Copyright © Government of South Australia 2002
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PROHIBITION OF HUMAN CLONING BILL

The Hon. L. STEVENS (Minister for Health) obtained leave and introduced a bill for an act to prohibit human cloning and other unacceptable practices associated with reproductive technology and for other purposes. Read a first time.

The Hon. L. STEVENS: I move:

That this bill be now read a second time.

I seek leave to have the second reading explanation inserted in Hansard without my reading it.

Leave granted.

The SPEAKER: Leave is granted, although I must say personally reluctantly for such an important measure.

The Prohibition of Human Cloning Bill 2003, and the Research Involving Human Embryos Bill 2003 that is also being intro­duced, have been drafted to enable South Australia to be a party to the national scheme for prohibiting human cloning and regulat­ing research on human embryos.

The Commonwealth Acts in this area were passed in December 2002 and now need to be comple­mented by South Australian legislation to ensure that all such activity is covered within South Australia.

The Bills have been drafted to reflect the Council of Australian Governments (COAG) Agreement of 5 April 2002, the Common­wealth legislation, and to incorporate South Australian legislative require­ments.

It is intended that once the Bills are passed, the resul­ting South Australian Acts will form, with the Commonwealth Acts, part of a national regulatory system to address con­cerns, including ethical concerns, about scientific devel­op­ments in human reproduction and the use of human em­bryos.

HISTORY

The Commonwealth legislation was draft­ed fol­lowing COAG's agreement on 5 April 2002 that the Commonwealth, States and Territories would—

×introduce nationally consistent legislation banning human cloning and other unac­ceptable practices; and

×establish a national regulatory framework for the use of excess embryos created through assisted reproductive technology treatment, with the National Health and Medical Research Council (NHMRC) as the licensing and regulatory body.

Upon coming to this decision, COAG considered the Australian Health Ministers' `Re­port on Human Cloning, Assisted Reproductive Technology and Related Matters'. This report was developed after consultation with all States and Territories, the NHMRC, its Australian Health Ethics Committee (AHEC), the Australian Acad­emy of Science and practitioners and researchers.

It also took account of the Andrews Re­port into human cloning and embryo research prepared by the Federal Government House of Representatives Standing Commit­tee on Legal and Constitu­tional Affairs.

Recognising that this is a difficult area of public policy, in­volving complex and sensitive ethical and scientific issues on which the community holds a wide range of views, COAG agreed to allow embryo research under a strict regulatory regime only on existing excess embryos created for assisted reproductive technology treatment. These embryos would otherwise have been destroyed, and it was required that only embryos in existence before 5 April 2002 could be used.

COAG agreed to prohibit the creation of embryos specifi­cally for research purposes and stipulated that research only be con­ducted with the consent of embryo donors, who are able to specify restrictions on the research uses of such embryos.

NATIONAL CONSISTENCY

Under the COAG Agreement Premiers committed to introduc­ing corresponding legislation to implement a coherent national scheme applying consistent rules across Australia to the use of excess embryos.

The Commonwealth legislation is consistent with the COAG Agreement and empowers the Commonwealth Minister to declare a state law a corresponding law for the purposes of this national scheme.

Commonwealth legislation has limited cover due to consti­tutional issues while State legislation covers all activity within a State. Therefore every State and Territory needs to introduce or amend legislation to ensure that there is a national scheme cover­ing everyone in Australia regu­lating the use of excess embryos for research, teaching, training, quality control, audit and commercial endeavours.

The Commonwealth Act requires that it is reviewed after 2 years, and it is intended that corresponding state legisla­tion that forms part of the national scheme will be con­sidered in the light of the results of that review.

THE COMMONWEALTH LEGISLATION

The Commonwealth Research Involving Embryos and Prohi­bition of Human Cloning Bill was tabled in the Federal Parliament on 27 June 2002. The Bill was re­ferred to a Senate Inquiry and split in two in the House of Repre­sentatives. The Prohibition of Human Cloning Act and the Research Involving Human Embryos Act were passed by the House of Representatives and the Senate in December 2002.

These Acts:

×prohibit the creation, implantation, export or import of a hu­man embryo clone;

×prohibit the creation, implantation, export or import of certain other embryos for ethical and safety reasons;

×establish the NHMRC Embryo Research Licensing Committee to assess and license research and other uses of excess em­bryos;

×provide for a centralised, publicly available database of informa­tion about all licences issued by the NHMRC Licens­ing Committee.

Because Commonwealth legislation over-rides State legis­lation where there are inconsistencies between the two, the Commonwealth prohibitions came into effect on 16 January this year and now apply in South Australia.

The licensing scheme comes into operation six months after the legislation passed, so licences for using embryos will be able to be issued in June 2003.

This allows states to introduce and pass legislation or amend current legislation (or both) before the Commonwealth legislation over-rides any inconsistent local legislation.

CURRENT STATE LEGISLATION

The South Australian Reproductive Technology Act 1988 regulates clinical practice and embryo research in South Australia and established the SA Council on Repro­ductive Technology.

Under section 14 of the Act, the Council currently licenses research using embryos and gametes in South Australia, but only research that is not detrimental to the embryo.

These Bills propose a scheme that will replace section 14 of the Act with an Act dedicated to regulating the use of excess embryos including research into infertility and embryonic stem cells and other types of research now possible using embryos, but extended to other uses of embryos such as teaching, training, commercial applica­tions and quality assessment.

ACROSS AUSTRALIA

This nationally consistent scheme means that for research­ers in some jurisdictions the rules will be significantly tightened, while for others their research capacity will be extended.

South Australia, Western Australia and Victoria have similar legislation and have applied very restrictive licens­ing require­ments to embryo research for some years.

For the national scheme to be effected, these three states need to amend their legislation. Other States and Territor­ies need to introduce legislation, implementing legal over­sight of embryo research for the first time.

CORRESPONDING STATE LEGISLATION

It is important that South Australia has its own legisla­tion in this area, especially to cover those who are not captured under the Commonwealth legislation.

The two Bills presented to the SA Parliament confer ad­minis­trative functions on the NHMRC Licensing Com­mit­tee under the State Act by appointing the NHMRC Licens­ing Committee as the authorised licensing body under State legislation and authorising the Committee to appoint inspectors.

This, together with a proposed Intergovernmental Agree­ment, preserves for the South Australian Government some degree of influence over future amendments to the legislation constituting the national scheme and allows the South Australian Parliament to consider amendments to the South Australian Act and Regula­tions.

THE SOUTH AUSTRALIAN PROHIBITION OF HUMAN CLONING BILL 2003

The Prohibition of Human Cloning Bill incorporates the relevant provisions and definitions of the Commonwealth Prohibi­tion of Human Cloning Act 2003.

SAFEGUARDS

This Bill takes a very conservative approach.

It places strict limitations on embryo research, prohibit­ing the creation of embryos for research. It prohibits both reproductive cloning of whole human beings and therapeu­tic cloning for treat­ment of patients.

The definition of a human embryo is designed to be broad and to capture somatic cell nuclear transfer (thera­peutic cloning tech­niques using human ova and somatic cell DNA) and parthenogen­esis (triggering human ova to develop in a similar way to an embryo without fertilisation by a sperm), and sufficiently inclu­sive so as to capture emerging technologies.

The Bill includes a series of other prohibitions that mirror many of those included currently in the Code of Ethical Research Practice which is incorporated as a regu­lation under the SA Repro­ductive Technology Act.

These include bans on:

×creating an embryo with genetic material from more than two people;

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

×using precursor cells from a human embryo or a human foetus to create a human embryo;

×altering the genome of a human cell in such a way that the alteration can be inherited by descendants ;

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

×creating a chimeric or hybrid embryo that is generated from a combination of human and animal cells;

×placing a human embryo in an animal or an animal embryo in a human for any period of gestation;

×placing a human embryo in the body of a human, other than in a woman's reproductive tract;

×importing or exporting a prohibited embryo from any of the previous categories.

It is also makes it an offence to receive, give or offer valuable consideration to another person for the supply of a human egg, human sperm or a human embryo.

ENSURING COMPLIANCE WITH THE PROVI­SIONS

The Commonwealth Research Involving Human Em­bryos Act enables the NHMRC to appoint inspectors to monitor the activities of laboratories and ensure prohibi­tions are enforced. The Bill enables those same inspectors to in­spect premises covered by the State or Commonwealth legisla­tion.

Explanation of Clauses

Clause 1: Short title

This clause is formal.

Clause 2: Commencement

The measure will be brought into operation by proclamation.

Clause 3: Interpretation

This clause sets out a number of definitions for words and phrases used in the Bill. These definitions determine the meaning that is to be attributed to certain words or phrases whenever they are used in the Bill or regulations. Key definitions, which are essential to defining the scope of the legislation and describing how it will be administered, include the following:

`accredited ART centre' is defined to mean a person or body accredited to carry out assisted re­productive technology by—

(a)the Reproductive Technology Accredita­tion Com­mittee of the Fertility Society of Australia; or

(b)if the regulations prescribed another body or other bodies in addition to, or instead of, the body men­tioned in paragraph (a)—that other body or any of those other bodies, as the case requires.

`excess ART embryo' means a human embryo where—

(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 any spouse (at the time the embryo was creat­ed) of that woman.

The determination with respect to being excess to the needs of the woman and any spouse of the woman (at the time the relevant embryo was creat­ed) is provided for under clause 3(5).

`human embryo' which is defined to mean a live embryo that has a human genome or an altered human genome, that has been developing for less than 8 weeks since:

×the appearance of 2 pro-nuclei; or

×the initiation of development by other means.

This definition is intended to include:

a.a human embryo created by the fertilisation of a human egg by human sperm.

The Bill relies upon the appearance of 2 pro-nuclei to establish the existence of a human embryo that has been created by the fertilisation of a human egg by human sperm. The appearance of the pro-nuclei indi­cates that the nuclei from the sperm and the egg are aligning prior to possible fusion. For the pur­poses of this legislation, the 8 weeks of development is taken to start with the appearance of 2 pro-nuclei. The legisla­tion does not rely on defining when ferti­lisation com­mences or is complete.

b.a human embryo that has had its development initi­ated by any other means.

It is intended that the definition includes the follow­ing types of embryos:

×a human egg that has had its nucleus replaced by the nucleus of a somatic cell (i.e. a cell from the body) by the process referred to as somatic cell nuclear transfer (SCNT); and

×a parthenogenetic 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 has the capacity to continue its development in a similar manner to a hu­man embryo created by fertilisation.

It should be noted that the procedures outlined above are provided as examples only as there may be other ways that the development of an embryo may be initiated. For the purposes of the legislation the 8 weeks of development is taken to start with the initiation of development by other means.

Clause 3(3) 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.

`human embryo clone', which 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.

Clause 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. This allows for:

×the presence of DNA outside the nucleus (i.e. mito­chondrial DNA) that is not identical to the living or dead human from which the nuclear 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 within 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.

Clause 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 fertilisation 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 fertili­sation, whereby micro-surgical techniques are used to divide an embryo in the early stages of development to produce two or more identical embryos.

Clause 4: Nationally consistent scheme

This clause specifically states that it is intended that the principal objects of the measure be achieved through a regulatory frame­work and a range of offences that operate in conjunction with, and in a manner that is consistent with, corresponding Commonwealth and State laws.

Clause 5: Offence—creating a human embryo clone

It will be an offence to intentionally create a human clone.

Clause 6: Offence—placing a human embryo clone in the human body or the body of an animal

It will be an offence to place a human clone in the body of a human or a body of an animal.

Clause 7: Offence—importing or exporting a human em­bryo clone

This clause makes it an offence to intentionally import a human embryo clone into South Australia or intentionally export a human embryo clone from South Australia. This ensures that all avenues for obtaining a human embryo clone in the State are covered, whilst ensuring that a per­son cannot export out of the State a human embryo clone that has been illegally created or obtained.

Clause 8: No defence that human embryo clone could not survive

This clause provides that any human embryo clone that is inten­tionally created, implanted, imported or exported does not have to have the capacity to survive to the point of live birth in order for an offence to be established under clauses 5, 6 or 7.

Clause 9: Offence—creating a human embryo other than by fertilisation, or developing such an embryo

The effect of this clause is that a human embryo intention­ally created through any process must only be created by the fertilisa­tion of a human egg by human sperm. As such, an embryo must not be created by embryo splitting, by parthenogenesis, by somatic cell nuclear transfer or by any other technique that does not in­volve fertilisation of a human egg by human sperm.

It is also an offence to develop a human embryo created by a means other than the fertilisation of a human egg by human sperm. This ensures that if such an embryo was imported into the State it could not be developed by the person who imported it or any other person without an offence being committed.

Clause 10: Offence—creating a human embryo for a pur­pose other than achieving pregnancy in a woman

The effect of this clause is that a person can only create a human embryo outside the body of a woman if it is intend­ed, at the time of creation, that the embryo could be im­planted in an attempt to achieve pregnancy in a particular woman.

This clause is not intended to prohibit certain uses of human embryos that are carried out as part of attempting to achieve pregnancy in a woman in ART clinical practice, such as carrying out diagnostic procedures or undertaking therapeutic procedures on the embryo.

Furthermore, it is not intended that this clause—

×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 a part of routine ART clinical prac­tice; or

×prevent the circumstance whereby a human embryo created by an ART clinic, originally intended for im­plantation into a woman, may be found to not be suit­able for implantation, or may at some point not be required by the woman for whom it was original­ly created. In these situations it is possible that such embryos could become excess ART embryos and at that point they may be used for purposes other than to attempt to achieve pregnancy in a woman subject to the system of regulatory oversight described in Part 2 of the Bill.

Clause 11: Offence—creating or developing a human embryo containing genetic material provided by more than 2 persons

This clause makes it an offence to intentionally create a human embryo containing genetic material provided by more than 2 people. It is also an offence to develop a human embryo contain­ing genetic material provided by more than 2 people.

Clause 12: Offence—developing a human embryo outside the body of a woman for more than 14 days

This clause requires that a human embryo created outside the body of a woman must not be allowed to develop beyond 14 days. This does not include any time that the embryo's development is suspended whilst in storage (for example while the embryo is frozen).

In practice, this means that human embryos created by assisted reproductive technology must be implanted, stored or allowed to die (if unsuitable for implantation or excess to the needs of the couple for whom the embryo was creat­ed) before the 14th day of their development. It is standard ART clinical practice for em­bryos to be implant­ed when they have reached between three and seven days of devel­opment.

Clause 13: Offence—using precursor cells from a hu­man embryo or a human foetus to create a human embryo, or developing such an embryo

This clause prevents the creation of a human embryo with precur­sor cells taken from another human embryo or a human foetus. It is also an offence to develop a human embryo created by precursor cells taken from an embryo or foetus.

The purpose of this clause is to prevent individuals from obtaining precursor cells and using these cells in an at­tempt to develop a human embryo whether for reproduc­tive or any other purposes. The reasons for this practice being prohibited is that if precursor cells were to be used in such an attempt then children could potentially be born (using ova and/or sperm derived from a foetus or embryo) never having had a living genetic parent.

Clause 14: Offence—heritable alterations to genome

This clause 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. This clause 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.

Clause 15: Offence—collecting a viable human embryo from the body of a woman

This clause prevents 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.

Clause 16: Offence—creating a chimeric or hybrid embryo

This clause makes it an offence to intentionally create a chimeric embryo or to intentionally create a hybrid em­bryo. Under the definitions included in clause 3, chimeric embryo and hybrid embryo have the following meanings:

`chimeric embryo' means—

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

(b)a thing declared by the regulations to be a chimeric embryo;

`hybrid embryo' means—

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

(b)an embryo created by the fertilisation of an animal egg by human sperm; or

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

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

(e)a thing declared by the regulations to be a hybrid embryo.

It is not intended that this clause prohibit the creation of transgenic animals. Transgenic animals are created through the insertion of one or more foreign genes (includ­ing human genes) into an animal embryo. It is important to note that transgenic animals are regulated under the Gene Technology Act 2001 as a genetically modified organism. Before anyone could genetically modify an animal em­bryo, a licence must be sought from the Gene Technology Regulator. The Gene Technology Regulator would con­duct a comprehensive risk assessment and may seek ad­vice on the ethical issues posed by this practice from the Gene Technology Ethics Committee. Any such work would also need to meet the require­ments of an Animal Welfare Committee (in accordance with NHMRC Guide­lines).

Clause 17: Offence—placing of an embryo

This clause prevents the placement of—

×a human embryo in an animal;

×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;

×an animal embryo in a human, for any period of gesta­tion.

Clause 18: Offence—importing, exporting or placing a prohib­ited embryo

This clause prevents certain additional dealings and pro­cedures associated with `prohibited embryos', as defined by subclause (4).

Clause 19: Offence—commercial trading in human eggs, human sperm or human embryos

This clause prevents the commercial trading of human eggs, sperm and embryos. Both parties that are 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 that 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 embryos that are excess to their needs 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.

Clause 20: Powers of inspectors

The inspectors under this measure are to be inspectors who have been appointed under a related Commonwealth law.

This clause sets out the powers of an inspector to enter and search premises. An inspector will not be able to enter premises under this clause unless—

(a)the occupier of the premises has consented to the entry; or

(b)activities being carried out on the premises are covered by a licence and the entry is at a reason­able time; or

(c)the entry is under the authority of a warrant; or

(d)the inspector considers on reasonable grounds that the circumstances require immediate entry.

Clause 21: Announcement before entry

An inspector must give the occupier of premises a reason­able opportunity to consent to entry to the premises before exercising a statutory power to gain entry.

Clause 22: Inspector must produce identity card on re­quest

This clause provides that an inspector cannot exercise any of the powers under this Part in relation to premises unless he or she produces his or her identity card upon being requested to do so by the occupier of those premises.

Clause 23: Compensation for damage

This clause provides that if damage is caused to equipment or other facilities as a result of it being operated by an inspector and the damage resulted from insufficient care being exercised by the inspector in operating the equip­ment, compensation is payable to the owner under the terms of the provision.

Clause 24: Return of seized things

This clause sets out a scheme for dealing with any item that has been seized by an inspector under this Part.

Clause 25: Related matters

It will be an offence to hinder or obstruct an inspector in the exercise of statutory powers under this Part. A person will not be required to answer a question if to do so might tend to incriminate the person or make the person liable to a penalty.

Clause 26: Commonwealth/State arrangements

This clause is intended to facilitate the interaction between this measure and related Commonwealth Acts.

Clause 27: Delegations

This provision will allow the Minister to delegate func­tions and powers under the measure.

Clause 28: False or misleading information

It will be a specific offence to provide false or misleading material in any information under the measure.

Clause 29: Liability of directors

This clause relates to the responsibility of directors of corporations for breaches of the Act.

Clause 30: Evidential burden in relation to exceptions etc

This clause is intended to ensure consistency between this measure and Commonwealth law with respect to certain evidential burdens.

Clause 31: Regulations

The Governor will be able to make regulations for the purposes of the measure.

The Hon. W.A. MATTHEW secured the adjournment of the debate.