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Where am I now? Lawlink > Law Reform Commission > Publications > 2. The Current State of IVF Regulation

Report 58 (1988) - Artificial Conception: In Vitro Fertilization

2. The Current State of IVF Regulation

In Vitro Fertilization (IVF) Public Hearing

History of this Reference (Digest)

Outline of Report


I. INTRODUCTION

2.1 The birth of children conceived as the result of IVF is a recent phenomenon. Australia’s first IVF baby, Candice Reid, was born in 1980.1 The application of traditional legal principles to this new medical procedure was likely to produce results that were unexpected and often unwanted. For example, common law principles for determining paternity, maternity and legal personality were formulated long before IVF technology was developed and based on assumptions about conception and parenting which are no longer valid.

2.2 As IVF techniques have developed, attempts have been made to apply legal rules and principles to the problems created by the process as well as developing new legislation and regulatory schemes. This Chapter will assess the current state of IVF regulation on three different levels:

  • Common law
  • Legislative responses to IVF
  • Non-legislative responses to IVF

II. COMMON LAW STATUS OF THE HUMAN EMBRYO

2.3 At common law, it has traditionally been the act of “live birth” - the complete extrusion of the foetus from the body of the mother - which endows a foetus with a legal personality and the rights and responsibilities associated with being a person. There is a substantial list of authorities in which the courts have refused to confer legal rights on a human embryo or foetus unless, and until, it is born and has a separate existence from its mother.2

2.4 This is not to say that the foetus is denied all legal rights. The foetus is considered to have potential or contingent legal interests which will only vest and become enforceable upon its live birth. 3 Two areas in which the foetus is accorded contingent legal rights are the law of succession and tort law. The question whether the IVF embryo should be given a special status at law on the basis of its unique nature and potentiality is discussed in Chapter 3.4

III. LEGISLATIVE RESPONSES TO IVF

A. Introduction

2.6 Our discussion paper set out a detailed description of the law in NSW and Australia as it applies to IVF.5 As shown there, the law applicable to IVF covers a wide range of questions including the maternity and paternity of IVF children, the ownership and storage of human reproductive tissues, as well as the important question of regulation of IVF practices and research. In this report we merely bring our description of the law up to date.

B. Maternity and Paternity

2.7 Problems can arise as to the maternity and paternity of children born on an IVF program, where donated reproductive “issues are used. At common law a child conceived following the use of donated gametes would be considered illegitimate. It is likely that the donor would be legally considered the father or mother of the child, and have all the rights and obligations attendant upon such a status.6

2.8 The common law rules governing legitimacy of children have been modified in most Australian jurisdictions by legislation. In New South Wales, the Children (Equality of Status) Act 1976 effectively abolishes the concept of illegitimacy and removes the stigma of being born ex nuptial.7

2.9 Status of children legislation has also been enacted at both federal and State levels to accommodate many of the legal problems created by artificial conception techiques. Under the legislation, new notions of paternity have been created:


    Where a married woman, in accordance with the consent of her husband, has undergone a fertilization procedure [using donor sperm] as a result of which she has become pregnant, the husband shall be presumed, for all purposes, to have caused the pregnancy and to be the father of any child born as a result of the pregnancy.8

2.10 All Australian jurisdictions,9 apart from New South Wales and Queensland,10 also provide that when a woman gives birth to a child following IVF using donated ova, the birth mother is presumed to be the mother of that child. In New South Wales, the position of a child born from donor ova is still unclear. With no statutory or common law guidance to assist, a child so conceived can have up to three “mothers”:

  • a genetic mother (the ovum donor)
  • a gestational mother (who carries and gives birth to the child)
  • a social mother (who nurtures and cares for the child from birth).

C. Ownership and Control of Reproductive Tissues

2.11 The common law makes no distinction between reproductive and other human tissues. The general rule is that there can be no proprietary interest in human tissues and organs, and the person who possesses tissue controls it. Statutory modification of the common law is found in the Human Tissue Act 1983 which governs the acquisition and donation of human tissues for therapeutic purposes. The Act restricts the use of human tissue in the following ways:

  • Section 32 expressly prohibits commerce in “human tissue”. Human tissue is defined to include both ova and semen.
  • Section 21C provides that where semen has been obtained from a donor for a specific purpose it must be used for that purpose unless the donor has signed a certificate relating to its “medical suitability” for a different purpose.

D. Legislation Regulating the Practice of IVF

2.12 So far in Australia only Victoria and South Australia have enacted comprehensive legislation to deal directly with the practice of IVF.

1. Victoria

2.13 The effect of the Infertility (Medical Procedures) Act 1984 was described in the IVF discussion paper.11 Enacted in November 1984, the main provisions were proclaimed to commence on 1 July 1988.12 The Victorian Act provides three means of regulating IVF:


    (i) by limiting its practice to approved hospitals and practitioners;

    (ii) by limiting those who may have access to it;

    (iii) by requiring the keeping of detailed records and registers by both clinics and government.


2.14 Since the discussion paper was written, the Victorian Parliament has also passed the Infertility (Medical Services) Amendment Act 1987. This Act, a response to the newly developed micro-injection technique, allows limited experimentation on the fertilized ovum in the first 22 hours following fertilization.13 This amendment was proclaimed to commence operation on 1 July 1988.14

2. South Australia

2.15 In September 1987, following the Report of a Committee on Artificial Conception15 the bill for the Reproductive Technology Act 1987 was introduced. This Act aims to regulate “the use of reproductive technology and research involving experimentation with human reproductive material”. The Act:


    1. Establishes a Council on Reproductive Technology to monitor the practice of IVF and IVF research.16 It will also advise the Minister for Health on issues of reproductive technologies.17 Membership will be multi-disciplinary with equal representation of men and women.18


    2. Sets down provisions to guide the Council in formulating a code of IVF ethical practice.19


    3. Provides for separate licensing systems for both IVF practice and research.20 These systems will be administered by the South Australian Health Commission and the Council respectively.


    4. Creates a number of compulsory conditions to be written into licences, including provisions limiting access to rograms and the types of procedures available.21


    5. Prohibits any research which “may be detrimental to an embryo.”22


    6. Makes it an offence to divulge confidential information other than as provided by the Act.23

Like the Victorian Infertility (Medical Procedures) Act, the Reproductive Technology Act creates offences which are punishable by fines and imprisonment.24

IV. NON-LEGISLATIVE REGULATION OF THE PRACTICE OF IVF

2.16 In States like New South Wales where no comprehensive legislation has been enacted the practice of IVF is currently regulated by non-legislative means. The NSW Department of Health has officially endorsed the principles for IVF practice adopted by the National Health and Medical Research Council (NHMRC).25 The work of this body was set out in some detail in the discussion paper.26 The principles set out by the NHMRC in relation to IVF practice include the following:


    (i) each clinic offering IVF “should have all aspects of the program approved by an institutional ethics committee”, and registers recording data relating to all attempts at IVF should be kept by the clinic;

    (ii) research with ova, sperm and fertilized ova should he allowed, but continuation of embryonic development in vitro beyond the stage at which implantation usually takes place should not be permitted;

    (iii) sperm and ova should be considered to belong to the donors, and the wishes of donors regarding disposal of their gametes should be respected as far as possible; and

    (iv) only early “undifferentiated” embryos should be stored, and time limits should be imposed on the duration of storage.


While this scheme has no legal sanctions, it provides advantages over strict legislative schemes by allowing much greater flexibility in responding to changing developments in IVF.

2.17 In addition Australian medical and scientific communities involved in the practice of IVF are subject to professional self -regulation. A breach of medical ethics may expose a medical practitioner to disciplinary proceedings under the Medical Practitioners Act 1938 which provides that a medical practitioner who has been found guilty of “misconduct in a professional respect” may be disqualified from continuing to practise medicine if the breach has been sufficiently serious.27 Other sanctions include reprimands, suspensions from practising medicine and fines.28

2.18 A new federal committee advising the Australian Health Ministers’ Conference (AHMC) on important bioethical issues such as IVF and embryo research was announced by the Minister for Health recently and endorsed at the annual meeting of the Health Ministers. Called the National Bioethics Consultative Committee, (NBCC) its aim is to bring a more coordinated, national approach to significant bioethical questions. The Committee will provide advice and undertake studies on matters requested by the AHMC on ethical, legal and social. issues in the biomedical area. Requests for advice and research may also be made by the Standing Committee of Attorneys General and the Council of Social Welfare Ministers through the AHMC. The composition of the committee seeks to obtain a balance of expertise, community views, gender, age and geographical region. The 13 members were appointed in March 1988 and represent the following areas:


    Biomedical research

    Community representation

    Economics

    Health care provision (other than medicine)

    Law

    Medicine

    Moral theology

    Philosophy/ethics

    Social science

    Women’s health


V. RECENT INTERNATIONAL DEVELOPMENTS

2.19 Responses to IVF on an international level were outlined in detail in the IVF discussion paper.29 Since the release of that document, two further developments have occurred which should be noted here.

A. United Kingdom

2.20 In July 1984 the report of the Committee of Inquiry into Human Fertilization and Embryology (the Warnock Committee), outlined a number of recommendations bearing on IVF. At the time of writing, only one of the recommendations had been implemented in the Surrogacy Arrangements Act 1985. This Act deals exclusively with surrogacy, banning the use of intermediaries. it does not extend to IVF.

2.21 In November 1987 the Department of Health and Social Security issued a White Paper30 intended to clear the way for eventual implementation of the Warnock Report. The Paper covers statutory IVF licensing, embryo research, surrogacy, counselling, and registration. It is envisaged that after it is debated in both Houses a draft bill will be tabled in Parliament in the 1988-89 session.

B. The Council of Europe

2.22 The Council of Europe began work in 1984 to prepare a model code for the regulation of human artificial reproduction. Since 1984, regular meetings have been held of the Council’s Committee of Experts in Medical Research on Human Beings (CAHBI), at which each of the Council’s 21 member nations is represented, together with delegations from invited observer nations and international bodies. In April 1987 draft principles were completed by CAHBI. If approved by all members, these draft principles will be recommended by the Council to their member governments for adoption either by legislation or otherwise.


FOOTNOTES

1. Twelve of the world’s first 16 IVF babies were born in Australia; D Overdiun and J Fleming, Life in a Test Tube (1982) at 63.

2. See Attorney General for the State of Queensland (Ex rel Kerr v T (1983) 57 ALJR 285 at 286: “As at present advise....a foetus has no right of its own until it is born and has a separate existence from its mother”; and see In re F (in utero) [1988] 2 WLR 1288; see also Paton v British Pregnancy Advisory Service [1979] QB 276.

3. Ibid.

4. At paras 3.12-3.15, see also Reasons for Recommendations, Chapter 5 paras 5.38 to S.40.

5. NSW Law Reform Commission, In Vitro Fertilization (DP 15, 1987) at para 3.1-3.14.

6. Id at para 3.S-3.6; also S Mason “Abnormal Conception” (1982) 56 Australian Law Journal 347 at 348-349.

7. Section 10.

8. Artificial Conception Act 1984 (NSW),s5.

9. Status of Children Act 1984 (Vic); Family Relations (Amendment) Act 1984 (SA); Status of Children (Amendment) Act 1984 (Tas); Artificial Concention Act 1984 (WA); Artificial Conception Ordinance 1985 (ACT); Status of Children Amendment Act 1985 (NT); Family Law Amendment Act 1983 (Cth); Marriage Amendment Act 1985 (Cth).

10. At the time of writing, legislation covering both maternity and paternity was before the Queensland Parliament.

11. NSW Law Reform Commission, In Vitro Fertilization (DP 15 1987) at para 5.11-5.12.

12. Victorian Government Gazette (4.S.88) at 1123.

13. Section 9A.

14. Victorian Government Gazette (4.5.88) at 1123.

15. Select Committee of the Legislative Council on Artificial Insemination by Donor, In Vitro Fertilization and Embryo Transfer Procedures and Related Matters in South Australia, Report (April 1987).

16. Section 5(l).

17. Section 10.

18. Section S(3).

19. Sections 10(3) and 10(4).

20. Sections 13 (Practice Licences) and section 14 (Research Licences).

21. Section 13(3)(b) and 13(3)(d).

22. Section 14(2)(b).

23. Section 18.

24. Ibid. The penalty for unauthorised disclosure of information is $5000 or imprisonment for six months.

25. National Health and Medical Research Council, Ethics in Medical Research (1983), Supplementary Note 4 at 26; Fertility Society of Australia “Programme standards for in vitro fertilisation units in Australia” (1985) 3(4) Artificial Reproduction and Fertility 349; New South Wales Department of Health Policy Statement: In Vitro Fertilisation (December 1985).

26. At 3.12.

27. Section 27.

28. Medical Practitioners Act 1938, s27.

29. Paragraphs 5.19-5.11; 5.13-15.

30. Human Fertilization and Embryology: A Framework for Legislation, Cm 259.



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