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Discussion Paper 15 (1987) - Artificial Conception: In Vitro Fertilization

11. An Advisory Committee

History of this Reference (Digest)

I. INTRODUCTION

11.1 Our general approach to regulation of the new reproductive technologies and, in particular, AI¹ and IVF has been to keep legislation and traditional criminal sanctions and penalties to a Minimum. Chapter 5 of this paper discloses the basis of our approach. Some of the factors which influence us are:

surveys disclose strong and continuing community approval, over a substantial period, of IVF as a treatment for infertility in marriage;²
IVF can be seen as a medical procedure designed to alleviate a patient’s infertility and each step could be classified as a proper subject of medical practice.³ Registration as a medical practitioner is the subject of detailed statutory regulation;⁴
since 1982, Australia has had an official national regulatory code for IVF practice and associated research. This is comprised in the NHMRC Statement on Human Experimentation and its supplementary statements, in particular those entitled In Vitro Fertilization and Embryo Transfer and Institutional Ethics Committees;⁵and
there aready exists professional self-regulation involving extensive oversight of the practice of IVF by a variety of institutions and bodies including the Fertility Society of Australia, the Medical Colleges, the National Perinatal Statistics Unit and institutional ethics committees.

11.2 However, we recognise elements in the practice of IVF which do require some legislative statement. To reiterate, ⁶some of the factors which cause concern in relation to IVF include the following:

potentially, any woman can receive IVF;
IVF can involve the use of frozen and donated gametes;
IVF involves manipulation of a human embryo; and
the continued practice of IVF will require continued research on IVF embryos.

11.3 The Commission would like to see in New South Wales and indeed nationwide, a scheme of regulation of the new birth technologies which is flexible and responsive to change. Such a scheme, involving some legislative statement together with reliance upon guidelines and public accountability would, in our opinion, be enhanced by the establishment of an official advisory body. We have already published views on this subject on two occasions, namely in our Discussion Paper and our Report respectively entitled Human Artificial Insemination.

II. OTHER APPROACHES

A. Introduction

11.4 It may be helpful here to outline the recommendations of some official Inquiries in relation to the creation of an advisory body on the new reproductive technologies, and to look at bodies already in existence in some jurisdictions.

B. Commonwealth and National

1. National Health and Medical Research Council (NHMRC)

11.5 At the 102nd Session of the NHMRC in November 1986 a working group was formed with the following terms of reference:

to consider the relative merits of various proposals made for a national body to be concerned with the oversight of reproductive technology;
to consider the advisability of fragmenting the ethical oversight.

The seven members of the working group included three who represent respectively on the NHMRC the Australian trade union movement, the Australian business community and Australian consumer associations. The working group met in Adelaide on 6 January 1987 and produced a report which was formally adopted by the NHMRC in April 1987. The principal recommendation called for the establishment of a national body, to be entitled the National Bioethics Consultative Council (NBCC). It was considered that this body should deal with biomedical ethics generally and should have broad terms of reference. This would enable it to address

... not only the growing edge of medical research in these areas but ethical questions that may arise from “novel” techniques that may be developed for already established practices.

⁷

The proposed body was seen as having a consultative and educative role but no legislative or administrative function.

2. Family Law Council

11.6 The Family Law Council in its 1985 report, Creating Children, proposed the establishment of a National Council on Reproductive Technology whose functions would include advising governments, reporting to various organisations and liaising with the NHMRC.⁸ It was recommended that the proposed body should have very wideranging powers including powers to require notification of all developments in reproductive technology, to recommend and support research, to develop guidelines and standards and to provide information to the community.⁹

3. The Senate Select Committee on the Human Embryo Experimentation Bill 1985

11.7 The Senate Select Committee was in favour of a national body along the lines of that advocated by the Family Law Council. The majority recommended that the body should be broadly representative and responsible to the Federal Attorney-General. The Committee saw the body as having distinct executive functions including formulating guidelines, considering research protocols, monitoring research procedures and initiating action by way of prosecution or injunction. It was also to have an educative role, involving continuing consultation with the public, publication of background information, holding of seminars and the institution of public inquiries.¹⁰

4. National Round Table Conference - 1986

11.8 On 29 July 1986 a National Round Table Conference on the regulation of IVF and related research took place in Canberra. The 51 participants and 10 observers included the Minister for Health of the Commonwealth, the Attorney General of New South Wales, the Governor of Victoria, the President of the Legislative Council of South Australia, Baroness Warnock of the United Kingdom, Senator Tate (chairman of the Senate Select Committee described above) and deputies for Health Ministers, Social Welfare Ministers and Attorneys General from the States and Territories. Numbers of significant Australian constituencies were separately represented.

11.9 The conclusions of this conference were conveyed formally in October 1986 by letter to the three Standing Committees of the Ministers described in the preceding paragraph. These conclusions included the identification and establishment of “a mechanism for collaboration between Australian jurisdictions to achieve ... consistency and, where appropriate, uniformity...in the regulation of in vitro fertilization and other reproductive technologies.” Another conclusion was that the Ministerial Committees should consider the establishment of “some kind of national advisory mechanism or body.”

5. National Momentum

11.10 Since the National Round Table Conference a momentum has developed, supported by Australian governments, towards the formation of a national consultative body. In April 1987 the Australian Health Ministers Conference resolved to support the establishment of such a body and to obtain advice on its possible scope and nature. Consideration is also being given in 1987 to the same notion by the other two Ministerial Standing Committees.

C. Victoria

11.11 In August i984, the Victorian Committee recommended the creation of a multidisciplinary body to be called the Standing Review and Advisory Body on Fertility, Reproduction and Related Matters¹¹ and this recommendation was embodied in the Infertility (Medical Procedures) Act 1984. The statutory functions of the eight-member Standing Review and Advisory Committee¹² (SRAC) include the following:

to advise the Minister in relation to infertility and procedures for alleviating infertility; and
to consider requests for approval of, and if it sees fit, to approve, experimental procedures on the IVF conceptus.

The Committee was duly constituted and has been operating since October 1985. A number of requests for approval of research projects have already put to it.¹³

D. United Kingdom

11.12 In 1984, the United Kingdom Committee recommended the establishment of a new statutory licensing authority to regulate research and infertility services.¹⁴ The Committee considered that the proposed body should have wideranging membership with lay interests well represented. The body would have two distinct functions: an advisory function and an executive function. The first function would involve giving advice to government on specific issues. The second function would involve the granting of licences to those wanting to offer infertility treatments and to researchers. The Committee envisaged both practitioners and premises being licensed, and some consideration being given to regular review of the health and welfare of children born as a result of IVF procedures.

11.13 In 1985, the Medical Research Council and the Royal College of Obstetricians and Gynaecologists agreed to set up as a temporary measure, a jointly-sponsored Organisation until the Government introduced the statutory licensing system proposed by the United Kingdom Committee. The Organisation is called the Voluntary Licensing Authority (VLA) and first met on 26 March 1985. It has drawn up guidelines for clinical IVF practice and research based on recommendations contained in the United Kingdom Report. Its second annual report was published in April 1987 and contains a record of progress in the birth technologies in the United Kingdom together with details of associated research.

E. France

11.14 France has had a National Consultative Ethics Committee (CCNE) since 1983. The Committee is a permanent body whose role is to discuss and report on bioethical issues raised by Ministers or by members of the public. Since its inception, the CCNE has issued reports and recommendations on a wide range of topics including the use of fetal issues for therapeutic, diagnostic or research purposes, and the ethical acceptability of research on IVF embryos.

11.15 The CCNE has no legislative, judicial or financial power and cannot impose sanctions for non-compliance with i t s recommendations. Its sole power is moral, and the source of that power is “the wisdom of its statements”.¹⁵ However, in the words of its President, its official statements “may be used by the legislator in the preparation of laws and decrees, by judges in the consideration of matters before them and by educators in medical and law faculties, as well as in secondary schools.”¹⁶ As a result, the findings of the CCNE are of wide significance.

III. OUR TENTATIVE APPROACH

A. The Need for Monitoring

11.16 The ethical, moral and technological issues involved in research into human reproduction are matters of public concern which go beyond the exclusive jurisdiction of the scientific and medical communities. Scientific research and the medical practices which result should be monitored and understood by the public. This is recognised by leading medical practitioners and scientists who have, over a long period, called for formal regulation and guidelines.¹⁷

11.17 The reverse side of the public’s entitlement to be kept informed of developments is the public’s obligation to inform itself and to make an effort to understand medical developments so that it can share in the responsibilities those developments impose. Biomedical research is a co-operative enterprise in which scientists and medical practitioners play a leading role but in which the public must also accept a share of responsibility. The social significance of research on human infertility is such that these professionals cannot be asked to develop alone the moral, ethical and legal principles which must accompany this research. A vital ingredient in these principles will be community response to information and advice from the professionals.

B. National and State Approaches

11.18 As we have seen, most of the major Inquiries to date have recommended the establishment of a national body to oversee developments in the field of reproductive technology. This Commission also recognizes the desirability of a national approach to the issues raised by the new reproductive technologies, and the advisability of a uniform approach to regulation throughout Australia. However, we feel it is not appropriate for us as a state body to volunteer advice to the federal government and other state governments on the detail of this matter.

11.19 Our tentative proposal is for the creation of a state advisory committee with multidisciplinary membership. One advantage of a state committee is that it is more accessible and responsive to the needs of local community groups than a national body. If the creation of a national advisory body becomes feasible, or occurs, we would see the state committee as continuing to perform its functions but, in addition, complementing and cooperating with the national body.

C. Purpose of the Committee

11.20 Before deciding what form a state committee should take, it is necessary to discuss what we consider to be its purpose. Often the reasons put forward for the creation of a committee proceed from the view that a “watchdog” is needed to oversee and control the activities of scientists and other professionals. Where a watchdog role is envisaged, the committee would require executive powers, including powers not only to monitor and supervise, but ultimately to veto research projects. Researchers would be required to report to the committee and be made accountable to it, with no provision for a return of service by the committee to the researchers.

11.21 On the other hand, if the purpose of the committee is to engender understanding and cooperation between the community and its doctors and scientists, a different role will be seen for it. If a balance is sought between the extremes of legislative prohibition and unrestrained self-regulation, as discussed in Chapter 5, a consultative committee could well act as the fulcrum. On this approach, the committee would be a significant, but not overriding, element in achieving regulation of IVF. Genuine debate and careful reflection are necessary and are more likely to be produced from the close and regular contact which can occur in a co-operative enterprise.

11.22 We believe that the purpose of the proposed committee should be primarily to inform the public and to assist IVF practitioners and researchers in decisions relating to the acceptability of their practices and proposals. The Commission envisages that the committee would have no executive powers. It could not stop or delay research, nor could it refer matters to other government instrumentalities to have research stopped or delayed. The committee would report to the Premier, report to Parliament and release statements to the media. It would also have power to undertake public and private inquiries, to require the supply of information and to publish information of public importance. That these are not insubstantial powers is demonstrated by reference to two bodies which currently rely on them, the Ombudsman¹⁸ and the Privacy Committee.¹⁹

11.23 The restraints and controls already operating within the Australian scientific community are numerous and some were described in paragraph 11.1 above. These influences militate against improper use of facilities and where it is clear that expert opinion has been persuaded of the worth and propriety of practice or research it seems inappropriate in principle that a non-expert committee standing outside the field should have a power to prevent such practices. If there be any power of veto available to the committee it should inhere in the power to expose practices and research proposals to public scrutiny thereby leaving the work to prove itself by the informal processes of the public arena.

D. Functions of the Committee

11.24 Bearing in mind our previous comments that the purpose of the proposed committee should be to inform the public and assist IVF practitioners and researchers, the Commission envisages the committee as having the following functions in relation to the new reproductive technologies:

to inform itself of research being conducted into infertility in men and women, internationally, nationally and in New South Wales; and to keep abreast of literature, experimentation and practice in New South Wales;
to inform itself of research into IVF and related fields internationally nationally and in New South Wales and, in particular, to be informed of the potential of the research;
to receive submissions on human reproduction and related topics, from the general public and from the scientific and medical communities;
to monitor such research in New South Wales;
to monitor medical practice in human reproduction;
where legislative regulation of a practice or procedure exists, to monitor the effect of such regulation and recommend change where desirable;
to visit and consult scientists, doctors and others engaged in research and practice in order to ensure personal knowledge and understanding;
to develop effective reporting procedures so that those engaged in research and practice in the field can keep the committee informed of developments;
to liaise with existing ethics committees and the NHMRC; and
to inform the public, the Parliament and professional groups in the field by any appropriate means.

E. A Wider Brief for the Committee

11.25 However, the Commission also believes that the brief of the proposed committee should be wider than IVF and the new birth technologies and should extend to all biomedical developments, including for example, euthanasia, the artificial support of the grossly deformed and defective both at the beginning and ending of life, gene therapy, genetic manipulation and organ transplantation. A committee with such a brief could not only render unnecessary the creation of additional “monitoring bodies” with comparable functions but could perform the positive function of detecting and perhaps reducing overlap between developments (and between research) in biotechnology.

F. Some Essential Requirements

11.26 In order for the proposed committee to be effective and efficient, we believe certain requirements must be met. The committee should be small in order to ensure a strong working group. Membership should not exceed 10. Expertise will be acquired by members during their term of office, so some continuity of membership is important. The committee must be active. It should keep itself informed, report regularly and give wide publicity to its deliberations. Its membership should be multidisciplinary and involve a fair representation of interests.

IV. ISSUES FOR REFORM

1. Is it desirable to establish an advisory (consultative) organization as part of a system of regulation of IVF?
2. If so, what should be the functions of such an organization?
3. If not, is some alternative initiative called for?

Footnotes

1. AI Discussion Paper, chs 5 to 22, passim; AI Final Report, chs 4 to 15, passim.

2. See eg M Brumby and M Levine “Australian Attitudes Towards IVF: A Comparison of the Values of Supporters and Opponents” (1986) 11(4) Australian Journal of Early Childhood 24; Morgan Gallup Poll in Bulletin, 1 April 1986.

3. See ch 5.

4. Medical Practitioners Act 1938, ss15-17, 19 and 21.

5. National Health and Medical Research Council Ethics in Medical Research (1983) at 26-28 and 29-30.

6. Para 5.4.

7. Report of the Working Group to Consider the Establishment of a National Body on Guidelines and Research on In-vitro Fertilization (IVF), adopted by the AHMRC at the meeting of Health Ministers (April 1987) at 2.

8. Family Law Council Report at para 7.8.3.

9. Ibid.

10. Senate Select Committee Report at paras 4.45 to 4.49.

11. Victorian Report (1984) at paras 5.4 to 5.7.

12. Infertility (Medical Procedures) Act 1984 s29.

13. Letter from Dr A Trounson to SRAC dated 24 February 1987; letter from SRAC to Professor Wood and Dr Rogers dated 12 March 1987.

14. United Kingdom Report at para 13.3.

15. Jean Bernard “Ethical Problems Arising from the New Techniques in Human Procreation”, paper delivered to the Academy of the Kingdom of Morocco (27 November 1986).

16. Ibid.

17. For example, in early 1980 Mr Patrick Steptoe in England and Professor Carl Wood in Australia stressed the need for regulation. In a personal discussion with the Commissioner-in-charge of this reference, Mr. Steptoe said that he firmly believed “that there should be national and international guidelines or laws to regulate all the practices of IVF, ET and AI.” He said that his colleague Dr Robert Edwards had already participated in drafting model guidelines concerning IVF. On 16 April 1980, The Age of Melbourne reported a public appeal by the Australian pioneer Professor Carl Wood for “guidelines for scientific work in this area [IVF] to be delineated by society consistent with the cultural, religious and ethical standards of the community.”

18. Ombudsman Act 1974.

19. Privacy Committee Act 1975.

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