Legislative Council Fifty-First Parliament, Third Session (51-3) 51 3 Parliament of South Australia Legislative Council published Bills Statutes Amendment (Prohibition of Human Cloning for Reproduction and Regulation of Research Involving Human Embryos) Bill STATUTES AMENDMENT (PROHIBITION OF HUMAN CLONING FOR REPRODUCTION AND REGULATION OF RESEARCH INVOLVING HUMAN EMBRYOS) BILL Second Reading Second Reading Second reading The Hon. G.E. GAGO Legislative Council Minister for State/Local Government Relations, Minister for the Status of Women, Minister for Consumer Affairs, Minister for Government Enterprises, Minister Assisting the Minister for Transport, Infrastructure and Energy The Hon. G.E. GAGO (Minister for State/Local Government Relations, Minister for the Status of Women, Minister for Consumer Affairs, Minister for Government Enterprises, Minister Assisting the Minister for Transport, Infrastructure and Energy) (16:53): I move: That this bill be now read a second time. I seek leave to have the second reading explanation inserted in Hansard without my reading it. Leave granted. Parliament is being asked to consider amendments to the South Australian Prohibition of Human Cloning Act 2003 and Research Involving Human Embryos Act 2003 to bring these Acts into line with the equivalent recently amended Commonwealth Acts. The amendments to both Acts are contained in a single Bill, the Statutes Amendment (Prohibition of Human Cloning for Reproduction and Regulation of Research Involving Human Embryos) Bill 2008, and it is proposed that they be considered in a cognate debate. Human cloning and embryo research legislation has been subject to a conscience vote in every jurisdiction, including in the South Australian Parliament, when the Bills for these Acts were first debated in 2003. This Bill raises important moral and ethical questions that require deep consideration, and I note that both major parties have accorded their members a conscience vote on the amendments to the South Australian laws. The national scheme and recent changes The Commonwealth Acts were passed in 2002, and the South Australian Parliament passed equivalent legislation in 2003. The original Commonwealth legislation prohibited the creation of embryos for research, allowed research using embryos donated to research by couples who had completed their infertility treatment, but restricted what could be done with such embryos; the current South Australian laws are consistent with this original model. The Commonwealth legislation, together with equivalent legislation in all States and Territories and the National Health and Medical Research Council Embryo Research Licensing Committee, creates a national legislative scheme for prohibiting human cloning and regulating embryo research. This national scheme regulates the use of human embryos that are excess to fertility treatment and hybrid embryos, but not animal embryos nor human embryonic stem cells. The Commonwealth amendments extended the national scheme to also regulate embryos created by means other than fertilisation and human eggs used for such processes. In South Australia, clinical reproductive medicine practice is separately regulated by the Reproductive Technology (Clinical Practices) Act 1988. The national scheme needs to be responsive to developments in technology and shifts in community attitudes and standards. For that reason, the Commonwealth Prohibition of Human Cloning Act and the Research Involving Human Embryos Act included requirements for a 3-year review. The Review, chaired by the late John Lockhart AO QC, was conducted in 2005 and held consultations around the country. South Australian experts, academics and community representatives contributed to the inquiry. On the basis of their consultations and background research, including into community attitudes to embryo research, the Lockhart Review made 54 wide ranging recommendations. The Review proposed changes to legislation to extend embryo research to allow the creation of embryos for research, but recommended that the prohibition on the creation of embryos by fertilisation for any purpose other than assisted reproductive medicine procedures be retained. They also recommended that certain research procedures be permitted on embryos created through laboratory techniques, but not on embryos created by the fertilisation of an egg by a sperm. Most of the recommendations aimed to streamline current processes for embryo research licensing and to strengthen oversight. The recommendations of the Lockhart Review were referred to the Australian Parliament and the Council of Australian Governments in December 2005. Some recommendations required changes to legislation while others related to national policies and procedures. A Private Member's Bill tabled by Senator the Hon Kay Patterson reflected almost all the Lockhart Review's recommendations for legislative changes and was passed by the Australian Parliament on 12 December 2006. The Commonwealth amendments were promulgated on 12 June 2007. Human reproductive cloning remains prohibited in Australia. The Commonwealth amendments retained limitations on research and training using embryos created by fertilisation, but now permit the creation of embryos for research by means other than fertilisation whilst prohibiting the implantation or development of any embryo created in a laboratory for more than 14 days. Corresponding Act status The Commonwealth legislation makes provision for the Minister for Health and Ageing to declare a State or Territory Act corresponding for the purposes of the national scheme. State and Territory laws rely on the NHMRC Licensing Committee established under the Commonwealth legislation to licence embryo research. Only a corresponding State law can effectively confer regulatory powers and functions on the NHMRC Embryo Licensing Committee. When the Commonwealth amendments came into force on 12 June 2007 the Parliamentary Secretary to the Minister for Health and Ageing advised that he had revoked the previous declaration. The South Australian Research Involving Human Embryos Act 2003 then ceased to be a 'corresponding Act', so the NHMRC Embryo Licensing Committee can no longer exercise functions under the State Act. If the Act is amended, South Australia will need to ask the Minister for Health and Ageing to determine whether the State Act is corresponding and make a new declaration. This Bill has been drafted to amend South Australian laws to make them substantially the same as equivalent interstate laws (where amendments have already been made). It is expected the amended legislation would be regarded as corresponding with the amended Commonwealth laws. At the meeting of the Council of Australian Governments in April 2007, the Premier of South Australia, together with his colleagues from all Australian jurisdictions, signed an Agreement that commits all State and Territory leaders to use their best endeavours to introduce corresponding legislation into their legislatures by 12 June 2008 and for all parties to maintain nationally consistent arrangements over time. State and Territory governments are considering the relevant Commonwealth amendments and their implications for local laws. The Victorian, New South Wales, ACT, Tasmanian and Queensland Parliaments have amended their equivalent legislation. The Western Australian Parliament did not pass amendments to their equivalent laws. As it has ceased to be a 'corresponding Act' and has not been amended, the Commonwealth's NHMRC Licensing Committee cannot issue a licence for research using human embryos under the WA Act. It is unclear whether NHMRC inspectors could inspect and monitor compliance with prohibitions and research requirements by Western Australian laboratories. This Parliament now has an opportunity to consider changes to these challenging but important laws. Coverage of Commonwealth and State laws Why do we need both State and Commonwealth legislation? Commonwealth legislative powers are not wide enough to cover all agencies and individuals in South Australia that might possibly undertake reproductive technology activities or human embryo research. In summary, the Commonwealth laws cover Australian Government authorities, constitutional corporations, and trade and commerce. The Commonwealth laws do not cover South Australian Government agencies, non-trading corporations nor individuals operating outside a trading corporation; these are covered only by the South Australian Acts. The South Australian and national laws are currently different; embryos can be created under Commonwealth laws that would be unlawful under State law. As Members would know, the section 109 of the Australian Constitution provides that when a law of a State is inconsistent with a law of the Commonwealth, the latter shall prevail, and the former shall, to the extent of the inconsistency, be invalid. Since 12 June this year, South Australian researchers regulated under the Commonwealth Acts have been able to apply for a licence under the Commonwealth legislation to conduct research that is currently not permitted by State legislation. The corresponding Act declaration has been revoked, so researchers covered only by South Australian Acts are currently not permitted to seek a licence from the NHMRC Licensing Committee. All current South Australian human reproductive medicine and embryo research and training activity is being conducted within either a corporation (Repromed laboratories) or a university (the University of Adelaide Medical School laboratories). It is thought to be unlikely that future research or training proposals will emanate from facilities that are not a university, a research institute or a corporation. There is, however, some legal uncertainty about whether our universities are constitutional corporations and are therefore facilities covered by the Commonwealth legislation. To date, no South Australian researchers have sought a licence to conduct human embryo research, but have focussed their efforts on either animal embryos or human embryonic stem cell lines developed elsewhere which do not require a licence. However research teams are planning to apply for such research licences in the near future, and since embryonic stem cell research is often conducted as part of national collaborations, legal clarity and national consistency is important. If Parliament does not pass this Amendment Bill, then researchers will still be able to apply for a licence to conduct research that is legal under the Commonwealth Acts provided they are clearly operating within a corporation. However the capacity of researchers operating within the university environment to contribute to national research collaborations may be compromised if their legal status remains uncertain. Amending the South Australian Prohibition on Human Cloning Act and the Research Involving Human Embryos Act to ensure consistency with the equivalent Commonwealth Acts will ensure that, wherever they conduct their work, all South Australian researchers will be covered by substantially identical legislation, providing regulatory consistency where the legal coverage of Commonwealth and State laws is considered uncertain. Induced Pluripotent Stem Cells (iPSCs) The use of induced Pluripotent Stem Cells (iPSCs) has not superseded embryonic stem cell research as some Members in the other place have suggested. Although iPSCs may be a promising tool for basic research, disease modelling and drug trials, they remain an unknown quantity. IPSCs are genetically modified and the use of genetic alterations and viruses in their creation makes them less predictable and risks causing tumours. Professor Peter Rathjen informed the briefing session for Members of Parliament in April that the derivation of iPSCs takes somatic cells backwards to their original form in the embryo, an abnormal process which may generate abnormal cells, whereas the development of embryonic stem cells follows the normal direction of developing early cells into mature cells in a controlled manner. He advised that much more work is needed before iPSCs could prove safe or useful in humans. Australian researcher Professor Alan Trounson, who heads the world's biggest stem cell research project at the California Institute for Regenerative Medicine, has advised that stem cells derived from skin have not been fully investigated and are still far from ready for clinical use because of their potential to cause cancer. Professor Trounson advised that embryonic stem cells, which do not carry the same risk of mutation, are currently the only option for therapeutic trials, and that many scientists will continue to research embryonic stem cells because they are the gold standard. Embryonic stem cells (ESCs) are a known quantity—they bring embryo cells forward to their final form in the body, a normal process in embryo development which after 20 years of research is now relatively well controlled. The majority of scientific opinion seems to be that embryonic stem cell research should continue while the problems with iPSCs are being investigated. Embryonic stem cells can address questions about early human development and, in particular, infertility research that iPSCs cannot. Research with both iPSCs and embryonic stem cells may eventually lead to the development of patient-specific stem cell lines suitable for clinical use. Summary of the proposed amendments The proposed amendments mirror the changes to the Commonwealth laws and apply them to the South Australian Prohibition on Human Cloning Act and the Research Involving Human Embryos Act. The Bill retains a prohibition against human reproductive cloning, which is universally unacceptable, and a strict licensing, monitoring and compliance regime. Not all the Commonwealth amendments need to be reflected in the South Australian Acts as some relate only to the activities of the NHMRC Embryo Licensing Committee established under the Commonwealth legislation. The Bill amends each Act to include a new definition of an embryo that changes the point of identification from the commencement of fertilisation (which is impracticable to ascertain) to its completion (which is detectable microscopically). The Bill extends the scope to regulate the creation, development and use of all embryos, not just excess ART embryos, and to regulate the use of donated eggs (oocytes). The amendments differentiate between embryos created by fertilisation of an egg by a sperm for the purpose of creating a baby, and embryos created by technical manipulation of cells and DNA for research and potential therapies. For clarity I will refer to embryos created by fertilisation as reproductive embryos and embryos created by technical manipulation as research embryos. Creating reproductive embryos for research purposes remains prohibited; they can only be created for the purpose of establishing a pregnancy but couples undergoing infertility treatment will still be able to donate their excess embryos to research. Strict legislated criteria must be met before a licence will be issued to create research embryos; implanting embryos not created through fertilisation is prohibited. Neither reproductive embryos nor research embryos will be able to be developed for more than 14 days in a laboratory; this is the point at which the rudimentary nervous system—the ‘primitive streak'—first appears. When the Bill was first introduced in the other place, this 14 day limit also applied to the creation and use of hybrid embryos. However, given that a licence in relation to hybrid embryos can only given for testing sperm quality and only up to the first mitotic division—that is, generally less than 24 hours, an amendment was passed to correct this inconsistency. As a result, the Bill now proposes that hybrid embryos may only be developed up to the first mitotic division and not 14 days as is the case for other research and reproductive embryos. The Minister for Health has advised that he will be writing to the other jurisdictions regarding this inconsistency. The amendments required to the SA Prohibition of Human Cloning Act 2003 to ensure it corresponds with the amended Commonwealth Act include: changing the name to reflect that it is reproductive cloning that will be prohibited; and increasing penalties for breaching prohibitions to 15 years; and reclassifying prohibited practices into those completely prohibited and those prohibited unless authorised by a licence. In general, prohibitions on using reproductive embryos for research will be retained. The 'embryo parents' decide whether to donate their excess embryos to research and the type of research to which they are prepared to donate them, and can set binding conditions on researchers when they consent to their use. Creating a chimera by adding components of an animal cell to a human embryo and implanting any type of human embryo in an animal will remain completely prohibited. Creating embryos with genetic material from more than two persons or from precursor cells will remain completely prohibited for reproductive embryos, but permitted for research embryos under licence. Creating hybrid embryos by combining human and animal cells will remain completely prohibited, with the single exception of a diagnostic test for sperm quality which will be permitted only under licence in reproductive medicine clinics. A licence will be permissible for using animal eggs to test the fertilisation capacity of sperm, but embryo development will only be permitted in this case until a detectable change indicates a result, which is the first cell division which generally occurs in less than 24 hours. The amendments required to the SA Research Involving Human Embryos Act 2003 to ensure it corresponds with the amended Commonwealth Act include: extending criteria for licences issued for research and training to include the use of embryos not created by fertilisation; and clarifying what constitutes proper consent by donors and embryos unsuitable for implantation. Somatic cell nuclear transfer and other research techniques The Bill will legalise the creation of embryos under a licence by a range of laboratory techniques now allowed under the amended Commonwealth Acts. These will include: somatic cell nuclear transfer or SCNT, where the nucleus of a human egg is replaced by the nucleus of a somatic cell (a cell from a human body) and the resultant cell is stimulated to develop for 5 to 7 days to blastocyst stage when embryonic stem cells can be removed; and parthenogenesis, where a human embryo could potentially be formed by stimulating a human egg to undergo spontaneous activation; such embryos may have the capacity for limited development. SCNT was used to create 'Dolly' the sheep, but since development past 14 days and implantation of such embryos will be prohibited, SCNT in humans will only be licensed to derive embryonic stem cells or for laboratory research, not to produce babies. Embryonic stem cell research seeks to generate patient-matched stem cells for research to enable development of specific cellular therapies with the potential to overcome problems such as tissue rejection, so this process is sometimes called 'therapeutic cloning'. SCNT will also allow the development of embryonic stem cells containing specific disease genes, which may assist better understanding of the causes of disease and identification of drugs and treatments. Excess ART embryos are not suitable for this type of research because stem cells derived from ART embryos would not be a genetic 'match' to the patients for whom potential cellular therapies were being developed or would not carry the disease in question. However, maintaining and improving the quality and safety of infertility treatment and procedures and minimising the risks to children born of assisted reproductive medicine relies upon excess reproductive embryos generously donated by parents to research and training. Protections The Research Involving Human Embryos Act 2003 will retain its stringent licensing and reporting requirements. Before the NHMRC Embryo Licensing Committee issues a licence for research, diagnostic testing or training, very strict criteria must be met, including: research ethics approval from the local Human Research Ethics Committee; and restricting the number of embryos to that likely to be necessary for the project; and the likelihood of significant advance in knowledge, treatment technologies or other applications from the proposed project; and evidence of proper informed consent by those donating cells or embryos and their partners; and accounting for every embryo licensed and abiding by conditions set by donors; and transparent reporting requirements. The Bill does not change any of these criteria, but strengthens and extends the consent provisions to include all donors whose genetic material is incorporated in the cells used, and their spouses if the embryo is a reproductive embryo. The Commonwealth Amendment Bill extended the monitoring, oversight and search provisions for NHMRC inspectors. However, the amendments required to State laws are minimal because the South Australian provisions are already more comprehensive than those in other jurisdictions' legislation. NHMRC Guidelines Researchers and clinicians are required under Commonwealth and State law to abide by guidelines issued by the NHMRC. The NHMRC has produced criteria to define embryos unsuitable for implantation, and recently revised and released their National Statement and their Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research, which are referenced in the South Australian Research Involving Human Embryos Act 2003. A clause was added during the Act's passage in 2003 requiring that any NHMRC guideline or policy referenced in the legislation be tabled in Parliament within 3 sitting days from changes taking effect and referred to the Parliamentary Social Development Committee, both initially and each time it is changed. This requirement is unique to South Australia. The NHMRC reviews and revises its guidelines routinely every 5 years and South Australia keenly engages in its national consultations. The Social Development Committee considered revised NHMRC Ethical Guidelines in 2005, and considered further revisions to both the NHMRC Ethical Guidelines and the National Statement in 2007. The Social Development Committee cannot in fact change nationally agreed guidelines issued under the Commonwealth NHMRC Act. The Bill retains the requirement for relevant new or revised NHMRC guidelines to be tabled in Parliament and referred to the Social Development Committee, but extends the time period from 3 to 6 sitting days (which is the usual period in South Australian legislation) from commencement of their operation to allow final printed copies to be procured for tabling in the Parliament. National consistency and transparency This is an area of rapid change, not only in research capability but also in community attitudes and standards. Governments and Parliaments have a responsibility to encourage high quality and ethically sound scientific research and medical practice. Society generally needs to be assured that research that uses embryos is strictly regulated under a coherent national scheme. South Australia hosts a recognised centre of excellence for infertility research at the University of Adelaide, and scientists and researchers are seeking the surety of nationally consistent regulation and licensing so the public can be confident that they operate according to nationally endorsed legal and ethical standards, with strict oversight and monitoring and transparent accountability requirements. This Bill will ensure that further advances in this field are made within a responsible regulatory framework with strong oversight and protections and transparent public reporting. The Commonwealth Acts provide for a further review in 3 years, allowing for continuing Parliamentary oversight into the future. An explanatory guide with more detailed explanations and fact sheets for the public have been prepared and are available on the Department of Health website. I commend the Bill to the House. Explanation of Clauses Explanation of Clauses Part 1—Preliminary 1—Short title 2—Commencement 3—Amendment provisions These clauses are formal. Part 2—Amendment of Prohibition of Human Cloning Act 2003 4—Amendment of long title 5—Amendment of section 1—Short title These clauses amend the long and short titles of the Act to reflect the fact that the Act, as amended by this measure, will no longer prohibit the creation of human embryos for research purposes. 6—Amendment of section 3—Interpretation This clause amends section 3 of the Act to replace the existing definition of human embryo with a new definition developed by the NHMRC. It also clarifies that 'human embryo' refers to a living embryo only and does not include a human embryonic stem cell line or a hybrid embryo, and that a reference to a human oocyte is the same as a reference to a human egg. 7—Substitution of Part 2 This clause substitutes Part 2 of the Act. The new Part contains 2 Divisions. Division 1 deals with practices that are completely prohibited and Division 2 deals with practices that are prohibited without a licence issued by the NHMRC Licensing Committee. Part 2—Prohibited practices Division 1—Practices that are completely prohibited 5—Offence—placing a human embryo clone in the human body or the body of an animal This section makes it an offence for a person to place a human embryo clone in the body of a human or in the body of an animal. The effect of this provision is to ban human cloning for the purposes of reproduction. The maximum penalty is imprisonment for 15 years. 6—No defence that human embryo clone could not survive This section provides that it is no defence that the human embryo clone did not or could not survive. 7—Offence—creating a human embryo for a purpose other than achieving pregnancy in a woman This section makes it an offence for a person to create a human embryo by fertilisation of a human egg by a human sperm outside the body of a woman, unless the person's intention in creating the embryo is to attempt to achieve pregnancy in a particular woman. The maximum penalty is imprisonment for 15 years. 8—Offence—creating or developing a human embryo by fertilisation that contains genetic material provided by more than 2 persons This section makes it an offence for a person to create or develop a human embryo by fertilisation of a human egg by a human sperm outside the body of a woman if the embryo contains genetic material provided by more than 2 persons. The maximum penalty is imprisonment for 15 years. 9—Offence—developing a human embryo outside the body of a woman for more than 14 days This section makes it an offence for a person to develop a human embryo outside the body of a woman for more than 14 days, excluding any time that the embryo's development is suspended. The maximum penalty is imprisonment for 15 years. 10—Offence—heritable alterations to genome This section makes it an offence for a person to intentionally alter the genome of a human cell in such a way that the alteration is inheritable by descendants of the human whose cell was altered. The maximum penalty is imprisonment for 15 years. 11—Offence—collecting a viable human embryo from the body of a woman This section makes it an offence for a person to remove a human embryo from the body of a woman, intending to collect a viable human embryo. The maximum penalty is imprisonment for 15 years. 12—Offence—creating a chimeric embryo This section makes it an offence for a person to intentionally create a chimeric embryo. The maximum penalty is imprisonment for 15 years. A chimeric embryo is a human embryo into which a cell of an animal, or any component part of a cell of an animal, has been introduced. It includes anything else that is declared by the regulations to be a chimeric embryo. 13—Offence—developing a hybrid embryo This section makes it an offence for a person to intentionally develop a hybrid embryo that has undergone the first mitotic division. The maximum penalty is imprisonment for 15 years. 14—Offence—placing of an embryo This section makes it an offence for a person to intentionally place a human embryo in the body of an animal, or in a part of a human body other than a woman's reproductive tract. It also makes it an offence to intentionally place an animal embryo in the body of a human for any period of gestation. The maximum penalty is imprisonment for 15 years. 15—Offence—importing, exporting or placing a prohibited embryo This section makes it an offence for a person to intentionally import an embryo into South Australia knowing that, or reckless as to whether, the embryo is a prohibited embryo. It makes it an offence for a person to intentionally export an embryo from South Australia knowing that, or reckless as to whether, the embryo is a prohibited embryo. The section also makes it an offence for a person to intentionally place an embryo in the body of a woman knowing that, or reckless as to whether, the embryo is a prohibited embryo. The maximum penalty is 15 years. A prohibited embryo is— (a)	a human embryo created by a process other than the fertilisation of a human egg by human sperm; or (b)	a human embryo created outside the body of a woman, unless the intention of the person who created the embryo was to attempt to achieve pregnancy in a particular woman; or (c)	a human embryo created using human egg and human sperm and containing genetic material provided by more than 2 persons; or (d)	human embryo that has been developing outside the body of a woman for a period of more than 14 days, excluding any period throughout which development is suspended; or (e)	a human embryo created using precursor cells taken from a human embryo or a human fetus; or (f)	a human embryo that contains a human cell whose genome has been altered in such a way that the alteration is heritable by human descendants of the human whose cell was altered; or (g)	a human embryo that was removed from the body of a woman by a person intending to collect a viable human embryo; or (h)	a chimeric embryo or a hybrid embryo. 16—Offence—commercial trading in human eggs, human sperm or human embryos This section makes it an offence for a person to intentionally give or offer valuable consideration to another person for the supply of a human egg, human sperm or a human embryo, or to intentionally receive, or offer to receive, valuable consideration from another person for the supply of a human egg, human sperm or a human embryo. The maximum penalty is imprisonment for 15 years. However, valuable consideration does not include the payment of reasonable expenses incurred by the person in connection with the supply. Division 2—Practices that are prohibited unless authorised by a licence 17—Offence—creating a human embryo other than by fertilisation, or developing such an embryo This section makes it an offence for a person to intentionally create a human embryo by a process other than fertilisation of a human egg by a human sperm, or to develop a human embryo so created, if the creation or development of the embryo by that person is not authorised by a licence. The maximum penalty is imprisonment for 10 years. 18—Offence—creating or developing a human embryo containing genetic material provided by more than 2 persons This section makes it an offence for a person to intentionally create or develop a human embryo by a process other than fertilisation of a human egg by a human sperm, if the human embryo contains genetic material provided by more than 2 persons and the creation or development of the embryo by that person is not authorised by a licence. The maximum penalty is imprisonment for 10 years. 19—Offence—using precursor cells from a human embryo or a human fetus to create a human embryo, or developing such an embryo This section makes it an offence for a person to use precursor cells taken from a human embryo or fetus, intending to create a human embryo, or to intentionally develop an embryo so created, if the person does so without being authorised by a licence, and knows or is reckless as to the fact that the person is acting without a licence. The maximum penalty is imprisonment for 10 years. 19A—Offence—creating a hybrid embryo This section makes it an offence for a person to intentionally create or develop a hybrid embryo. The maximum penalty is imprisonment for 10 years. A person does not commit an offence if the creation or development of the embryo by the person is authorised by a licence. Part 3—Amendment of Research Involving Human Embryos Act 2003 8—Amendment of section 3—Interpretation This clause amends section 3 of the Act to replace the existing definition of human embryo with a new definition developed by the NHMRC. It inserts definitions of hybrid embryo, unsuitable for implantation and use, and substitutes the definitions of proper consent and responsible person. It clarifies that 'human embryo' refers to a living embryo only and does not include a human embryonic stem cell line or a hybrid embryo, and that a reference to a human oocyte is the same as a reference to a human egg. 9—Substitution of heading to Part 2 This clause substitutes the heading to Part 2 of the Act. Part 2—Regulation of the use of excess ART embryos, other embryos and human eggs 10—Insertion of sections 5A and 5B This clause inserts 2 new sections into the Act. 5A—Offence—use of other embryos This section makes it an offence for a person to intentionally use an embryo if the embryo is— (a)	a human embryo created by a process other than the fertilisation of a human egg by a human sperm; or (b)	a human embryo created by a process other than the fertilisation of a human egg by a human sperm that contains genetic material provided by more than 2 persons; or (c)	a human embryo created using precursor cells taken from a human embryo or a human fetus; or (d)	a hybrid embryo, and the use is not authorised by a licence. The maximum penalty is imprisonment for 5 years. 5B—Offence—certain activities involving use of human eggs This section makes it an offence for a person to undertake research or training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in ART if the person is not authorised by a licence to undertake the research or training. The maximum penalty is imprisonment for 5 years. 11—Amendment of section 6—Offence—use of embryo that is not an excess ART embryo This clause amends section 6 of the Act to make it an offence for a person to intentionally use, outside the body of a woman, a human embryo created by fertilisation of a human egg by a human sperm if it is not an excess ART embryo and the use is not for a purpose related to the assisted reproductive technology treatment of a woman carried out by an accredited ART centre under a South Australian clinical practice licence, and the person knows or is reckless as to that fact. 12—Insertion of section 7A This clause inserts a new provision. 7A—Person not liable for conduct purportedly authorised This section makes it clear that a person is not criminally responsible for an offence against the Act in respect of particular conduct if— (a)	the conduct by the person is purportedly authorised by a provision of a licence; and (b)	the licence or the provision is invalid, whether because of a technical defect or irregularity or for any other reason; and (c)	the person did not know, and could not reasonably be expected to have known, of the invalidity of the licence or the provision. 13—Amendment of section 10—Person may apply for licence This clause amends section 10 of the Act to expand the classes of activities for which a licence may be sought. Currently only the use of excess ART embryos may be licensed. Under the proposed changes a person will be able to apply to the NHMRC Licensing Committee for a licence authorising 1 or more of the following: (a)	use of excess ART embryos; (b)	creation of human embryos other than by fertilisation of a human egg by a human sperm, and use of such embryos; (c)	creation of human embryos other than by fertilisation of a human egg by a human sperm that contain genetic material provided by more than 2 persons, and use of such embryos; (d)	creation of human embryos using precursor cells from a human embryo or a human fetus, and use of such embryos; (e)	research and training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in ART; (f)	creation of hybrid embryos by the fertilisation of an animal egg by a human sperm, and use of such embryos up to, but not including, the first mitotic division, if— (i)	the creation or use is for the purposes of testing sperm quality; and (ii)	the creation or use will occur in an accredited ART centre. The section makes it clear that (a), (b), (c) and (d) do not permit the NHMRC Licensing Committee to authorise any use of an excess ART embryo or other embryo that would result in the development of the embryo for a period of more than 14 days, excluding any period when development is suspended. 14—Amendment of section 11—Determination of application by Committee 15—Amendment of section 14—Licence is subject to conditions The amendments made to sections 11 and 14 of the Act by these clauses are consequential on the amendments to section 10. It ensures that the provisions relating to the determination of applications for licences and the imposition of licence conditions apply in relation to licences authorising activities relating to human eggs and embryos other than excess ART embryos. 16—Amendment of section 16—Suspension or revocation of licence This clause amends section 16 of the Act to alter the reference to legislation the title of which is amended by this measure. 17—Amendment of section 19—NHMRC Committee to make certain information publicly available This clause amends section 19 of the Act to require the NHMRC Licensing Committee to include in its licence database the number of ART embryos or human eggs authorised to be used under a licence, and the number of other embryos authorised to be created or used under a licence. 18—Amendment of section 21—Interpretation This clause amends section 19 of the Act to enable the holder of a licence to apply for a review of a decision to modify NHMRC guidelines in respect of the licence. The relevant guidelines are those issued by the CEO of the NHMRC under Commonwealth legislation and prescribed by regulations under the Commonwealth Research Involving Human Embryos Act 2002 for the purposes of the definition of proper consent in that Act. 19—Amendment of section 22—Review of decisions The amendment made to section 22 of the Act by this clause is consequential on the insertion of section 14(8) in the Act. 20—Amendment of section 23—Powers of inspectors This clause amends section 23 of the Act so that if, during a search of premises, an inspector believes on reasonable grounds that there is at the premises, a human egg or embryo other than a human embryo that may afford evidence of the commission of an offence against the Act, the inspector may secure the egg or embryo pending the obtaining of a warrant to seize it. 21—Amendment of section 30—NHMRC guidelines This clause amends section 30 of the Act so that alterations to NHMRC guidelines are required to be tabled in Parliament within 6 sitting days of taking effect under the Act. Part 4—Transitional provision 22—Transitional provision This clause provides that if an application for a licence under section 10 of the Research Involving Human Embryos Act 2003 made before the commencement of this clause has not been determined at the commencement of this clause, the application is to be determined as if it had been made after that commencement. The Hon. SANDRA KANCK Legislative Council The Hon. SANDRA KANCK (16:53): It seems peculiar to me that in this one area of scientific research parliament will make a decision about the conditions of its practice in this state. Because members of both the government and opposition parties have been granted a conscience vote it is resulting in a lot of lobbying. To me it is creating more heat than light, however. The Democrats have always prided ourselves on exercising a conscience vote, and every time I make a decision on bills I exercise my conscience. But for the major parties it is allowed only on these issues which are perceived somehow as moral issues, although I think there are many other bills that are moral issues. It makes me wonder why a conscience vote is allowed only on this sort of technology. We have not, for instance, ever had a vote about researchers working on nuclear power, and I think that the implications of nuclear power with respect to human life are far worse than anything that could result from this legislation. In 2003, we had a bill that was the precursor to this one, and at that time I observed the old adage that there is no point in shutting the stable door after the horse has bolted. I also expressed some concerns about the bill and, just as I did then, I am going to express similar concerns now. I wonder why there is so much fuss about a bill such as this. I think we should be really clear about it. This is a bill aimed at financially comfortable people in a developed country. There might be a trickle down theory that is arguable (I have not heard it yet) that, as a consequence, people in developing countries might gain some benefit, and if there is such an argument I would be interested to hear it. However, most of the arguments that I have heard and read in support of this type of research are about people in our country and how they could benefit from it. We in the developed world, despite all our wealth and possessions, are so fearful of dying and of imperfection that it seems that we are prepared to throw in enormous amounts of money and effort to procure cures. We look at ways in which to alter what are seen as imperfections through cosmetic surgery through to ways that might make us live longer, such as stem cell research. To a large extent, I see these as mere indulgences. As part of the population of the developed world, we are the ones who are hugely responsible for environmental destruction and climatic change on a per capita basis. Yet the aim of this type of research is principally to ensure that we in the rich part of the world survive even longer and, if we survive even longer, it means that we can continue to make even greater demands on this planet. By contrast, every day in this world 25,000 people die of poverty and hunger. With that in mind, I attended a briefing on this bill from a group of MPs who were opposing it expecting to be given information like that, because the arguments that we are hearing about this bill are about the value of human life. I did not stay the course at that briefing; they lost me almost from the start when it became clear that their argument was about an embryo being a human being. The view of the presenters at that forum appeared to be that cloning was okay provided it did not use human embryos. So, they did not address my concerns at all. It seems, from what they were saying, that, provided human embryos are not involved, we can still go down that path of hang the expense so that we can be brought closer to either physical perfection or living longer lives. Since this legislation was introduced in the House of Assembly last year, I have received about 70 emails opposing it, but 50 of those have been in the past two weeks. Many of those emails are arguing that the embryos that will be used in experimentation are human lives. I would argue that, yes, they are alive and, yes, they are the genesis for a human being, but they do not meet my expectation of a human life. The legislation envisages that embryos that would be used would be no more than eight weeks old, although my understanding is that in the laboratory the embryos used are usually four to seven days old. In my view, that is nothing more than a collection of cells. Most women who have had a miscarriage (and I am one of them) would not have looked at that small blob of blood and tissue and described it as a baby. So, where should our research efforts and the associated funding be directed? Unfortunately, this bill does not grant us the opportunity to be involved in the debate to answer that question. If I was able to do so, I would be talking about the more than 6,000 people who each day in sub-Saharan Africa die of AIDS. On our doorstep, PNG is on the edge of an AIDS epidemic. The World Health Organisation has estimated that on present rates one in five men, women and children will be infected with HIV in the next decade. Might it be better for our researchers to put their efforts into that field? For me, we are not having the right debate. Many of the emails, as with the briefing I went to against the bill, argue for a different technology and claim that, with this new technology, the use of embryonic cells will be made redundant. If that is the case, it will be able to establish itself as a viable methodology and the use of embryonic stem cells will gradually fade out. It does not necessarily argue against this current legislation. In terms of the aspects of the bill dealing with cloning, my understanding of this technology is that there are still a lot of problems with it. In the highly celebrated case of Dolly the sheep, the new lambs were, from a cellular perspective, as old as Dolly herself, so the technology is very limited. In a sense the research being done is speculative and, without solving that problem of inbuilt age that comes with the cloning, it is a form of research that is hardly likely to take us anywhere. It reminds me of the sign in the pub 'Free drinks tomorrow', and when the punters turn up to get their free drinks the barman says, 'This is today; tomorrow is tomorrow'. So tomorrow never comes, but it is always a tantalising dream. Similarly in the energy sector, for two decades I have been hearing of the breakthrough that is to happen soon or next year with hydrogen technology, and it never happens. So, just like the promises of a hydrogen-based economy, I am not even sure that the new technology of cloning will ever deliver. Despite that cynicism on my part, I support the bill because it might reduce some costs in our health system. If through this technology we are able to treat spinal injuries so that the health system does not need to provide permanent beds in institutional care or other imposts to the health system, we could be a lot better off. I do not know whether this outcome will eventuate. In closing, although this bill is exciting a lot of people, it fails to excite me but not enough to oppose it and I indicate my support for the second reading. The Hon. D.G.E. HOOD Legislative Council The Hon. D.G.E. HOOD (17:03): I rise to state the Family First position on this bill, and at the outset I indicate that my colleague the Hon. Mr Brokenshire will also make a contribution, probably in the next sitting week. In many ways this legislation is completely unnecessary. Today we are being asked to consider this legislation, which is not only unnecessary but also ethically problematic. I will make a few initial points, which I will attempt to address during my brief contribution today. This bill was introduced prior to scientific developments, which in my view now render it completely unnecessary. Despite those developments, which of course were the discovery of the iPS cells in November last year, we still have a situation where we are forced to debate this bill. That is the first issue I will cover in my contribution. The second one is to alert the chamber, for those who are not aware, that Western Australia has recently refused to pass a very similar bill to this one because, in short, that state came to the conclusion that the technology and therefore the presumption behind the bill is now obsolete. Thirdly, I will make mention of the fact that Professor Sir Ian Wilmut, famous for cloning Dolly the sheep, has abandoned this form of research in favour of the reprogramming of skin cells, which accomplishes the same thing that is attempted to allow for in this bill. There we have the founder of this cloning science, Professor Sir Ian Wilmut, who cloned Dolly the sheep, now moving on from this type of cloning to focus more on what he sees as the newer more promising arm of science, namely, the iPS technology. The fourth aspect that is very important and deserves mention in this discussion is that the new so-called induced pluripotent stem cell technology, to which I just alluded, is producing stem cells in large quantities, while the old cloning technology, with which this bill deals and is being debated today, has yet to produce a single stem cell from a cloned human embryo in the whole world. To paraphrase and repeat that, the new technology (iPS) is producing useable stem cells that are being used in the preparation of creating treatments for serious disease states which, of course, is the whole point of the iPS technology. However, the cloning technology, which we are debating here today, has never produced a single useable stem cell in all the time that it has been researched. What we are debating today is: should we continue down a path of using a technology that has, so far, proved to be totally unhelpful, if you like—that is, it has never produced a single stem cell from a cloned human embryo—or do we have the courage to do what they did in the Western Australian parliament and say, 'That technology is no longer necessary'? Not only is it unnecessary and redundant, it is also regarded as ethically contentious, to say the very least, by many people—and not just people who have a religious faith. I have been approached by many people who claim not to have a religious faith but who do have some strong concerns about the ethical nature of the bill before us today. In summarising my introduction, that is why I say this bill is both ethically questionable and obsolete at the same time. This bill permits the cloning and destruction of human embryos solely for research purposes. It also allows the mixing of human and animal genetic material to create an embryo. That is a significant step in its own right. Back in 2003 this parliament voted to outlaw, if you like, or to ban, the mixing of hybrid embryos—the mixing of animal and human embryos. The parliament voted resoundingly to defeat that bill in 2003. This bill, if passed—so as to be clear and to place on the record—will allow the mixing of human sperm with animal embryos for the creation of what is called a hybrid embryo—a mixture of a person and an animal in one embryo. Why on earth would we want to do that? If we really take time to think about that, it is a repugnant thought to most of us. Very few people would see it as any sort of advance whatsoever. Let me be clear: this bill has little to do with embryonic stem cell research per se. It is already allowed under legislation in South Australia. One of the things I found somewhat disturbing in my discussion with others about this bill is that there appears to be some level of misunderstanding which is that, in passing this bill, we are not, as a parliament, allowing or preventing embryonic stem cell research as such. Many forms of embryonic stem cell research are already legal in South Australia. The defeating of this bill—that is, voting against this bill—will not stop the current forms of embryonic stem cell research that already occur in South Australia on a daily basis. For example, if a couple go through IVF treatment and they deem, at some point, that they no longer wish to have any more children—and let us say they have been fortunate and had two children through the IVF process and they have four remaining embryos and they choose not to use them because they believe two children is the right number for their family—then their remaining embryos, under law in South Australia at the moment, can be used for research purposes so long as the couple agree. Embryonic stem cell research is alive and well in South Australia—not that I agree with it; I do not—but that is the state of law in South Australia. I want to make that clear to other members when they are considering their position on this very important issue. Voting against and defeating this bill will not stop embryonic stem cell research in South Australia. I do not like any sort of embryonic stem cell research but, as I said, this bill will neither ban it nor allow it. This bill is solely about—and this is the important point—extending research into new and unknown realms which allow for the cloning of embryos; that is, making a copy, if you like, of embryos which are destined to be destroyed, and the mixing of human and animal genetic material. In a nutshell, this bill allows the creation (or cloning) of embryos specifically for the purpose of destroying them—they will be subject to research, and they will then be destroyed. The most repugnant aspect of this bill is that, all of a sudden, there will be the capacity for the combination of human sperm and animal embryos. Family First strongly opposes this bill, as we have strongly opposed previous measures to allow human embryonic stem cell research. On 26 September, I presented a petition to this place, signed by 1,993 residents of South Australia who are opposed to this bill. I remind members that many people across South Australia, whether or not they are people of faith, although people of faith have a particular interest in this legislation, are concerned about the prospect of this bill being passed. I reiterate that it is not just church people or people of religious faith who object to this legislation. I have been approached by dozens of people who claim to be of no religious faith, but they have concerns, particularly about the prospect of the combination of a hybrid embryo (that is, the creation of an embryo with genetic material from a human being and genetic material from an animal), and that is what this bill will enable to be done. Organisations that have been leading the fight against this bill, such as FamilyVoice Australia, Medicine with Morality, and Australians for Ethical Stem Cell Research, speak for thousands of people deeply concerned about this bill. I for one do not welcome human/animal hybrid embryos or the creation of human embryos simply for the purpose of destroying them. I will explain in simple terms how this technology works. I have consulted some learned people, and I believe this is a very simple and good summary of the basic science. To the best of my understanding, in cloning the nucleus is removed from an egg cell and a nucleus from another part of the body (that is, a somatic cell) is inserted. To trick the egg cell into believing that it has been properly fertilised, it is then 'zapped' with electricity and becomes a zygote (that is, a new individual), with the potential, if implanted in a womb, to develop and be born, just like Dolly the sheep. A cloned human embryo, like a human embryo produced in a glass dish by IVF, is fully a human being, in my view. I say that because, if that embryo were to be implanted in a womb, it would develop into a human being who would live and breath and do all of the things that a baby would do. Similarly (and this is a horrifying thought for many people), if a hybrid embryo (that is, a combination of human and animal embryos) were to be implanted in a womb, it might develop into whatever—I am not sure what name we would give it; we could call it an animal, or half human/half animal, or whatever it is. If such an embryo were implanted in a womb (and an animal's womb could be used), it would be born and have life. Returning to the science, this kind of cloning is called somatic cell nuclear transfer (or SCNT). One difficulty is that only about 95 per cent of a cell's DNA is within the nucleus proper, within the nucleus itself. In the fluid surrounding the nucleus, there are small particles called mitochondria, which also contain DNA, up to 5 per cent of the total content. Suppose a person wants to be cloned in this way. Imagine that one of the cells in his or her body is inserted into a woman's donated egg cell, and then it is 'zapped' to make an embryo clone of the patient. The embryo's DNA will be only 95 per cent the same as the patient. The embryo's mitochondria, with 5 per cent of the cell's total DNA, will be the same as the woman egg donor. Any stem cells produced from the cloned embryo would be a close match—and this is very important—but they would not be a perfect match to the patient. So, that is the science of embryonic stem cell research. In stark contrast, adult stem cells are an exact 100 per cent match, because they come entirely from the patient, that is, the nucleus and the mitochondria. Further, there are no rejection risks of any kind. The combination of these two factors is why research into adult stem cell technology is now producing such significant results. Just to reiterate that point, one of the problems and the reason for the lack of success with embryonic stem cell research as a whole—that is, the whole field; not just cloning—is that it is not a perfect match. It cannot be a perfect match because the material comes from two different places, whereas, in the case of adult stem cells, the match is absolutely perfect. There is no risk whatsoever of rejection, and that is why all of the breakthroughs so far that have occurred with respect to this technology, and all of the advances in terms of actually developing substances that can treat serious conditions such as diabetes and these other conditions that we all would love to see cured, have come from the adult stem cell research side of the equation—all of them, without exception. There are other problems with SCNT cloning. To create Dolly the sheep, Professor Ian Wilmut—and this is not widely known, although it is certainly fact—zapped some 277 eggs but only one embryo cloned in this way ended up as a viable sheep. Creating cloned embryos requires many eggs and that itself is a problem now. To produce them, women have to take powerful drugs to stimulate their ovaries and, unfortunately, one of the side effects is that up to 8 per cent of women who take these drugs develop a condition known as ovarian hyperstimulation, which is a very painful and serious condition and, indeed, some women have died from this condition. A woman who is close to my family has actually experienced that condition of ovarian hyperstimulation. I was able to have a discussion with her recently about the symptoms she endured while she was suffering from ovarian hyperstimulation, and she quite emphatically said to me that she wished she were dead during that period, that it was absolutely horrifically painful. She was hospitalised and she did come through it, thank goodness, but it took seven or eight days or so before she got back any sense of functioning at all. She was essentially in tremendous pain in hospital. The research shows that up to 8 per cent of women who take these drugs develop ovarian hyperstimulation. The point I am trying to make is that this is not problem-free science. It worries me to think that, in many well-documented examples overseas, poorer women, particularly, who have been coaxed into undergoing this dangerous procedure using various inducements, have actually suffered the unfortunate consequence of ovarian hyperstimulation. Even so, supplies of human eggs are actually difficult to obtain. Because of the shortage, some scientists want to use the eggs of other mammals such as rabbits, cows, sheep or monkeys whose mitochondrial DNA is even more different from human beings and, importantly, shows greater difference from the patient who, ideally, will be assisted by this technology. So, in this bill, there is a paradox. Human-animal hybrids are supposedly banned, but clause 13 would allow testing of the viability of human sperm by placing the sperm with eggs of a rabbit or cow or some other animal creating for a short time a human-animal hybrid. I believe this is the thin end of the wedge. There are other ways to test sperm which have been well documented also, and even better ways could be developed. I do not believe that we should head down this dangerous, ethically unacceptable path of mixing humans with animals. Just to be clear, members who choose to support this bill in its unamended state are choosing to support experiments using a combination of human sperm and animal embryos to form one embryo. I can barely begin to imagine the significant moral and ethical problems that will emerge if a scientist were to attempt to incubate one of these human-animal embryos or implant it into an animal's womb. In fact, there have been one or two cases of human-animal embryos being created by scientists and living for several days in a test tube before dying. Again, I reiterate that if that embryo were placed in a womb—all things being equal, assuming a healthy womb and the like—it might take hold and then go through the process of becoming a full-grown animal (I guess, is the best word for it). It is concerning that, because of this bill, we have to even address and specifically prohibit this repugnant practice from occurring in clauses 5 and 14. I remind members that in the past week or so a Flinders University laboratory has been shut down for unauthorised genetic experiments on mice. Who would have thought, five years ago when MPs in this place emphatically ruled out all forms of human cloning, that we would now be debating a bill to allow some human cloning—even human-animal hybrids in certain circumstances. I think at this point it is valid to ask: if in 2003 the parliament (of course, I was not here at the time) made the decision that this form of science was unacceptable, what has changed that makes it acceptable now? If someone voted against the bill in 2003, what has changed in that five-year period that would make them vote for it today? If anything, there are more reasons to vote against such a bill today than there were in 2003—and I will go into that a little now. Since then, research teams in the United States and Japan have famously shown that a simple lab technique involving skin cells can rival the complex and highly controversial idea of extracting stem cells from cloned embryos. The stem cells derived from a patient's own skin cells have exactly the same DNA as the patient and so are a much better match than the embryonic stem cells, as I mentioned earlier. So, at a time when there are calls to wind back and remove the 2007 federal cloning legislation from the statute book (including a call from Emeritus Professor Jack Martin of the University of Melbourne), we in South Australia are being asked to pass new laws allowing the practice. As I mentioned at the outset, Western Australia, one of the first jurisdictions in the world to consider embryonic stem cell research following the discovery of induced pluripotent stem (iPS) cells, recently refused to pass cloning legislation. My understanding is that it was the first parliament in the world, since the discovery of induced pluripotent stem (iPS) cells last year, to actually debate the issue of therapeutic cloning. If I am correct (and I believe I am), the first jurisdiction to debate the matter since the discovery of iPS cells rejected the legislation; as I said at the outset, they mentioned that the new discoveries rendered legislation such as the legislation we are considering today completely unnecessary. Professor Sir Ian Wilmut, the scientist who became famous for cloning Dolly the sheep (after 276 unsuccessful attempts, I might add), has now announced that he will abandon cloning in favour of research into ethnically reprogrammed skin cells, called induced pluripotent stem cells (the iPS cells to which I alluded a moment ago). This research does not involve harm to human embryos; that is his primary reason for making the change, as well as his belief that—and I am paraphrasing of course, but I think I am safe in doing so as he said it publicly—iPS cells and that whole field of science offers so much more scope for genuine advancement in the field. Eleven years after the Dolly experiment (and Dolly had to be put down because of bad health problems) there has been zero progress in finding cures or treatments using cloned embryonic stem cells. Again, even the fathers of the field, the great leaders of the field such as Professor Wilmut, are abandoning that science. Yet here we are debating it today. In stark contrast to embryonic stem cell research, adult stem cell research—with no ethical problems whatsoever; there is no group lobbying against adult stem cell research; as far as I am aware, everyone is completely comfortable with the ethics of adult stem cell research—has seen a number of achievements, including treatment for over 70 conditions such as heart disease, bone and blood-based cancers, and leukaemia. There is such a thing as backing a winner, and I think in the case of adult stem cell research the runs are on the board. This is science where breakthroughs are actually occurring—in stark contrast to embryonic stem cell research where there has been no progress, certainly nothing that has resulted in anything like a treatment for any of those conditions. Let me touch briefly on some of the arguments made in the other place for cloned embryonic stem cell research over the iPS method. I have been through most of the contributions, and I note that one member (and I will not name them) argued that iPS cells cause tumours. I am afraid that they do not fully understand the science, or really understand it at all, because the truth is that that is the science—that is, adult stem cells and embryonic stem cells cause tumours; that is how they work. They are so reactive, so to speak, that they create tumours, and that is exactly why they are useful. If anyone has been seduced by the argument that iPS cells cause tumours, allow me to put their mind at rest once and for all. Whilst that is true, it is absolutely true for embryonic stem cells as well; indeed, it is useful that they do, and that is why they work and why the science is so exciting and unexplored at this point. Both embryonic and iPS stem cells form tumours when injected into a patient because they are pluripotent. They have the power or potency to form plural (that is, more than one) types of tissue. So, they form not only the tissue you might want, such as heart cells, but they also form tumours containing teeth, skin, hair and so forth. Let me say it again: that is true of not just iPS cells but also of embryonic stem cells. That is the science. It is not a negative issue on either side of the debate: it is true for both sides, if you like. Despite years of expensive research, no scientist has yet been able to produce a stem cell from a cloned human embryo—not one. Yet in just one year iPS stem cells have already been produced in large numbers—again with no ethical problems whatsoever. It was also mentioned in the other place by another member that it was guessed, if you like, that it may be five, 10 or 15 years until cures are available from iPS cells and therefore embryonic stem cell research should go ahead. The reality is that there is nothing to support that statement whatsoever. Indeed, I have a letter from Australians for Ethical Stem Cell Research that goes into great detail to debunk the claim that it will be many years before we see breakthroughs using adult stem cells or the iPS cell method. Remember: as we speak, the runs are on the board for iPS cells—breakthroughs are occurring frequently with this technology and actual treatments are being used. There has been real progress in that field. At this stage, there is no progress whatsoever in embryonic stem cell research in any usable way. Both embryonic and iPS stem cells form tumours and cannot be used in direct treatments for diseases. Human iPS cells are already proving useful for research and drug development, and they are being studied right now in major diseases. However, embryonic stem cells from cloned human embryos do not yet exist. They are not yet providing cures and, according to many learned people in this field, they are not likely to do so in the future. Indeed, Professor Ian Wilmut has made comments to that effect, and it formed one of his reasons for abandoning the embryonic stem cell field of research. The only stem cells that are safe and tumour free are adult stem cells, because they are also free from immune rejection. Indeed, they are the cells extracted from the patient's bone marrow (or even from the nose in some cases) that are now being used in direct therapy for dozens of conditions world wide. In summary, even if we put ethical questions aside (and I accept that people have different views on these matters), many scientists say that cloned embryonic stem cell research is proving to be a dead end. To be clear, if this bill goes through, that is the path we are going down. Professor Norman wrote to MPs on behalf of the Robinson Institute asking that the legislation be passed. The one and only justification he gave for cloning, as allowed by this bill, was: Therapeutic cloning would allow patients or groups to have personalised stem cells which minimise their need for immunosuppression and would allow disease specific cell lines to be made from patients which could be used to study a disease and test drugs. However, as Professor Martin has advised members through his letter recently, this argument has not been valid since November last year, now that the exact same personalised stem cells are up and running in dozens of patients using iPS technology, nor are the viral concerns raised by Profession Norman relevant any more, given discoveries in September just this year which have allowed the generation of iPS cells without viral vectors. In short, there is no reason to use the embryonic stem cell method. It is I think disappointing that members have received a letter which omitted those two very important facts. Scientists across the world who were researching in the area of cloned embryonic stem cells have turned their back on that research due to the cost and simply because the results they were getting were not satisfactory. That is not every scientist, of course; there are some who still want to go down that path but, clearly, many leaders in the field are publicly walking away from that arm of research. Why? Because there were no breakthroughs; not necessarily for ethical reasons, although some of them would have had ethical challenges with embryonic stem cell research, but because many of those scientists have taken a pragmatic route and said, 'This is too hard; the iPS research is so much more promising,' and, as a bonus, it has none of the ethical questions surrounding it that embryonic stem cells do. I have a letter from Dr van Gend, who in his letter sums it up this way: Cloning has been made redundant by iPS and can be rejected as both unethical and unnecessary. This is a professor in his field. I repeat that: Cloning has been made redundant by iPS, and can be rejected as both unethical and unnecessary. I realise that this is a complicated issue and that the science for many of us can be baffling at times. I am happy to provide members with a copy of the letter which explains these specific scientific concerns, although I understand Dr van Gend sent members copies of the letter that he sent to me. He has indicated to me personally that he would be happy to talk on the phone with any member who so chose—I have his mobile phone number—for as long as they liked so they could understand the issues. He is not attempting necessarily to blind people to his opinion, if you like, or get them over to his side of the argument—although I guess that is ultimately what he would like to do—but he is happy to explain the science so that people can make their own decisions. I reiterate that, if you look at this, in one form of this research, that is, the iPS cells, there have been tremendous advances on that side of the science. There have been no substantial advances on the embryonic side at this stage. Furthermore, there are significant ethical questions with embryonic stem cell research. Further research must be directed towards adult stem cell research and not cloned and embryonic stem cell research, and I sincerely hope that the current, unnecessary bill will be soundly defeated in this place. If a member is considering voting for this legislation, I ask them to outline one single advantage that embryonic stem cell research offers over iPS cell or adult stem cell research. Any member doing that will come to the conclusion—and has to come to the conclusion, because it is fact—that there are simply no advantages in the embryonic stem cell research method over adult stem cell research. There is not one. I challenge anyone to name one. There simply is not one, and therefore this bill is absolutely unnecessary. Given the current pace of change, I propose that we let this bill lapse. If there does in fact turn out to be a real demand for cloned embryos in the future, as some have speculated, the government can revisit this issue then. I think it is highly unlikely—in fact, I think it is absolutely unlikely. Stem cell research will continue in the meantime, as it has since 2003 when this parliament decided that cloning was unacceptable to it, but currently there is no sound argument for expanding the technology into cloning and, specifically, the mixing of human and animal DNA. I will conclude with a few remarks. At the end of the day, it comes down to this: there are no documented advantages with embryonic stem cell research over adult stem cell research (or iPS cell research) at this time. It is as simple as that. Secondly, so far it has proved impossible to develop any genuine advances using embryonic stem cells. The reality is that many senior scientists who have devoted their careers to stem cell research are abandoning embryonic stem cell research at a rate of knots, including the famous Professor Wilmut, who was responsible for cloning Dolly the sheep. So, the issue there is that there have been no advances. Senior people in this field are abandoning it, because they see it as offering limited scope for genuine advancement. The other issue is the very significant ethical questions contained in this bill, and specifically they are as follows. If we pass this bill, we as a parliament will say that it is okay to create life—to create an embryo—for the sole purpose of destroying it. We will also have a situation where, for the first time, we will allow the mixing of genetic material from human beings and animals. That is something of which I will not be a part, and I strongly oppose this bill, Family First opposes this bill, and I urge members to stand with me in opposing it. Debate adjourned on motion of Hon. J. Gazzola. At 17:36 the council adjourned until Wednesday 12 November 2008 at 14:15.