The report was produced for the national parliament and the Council of Australian Governments (COAG) by a Review Committee chaired by former Federal Court judge Peter Heerey QC.
It considered the Prohibition of Human Cloning for Reproduction Act 2002 (Cth) - initially the Prohibition of Human Cloning for Reproduction Act - and the Research Involving Human Embryos Act 2002 (Cth).
The Committee considers that the basic structure of the legislation should remain but offers 33 recommendations about the framework for human embryo research. Those recommendations centre on updating and clarifying the legislation, which bans human cloning "and other unacceptable practices" and imposes a strict regulatory regime, (including requirements for the consent of donors) on 'excess embryos' from assisted reproductive technology (ART) procedures. The legislation followed the 2001 Human Cloning: Scientific, Ethical and Regulatory Aspects of Human Cloning and Stem Cell Research report by the House of Representatives Standing Committee on Legal and Constitutional Affairs.
The terms of reference for the Review were to report on the scope and operation of the Acts, with recommendations regarding that take into account -
a) developments in assisted reproductive technology, including technological, medical and scientific developments, and the actual or potential clinical and therapeutic applications of such research;The report features 33 recommendations -
b) developments in embryonic stem cell research, including technological, medical and scientific developments, and the actual or potential clinical and therapeutic applications of such research;
c) community standards;
d) a brief analysis of international developments and legislation relating to the use of human embryos and related research;
e) an analysis of research resulting from the licenses granted;
f) any National Stem Cell Centre and any national register of donated excess ART embryos;
g) an evaluation of the effectiveness of legislative provisions and NHMRC guidelines relating to proper consent;
h) an evaluation of the range of matters for which the NHMRC Licensing Committee may issue a licence and any recommendations to increase, decrease or alter these arising from the evaluation;
i) an analysis of any research or clinical practice which has been prevented as a result of legislative restrictions;
j) the extent to which the NHMRC Licensing Committee has effectively used information and education tools to assist researchers working in the field, and any ongoing need for legally binding rulings;
k) the extent of Commonwealth/State cooperation in the area of human embryo research and the requirement for further Commonwealth or State legislation on the matter.
R1: Cloning of a human being for reproduction should remain a criminal offence. The other criminal offences in the Prohibition of Human Cloning for Reproduction Act 2002 should also remain.
R2: Research involving embryos and ES cells should continue to be permitted subject to the statutory controls in the present legislation.
R3: Provisions in the current legislation regarding SCNT should not be amended. However, in reaching this recommendation, the Review Committee notes the lack of progress in SCNT research in animals and humans. The Committee believes that this must impact on the Licensing Committee’s interpretation of its statutory obligation, when it is considering any future application for a licence to undertake research involving SCNT, to take into account ‘the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs, or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means’ when it is considering any future application for a licence to undertake research involving SCNT.
R4: Provisions in the current legislation regarding the cooling-off period related to the use of excess ART embryos for research should not be amended.
R5: There should be no change to the legislation that would permit research on embryos later than the point where the egg divides into two cells (the first mitotic division).
R6: There should be no change to s 21 of the Prohibition of Human Cloning for Reproduction Act 2002 in relation to the payment of ‘reasonable expenses’.
R7: There should be no change to the current legislation in relation to the use of DNA from more than two persons.
R8: The current framework for research involving human embryos which involves ethical assessment by a Human Research Ethics Committee and assessment of applications for licenses by the Licensing Committee should continue.
R9: In consultation with the Licensing Committee and other relevant stakeholders, the AHEC and NHMRC should establish a system of credentialing for HRECs that consider research involving embryos.
R10: s20(1)(d) of the Research Involving Human Embryos Act 2002 should remain unchanged, permitting under licence the creation and use for research purposes of human embryos using precursor cells from a human embryo or a human fetus.
R11: s 20(1) of the Research Involving Human Embryos Act 2002 should be amended to include that a person may apply to the NHMRC Licensing Committee for a licence authorising the creation and use of human embryos by fertilisation of a human egg by a human IVD sperm, fertilisation of a human IVD egg by human sperm, and fertilisation of a human IVD egg with human IVD sperm, in each case provided that the sperm and egg are not derived from the same person.
R12: The legislation should be amended to include a definition of IVD gametes. Such a definition could be ‘human sperm or eggs derived from precursor cells or by in vitro means’.
R13: s 20(4) of the Prohibition of Human Cloning for Reproduction Act 2002 should be amended to include embryos created with the use of IVD sperm or eggs in the definition of ‘prohibited embryo’. Such a definition could include ‘hybrid embryos within the meaning of s 8 of this Act’.
R14: The Prohibition of Human Cloning for Reproduction Act 2002 should be amended to extend the definition of ‘hybrid embryos’ to include an embryo created by the use of IVD gametes. Such a definition could be ‘In the foregoing human egg or human sperm includes IVD gametes’.
R15: s 21 of the Prohibition of Human Cloning for Reproduction Act 2002 should be amended to include IVD gametes.
R16: There should be no specific definition of human sperm and egg.
R17: The Prohibition of Human Cloning for Reproduction Act 2002 should be amended to include a definition of fertilisation.
R18: s 8 of the Research Involving Human Embryos Act 2002 should be amended to clarify who is required to give consent in relation to donation of fetal tissues and who is required to give consent in relation to donation of failed-to-fertilise or abnormally fertilised eggs.
R19: s 24(5) of the Research Involving Human Embryos Act 2002 should be amended to provide that a condition of a licence may include a limitation on the number of embryos or eggs for which consent is to be obtained prior to research use.
R20: When the current NHMRC Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research undergo review, consideration should be given to including guidance that excess embryos donated for research should be kept in storage for a maximum of five years, after which their custodians should arrange for the respectful disposal of these embryos. Consideration should also be given to guidance that respectful disposal of these embryos should occur if it becomes clear even within that five year period that these embryos are most unlikely to be used in research.
R21: The term ‘significant advance’ in s 21(4) of the Research Involving Human Embryos Act 2002 should not be the subject of legislative definition.
R22: s 21(2) of the Research Involving Human Embryos Act 2002 should be amended to provide that the Licensing Committee may require that an application be withdrawn if the Licensing Committee does not have sufficient information to allow it to make a decision to issue or not issue a licence.
R23: s 26 of the Research Involving Human Embryos Act 2002 should be amended to provide that the Licensing Committee may, by notice in writing to the licence holder, suspend or revoke a licence if it considers that the endpoints of the licensed activity have been achieved or that the licensed activity no longer would be expected to lead to a significant advance.
R24: s 26 of the Research Involving Human Embryos Act 2002 should be amended to provide that the Licensing Committee may, by notice in writing to the licence holder, suspend or revoke a licence if the Licensing Committee believes on reasonable grounds it is necessary or desirable to do so.
R25: s 27 of the Research Involving Human Embryos Act 2002 should be amended to provide that a licence may only be surrendered with the prior consent of the Licensing Committee.
R26: s 21(3)(c) of the Research Involving Human Embryos Act 2002 should be amended to provide that a HREC should have regard, amongst other things, to the matters which the Licensing Committee itself must have regard under s 21(3) and s 21 (4).
R27: There should be no change to the categories of membership of the Licensing Committee.
R28: Note (b) to s 23B(3) of the Prohibition of Human Cloning for Reproduction Act 2002 should be amended to reflect s 20(1)(f) of the Research Involving Human Embryos Act 2002.
R29: ss 26(2) and 41 of the Research Involving Human Embryos Act 2002 should be amended to refer to the Prohibition of Human Cloning for Reproduction Act 2002.
R30: The Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002 should be amended to make reference to the Ethical guidelines on the use of assisted reproductive technology in clinical practice and research and the National statement on ethical conduct in human research as in force from time to time.
R31: The Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002 should be amended to make reference to a National Stem Cell Bank instead of a National Stem Cell Centre.
R32: s 1 of the Research Involving Human Embryos Act 2002 should be updated to list specified prescribed bodies such asthe Australian Academy of Science, CHOICE, Law Council of Australia, Australasian Association of Bioethics and Health Law, Fertility Society of Australia and Society for Reproductive Biology
R33: The Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002 should be amended to provide for a review of these Acts be undertaken at five year intervals.
