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Reproductive Technology Submissions

Submission to the National Health and Medical Research Council on the review of the NHMRC's Ethical Guidelines on assisted reproductive technology (1996) - November 2001

 

Introduction
The Australian Federation of Right to Life Associations is a national peak body of pro-life groups with representatives in every Australian State and Territory except Victoria. The Federation and its member associations are dedicated to protecting human life from its inception until natural death. As the Ethical Guidelines on assisted reproductive technology deal with issues surrounding the destruction of human embryos, this submission sets out a case for better and more effective protection for these human beings
at the very beginning of their existence.

Briefly, the Federation argues that:

  • the Guidelines are not adequate to ensure the protection of human embryos from destructive research;
  • the Guidelines are only as effective as the Institutional Ethics Committees, which are hamstrung in their effectiveness by their close relationship with the researchers they attempt to regulate;
  • a number of amendments should be made to build on the strengths of the Guidelines in order to improve the protections offered to human embryos; and
  • the best approach to the control of artificial reproductive technologies in respect of both clinical practice and research protocols is through legislation which can effectively protect the dignity of human life even if that will require clear prohibitions and attendant sanction for breaches.

 

Executive Summary
A significant weakness of the Ethical Guidelines on assisted reproductive technology (the Guidelines) is that they mediate the practice of clinical medicine through Institutional Ethics Committees (IECs), largely self-regulating bodies located in each institution. In practice this works against effective controls over research, raising difficulties similar to those experienced with industry self-regulation. In the absence of legislation, there are no effective mechanisms of enforcement to ensure compliance with the Guidelines.

The involvement of participants in Assisted Reproductive Technology (ART) programs in the decision of an IEC to allow destructive experimentation on their 'excess' embryos (see Guidelines 3 and 6.4) can scarcely be characterised as informed consent and free consent when such person are anxious to remain in the ART program in order to produce a child.

Allowing counselling to be offered either within or independently of an ART clinic puts at risk the delivery independent, disinterested counsel (Guideline 4).

The promotion of a national data collection to assist evaluation of the long term effects of treatment methods is a very useful approach, but its inception will be hampered if compliance remains voluntary (see Guideline 5).

Though the Guidelines admit that there is are serious differences of opinion in the community over the permissibility of destructive research on embryos the practice can nonetheless be permitted by an IEC on certain rather flexible conditions (see Guideline 6). The community generally should be given the opportunity to lodge objections to new or current ART applications before they become entrenched.

While there is provision for conscientious objection (Guideline 10), there is no formal mechanism for hearing complaints from those who claim to have been pressured to participate in ART procedures and/or discriminated against in some way.

The Federation supports the ban on practices cited in Guidelines 11.3 to 11.11, but is critical of those items in the same guideline which tolerate destructive research on human embryos (Guideline 11). Unfortunately, it is openly acknowledged that certain practices prohibited by the Guidelines, are in fact taking place.

In addition, new practices have emerged; examples are work with embryonic stem-cell lines, pre-implantation diagnosis of the embryo's genetic make-up and consequent selection/destruction. These lack sufficient regulation and should be addressed urgently.

The Federation considers that the only effective way to regulate the approval, monitoring and evaluation of ART and research involving embryos or embryonic stem-cells is by legislative provision. Legislation should have definitions of an embryo and of cloning framed in terms which will protect human life no matter the manner of its beginning.

The Federation proposes, therefore, that the Council of Australian Governments (COAG) give consideration to implementing uniform Commonwealth legislation in this area with the eventual outcome of complementary Commonwealth and State/Territory provisions.

 

Strengths and weaknesses of the existing Guidelines
The National Health and Medical Research Council (NHMRC) Guidelines do not address directly many of the social issues involved in the practice of Assisted Reproductive Technology (ART), such as eligibility criteria for adults requesting assisted reproduction service, surrogacy, the use of genetic diagnosis for selection and gene therapy.

It is this omission which tends to isolate clinical practice and medical research related to ART from the social and ethical constraints usually imposed on human behaviour by law. The fact that the Guidelines are mediated in the actual practice of clinical medicine and scientific research through influential but largely self-regulating bodies militates against adequate legal and social controls. The ineffectiveness of the Guidelines as presently constituted is not unique in suffering these limitations. Bodies like the Reproductive Technology Accreditation Committee whose task is to set standards for the clinical practice for IVF and related reproductive technologies are not at sufficient arms-length from those involved in the very clinical practice and research work it seeks to regulate.

The NHMRC Guidelines will in practice take effect only to the degree that they can be imposed and monitored through the Institutional Ethics Committees (IECs). Their effectiveness depends critically on the good faith compliance with their content by practitioners within these institutions. For example, the Accreditation and approval processes require that research projects including the use of gametes and/or embryos in an ART procedure must comply with the specific State legislation and approved by an IEC (2.2). In the absence of State legislation, what mechanisms for enforcement of the Guidelines are available to IECs? How willing would an IEC be to invoke sanctions against a powerful colleague who has a record of successful research and attracts funds to that institution?

The Guidelines require that changes in treatment methods and developments in ART are not to be introduced without the formal approval of an IEC (2.3). Again, what measures of control, monitoring and sanctions are available to, and likely to be enforced by an IEC if the interests of the institution appear to depend on both avoiding open conflict and retaining those practitioners who get results and publicity by ignoring the restraints contained in the Guidelines?

Are all research protocols approved by IECs reported to a national body as para.2.5 of the Guidelines enjoins? Is there any sanction to be exercised against an IEC which does not comply? What of research which has eluded the scrutiny of the IEC in the first instance?

In respect of Informed decision-making (guideline 3), the objectives are laudable but unrealistic. It is putting a considerable strain on the capacity of a man or woman to make a balanced assessment of the "accurate and objective information" detailed in para.3.1.1 (success and failure rates; treatment options; physical and psychosocial risks, risk of adverse outcome for the child to be born; the risks associated with multiple births, risk of ectopic pregnancy and so on) . Since the participants are by definition willing to engage in ART in order to achieve a child, what control can they have on these adverse outcomes. It would be preferable if such substantial risks were excised by the practices allowed in ART (see guideline 6 - Practices to be prohibited) rather than pushing the 'choice' on to the anxious participant.

Particularly challenging for the participants in ART is the nature of consent to be given, especially that consent related to specified research which can involve destruction of their embryos (see guideline 6.4). What pressure might be put upon participants to agree to this use of 'excess' embryos in their anxiety to be received into an ART program? The obtaining of consent to the storage and use of gametes and their fate beyond the maximum period allowed entrenches a practice which should be the subject of legislation effected after extensive community debate. The control of the disposition of human beings after and beyond the immediate context of reproduction and implantation enshrines a particular view of the human embryo ie that it is to be treated by arrangements appropriate to the disposal of property rather than respected as an individual with status to be defined in law. Again it is doubtful if the participants are encouraged to address such weighty issues when they are already caught in a clinical context.

This difficulty of ensuring that participants in the clinical practice of ART are capable of weighing up the myriad issues which might affect themselves and any embryos produced by the process (both those who come to birth and those who are miscarried, stored or destroyed) is not alleviated by the principles set out in guideline 4 - Counselling. While it is appropriate that "counselling of a supportive or therapeutic nature should be available as an integral part of any ART program" (para.4.1), the concession that this counselling may be provided either within or independently of the clinic vitiates against its chances of providing objective advice and information devoid of the obvious risks of contamination by considerations of self-interest.

Guideline 5 - Research, dissemination of results and the role of IECs - is to be supported for its promotion of national data collection to assist in the evaluation of long-term effects of treatment methods. However, the voluntary nature of compliance with these standards is an inherent weakness. It is outside the ambit of the Guidelines to provide some mechanism to evaluate the data on the follow-up studies and to suggest what would be an advisable line of action if certain practices were demonstrated with reasonable certainty to have adverse outcomes for participants and their offspring (see loss of identity etc)

The content of guideline 6 - Research on embryos - reveals the inadequacy of Guidelines rather than legislation to control this area of research. Guideline 6 admits the existence of conflict between the view that destructive or harmful experimentation on human embryos is unacceptable and the opposing view that such procedures may be justified where it is undertaken for the direct benefit of other embryos. In fact there is an unambiguous statement that "[a]t the present time these differences cannot be resolved". Nonetheless, guideline 6 gives support to those who hold the second position by allowing approval for non-therapeutic research which involves the destruction of the embryo (para.6.4) on certain conditions. It does not improve the surrender of principle here that destructive experimentation can be allowed on the following conditions: if there is "a likelihood of significant advance in knowledge or improvement in technologies for treatment"; that the research involves only "a restricted number of embryos"; and that the gamete providers have consented to the research (see comment above on guideline 3 - Informed decision-making). If such an important philosophical and ethical issue has not been resolved, then the Guidelines should proceed with caution.

Guideline 7 -Storage of gametes and embryos - is tolerable only in that it is consequential on other practices which are unacceptable in the view of the authors of this submission. If the production of excess embryos is permitted in ART programs, then some provision has to be made for their storage and possible death (see part 2 of this submission).

The recommendations advanced in guideline 8 - Record keeping - are acceptable posited on the type of experimentation and clinical practice which has been permitted. Particularly to be supported is the recommendation that donor records should be maintained indefinitely and that these should be transferred to another practitioner when a practitioner ceases to be involved with ART programs. Such recording is an essential pre-requisite for assisting children born from the use of ART procedures to identify their parents.

Guideline 9 - Complaints and appeals - are only suggestions for various regimes of dealing with appeals from persons aggrieved by decisions made in the area of ART. In enumerating possible statutory or administrative bodies such as those dealing with health services complaints of the Human Rights and Equal Opportunity Commission the guideline indicates too narrow a compass for satisfactory dealing with matter falling within the scope of ART programs. While these avenues might suit an individual who is the subject of damaging clinical procedures or has been treated in a discriminatory way, no capacity for objection to particular clinical practices or research procedures is recommended. The widest possible forum should be facilitated for the discussion of new technologies concerning the treatment of human subjects. Professional scientists associated or not with ART programs, ethicists and various groups should be able to lodge objections to current or new ART applications when it would be in the public interest to examine critically the direction of proposed research which may not clearly be caught within the compass of legislative regulation.

Guideline 10 - Conscientious objection - is supported in its statement of the principle that staff who conscientiously object to ART programs should not be obliged to participate in them nor be put at a disadvantage because of their objection. However, no mechanism is suggested for those who claim that they have been pressured to participate and/or discriminated against in their workplace or career opportunities. Without some independent forum to which complaints of this nature can be taken, the statement in this guideline is nothing more than wishful thinking.

Guideline 11 - Prohibited/unacceptable practices - describes some 11 practices which are ethically unacceptable and should be prohibited. The Federation supports the ban on those practices cited in paras 11.3 to 11.11 (cloning of individuals; use of fetal gametes for fertilisation; missing of human and animal gametes; confusion of parental identity by mixing gametes or embryos; placing an embryo in a body cavity other than a human female reproductive tract; embryo flushing; commercial trading in gametes or embryos; paying donors of gametes or embryos over and beyond expenses; use in ART programs of gametes or embryos harvested from cadavers).

However, the Federation takes strong issue with the first two items for their implications of what is approved in ART programs. Prohibited are:

  • developing embryos for purposes other than for their use in an approved ART treatment program. This 'prohibition' is nothing more than a disguise for accepting any program approved by IECs . Such approved programs can include non-therapeutic research which involves the destruction of the embryo (see guideline 6.4);
  • culturing of an embryo in vitro for more than 14 days. This 'prohibition' is merely a procedural matter which puts a time limitation on what is obviously destructive research.

The Federation is very critical of these items under guideline 11 which tolerate destructive research on human embryos under the guise of protection of embryos and restriction on experimental practice.

 

Issues that have emerged since the publication of the existing Guidelines

Destructive research on embryonic stem-cell lines
The issue of predominant importance which has arisen since the issue of the current Guidelines relates to the rapid advance of work with stem-cell lines. There is frequent publicity given to the potential, mainly hoped for rather than actual, of such research to bring great benefit to our species. In particular there is vivid argument these benefits will be obtained most easily if the research is done on stem-cell lines derived from embryos.

This rapid advance and the optimistic statements by the scientists involved themselves or by science reporters in both scientific and popular media would appear to have virtually swept aside any principles that according to international protocols, let alone that present in NHMRC Guidelines, should govern this research.

The inherent weakness in NHMRC guideline 6 - Research on embryos - has been repeatedly demonstrated by the recent flourishing of experimental protocols conducted in Australia involving the use of embryonic stem-cell lines. Guideline 6 allows an IEC to give approval to the conduct of non-therapeutic research which involves the destruction of the embryo, provided the following conditions exist:

  • a likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the proposed research;
  • that the research involves a restricted number of embryos; and
  • the gamete providers, and their spouses or partners, have agreed to the specific form of research (see guideline 3.2.5).

It is nave to expect that any researcher wishing to conduct such destructive research would not claim the likelihood of ultimate benefit advance in knowledge and/or improvement in treatment technologies.

The meaning of "a restricted number" is capable of expansive definition depending on the needs of the proposed research protocol. Is the requirement addressed only to the number of embryos produced in Australia or can a researcher import embryos without limit?

Comment on the lack of objectivity of participants in ART programs motivated by a strong desire to obtain a child through such procedures has been discussed above. Further, how can the consent of such persons be invoked and authenticated when the embryonic stem-cell lines are imported?

Importation of stem-cell lines
It is only reasonable to conclude that the importation of stem-cell lines is designed to avoid the constraints on destructive research which the NHMRC Guidelines attempt to impose through the operation of the IECs. This practice, at present neither regulated nor prohibited by legislation, avoids the already permissive requirements of guideline 6.

Ownership of stem-cell lines and the commercial possibilities
The potential profitability of products and procedures that might result from embryonic stem-cell research provides motivation for research units to ignore, or defy either legislative restrictions or the principles set down in ethical Guidelines such as those of the NHMRC. Embryonic stem-cell lines recently released by the decision of President Bush of the United States of America are 'owned' by commercial/academic research units and/or pharmaceutical companies; some half dozen are 'owned' by a prominent group of Victorian researchers. It seems that the legal and ethical debate is presumed by these interests to be at a conclusion and the destruction of the embryos from which the stem-cell lines were obtained is a fait accompli of significance only in the profitability of the uses to which its remains can be put.

Apparent defiance of professional ethical Guidelines and of community opinion
Any informed reader of either the scientific or popular press is aware that new procedures are often developed and then announced publicly, accompanied with the mantra that the research worker(s) is looking for community guidance on the new methodology. This type of broadcast is less than sincere as the public at large is not well-informed on the issues involved. Those community groups which are in a position to comment on moral and ethical implications of the new offering can find that it is difficult to obtain access to a forum with some capacity for winding-back, or putting on hold the innovation until its compliance with legislative restrictions or ethical constraints is thoroughly examined.

Other practices prohibited in the Guidelines
It is reported from time to time that certain practices prohibited by guideline 11 of the Guidelines - Prohibited/unacceptable practices - are being ignored. Among the matters reported have been the mixing of human and animal gametes to produce hybrid embryos; mixing of gametes or different parental origin so as to confuse the biological parentage of the conceptus, apparently to boost the likelihood of conception for participants in an ART program.

It is difficult for community bodies to be certain of the accuracy of these reports in the popular press. All research groups in receipt of public funds, either directly or indirectly through their being part of an institution so funded wholly or in part, should be asked to account for their methodologies regularly and to declare formally that they have not conducted any of the practices prohibited in guideline 11 of the Guidelines.

Pre-implantation diagnosis (PID)
Purported diagnosis of genetic disorders at the embryonic stage of development is one of the great benefits claimed to justify a practice which may involve the destruction of a human embryo or a decision not to implant a 'defective' embryo. This practice should be the subject of community and professional discussion as it is clearly a case of a non-therapeutic procedure being performed on a human subject. In addition the claimed benefits of such procedures have not been objectively established. Many genetic disorders are not caused by one gene mutation but by more than one or several in interaction and further influenced by environmental factors. The wanton destruction of human embryos on the dubious basis of potential defect smacks of eugenic rather than medical practice.

Content of Guidelines to regulate existing and new practices, in particular research on embryos and the development and use of stem cells derived from embryos

Guidelines to regulate existing and new practices should recognise as a basic principle that non-therapeutic experimentation or clinical practice on a human subject is not to be permitted except with the consent of the subject. This consent is patently lacking in the case of experimentation on human embryos. The permission of parents does not definitively answer the case, no more than it would for the case of a fully developed child. There is a public interest in the protection of human subjects which overrides either inappropriate guardianship powers or the unfettered activities of scientific or commercial interests.

Therapeutic and non-therapeutic research
Therapeutic research is that undertaken for the good or attempted good of the human subject involved. Non-therapeutic research or procedures are those carried out on a human subject, not for the good of that subject but for the benefit of another person(s). The use of the phrases like "therapeutic embryonic research" which involve the destruction of the embryo (cloned or otherwise) is a semantic evasion of the true nature of such procedures and stands in contradiction to the definitions used in international protocols concerning experimentation on human subjects.

Reproductive and 'therapeutic' cloning
Another source of confusion is terminology used currently by those who wish to engage in destructive embryonic research which is dependent on cloning or copying of an existing embryo. Legislators and regulators are asked to accept that there is some basic distinction between cloning for reproductive purposes and cloning of embryos for purposes of research (usually by the removal of stem cells). The uses to which clones will be put may differ, but all cloning is in essence reproductive, as it necessarily involves the copying of an existing embryo and the creation of another.

It is ironic that the scientific community almost unanimously rejects what it cares to call "reproductive cloning", that is the growth to maturity of a cloned individual; yet it supports destructive procedures conducted on clones for the good of others. While the first practice may well be condemned as an exercise in either dangerous egotism or social experimentation, the latter practice is undeniably immediately lethal to its subjects.

Research using stem-cells derived from embryos and which involves the destruction of either the original embryo and/or any of its derived clones should be prohibited.

Definition of an embryo
Any Guidelines developed to regulate the conduct of experimental protocols or clinical practice should define a 'human embryo' so that the term will include those embryos produced by sexual reproduction, somatic cell nuclear transfer, cloning by splitting, or any other means that produce an individual human organism capable of full development.

Definition of a clone
Definition of a clone should be careful not to use a form of words which will effectively exclude all clones (as commonly understood) from any regulation as intended. Clones are not necessarily genetically identical as 'clones' produced by somatic nuclear transfer will possess in their genetic make-up a contribution from mitochondrial genetic material accompanying the enucleated ovum in which the somatic cell is placed for stimulation, division and development.

 

Practices which should be prohibited (and the most appropriate means of prohibiting them) and practices prohibited in the existing Guidelines which should no longer be prohibited

Basic principles
The Federation considers that all destructive, non-therapeutic research on embryos should be prohibited whether the embryos are produced by sexual reproduction, somatic cell nuclear transfer, cloning by splitting, or any other means that produce an individual organism with capacity to develop into an independent human organism.

Prohibitions set out in guideline 11 of the Guidelines
The Federation therefore supports the maintenance of the prohibition of the practices described in items 11.3 to 11.11 in guideline 11 - Prohibited/unacceptable practices - of the Guidelines. These include: cloning of individuals; use of fetal gametes for fertilisation; missing of human and animal gametes; confusion of parental identity by mixing gametes or embryos; placing an embryo in a body cavity other than a human female reproductive tract; embryo flushing; commercial trading in gametes or embryos; paying donors of gametes or embryos over and beyond expenses; use in ART programs of gametes or embryos harvested from cadavers.

Practices permitted in guideline 11 of the NHMRC Guidelines
Those practices permitted by items 11.1 and 11.2 are by induction:

  • developing embryos for use in an approved ART treatment program. (see guideline 11.1) and
  • culturing of an embryo in vitro for a period no longer than 14 days (see guideline 11.2).

Programs approved by an IEC can include non-therapeutic research which involves the destruction of the embryo (see guideline 6.4). The time limitation on culturing an embryo is merely a procedural matter which permits destructive research for a given period. Both items 11.1 and 11.2 of guideline 11 of the NHMRC Guidelines should be omitted and a ban on destructive embryo research submitted. It is appreciated that this would involve the removal of guideline 6.4 which gives grounds for an IEC to allow non-therapeutic (destructive) research on embryos.

Production of 'excess' embryos
Also prohibited should be the production of 'excess' ( to the immediate possibility of successful implantation) embryos in assisted reproductive procedures. This excess production inevitably:

  • raises problems of appropriate storage of embryos and the devising of protocols for their destruction when they are not implanted after a considerable time; and
  • provides embryos which are then targeted for research programs (often destructive or non-therapeutic) with hopeful researchers indulging in the special pleading that such material should not go to waste. There is a special interest issue here in that those who wish to use such 'excess' or 'waste' embryos are often also engaged directly or indirectly in their excess production through ART linked programs.

Multiple implantations
The production of embryos in excess of the number able to be carried with safety by the female participant in an ART program gives rise not only to the two outcomes just indicated but can place the woman in an invidious situation. There is the temptation for the woman to allow the ART practitioner to place a larger number of embryos into her reproductive tract than can be safely carried. This is presented routinely as insurance against failure of one or more embryos to 'take'. Again, if all take, then selective abortion is advised to reduce the number that may be carried to term. These practices show profound disrespect for the status of the human embryo. That those anxious to bear children can easily be persuaded to agree to such practices is understandable. Nonetheless such practices should be prohibited.

Stem-cell research on embryos, original conceptus or cloned
Destructive research performed on an embryo, whether the product of sexual reproduction or produced by any other means, or on any embryo(s) cloned from another embryo, should be prohibited.

 

The role of Human Research Ethics Committees

Inadequacy of regulation without legislative enforcement
It is evident from the difficulties currently experienced in ensuring that the current NHMRC Guidelines are observed in clinical practice and experimental protocols that there are inherent, and probably insuperable, problems with regulation effected in this manner. The NHMRC Guidelines reflect primarily the interests of the professional medical and research personnel who are to be regulated and in that sense are akin to an industry self-regulatory mechanism.

The problems outlined in this submission point to:

  • conflict in the discharge of the responsibilities of an IEC when its members may include persons whose interests are directly or indirectly are affected;
  • difficulty of imposing restraints on professional colleagues. Colleagues who insist on the efficacy of proposed work involving destruction of embryos, for example, are likely to prevail and have their work endorsed despite misgivings of the IEC;
  • disinclination to attribute motives of self-promotion and/or commercial gain to medical and scientific staff members of an institution;
  • lack of adequate sanctions attendant on a breach of the Guidelines. Suspension from duties, publication of breaches, or recommendation to a regulatory body that funding be withdrawn may well bring disrepute on the institution.

Legislation the preferred mechanism of control
For the adequate control of research on human subjects including research on human embryos, the Federation considers that voluntary ethical Guidelines monitored by professional bodies are inadequate. Nor should regulation be left to executive government decision. Such important matters involving the status and treatment of the human embryo should be the subject of parliamentary scrutiny and legislation.

Necessity for uniform legislation in Australian jurisdictions
Recognising that three States have already legislated to control embryo experimentation in some respects, the Federation suggests that the Council of Australian Governments (COAG) give consideration to supporting uniform Commonwealth legislation in this area. This legislation should not be an amalgam of the most permissive provisions of existing State provisions, but should opt for its own regimen after close consideration of submissions such as this and the report of the Andrews parliamentary committee.

As responsibilities for regulation of health matters and for the protection of human subjects are properly the business of the Australian States and Territories, the Commonwealth might progressively withdraw from the field as each of the other jurisdictions introduce their own legislation. Commonwealth legislative provisions should not be removed unless the particular provisions of the legislation of a State or Territory do not enforce the same conduct as that of the Commonwealth legislation.

Legislative regulation of multi-country based research
An advantage of uniform legislation, however it is achieved, is that it should prevent what is called "jurisdiction shopping" a practice by which a clinician or researcher chooses to conduct those parts of a protocol which might be forbidden in one jurisdiction in another where that particular practice is not prescribed. In this regard, Australian legislation should prohibit the splitting of clinical or research protocols in practice between Australia and other countries so that what is prescribed in Australia can be done in part in another country where the regime is more permissive. In particular, Commonwealth legislation would be required absolutely to prevent the importation of stem-cell lines for use in Australia where the method of procuring these materials or the number of embryos involved would be prohibited in Australia.

Recommendations

Legislation necessary for control of ART and the use of embryos
For the adequate control of research on human subjects including research on human embryos, the Federation considers that voluntary ethical Guidelines monitored by professional bodies are inadequate. Nor should regulation be left to executive government decision. Such important matters legislative matters involving the status and treatment of the human embryo should be the subject of parliamentary scrutiny and legislation.

Necessity for uniform legislation across Australian jurisdictions
Recognising that three States have already legislated to control embryo experimentation in some respects, the Federation suggests that the Council of Australian Governments (COAG) give consideration to supporting uniform Commonwealth legislation in this area. This legislation should not be an amalgam of the most permissive provisions of existing State provisions, but should opt for its own regimen after close consideration of submissions such as this and the report of the Andrews parliamentary committee.

As responsibilities for regulation of health matters and for the protection of human subjects are properly the business of the Australian States and Territories, the Commonwealth might progressively withdraw from the field as each of the other jurisdictions introduce their own legislation. Commonwealth legislative provisions should not be removed unless the particular provisions of the legislation of a State or Territory do not enforce the same conduct as that of the Commonwealth legislation.

In this regard, Australian legislation should prohibit the splitting of clinical or research protocols in practice between Australia and other countries so that what is prescribed in Australia can be done in part in another country where the regime is more permissive. In particular, Commonwealth legislation would be required absolutely to prevent the importation of stem-cell lines for use in Australia where the method of procuring these materials or the number of embryos involved would be prohibited in Australia.

Ethical Guidelines should be broader in scope
Any ethical Guidelines/legislation addressing ART programs and related research should address matters of social significance such as the eligibility criteria for adults requesting assisted reproduction service, the practice of surrogacy, and the use of genetic diagnosis for selection and gene therapy.

Matters for legislative control
Legislative provisions for the control of ART programs and the attendant research programs should:

  • control approval of programs;
  • impose effective monitoring and evaluation and reporting processes;
  • possess the capacity to impose sanctions, both criminal and civil on those who are in breach of the provisions; and
  • require the collection of data on a national basis to assist in the evaluation of long-term effects of treatment methods.

Definitions to be included in legislation
Legislative provisions and/or other regulatory mechanisms should provide clear definitions of :

  • an embryo so that the term will include those embryos produced by sexual reproduction, somatic cell nuclear transfer, cloning by splitting, or any other means that produce an individual human organism capable of full development; and
  • a clone, recognising that a clone, in the sense that the community recognises, may not be genetically identical to its predecessor as those produced by somatic nuclear transfer will possess in their genetic make-up a contribution from mitochondrial genetic material accompanying the enucleated ovum in which the somatic cell is placed for stimulation, division and development.

Practices to be prohibited
A. Those practices cited in paras 11.3 to 11.11 of the Guidelines (cloning of individuals; use of fetal gametes for fertilisation; missing of human and animal gametes; confusion of parental identity by mixing gametes or embryos; placing an embryo in a body cavity other than a human female reproductive tract; embryo flushing; commercial trading in gametes or embryos; paying donors of gametes or embryos over and beyond expenses; use in ART programs of gametes or embryos harvested from cadavers) should continue to be prohibited.

B. Also prohibited should be destructive research* on embryos, that is:
research which involves the death of the embryo, serious damage to the embryo, or affects its capacity to proceed to normal, full development;

  • the destruction of the embryo to obtain stem-cells;
  • pre-implantation diagnosis (PID), that is the the genetic testing of embryos before implantation for the purpose of selection for survival.

    *Note: this type of research should not be labelled 'therapeutic research' on the grounds that the procedure(s) might benefit other persons. No human subject should be treated as a means to the good of others.

C. Also prohibited should be:

  • the production of embryos excess to the number of embryos which can be successfully implanted in the woman participating in the ART program; and,
  • the importation of embryonic stem-cells.

Protection of persons affected by ART programs and related research
Legislative provisions should ensure that:

  • counselling of any persons considering entering an ART program should be conducted independently of the clinic delivering the service. The consent of such persons to research protocols involving their gametes or embryos resulting from use of their gametes should not be a factor validating such research;
  • donor records should be maintained indefinitely and that these should be transferred to another practitioner when a practitioner ceases to be involved with ART programs. Such recording is an essential pre-requisite for assisting children born from the use of ART procedures to identify their parents;
  • medical and research personnel who object to an ART clinical practice or research protocol should be protected from punitive action in respect of their employment; and,
  • individuals and community groups should have standing in an appropriate forum, including the courts, to object to ART programs in relation to a clinical practice or a research protocol.

Submission to the House of Representatives Standing Committee on Legal and Constitutional Affairs Inquiry into the Scientific, Ethical and Regulatory Aspects of Human Cloning - November 1999