and or embryos that they can restrict any such consent to certain purposes, and for appropriate counselling prior to consent.

25.	Cl.36 (4) (b) requires that it is sufficient for the granting of a licence if “there is a likelihood of significant advance in knowledge.”  This is flawed for many reasons.  No specificity is set in relation to the degree of “likelihood”; in theory, a minuscule likelihood would suffice.  Just as relevantly, the COAG documentation (Appendix 1) qualified this paragraph specifically by referring to the requirement that the advance in knowledge or improvement in technologies were [both] to be related directly to “treatment”.

26.	Cl.60 of the Bill ought be repealed.  It must only be after due debate in Parliament that questions of any change in access to embryos for the human equivalent of strip-mining or bio-prospecting ought be addressed.13  Put another way, on matters relating to the destruction of life (especially for profit) Parliament ought never cede its authority to COAG or any other body.14

Other Considerations 

27.	There is growing evidence that children born from IVF suffer from a range of adverse medical conditions.15  Presumably IVF practitioners have selected for implantation those embryos which are deemed the “best of the crop.”  If that is so, it would mean that those embryos now deemed “spare” or “excess” might well be of a second order in quality.  One might ask, from the prevailing utilitarian perspective, whether researchers would really want, or should be allowed, to use embryos of perhaps inferior quality?  If not, would there not then be a push for the need for and use of “fresh” embryos?  This has already been suggested in the debate by some of the biotech companies.  How would a pro-research licensing committee resist such an application?

28.	Another matter to address concerns the controverted question that is advanced along the lines of `the frozen generation is going to die anyway’ and that there is, in the eyes of some, `no relevant moral difference between allowing an embryo to succumb and facilitating its destruction via experimentation.’  The distinction between `allowing to succumb’ and `expediting the demise through destructive research’ is a very common distinction in law and in ethics.  It is commonly appreciated in relation to the care provided to those who are contending with a terminal condition.  It is one thing to allow a medical condition `to take its course’, and it is quite another to administer a lethal injection - with or without an understandable motive to relieve suffering.  In the first case, both law and ethics recognise that allowing a person to succumb to a condition is a fact of life, so to speak.  Those same disciplines also recognise that to administer a lethal injection is to kill.  The intention of the actor must be distinguished from the motive of the actor.  To give a homely example, the legend of Robin Hood holds that he stole from the rich to give to the poor.  His motive was the laudable alleviation of poverty; his intention, however, as a matter of law and of ethics, was to steal.16  So, too, here: all would prefer that suffering of all kinds could be relieved.  This is classified, at law, as motive.  However, the kinds of acts engaged in (a) allowing an embryo to succumb and (b) `strip-mining’, as an instance of biomedical prospecting, knowing that the strip-mining involved will destroy the embryo, are, as a matter of law, and as a matter of ethics, actions of completely different character, even though the end result - the death of the embryo - is the same.  One course follows the course of nature; the other is the inevitable consequence of a deliberate act, deliberately chosen.  This act is not made licit, nor does its ethical character alter, by virtue of the granting of a licence, by a committee, to kill.  Of course, to this should be added that to suspend the life of embryos by cryopreservation for any period of time is, itself, contrary to nature and an affront to human dignity.  Cryopreservation is a completely un-natural environment.

29.	A final matter relates to the exploitation of women.  Archbishop Carroll has already noted this in his submission to the Committee.  In these circumstances it is sufficient to note that feminist writers, and others, for some time have documented the exploitation of women by the IVF industry and various parts of the research community.  Relevant texts are noted below.17

Conclusion 
The cornerstone of the Embryo Bill is the deliberate destruction of nascent human life.  It purports to legitimise the intentional destruction of life, for commercial gains which are more likely than the unverified claims made by the researchers who will profit financially.  Its ethical principle is that the [unsubstantiated] end justifies the indefensible means.  It makes human life an expendable commodity.  For these reasons, the Embryo Bill is morally repugnant legislation.  The Cloning Bill ought be supported.

Dr Warwick Neville
Research Fellow
Australian Catholic Bishops Conference
Solicitor of the Supreme Court of New South Wales
Barrister of the High Court of Australia