I. INTRODUCTION
4.1 one of the, Commission’s chief concerns in this inquiry, has been an awareness of the need to respond to and reflect the concerns f elt in the community about IVF and associated issues. This has resulted in the legislative framework for regulation and control which is described below and in the Recommendations for Reform in Chapter 5. The Commission recognizes that many in the community see a pressing need for immediate action. It has become obvious to the Commission, however, that there are major problems in applying legal norms and solutions to IVF. One of the major difficulties lies in accommodating what is often revolutionary scientific development within the normally static system of law which we have in Australia. Constant changes and discoveries, as well as the learning of new techniques, combine to make any strict legislative scheme almost immediately obsolete.
4.2 The Commission has come to the conclusion that it should not attempt to settle all the issues raised by practice and research in IVF at present. We can propose a framework for decision making and establish the principles against which future developments can be assessed, but many matters are better left for decision in the future when their context is better defined. Thus, we have not recommended prohibition of either the practice of IVF or research into it, but we have recommended that before any new projects are embarked upon they should be fully assessed and their worth evaluated by an independent group of people representing all the major areas of interest in the technology, including members of the general community. We believe that this group can develop the expertise necessary to protect society’s interests better than we can now by proposing the passage of detailed legislation.
4.3 Some matters we have not left for determination by the representative group, however. These are the issues which we regard of such fundamental importance that they should be included in the initial legislation. Amongst them are our recommendations that only medical practitioners should be permitted to practise IVF and that any licence issued should contain a description of the type of practice it permits. These matters are discussed in 5.13.
4.4 All the major reports on the topic of IVF have recognized that it is an area where there are no correct answers.1 The public has not made up its mind on the new technology and the scientists have not completed their work. The Warnock Committee was well aware of these problems, and recommended the creation of a licensing authority with a wide membership and a major advisory function. Other European states have taken a similar approach.2 Within Australia, the reports of the Senate Select Committee, the Family Law Council and the Waller Committee all call for the establishment of similar bodies.
II. THE REGULATORY SCHEME
A. Establishment of the New South Wales Biomedical Council
4.5 The Commission considers that part of its role is to provide guidance for the future development of IVF. it therefore recommends that Parliament establish a permanent body to oversee the development of IVF and to monitor community opinion. This body should be called the Biomedical Council. As it is important for such an organization to represent all interests in the community, we have recommended a multi-disciplinary membership, with representatives from the general community as well. Also important is our recommendation that a substantial number of women sit on the Council. Because of the fundamental impact IVF practice and technology may have on their lives, the Commission believes that women should make up half of the Council’s membership.
B. Functions of Council
1. To Advise the Minister
4.6 The new Council’s first task should be to inform itself thoroughly so as to be able to advise the Minister for Health on all matters related to reproductive technology and biomedicine. The Council should also have a duty to report to Parliament annually through the Minister for Health. These reports should provide up to date information on IVF practice and research in the State as well as advising Parliament of likely developments in the future. In this way both the Minister and Parliament will receive the information necessary to form the basis of future regulation.
2. To Formulate Guidelines for Practice and Research and to Liaise with Other Advisory Bodies
4.7 The next task of the Council should be to formulate guidelines for practice and research in IVF. Compliance with these guidelines should be made a condition of the issue of a licence. As part of this function the Council would liaise with and help coordinate the work of other State and federal organizations performing similar functions in Australia. The Council would be obliged to keep the guidelines under constant review and to review them thoroughly at least once every three years.
C. New South Wales Biomedical Council and the Licensing System
4.8 The New South Wales Biomedical Council should become the central feature in a general licensing system, the structure of which is illustrated in the chart which appears in Appendix D. All institutions and individuals engaging in IVF practice and research should be licensed. We recommend that some of the conditions of the licences should be contained in legislation at the outset, but others may be formulated by the Biomedical Council and added to the legislation in the future. The matters to be contained in legislation at the outset appear in Chapter 5 as Recommendation 6. The Council would also develop guidelines into a Copies of Ethical Practice, compliance with which will be one of the statutorily imposed conditions of each licence.
4.9 The licences should be divided into two categories. There would be licences to practise IVF and licences to conduct research. The practice licences should be issued by the Department of Health. The Health Department would also have power to revoke and review the practice licences. The research licences should be granted by the Council itself. All institutions and individuals wishing to engage in IVF research should be required to obtain a licence. The conditions of the research licences would also be enforced by the Council. Breach of a condition of either a practice or a research licence could lead to revocation of the licence, and the revocation procedure should be backed by criminal sanctions imposed for practising without a licence.
D. Strict Controls on Research
4.10 Although licensed, a research institution or individual should still be required to seek the approval of an institutional ethics committee before beginning any research. This is standard practice in most institutions already.3 In addition, however, the researcher and institution should be required to obtain approval from the New South Wales Biomedical Council for every research project. In this way the Commission envisages that the Council will be able to maintain strict controls over all research in New South Wales. As compliance with the Code of Ethical Practice is to be one of the conditions of the licence, breach of the Code would allow revocation of the licence by the Council. Subsequently engaging in research work without a licence would be an offence. It is important to stress that all institutions and individuals considering IVF practice or research would be required to have a licence. Each IVF clinic should be responsible for ensuring compliance with the conditions of its licence by all doctors and scientists in its employment. Revocation of an individual’s licence could therefore lead to revocation of the licence of an institution.
III. NEW SOUTH WALES BIOMEDICAL COUNCIL
A. The Three Functions of the Council
4.11 The New South Wales Biomedical Council is central to our recommendations for reform, and the Commission envisages its duties as covering three major areas:
1. An advisory role: Advising the Minister for Health on issues arising in reproductive technology and biomedicine and promoting research and informed debate on these topics.
2. A legislative or policy role: Developing the licensing system from the compulsory conditions provided by legislation and by formulating the terms of the Code of Ethical Practice. There will need to be constant review of the statutory conditions and the Code by the Biomedical Council as circumstances and community attitudes change.
3. A regulatory role: Issuing research licences and policing them to ensure compliance. This would include giving approval for each research project undertaken by a licensed research institution or individual.
B. Membership
4.12 The Council should be a small organization, with no more than 11 members and a small support staff attached to the Department for Health. The Commission recommends that members of the Council should be drawn from a wide variety of disciplines and other areas of interest, and that there should be, as far as is practicable, equal representation of men and women. Appointments to the Council should be made, from the statutory list of disciplines and areas of interest, by the Governor. The Governor should also nominate the person who is to chair the proceedings of the Council. It is the Commission’s view that the public importance of the Council and the representative nature of its membership require that the appointments be made by the Governor. While the Commission recommends that one member of the Council should represent the Department of Health, we do not think that this person should be eligible for appointment as chairperson.
IV. PRACTICE LICENCES
4.13 All clinics offering IVF procedures would be required to obtain a licence from he Department of Health. In recommending the issue of licences in this manner, the Commission believes the system of regulation should be able to take advantage of existing resources and thus keep the administrative functions of the New South Wales Biomedical Council to a minimum.
4.14 As already outlined all practice licences would contain a number of conditions imposed by the legislation. These would not be subject to alteration, except by Parliament. To supplement these compulsory conditions the Council should be given power to formulate extra conditions and to advise the Minister for Health on their inclusion in the legislation. In its recommendations the Commission has deliberately kept the number of statutory conditions to a minimum, to ensure flexibility, allowing the Council to develop further conditions as the technology and understanding of its implications, develop. Breach of any licence condition should be a ground for revocation of the practice licence. Failure to operate with a licence would be an offence under the legislation.
4.15 The compulsory licence conditions should include a requirement that all IVF clinics and researchers comply with a Code of Ethical Practice. The Commission envisages that this Code would contain the governing principles for all aspects of IVF practice. Their formulation and review should be one of the major tasks of the Council. Our recommendations list several matters to be included in the Code by statute (see recommendation 6). For example, the prohibition placed on the development of an embryo beyond the time at which implantation would normally occur would become part of the Code. As compliance with the Code is a condition of a licence, any breach of the Code would be a ground for its revocation.
V. RESEARCH LICENCES
4.16 The structure of the system of research licences would be much the same as that for practice licences. All institutions and individuals who wish to engage in research would be required to obtain a licence, and all would be required to conform to the general Code of Ethical Practice, which would cover research programs as well as practice. The main difference between the two schemes lies in the fact that the research licences would be the direct responsibility of the Council. They would be issued directly by the New South Wales Biomedical Council, rather than by the Department of Health. In addition, all licensed institutions would be required to obtain the approval of the Council for each research project they proposed to conduct. This approval would be required in addition to the current obligation to obtain approval from an institutional ethics committee. Breach of a condition, or a term of the Code of Ethical Practice would provide a ground for revocation of the licence by the Council and responsibility for ensuring compliance by individual licensees would be imposed on the licensed institution.
FOOTNOTES
1. Family Law Council, Creating Children: A uniform approach to the law and practice of reproduction technology in Australia. (AGPS, Canberra, 1985) at 88, para 6.8.22; Ontario Law Reform Commission, Report on Human Artificial Reproduction and Related Matters (Vol II, 1985) at 209; Department of Health and Social Security, Report of the Committee of Inquiry into Human Fertilization and Embryology (Warnock Report) (HMSO Cmnd 9314, London, 1984) at v; Committee to consider the Social, Ethical and Legal Issues Arising from In Vitro Fertilization (Waller Committee) Report on the Disposition of Embryos Produced by In Vitro Fertilization (Vic Govt Printer, August 1984) at para 3.2, and see also the minority view of Professor Priscilla Kincaid-Sniith and Professor Roger Pepperell at Appendix C, at p35, paragraph c2.5.
2. Denmark has established a 17 member ethics council which will be required to assess future and current directions in IVF; Biomedical and Ethical Issues in France are dealt with via the Comite Consultatif National d’Ethique, a consultative, body with no regulatory powers; In 1981 the Swedish Government formed a committee which continues to investigate issues of Artificial Conception.
3. National Health and Medical Research Council. Ethics in Medical Research at 11. (AGPS, Canberra, 1983).
