Scrutiny of Acts and Regulations Committee

Alert Digest No 4 of 2007

Tuesday, 17 April 2007

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See also:

Minutes of Evidence, 4 April 2007

Dr Nicholas Tonti-Filippini
[RTF] [PDF]

Professor Loane Skene, University of Melbourne and
Deputy Chair of the Lockhart Review Committee (Commonwealth)
[RTF] [PDF]

Dr Jock Findlay, Member of the National Health and Medical Research Council and
Chair of the Victorian Infertility Treatment Authority
[RTF] [PDF]

Submissions

Dr Nicholas Tonti-Filippini
[RTF] [PDF]

Feminist International Network of Resistance to Reproductive and Genetic Engineering
[RTF] [PDF]

Women’s Forum Australia
[RTF] [PDF]

Hands Off Our Ovaries
[PDF]

Minister's Response

Alert Digest No 9 of 2007 - 17 July 2007


Infertility Treatment Amendment Bill 2007

Introduced: 13 March 2007
Second Reading Speech: 14 March 2007
House: Legislative Assembly
Minister introducing Bill: Hon. Bronwyn Pike MLA
Portfolio responsibility: Minister for Health

Purpose

This Bill amends the Infertility Treatment Act 1995 (the ‘Act’) in a manner consistent with amendments made to the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002 of the Commonwealth (the Commonwealth Acts) by the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 (the Commonwealth Amendment Act). The amendments are based on the 2005 recommendations of the Legislative Review Committee (also known as the Lockhart Committee).

The Committee notes this extract from the Second Reading Speech –

The Bill enables certain types of research involving embryos to be permitted provided that the research is approved by the NHMRC licensing committee (in accordance with legislated criteria) and that the activity is undertaken in accordance with a licence issued by the NHMRC licensing committee.

In no circumstances can any embryo be developed, outside the body of a woman, beyond 14 days.

Additionally, women who donate eggs through an assisted reproductive technology program must, under the Infertility Treatment Act 1995, be provided with mandatory counselling by an approved counsellor (section 16). The topics to be covered in counselling are specified in the Infertility Treatment Regulations 1997 (section 7). These legislative provisions enable women access to independent advice, support and information prior to donation.

Committee Hearings

The Committee held private hearings at a Committee meeting on 4 April 2007. The Committee received evidence from –

  • Dr Nicholas Tonti-Filippini – Ethicist, Consultant.

  • Professor Loane Skene – University of Melbourne – Deputy Chair of the Lockhart Review Committee (Commonwealth).

  • Dr Jock Findlay, Member of the National Health and Medical Research Council and Chair of the Victorian Infertility Treatment Authority.

A transcript of the evidence provided by these witnesses to the Committee is available in hard copy at the Parliamentary library and will also be available on the Committee’s Website.

Submissions

The Committee received written submissions from the following persons and organisations –

  • Dr Nicholas Tonti-Filippini – Ethicist, Consultant;

  • Feminist International Network of Resistance to Reproductive and Genetic Engineering;

  • Women’s Forum Australia;

  • Hands Off Our Ovaries.

The Committee resolved to release the above submissions and copies may be obtained from the Committee office.

Content and Committee comment

In summary, the proposed amendments to Parts 2A and 4A of the Principal Act—

  • retain existing prohibitions on activities such as the following—

    • placing a human embryo clone in the human body or the body of an animal;

    • importing or exporting a human embryo clone;

    • creating a human embryo by fertilisation of a human egg by human sperm, for a purpose other than achieving pregnancy in a woman;

    • creating or developing a human embryo by fertilisation of human egg by human sperm which contains genetic material provided by more than 2 persons;

    • developing a human embryo outside the body of a woman for more than 14 days;

    • making heritable alterations to a human genome;

    • collecting a viable human embryo from the body of a woman;

    • creating or developing a chimeric embryo;

    • developing a hybrid embryo beyond 14 days;

    • placing a human embryo in an animal, a human embryo into the body of a human other than into the female reproductive tract or an animal embryo in a human;

    • importing, exporting or placing in the body of a woman, a prohibited embryo.

  • enable certain types of research involving embryos to be permitted provided that the research is approved by the NHMRC Licensing Committee (in accordance with legislated criteria) and that the activity is undertaken in accordance with a licence issued by the NHMRC Licensing Committee. In summary, a person may apply for a licence to do the following—

    • use excess ART embryos;

    • create human embryos other than by fertilisation of a human egg by a human sperm, and use such embryos;

    • create human embryos (by a process other than fertilisation of human egg by human sperm) containing genetic material provided by more than 2 persons, and use such embryos;

    • create human embryos using precursor cells from a human embryo or a human foetus, and use such embryos;

    • undertake research and training involving the fertilisation of a human egg, up to but not including the first mitotic division, outside the body of a woman for the purposes of research or training;

    • create hybrid embryos by the fertilisation of an animal egg by human sperm, and develop such embryos up to, but not including, the first mitotic division provided that the creation or use is for the purposes of testing sperm quality and will occur in an accredited ART centre.

  • unless a shorter time is specified, the uses of embryos that may be authorised by a licence may only be authorised for development up to 14 days (excluding any period during which development is suspended). In no circumstances can any embryo be developed, outside the body of a woman, beyond 14 days.

[2]. The provisions in the Bill come into force on 12 June 2007.

[7]. Inserts in Part 2A of the Act two new offences related to licensing. New sections 21CA and 21CB are offence provisions involving use of embryos without a licence issued by the NHMRC Licensing Committee.

[10]. Substitutes a new section 21H of the Act to enable certain activities to be undertaken provided a licence has been granted by the NHMRC Licensing Committee. The purpose of the new section 21H(1) is to set out all of the activities for which a person may request a licence from the NHMRC Licensing Committee. If the activity does not fall within this list, it is not able to be licensed by the NHMRC Licensing Committee (this means that it is either

[26]. Repeals section 38E of the Act, which made it an offence to create a human embryo other than by fertilisation, or develop such an embryo. This will now be allowed under licence.

[38]. Provides for practices that are prohibited unless authorised by a licence.

[40]. Inserts transitional provisions to clarify that the amendments in the Bill in no way impact or invalidate any existing licences that may have been issued by the NHMRC Licensing Committee under section 21I.

Further, if a person applied for a licence under subsection 21H before these amendments take effect and the licence application has not been decided by the NHMRC Licensing Committee then the person is taken, on and from the commencement of the amendments made by the Bill, to have applied for the licence under section 21H, as amended by the Bill.

[41]. Provides for the automatic repeal of this amending Act one year after all of its provisions have come into operation.

The Committee provides this report to Parliament pursuant to terms of reference provided in section 30 of the ‘Charter’ and section 17(a)(viii) of the Parliamentary Committees Act 2003 concerning incompatibility with human rights

1. Section 9 of the Charter (right to life)

Keywords: Right to life – Person defined as a human being – Charter excludes laws concerning abortion and child destruction – Whether embryo or foetus a ‘human being’ (person) for the purposes of the Charter

The Committee notes that the most fundamental of all human rights is that ‘every person has the right to life and has the right not to be arbitrarily deprived of life’ and that this right is recognised in International law as absolute.

The Committee observes that all human rights in the Charter are subject to the reasonable limitations provision in section 7 of the Charter (reasonable limitations that may be demonstrably justified in a democratic society). The Committee observes that given this absolute right recognised in International law any limitation would have to be exceptional and manifestly demonstrable.

The Committee notes that section 6 of the Charter provides that all persons have the human rights set out in Part 2 of the Charter. ‘Person’ is defined by section 3 of the Charter as meaning a ‘human being’. The Charter provides no guidance or definition of ‘human being’.

The Committee observes that the right to life in section 9 of the Charter is qualified by section 48 of the Charter which excludes from the Charter’s ambit, laws in respect to ‘abortion’ and ‘child destruction’. However, section 9 is otherwise unqualified and provides no guidance whether ‘a human being’ includes an embryo or foetus. The Committee observes that the common law legal position in Victoria is that a human being is not a legal person until he or she is born. The Committee further observes that the Human Rights Act 2004 of the Australian Capital Territory qualifies the right to life as a right ‘applying to a person from the time of birth’.*

The Committee considered the difficult question of providing a definition of ‘human being’ for the purposes of the Charter right and concluded that as this area of law involved fundamental questions of ethics and personal conscience the Committee would instead, refer for Parliament’s consideration the question of whether any of the provisions of the Infertility Treatment Amendment Bill 2007 tests or infringes the ‘right to life’ within the meaning of the Charter.

*Human Rights Act 2004 (ACT), section 9(2).

2. Section 10(c) of the Charter (person must not be subjected to experimentation without full, free and informed consent)

Keywords: Medical and scientific research – embryo donation – non-therapeutic volunteer donors – medical risks – whether consent to experimentation full, free and informed.

The proposed legislation would allow the development of stem cell lines by somatic cell nuclear transfer (‘SCNT’). To successfully pursue this research demands a sufficient supply of human eggs (‘oocytes’). Ensuring women have full, free and informed consent in these circumstances presented the Committee with some challenging issues.

Egg donations are not like blood donations because the process involves significant discomfort, hardship and risks. Nor are donations like bone marrow or live organ donations in which there are substantial risks but the donations are clearly for therapeutic purposes rather than scientific research.

An egg donor for stem cell research is subject to the same treatment as an egg donor for IVF treatment. However the reason for the donation is quite different, since SCNT is to advance medical knowledge rather than reproduction. Egg donation after induced ovulation presents certain risks to the donor and the aim is non-therapeutic scientific research.

The Committee received a number of submissions and conducted a hearing. The Committee was presented with two conflicting arguments. Submissions argued that women should be free to make altruistic decisions to further science. Other submissions argued that science and women’s welfare in egg donation are conflicting to the point that they are incompatible with the women’s human rights. Some submissions referred to the World Medical Assembly’s Helsinki Declaration. The Declaration of Helsinki is a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Relevantly the Declaration provides –

16. Every medical research project involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the subject or to others. This does not preclude the participation of healthy volunteers in medical research. The design of all studies should be publicly available.

17. Physicians should abstain from engaging in research projects involving human subjects unless they are confident that the risks involved have been adequately assessed and can be satisfactorily managed. Physicians should cease any investigation if the risks are found to outweigh the potential benefits or if there is conclusive proof of positive and beneficial results.

18. Medical research involving human subjects should only be conducted if the importance of the objective outweighs the inherent risks and burdens to the subject. This is especially important when the human subjects are healthy volunteers.

19. Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research.

20. The subjects must be volunteers and informed participants in the research project.

The Helsinki declaration suggests that the researcher in medical research has to go beyond full, free and informed consent with the added obligation to do no harm.

In the hearings it was pointed out that that concerns of risks, informed consent and scientific research occur in other areas of medical research. In this research the obligations of medical researchers remains to reduce risk, secure informed consent and to protect the life and health of the person on whom biomedical research is being carried out.

It was suggested to the Committee that this puts healthy egg donors into the same category as other healthy subjects who are subject to experimental drugs and procedures under ethical board sanctioned medical research.

It is the Committee’s belief that to ensure full, free and informed consent demands there are certain obligations on researchers. Researchers need to minimise risks. The donors must be sufficiently and independently informed of all known and potential risks. Donors must be aware of the discomfort of the procedure and they are only able to donate for altruistic reasons.

In the case of IVF patients who may be asked to donate eggs that have failed to fertilise or to share some fresh eggs, there must be a strict separation between the patient’s treatment team and the researchers requesting the eggs, otherwise they might feel pressured to donate. Similarly relatives and co-workers of those doing research on eggs would be in a relationship of dependence with the researchers and therefore should not be allowed to provide eggs for research. Real care needs to be taken to ensure there are no financial or other inducements, and that vulnerable and dependent groups are not recruited.

The Committee considered that there are human rights concerns regarding issues of consent and relationships of dependency. In time these concerns may be addressed by the ‘Ethical guidelines on the use of assisted reproductive technology in clinical practice and research’, however the Committee notes that these guidelines have not been finalised in time for Members consideration of this Bill.

The Committee resolved to write to the Health Minister outlining these concerns and seeking further information concerning the following matters –

  1. The independence from research entities of counselling services (medical and other counselling) provided to potential donors;

  2. The extent and nature of medical and other advice given to potential donors and whether such advice covers general and donor specific health risks that may arise from, or as a consequence of the medical procedures involved in embryo donation;

  3. Whether there will be provided post donation medical and other counselling and monitoring of the physical and mental health of donors;

  4. Whether donors will be entitled to free additional health insurance covering the general and specific risks arising out of or as a consequence of embryo donation;

  5. The practices and procedures to be established minimising the possible exploitation of women in vulnerable groups and the special care that may be needed to ensure ‘informed consent’ is realistic; and

  6. The extent of any prohibitions or regulation in respect to undue inducements to potential donors (other than reimbursement of reasonable direct costs and health insurance).

Pending the Minister’s advice the Committee draws attention to these matters.

3. Statement of Compatibility

Keywords: Provisions of Bill fairly raise question of Charter right under section 10(c) concerning ‘full, free and informed consent’ – Sufficiency of Statement of Compatibility – Need for section 7(2) consideration – Parliamentary scrutiny of exercise of legislative power.

The Committee notes the Statement of Compatibility (‘Statement’) provided by the Minister introducing the Bill states that no human rights issue is raised by the Bill.

However, the Committee does considers that the Bill fairly raises a Charter implication under section 10(c).

Section 10(c) of the Charter provides that –

‘A person must not be subjected to medical or scientific experimentation or treatment without his or her full, free and informed consent’.

The Committee considers that material such as explanatory memoranda and statements of compatibility assist the Parliament in its deliberations and in particular assist the Committee in its scrutiny functions under the Charter and the Parliamentary Committees Act 2003. The Committee draws attention to Practice Note No. 1 of 2005 where it endorsed the following observation made by the Australian Senate’s Standing Committee on the Scrutiny of Bills –

‘The committee relies on the explanatory memorandum to explain the purpose and effect of the associated bill and the operation of its individual provisions. In particular, the committee expects that an explanation will be given for any provision within a bill that appears to test or infringe the committee’s terms of reference and provide reasons or justification for this.’

**Senate Standing Committee for the Scrutiny of Bills – The Quality of Explanatory Memoranda Accompanying Bills, 24 March 2004

The Committee considers that where there is a reasonable prospect that a provision in a Bill may test or infringe Charter compatibility that issue should be drawn to the attention of the Parliament and a reasoned, even if brief, analysis of why the provision is nevertheless considered compatible with the Charter should be outlined.

The Committee observes that in some earlier Statements accompanying Bills there has been a brief reasoning why provisions that appear to test a Charter right are considered nevertheless to be compatible because of other competing public policy objectives.

In respect to this Bill the Committee considers that the Parliament would have been better informed with at least a brief discussion concerning the pivotal question of when human rights may be limited within the meaning of section 7(2) of the Charter.

In approaching the Committee’s new reporting function in respect to provisions that may test or infringe a Charter right the Committee will consider a statement of compatibility as having the same status as an explanatory memorandum and where the Committee considers a Statement to be inadequate the Committee will draw this to the attention of Members.

The Committee will write to the Minister expressing its concerns in respect to this Statement of Compatibility.

The Committee makes no further comment.


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Scrutiny of Acts and Regulations Committee
Parliament of Victoria