Patterson tables embryonic stem cell bill

Liberal backbencher Senator Kay Patterson last night tabled her promised private member's bill on embryonic stem cell research and therapeutic cloning.

The proposed amendments to current legislation outlawing therapeutic cloning closely follow the recommendations of the Lockhart Review.

"A strong regulatory framework will govern the use of stem cell research to benefit the Australian community and potentially assist in the treatment of serious diseases and medical disorders," Patterson said.

She said the amendments would maintain a strong and effective monitoring and licensing framework to prevent improper and unacceptable practices and continue a range of prohibitions including the ban on reproductive cloning.

"Implementing the recommendations of the Lockhart Review, which were made after diligent consideration of extremely sensitive issues, will give due respect to the hard work done by the members of the review and ensure that similar reviews in the future will be treated with an appropriate degree of respect," Patterson said.

"The science around this issue, and the debate over the findings of the Lockhart Review, are too important to indulge in personal attacks on the credibility of the committee or blur the issue with misleading information.

"It will be up to the Parliament to decide if these recommendations are accepted or rejected. Such decisions must be properly informed and so I sincerely hope all information provided to my colleagues will be factual.

"I encourage everyone to read the Lockhart Review, and the explanatory memorandum accompanying my bill which also gives reasons for the proposed changes to the existing Acts."

Text of explanatory memorandum

This bill amends the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002 consistent with the 2005 recommendations of the Legislative Review Committee (also known as the Lockhart Committee).

Background

In June 2005, the Minister for Ageing, the Hon. Julie Bishop MP (who then had portfolio responsibility for human cloning and stem cell research), appointed a six-member Legislative Review Committee to independently review the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002. This was in accordance with a requirement in both Acts that they be reviewed by an independent committee by December 2005.

The Legislative Review Committee was chaired by the late John S Lockhart AO QC, a former Justice of the Federal Court of Australia. The other members were Associate Professor Ian Kerridge (New South Wales) a clinical ethicist; Professor Barry Marshall (Western Australia), a specialist gastroenterologist and community advocate; Associate Professor Pamela McCombe (Queensland), a clinical neurologist; Professor Peter Schofield (New South Wales), a neuroscientist; and Professor Loane Skene (Victoria), a lawyer and ethicist. All appointments to the Legislation Review Committee were agreed by each State and Territory as required by the Acts themselves.

The Committee reported to the Minister in December 2005 noting that it had "consulted the community extensively through a review website, written submissions, face-to-face meetings with key stakeholders, public hearings and some private meetings (at stakeholders' requests), facilitated stakeholder discussion forums, and selected site visits. In addition, the Committee reviewed the latest results of focus group and telephone survey research by the Public Awareness Program of Biotechnology Australia, and a literature review (commissioned by the NHMRC on behalf of the Minister for Ageing) of recent scientific and technological advances in human cloning, human embryo research and related matters, including stem cell technologies." (page xxiii)

The Committee made 54 recommendations and outlined its rationale for the recommendations as follows: "Australian society is made up of diverse 'communities' with different perspectives, interests and values. Furthermore, an individual may be the member of multiple communities, each with divergent perspectives, or 'standards', and these standards vary between and within communities and over time. Because of these divergent values and interests represented within Australian society, the Committee has accepted that some disagreement will remain, whether or not any changes are made to the two Acts.

However, certain moral values are held in common by all communities, such as commitment to social justice and equity and to the care of vulnerable people. This is reflected in broad community support for medical research aimed at understanding, preventing or treating disease, and for research and clinical practice aimed at assisting people to have children (including a general acceptance that this process may involve the 'wastage' of some embryos). Therefore, in considering whether certain activities should be made illegal, the social and moral value that some communities attach to the human embryo needs to be balanced against the social and moral value that other communities attach to the treatment of disease and to helping people to have a family". (page xiii)

In framing its recommendations, "the Committee considered that the higher the potential benefits of an activity, the greater the need for ethical objections to be of a high level and widely accepted in order to prevent that activity. Conversely, where benefits are not yet established, or where there is widespread and deeply held community objection, then total prohibition through the legal system may be justified. In addition, even though some people think that an activity is unethical, it does not necessarily follow that the activity should be made illegal. Furthermore, the wider the range of ethical views on a particular activity, the weaker becomes the case for declaring that activity to be illegal, with all the attendant consequences of criminal conduct." (page xiv)

The Committee noted that "despite the divergent views received by the Committee during the reviews, both proponents and opponents of embryo research agreed that the current system of legislation is valuable. Therefore, the Committee recommended a continuation of national legislation imposing prohibitions on human reproductive cloning and some other ART practices, as well as strict control and monitoring, under licence, of human embryo research." (page xiv)

The amendments in this Bill are based on the recommendations of the Lockhart Review (Legislation Review: Prohibition of Human Cloning Act 2002 and Research Involving Human Embryos Act 2002, Reports, December 2005, Legislation Review Committee. (www.lockhartreview.com.au) The Lockhart recommendations, and how they have been addressed in this Bill, are detailed in Appendix I of this Explanatory Memorandum. Summary of proposed changes to the Acts

In summary, the proposed amendments to the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002:

• retain existing prohibitions on activities such as: • 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; and • 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: • 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 fetus, 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; and • create hybrid embryos by introducing the nucleus of a human cell into an animal egg, and use of such embryos.

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.

The full text of the explanatory memorandum is at: www.aph.gov.au/Senate/work/tabled_bills/2006/5023_em.htm

The full text of the bill is at: www.aph.gov.au/Senate/work/tabled_bills/2006/5023_bill.htm