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Where am I now? Lawlink > Law Reform Commission > Publications > 5. Regulation of the Practice of IVF and Associated Procedures
Discussion Paper 15 (1987) - Artificial Conception: In Vitro Fertilization
5. Regulation of the Practice of IVF and Associated Procedures
I. THE BASIC QUESTIONS
5.1 This Chapter addresses the primary requirement of the Commission’s terms of reference, “to inquire into and report on the need to make laws on IVF and ET.” The word “regulation” in the Chapter title is used deliberately in recognition of the growing opinion worldwide that legislation as the sole official response to the issues raised by IVF may not adequately serve the public interest.1
5.2 Bearing in mind that IVF is currently practised in many countries, the significant questions for any particular state or nation are three:
- should IVF be prohibited?
- if not, should IVF practice be regulated at all? And
- if IVF practice should be regulated, what should be the nature and extent of the regulation?
We hope to answer these questions in our report on IVF. Our present purpose is to seek public response and submissions. Informed answers require acquaintance with the evolution, practice and development of IVF as well as information about official steps taken in recent years by way of inquiry, prohibition (actual and attempted) and regulation.
II. FACTS AND FACTORS
5.3 Our research and consultation discloses that as currently practised in Australia, IVF is invariably characterised by the following events:
- diagnosis of infertility and acceptance of the patient into an IVF program;
- the performance of all procedures and activities in a hospital or other “medical” context, by medical practitioners with associated scientists, other professionals (for example, counsellors) and trained staff;
- ovum retrieval from the patient after careful preparation for that procedure;
- supply of semen and its preparation for use in IVF;
- fertilization in vitro of retrieved ova by prepared semen followed by placement in a culture medium, systematic observation and selection of conceptus for embryo transfer (ET); and
- ET followed by all necessary subsequent activities leading to diagnosis of pregnancy.
One interpretation of the “facts” as presented, would be that IVF is no more than a medical procedure designed to alleviate a patient’s infertility. Each step in the IVF procedure, considered separately, may be classified as a proper subject of medical practice and hence, standing alone, might suggest no special requirement for regulation additional to the legal and ethical constraints already imposed on the practice of medicine. However, the scope of IVF as a whole is far greater than the scope of the sum of its parts as expressed above. Within the IVF framework exist possibilities for endless combinations and permutations, some of which do cause concern and suggest the need for additional regulation.
5.4 The following factors may be relevant to decisions regarding the nature and extent of proposed regulation of the practice of IVF:
- IVF developed as a technological response to certain kinds of infertility;
- potentially, any woman can receive IVF, whether or not she is infertile;
- IVF can involve the use of gametes which have been donated;
- IVF can involve the use of gametes or embryos which have been frozen;
- IVF involves the manipulation of a human embryo;
- IVF became a successful procedure as a direct result of research and experiment upon human gametes and embryos; and
- there is widespread public approval of IVF as a treatment for infertile married couples, although segments of the public have strong moral objections to IVF and to the prospect of research or experimentation on the IVF conceptus.
III. THE OPTIONS FOR REGULATION
A. The Basic Questions
1. Should IVF be totally prohibited?
5.5 Prohibition of the practice of IVF would be relatively easy to accomplish. Unlike AI, the assistance of professionals is required to accomplish IVF and ET, and prohibition backed by a criminal sanction would almost certainly put an end to the practice. However, it seems plain that, for a number of reasons, this course should not be followed. First, as mentioned previously (see Chapter 4), there is clear evidence of Australian public approval of IVF in “the most common situation”. Indeed, there is already in existence a body of regulation which assumes the continuance of IVF practice. In Australia, this is provided by the existence of the Infertility (Medical Procedures) Act 1984 of Victoria which, when it commences, will regulate (but not prohibit) IVF, the “status” legislation in force throughout Australia2 and the official regulatory system for IVF established by the NHMRC. Secondly, no official Inquiry in Australia, North America or Europe has recommended prohibition of IVF as a procedure for the alleviation of human infertility.
2. Should IVF be regulated at all?
5.6 As for the performance or practice of IVF being left entirely unregulated, we regard this as little more than a statement of a logical possibility. Total lack of regulation would mean that any person could lawfully carry out the procedure, whether or not medically qualified. The complexity of IVF, its origin and the high degree of medical and scientific skill necessary for its successful performance mean that at the least, IVF must be seen as part of the practice of medicine which already carries with it a system of legal regulation set out in the Medical Practitioners Act 1938.
3. What should be the nature and extent of regulation?
5.7. This is the most critical practical question in the debate on artificial conception. It requires consideration of options for regulation which may include any one or more the following:
- statutory enactment with traditional criminal punishments;
- statutory enactment on a looser basis that includes or permits official guidelines;
- selective reliance on professional guidelines and self-regulation;
- financial or “purse-string” control; “sunset” clauses; and licensing.
5.8 None of the major Inquiries to date, with the exception of the Ontario Law Reform Commission, has analysed or discussed the means and methods of achieving effective regulation of IVF. We believe that such analysis and discussion is necessary, and that an acceptable position can only be reached after certain questions have been answered. The first is whether society accepts IVF as a beneficial procedure. We have already demonstrated that this is so, when IVF is used as a treatment for marital infertility. The next question is, how can we ensure that the benefits offered by IVF to the infertile will be secured? The final question is, how can the public be assured that acceptable bounds of morality and ethics will not be broken by practitioners and researchers working in this unique, unprecedented field? Effective regulation of IVF requires the satisfaction of two objectives, the first being to secure the benefits that IVF offers to society and the second to restrain excess and abuse.
B. Recommendations of Other Inquiries
1. The United Kingdom Report
5.9 The pivotal recommendation on regulation made by the United Kingdom Committee would require the establishment of a new statutory licensing authority to regulate both research and certain infertility series.3 The “services” which would be licensed include:
- the practice of IVF;4
- research on human in vitro embryos and the handling of such embryos;5
- ovum donation;6
- donation of IVF embryos;7
- supply of semen and storage of ova, semen and embryos;8
- AID;9
- commerce in human gametes and embryos;10 and
- trans-species fertilization.11
5.10 The effect of the United Kingdom committee recommendation is that all artificial conception procedures including research on IVF embryos would be unlawful, unless specially licensed. The decision is justified in terms of “public concern”.12 While the report envisages that IVF will be performed in “specialised units” or “clinics”13 it does not, as expressed, preclude the practice of IVF by individual medical practitioners or compel resort to particular kinds of institution.
2. The Victorian Inquiry
5.11 The first report of the Victorian Committee was completed in September 1982. The Committee recommended “that IVF should only be conducted in hospitals authorized to do so by, and responsible to, the Health Commission of Victoria”.14 The recommendations stated that legislation should be enacted to this effect and that IVF should only be available to persons who are married, who had already spent a year receiving other medical treatment for infertility and who had received counselling.15
5.12 The reasons given for these proposed strictures were:
- that the process of IVF is complicated, requiring skilled doctors, technicians and support staff; and
- that the procedure is a relatively expensive one.16
The Victorian Report and t lie subsequent legislation, the Infertility (Medical Procedures) Act 1984, restrict the potential recipients of licences or approvals’ to hospitals, thus excluding individual medical practitioners and other medical bodies or organisations.17
3. The Ontario Report
5.13 The Ontario Report directed specific attention to the question whether IVF should be classified as “the practice of medicine” and thus left to the control of registered or licensed medical practitioners under the Health Disciplines Act.18 After analysis and discussion the Ontario Report concluded that IVF should be so classified. As a result, IVF would require no special licensing and the public would be considered to be adequately protected by confining the practice to the medical profession. This may be contrasted with the stricter view of the United Kingdom Committee which envisages special licensing of medical practitioners and institutions and the Victorian legislation which imposes an additional restriction limiting licenses to hospitals.
5.14 Treating the subject of the regulation of IVF under two headings, “The ‘State Regulation’ Approach” and “The Private Ordering Approach” the report discusses the extremes of total prohibition and total absence of legal intervention.19 It concludes that:
... some matters - clearly those that involve outright prohibition of certain activities - necessitate statutory control. Other matters may be left to regulations.. And yet further profession, either formally or informally. In all, or most, of these cases, recourse may well be had to the courts to interpret legislation or relevant codes of ethics or professional conduct.20
C. A Possible Model
5.15 The tentative views of this Commission favour the Ontario approach. We consider that the onus of justifying specific legislative regulation lies on those who would seek to treat the practice of IVF differently from that of any other matters may be determined by the medical medical specialty. We believe that it is apparent from a reading of the list of facts and factors in this Chapter, that there are many aspects of IVF that call for no special regulation, provided the practice of IVF is confined to the medical profession. On the other hand some aspects clearly call for special regulation. Even so, we take the view that effective regulation of IVF and associated research may be readily accomplished without blanket licensing requirements that extend to every aspect of IVF and without restricting the practice of every aspect of IVF to particular kinds of institution.
5.16 We believe that it is imperative to bear in mind at all times the continuous rapid changes in reproductive technology. Over the past five years, certain aspects of the IVF procedure have become much simpler and less traumatic for patients.21 IVF techniques have become refined to the point where it is no longer necessary to have available the facilities of a hospital although in New South Wales all but one IVF clinic are conducted in a hospital setting.
5.17 This leads us to suggest that the aspects of IVF that need particular attention by way of special regulation under present circumstances may be no more than:
- freezing and storage of gametes and conceptuses;
- donation to a female patient of semen, an ovum or an IVF conceptus;
- dominion or ownership of stored gametes and conceptuses; and
- research on the IVF conceptus.
By isolating and concentrating on such features it is possible to accommodate future changes in technology, to deal constructively with the features of IVF that give rise to problems that cannot be solved without regulation and to achieve a realism that is not possible with a single global response to all forms of artificial conception. A global response suggests either a moral judgment or a failure to analyse in detail the procedures under examination.
5.18 Some three years after both the United Kingdom Report and the Victorian Report there is still no legislation in force in Britain or Victoria regulating IVF practice. Baroness Warnock said in Australia in July 1986 that she did not expect to see legislation in Britain in the foreseeable future.22 In December 1986, the British Department of Health and Social Security published a Consultation Paper, entitled “Legislation on Human Infertility Services and Embryo Research” in which it was said that given:
.. . the range and complexity of issues raised by the Warnock Report and the strength and diversity of opinion expressed... it [is] desirable that there be a further period for consultation before any legislation is drafted.23
The Victorian legislation was enacted in November 1984 but in mid-1987, still not proclaimed to commence, has been taken back to the Victorian public for further consultation. Provisions of the Victorian Act regulating research on the IVF conceptus, and regulating surrogacy, have been proclaimed to commence.
5.19 A significant consideration is the goal of uniformity, or at least consistency, of regulation in a federation such as Australia. The possibility of substantial regulatory variation from state to state cannot he viewed with equanimity. These matters suggest that serious thought should be given to the potential of the existing nationwide NHMRC system with its network of institutional ethics committees and uniform IVF regulations, already described in Chapter 3. There is plainly room for improvement of the NHMRC system. However, adaptation of this flexible code to varying state and territorial requirements (while retaining central uniformity), and legislative adoption of principles that by now are well known and established, would not be difficult. The groundwork has already been done.
IV. ISSUES FOR REFORM
1. Should IVF be prohibited?
2. If not, should IVF practice be regulated at all?
3. If IVF practice should be regulated what should be the nature and extent of regulation?
Footnotes
1. See eg Ontario Report Vol I at 123-130; I Davies “Fabricated Man: The Dilemma Posed by Artificial Reproductive Techniques” (1984) 35(4) Northern Ireland Legal Quarterly 354 at 377 - 380 ; M Charlesworth “Bio Technology and Bioethics: New Ways of life and death” (1984) 61(3) Current Affairs Bulletin 4 at 19-22; Russell Scott “Regulating Biomedicine by Law-Delusions at the Epicentre”, paper delivered at 56th ANZAAS Congress (29 January 1987, New Zealand).
2. In chronological order, Artificial Conception Act 1984, Status of Children (Amendment) Act 1984 (Vic), Family Relationships Act Amendment Act 1984 (SA), Artificial Conception Act 1985 (WA) , Artificial Conception Ordinance 1985 (ACT), Status of Children Amendment Act 1985 (NT), Status of Children Amendment Act 1985 (Tas).
3. United Kingdom Report at para 13.3.
4. Id at para 5.10.
5. Id at para 11.18.
6. Id at para 6.6
7. Id at para 7.4
8. Id at para 13.7
9. Id at para 4.16.
10. Id at para 13.13.
11. Id at para 12-3.
12. Id at para 13.1
13. Id at para 2.16.
14. Victorian Report (1982) at para 5.8-1.
15. Id at para 5.10.2.
16. Id at para S.8-1.
17. Infertility (Medical Procedures) Act 1984 s7.
18. Ontario Report Vol 1 at 30 et seq.
19. Id at ch 4
20. Id at 130.
21. See para 2.7. Information supplied orally by Dr R Jansen at Artificial Conception Division Meeting of the New South Wales Law Reform Commission on 12 November 1986.
22. At the Round Table Conference, Canberra (29 September 1986).
23. Department of Health and Social Security, Legislation on Human Infertility Services and Embryo Research (Consultation Paper, Cm 46, December 1986) at para 4.
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