STATUTES AMENDMENT (PROHIBITION OF HUMAN CLONING FOR REPRODUCTION AND REGULATION OF RESEARCH INVOLVING HUMAN EMBRYOS) BILL

Introduction and First Reading

The Hon. J.D. HILL (Kaurna—Minister for Health, Minister for the Southern Suburbs, Minister Assisting the Premier in the Arts) (16:00): Obtained leave and introduced a bill for an act to amend the Prohibition of Human Cloning Act 2003 and the Research Involving Human Embryos Act 2003. Read a first time.

Second Reading

The Hon. J.D. HILL (Kaurna—Minister for Health, Minister for the Southern Suburbs, Minister Assisting the Premier in the Arts) (16:01): I move:

That this bill be now read a second time.

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

Leave granted.

Parliament is being asked to consider amendments to the South Australian Prohibition of Human Cloning Act 2003 and Research Involving Human Embryos Act 2003 to bring these Acts into line with the equivalent recently amended Commonwealth Acts. The amendments to both Acts are contained in a single Bill, the Statutes Amendment (Prohibition of Human Cloning for Reproduction and Regulation of Research Involving Human Embryos) Bill 2008, and it is proposed that they be considered in a cognate debate.

Human cloning and embryo research legislation has been subject to a conscience vote in every jurisdiction, including in the South Australian Parliament, when the Bills for these Acts were first debated in 2003. This Bill raises important moral and ethical questions that require deep consideration, and I note that both major parties have accorded their members a conscience vote on the amendments to the South Australian laws.

The national scheme and recent changes

The Commonwealth Acts were passed in 2002, and the South Australian Parliament passed equivalent legislation in 2003. The original Commonwealth legislation prohibited the creation of embryos for research, allowed research using embryos donated to research by couples who had completed their infertility treatment, but restricted what could be done with such embryos; the current South Australian laws are consistent with this original model.

The Commonwealth legislation, together with equivalent legislation in all States and Territories and the National Health and Medical Research Council Embryo Research Licensing Committee, creates a national legislative scheme for prohibiting human cloning and regulating embryo research. This national scheme regulates the use of human embryos that are excess to fertility treatment and hybrid embryos, but not animal embryos nor human embryonic stem cells. The Commonwealth amendments extended the national scheme to also regulate embryos created by means other than fertilisation and human eggs used for such processes. In South Australia, clinical reproductive medicine practice is separately regulated by the Reproductive Technology (Clinical Practices) Act 1988.

The national scheme needs to be responsive to developments in technology and shifts in community attitudes and standards. For that reason, the Commonwealth Prohibition of Human Cloning Act and the Research Involving Human Embryos Act included requirements for a 3-year review. The Review, chaired by the late John Lockhart AO QC, was conducted in 2005 and held consultations around the country. South Australian experts, academics and community representatives contributed to the inquiry.

On the basis of their consultations and background research, including into community attitudes to embryo research, the Lockhart Review made 54 wide ranging recommendations. The Review proposed changes to legislation to extend embryo research to allow the creation of embryos for research, but recommended that the prohibition on the creation of embryos by fertilisation for any purpose other than assisted reproductive medicine procedures be retained. They also recommended that certain research procedures be permitted on embryos created through laboratory techniques, but not on embryos created by the fertilisation of an egg by a sperm. Most of the recommendations aimed to streamline current processes for embryo research licensing and to strengthen oversight.

The recommendations of the Lockhart Review were referred to the Australian Parliament and the Council of Australian Governments in December 2005. Some recommendations required changes to legislation while others related to national policies and procedures. A Private Member’s Bill tabled by Senator the Hon Kay Patterson reflected almost all the Lockhart Review’s recommendations for legislative changes and was passed by the Australian Parliament on 12 December 2006. The Commonwealth amendments were promulgated on 12 June 2007.

Human reproductive cloning remains prohibited in Australia. The Commonwealth amendments retained limitations on research and training using embryos created by fertilisation, but now permit the creation of embryos for research by means other than fertilisation whilst prohibiting the implantation or development of any embryo created in a laboratory for more than 14 days.

Corresponding Act status

The Commonwealth legislation makes provision for the Minister for Health and Ageing to declare a State or Territory Act corresponding for the purposes of the national scheme. State and Territory laws rely on the NHMRC Licensing Committee established under the Commonwealth legislation to licence embryo research. Only a corresponding State law can effectively confer regulatory powers and functions on the NHMRC Embryo Licensing Committee.

When the Commonwealth amendments came into force on 12 June 2007 the Parliamentary Secretary to the Minister for Health and Ageing advised that he had revoked the previous declaration. The South Australian Research Involving Human Embryos Act 2003 then ceased to be a 'corresponding Act', so the NHMRC Embryo Licensing Committee can no longer exercise functions under the State Act. If the Act is amended, South Australia will need to ask the Minister for Health and Ageing to determine whether the State Act is corresponding and make a new declaration. This Bill has been drafted to amend South Australian laws to make them substantially the same as equivalent interstate laws (where amendments have already been made). It is expected the amended legislation would be regarded as corresponding with the amended Commonwealth laws.

At the meeting of the Council of Australian Governments in April 2007, the Premier of South Australia, together with his colleagues from all Australian jurisdictions, signed an Agreement that commits all State and Territory leaders to use their best endeavours to introduce corresponding legislation into their legislatures by 12 June 2008 and for all parties to maintain nationally consistent arrangements over time.

State and Territory governments are considering the relevant Commonwealth amendments and their implications for local laws. The Victorian, New South Wales and Queensland Parliaments have amended their equivalent legislation, and Tasmania and Western Australia have tabled amendment Bills. This Parliament now has an opportunity to consider changes to these challenging but important laws.

Coverage of Commonwealth and State laws

Why do we need both State and Commonwealth legislation? Commonwealth legislative powers are not wide enough to cover all agencies and individuals in South Australia that might possibly undertake reproductive technology activities or human embryo research. In summary, the Commonwealth laws cover Australian Government authorities, constitutional corporations, and trade and commerce. The Commonwealth laws do not cover South Australian Government agencies, non-trading corporations nor individuals operating outside a trading corporation; these are covered only by the South Australian Acts.

The South Australian and national laws are currently different; embryos can be created under Commonwealth laws that would be unlawful under State law. As Members would know, the section 109 of the Australian Constitution provides that when a law of a State is inconsistent with a law of the Commonwealth, the latter shall prevail, and the former shall, to the extent of the inconsistency, be invalid. Since 12 June this year, South Australian researchers regulated under the Commonwealth Acts have been able to apply for a licence under the Commonwealth legislation to conduct research that is currently not permitted by State legislation. The corresponding Act declaration has been revoked, so researchers covered only by South Australian Acts are currently not permitted to seek a licence from the NHMRC Licensing Committee.

All current South Australian human reproductive medicine and embryo research and training activity is being conducted within either a corporation (Repromed laboratories) or a university (the University of Adelaide Medical School laboratories). It is thought to be unlikely that future research or training proposals will emanate from facilities that are not a university, a research institute or a corporation. There is, however, some legal uncertainty about whether our universities are constitutional corporations and are therefore facilities covered by the Commonwealth legislation.

To date, no South Australian researchers have sought a licence to conduct human embryo research, but have focussed their efforts on either animal embryos or human embryonic stem cell lines developed elsewhere which do not require a licence. However research teams are planning to apply for such research licences in the near future, and since embryonic stem cell research is often conducted as part of national collaborations, legal clarity and national consistency is important.

If Parliament does not pass this Amendment Bill, then researchers will still be able to apply for a licence to conduct research that is legal under the Commonwealth Acts provided they are clearly operating within a corporation. However the capacity of researchers operating within the university environment to contribute to national research collaborations may be compromised if their legal status remains uncertain.

Amending the South Australian Prohibition on Human Cloning Act and the Research Involving Human Embryos Act to ensure consistency with the equivalent Commonwealth Acts will ensure that, wherever they conduct their work, all South Australian researchers will be covered by substantially identical legislation, providing regulatory consistency where the legal coverage of Commonwealth and State laws is considered uncertain.

Summary of the proposed amendments

The proposed amendments mirror the changes to the Commonwealth laws and apply them to the South Australian Prohibition on Human Cloning Act and the Research Involving Human Embryos Act. The Bill retains a prohibition against human reproductive cloning, which is universally unacceptable, and a strict licensing, monitoring and compliance regime. Not all the Commonwealth amendments need to be reflected in the South Australian Acts as some relate only to the activities of the NHMRC Embryo Licensing Committee established under the Commonwealth legislation.

The Bill amends each Act to include a new definition of an embryo that changes the point of identification from the commencement of fertilisation (which is impracticable to ascertain) to its completion (which is detectable microscopically). The Bill extends the scope to regulate the creation, development and use of all embryos, not just excess ART embryos, and to regulate the use of donated eggs (oocytes).

The amendments differentiate between embryos created by fertilisation of an egg by a sperm for the purpose of creating a baby, and embryos created by technical manipulation of cells and DNA for research and potential therapies. For clarity I will refer to embryos created by fertilisation as reproductive embryos and embryos created by technical manipulation as research embryos.

Creating reproductive embryos for research purposes remains prohibited; they can only be created for the purpose of establishing a pregnancy but couples undergoing infertility treatment will still be able to donate their excess embryos to research.

Strict legislated criteria must be met before a licence will be issued to create research embryos; implanting embryos not created through fertilisation is prohibited.

Neither reproductive embryos nor research embryos will be able to be developed for more than 14 days in a laboratory; this is the point at which the rudimentary nervous system—the ‘primitive streak’—first appears.

The amendments required to the SA Prohibition of Human Cloning Act 2003 to ensure it corresponds with the amended Commonwealth Act include:

changing the name to reflect that it is reproductive cloning that will be prohibited; and

increasing penalties for breaching prohibitions to 15 years; and

reclassifying prohibited practices into those completely prohibited and those prohibited unless authorised by a licence.

In general, prohibitions on using reproductive embryos for research will be retained. The 'embryo parents' decide whether to donate their excess embryos to research and the type of research to which they are prepared to donate them, and can set binding conditions on researchers when they consent to their use.

Creating a chimera by adding components of an animal cell to a human embryo and implanting any type of human embryo in an animal will remain completely prohibited. Creating embryos with genetic material from more than two persons or from precursor cells will remain completely prohibited for reproductive embryos, but permitted for research embryos under licence.

Creating hybrid embryos by combining human and animal cells will remain completely prohibited, with the single exception of a diagnostic test for sperm quality which will be permitted only under licence in reproductive medicine clinics. A licence will be permissible for using animal eggs to test the fertilisation capacity of sperm, but embryo development will only be permitted in this case until a detectable change indicates a result, which is the first cell division on day 2.

The amendments required to the SA Research Involving Human Embryos Act 2003 to ensure it corresponds with the amended Commonwealth Act include:

extending criteria for licences issued for research and training to include the use of embryos not created by fertilisation; and

clarifying what constitutes proper consent by donors and embryos unsuitable for implantation.

Somatic cell nuclear transfer and other research techniques

The Bill will legalise the creation of embryos under a licence by a range of laboratory techniques now allowed under the amended Commonwealth Acts.

These will include:

somatic cell nuclear transfer or SCNT, where the nucleus of a human egg is replaced by the nucleus of a somatic cell (a cell from a human body) and the resultant cell is stimulated to develop for 5 to 7 days to blastocyst stage when embryonic stem cells can be removed; and

parthenogenesis, where a human embryo could potentially be formed by stimulating a human egg to undergo spontaneous activation; such embryos may have the capacity for limited development.

SCNT was used to create ‘Dolly’ the sheep, but since development past 14 days and implantation of such embryos will be prohibited, SCNT in humans will only be licensed to derive embryonic stem cells or for laboratory research, not to produce babies.

Embryonic stem cell research seeks to generate patient-matched stem cells for research to enable development of specific cellular therapies with the potential to overcome problems such as tissue rejection, so this process is sometimes called 'therapeutic cloning'. SCNT will also allow the development of embryonic stem cells containing specific disease genes, which may assist better understanding of the causes of disease and identification of drugs and treatments.

Excess ART embryos are not suitable for this type of research because stem cells derived from ART embryos would not be a genetic 'match' to the patients for whom potential cellular therapies were being developed or would not carry the disease in question. However, maintaining and improving the quality and safety of infertility treatment and procedures and minimising the risks to children born of assisted reproductive medicine relies upon excess reproductive embryos generously donated by parents to research and training.

Protections

The Research Involving Human Embryos Act 2003 will retain its stringent licensing and reporting requirements. Before the NHMRC Embryo Licensing Committee issues a licence for research, diagnostic testing or training, very strict criteria must be met, including:

research ethics approval from the local Human Research Ethics Committee; and

restricting the number of embryos to that likely to be necessary for the project; and

the likelihood of significant advance in knowledge, treatment technologies or other applications from the proposed project; and

evidence of proper informed consent by those donating cells or embryos and their partners; and

accounting for every embryo licensed and abiding by conditions set by donors; and

transparent reporting requirements.

The Bill does not change any of these criteria, but strengthens and extends the consent provisions to include all donors whose genetic material is incorporated in the cells used, and their spouses if the embryo is a reproductive embryo.

The Commonwealth Amendment Bill extended the monitoring, oversight and search provisions for NHMRC inspectors. However, the amendments required to State laws are minimal because the South Australian provisions are already more comprehensive than those in other jurisdictions’ legislation.

NHMRC Guidelines

Researchers and clinicians are required under Commonwealth and State law to abide by guidelines issued by the NHMRC. The NHMRC has produced criteria to define embryos unsuitable for implantation, and recently revised and released their National Statement and their Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research, which are referenced in the South Australian Research Involving Human Embryos Act 2003.

A clause was added during the Act’s passage in 2003 requiring that any NHMRC guideline or policy referenced in the legislation be tabled in Parliament within 3 sitting days from changes taking effect and referred to the Parliamentary Social Development Committee, both initially and each time it is changed. This requirement is unique to South Australia.

The NHMRC reviews and revises its guidelines routinely every 5 years and South Australia keenly engages in its national consultations. The Social Development Committee considered revised NHMRC Ethical Guidelines in 2005, and will consider further revisions to both the NHMRC Ethical Guidelines and the National Statement in 2007. The Social Development Committee cannot in fact change nationally agreed guidelines issued under the Commonwealth NHMRC Act.

The Bill retains the requirement for relevant new or revised NHMRC guidelines to be tabled in Parliament and referred to the Social Development Committee, but extends the time period from 3 to 6 sitting days (which is the usual period in South Australian legislation) from commencement of their operation to allow final printed copies to be procured for tabling in the Parliament.

National consistency and transparency

This is an area of rapid change, not only in research capability but also in community attitudes and standards. Governments and Parliaments have a responsibility to encourage high quality and ethically sound scientific research and medical practice. Society generally needs to be assured that research that uses embryos is strictly regulated under a coherent national scheme. South Australia hosts a recognised centre of excellence for infertility research at the University of Adelaide, and scientists and researchers are seeking the surety of nationally consistent regulation and licensing so the public can be confident that they operate according to nationally endorsed legal and ethical standards, with strict oversight and monitoring and transparent accountability requirements.

This Bill will ensure that further advances in this field are made within a responsible regulatory framework with strong oversight and protections and transparent public reporting. The Commonwealth Acts provide for a further review in 3 years, allowing for continuing Parliamentary oversight into the future.

An explanatory guide with more detailed explanations and fact sheets for the public have been prepared and are available on the Department of Health website.

I commend the Bill to the House.

Explanation of Clauses

Part 1—Preliminary

1—Short title

2—Commencement

3—Amendment provisions

These clauses are formal.

Part 2—Amendment of Prohibition of Human Cloning Act 2003

4—Amendment of long title

5—Amendment of section 1—Short title

These clauses amend the long and short titles of the Act to reflect the fact that the Act, as amended by this measure, will no longer prohibit the creation of human embryos for research purposes.

6—Amendment of section 3—Interpretation

This clause amends section 3 of the Act to replace the existing definition of human embryo with a new definition developed by the NHMRC. It also clarifies that 'human embryo' refers to a living embryo only and does not include a human embryonic stem cell line or a hybrid embryo, and that a reference to a human oocyte is the same as a reference to a human egg.

7—Substitution of Part 2

This clause substitutes Part 2 of the Act. The new Part contains 2 Divisions. Division 1 deals with practices that are completely prohibited and Division 2 deals with practices that are prohibited without a licence issued by the NHMRC Licensing Committee.

Part 2—Prohibited practices

Division 1—Practices that are completely prohibited

5—Offence—placing a human embryo clone in the human body or the body of an animal

This section makes it an offence for a person to place a human embryo clone in the body of a human or in the body of an animal. The effect of this provision is to ban human cloning for the purposes of reproduction. The maximum penalty is imprisonment for 15 years.

6—No defence that human embryo clone could not survive

This section provides that it is no defence that the human embryo clone did not or could not survive.

7—Offence—creating a human embryo for a purpose other than achieving pregnancy in a woman

This section makes it an offence for a person to create a human embryo by fertilisation of a human egg by a human sperm outside the body of a woman, unless the person’s intention in creating the embryo is to attempt to achieve pregnancy in a particular woman. The maximum penalty is imprisonment for 15 years.

8—Offence—creating or developing a human embryo by fertilisation that contains genetic material provided by more than 2 persons

This section makes it an offence for a person to create or develop a human embryo by fertilisation of a human egg by a human sperm outside the body of a woman if the embryo contains genetic material provided by more than 2 persons. The maximum penalty is imprisonment for 15 years.

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

This section makes it an offence for a person to develop a human embryo outside the body of a woman for more than 14 days, excluding any time that the embryo’s development is suspended. The maximum penalty is imprisonment for 15 years.

10—Offence—heritable alterations to genome

This section makes it an offence for a person to intentionally alter the genome of a human cell in such a way that the alteration is inheritable by descendants of the human whose cell was altered. The maximum penalty is imprisonment for 15 years.

11—Offence—collecting a viable human embryo from the body of a woman

This section makes it an offence for a person to remove a human embryo from the body of a woman, intending to collect a viable human embryo. The maximum penalty is imprisonment for 15 years.

12—Offence—creating a chimeric embryo

This section makes it an offence for a person to intentionally create a chimeric embryo. The maximum penalty is imprisonment for 15 years. A chimeric embryo is a human embryo into which a cell of an animal, or any component part of a cell of an animal, has been introduced. It includes anything else that is declared by the regulations to be a chimeric embryo.

13—Offence—developing a hybrid embryo

This section makes it an offence for a person to intentionally develop a hybrid embryo for a period of more than 14 days, excluding any period when development is suspended. The maximum penalty is imprisonment for 15 years.

14—Offence—placing of an embryo

This section makes it an offence for a person to intentionally place a human embryo in the body of an animal, or in a part of a human body other than a woman's reproductive tract. It also makes it an offence to intentionally place an animal embryo in the body of a human for any period of gestation. The maximum penalty is imprisonment for 15 years.

15—Offence—importing, exporting or placing a prohibited embryo

This section makes it an offence for a person to intentionally import an embryo into South Australia knowing that, or reckless as to whether, the embryo is a prohibited embryo. It makes it an offence for a person to intentionally export an embryo from South Australia knowing that, or reckless as to whether, the embryo is a prohibited embryo. The section also makes it an offence for a person to intentionally place an embryo in the body of a woman knowing that, or reckless as to whether, the embryo is a prohibited embryo. The maximum penalty is 15 years.

A prohibited embryo is—

(a) a human embryo created by a process other than the fertilisation of a human egg by human sperm; or

(b) a human embryo created outside the body of a woman, unless the intention of the person who created the embryo was to attempt to achieve pregnancy in a particular woman; or

(c) a human embryo created using human egg and human sperm and containing genetic material provided by more than 2 persons; or

(d) human embryo that has been developing outside the body of a woman for a period of more than 14 days, excluding any period throughout which development is suspended; or

(e) a human embryo created using precursor cells taken from a human embryo or a human fetus; or

(f) a human embryo that contains a human cell whose genome has been altered in such a way that the alteration is heritable by human descendants of the human whose cell was altered; or

(g) a human embryo that was removed from the body of a woman by a person intending to collect a viable human embryo; or

(h) a chimeric embryo or a hybrid embryo.

16—Offence—commercial trading in human eggs, human sperm or human embryos

This section makes it an offence for a person to intentionally give or offer valuable consideration to another person for the supply of a human egg, human sperm or a human embryo, or to intentionally receive, or offer to receive, valuable consideration from another person for the supply of a human egg, human sperm or a human embryo. The maximum penalty is imprisonment for 15 years. However, valuable consideration does not include the payment of reasonable expenses incurred by the person in connection with the supply.

Division 2—Practices that are prohibited unless authorised by a licence

17—Offence—creating a human embryo other than by fertilisation, or developing such an embryo

This section makes it an offence for a person to intentionally create a human embryo by a process other than fertilisation of a human egg by a human sperm, or to develop a human embryo so created, if the creation or development of the embryo by that person is not authorised by a licence. The maximum penalty is imprisonment for 10 years.

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

This section makes it an offence for a person to intentionally create or develop a human embryo by a process other than fertilisation of a human egg by a human sperm, if the human embryo contains genetic material provided by more than 2 persons and the creation or development of the embryo by that person is not authorised by a licence. The maximum penalty is imprisonment for 10 years.

19—Offence—using precursor cells from a human embryo or a human fetus to create a human embryo, or developing such an embryo

This section makes it an offence for a person to use precursor cells taken from a human embryo or fetus, intending to create a human embryo, or to intentionally develop an embryo so created, if the person does so without being authorised by a licence, and knows or is reckless as to the fact that the person is acting without a licence. The maximum penalty is imprisonment for 10 years.

19A—Offence—creating a hybrid embryo

This section makes it an offence for a person to intentionally create or develop a hybrid embryo. The maximum penalty is imprisonment for 10 years. A person does not commit an offence if the creation or development of the embryo by the person is authorised by a licence.

Part 3—Amendment of Research Involving Human Embryos Act 2003

8—Amendment of section 3—Interpretation

This clause amends section 3 of the Act to replace the existing definition of human embryo with a new definition developed by the NHMRC. It inserts definitions of hybrid embryo, unsuitable for implantation and use, and substitutes the definitions of proper consent and responsible person. It clarifies that 'human embryo' refers to a living embryo only and does not include a human embryonic stem cell line or a hybrid embryo, and that a reference to a human oocyte is the same as a reference to a human egg.

9—Substitution of heading to Part 2

This clause substitutes the heading to Part 2 of the Act.

Part 2—Regulation of the use of excess ART embryos, other embryos and human eggs

10—Insertion of sections 5A and 5B

This clause inserts 2 new sections into the Act.

5A—Offence—use of other embryos

This section makes it an offence for a person to intentionally use an embryo if the embryo is—

(a) a human embryo created by a process other than the fertilisation of a human egg by a human sperm; or

(b) a human embryo created by a process other than the fertilisation of a human egg by a human sperm that contains genetic material provided by more than 2 persons; or

(c) a human embryo created using precursor cells taken from a human embryo or a human fetus; or

(d) a hybrid embryo,

and the use is not authorised by a licence. The maximum penalty is imprisonment for 5 years.

5B—Offence—certain activities involving use of human eggs

This section makes it an offence for a person to undertake research or training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in ART if the person is not authorised by a licence to undertake the research or training. The maximum penalty is imprisonment for 5 years.

11—Amendment of section 6—Offence—use of embryo that is not an excess ART embryo

This clause amends section 6 of the Act to make it an offence for a person to intentionally use, outside the body of a woman, a human embryo created by fertilisation of a human egg by a human sperm if it is not an excess ART embryo and the use is not for a purpose related to the assisted reproductive technology treatment of a woman carried out by an accredited ART centre under a South Australian clinical practice licence, and the person knows or is reckless as to that fact.

12—Insertion of section 7A

This clause inserts a new provision.

7A—Person not liable for conduct purportedly authorised

This section makes it clear that a person is not criminally responsible for an offence against the Act in respect of particular conduct if—

(a) the conduct by the person is purportedly authorised by a provision of a licence; and

(b) the licence or the provision is invalid, whether because of a technical defect or irregularity or for any other reason; and

(c) the person did not know, and could not reasonably be expected to have known, of the invalidity of the licence or the provision.

13—Amendment of section 10—Person may apply for licence

This clause amends section 10 of the Act to expand the classes of activities for which a licence may be sought. Currently only the use of excess ART embryos may be licensed. Under the proposed changes a person will be able to apply to the NHMRC Licensing Committee for a licence authorising 1 or more of the following:

(a) use of excess ART embryos;

(b) creation of human embryos other than by fertilisation of a human egg by a human sperm, and use of such embryos;

(c) creation of human embryos other than by fertilisation of a human egg by a human sperm that contain genetic material provided by more than 2 persons, and use of such embryos;

(d) creation of human embryos using precursor cells from a human embryo or a human fetus, and use of such embryos;

(e) research and training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in ART;

(f) creation of hybrid embryos by the fertilisation of an animal egg by a human sperm, and use of such embryos up to, but not including, the first mitotic division, if—

(i) the creation or use is for the purposes of testing sperm quality; and

(ii) the creation or use will occur in an accredited ART centre.

The section makes it clear that (a), (b), (c) and (d) do not permit the NHMRC Licensing Committee to authorise any use of an excess ART embryo or other embryo that would result in the development of the embryo for a period of more than 14 days, excluding any period when development is suspended.

14—Amendment of section 11—Determination of application by Committee

15—Amendment of section 14—Licence is subject to conditions

The amendments made to sections 11 and 14 of the Act by these clauses are consequential on the amendments to section 10. It ensures that the provisions relating to the determination of applications for licences and the imposition of licence conditions apply in relation to licences authorising activities relating to human eggs and embryos other than excess ART embryos.

16—Amendment of section 16—Suspension or revocation of licence

This clause amends section 16 of the Act to alter the reference to legislation the title of which is amended by this measure.

17—Amendment of section 19—NHMRC Committee to make certain information publicly available

This clause amends section 19 of the Act to require the NHMRC Licensing Committee to include in its licence database the number of ART embryos or human eggs authorised to be used under a licence, and the number of other embryos authorised to be created or used under a licence.

18—Amendment of section 21—Interpretation

This clause amends section 19 of the Act to enable the holder of a licence to apply for a review of a decision to modify NHMRC guidelines in respect of the licence. The relevant guidelines are those issued by the CEO of the NHMRC under Commonwealth legislation and prescribed by regulations under the Commonwealth Research Involving Human Embryos Act 2002 for the purposes of the definition of 'proper consent' in that Act.

19—Amendment of section 22—Review of decisions

The amendment made to section 22 of the Act by this clause is consequential on the insertion of section 14(8) in the Act.

20—Amendment of section 23—Powers of inspectors

This clause amends section 23 of the Act so that if, during a search of premises, an inspector believes on reasonable grounds that there is at the premises, a human egg or embryo other than a human embryo that may afford evidence of the commission of an offence against the Act, the inspector may secure the egg or embryo pending the obtaining of a warrant to seize it.

21—Amendment of section 30—NHMRC guidelines

This clause amends section 30 of the Act so that alterations to NHMRC guidelines are required to be tabled in Parliament within 6 sitting days of taking effect under the Act.

Part 4—Transitional provision

22—Transitional provision

This clause provides that if an application for a licence under section 10 of the Research Involving Human Embryos Act 2003 made before the commencement of this clause has not been determined at the commencement of this clause, the application is to be determined as if it had been made after that commencement.

Debate adjourned on motion of Ms Chapman.