I. THE NEW SOUTH WALES BIOMEDICAL COUNCIL

A. Membership and Functions

Recommendation 1:

Legislation should establish a Council to be called the New South Wales Biomedical Council, with membership and functions as follows:

1. Membership

(i) There shall be no more than 11 members of the Council.

(ii) Members shall be selected to represent one or more of the following disciplines or fields of interest:

• The community
• Infertility support groups
• Health care planning
• Medicine including reproductive medicine
• Biomedical research including research related to human reproduction
• Law
• Representative of the Department of Health
• Moral theology
• Philosophy and ethics
• Women’s health
• Social science

(iii) There should be as far as possible, an equal representation of men and women.

5.1 The composition and number of members for the Biomedical Council have been modelled on the broad representative approach of the National Bioethics Consultative Committee (NBCC).

2. Functions

(i) To advise the Minister on any question or issue arising in relation to biomedicine.

(ii) To promote (by the dissemination of information and in other ways) informed public debate on ethical, social and scientific issues that arise from reproductive technology and biomedicine generally.

(iii) To formulate, and keep under review, a code of ethical practice to govern the use of artificial fertilization procedures and research on the human embryo.

(iv) To advise the Minister on the conditions to be included in practice and research licences.

(v) To promote research into the causes of human infertility.

(vi) To advise the Minister on questions arising out of or in relation to reproductive technology.

(vii) To collaborate with other bodies carrying out similar functions in Australia.

(viii) To provide for compulsory review of the storage of embryos by IVF clinics (Recommendation 22) and as part of this function, to make decisions as to the transfer or discontinuance of storage of records (Recommendation 29).

(ix) To review the 10 year limit on the storage of embryos (Recommendation 22).

(x) To set out in a code of ethical practice the nature of information required to be recorded by IVF clinics (Recommendation 28).

(xi) To make decisions as to access to non-identifying information when there is no agreement between the record-keeper and the person seeking access to that information (Recommendation 30).

(xii) To consider and approve or disapprove all research projects proposed by holders of research licences (Recommendation 19) and as part of this function, to consider and approve or disapprove any proposal in such a project to allow the transfer to a woman of an embryo that has been the subject of research (Recommendation 16).

(xiii) To monitor developments in relation to access to identifying information, with a view to making recommendations to the Minister if circumstances alter (Recommendation 32).

(xiv) Such other functions as the Minister may specify from time to time.

5.2 The functions of the Council derive from the recommendations in this Report, proposals outlined by the Federal Minister for Health for the National Bioethics Consultative Committee and powers given the South Australian Council on Reproductive Technology under the Reproductive Technologies Act, 1987. Their purposes are explained in Chapter 4.

B. Code of Ethical Practice

Recommendation 2:

A code of ethical practice should be formulated and kept under review by the Biomedical Council. The Code should be reviewed regularly by the Council but the following matters should be included in the Code by legislation at the outset:

(i) An embryo may only be stored for 10 years, after which it may not be kept alive. (Recommendation 22).

(ii) An embryo may not be used, dealt with or disposed of unless the couple for whom the ovum was fertilized agree. Where one of the couple dies, the survivor retains the power of use, dealing and disposition. Where both die, such power vests in the clinic or storage facility. (Recommendations 24, 25 and 26).

(iii) No embryo should be allowed to develop in vitro, beyond the point at which implantation would normally occur, and should therefore not be kept alive longer than 14 days (excluding any period in storage.) (Recommendation 15).

The Code of Ethical Practice is discussed in relation to Recommendation 6 at 5.12-5.14.

II. PRACTICE OF IVF

A. Regulation Not Prohibition

Recommendation 3:

(i) There should be no prohibition of the practice of IVF or GIFT by legislation or other official action.

(ii) Regulatory measures should be applied to the practice and procedures of IVF and GIFT in accordance with the succeeding recommendations.

5.3 Our recommendations on regulation of the practice and procedures of IVF apply to the procedure known as GIFT, as well as to IVF itself. Although GIFT does not involve fertilization of ova outside the body of a woman, the technologies used are so similar to those used in the IVF process that they should be subjected to the same regulation as applies to the IVF process.

5.4 Until recently the debate surrounding the prohibition of IVF has centered on the subject of embryo experimentation rather than the practice of IVF per se. Issues such as the effect of superovulatory drugs,¹ the financial cost to the community,² multiple pregnancies,³ the commercialization of IVF⁴ and its links with controversial surrogacy cases⁵ have heightened public concern over IVF practice and procedure. The mass media, often a good barometer of popular sentiment, is now approaching the subject with a more circumspect eye, in contrast to the rather romanticized image conveyed in the past.⁶

5.5 With the increasing community disquiet over IVF, the Commission has thought it necessary to make recommendations on its practice and procedures. A neat calculus of the benefits and harms of IVF is not easy to state.⁷ In the Commission’s opinion, because it assists infertile couples to have children, thereby fostering and encouraging stable family units as well as alleviating the emotional stress of childlessness, the procedure is worthy of support. The benefits outweigh the arguments for prohibition which we identified in Chapter 4 of the discussion paper.

5.6 In making this recommendation the Commission notes that nowhere in the Western world has legislation been enacted to prohibit the practice of IVF. Although only of persuasive value, the evidence from the public opinion polls reviewed in the discussion paper suggests that the practice of IVF, at least where stable married couples are involved, commands substantial support in the community.⁸ In making the recommendation to permit IVF to continue the Commission recognizes that there is still public concern over certain aspects of the procedure and acknowledges a need for real and effective regulation. The primary aim of the regulations proposed is the protection of the public, whether the consumer, the child or the community at large.

B. A Licensing System Controlled by the Department of Health

Recommendation 4:

Legislation should be enacted to establish a licensing system whereby the practice and procedures of IVF may be both carried out and controlled under conditions consistent with the public interest. The conditions of the licences should be determined by the New South Wales Biomedical Council and the system should be administered by the Department of Health.

5.7 The practice of IVF has two aspects: a medical and a social dimension. Although IVF is a treatment for infertility employing predominantly medical skills and techniques, the motivation and many of the ramifications for the patient are social. Solutions to the moral, ethical and social questions raised by IVF are often beyond the competence of individual IVF practitioners and hospital ethics committees. As Justice Kirby has pointed out:

The individual practitioner may be as uncertain as the next man in society about rules that should govern his conduct. He too may not have the time to reflect upon the issues of state and many of them will be uncertain in any case. An ethics committee generally meets in private. It is not obliged to give reasons there is too much secrecy, too little frank dialogue with the whole community which is affected.⁹

5.8 The type of regulation required is one that ensures a properly controlled and monitored system without unduly restricting personal choice or scientific freedom. The licensing system provided in the South Australian Reproductive Technologies Act 1987 provides a model for the Commission. Its chief virtue is that it allows flexibility in operation which is not possible when all the details of the scheme are contained in legislation. Safeguards may be needed to ensure that the system remains responsive and accountable to public demand. These should be provided by ensuring public representation on the Biomedical Council and by giving the Council a public voice in its reports to Parliament through the Minister for Health.

5.9 The principal ingredients of the South Australian Act are :

(i) The issue and supervision of licences to practise IVF is the responsibility of the South Australian Health Commission, a Government department.¹⁰

We recommend that the Department of Health undertakes these responsibilities, but that the Biomedical Council should be the body responsible for formulating and advising the Minister for Health on the conditions to be contained in the licences.

(ii) The South Australian legislation imposes a number of compulsory conditions upon the grant of a licence, some negative and some positive. The negative conditions forbid the Commission from issuing a licence unless it is satisfied that there is “a genuine and substantial social need that cannot be adequately met by existing licensees”, and that the applicant for the licence has appropriate staff and facilities to carry out artificial fertilization procedures. A number of positive conditions are to be inserted in every licence including requirements for the keeping of records, for compliance with a published code of ethical practice and for infertile married couples to be the only eligible patients. In this context the term “married couple” extends to couples living in stable de facto relationships.¹¹

We recommend in Recommendation 6 that a licence be subject to conditions which (a) define the kinds of artificial fertilization procedure authorised; (b) require the licensee to ensure that the New South Wales Biomedical Council’s Code of Ethical Practice is observed; and (c) require that IVF be practised only by or under the direction of a medical practitioner. The Commission’s recommendations on the other matters addressed in the South Australian Act appear in Recommendation 7.

(iii) The South Australian Act also prescribes the circumstances under which licences may be varied and revoked and makes provision for appeals to the Supreme Court.¹²

We recommend that in this State existing procedures under the Medical Practitioners Act 1938 be utilized to enforce compliance with IVF licences, with the one reservation that it should always be open to the New South Wales Biomedical Council to initiate proceedings for breach of a condition in a research licence. We envisage that proceedings for breach of a practice licence would be commenced by the New South Wales Medical Board, in the same way as complaints are dealt with under s28 of the Medical Practitioners Act. The complaint could also be settled in the same way as the Board may settle s28 complaints. The means of disposing of these complaints are provided in s3l of the Act. They may be referred to the Medical Tribunal, or the Board can decide to direct the practitioner concerned to accept counselling. These procedures should also be available to sanction breaches of research licences. However, because the Commission is concerned that the Biomedical Council should not lose the initiative in the superintendence of IVF research in the State, we recommend that provision be made for it to refer matters to the Medical Tribunal when not satisfied with the response of the Medical Board. The Council would then have responsibility for prosecuting the proceedings for breach before the Tribunal, and if not satisfied with the outcome, could take an appeal to the Supreme Court on questions of law, under s32U(1)(a) of the Medical Practitioners Act. The Commission does not recommend that any further provision be made for appeal to the Supreme Court. We are satisfied that the merits of the case can be satisfactorily dealt with in the Medical Tribunal and that any questions of procedural irregularity can go before the Supreme Court by use of the procedures currently available for judicial review of administrative decisions.

(iv) Behind the Health Commission in South Australia stands a newly-created Council on Reproductive Technology whose functions include the formulation of a compulsory code of ethical practice, the delivery of advice to the Commission and the fostering of uniform procedures with other States. The Council also has general powers to regulate research into human infertility. Further conditions, beyond those contained in the Act, can be added by the Council and Commission in co-operation.¹³

We recommend that the New South Wales Biomedical Council have similar powers to regulate research, including the power to initiate proceeding for breach of the licence before the medical Tribunal. It is the view of this Commission that the approval and regulation of research projects should be controlled only by the Council because it is a representative body and because it is to be endowed with the powers and resources to conduct investigations and to keep abreast of contemporary literature and research practices.

C. Medical Practitioners Only

Recommendation 5:

IVF should only be practised or performed by, or under the direction of, a medical practitioner.

5.10 The complexity of the IVF procedure and the high degree of medical and scientific skill necessary for its performance require that it be classified as the practice of medicine, which is itself already regulated by statute. Further regulations, specific to IVF, are set out in Recommendation 6.

5.11 Both the patients and the general public will receive a measure of protection from classifying IVF as the practice of medicine. In addition to common law duties imposed upon the medical practitioner, there are well established statutory controls applying to medical practice under the Medical Practitioners Act 1938. Professional standards applying to the practice of medicine are also set down by bodies such as the Australian Medical Association, the Fertility Society of Australia and the royal medical colleges.

D. Clinics to be Licensed

Recommendation 6:

Legislation should provide that all IVF clinics are required to obtain a practice licence which should include the following conditions:


(i) A condition defining the kinds of artificial fertilization procedures authorized by the licence.

(ii) A condition requiring the licensee to ensure that the Council’s Code of Ethical Practice is observed.

(iii) A condition requiring that IVF will be practised only by or under the direction of a medical practitioner (Recommendation 5).

(iv) A condition requiring that adequate counselling facilities be available and be formally offered to prospective patients (Recommendation 10).

(v) Such other conditions as the Minister may determine.

5.12 The Commission believes that some matters should be fixed by legislation and not left for determination by the Biomedical Council. These matters are set out here. Other matters are amenable to decision by the Council and, the Commission believes, should be the subject of a Code of Ethical Practice to be drawn up by the Council. Some additional matters, referred to in Recommendation 2, should be included in the Code by legislation.

5.13 As explained in Chapter 4, the Commission believes that the flexibility of policy and decision-making which it requires can only be achieved by establishing a representative body to evaluate the community’s needs as the potential of the technology is revealed. The means by which the New South Wales Biomedical Council will make its decisions known are threefold:

• by advice to the Minister;
• by the tabling of its reports in Parliament; and
• by the formulation and review of the Code of Ethical Practice.

5.14 Some matters are regarded as so fundamental that they should be included as part of the original legislative framework. Amongst them are our recommendations that IVF be practised by medical practitioners only and that the licence contain a description of the type of practice it permits. if the Council comes to the conclusion that more matters are of a similarly fundamental nature, it may advise the Minister and have the legislation amended to reflect its views. In general, however, we see the flexibility we require as being achieved as the Council develops and reviews its Code of Ethical Practice. As this will be a document of which the Council has control it may alter it at will to accord with the demands of the time. The Commission would expect that some forms of the Code will become fixed to form the basis of the conditions of practice and research. Others will need to change as new information is received and old techniques arc superseded. In the Code of Ethical Practice the Council will have the means available to keep abreast of the technology. The Code of Ethical Practice should be kept under constant review by the Council. To ensure that it does not become dated, the Council should be obliged to undertake a formal review of its terms at regular intervals of not less than three years.

E. Admission to IVF Program

Recommendation 7:

Legislation should be enacted to provide that before commencing or authorizing the commencement of a procedure of IVF and ET in relation to a woman, a medical practitioner should give due consideration to the following matters:


(i) Whether the woman is a member of a couple who are infertile, or whose children are likely to be affected by a genetic abnormality or disease;

(ii) The welfare and interests of any child born as a result of the IVF procedure;

(iii) THE home environment and stability of the household in which the child would live;

(iv) Whether or not counselling is desirable;

(v) The prospective parent’s physical and mental health, age and emotional reaction to IVF and ET.

This recommendation is discussed with Recommendation 9 at 5.16-5.18

F. Consent to Treatment

Recommendation 8:

No legislation imposing compulsory requirements for consent should be enacted. This matter should be left to the general common law principles that govern consent to medical treatment.

5.15 As the Commission has recommended (in Recommendation 5) that practice and research in IVF should be regarded as part of the practice of medicine, we do not think it necessary to make special provision for the giving of consent to treatment. Practitioners who treat patients without obtaining their consent render themselves liable to civil or criminal actions in trespass. In its circulars the Department of Health recommends that consent be obtained before any surgical operation, procedure or medical treatment is undertaken. The Department also provides examples of the forms of consent it recommends be used. Under these circumstances we regard the addition of a special statutory requirement of consent for the IVF procedure as unnecessary duplication. The principles of common law, supported by the practices of the Department of Health, provide sufficient guarantee that the IVF procedure will not be embarked upon without consent.

G. Medical Misconduct

Recommendation 9:

Breach of the duty imposed by Recommendation 7 should be capable of being found to be “Misconduct in a professional respect” either within section 27(2) of the Medical Practitioners Act 1938, or by a comparable provision.

5.16 Eligibility to be considered for treatment for infertility should not be restricted but should be regarded in the same way as eligibility for any other medical treatment. Thus, a person who is not affected by infertility of a type that can reasonably be treated by IVF, should not be able to compel the provision of IVF any more than a healthy person could compel a doctor to perform a pointless operation.

5.17 A person who suffers from infertility should be entitled to be considered for treatment. If the IVF practitioner declines to treat, the reasons for refusal should be made available to the person concerned. The Commission envisages that the decision to accept a patient on the IVF program will not be made in isolation by the medical practitioner but after consultation with the counselling unit linked to the IVF clinic (see Recommendation 10). The final authorization, however, should remain with the practitioner. These recommendations appear in the Commission Report on Artificial Insemination. A full explanation of our reasons for their inclusion appears in Chapter 6 of that Report.

5.18 The Commission also suggests that a provision similar to section 9 of the draft Artificial Conception (Amendment) Bill, contained in Appendix A of the Commission’s Report on Human Artificial Insemination be enacted to give effect to Recommendations 7 and 9. This suggestion is made for the purposes of legislative drafting.

H. Counselling of Patients

Recommendation 10:

Counselling should not be made compulsory for every IVF patient; however it should be a compuslory condition of practice licences that adequate counselling facilities be available and be formally offered to prospective IVF patients in every IVF clinic.

5.19 Because of the complicated medical procedures involved, and the emotional and physical stresses often endured during the treatments, counselling becomes a very important part of IVF treatment. It is important that patients are made aware of what is happening, and counselling is one way of ensuring this. Many submissions made to the Commission argued that counselling should be made a compulsory prerequisite for admission to a program. Other submissions, particularly those from individual patients and patient groups, were opposed to any sort of compulsory counselling which was imposed by statute or regulation.

5.20 The Commission has recommended that all clinics should, as a compulsory condition of their practice licence, offer counselling facilities. Failure to do so will mean breach of the licence, possibly leading to its revocation. This does not mean that all patients will be obliged to use the service; merely that it must be offered, and we envisage that it should be readily available and given adequate resources. It should not be regarded as a formality.

5.21 The Commission envisages that the New South Wales Biomedical Council will formulate the standards required for adequate counselling and that in doing so, the Council will consult patients and medical practitioners, and particularly social workers already working in the infertility area.

I. No Special Legal Liability

Recommendation 11:

No legislation should be enacted to impose any specific legal liability upon medical practitioners or parents of IVF children to pay compensation for damage or injury resulting from IVF. This matter should be left to the courts for judicial determination.

5.22 Although there are no principles of common law which deal specifically with the IVF procedure, general legal duties relevant to medical and professional practice exist which are applicable to the parties to IVF. For instance, once a medical practitioner accepts a person as an IVF patient and commences treatment, the practitioner owes the patient a duty of care. The standard of care required is the general professional standard to which a reasonably careful, skilled and informed practitioner should conform.¹⁴

5.23 In the Human Artificial Insemination Report the Commission recommended that no action should be taken to enact legislation imposing specific legal liability upon medical personnel or parents to pay compensation for damages or injury resulting from AI.¹⁵ The Commission felt that the law in this area are best left to the courts for determination. This is also our conclusion here.

III. RESEARCH ON HUMAN EMBRYO

Recommendation 12:

No general prohibition of research on the human embryo should be enacted (by majority).

5.24 By a majority the Commission recommends that there be no general prohibition on the practice of IVF and no prohibition on research being carried out on the IVF embryo for a period of 14 days after fertilization of the ovum. Again by a majority, we recommend that there be no prohibition on the creation of embryos solely for the purpose of research nor on the transfer to a woman of an embryo that has been the subject of research. The research is to be conducted under the umbrella of a licensing system supervised by the New South Wales Biomedical Council. It is envisaged that the Council will license institutions and personnel undertaking research, and that each new project will be submitted to the Council for approval before research is commenced. The licensee will then be required to comply with a Code of Ethical Practice and any further conditions formulated by the Council. Details of our proposals are given in Chapter 4 and in the commentary on Recommendations 14-16 below. The views of the two Commissioners who dissented from Recommendations 12 and 14 appear in the Minority Opinion in Appendix A to this report.

Recommendation 13:

The Commission recommends the two procedures known as cloning and trans-species fertilization should be prohibited.

5.25 The process known as cloning is said to occur when “viable or potentially viable offspring that are multiple and genetically identical” are created from human tissues.¹⁶ This process is considered ethically unacceptable by the NHMRC and has been prohibited in Victoria.¹⁷ Although not falling within its terms of reference, the Senate Select Committee also condemned the procedure.¹⁸ While it was not convinced that there was cause to fear use of the procedure in the future, the Warnock Committee recommended that it be kept under review.¹⁹ In recommending the prohibition on cloning the Commission does not intend to prohibit the process of embryonic biopsy. In this process cells are removed from the embryo at a stage when their removal does not interrupt its development. If pursued, the technique of embryonic biopsy has potential for use in the early diagnosis of foetal abnormality. The Commission prefers to leave the question of the acceptability of this procedure to the New South Wales Biomedical Council for decision when more is known about the technique.

5.26 The process of trans-species fertilization has also been condemned elsewhere. The process occurs when the gametes of a man or woman are fertilized by the gametes of an animal. The Victorian Infertility (Medical Procedures) Act 1984 prohibits it²⁰ and the Warnock Committee recommended that, except when used in close association with “a recognized program for alleviating infertility”, it should be treated as a criminal offence.²¹ The Senate Select Committee also suggested that the practice be prohibited.²² This Commission regards these two practices as so abhorrent that they should not be left to be regulated by ethical guidelines. We therefore recommend that both procedures be prohibited by statute. Mr Russell Scott was no longer a member of the Commission when this Recommendation was settled.

Recommendation 14:

No general legislative prohibition should be enacted to prohibit the creation of embryos solely for the purpose of research (by majority).

This recommendation is discussed below Recommendation 16.

Recommendation 15:

Accepting the principle that an embryo should not be allowed to develop beyond the time at which implantation would normally take place, the Commission recommends that no embryo be kept alive longer than 14 days (excluding any time kept in storage).

This recommendation is discussed below Recommendation 16.

Recommendation 16:

No general legislative prohibition should be enacted on the transfer to a woman of an embryo that has been the subject of research (by majority). Conversely, such transfer should not be made compulsory. The New South Wales Biomedical Council should be given the duty and power of considering and permitting the transfer of such embryos as part of its function of considering each research protocol (see Recommendation 19).

5.27 The recommendations of this Commission are similar to those made by most other major inquiries into IVF. None has recommended that research on the human embryo be prohibited, but most have been divided on the question of whether conditions should be imposed on its conduct. There have also been divisions of opinion in this Commission on these recommendations. These are detailed below. The other inquiries have each recommended that IVF technology be supervised by an advisory council.²³ This Commission concurs in the view that there is a need for a council to advise the Minister for Health on developments in IVF technology. Such a council should also scrutinise all proposals made for research and regulate their conduct.

5.28 The recommendations of the Commission are in essence, that research into IVF should be allowed to proceed under the supervision of an advisory council to be called the New South Wales Biomedical Council which reports and is answerable to Parliament through the Minister for Health. The majority of the Commission believes that it should be open to the Council to approve proposals for research which involve the use of embryos for purposes which may not be beneficial to them. This type of research is referred to as non-therapeutic experimentation by the Senate Select committee in its Report.²⁴ Two members of the Commission have dissented from this recommendation. They would place a legislative prohibition on what they call destructive non-therapeutic experimentation. A statement of their reasons appears in Appendix A.

5.29 The Commission also recommends that the Council should have power to approve a research project which involves the creation of embryos for the purposes of research. Those members of the Commission who dissented on the question of non-therapeutic research also dissented from this recommendation. Their views appear in the minority opinion in Appendix A.

5.30 A majority of the Commission recommends that it should be open to the Council to approve research which involves the transfer to a woman of embryos which have been the subject of research. Mr Russell Scott dissented from this recommendation.

5.31 It is expected that these recommendations will be met by strong opposition from some members of the community. Our reasons for not accepting some of the views that have been put to us are set out below.

The public good

5.32 The main reason behind most of the Commission’s recommendations on research relates to the novelty of the technology. It is the Commission’s firm belief that research and practice in IVF are in a very early stage of development, and that significant and unknown advances in technique and knowledge are still to be made. The task before the Commission. was to design a system to regulate research and practice at a time when much of what is to be known of IVF technology has yet to be discovered. In view of this, it is unacceptable to the Commission to prohibit research completely. We prefer to establish a council with expertise and authority to examine and approve or reject individual proposals for research.

5.33 Two members of the Commission are not prepared to permit the Biomedical Council to approve research not beneficial to the embryo, but the majority would confer this power on the Council. The reasons given by the minority appear in Appendix A, and those of the majority view are presented here. it should be made clear at the outset that the recommendation made by the majority does not contemplate that research on the embryo will be conducted without preliminary research on other subjects in accordance with normal scientific practice. The recommendation is made in the expectation that the Council will view all applications for approval for research on the human embryo as exceptional and requiring the most convincing evidence to support them. There is an assumption in our recommendation that the protocols for medical research as prescribed in the Declaration of Helsinki and as adopted by the NHMRC have been complied with. This means, for instance, that where practicable thorough research will have been carried out on animal subjects first and an estimation made of the likely benefits and rates of success of further research on human subjects.²⁵ It should be made clear at this point that the Commission does not intend its comments on research and experimentation to extend to non-invasive procedures which involve only observation of the embryo.

5.34 It is the Commission’s view that the need to comply with existing research protocols first will meet the most serious objections the Senate Select Committee had to experimentation on human embryos. That Committee defined experimentation as involving “the testing of an hypothesis with no certainty as to result, though with a degree of expectation that a particular outcome is probable depending on the aim and type of experiment”.²⁶ Such experimentation could be therapeutic or non-therapeutic. Based at least in part on the belief that at present all non-therapeutic experimentation on embryos was “intrusive and destructive”,²⁷ the majority of the Senate Select Committee decided not to permit non-therapeutic experimentation. It did acknowledge, however, that “in the future, non-destructive, non-therapeutic procedures may be developed”.²⁸

5.35 A majority of this Commission is prepared to leave the decision whether research or experimentation is carried out on human embryo to the New South Wales Biomedical Council which it proposes should be established. The decision will then be made on the basis of scientific knowledge established at the time of the request for approval of the research and in the context of the particular circumstances surrounding each request. The Council will at that time be better equipped than this Commission, or any other contemporary inquiry, to make a decision which is fully informed both as to scientific fact and community acceptance. The decision the Council will have to make will be less hypothetical than the general question of principle we are asked to settle. Therefore, we would expect it to be a better decision than any we can make at present.

The need for research

5.36 The majority of this Commission has also been influenced by the strongly expressed opinion of the NHMRC that “research with sperm, ova and fertilized ova has been and remains inseparable from the development of safe and effective IVF and ET”.²⁹ The NHMRC guideline stated further that, “as part of this research other important scientific information concerning human reproductive biology may emerge”.³⁰ Scientists working in the field are also convinced that the technology is still at a very early stage of development and that its success rates can only be improved through further research and experimentation.³¹ Both the Waller Committee and the Ontario Law Reform Commission recognized the need for further scientific research to allow development of the techniques used in IVF and an improvement in the success rates.³² The Ontario Commission also acknowledged “it seems to be widely recognized that embryonic research is necessary for human welfare, not simply for the development and refinement of the IVF procedure itself”.³³

5.37 Given the uncertainty surrounding the potential of the technology the Commission is not prepared to recommend a legislative halt to what may be important scientific development. The Commission believes that the establishment of the Council will provide the safeguard necessary to prevent unacceptable research projects.

Therapeutic research only

5.38 The majority of the Commission is not persuaded that research on the embryo must be restricted to therapeutic, non-destructive research. The views of the two members who would so restrict the research are given in Appendix A. The demand to restrict research in this way arises from the debate on the status of the embryo. Put in its strongest form this view concludes that because no distinction can be made between the human embryo and a fully formed person, the embryo should be accorded the same respect as is due to any person. This approach requires research which is not beneficial to the individual embryo to be proscribed because it regards the Declaration of Helsinki, adopted by the World Medical Assembly in 1964 , as being applicable to embryos. The Declaration dictates: “in research on man, the interests of science and society should never take precedence over considerations related to the wellbeing of the subject”.³⁴

5.39 The majority of the Commission is not persuaded by the argument that the Declaration of Helsinki should be applied automatically to the human embryo in vitro. We are in agreement with the findings of many other inquiries on this point and in this regard accept the general view expressed by the Ethics Board of the United States Department of Health, Education and Welfare in its report of 1979 that:

... the human embryo is entitled to profound respect; but this respect does not necessarily encompass the full legal moral rights attributed to persons.³⁵

The Warnock Committee in England and the minority of the Senate Select Committee arrived at a similar view of the status of the human embryo.³⁶ By contrast, the majority of the Senate Committee was of the view that the embryo should be “regarded as genetically new human life organized as a distinct entity”, and that its “known and social future’’ compelled respect.³⁷ That Committee’s conclusion was “prudence dictates that, until the contrary is demonstrated ‘beyond reasonable doubt’... the embryo of the human species should be regarded as if it were a human subject for the purpose of biomedical ethics”.³⁸ Basing its views on the work of a medical ethics committee appointed by the French Government in 1983, the Family Law Council also reached the conclusion that the respect due to the human embryo meant that it should not be subjected to research.³⁹ However, the Council withdrew from this position somewhat when in its next recommendation it proposed the establishment of a national council of reproductive technology which would “consider, as a priority, and keep under review the question of research/experimentation on human embryos”.⁴⁰

5.40 The majority of the Commission can agree with the view, expressed in other inquiries and by many individuals, that the determination of the status of the human embryo is not a matter of simple biology.⁴¹ It is a moral, ethical and ultimately a legal question upon which there is currently no consensus.⁴² The unanimous opinion of this Commission is that the human embryo should not be accorded the same status as a human person, however, there is a division of opinion as to how much respect is due to the embryo. The minority would give far greater respect to the embryo than the majority in that they would apply the Helsinki Declaration to research on the embryo by a legislative prohibition on destructive, non-therapeutic research. In view of the continuing debate, the majority of this Commission does not recommend that the Council’s power to examine and approve research proposals should be restricted by a legislative prohibition on non-therapeutic research. We agree with the Family Law Council that, “whether research should be permitted, and if so under what constraints and limits - is a social, moral and ethical [question], and as such must be... dealt with by a body as representative of community views, and as free from bias, as is possible”.⁴³ The Family Law Council recommended a national advisory council. We recommend that the New South Wales Biomedical Council we propose should be regarded as fulfilling this role for New South Wales.

Creation solely for the purposes of research

5.41 As indicated above (para 5.29) a majority of the Commission recommends that the New South Wales Biomedical Council should have power to approve projects which contemplate the creation of embryos solely for the purpose of research. Again, our view has been reached in the belief that the powers of the Council should not be circumscribed by legislative prohibitions which may turn out to be founded on misconceptions or misinformation. It is not envisaged that the Council will readily approve a project which involves the creation of embryos solely for research purposes, even if the research can be regarded as therapeutic and non-destructive. However, we do not wish-to prevent consideration of such proposals.

Use of Spare Embryos

5.42 The Commission also finds the arguments which would limit research to so-called spare embryos unconvincing.⁴⁴ They are neither sufficient to answer the arguments based on status⁴⁵ nor persuasive in the context of the realities of scientific research.⁴⁶ The Commission is not persuaded that the intention with which an embryo is created should be a crucial factor in whether it can be used as a subject for research. Although a prohibition on the creation of embryos solely for the purposes of research would restrict the numbers of embryos which could be used for the purpose, it would not satisfy those who have moral objections based on the status of the embryo. Nor does the identification of an embryo as spare and therefore available for research purposes, satisfy this Commission’s requirement, stated in paragraph

5.39 above, that the embryo is entitled to profound respect. We believe that respect is better accorded to the embryo under the scheme we recommend in which each proposal for each research project is evaluated by the Biomedical Council in order to establish that the intrusion on the integrity of the embryo is justified by reference both to the rigour of the experimentation which has preceded it and to the benefits which are likely to ensue. The Commission also has difficulty in accepting the scientific basis of the spare embryo theory. Most scientific experiments require some guarantee that the sample on which the tests are to be made is of a sufficient size and that it has been randomly selected. The results of any experiment conducted under less than optimum conditions are not likely to be trusted. It seems important that if research on the human embryo is to be permitted, each project should be conducted under the most ideal conditions attainable. In this way, and not by use of the spare embryo theory, the numbers of embryos used for the purpose should be kept to a minimum. In this way also, there will be some guarantee that those embryos used for research purposes will not be wasted in the process.

Use of Embryo After Research

5.43 The majority of the Commission adopted a pragmatic view of the powers of the New South Wales Biomedical Council in making the recommendation that there should be no legislative prohibition on the use of an embryo for reproductive purposes after it has been subjected to research. One member of the Commission dissented. Mr Russell Scott considered that legislation should be enacted to prohibit the transfer to a woman of an embryo on which research had been conducted. The purpose of the majority recommendation is to ensure that we do not create an anomalous position in which therapeutic research carried out on an embryo would be frustrated by a prohibition on its transfer to a woman. We would not expect the Council to approve projects involving transfer of the embryo to a woman in which no guarantee could be given of the embryo’s potential for normal growth. The Commission does not envisage that on most occasions transfer to a woman will be part of the experimental process. The expectation is that the research will have been completed prior to the transfer and that no attempt will be made to transfer an imperfect or incomplete embryo.

5.44 There should be no compulsion to transfer an embryo which has been the subject of therapeutic research to a woman. It is the Commission’s view that the woman’s personal liberty demands that she be given the choice to refuse to accept the embryo. Where the woman does not wish to receive the embryo, she and her partner should have the right to decide how to dispose of it. As stated in their minority opinion (para 19), two members of the Commission would place limits on the types of research for which the embryo may be used. The rights of the parties for whom the embryo was created would be restricted accordingly. The majority’s recommendations on this question are discussed above.

Recommendation 17:

Legislation should be enacted to establish a licensing system whereby research on the human embryo may be both carried out and controlled under conditions consistent with the public interest. This system should be administered by the New South Wales Biomedical Council.

This recommendation is discussed in Chapter 4 and below Recommendations 12-14.

Recommendation 18:

Legislation should provide that any person or institution intending to carry out research on the IVF embryo, should be required to obtain a research licence, which should include the following conditions:


(i) Defining the kinds of research authorised by the licence.

(ii) Requiring the licensee to observe a code of ethical practice formulated by the Council in relation to such research.

(iii) Requiring the licensee to maintain adequate records.

(iv) Such other conditions as the Council may determine.

This recommendation is discussed in Chapter 4 and below Recommendation 12.

Recommendation 19:

Every research project proposed by a licensee shall, in addition to the usual process of approval through institutional ethics committees, be submitted to the New South Wales Biomedical Council for consideration and approval.

This recommendation is discussed in Chapter 4 and below Recommendation 12.

Recommendation 20:

The New South Wales Biomedical Council should supervise and review each institution’s research records.

5.45 It is important that the New South Wales Biomedical Council has access to all the facilities and records of all research projects. It is only through visiting the research institutions that the Council will be able to ensure that it is properly informed of contemporary scientific development and of the level of compliance with the licences it issues. It is expected that the Council will work co-operatively with the institutions and their research workers, but in cases of friction or misunderstanding it is essential that it has the authority to enforce its visiting and investigative powers.

IV. STORAGE AND DISPOSAL OF EMBRYO

A. Ethical Code to Regulate

Recommendation 21:

Subject to the other recommendations made in this report, legislation should be enacted to provide that the IVF embryo may not be stored or dealt with except in accordance with the Code of Ethical Practice. The Code should regulate all dealings with the IVF human embryo.

The Code of Ethical Practice is discussed below Recommendation 6 at 5.12-5.14.

B. Ten Year Limit on Storage

Recommendation 22:

There should be an overall time limit placed on the storage of embryos. The Commission recommends an initial limit of 10 years, after which the embryo may not be kept alive. Power should be vested in the New South Wales Biomedical Council to vary that limit and provide for compulsory review of storage by a clinic at prescribed intervals.

5.46 The period of 10 years accords with recommendations made in the United Kingdom and Ontario reports and by the NHMRC.⁴⁷ The recommendation for this limit is prompted by concern for the possible adverse effects of long-term storage and the legal and ethical implications of disposing of embryos whose parents have died, divorced or separated. However, to ensure the regulations are responsive to changes in medical science, we recommend that the New South Wales Biomedical Council be given power to alter the time limit and to provide guidelines for compulsory regular reviews of storage of embryos.

C. Consent to Use and Disposal of Gametes

Recommendation 23:

(i) The power to deal with and dispose of sperm and ova produced for IVF should vest in the respective gamete providers.

(ii) In the case of the unconditional donation of gametes, the power to determine the use, storage and disposal of gametes should vest in the IVF clinic.

5.47 In a typical IVF procedure with the use of “super-ovulation” the woman may produce more ova than is necessary for the treatment cycle and the question of the disposal of the excess ova will arise. The common law recognizes no rights of control over ova or sperm stored as a consequence of IVF procedures.⁴⁸ While the courts may be able to construe an agreement to enforce the wishes of the gamete providers, the situation is uncertain and the Commission believes that legal regulation is required.

5.48 In relation to unconditional donation of gametes, we recommended in the Report on Artificial Insemination that legislation be enacted to give the clinic power to determine use, storage and disposal when semen is donated unconditionally.⁴⁹ The Commission considers that there is no reason to distinguish between an unconditional donation of semen and an unconditional donation of ova. Therefore we recommend that the clinic be given power to dispose of ova which have been donated unconditionally.

5.49 This recommendation will not prevent parties making an agreement setting out the terms on which the donation was made. Where such an agreement has been made to regulate the terms under which the gametes are to be stored, the clinic will be obliged to respect it. If compliance with the terms of the agreement becomes impossible the clinic will be obliged to contact the depositor and to make alternative arrangements. if the depositor has died or cannot be traced, the clinic should have power to dispose of the gametes.

D. Consents to Use and Disposal of Embryos

Recommendation 24:

Within the proposed time limit the stored embryo cannot be used dealt with or disposed of unless the couple for whom the ovum was fertilized agree.

This recommendation is discussed below Recommendation 26.

Recommendation 25:

Where one of the couple for whom the ovum was fertilized dies the power to make decisions as to use or disposal vests in the survivor.

This recommendation is discussed below Recommendation 26.

Recommendation 26:

Where the couple are dead, the power to make decisions as to the use or disposal of the stored embryo vests in the clinic or storage facility.

5.50 The principles we have applied to the storage and disposal of gametes are in general the same as those we would apply to embryos. The model we have used is that of guardianship. We regard those for whom the ovum was fertilized as the people most appropriate to make the decisions on disposal of the embryo. Equally, it is the people for whom the embryo was created who should decide on its use or storage. We would prefer that the decision be made jointly by those for whom the embryo was created. After the death of one of them, we recommend that the decision be taken by the survivor. It is only when both parties have died that the clinic or storage facility should be given power to make decisions on the use or disposal of the embryo. As expressed in their Opinion in Appendix A, at paragraph 19, two members of the Commission would qualify the rights to be given to the guardians by restricting the types of research or experimentation which they could approve.

5.51 This leaves the difficult question of what is to happen if the parties cannot agree on use, storage or destruction. The Commission has not made an express recommendation ‘on this matter because it regards the decision on disposal as of such fundamental importance that it should not be taken out of the hands of the parties concerned. Where they cannot agree therefore, the Commission would expect the status quo to be maintained. If the embryo is in storage when the dispute arises, it will continue there, until the statutory limit of 10 years of storage is reached and it must be destroyed. Where the dispute arises earlier and before storage has taken place, destruction would occur after the 14 day period recommended in this report, unless the parties agreed to storage pending settlement of their dispute. The Commission would expect that the clinic’s counselling facilities would be offered to anyone engaged in such a dispute in the hope that agreement could be reached.

V. RECORD KEEPING AND ACCESS TO INFORMATION

A. Clinics to Keep Records

Recommendation 27:

All IVF records should be created, kept and maintained by the IVF clinics themselves.

5.52 The Commission believes that there is no need for a central register of IVF information to be created. There are many disadvantages in the centralization of information; the primary one being the potential for invasion of privacy. A central register could give the state access to intimate personal information about citizens that is unique. This may infringe a person’s desire for privacy and anonymity and have important repercussions on gamete donations. To a lesser extent, the use of such a central register would involve a duplication of records already kept that could be both labour-intensive and expensive to set up and maintain.

5.53 One of the major concerns of leaving the management of records to individual clinics has been the fear of loss of information through poor organization or the closure of a clinic. The Commission believes that the system of licensing proposed in Recommendation 6 overcomes these concerns. All clinics will be licensed and will therefore be required to satisfy the Department of Health of their suitability to practise. In addition the Commission envisages that the Department would be given powers similar to those embodied in section 17 of the South Australian Act, permitting an authorized person to enter and inspect any premises, to ensure compliance with the conditions imposed on the maintenance of records.

B. Code of Ethical Practice

Recommendation 28:

All clinical reports relating to the IVF and ET procedure and to the parties involved in that procedure should be retained. The extent of the records, their content, and the methods used to preserve anonymity are matters for good medical practice. In addition the New South Wales Biomedical Council should be empowered to set out facts which must be recorded in the Code of Ethical Practice.

This recommendation is discussed below Recommendation 27.

Recommendation 29:

No time limit should be fixed on the retention of the records of IVF clinics. Transfer or discontinuance of storage of records should only be allowed on permission of the Biomedical Council.

5.54 According to our information, all IVF clinics in New South Wales retain recorded information indefinitely, although there is no formal requirement for them to do so. In our view, there should be no fixed time limit for retention of records. Recorded information should be kept indefinitely, but a procedure should be provided whereby a record keeper may apply for permission to dispose of records or transfer them to an acceptable custodian. Permission to discontinue or transfer storage could be granted by the New South Wales Biomedical Council.

C. Access to Non-Identifying Information

Recommendation 30:

A statutory entitlement should be created whereby IVF children, gamete donors and any other person, upon showing “good cause” may have access to recorded non-identifying information either by agreement with the record keeper or, failing agreement, upon the decision of the New South Wales Biomedical Council.

5.55 This recommendation is consistent with the Commission’s conclusions in the Human Artificial Insemination Report.⁵⁰ Where the anonymity of parties to IVF is not affected, access to information should be available to persons with a sufficient interest or a good cause. For example, access to certain non-identifying information contained in IVF records may be justified for research purposes such as the gathering of statistical information for the National Perinatal Statistics Unit reports on IVF pregnancies in Australia and New Zealand. “Good cause” should be based on the Health and welfare of the parties to IVF.⁵¹

D. Access to Identifying Information

Recommendation 31:

No person should have a legal right of access to information that may identify a party to IVF and no record keeper may divulge such information, unless:

(i)The person who is the subject of the information formally consents.

(ii) The disclosure of information is required for the administration or enforcement of provisions of the IVF legislation.

(iii) The disclosure of information is required in the course of the official duties of persons engaged in the administration of a hospital or other place where IVF procedures are carried out or records relating to IVF or the donation of gametes are kept.

(iv) The information is required for the purposes of medical research and its release has been approved by the Biomedical Council.

(v) A judge or magistrate orders disclosure in connection with any legal proceedings or report of those proceedings.

5.56 When donated gametes are used in the conception of an IVF child there may be a conflict of interests between the gamete donor’s expressed wish for anonymity and the IVF child’s wish to learn his or her genetic origins.

5.57 The Commission accepts that the guiding principle should be that the welfare of the IVF child should be the paramount consideration in any dispute. With respect to access to identifying information, what is in the best interests of the IVF child is a difficult and sensitive question. Current trends in adoption law and practice in jurisdictions such as Victoria, New Zealand and England are towards providing a legal right for an adopted person, upon reaching majority, to have access to identifying information about his or her biological parents.⁵² As the Commission noted in the AI Report, however, the adoption parallel is not strictly inalogous to IVF. IVF children will know the biological identity of at least one of their parents, unless it is the rare case of IVF using both donor sperm and ova.⁵³

5.58 The status of children legislation, on the other hand, deliberately circumvents the truth of biological origins. The Artificial Conception Act 1984 and the Children (Equality of Status) Act 1976 both reject biological paternity, in favour of social paternity. The husband who consents to the use of donated semen for his wife’s pregnancy, is conclusively presumed to have caused the pregnancy and to be the father for all legal purposes.⁵⁴ This approach has been criticized by bodies such as the Chalmers Committee and the Family Law Council.⁵⁵ They argue that it distorts the truth of the parent-child relationship as well as having implications for birth registration records.

5.59 For the purposes of consistency with the Artificial Conception Act the Commission recommends that there be no legal right of access to identifying information. However, in recognition of the recent trends in adoption law and the likelihood that at a future time the perception of the best interests of the child may alter, the Commission further recommends that the New South Wales Biomedical Council be given power to review the legislation. This recommendation appears below as Recommendation 32.

E. Biomedical Council to Review

Recommendation 32:

The Commission acknowledges the concerns expressed in relation to access to identifying information therefore in recognition of the possible claims of IVF children the New South Wales Biomedical Council should be vested with the power to review legislation implementing Recommendation 30 with a view to recommending alterations as changing circumstances dictate.

This recommendation is discussed with Recommendation 31 above.

F. Legislation to be Retrospective

Recommendation 33:

Legislation creating access to non-identifying information should be retrospective in respect of records in existence at the time the legislation takes effect. In relation to identifying information, the Commission makes no recommendations as to retrospectivity.

5.61 Extensive and detailed records of information about the parties to IVF have been created by all IVF clinics in response to directives from the NHMRC and the Fertility Society of Australia. Parliament has power to enact legislation with retrospective effect if it chooses, and modern statutes often contain specific provisions allowing for the prospective and retrospective operation of legislative provisions. Hence, in order to achieve certainty, it is desirable that a legislative statement be made with regard to the operation of laws dealing with access to information whether or not the information is already in evidence.

5.62 Section 17 of the Commission’s draft Artificial Conception (Amendment) Bill, contained at Appendix A of the Report on Human Artificial Insemination provides an acceptable model which would carry this recommendation into effect. Section 17 provides:

17. (1) In this section, “non-identifying information” means information relating to artificial insemination, but does not include information whereby the identity of any party to artificial insemination might become publicly known.

(2) A person is entitled to be supplied with non-identifying information in any records relating to artificial insemination if -


(a) the person has good cause to be supplied with the information; and

(b) the information is supplied by agreement with the person having custody of those records or by direction of an authorised officer.


(3) For the purposes of this section, a person has good cause to be supplied with non-identifying information if the person who agrees to supply the information or the authorised officer who directs that the information be supplied is satisfied that the supply of the information is in the interests of the health and welfare of a party to artificial insemination.

(4) In this section -


“authorised officer” means a person for the time being authorised by the Minister for the purposes of this section;

“records” includes records made before the commencement of this section.

G. Confidentiality and the Donor

Recommendation 34:

Subject to the preceding recommendations in relation to access to identifying and non-identifying information, legislation should be enacted to give the gamete donor the same duties of confidentiality and anonymity as a patient, particularly for the purposes of record keeping.

5.64 Because of the circumstances of artificial conception and the sensitive nature of the donation the Commission recommended in the Human Artificial Insemination Report that the law should impose upon practitioner- and clinics the same obligation to observe confidentiality in relation to semen donors as medical practitioners have to patients, and that the donor should be treated as though he is a patient for the purpose of record keeping.⁵⁶ We believe the same principles are applicable to gamete donors in IVF.

H. Non-Disclosure by Donor

Recommendation 35:

A criminal offence should be created in relation to a person who knowingly conceals or misrepresents information about his or her health when offering or agreeing to donate his or her gametes for the purposes of IVF.

5.65 Potential donors should be warned of this sanction when giving their personal particulars. This recommendation follows one made in paragraph 5.18 of the Human Artificial Insemination Report.⁵⁷

5.66 Section 11 of the Commission’s draft Artificial Conception (Amendment) Bill, contained at Appendix A of the Report on Human Artificial Insemination provides an acceptable model to carry this recommendation into effect. It provides:

11. A donor of semen shall not -

(a) knowingly sign a certificate which contains any statement which is false or misleading in a material particular; or

(b) knowingly make any other statement (whether or not in writing) relating to the medical suitability of the donor which is false or misleading in a material particular.

Penalty: $5,000 or imprisonment for 1 year, or both.

I. Release of Health Information

Recommendation 36:

The supply of information suggesting that a person’s health is at risk involves an ethical duty of medical practitioners which operates in all areas of medical practice. The Commission therefore recommends that no statutory obligation should be created to require the supply of such information. This matter should be left to the courts for judicial determination.

5.67 In principle, the Commission believes that information that discloses a risk or danger to the health of a party to IVF should be disclosed to that person. It is not convinced, however, that a statutory obligation to this effect is called for. Medical practitioners are under a general duty to disclose to their patients information that suggests their health is at risk. The nature of the risk and the sensitivity of the information should be taken into account when determining the most appropriate method of dealing with the problem. Just how much information should be disclosed is best left for determination. At present, the common law is moving steadily in the direction of creating positive duties of disclosure.⁵⁸

VI. PARENTAGE OF IVF CHILD

A. Maternity

Recommendation 37:

Where IVF involves the use of donated ova, legislation should be enacted to determine conclusively the issue of maternity by stating that the woman who gives birth to a child will be presumed at law to be its mother.

5.68 Legislation is desirable to resolve any doubts in relation to a child’s maternity and paternity,⁵⁹ and it is desirable that the woman who bears the child and intends to raise it, should be conclusively be presumed to be its mother.

5.69 While the Artificial Conception Act 1984, deals conclusively with the issue of paternity, there is no equivalent legislation in relation to donor ova, although the issues and requirements are the same. This recommendation is consistent with the approach taken by the Commission in the Report on Human Artificial Insemination⁶⁰ and would bring New South Wales into line with legislation in most other Australian States.⁶¹

B. Posthumous Conception and Inheritance

Recommendation 38:

Subject to Recommendation 39, no legal regulation or prohibition of IVF is called for in relation to the use of IVF procedures to achieve pregnancy with the stored gametes of a deceased person.

This recommendation is discussed below Recommendation 39.

Recommendation 39:

Where a child is conceived posthumously through the IVF process, that is, where a human ovum is fertilized in vitro af ter the death of one or both of the gamete providers, the Commission makes the following recommendations:


(i) The law should allow, or should not preclude a specific testamentary gift in favour of a posthumously conceived child or a child born from a stored embryo.

5.70 The law should not preclude the creation of a specific gift by will in favour of children conceived posthumously. Anyone who wishes to provide for a child conceived posthumously should be entitled to include an express provision to that effect in their will. This is consistent with the Commission’s recommendations on Artificial Insemination⁶² and also with paragraph (ii) below.

(ii) Where an ovum of a widow is fertilized in an IVF procedure, by the posthumous use of her deceased husband’s semen and transferred to her by embryo transfer, the resulting child should be recognized as the lawful child of the dead husband except for the purposes of inheritance and succession.

5.71 This recommendation also reflects those made in the report on Artificial Insemination.⁶³ Under current law, the child born to a married woman through the use of donated sperm is presumed to be the child of her husband.⁶⁴ For these purposes “married woman” includes someone living in a stable de facto relationship.⁶⁵ Problems may arise where a woman wishes to use the Al procedure to become pregnant using her deceased husband’s semen. We argued in Chapter 12 of the report on Artificial Insemination that under the terms of the Artificial Conception Act 1984 the dead husband of such a woman may be excluded from paternity. The Commission considers that the law should be amended to make it clear that the deceased husband should be recorded as the father of the child so long as the woman is his widow at the time of insemination.

5.72 However, the Commission has also concluded that the recognition of paternity should not extend to recognition of the child under the laws of inheritance and succession. Serious practical difficulties would be created if the child were automatically treated as the child of the deceased under the scheme of distribution on intestacy in New South Wales. Similarly, if the child were considered his child in a gift to his “children” mentioned in his will. The executor or administrator of the deceased’s estate could not confidently make a distribution of assets until exhaustive investigations had been undertaken to ensure that there was no possibility of the subsequent birth of persons who may be regarded as children of the deceased. It is only by excluding posthumously conceived IVF children from these benefits that this problem can be overcome.

(iii) The Commission recommends that children conceived posthumously as a result of IVF procedures and children born from stored embryos should be able to make a claim against the estates of their genetic parents under the Family Provisions Act 1982.

5.73 This recommendation also appears in the report on Artificial Insemination and is designed to allow IVF children to take advantage of the benefits to which they are entitled under the Family Provision Act. Benefiting under the Family Provision Act can be distinguished from those including the IVF child amongst the beneficiaries under a will or intestacy. To share in an estate under the terms of this Act the IVF child will have to be able to show a close relationship with the testator and an obligation owed by him or her. Mr Russell Scott had left the Commission before this recommendation was settled.

Recommendation 40:

Where the ovum of a deceased woman is fertilized by IVF, the subsequent transfer of the embryo will necessarily involve another woman. The circumstances therefore cannot be equated with the circumstances referred to in Recommendation 39(ii), and the Commission makes no recommendations. This matter will be considered in our report on surrogate motherhood.

5.74 As the posthumous use of ova would require the use of a surrogate mother, the Commission has decided to consider this matter in detail in the Surrogate Motherhood discussion paper and report.

C. Registration of Birth

Recommendation 41:

There should not be any alteration in the law relating to the registration of births of IVF children where donated reproductive tissues have been used.

5.75 In the Commission’s view the names of the persons presumed by law to be the parents should be the names recorded in the register of births. This recommendation is consistent with the views expressed by the Commission in Chapter 11 in the report on Human Artificial Insemination.⁶⁶ In that report we indicated that the question of the registration of births was to be addressed by the Commission in another reference. Although we thought that existing legislative presumptions of parentage should be respected in the registration legislation we left the matter for decision in our later report on the Registration and Certification of Births, Deaths and Marriages. That report is due for completion soon. We propose to make our final recommendation on the matter in that report.

5.76 However, the Commission recommends that all IVF practitioners be required to record information in relation to the genetic parenthood of children born as a result of an IVF procedure, where donated human reproductive tissue is used. The Biomedical Council should be given power to review the terms of Recommendation 40 and evaluate the needs of IVF children and make further recommendations at the appropriate time. Mr Russell Scott had left the Commission before this recommendation was settled.

1. S Voumand “Fertility drug a cancer suspect: sociologist” Age 17 May 1988; S Voumand, “Scientists worried about IVF Drugs” Age 8 June 1988; R Klein, “The Exploitation of Infertility: The New Reproductive Technologies and their Impact on Women”, paper delivered at ANZAAS Centenary Congress, University of Sydney (Sydney May 1988).

2. P Clark, “Blewett counts cost of the $40,000 baby” Sydney Morning Herald 12 May 1988 at 1; J Allensdar and C McGee, “Cash battle for the baby-makers” Australian 13 May 1988 at 9; I Svendsen “Canberra to review IVF program funds” Age 12 May 1988 at 1. See also G Batman, Commonwealth Perspectives on IVF Funding: A Discussion Paper (Cth Dept of Community Services and Health, Canberra 1998).

3. “Fabulous Four: Quads jackpot a GIFT” Daily Telegraph 22 June 1988 at 1, 4.

4. D Cameron, “IVF company stated as McDonald’s operation” Sydney Morning Herald 12 April 1988 at 3; R Koval, “What price the Sale of Reproductive Technology?”, paper delivered at Liberation or Loss? conference (Canberra May 1986).

5. J Comley and M Pirrie, “Cain willing to change law for IVF baby” Age 4 April 1988 at 1; R West, “Victoria’s first IVF surrogate mother may also be the last” Age 20 April 1988 at 22.

6. See, for example, L Keens, “IVF: Is it worth it?” Australian Womens Weekly June 1988 at 91.

7. See discussion of the principles of utilitarianism with respect to scientific research in M Warnock, “Law and the Pursuit of Knowledge” (1986) 175 Conquest 1.

8. IVF Discussion Paper, paras 4.4-4.7.

9. M Kirby, “Law for Test-Tube Man?”, paper delivered at Queen Victoria Medical Centre (Melbourne September 1981) at 16, 17.

10. Section 13.

11. Ibid.

12. Sections 15, 16.

13. Sections 10, 14.

14. Bolam v Friern Hospital Management Committee [1957] 2 All ER 118; Furniss v Fitchett [1958] NZLR 396.

15. AI Report, 414.2-14.9.

16. National Health and Medical research Council, Ethics in Medical Research (AGPS Canberra 19831, Supplementary Note 4 at para 8.

17. Infertility (Medical Procedures) Act 1984 (Vic) s6.

18. Senate Select Committee Report, para 4.4.1.

19. Warnock Report, paras 12.11-12.16.

20. Section 6.

21. Warnock Report, paras 12.2-12.3.

22. Senate Select Committee Report, para 4.41.

23. United Kingdom Report, para 11.18 at 64; Ontario Report, 208-209 Victorian Report Recommendation 6.16; Senate Select Committee Report para 4.4S; Family Law Council Report, Recommendation 2; Reproductive Technology Act, 1987 (SA) s5.

24. Senate Select Committee Report, para 2.29-2.34.

25. NHMRC Statement on Human Experimentation at para 4.

26. Senate Select Committee Report, para 2.22.

27. Id para 2.29.

28. Id para 2.30.

29. NHMRC, Supplementary Note 4 - In Vitro Fertilisation and Embryo Transfer, para S.

30. Ibid.

31. I Johnston & A Lopata - Letter to PL Carron, 13/l/86, 2 (Confidential - Senate Inquiry?).

32. Victorian Report, para 3.25; Ontario Report, 208.

33. Ontario Report, 208.

34. Set out in the Senate Select Committee Report and adopted by that Committee, Appendix 4, 156, see III, 4 of the Declaration.

35. Ethics Advisory Board, Department of Health, Education and Welfare, HEW Support of Research Involving Human In Vitro Fertilization and Embryo Transfer (4 May 1979) 101, referred to in the Commissioners Discussion Paper on In Vitro Fertilization (DP 15, 1987) para 8.13.

36. United Kingdom Report at para 11.17; Senate Select Committee Report at paras D.11 to D.20.

37. Senate Select Committee Report, para 3.5-3.6.

38. Id para 3.18.

39. Family Law Council Report, paras 6.8.19-6.8.22.

40. Id para 6.8.23.

41. Submission of Fr Brian Lucas to the NSWLRC Public Hearing on IVF, 15 April 1988.

42. Senate Select Committee Report, para 2.40; Family Law Council Report, para 6.8.22.

43. Family Law Council Report, para 6.8.22.

44. Victorian Report, para 3.26.

45. The Family Law Council agrees with us in relation to the status argument, para 6.8.20, as does the Senate Select Committee, para 3.33.

46. JA Robertson, “Extracorporeal Embryos and the Abortion Debate” (1986) 2 Journal of Contemporary Health Law and Policy 53, 68-70.

47. Warnock Report at para 10.10; Ontario Report at 217; and National Health and Medical Research Council, Ethics in Medical Research (AGPS Canberra 1983) Supplementary Note 4 at 26.

48. See generally, R Scott The Body as Property (Allen Lane London 1981).

49. AI Report, para 10.13.

50. Id, para 13.23.

51. Ibid.

52. Adoption Act 1984 (Vic) ; Adult Adoption Information Act 1985 (NZ); Adoption Act 1976 (UK).

53. AI Report, paras 13.4, 13.12 and 13.17.

54. Section S(2).

55. Family Law Council Report at para 6.2; Chalmers Committee Interim Report at 53.

56. AI Report, paras 8.13, 14.10.

57. Id, paras 5.17-5.18.

58. Hawkins v Clayton (Unreported High Court, 8 April 1988).

59. Section 5(2).

60. Al Report, para 11.4.

61. Status of Children (Amendment) Act 1 9 84 (Vic); Family Relationships Act Amendment Act 1984 (SA); Status of Children Amendment Act 1985 (Tas); Artificial Conception Act 1983 (WA). At the time of writing, there was a bill before the Queensland Parliament on status of children legislation.

62. AI Report, paras 12.4, 12.8.

63. Id, paras 12.9-12.11.

64. Artificial Conception Act 1984 ss5, 6.

65. Id, section 3.

66. AI Report, paras 11.1-11.4.