INFERTILITY TREATMENT AMENDMENT BILL 2007 Explanatory Memoranda

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INFERTILITY TREATMENT AMENDMENT BILL 2007

Infertility Treatment Amendment Bill 2007 Introduction Print EXPLANATORY MEMORANDUM General This Bill amends the Infertility Treatment Act 1995 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). Background In June 2005, the Commonwealth 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 Commonwealth Acts. This was in accordance with a requirement in the Commonwealth 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 561026 1 BILL LA INTRODUCTION 14/3/2007

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 National Health and Medical Research Council (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) 2

In Victoria, the provisions contained in the Commonwealth Acts are found in Parts 2A and 4A of the Infertility Treatment Act 1995 (the Principal Act). The amendments made to the Principal Act in this Bill mirror those found in the Commonwealth Amendment Act and 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 1 of this Memorandum. 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. 3

· 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 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. · 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. Clause Notes Clause 1 sets out the main purpose of the Bill. Clause 2 is the commencement provision. Clause 3 states that the Infertility Treatment Act 1995 is referred to as the Principal Act in the Bill. 4

Clause 4 amends definitions in section 3 of the Principal Act. Clause 4(1) replaces the existing definition of human embryo in section 3(1) of the Principal Act with a new definition developed by the NHMRC. The NHMRC arrived at this definition by forming the Biological Definition of Embryo Working Party, comprising three NHMRC Embryo Research Licensing Committee members and three other Australian experts. Their Draft Report of the Biological Definition of Embryo Working Party was peer reviewed by Australian and international experts. This definition differs slightly from the definition included in the Lockhart Report. This is because the NHMRC had not finalised its recommended definition at the time that the Lockhart Report was finalised in December 2005. Following the release of the Lockhart Report, the NHMRC finalised the definition of a human embryo and this was slightly different from the draft definition that was referenced in the Lockhart Report. This issue has been discussed with the members of the Lockhart Committee and they have agreed that their intention was that the definition of human embryo used should be that developed by the NHMRC. The key differences between the NHMRC definition (as endorsed by the Lockhart Committee since the release of its Report) and the existing definition in the Infertility Treatment Act 1995 are as follows-- · the point at which a human embryo is defined to commence existence. The identification of the first mitotic division as the time when fertilization is complete and the time at which the fertilized egg becomes an embryo. This recognises that fertilization is a process and that an embryo does not arise until the process is complete; · the definition used for embryos created other than by human egg and sperm. In the new NHMRC definition, the capacity to develop to the stage of the appearance of the "primitive streak" is taken as the marker of an entity that is an embryo. This is a conservative definition and acknowledges that entities such as those that have arisen by somatic cell nuclear transfer (SCNT) are indeed embryos. 5

It is intended that paragraph (b) of the NHMRC definition would capture the following types of embryos-- · a human egg which has had its nucleus replaced by the nucleus of a somatic cell (that is a cell from a human body) by the process referred to as SCNT; · a parthenogenic human embryo. It is possible that a human egg could be mechanically or chemically stimulated to undergo spontaneous activation and exhibit some of the characteristics of a fertilised human egg. A parthenogenetic human embryo may have the capacity to continue limited development in a similar manner to a human embryo created by fertilisation. Section 3(1B) of the Principal Act is retained and this clarifies that for the purposes of the definition of human embryo, in working out the length of period of development of a human embryo, any period when development of the embryo is suspended (for example, while it is frozen) is not included. For example, if an embryo is placed in storage 2 days after fertilisation and is held in storage for 10 weeks, it is still considered to be a 2 day embryo in terms of its development. Clause 4(2) clarifies a number of words used in the Principal Act. For example, the subclause clarifies that "human embryo" refers to a living embryo only and does not include a human embryonic stem cell line or a hybrid embryo. While this should be clear from the definition of human embryo itself, it is considered important that this be put beyond doubt. The subclause also inserts a new subparagraph, clarifying that a reference to a human oocyte is the same as a reference to a human egg. This provision recognises that the NHMRC definition of a human embryo refers to a human oocyte whereas the existing prohibitions in Part 4A of the Principal Act refer to a human egg. Rather than changing all of the existing references from human egg to human oocyte, section 3(1F) has been included to make it clear that both expressions are intended to have exactly the same meaning. Clause 5 amends the heading to Part 2A of the Principal Act which is currently entitled "Regulation of certain uses involving excess ART embryos". The new heading will be "Regulation of certain uses involving excess ART embryos, other embryos and human eggs". 6

Clause 6 amends section 21A of the Principal Act by inserting new definitions, and amending an existing definition, relevant to Part 2A. Clause 6(a) repeals the existing definition of proper consent and substitutes the following definition-- proper consent, in relation to the use of an excess ART embryo or a human egg, or the creation or use of any other embryo, means consent obtained in accordance with guidelines issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992 of the Commonwealth and prescribed by regulations under the Commonwealth Act the purposes of this definition. Clause 6(b) amends the definition of responsible person in section 21A. There has been no change to the definition of responsible person in relation to an excess ART embryo. Paragraphs (b) and (c) have been added to ensure that all appropriate people provide consent in relation to the use of a human egg for research or the creation and use of an embryo created by means other than fertilisation of human egg by human sperm. Clause 6(c) adds a new definition of unsuitable for implantation to section 21A of the Principal Act. In summary, a human embryo that is unsuitable for implantation, is one that-- · is diagnosed by preimplantation genetic diagnosis as unsuitable for implantation, in accordance with the Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (2004); or · is determined to be unsuitable for implantation in accordance with objective criteria to be specified in guidelines developed by the NHMRC and prescribed in regulations made under the Commonwealth Act. Clause 6(c) also inserts a new definition in section 21A which clarifies that, for the purposes of the Act, use includes develop, or development, as the case requires. This has been included for convenience only so that when the Principal Act refers to use of an embryo (for example, as authorised by the Act) this includes development of an embryo. It should be noted that all of the provisions that reference "use" (including development) also operate in conjunction with section 38H(1) of the Principal Act which prohibits development of an embryo beyond 14 days. 7

Clause 7 inserts in Part 2A of the Principal Act the following two new offences related to licensing. New section 21CA Offence--use of other embryos. Proposed section 2ICA provides that a person commits an offence if a person intentionally uses the following types of embryos without a licence issued by the NHMRC Licensing Committee-- · a human embryo created by a process other than the fertilisation of a human egg by a human sperm; · a human embryo that contains genetic material provided by more than 2 persons; · a human embryo created using precursor cells from a human embryo or a human foetus; · a hybrid embryo. This provision is needed because Part 4A relates specifically to creation and development of embryos and the requirement for licensing in these circumstances. This provision relates to "use" of embryos that have been created or developed under a licence. This provision makes it clear that not only must the creation or development of these types of embryos be authorised by a licence but the use of such embryos must also be authorised by a licence. The maximum penalty for non-compliance with this provision is imprisonment for 5 years. This is consistent with the existing offences in this Part of the Principal Act. New section 21CB Offence--certain activities involving use of human eggs. Proposed section 21CB creates an offence if someone undertakes research or training involving the fertilisation of a human egg by human sperm, up to but not including the first mitotic division, outside the body of a woman for the purposes of ART research or training without a licence issued by the NHMRC Licensing Committee. This implements Recommendations 15 and 16 of the Lockhart Committee. The offence attracts a maximum penalty of imprisonment for up to 5 years. This is consistent with similar existing offences in the Principal Act. 8

Clause 8 amends section 21D of the Principal Act which currently bans the use, outside the body of a woman, of an embryo that is not an excess ART embryo unless the use is for the purposes of ART. The purpose of existing section 21D is to prohibit people from using non-excess ART embryos for research purposes. This clause amends section 21D by continuing the ban on the use of non-excess ART embryos created by the fertilisation of human eggs by human sperm but makes it clear that the ban does not extend to use of embryos that have been created by means other than the fertilisation of human egg by human sperm. Use of any such embryos is only permitted under licence by the NHMRC Licensing Committee. This is an amendment that is consequential to the recommendations of the Lockhart Review which allow the creation of embryos for research if such embryos are created other than by fertilisation of a human egg by human sperm. Clause 9 inserts a proposed new section 21EA after section 21E of the Principal Act. New section 21EA--Person not liable for conduct purportedly authorised The new section clarifies that a person is not criminally responsible for an offence against the Act if-- · the conduct by the person is purportedly authorised by a provision of a licence; and · the licence or the provision is invalid, whether because of a technical defect or irregularity or for any other reason; and · the person did not know, and could not reasonably be expected to have known, of the invalidity of the licence or the provision. This provision is intended to address the underlying policy objective of Recommendations 5052 of the Lockhart Committee. Those recommendations suggest that the NHMRC Licensing Committee should be given the power to give legally binding rulings on the interpretation of the legislation and that a person who conducts research on the basis of a ruling should be protected from liability under the legislation. 9

This recommendation raises significant constitutional issues relating to the impermissible exercise of judicial power by a non-judicial body. For example, in the Brandy case, the High Court unanimously held that the power of the Commonwealth Human Rights and Equal Opportunities Commission to decide whether conduct was unlawful and to award damages was an impermissible conferral of judicial power, because of the binding and conclusive nature of the Commission's determinations. Recognising these concerns, proposed new section 21EA avoids these constitutional issues, but attempts to address the basic concern of the Lockhart Committee which appeared to be the potential liability of researchers where they are acting in good faith in accordance with a licence but where the NHMRC Licensing Committee in fact had no power to issue the licence. Clause 10 amends section 21H of the Principal Act. Section 21H(1) currently provides that a person may apply to the NHMRC Licensing Committee for a licence authorising the use of excess ART embryos. Consistent with the recommendations of the Lockhart Committee, the proposed amendments to the Act 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 prohibited absolutely or does not fall within the scope of this legislation). It is proposed that a person may apply to the NHMRC Licensing Committee for a licence authorising one or more of the following-- · use of excess ART embryos; · creation of human embryos other than by fertilisation of a human egg by a human sperm, and use of such embryos; · creation of human embryos (other than by fertilisation of a human egg by a human sperm) and containing genetic material provided by more than 2 persons, and use of such embryos; 10

· creation of human embryos using precursor cells from a human embryo or a human foetus, and use of such embryos; · research and training involving the fertilisation of a human egg, up to the first mitotic division, outside the body of a woman for the purposes of research or training; · creation of hybrid embryos by the fertilisation of an animal egg by human sperm, and use of such embryos up to the first mitotic division, if-- · the creation or use is for the purposes of testing sperm quality; and · the creation or use will occur in an accredited ART centre. Section 21H(1A) has been included to make it clear that the new section 21H(1) does 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. Clause 11 amends section 21I of the Principal Act. Section 21I(3)(a)(i) provides that the NHMRC Licensing Committee must not issue a licence unless it is satisfied that appropriate protocols are in place to enable proper consent to be obtained before an excess ART embryo is used under a licence. This clause amends section 21I(3)(a)(i) to make it clear that if the NHMRC Licensing Committee is considering an application in relation to any other embryo or human egg then the same issue must be taken into account. Section 21I(4)(a) and (b) provide that when deciding whether to grant a licence the NHMRC Licensing Committee must take into account restricting the number of embryos necessary to achieve the goals of the project and also whether there are likely to be any significant advances in knowledge or improvements in technologies for treatment as the result of the use of the excess ART embryos. This clause amends these provisions to insert the same requirements when the NHMRC Licensing Committee is considering any other licence application (including any licence application in relation to, for example, the creation of embryos by SCNT or the fertilisation of human eggs up to the first mitotic division). 11

Clause 12 amends section 21L so that wherever there is a reference to "an excess ART embryo" (or similar), this is replaced with a reference to "an excess ART embryo, human egg or any other embryo" (or similar). This ensures that all of the licensing conditions that can be imposed in relation to the use of excess ART embryos can also be imposed in relation to the use of human eggs under a licence and the creation and use of any other embryos under a licence. Clause 12(7) inserts a new subsection (8) at the end of section 21L which provides that a licence in relation to embryos that are unsuitable for implantation (as defined) may provide that the NHMRC guidelines referred to in the definition of proper consent may apply in a modified form in relation to the use, under the licence, of excess ART embryos that are unsuitable for implantation. The purpose of this provision is to address Recommendations 20, 21 and 22 of the Lockhart Committee. The Lockhart Committee recommended that fresh ART embryos that are unsuitable for implantation, as defined by objective criteria, be able to be licensed for use for training and research. Currently the Principal Act does not expressly prohibit this. However, there is a statutory condition of licence that the responsible people in relation to an excess ART embryo must give proper consent to any research, in accordance with NHMRC guidelines. The relevant guidelines are the Australian Health Ethics Committee Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research 2004. These Guidelines provide that-- "A person responsible for an embryo must be free at any time to withdraw consent to further involvement in the research. In view of the fact that once an embryo has been destroyed it cannot be restored, it is recommended that the consent of the persons responsible to a use that will damage or destroy an embryo must not be acted upon until a suitable fixed period of time for reconsideration has been allowed, normally at least two weeks after their consent to such research. This 'cooling-off' period before consent becomes effective must be explained to the persons responsible when consent is obtained.". (page 53) Based on the Lockhart Committee discussion of the issue, it would appear that researchers and the NHMRC Licensing Committee has been interpreting this requirement such that embryos that are unsuitable for implantation and are not frozen (because they are unable to be frozen or because they are 12

unsuitable for implantation), cannot be used for research because the 14 day cooling-off period would preclude this. To address this issue, it is proposed that a new section 24(8) be added that clarifies that if the NHMRC Licensing Committee considers it appropriate, it may approve the use of embryos that are unsuitable for implantation and alter the cooling-off period that would be "normally at least two weeks" as recommended by the NHMRC. This would allow the use of excess ART embryos that are unsuitable for implantation and would still ensure that appropriate consent is obtained from the responsible people. In no circumstances would embryos that are not excess be able to be used. It is proposed that the NHMRC develop clear and objective criteria defining those embryos that are unsuitable for implantation. Clause 13 amends section 21Q(1)(b) and 21Q(1)(d) so that wherever there is a reference to "excess ART embryos" (or similar), this is replaced with a reference to excess ART embryos, human egg and other embryos. This means that the NHMRC must now also include on its database information about licences issued authorising the creation and use of other embryos and the use of human eggs. Clause 14 amends section 21S of the Principal Act. Recognising the new decision-making role of the NHMRC under section 21L(8) (in terms of being able to modify a statutory condition of licence such that different rules should apply in relation to proper consent for use of embryos that are unsuitable for implantation), this clause amends section 21S to make this decision reviewable by the Administrative Appeals Tribunal. Clause 15 amends section 21T of the Principal Act to make this decision reviewable by the Administrative Appeals Tribunal. Clause 16 amends Part 2A of the Principal Act in relation to inspectors' monitoring powers. The Lockhart Committee recommended that the monitoring powers be strengthened to enable entry, inspection and enforcement in relation to non-licensed facilities in the same manner and by the observance of the same procedures as applicable to search warrants under Commonwealth legislation (Recommendation 39). 13

To give effect to this recommendation, changes have been made in Part 2A of the Principal Act to enable inspectors to apply to a Magistrate for a search warrant in relation to non-licensed premises. The approach adopted is consistent with the approach detailed in the Gene Technology Act 2000 of the Commonwealth (as referenced by the Lockhart Committee) and with general Australian Government law enforcement policy. Clause 16 amends section 21U (which deals with powers available to inspectors for monitoring compliance) to enable inspectors to enter premises where the entry is made under a warrant under new section 21WA. Clause 17 inserts the words "other embryo, human egg" after the word "human embryo" in section 21V of the Principal Act so that the monitoring powers apply not just to a human embryo but also to any other embryo or human egg. Clause 17(3) amends section 21V(1) by adding two additional powers that may be exercised by inspectors authorised to enter premises by a warrant under section 21WA. An inspector may require any person in or on the premises to-- · answer any questions put by the inspector; and · produce any book, record or document requested by the inspector. Clause 18 amends section 21W of the Principal Act to ensure that the power to secure applies not just to a human embryo but also to any other embryo or human egg. Clause 19 inserts new sections 21WA to 21WD into the Principal Act. New section 21WA provides that an inspector may apply to a magistrate for a warrant and the magistrate may issue a warrant if he/she is satisfied that it is reasonably necessary that one or more inspectors should have access to the premises for the purposes of finding out whether Part 2A or any regulations made for the purposes of the Part have been complied with. The warrant enables one or more inspectors to enter premises and exercise the powers set out in section 21V in relation to the premises. 14

New section 21WB provides that if a warrant under section 21WA is being executed and the occupier of the premises or another person who represents the occupier is present at the premises, then the inspector must make a copy of the warrant available to the person and identify himself or herself to that person. New section 21WC provides that an inspector must, before entering premises under a warrant, announce that he or she is authorised to enter the premises and give any person at the premises an opportunity to allow entry to the premises. New section 21WD provides that if a warrant is being executed and the occupier of the premises (or another person who represents the occupier) is present at the premises, the person is entitled to observe the search being conducted but must not impede the search. Clause 20 inserts a new section 21ZA into the Principal Act to ensure that the monitoring powers exercised by inspectors in Victoria are consistent with the powers exercised under the Commonwealth Acts. Clause 21 replaces the heading to Part 4A of the Principal Act which is currently entitled "Prohibited Practices" with a new heading "Prohibited Practices including Prohibition on Human Cloning for Reproduction". Division 1 of Part 4A describes those practices which are completely prohibited and Division 2 describes those practices which are prohibited unless they are authorised by a licence issued by the NHMRC Licensing Committee. Clause 22 replaces the heading to Division 1 of Part 4 of the Principal Act, which is currently entitled "Human Cloning" with a new heading "Practices that are Completely Prohibited". Clause 23 repeals section 38A of the Principal Act which made it an offence to create a human embryo clone. However, section 38B is retained, and the effect of section 38B is to ban human cloning for the purposes of reproduction. The maximum penalty for this offence is imprisonment for 15 years. The retention of this ban is consistent with Recommendation 2 of the Lockhart Committee. Clause 24 amends section 38D of the Principal Act to remove a reference to the repealed section 38A. 15

Clause 25 repeals the current heading to Division 2 of Part 4A of the Principal Act. Clause 26 repeals section 38E of the Principal Act, which made it an offence to create a human embryo other than by fertilisation, or develop such an embryo. Under Division 2 of Part 4A this activity will now be allowed under licence. Clause 27 amends section 38F of the Principal Act so that it prohibits a person from intentionally creating a human embryo by a process of the 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. This offence attracts a maximum penalty of 15 years imprisonment. The effect of this prohibition is that a person must not create an embryo by the fertilisation of human egg and human sperm for the purposes of research. Such an embryo may only be created for the ART treatment of a particular woman. This clause reflects Recommendations 12 and 13 of the Lockhart Committee. Clause 28 amends section 38G of the Principal Act to provide that a person commits an offence if the person intentionally creates or develops a human embryo by a process of the fertilisation of a human egg by a human sperm outside the body of a woman and the human embryo contains genetic material provided by more than 2 persons. The maximum penalty for this offence is 15 years imprisonment. This increases the existing penalty for creation of an embryo involving genetic material from more than two people. The Lockhart Committee recommended that development of a human embryo using genetic material from more than two people be permitted under license. However, if this involves the creation of an embryo by fertilisation of human egg by human sperm then this would be inconsistent with Lockhart Recommendation 13 that recommends that embryos, created by human egg and human sperm, should not be created for the purposes of research. Therefore this offence has been drafted so as to prohibit the creation of an embryo by human egg and human sperm regardless of whether that also involves genetic material from more than two people. If the creation of the human embryo involves genetic material from more than two people but it has been created by other means (i.e. not by fertilisation of human egg by human sperm) then this can potentially be licensed by the NHMRC Licensing Committee (refer new section 38OB). 16

This approach reflects the spirit of Recommendations 13 and 26 of the Lockhart Committee. Clause 29 increases the maximum penalty for the existing offence in section 38H of the Principal Act from 10 to 15 years imprisonment. Section 38H requires that a human embryo must not be allowed to develop, outside the body of a woman, beyond 14 days (excluding any time that the embryo's development is suspended whilst frozen in storage). This provision applies regardless of how the embryo was created and whether or not it was created using human sperm and human egg or by any other means. This means that a human embryo created by asexual means, such as by parthenogenesis, embryo splitting or somatic cell nuclear transfer, cannot be developed beyond 14 days. In the case of embryos created for ART, this provision does not adversely impact ART clinical practice where it is standard clinical practice for embryos to be implanted when they have reached between three and seven days of development. This clause reflects Recommendation 4 of the Lockhart Committee (development of a human embryo created by any means beyond 14 days gestation in any external culture or device should continue to be prohibited). Clause 30 repeals section 38I of the Principal Act, which made it an offence to use precursor cells from a human embryo of human fetus to create a human embryo, or develop such an embryo. This activity will be allowed under licence (see clause 38 inserting new Division 2 in Part 4A). Clause 31 increases the maximum penalty for the existing offence in section 38J of the Principal Act from 10 to 15 years imprisonment. Section 38J prohibits any manipulation of a human genome that is intended to be heritable, that is, able to be passed on to subsequent generations of humans. The section bans what is commonly referred to as germ line gene therapy. In germ line gene therapy, changes would be made to the genome of egg or sperm cells, or even to the cells of the early embryo. The genetic modification would then be passed on to any offspring born to the person whose cell was genetically modified and also to subsequent generations. 17

Clause 32 increases the maximum penalty for the existing offence in section 38K of the Principal Act from 10 years to 15 years imprisonment. Section 38K prohibits the removal of viable human embryos from the body of a woman after fertilisation has taken place in vivo--a practice sometimes referred to as embryo flushing. Embryo flushing is commonly used in animal husbandry and while there have been no recent reports of it being used in humans there is a concern that a healthy human embryo could be removed from a woman's uterus before it implants so that it could be used for research or for transfer to another woman. The retention of this prohibition reflects Recommendation 11 of the Lockhart Committee (collection of a viable human embryo from the body of a woman should continue to be prohibited). Clause 33 amends section 38L of the Principal Act to remove the prohibition on the creation of a hybrid embryo while retaining the prohibition on the intentional creation of a chimeric embryo (as defined in the Principal Act). 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. A chimeric embryo is also defined to include anything else that is declared by the regulations to be a chimeric embryo. As at September 2006, there were no additional types of chimeric embryo prescribed in the regulations. The retention of this prohibition is consistent with the Lockhart Committee's recommendation that chimeric embryos should continue to be prohibited (Recommendation 6). Recommendation 6 also addressed the issue of human-animal hybrid embryos and notes that in certain limited circumstances, human-animal hybrids should be permitted to be created under licence. There does not appear to be any recommendation suggesting that chimeric embryos be created under licence. As such, the complete ban on the creation of any chimeric embryos has been retained through this clause. Failure to comply with the prohibition attracts a maximum penalty of 15 years imprisonment (increasing the current penalty in section 38L). Clause 34 inserts a new section 38LA into the Principal Act that provides that a person commits an offence if the person intentionally develops a hybrid embryo for a period of more than 14 days, excluding any period when development is suspended. 18

This section should be read in conjunction with clause 37 which inserts a new section 38OD in Part 4A to enable the creation and development of certain hybrid embryos under licence. This clause makes it clear that even if a person is authorised to create a hybrid embryo under a licence issued by the NHMRC Licensing Committee they are not ever permitted to develop such a hybrid embryo beyond 14 days. This section is consistent with Recommendations 17 and 24 of the Lockhart Committee. In these Recommendations, the Lockhart Committee suggests that only very specific types of interspecies fertilisation and hybrid embryos be permitted to be created. In order to implement this intent, three interacting sections of the Principal Act are proposed. New section 38LA bans the development of a hybrid embryo beyond 14 days (but does not ban the creation of hybrid embryos), new section 38OD provides that if someone wishes to create a hybrid embryo they must only do so in accordance with a licence and the proposed amended section 21H makes it clear that the only types of hybrid embryos for which a licence may be granted are the two specific types mentioned in the Lockhart Recommendations. Clause 35 increases the maximum penalty for the existing offence in section 38M of the Principal Act from 10 years to 15 years imprisonment. Section 38M currently prohibits the placement of-- · a human embryo in an animal; or · a human embryo into the body of a human, including a man or any part of a woman's body, other than the female reproductive tract; or · an animal embryo in a human, for any period of gestation. Section 38M should be read in conjunction with section 38B which bans the placement of a human embryo clone in the body of a woman or animal and section 38N(3) which bans the placement of any "prohibited embryo" in the body of a woman. Clause 36 increases the maximum penalty for the existing offence in section 38N of the Principal Act from 10 years to 15 years imprisonment. 19

Section 38N prohibits the intentional import into Australia, intentional export from Australia or the intentional placement in the body of a woman of "prohibited embryos". A prohibited embryo is defined to mean the following-- · a human embryo created by a process other than the fertilisation of a human egg by human sperm; · 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; · a human embryo that is created using human egg and human sperm and contains genetic material provided by more than 2 persons; · a 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; · a human embryo created using precursor cells taken from a human embryo or a human foetus; · 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; · a human embryo that was removed from the body of a woman by a person intending to collect a viable human embryo; · a chimeric embryo or a hybrid embryo. The Commonwealth Amendment Act repealed Regulation 7 of the Customs (Prohibited Exports) Regulations 1958 in order to remove restrictions on couples who wish to take their ART embryos from Australia in order to continue their ART treatment in another country. It is intended that the practice of importing or exporting embryos (that have been created by fertilisation of a human egg by human sperm) for the ART treatment of a particular couple, will be permitted, subject to the Quarantine Act 1908 of the Commonwealth. 20

Clause 37 increases the maximum penalty for the existing offences in section 38O of the Principal Act from 10 years to 15 years imprisonment. Section 38O reflects Recommendation 33 of the Lockhart Report which states that the present prohibition of the sale of sperm, eggs and embryos should continue, but the reimbursement of reasonable expenses should continue to be permitted. The section prevents the commercial trading of human eggs, sperm and embryos. Both parties involved in commercial trading of such material would be committing an offence (for example, the person who sells the egg, sperm or embryo and the person who purchases the egg, sperm or embryo). The only consideration which may be given in relation to the supply of gametes or embryos is reimbursement of reasonable expenses related to that supply, including expenses incurred for the collection, storage and transport where relevant. This means if, for example, semen is transferred from one clinic to another, the second clinic could reimburse the first clinic for the costs of storage and transport of the semen. A further example is where a woman who is to be treated with donated eggs could pay for the cost of the egg retrieval from another woman. Reasonable expenses in relation to the supply of a human embryo, where that embryo is donated to another couple, do not include any expenses incurred by the person or couple (for whom the embryo was originally created), before the embryo was determined to be excess to their needs. That is, if a person has excess embryos and they wish to donate the embryos to other people, they cannot have the costs of their IVF treatment reimbursed by the person receiving the donated embryos. This clause is not intended to address the issue of surrogacy. It is proposed that surrogacy continue to be dealt with through State and Territory legislation and that it not be addressed as part of this particular national scheme. Clause 38 inserts a new Division 2 in Part 4A of the Principal Act to provide for practices that are prohibited unless authorised by a licence. New section 38OA provides that a person must not create a human embryo by a process other than the fertilisation of a human egg by a human sperm (or develop a human embryo so created) unless they are authorised to do so by a licence issued by the NHMRC Licensing Committee. 21

This allows researchers to apply to the NHMRC Licensing Committee to create embryos using techniques such as SCNT. This reflects Recommendation 23 of the Lockhart Report. Rather than specifically prohibiting human somatic cell nuclear transfer without a licence, the clause has been drafted more generally to cover creation of embryos by any means other than fertilisation of human egg by human sperm. This is consistent with the NHMRC definition of a human embryo, which recognises that technology may change and that all embryos however created must be captured by the legislation. It is important that this section be read in the context of section 38H which bans the development of a human embryo outside the body of a woman for more than 14 days and sections 38B and 38N(3) which ban the placement in the body of a woman of a human embryo clone, or any other human embryo created other than by the fertilisation of a human egg by a human sperm. The maximum penalty for failure to comply with this provision is imprisonment for 10 years. New section 38OB provides that a person may only create or develop a human embryo (by a process other than the fertilisation of human egg by human sperm) that contains genetic material provided by more than 2 persons if it is authorised by a license issued by the NHMRC Licensing Committee. This section only allows creation of embryos containing genetic material from 2 or more people if the embryo has been created by a means other than fertilisation. As noted in relation to the amendment to section 38G in clause 27 above, the Lockhart Committee recommended that development of a human embryo using genetic material from more than two people be permitted under licence. However, if this involves the creation of an embryo by fertilisation of human egg by human sperm then this would be inconsistent with Lockhart Recommendation 13 that suggests that embryos, created by human egg and human sperm, should not be created for the purposes of research. Therefore this offence has been drafted so as to only allow the licensing of the creation and development of a human embryo involving genetic material from more than two people if it has been created by means other than fertilisation of human egg by human sperm. This approach reflects the spirit of Recommendations 13 and 26 of the Lockhart Committee. 22

The notes at the base of the provision remind readers that the development of a human embryo outside the body of a woman for more than 14 days is prohibited by clause 38H. The maximum penalty for an offence against this provision is imprisonment for 10 years. New section 38OC provides that a person commits an offence if the person uses precursor cells taken from a human embryo or a human foetus to create (or develop) an embryo unless they are authorised to do so by a licence issued by the NHMRC Licensing Committee. The maximum penalty for non-compliance with this clause is imprisonment for 10 years. This new section implements Recommendation 27 of the Lockhart Committee which provided that creation of embryos using precursor cells from a human embryo or a human fetus should be permitted, under licence, for research, training and clinical applications, including production of human embryonic stem cells, as long as the research satisfies all the criteria outlined in the Principal Act, as amended by the Bill, and these embryos are not implanted into the body of a woman or allowed to develop for more than 14 days. New section 38OD bans the creation or development of a hybrid embryo unless the creation or development of the hybrid embryo is authorised by a licence issued by the NHMRC Licensing Committee. It is important that this section be read in conjunction with proposed amended section 21H that further restricts the circumstances in which someone may apply for a licence to create or develop a hybrid embryo. Proposed amended section 21H(1) makes it clear that a licence may only be issued in the following circumstances-- · for the purposes of testing sperm quality in an accredited ART centre. In this case, the hybrid embryo may only be developed up to (but not including) the first mitotic division. This is consistent with Recommendation 17 of the Lockhart Committee and would enable ART tests that were carried out by ART clinics prior to the commencement of Part 4A to once again be permitted. In the context of the changes that this Bill proposes, it could be argued that there may be doubt surrounding whether the definition of a "hybrid embryo" captures sperm quality tests where the animal egg is combined with human sperm but does not 23

develop past the first mitotic division. To put this beyond doubt, it is suggested that regulations be made prescribing animal eggs in the process of fertilisation by a human sperm (but yet to reach the first cell division) as hybrid embryos; · for the creation of a hybrid embryo created by introducing the nucleus of a human cell into an animal egg. In this case, the hybrid embryo may be developed up to 14 days. This is consistent with Lockhart Recommendation 24 that states that "In order to reduce the need for human oocytes, transfer of human somatic cell nuclei into animal oocytes should be allowed, under licence, for the creation and use of human embryo clones for research, training and clinical application, including the production of human embryonic stem cells, as long as the activity satisfies all the criteria outlined in the amended Act and these embryos are not implanted into the body of a woman or allowed to develop for more than 14 days". This offence attracts a maximum penalty of 10 years imprisonment. Clause 39 amends section 162 of the Principal Act to exclude both Part 2A and Part 4A from the general search warrant provisions. This is because the search warrant provisions in Part 2A apply to allow inspectors to enforce Parts 2A and 4A and duplication with the general provision is not required. Clause 40 inserts transitional provisions in Part 14 of the Principal Act 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. Clause 41 provides for the automatic repeal of this amending Act one year after all of its provisions have come into operation. As suggested by the Scrutiny of Acts and Regulations Committee, all amending Acts now contain an automatic repeal provision, which will save the time and expense of having to repeal amending Acts in statute law revision Bills. The repeal of this Act does not affect in any way the operation of the 24

amendments made by this Act (see section 15(1) of the Interpretation of Legislation Act 1984). Table 1: Summary of proposed changes to prohibitions detailed in Part 4A of the Infertility Treatment Act 1995 Current New Short description of Section Section the change Offence--creating a human Section Deleted Human embryo embryo clone 38A clones will be allowed to be created for research only up to 14 days and provided the creation is licensed Offence--placing a human Section No change embryo clone in the human 38B body or the body of a woman Offence--importing or Section No change exporting a human embryo 38C clone No defence that human Section No change (except to embryo clone could not 38D internal cross survive referencing of sections) Offence--creating a human Section Deleted Creation of an embryo other than by 38E embryo other than fertilisation, or developing by human sperm and such an embryo egg will only be permitted under licence and only up to 14 days (section 38OA) Offence--creating a human Section Embryos created embryo for a purpose other 38F using sperm and egg than achieving pregnancy in may only be created a woman for achieving pregnancy. Penalty increased Embryos created by any other means will only be able to be created under licence (section 38OA) 25

Current New Short description of Section Section the change Offence--creating or Section Creation of an developing a human embryo 38G embryo by human containing genetic material sperm & egg & provided by more than involving genetic 2 persons material from 2 or more people will be prohibited. Penalty increased. Creation of an embryo by other means (where it includes genetic material from 2 or more people) will only be permitted under licence (section 38OB) Offence--developing a Section No change except human embryo outside the 38H penalty increased body of a woman for more than 14 days Offence--using precursor Section Deleted Only permitted cells from a human embryo 38I under licence (up to or a human fetus to create a 14 days human embryo, or development) developing such an embryo section 38OC Offence--heritable Section No change except alterations to genome 38J penalty increased Offence--collecting a viable Section No change except embryo from the body of a 38K penalty increased woman Offence--creating a Section Section No change except chimeric embryo 38L(1) 17 penalty increased Offence creating a hybrid Section Deleted Creating & embryo 38L(2) developing a hybrid embryo up to 14 days will only be permitted under licence and in very limited circumstances (section 38OD) 26

Current New Short description of Section Section the change Offence--placing of an Section No change except embryo 38M penalty increased Offence--importing, Section No change except exporting or placing a 38N penalty increased prohibited embryo Offence--commercial Section No change except trading in human eggs, 38O penalty increased human sperm or human embryos Appendix 1: Summary of Lockhart recommendations and how these are addressed in the Bill How the issue is addressed in Lockhart Review recommendation the Bill 1 Clinical practice and scientific The national legislative research involving assisted scheme will continue to exist. reproductive technologies (ART) and the creation and use of human embryos for research purposes should continue to be subject to specific national legislation. 2 Reproductive cloning should Sections 38B and 38H continue to be prohibited. continue to ban the development of a human embryo clone for longer than 14 days and the implantation of such a clone in a human or animal. Section 38N also bans the development and implantation of any embryo that does not result from the fertilisation of a human egg by human sperm. 3 Implantation into the reproductive This is banned in section 38N tract of a woman of a human of the Act. embryo created by any means other than fertilisation of an egg by a sperm should continue to be prohibited. 27

How the issue is addressed in Lockhart Review recommendation the Bill 4 Development of a human embryo This is banned in section 38H created by any means beyond 14 of the Act. days gestation in any external culture or device should continue to be prohibited. 5 Implantation into the reproductive This is banned in section 38N tract of a woman of a human of the Act. animal hybrid or chimeric embryo should continue be prohibited. 6 Development of a humananimal Creation of chimeric embryos hybrid or chimeric embryo should is banned in section 38L of the continue to be prohibited, except as Act. The creation and indicated in Recommendation 17. development of hybrid embryos is banned by proposed section 38OD , unless authorised by licence. The only licences that may be issued are ones giving effect to recommendations 17 and 24. Development of hybrid embryos beyond 14 days is banned in all cases by proposed section 38LA. 7 Placing a human embryo into an This is banned in section 38M animal or into the body of a human of the Act. apart from into a woman's reproductive tract, or placing an animal embryo into the body of a human, for any period of gestation, should all remain prohibited. 8 Implantation into the reproductive This is banned in section 38N tract of a woman of an embryo of the Act. created with genetic material provided by more than two people should continue to be prohibited. 9 Implantation into the reproductive This is banned in section 38N tract of a woman of an embryo of the Act. created using precursor cells from a human embryo or a human fetus should continue to be prohibited. 28

How the issue is addressed in Lockhart Review recommendation the Bill 10 Implantation into the reproductive This is banned in section 38N tract of a woman of an embryo Act. carrying heritable alterations to the genome should continue to be prohibited 11 Collection of a viable human This is banned in section 38K embryo from the body of a woman of the Act. should continue to be prohibited. 12 Creation of human embryos by This will continue to be the fertilisation of human eggs by case (section 38F of the Act). human sperm should remain restricted to ART treatment for the purposes of reproduction. 13 Creation of human embryos by This is banned in proposed fertilisation of human eggs by section 38F of the PHC Act, human sperm to create embryos for which makes it an offence to the purposes of research should create a human embryo by continue to be prohibited except in fertilisation of human egg the situation described in with human sperm for any Recommendation 15. purpose other than achieving pregnancy. 14 Use of excess ART embryos in Use of excess ART embryos research should continue to be in research will continue to be permitted, under licence, as under permitted, under licence current legislation. (proposed amended section 21H of the Act). 15 Research involving fertilisation of The proposed amendments to human eggs by human sperm up to, section 21H of the Act allow a but not including, the first cell person to apply to the division should be permitted for Licensing Committee to research, training and undertake research involving improvements in clinical practice of fertilisation of human eggs by ART. human sperm up to, but not including, the first cell division. Such activity not authorised by a licence is banned under proposed section 21CB of the Act. 29

How the issue is addressed in Lockhart Review recommendation the Bill 16 Testing of human oocytes for Testing by fertilisation up to maturity by fertilisation up to, but the first mitotic division will not including, the first cell division be permitted under licence or by parthenogenetic activation (proposed sections 21CB and should be permitted for research, 21H of the RIHE Act). training and improvements in Parthenogenic activation will clinical practice of ART. be also be permitted under licence in accord with recommendation 25 (amended section 21H of the Act allows a person to apply for a licence to create an embryo by any means other than fertilisation of human egg by human sperm). 17 Certain interspecies fertilisation and Proposed section 21H(1)(f) development up to, but not enables the granting of a including, the first cell division licence to permit this. should be permitted for testing gamete viability to assist ART training and practice. 18 The Licensing Committee should No legislative change develop a simple proforma required. application for licences to undertake training and quality assurance activities for ART clinics. 19 Consideration should be given to Proposed amended section the use of cytoplasmic transfer 21H of the Act will permit, (including transfer of mitochondrial under licence, certain types of DNA), under licence, for research research that may be useful in on mitochondrial disease and other relation to cytoplasmic uses to improve ART treatment. transfer. However, an embryo containing genetic material from more than two people (and created by the fertilisation of human egg and sperm) will not be able to be created for research purposes. 30

How the issue is addressed in Lockhart Review recommendation the Bill 20 An expert body should formulate The new definition of objective criteria to define those unsuitable for implantation in embryos that are unsuitable for section 21A of the Act implantation. provides for this. 21 Fresh ART embryos that are New section 21L(8) in the Act unsuitable for implantation, as enables the Licensing defined by the objective criteria, Committee to modify the should be permitted to be used, requirements for "proper under licence, for research, training consent" in relation to use of and improvements in clinical such embryos. This will practice. enable the current 14 day cooling-off period to be shortened, so as to allow the use of fresh embryos. 22 Fresh ART embryos that are New section 21L(8) in the Act diagnosed by preimplantation (described immediately above) genetic diagnosis (according to the will enable this. ART guidelines) as being unsuitable for implantation should be permitted to be used, under licence, for research, training and improvements in clinical practice. 23 Human somatic cell nuclear transfer Section 38E of the Act bans should be permitted, under licence, the creation or development of to create and use human embryo a human embryo by a process clones for research, training and other than fertilisation unless clinical application, including the this is licensed. Section 21H production of human embryonic of the Act provides for the stem cells, as long as the activity licensing of the creation and satisfies all the criteria outlined in use of such embryos. This has the amended Act and these embryos the effect of allowing SCNT are not implanted into the body of a under licence. The Act also woman or allowed to develop for bans the development of any more than 14 days. human embryo (including a human clone) outside the body of a woman beyond 14 days (section 38H), and the implantation of a human embryo clone (or any embryo that has not been created using sperm and egg) (sections 38B and 38N(3)). 31

How the issue is addressed in Lockhart Review recommendation the Bill 24 In order to reduce the need for Recommendation not human oocytes, transfer of human accepted. It is an offence to somatic cell nuclei into animal create, develop, or develop oocytes should be allowed, under beyond 14 days, such embryos licence, for the creation and use of for this purpose; sections 23B human embryo clones for research, and 38LA refer. training and clinical application, including the production of human embryonic stem cells, as long as the activity satisfies all the criteria outlined in the amended Act and these embryos are not implanted into the body of a woman or allowed to develop for more than 14 days. 25 Creation of human embryos and Proposed section 38OA of the human embryo clones by means Act bans such activity, except other than fertilisation of an egg by under licence. Proposed a sperm (such as nuclear or amended section 21H of the pronuclear transfer and Act provides for the granting parthenogenesis) should be of licences. Section 38B of permitted, under licence, for the Act bans the implantation research, training and clinical of such embryos and section applications, including production 38H of the Act bans their of human embryonic stem cells, as development for longer than long as the research satisfies all the 14 days. criteria outlined in the amended Act and these embryos are not implanted into the body of a woman or allowed to develop for more than 14 days. 26 Creation of human embryos using The combined effect of the genetic material from more than proposed sections 38G and two people, or including heritable 38OB, and section 21H of the genetic alterations, should be Act is that the Licensing permitted, under licence, for Committee may licence the research, training and clinical creation of embryos that applications, including production include genetic material from of human embryonic stem cells, as more than two people long as the research satisfies all the provided that the embryo is criteria outlined in the amended Act created by means other than 32

How the issue is addressed in Lockhart Review recommendation the Bill and these embryos are not fertilisation of a human egg by implanted into the body of a woman human sperm. Fertilisation or allowed to develop for more than studies may also be 14 days. undertaken, under licence, up to (but not including) the first mitotic division. 27 Creation of embryos using Proposed section 38OC of the precursor cells from a human Act bans such activity, except embryo or a human fetus should be under licence. Proposed permitted, under licence, for section 21H provides for the research, training and clinical granting of licences. Section applications, including production 38N of the Act bans the of human embryonic stem cells, as implantation of such embryos long as the research satisfies all the and section 38H bans their criteria outlined in the amended Act development for longer than and these embryos are not 14 days. implanted into the body of a woman or allowed to develop for more than 14 days. 28 The definition of a human embryo This was the NHMRC's draft in both Acts should be changed to: definition at the time the "A human embryo is a discrete Lockhart Report was written. living entity that has a human The final NHMRC definition genome or an altered human differed slightly from the draft genome and that has arisen from definition. The proposed new either: (i) the first mitotic cell definition in the Act is the division when fertilisation of a final NHMRC definition. human oocyte by a human sperm is complete; or (ii) any other process that initiates organised development of a biological entity with a human nuclear genome or altered human nuclear genome that has the potential to develop up to, or beyond, 14 days and has not yet reached eight weeks of development." 33

How the issue is addressed in Lockhart Review recommendation the Bill 29 The National Health and Medical For consideration by the Research Council (NHMRC) NHMRC--No changes to the should review its guidelines in legislation required. relation to consent to research on excess ART embryos, in order to clarify the consent process in relation to the following issues: · the circumstances, if any, where those who choose to donate excess ART embryos to research may be able to choose not to be contacted at some later stage to give consent to a particular research proposal · the circumstances, if any, where a human research ethics committee can determine that the researcher need not ask for further consent to use embryos already declared "excess" · the development of an appropriate form of consent that could be completed by the responsible persons for excess ART embryos shortly after the declaration that the embryos are excess · the manner in which those who donate embryos or gametes for the creation of ART embryos may express any preference for the type of research for which the tissue will be used, once the embryo is declared excess. 34

How the issue is addressed in Lockhart Review recommendation the Bill 30 The NHMRC should develop For consideration by the ethical guidelines for the use of NHMRC--No changes to the embryos that are unsuitable for legislation required. implantation for research, training and improvements in clinical practice (see Recommendations 2022). 31 The current principles of consent The proposed amendments to for participation in medical research the definition of "proper must apply to sperm, egg and consent" in the Act make it embryo donors, so as to ensure that clear that proper consent must decisions are freely made. be gained for any research involving human eggs or human embryos. 32 The NHMRC should develop For consideration by the guidelines for egg donation. NHMRC--No changes to the legislation required. 33 The present prohibition of the sale Section 38O of the Act of sperm, eggs and embryos should maintains the existing continue, but the reimbursement of prohibition. reasonable expenses should continue to be permitted. 34 The Embryo Research Licensing This continues to be the Committee of the NHMRC (the case--no changes to the Licensing Committee) should legislation required. continue to be the regulatory body responsible for assessing licence applications, issuing licences and monitoring compliance, as under current arrangements. 35 The role of the Licensing Proposed amendments to Committee should be extended to section 21H of the Act will include assessment of licensing enable the Licensing applications and issuing licences Committee to do this. for any additional activities permitted, under licence (see Recommendations 1427). 35

How the issue is addressed in Lockhart Review recommendation the Bill 36 The Australian Parliament and the Amendments to the Council of Australian Governments Commonwealth Research should give urgent attention to the Involving Human Embryos problem of delays in the filling of Act 2002 (new subsections (7) vacancies on the Licensing and (8)) address this Committee. recommendation. 37 There should be no attempt to This continues to be the case. recover the cost of administration, licensing, monitoring and inspection activities associated with the legislation from researchers at this point in time. 38 The Licensing Committee should This continues to be the case. continue to perform its functions in relation to licences and databases for research permitted by licences under the Research Involving Human Embryos Act. 39 Licensing Committee inspectors Proposed new sections 21WA, should be given powers, under the 21WB, 21WC and 21 WD in Prohibition of Human Cloning Act the Act provide for these and the Research Involving Human powers. Embryos Act, of entry, inspection and enforcement in relation to non- licensed facilities in the same manner and by the observance of the same procedures as applicable to search warrants under Commonwealth legislation, if such powers do not clearly exist. 40 There should be a continuation of No changes to legislation the role of the Reproductive required. Technology Accreditation Committee in the regulation of ART. 36

How the issue is addressed in Lockhart Review recommendation the Bill 41 The import or export of a patient's Regulation 7 of the Customs reproductive material, including (Prohibited Exports) ART embryos, for the purpose of Regulations 1958 has been that person's ongoing ART repealed. treatment should not require any regulation other than that required under existing quarantine regulation. 42 The import or export of ethically Section 23 C of the derived viable materials from Commonwealth Research human embryo clones should be Involving Human Embryos permitted after approval by the Act 2002 requires the Minister appropriate authority. for Customs to take all reasonable steps to ensure that regulations are made permitting this. 43 The existing requirements for the No changes to legislation import and export of human required. biological materials are satisfactory and, for ethically derived human embryonic stem cells, no further restrictions are necessary. 44 Trade in human gametes or This continues to be the case embryos, or any commodification under 38O of the Act. of these items, should continue to be prohibited. 45 Donors of tissue that is going to The proposed changes to the result in an immortal stem cell line Act ensure that there must be should be informed by means of proper consent (in accordance processes monitored by human with NHMRC guidelines) in research ethics committees about relation to any use or creation the potential use of that stem cell of embryos. line, including the potential for commercial gain and the fact that they may not have any rights in potential stem cell developments. 46 The development of biotechnology No changes to legislation and pharmaceutical products arising required. from stem cell research should be supported. 37

How the issue is addressed in Lockhart Review recommendation the Bill 47 A national stem cell bank should be The Commonwealth Research established. Involving Human Embryos Act 2002 requires the Federal Minister to report to Parliament (within 6 months) regarding the establishment of a national register of donated excess ART embryos. 48 Consideration should be given to No changes to legislation the feasibility of the Australian required. Stem Cell Centre operating the stem cell bank. 49 A national register of donated The Commonwealth Research excess ART embryos should be Involving Human Embryos established. Act 2002 requires the Federal Minister requires the Minister to report to Parliament (within 6 months) regarding the establishment of a national register of donated excess ART embryos. 50 The Licensing Committee should be Proposed section 21EA avoids authorised under the Prohibition of constitutional issues Human Cloning Act to give binding associated with binding rulings on the interpretation of that rulings, but addresses the Act, or the regulations made under basic concern of the Lockhart that Act, on condition that it reports Committee which appeared to immediately and in detail to the be the potential liability of NHMRC and to parliament on such researchers where they are rulings. acting in good faith in accordance with a licence but where the NHMRC Licensing Committee in fact had no power to issue the licence. 51 The Licensing Committee should be Proposed section 21EA authorised by the Research (as described above). Involving Human Embryos Act to give binding rulings and to grant licences on the basis of those rulings for research that is not within the literal wording of the Act, or the regulations made under 38

How the issue is addressed in Lockhart Review recommendation the Bill the Act, but is within their tenor, on condition that the Committee reports immediately and in detail to the NHMRC and to parliament on any rulings it gives, or any licences it grants, in that way. Appendix 1: Summary of Lockhart Committee recommendations and how these are addressed in the Bill Lockhart Committee How the issue is addressed in recommendation the Bill 1 Clinical practice and scientific The national legislative research involving assisted scheme will continue to exist. reproductive technologies (ART) and the creation and use of human embryos for research purposes should continue to be subject to specific national legislation. 2 Reproductive cloning should Sections 38B and 38H continue to be prohibited. continue to ban the development of a human embryo clone for longer than 14 days and the implantation of such a clone in a human or animal. Section 38N also bans the development and implantation of any embryo that does not result from the fertilisation of a human egg by human sperm. 3 Implantation into the reproductive This is banned in section 38N tract of a woman of a human of the Act. embryo created by any means other than fertilisation of an egg by a sperm should continue to be prohibited. 39

Lockhart Committee How the issue is addressed in recommendation the Bill 4 Development of a human embryo This is banned in section 38H created by any means beyond 14 of the Act. days gestation in any external culture or device should continue to be prohibited. 5 Implantation into the reproductive This is banned in section 38N tract of a woman of a human of the Act. animal hybrid or chimeric embryo should continue be prohibited. 6 Development of a humananimal Creation of chimeric embryos hybrid or chimeric embryo should is banned in section 38L of continue to be prohibited, except as the Act. The creation and indicated in Recommendation 17. development of hybrid embryos is banned by proposed section 38OD , unless authorised by licence. The only licences that may be issued are ones giving effect to recommendations 17 and 24. Development of hybrid embryos beyond 14 days is banned in all cases by proposed section 38LA. 7 Placing a human embryo into an This is banned in section 38M animal or into the body of a human of the Act. apart from into a woman's reproductive tract, or placing an animal embryo into the body of a human, for any period of gestation, should all remain prohibited. 8 Implantation into the reproductive This is banned in section 38N tract of a woman of an embryo of the Act. created with genetic material provided by more than two people should continue to be prohibited. 9 Implantation into the reproductive This is banned in section 38N tract of a woman of an embryo of the Act. created using precursor cells from a human embryo or a human fetus should continue to be prohibited. 40

Lockhart Committee How the issue is addressed in recommendation the Bill 10 Implantation into the reproductive This is banned in section 38N tract of a woman of an embryo Act. carrying heritable alterations to the genome should continue to be prohibited 11 Collection of a viable human This is banned in section 38K embryo from the body of a woman of the Act. should continue to be prohibited. 12 Creation of human embryos by This will continue to be the fertilisation of human eggs by case (section 38F of the Act). human sperm should remain restricted to ART treatment for the purposes of reproduction. 13 Creation of human embryos by This is banned in proposed fertilisation of human eggs by section 38F of the PHC Act, human sperm to create embryos for which makes it an offence to the purposes of research should create a human embryo by continue to be prohibited except in fertilisation of human egg the situation described in with human sperm for any Recommendation 15. purpose other than achieving pregnancy. 14 Use of excess ART embryos in Use of excess ART embryos research should continue to be in research will continue to be permitted, under licence, as under permitted, under licence current legislation. (proposed amended section 21H of the Act). 15 Research involving fertilisation of The proposed amendments to human eggs by human sperm up to, section 21H of the Act allow a but not including, the first cell person to apply to the division should be permitted for Licensing Committee to research, training and undertake research involving improvements in clinical practice of fertilisation of human eggs by ART. human sperm up to, but not including, the first cell division. Such activity not authorised by a licence is banned under proposed section 21CB of the Act. 41

Lockhart Committee How the issue is addressed in recommendation the Bill 16 Testing of human oocytes for Testing by fertilisation up to maturity by fertilisation up to, but the first mitotic division will not including, the first cell division be permitted under licence or by parthenogenetic activation (proposed sections 21CB and should be permitted for research, 21H of the RIHE Act). training and improvements in Parthenogenic activation will clinical practice of ART. be also be permitted under licence in accord with recommendation 25 (amended section 21H of the Act allows a person to apply for a licence to create an embryo by any means other than fertilisation of human egg by human sperm). 17 Certain interspecies fertilisation and Proposed section 21H(1)(f) development up to, but not enables the granting of a including, the first cell division licence to permit this. should be permitted for testing gamete viability to assist ART training and practice. 18 The Licensing Committee should No legislative change develop a simple proforma required. application for licences to undertake training and quality assurance activities for ART clinics. 19 Consideration should be given to Proposed amended section the use of cytoplasmic transfer 21H of the Act will permit, (including transfer of mitochondrial under licence, certain types of DNA), under licence, for research research that may be useful in on mitochondrial disease and other relation to cytoplasmic uses to improve ART treatment. transfer. However, an embryo containing genetic material from more than two people (and created by the fertilisation of human egg and sperm) will not be able to be created for research purposes. 20 An expert body should formulate The new definition of objective criteria to define those "unsuitable for implantation" embryos that are unsuitable for in section 21A of the Act implantation. provides for this. 42

Lockhart Committee How the issue is addressed in recommendation the Bill 21 Fresh ART embryos that are New section 21L(8) in the Act unsuitable for implantation, as enables the Licensing defined by the objective criteria, Committee to modify the should be permitted to be used, requirements for "proper under licence, for research, training consent" in relation to use of and improvements in clinical such embryos. This will practice. enable the current 14 day cooling-off period to be shortened, so as to allow the use of fresh embryos. 22 Fresh ART embryos that are New subsection 21L(8) in the diagnosed by preimplantation Act (described immediately genetic diagnosis (according to the above) will enable this. ART guidelines) as being unsuitable for implantation should be permitted to be used, under licence, for research, training and improvements in clinical practice. 23 Human somatic cell nuclear transfer Section 38E of the Act bans should be permitted, under licence, the creation or development of to create and use human embryo a human embryo by a process clones for research, training and other than fertilisation unless clinical application, including the this is licensed. Section 21H production of human embryonic of the Act provides for the stem cells, as long as the activity licensing of the creation and satisfies all the criteria outlined in use of such embryos. This has the amended Act and these embryos the effect of allowing SCNT are not implanted into the body of a under licence. The Act also woman or allowed to develop for bans the development of any more than 14 days. human embryo (including a human clone) outside the body of a woman beyond 14 days (section 38H), and the implantation of a human embryo clone (or any embryo that has not been created using sperm and egg) (sections 38B and 38N(3)). 43

Lockhart Committee How the issue is addressed in recommendation the Bill 24 In order to reduce the need for Recommendation not human oocytes, transfer of human accepted. It is an offence to somatic cell nuclei into animal create, develop, or develop oocytes should be allowed, under beyond 14 days, such licence, for the creation and use of embryos for this purpose; human embryo clones for research, sections 23B and 38LA refer. training and clinical application, including the production of human embryonic stem cells, as long as the activity satisfies all the criteria outlined in the amended Act and these embryos are not implanted into the body of a woman or allowed to develop for more than 14 days. 25 Creation of human embryos and Proposed section 38OA of the human embryo clones by means Act bans such activity, except other than fertilisation of an egg by under licence. Proposed a sperm (such as nuclear or amended section 21H of the pronuclear transfer and Act provides for the granting parthenogenesis) should be of licences. Section 38B of permitted, under licence, for the Act bans the implantation research, training and clinical of such embryos and section applications, including production 38H of the Act bans their of human embryonic stem cells, as development for longer than long as the research satisfies all the 14 days. criteria outlined in the amended Act and these embryos are not implanted into the body of a woman or allowed to develop for more than 14 days. 26 Creation of human embryos using The combined effect of the genetic material from more than proposed sections 38G and two people, or including heritable 38OB, and section 21H of the genetic alterations, should be Act is that the Licensing permitted, under licence, for Committee may licence the research, training and clinical creation of embryos that applications, including production include genetic material from of human embryonic stem cells, as more than two people long as the research satisfies all the provided that the embryo is criteria outlined in the amended Act created by means other than and these embryos are not fertilisation of a human egg implanted into the body of a woman by human sperm. Fertilisation 44

Lockhart Committee How the issue is addressed in recommendation the Bill or allowed to develop for more than studies may also be 14 days. undertaken, under licence, up to (but not including) the first mitotic division. 27 Creation of embryos using Proposed section 38OC of the precursor cells from a human Act bans such activity, except embryo or a human fetus should be under licence. Proposed permitted, under licence, for section 21H provides for the research, training and clinical granting of licences. Section applications, including production 38N of the Act bans the of human embryonic stem cells, as implantation of such embryos long as the research satisfies all the and section 38H bans their criteria outlined in the amended Act development for longer than and these embryos are not 14 days. implanted into the body of a woman or allowed to develop for more than 14 days. 28 The definition of a 'human embryo' This was the NHMRC's draft in both Acts should be changed to: definition at the time the 'A human embryo is a discrete Lockhart Report was written. living entity that has a human The final NHMRC definition genome or an altered human differed slightly from the draft genome and that has arisen from definition. The proposed new either: (i) the first mitotic cell definition in the Act is the division when fertilisation of a final NHMRC definition. human oocyte by a human sperm is complete; or (ii) any other process that initiates organised development of a biological entity with a human nuclear genome or altered human nuclear genome that has the potential to develop up to, or beyond, 14 days and has not yet reached eight weeks of development.' 29 The National Health and Medical For consideration by the Research Council (NHMRC) NHMRC--No changes to the should review its guidelines in legislation required. relation to consent to research on excess ART embryos, in order to clarify the consent process in relation to the following issues: 45

Lockhart Committee How the issue is addressed in recommendation the Bill · the circumstances, if any, where those who choose to donate excess ART embryos to research may be able to choose not to be contacted at some later stage to give consent to a particular research proposal · the circumstances, if any, where a human research ethics committee can determine that the researcher need not ask for further consent to use embryos already declared 'excess' · the development of an appropriate form of consent that could be completed by the responsible persons for excess ART embryos shortly after the declaration that the embryos are excess · the manner in which those who donate embryos or gametes for the creation of ART embryos may express any preference for the type of research for which the tissue will be used, once the embryo is declared excess. 30 The NHMRC should develop For consideration by the ethical guidelines for the use of NHMRC--No changes to the embryos that are unsuitable for legislation required. implantation for research, training and improvements in clinical practice (see Recommendations 2022). 31 The current principles of consent The proposed amendments to for participation in medical research the definition of "proper must apply to sperm, egg and consent" in the Act make it embryo donors, so as to ensure that clear that proper consent must decisions are freely made. be gained for any research involving human eggs or human embryos. 46

Lockhart Committee How the issue is addressed in recommendation the Bill 32 The NHMRC should develop For consideration by the guidelines for egg donation. NHMRC--No changes to the legislation required. 33 The present prohibition of the sale Section 38O of the Act of sperm, eggs and embryos should maintains the existing continue, but the reimbursement of prohibition. reasonable expenses should continue to be permitted. 34 The Embryo Research Licensing This continues to be the Committee of the NHMRC (the case--no changes to the Licensing Committee) should legislation required. continue to be the regulatory body responsible for assessing licence applications, issuing licences and monitoring compliance, as under current arrangements. 35 The role of the Licensing Proposed amendments to Committee should be extended to section 21H of the Act will include assessment of licensing enable the Licensing applications and issuing licences for Committee to do this. any additional activities permitted, under licence (see Recommendations 1427). 36 The Australian Parliament and the Amendments to the Council of Australian Governments Commonwealth Research should give urgent attention to the Involving Human Embryos problem of delays in the filling of Act 2002 (new subsections (7) vacancies on the Licensing and (8)) address this Committee. recommendation. 37 There should be no attempt to This continues to be the case. recover the cost of administration, licensing, monitoring and inspection activities associated with the legislation from researchers at this point in time. 38 The Licensing Committee should This continues to be the case. continue to perform its functions in relation to licences and databases for research permitted by licences under the Research Involving Human Embryos Act. 47

Lockhart Committee How the issue is addressed in recommendation the Bill 39 Licensing Committee inspectors Proposed new sections 21WA, should be given powers, under the 21WB, 21WC and 21 WD in Prohibition of Human Cloning Act the Act provide for these and the Research Involving Human powers. Embryos Act, of entry, inspection and enforcement in relation to non- licensed facilities in the same manner and by the observance of the same procedures as applicable to search warrants under Commonwealth legislation, if such powers do not clearly exist. 40 There should be a continuation of No changes to legislation the role of the Reproductive required. Technology Accreditation Committee in the regulation of ART. 41 The import or export of a patient's Regulation 7 of the Customs reproductive material, including (Prohibited Exports) ART embryos, for the purpose of Regulations 1958 has been that person's ongoing ART repealed. treatment should not require any regulation other than that required under existing quarantine regulation. 42 The import or export of ethically Section 23 C of the derived viable materials from Commonwealth Research human embryo clones should be Involving Human Embryos permitted after approval by the Act 2002 requires the Minister appropriate authority. for Customs to take all reasonable steps to ensure that regulations are made permitting this. 43 The existing requirements for the No changes to legislation import and export of human required. biological materials are satisfactory and, for ethically derived human embryonic stem cells, no further restrictions are necessary. 48

Lockhart Committee How the issue is addressed in recommendation the Bill 44 Trade in human gametes or This continues to be the case embryos, or any commodification under 38O of the Act. of these items, should continue to be prohibited. 45 Donors of tissue that is going to The proposed changes to the result in an immortal stem cell line Act ensure that there must be should be informed by means of proper consent (in accordance processes monitored by human with NHMRC guidelines) in research ethics committees about relation to any use or creation the potential use of that stem cell of embryos. line, including the potential for commercial gain and the fact that they may not have any rights in potential stem cell developments. 46 The development of biotechnology No changes to legislation and pharmaceutical products arising required. from stem cell research should be supported. 47 A national stem cell bank should be The Commonwealth Research established. Involving Human Embryos Act 2002 requires the Federal Minister to report to Parliament (within 6 months) regarding the establishment of a national register of donated excess ART embryos. 48 Consideration should be given to No changes to legislation the feasibility of the Australian required. Stem Cell Centre operating the stem cell bank. 49 A national register of donated The Commonwealth Research excess ART embryos should be Involving Human Embryos established. Act 2002 requires the Federal Minister requires the Minister to report to Parliament (within 6 months) regarding the establishment of a national register of donated excess ART embryos. 49

Lockhart Committee How the issue is addressed in recommendation the Bill 50 The Licensing Committee should Proposed section 21EA avoids be authorised under the Prohibition constitutional issues of Human Cloning Act to give associated with binding binding rulings on the interpretation rulings, but addresses the of that Act, or the regulations made basic concern of the Lockhart under that Act, on condition that it Committee which appeared to reports immediately and in detail to be the potential liability of the NHMRC and to parliament on researchers where they are such rulings. acting in good faith in accordance with a licence but where the NHMRC Licensing Committee in fact had no power to issue the licence. 51 The Licensing Committee should Proposed section 21EA (as be authorised by the Research described above). Involving Human Embryos Act to give binding rulings and to grant licences on the basis of those rulings for research that is not within the literal wording of the Act, or the regulations made under the Act, but is within their tenor, on condition that the Committee reports immediately and in detail to the NHMRC and to parliament on any rulings it gives, or any licences it grants, in that way. 50

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