Prohibition of Human Cloning for Reproduction Bill 2008

Prohibition of Human Cloning for Reproduction Bill 2008

Introduction Print

EXPLANATORY MEMORANDUM

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BILL LA INTRODUCTION 9/9/2008

General

This Bill re-enacts Part 4A out of the Infertility Treatment Act 1995 as a separate Bill, consistent with the Prohibition of Human Cloning Act 2002 of the Commonwealth. The Prohibition of Human Cloning Act 2008 continues to prohibit human cloning for reproduction and other unacceptable practices associated with reproductive technology.

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 Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002. This was in accordance with a requirement in both Acts that they be reviewed by an independent committee by December 2005.

The Legislative Review Committee was chaired by the late John S Lockhart AO QC, a former Justice of the Federal Court of Australia. The Lockhart Committee made 54 recommendations resulting in the amendment of the Commonwealth legislation. On 12 December 2006 the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006was enacted, with the Amendment Act taking effect on 12 June 2007.

At the Council of Australian Governments meeting on 13 April 2007, all States and the ACT gave an undertaking to use their best endeavours to introduce into their respective Parliaments a Bill that would have the effect of achieving national consistency with the Commonwealth Research Involving Human Embryos Act 2002and the Prohibition of Human Cloning Act 2002. In Victoria, the provisions related to this legislation were found in Parts2A and 4A of the Infertility Treatment Act 1995.

In 2007, amendments were made to these Parts to mirror the amended Commonwealth legislation. An undertaking was also given by the then Victorian Minister for Health to remove Parts 2A and 4A from the Infertility Treatment Act 1995 and to reproduce the material in two separate pieces of legislation, in the same way as the Commonwealth. The timing of this removal was contingent on the completion of the review of the Infertility Treatment Act 1995 by the Victorian Law Reform Commission.

The Victorian Law Reform Commissionsubmitted its recommendations to Government in March 2007 intheAssisted Reproductive Technology and Adoption Final Report. The Infertility Treatment Act 1995 is to be repealed by the Assisted Reproductive Treatment Bill 2008. Accordingly,Part 4A will be reproduced in stand alone legislation at the same time that the Infertility Treatment Act 1995 is repealed.

Clause Notes

Clause 1sets out the purpose of the Act.

Clause 2provides that the Bill is to commence on a day to be fixed by proclamation but no later than 1 January 2010.

Clause 3is the definition section. Key definitions, which are essential to defining the scope of the legislation and describing how it is to be administered, include the following—

chimeric embryo means—

• a human cell embryo into which a cell, or any component part of a cell, of an animal has been introduced; or

• a thing declared by the regulations to be a chimeric embryo.

excess ART embryohas the same meaning as defined in the Research Involving Human Embryos Act 2008. In that Act, section 4 sets out the meaning of the phrase excess ART embryo, requiring that—

(a)the embryo was created by assisted reproductive technology for use in the treatment of a woman; and

(b)the embryo is excess to the needs of the woman for whom it was created and her partner (if any) at the time the embryo was created.

Section 4 of that Act also provides that, for the purposes of paragraph (b) of that definition, a human embryo is excess to needs if—

• there is a determination in writing from the woman for whom the embryo was created and her partner (if any) that the embryo is excess to their needs; or

• the woman for whom the embryo was created and her partner (if any) have provided authority, in writing, for the embryo to be used for a purpose other than achieving pregnancy (for example, research or training purposes). In such a case it is assumed that, by determining that the embryo may be used for another purpose, the woman and her partner (if any) consider that it is excess to their needs. It should be noted that a determination that an embryo is excess is distinct from a consideration of whether there is proper consent from all responsible persons for use of the embryo.

human embryo which is defined to mean a discrete entity that has arisen from either—

• the first mitotic division when fertilisation of a human oocyte by a human sperm is complete; or

• 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, the stage at which the primitive streak appears—

and has not yet reached 8 weeks of development since the first mitotic division.

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 has been in use since 2007.

human embryo clone is defined to mean a human embryo that is a genetic copy of another living or dead human, but does not include a human embryo created by the fertilisation of a human egg by human sperm.

The reference to a human embryo clone not including a human embryo created by the fertilisation of a human egg by human sperm is to ensure that identical twins (or other identical multiples) that occur through the spontaneous division of an embryo (created by fertilisation) into two(or more) identical embryos are not defined as human embryo clones.

hybrid embryo means—

• an embryo created by the fertilisation of a human egg by animal sperm; or

• an embryo created by the fertilisation of an animal egg by human sperm; or

• a human egg into which the nucleus of an animal cell has been introduced; or

• an animal egg into which the nucleus of a human cell has been introduced; or
• a thing declared by the regulations to be a hybrid embryo.

licence is defined to mean a licence issued under section 14 of the Research Involving Human Embryos Act 2008.

Subsection 3(2) clarifies that in order to establish that a "human embryo clone" is a genetic copy of a living or dead human, it is sufficient to establish that a copy has been made of the genes in the nuclei of the cells of another living or dead human. Further,the copy of the genes does not have to be an identical genetic copy. This means that the human embryo clone does not have to be genetically identical to the original human. Thisallows for—

• the presence of DNA outside the nucleus (iemitochondrial DNA) that is not identical to the living or dead human from which the DNA was taken, as would occur in an embryo created using the somatic cell nuclear transfer technique;

• spontaneous changes to the nuclear DNA that may occur during the development of a human embryo clone; and

• the deliberate alteration of the DNA so that the intention is to produce a clone of another human, but where the nuclear DNA could no longer be considered an identical copy of the original DNA. This point is also addressed in the definition of "human embryo" which includes one that has an altered human genome. As such, an embryo that is a clone of another human and has had its genome deliberately altered will still be considered a human embryo and therefore, as its original genome was copied, a human embryo clone.

Subsection 3(3) of the Act 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 10weeks, it is still considered to be a 2 day embryo in terms of its development.

Subsection 3(4) clarifies that for the purposes of the definition of human embryo clone, a human embryo created by the technological process known as embryo splitting is taken not to be created by a process of fertilization of a human egg by human sperm and is therefore considered to be a human embryo clone. Embryo splitting is a technique that may be carried out on an embryo created by in vitro fertilization, whereby micro-surgical techniques are used to divide an embryo in the early stages of development to produce two or more identical embryos.

Subsection 3(5) clarifies that reference to an embryo, including a human embryo, is a reference to a living embryo.

Subsection 3(6) clarifies that a reference to a human oocyte is the same as a reference to a human egg.

Section 3(7) clarifies that a reference to a human embryo does not include a human embryonic stem cell line or a hybrid embryo.

Clause 4provides that Act will bind the Crown in right of the State of Victoria and, so far as the legislative power of Parliament permits, in all other capacities. This section also provides that nothing in this Act renders the Crown liable to be prosecuted for an offence.

Clause 5makes it an offence to intentionally place into the body of a human or an animal a human embryo that is a genetic copy of another living or dead human.

An offence against this provision is an indictable offence punishable by imprisonment for a term not exceeding 15 years.

Clause 6makes it an offence to intentionally import or export a human embryo clone into or from Victoria.

An offence against this provision is an indictable offence punishable by imprisonment for a term not exceeding 15 years.

Clause 7provides that any human embryo clone that is intentionally implanted, imported or exported does not have to survive to the point of live birth in order for an offence to be established under sections 5 and 6. This would include, but is not necessarily limited to, the following situations—

• where a human embryo clone is placed in a woman's reproductive tract but does not successfully implant in the uterus;
• where a human embryo clone is successfully implanted and begins to develop and then spontaneously terminates;
• where a human embryo clone is successfully implanted and begins to develop and is deliberately terminated; and
• where a human embryo clone is successfully implanted, develops to full term but is stillborn.

Clause 8prohibits a person from intentionally creating a human embryo by a process of fertilisation of a human egg and 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. It is not intended that this section prohibit certain uses that are carried out as a part of attempting to achieve pregnancy in a woman in ART clinical practice, such as carrying out diagnostic procedures (such as Pre-Implantation Genetic Diagnosis) or undertaking therapeutic procedures on the embryo.

Further it is not intended this section—

• restrict the number of embryos that may be created for the purposes of achieving pregnancy in a particular woman. The number of embryos created for the reproductive treatment of a particular woman needs to be determined on a case by case basis as part of routine ART clinical practice. ART clinical practice is regulated through legislation in three States (Victoria, South Australia and Western Australia) and the national system of accreditation carried out by the Reproductive Technology Accreditation Committee (of the Fertility Society of Australia) which includes application of the NHMRC Ethical Guidelines on Assisted Reproductive Technology 2007; or
• prevent the circumstance whereby a human embryo created by an ART centre, originally intended for implantation into a woman, may not be found suitable for implantation, or may at some point not be required by the woman for whom it was originally created. Inthese situations it is possible that such embryos could become excess ART embryos and at that point they may be used for purposes other than an attempt to achieve pregnancy in a woman subject to the system of licensing described in the Research Involving Human Embryos Act 2008.

Section 8(3) provides that despite section 130(1) of the Magistrates' Court Act 1989, a defendant does not bear an evidential burden of presenting or pointing to evidence in accordance with that section in relation to any matter in section 8. This means that the prosecution must establish that the offence has been committed rather than the defendant establishing that the offence was not committed. The prosecution must establish the case in relation to all of the offences detailed in this Bill, however, as this clause is worded slightly differently to the other clauses it could be interpreted to be reversing the burden of proof. This clause clarifies that this is not the case.

Clause 9provides 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 offence has been drafted so as to prohibit the creation of an embryo by fertilisation of a human egg by human sperm if the human embryo created 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 a human egg by human sperm) then this can potentially be licensed by the NHMRC Licensing Committee under the Research Involving Human Embryos Act 2008.

This section effectively bans the ART technique known as cytoplasmic transfer. Cytoplasmic transfer involves the injection of some of the cytoplasm (the part of the cell outside the nucleus) from a healthy donor egg into a recipient patient's egg with the aim of overcoming certain problems that the patient has with regards to pregnancy. This technique raises ethical concerns as any child born may have DNA from three separate people. TheDNA from the third party (the donor of the healthy egg) would be mitochondrial DNA which is thought not to have an impact on the physical characteristics of the child. However, the impact (if any) of the third party mitochondrial DNA on normal development is not totally clear.

Clause 10requires that a human embryo must not be allowed to develop, outside the body of a woman, beyond 14days (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.

An offence against this clause attracts a maximum penalty of 15years imprisonment.

Clause 11prohibits 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 geneticallymodified and also to subsequent generations.

An offence against this section is punishable by a maximum penalty of 15 years imprisonment.

Clause 12prohibits 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 maximum penalty for this offence is 15 years imprisonment.

Clause 13prohibits the intentional creation of chimeric embryos. Achimeric 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 2008, there were no additional types of chimeric embryo prescribed in the regulations.

This prohibition is consistent with the Lockhart Committee's recommendation that chimeric embryos should continue to be prohibited (Recommendation 6).

Failure to comply with the prohibition attracts a maximum penalty of 15 years imprisonment.

Clause 14provides 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.

Section 3 of the Bill defines hybrid embryo to mean—

• an embryo created by the fertilisation of a human egg by animal sperm; or

• an embryo created by the fertilisation of an animal egg by human sperm; or

• a human egg into which the nucleus of an animal cell has been introduced; or

• an animal egg into which the nucleus of a human cell has been introduced; or

• a thing declared by the regulations to be a hybrid embryo.

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 under the Research Involving Human Embryos Act 2008 they are not ever permitted to develop such a hybrid embryo beyond 14 days. The penalty for committing this offence is a maximum of 15 years imprisonment.