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Research Involving Embryos and Prohibition of Human Cloning Bill 2002

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2002

 

 

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

 

 

HOUSE OF REPRESENTATIVES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

RESEARCH INVOLVING EMBRYOS AND PROHIBITION OF HUMAN CLONING BILL 2002

 

 

 

 

EXPLANATORY MEMORANDUM

 

 

 

 

 

 

 

 

 

 

(Circulated by authority of the Prime Minister, the Hon John Howard MP)



RESEARCH INVOLVING EMBRYOS AND PROHIBITION OF HUMAN CLONING BILL 2002

 

OUTLINE

 

This Bill forms part of a national regulatory system to address concerns, including ethical concerns, about scientific developments in relation to human reproduction and the utilisation of human embryos.  This is to be achieved through a regulatory framework which:

 

(a)            prohibits certain practices associated with reproductive technologies, including the cloning of a human being; and

(b)           regulates activities that involve the use of certain human embryos created by assisted reproductive technology.

 

Consistent with its object, the Bill:

 

(a)                 prohibits the creation, importation, exportation or implantation of a human embryo clone;

(b)                prohibits the creation, importation, exportation or implantation of certain other embryos for ethical and safety reasons;

(c)                 establishes a principal committee within the National Health and Medical Research Council (NHMRC), the NHMRC Embryo Research Licensing Committee (the NHMRC Licensing Committee), for the purposes of performing functions and exercising powers under the Bill;

(d)                establishes a scheme for the assessment and licensing of certain activities involving the use of excess embryos created by assisted reproductive technology (excess ART embryos);  and

(e)                 provides for a centralised, publicly available database of information about all licences issued by the NHMRC Licensing Committee.

 

 

FINANCIAL IMPACT STATEMENT

 

In developing and implementing the Research Involving Embryos and Prohibition of Human Cloning Bill 2002, the Government will incur both establishment costs and ongoing costs.

 

Following the passage of the legislation, costs are realistically expected to be approximately $3m per annum, with an upper maximum of $6m. This involves a fixed cost to support the NHMRC Licensing Committee and provide for ongoing compliance monitoring related to the prohibited practices. There is also a variable cost, related to the number of applications received. While it is not possible to accurately predict this, the above estimate includes up to 120 applications per year, based on recent consultation with ART service providers and researchers. Establishment costs involve:

·         developing administrative processes for receiving and processing applications and issuing licences;

·         establishing the new NHMRC Licensing Committee;

·         recruiting appropriately skilled staff;

·         establishing a skilled inspectorate to ensure compliance with the Act through monitoring and inspection; 

·         assessment of research proposals; and

·         establishment and maintenance of data systems and public reporting.

 

 

REGULATION IMPACT STATEMENT

 

Please refer to Attachment 1 to this Explanatory Memorandum.



 

RESEARCH INVOLVING EMBRYOS AND PROHIBITION OF HUMAN CLONING BILL 2002

 

NOTES ON CLAUSES

 

PART 1 - PRELIMINARY

 

Clause 1 - Short title

 

This is a formal provision that specifies the short title of the Bill as the Research Involving Embryos and Prohibition of Human Cloning Act 2002 .

 

Clause 2 - Commencement

 

Sub-clause 2(1) provides that the various provisions take effect on the date specified in the table.

 

Item 1 of the table provides that clauses 1 and 2 of the Bill commence on the day on which the Bill receives Royal Assent.

 

Item 2 of the table provides that clauses 3 to 24 will commence 28 days after the day on which the Bill receives Royal Assent.  These clauses relate to the preliminary matters in the Bill and to the prohibited practices included in Part 2 of the Bill.

 

Item 3 of the table provides that clauses 25 to 27 will commence 6 months after the day on which the Bill receives Royal Assent.  Clause 25 provides that a person must not use an excess ART embryo unless that use is an exempt use or is authorised by a licence issued by the NHMRC Embryo Research Licensing Committee.  Clause 26 provides that a person must not use a non-excess ART embryo unless it is part of an ART program carried out by an accredited ART centre.  Clause 27 provides that a person must comply with any conditions of a licence. 

 

The delay of commencement for these clauses is to allow time:

 

·         for the establishment of the new NHMRC Licensing Committee; and

·         for applications for licences to be made.

 

During this 6 month transitional period researchers and others will continue to have to comply with existing State legislation and the NHMRC Ethical Guidelines on ART (1996).  

 

By delaying the commencement of these clauses for 6 months this will also allow States and Territories to introduce complementary legislation and, where necessary, repeal existing provisions of State legislation that ban the use of excess ART embryos.

 

Item 4 and Item 5 of the table provides that clauses 28 to 62 and Schedule 1 will commence 28 days after the day on which the Bill receives Royal Assent.  These clauses provide, among other things, for the establishment and administration of the NHMRC Licensing Committee as well as provisions on the review of the Act and regulations to be made under the Act.  Schedule 1 repeals certain sections of the Gene Technology Act 2000 that are replaced by clauses in Part 2 of this Bill. 

 

Clause 3 - Object of Act

 

This clause provides that the object of this Bill is to address concerns, including ethical concerns, about scientific developments in relation to human reproduction and the utilisation of human embryos:

 

(a)            by prohibiting certain practices; and

(b)           by regulating activities that involve the use of certain human embryos created by assisted reproductive technology.

 

Clause 4 - Operation of Act

 

This clause sets out the constitutional powers on which it is proposed that the Commonwealth legislation will rely.

 

The Commonwealth legislation will rely on:

 

·         the Corporations power (paragraph 51(xx) of the Constitution).  This means that  the Act will apply to all things done by corporations formed within the limits of the Commonwealth;

·         the trade and commerce power (paragraph 51(i) of the Constitution).  This means that the Act will apply to all things done in the course of trade and commerce;

·         the external affairs power (paragraph 51(xxix) of the Constitution).  This enables the Act to apply to matters of international concern;

·         powers of the Parliament in relation to the Commonwealth (section 52 of the Constitution).  This means the Act will apply to all things done by the Commonwealth and Commonwealth authorities (including Commonwealth Departments such as the Department of Health and Ageing, Commonwealth statutory authorities and Commonwealth companies);

·         the census and statistics power (paragraph 51(xi) of the Constitution).  This enables the Act to apply for purposes relating to the collection, compilation, analysis and dissemination of statistics (such as the provisions relating to the establishment of a database of licences issued by the NHMRC Licensing Committee); and

·         incidental power (paragraph 51(xxxix) of the Constitution).  This enables the establishment of the infrastructure necessary to support the regulatory system.

 



Clause 5 - Act to bind the Crown

 

Sub-clause 5(1 ) provides that the Bill will bind the Crown in each of its capacities.

 

Sub-clause 5(2) provides that the Crown may not be prosecuted for a criminal offence under this Bill.

 

Clause 6 - External Territories

 

This clause provides that the Bill will have application in every external Territory.  Therefore, the legislation will cover, for example, Norfolk Island, the Indian Ocean Territories (Cocos and Christmas Islands), Macquarie and Heard Islands, the Australian Antarctic Territory and the Jervis Bay Territory.

 

Clause 7 - Definitions

 

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.

 

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 means other than by the fertilisation of a human egg by human sperm.

 

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 (ie 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.

 

Subclause 7(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.

 

Subclause 7(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 (ie 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.

 

Subclause 7(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.

 

PART 2 - PROHIBITED PRACTICES

 

DIVISION 1 - Human cloning

 

Clause 8 - Offence - creating a human embryo clone

 

This clause makes it an offence to intentionally create an embryo that is a genetic copy of another living or dead human.

 

Creating a human embryo clone by any means is an offence.  That is, if any current procedures, like somatic cell nuclear transfer, embryo splitting, or any future procedures are used in an attempt to create a human embryo clone, then an offence is committed.

 

This clause is not intended to capture the circumstance where a human embryo created by assisted reproductive technology, spontaneously divides into two or more identical embryos (commonly known as identical twins, triplets etc).  Clause 7 clarifies that identical twins (created by the fertilisation of a human egg by human sperm) are not “human embryo clones”.

 

The maximum penalty that may be applied for creating a human embryo clone is 15 years imprisonment.  A court may, at its discretion, supplement the imprisonment term with a monetary penalty or convert the imprisonment term to a monetary penalty of up to $495,000 for a corporation and $99,000 for an individual.

 

Clause 9 - Offence - placing a human embryo clone in the human body or the body of an animal

 

This clause makes 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.  This clause is intended to cover the circumstance where, for example, a human embryo clone  may have been illegally created in Australia, or imported into Australia, and is subsequently implanted in a woman (or an animal).

 

The maximum penalty that may be applied for placing a human embryo clone in the human body or the body of an animal is 15 years imprisonment.  A court may, at its discretion, supplement the imprisonment term with a monetary penalty or convert the imprisonment term to a monetary penalty of up to $495,000 for a corporation and $99,000 for an individual.

 

Clause 10 - Offence - importing or exporting a human embryo clone

 

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

 

The maximum penalty that may be applied for importing or exporting a human embryo clone is 15 years imprisonment.  A court may, at its discretion, supplement the imprisonment term with a monetary penalty or convert the imprisonment term to a monetary penalty of up to $495,000 for a corporation and $99,000 for an individual.

 

Clause 11 - No defence that clone could not survive

 

This clause provides that any human embryo clone that is intentionally created, implanted, imported or exported does not have to survive to the point of live birth in order for an offence to be established under clauses 8, 9 or 10.  This would include, but is not necessarily limited to, the following situations:

 

·         where an unsuccessful attempt to create a human embryo clone is made;

·         where a human embryo clone is created and then allowed to die;

·         where a human embryo clone is created and deliberately destroyed without attempting implantation;

·         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; or

·         where a human embryo clone is successfully implanted, develops to full term but is still-born.

 

DIVISION 2 - Other prohibited practices

 

Clause 12 - 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 outside the body of a woman 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 Australia (an offence under clause 21) it could not be developed by the person who imported it or any other person without an offence being committed.

 

The definition of sperm (in clause 7) means that under this clause a human embryo is permitted to be created by fertilising a human egg with human spermatids.  Spermatids are one of the precursor cells of sperm and can be used in assisted reproductive treatment to create an embryo through the procedure known as intracytoplasmic sperm injection (ISCI), where a man may be unable to produce functional sperm cells.

 

The maximum penalty that may be applied for creating a human embryo other than by fertilisation of a human egg by human sperm is 10 years imprisonment.  A court may, at its discretion, supplement the imprisonment term with a monetary penalty or convert the imprisonment term to a monetary penalty of up to $330,000 for a corporation and $66,000 for an individual.

 

Clause 13 - Offence - creating a human embryo for a purpose other than achieving pregnancy in a woman

 

Th 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.

 

It is an offence to create human embryos specifically for other purposes such as for use in research or to derive embryonic stem cells for potential therapeutic use.  This clause is not intended to prohibit certain uses of human embryos 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 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.  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 (1996); or

·         prevent the circumstance whereby a human embryo created by an ART clinic, originally intended for implantation into a woman, may be found 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 3 of the Bill.

 

The maximum penalty that may be applied for creating a human embryo for a purpose other than achieving pregnancy in a woman is 10 years imprisonment.  A court may, at its discretion, supplement the imprisonment term with a monetary penalty or convert the imprisonment term to a monetary penalty of up to $330,000 for a corporation and $66,000 for an individual.

 

Sub-clause 13(2) provides that despite subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to any matter in subsection (1) of this section.  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 14 - 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. 

 

One of the effects of this clause is to ban a relatively new 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 achieving pregnancy.  It has been reported that this procedure may be particularly valuable to older women to assist them to become pregnant.

 

Both safety and ethical concerns have been raised regarding cytoplasmic transfer.  Firstly,  the technique is a very new technique and its safety with respect to babies created using the technique is yet to be established.  Additionally, any live born child may have DNA from three separate people, posing ethical concerns.  The DNA 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 at this stage.

 

The wording of this clause avoids any references to cytoplasmic transfer explicitly and instead utilises wording that reflects the concern that it results in the creation of human embryos with genetic material from more than two people.  In this way the prohibition is drafted sufficiently broadly to include other techniques, current or emerging, that may also involve the presence in a human embryo of a third party’s DNA. 

 

The maximum penalty that may be applied for creating or developing a human embryo containing genetic material provided by more than 2 persons is 10 years imprisonment.  A court may, at its discretion, supplement the imprisonment term with a monetary penalty or convert the imprisonment term to a monetary penalty of up to $330,000 for a corporation and $66,000 for an individual.

 

Clause 15 - 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.

 

It is important that this clause be read subject to clause 12 that bans the creation of a human embryo by any means other than the fertilisation of human egg by human sperm.  This means that a human embryo created by asexual means, such as by parthenogenesis, embryo splitting or somatic cell nuclear transfer, cannot be created or developed to any stage. 

 

This clause provides that the maximum penalty for developing a human embryo outside the body of a woman for more than 14 days is 10 years imprisonment.  A court may, at its discretion, supplement the imprisonment term with a monetary penalty or convert the imprisonment term to a monetary penalty of up to $330,000 for a corporation and $66,000 for an individual.

 

Clause 16 - Offence - using precursor cells from a human embryo or a human fetus to create a human embryo, or developing such an embryo

 

This clause prevents the creation of a human embryo with cells taken from another human embryo or a human fetus that have the potential to develop into egg or sperm cells.  It is also an offence to develop a human embryo created by precursor cells of eggs or sperm taken from an embryo or fetus. 

 

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 fetus or embryo) never having had a living genetic parent.

 

The maximum penalty for using precursor cells from a human embryo or a human fetus to create a human embryo, or develop such an embryo, is 10 years imprisonment.  A court may, at its discretion, supplement the imprisonment term with a monetary penalty or convert the imprisonment term to a monetary penalty of up to $330,000 for a corporation and $66,000 for an individual.

 

Clause 17 - 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. 

 

The maximum penalty for manipulating the human genome so that the change is heritable to future generations is 10 years imprisonment.  A court may, at its discretion, supplement the imprisonment term with a monetary penalty or convert the imprisonment term to a monetary penalty of up to $330,000 for a corporation and $66,000 for an individual.

 

Clause 18 - 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.  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. This clause bans such a practice. 

 

The maximum penalty for intentionally collecting a viable human embryo from a woman is 10 years imprisonment.  A court may, at its discretion, supplement the imprisonment term with a monetary penalty or convert the imprisonment term to a monetary penalty of up to $330,000 for a corporation and $66,000 for an individual.

 

Clause 19 - 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 7, 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;

(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 2000 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).

 

The maximum penalty for creating, or developing, a hybrid or chimeric embryo is 10 years imprisonment.  A court may, at its discretion, supplement the imprisonment term with a monetary penalty or convert the imprisonment term to a monetary penalty of up to $330,000 for a corporation and $66,000 for an individual.

 

Clause 20 - 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 womans body, other than the female reproductive tract.

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

 

Some concern has also been expressed about the possibility, in the future, of a human embryo being developed into a fetus, outside the body of a woman. This would be prevented by clause 15 that prohibits the development of an embryo in vitro for any period longer than 14 days.

 

The maximum penalty for any of the offences under this clause is 10 years imprisonment.  A court may, at its discretion, supplement the imprisonment term with a monetary penalty or convert the imprisonment term to a monetary penalty of up to $330,000 for a corporation and $66,000 for an individual.

 

Clause 21 - Offence - importing, exporting or placing a prohibited embryo

 

This clause prevents the intentional import into Australia, intentional export from Australia or the intentional placement in the body of a woman of any embryo that is referenced in clauses 12, 13, 14, 15, 16, 17, 18 and 19.  For the purposes of this clause, such embryos are referred to as “prohibited embryos”.  That is:

 

·         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 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 fetus;

·         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; or

·         a chimeric embryo or a hybrid embryo.

 

By including both importation and implantation within this clause it removes the possibility that one person will be able to import a prohibited embryo and give it to another person to be implanted in a woman.  In this case both people would be in breach of the legislation. Including exportation of a prohibited embryo as an offence ensures that a person cannot export a prohibited embryo that has been illegally created or obtained.

 

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 to continue, subject to other legislation such as the Quarantine Act 1908 or the Customs Act 1901 .  This may occur, for example, where a couple have had embryos created for the purposes of ART in another country, subsequently move to Australia, and wish to continue their ART treatment program in Australia.

 

The maximum penalty for importing, exporting or placing in the body of a woman, a prohibited embryo is 10 years imprisonment.  A court may, at its discretion, supplement the imprisonment term with a monetary penalty or convert the imprisonment term to a monetary penalty of up to $330,000 for a corporation and $66,000 for an individual.

 

Clause 22 - 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.

 

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.

 

The maximum penalty for trading in human embryos, sperm or eggs is 10 years imprisonment.  A court may, at its discretion, supplement the imprisonment term with a monetary penalty or convert the imprisonment term to a monetary penalty of up to $330,000 for a corporation and $66,000 for an individual.

 

PART 3 - REGULATION OF CERTAIN USES INVOLVING EXCESS ART EMBRYOS

 

DIVISION 1 - Interpretation

 

Clause 23 - Definitions

 

This clause sets out a number of definitions for words and phrases used in Part 3 of the Bill.  These definitions determine the meaning that is to be attributed to certain words or phrases whenever they are used in this Part.  Key definitions include:

 

accredited ART centre   - This 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 prescribe 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.

 

The Reproductive Technology Accreditation Committee (RTAC) of the Fertility Society of Australia currently oversees a system of industry based regulation for clinics using ART or carrying out associated research and sets professional and laboratory standards for clinical practice.   ART clinics are usually accredited by the RTAC for three years.  Accredited ART clinics are expected to comply with the RTAC Code of Practice for Centres using Assisted Reproductive Technology and any relevant Guidelines issued by the RTAC. 

 

proper consent is defined to mean consent that is obtained in accordance with the current NHMRC Ethical Guidelines on Assisted Reproductive Technology (1996) or any other guidelines that are notified in the Commonwealth Government Gazette as determined by the Chairperson of the NHMRC Licensing Committee.  The power to identify alternative (or supplementary) guidelines in the Commonwealth Government Gazette ensures that the most appropriate and recent guidelines describing the processes for consent are observed.  For example, the NHMRC Ethical Guidelines on Assisted Reproductive Technology are currently subject to review and it is likely that new guidelines will be issued in early 2003.  These new guidelines could be referenced in the Commonwealth Government Gazette and therefore replace the older guidelines. 

 

responsible person, in relation to an excess ART embryo, is defined to mean:

 

(a)                                         each person who provided the egg or sperm from which the embryo was created; and

(b)                                        the woman for whom the embryo was created, for the purpose of achieving her pregnancy; and

(c)                                         any person who was the spouse of a person mentioned in paragraph (a) at the time the egg or sperm mentioned in that paragraph was provided; and

(d)                                        any person who was the spouse of the woman mentioned in paragraph (b) at the time the embryo was created.

 

Clause 24 - Meaning of excess ART embryo

 

This clause defines what is meant by an “excess ART embryo”, requiring that:

 

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

·         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.

 

Sub-clause 24(2) provides that a human embryo is an “excess ART embryo”, if:

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

·         the woman for whom the embryo was created (and her spouse, 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 couple 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.

 

DIVISION 2 - Offences

 

Clause 25 - Offence - use of excess ART embryo

 

This clause essentially describes the scope of the regulatory scheme for excess ART embryos by describing the uses of excess ART embryos that require a licence and those that do not.

 

In summary, all uses of an excess ART embryo are required to be licensed by the NHMRC Licensing Committee unless such uses are “exempt uses” in accordance with sub-clause 25(2).

 

Sub-clause 25(2) provides that the following uses of an excess ART embryo are exempt (and therefore do not require licensing):

 

·         storage of an excess ART embryo;

·         removing an excess ART embryo from storage (provided that no subsequent use of the embryo is proposed that would otherwise require a licence);

·         transport of an excess ART embryo;

·         observation of an excess ART embryo (including taking a photograph of the embryo or taking a recording of the embryo from which a visual image can be produced);

·         allowing the excess ART embryo to die (succumb);

·         diagnostic investigations using excess ART embryos that are unsuitable for implantation (for example, chromosomally abnormal embryos) provided that the investigations are specifically related to achieving pregnancy in the woman for whom the embryo was created. In some cases, as a part of routine clinical practice, it may be beneficial to the woman for whom the embryo was created for diagnostic tests to be undertaken on ART embryos that are unsuitable for implantation to determine the reason why they are not suitable for implantation so as to improve the likelihood of successful pregnancy in the next attempt;

·         donating the excess ART embryo to another woman for the purpose of achieving pregnancy in that other woman;  and

·         any other use prescribed in the regulations.

 

All other uses of an excess ART embryo are required to be licensed by the NHMRC Licensing Committee.  This includes, for example, using excess ART embryos:

 

·         for research (for example, to derive stem cells or to improve ART clinical practice);

·         to train people in ART techniques;

·         for Quality Assurance testing to ensure that pre-implantation diagnostic tests give accurate results; and

·         to examine the effectiveness of new culture media.   

 

The NHMRC Licensing Committee will consider options to streamline the administration of the legislation, where the NHMRC Licensing Committee is satisfied that the use of the excess ART embryos will not damage or destroy the embryo.  For example, ART service providers could apply for one licence to undertake quality assurance work using an approved list of techniques and a defined number of excess ART embryos. It may also be appropriate to consider similar arrangements for certain uses of excess ART embryos that may damage the embryo but are a part of routine ART clinical practice, such as the use of embryos for training people in the techniques of assisted reproductive technology.

 

The effect of sub-clause 25(1) is to make it an offence to intentionally use an excess ART embryo unless the use is authorised by a licence or is one of the exempt uses detailed above.  The maximum penalty that may be applied for use of an excess ART embryo without a licence, or without that use being an exempt use, is 5 years imprisonment.  A court may, at its discretion, supplement the imprisonment term with a monetary penalty or convert the imprisonment term to a monetary penalty of up to $165,000 for a corporation and $33,000 for an individual.

 

Clause 26 - Offence - use of embryo that is not an excess embryo

 

This clause provides that it is an offence to intentionally use a non-excess ART embryo unless the use is part of an ART program carried out by an accredited ART clinic. 

 

Sub-clause 26(2) defines an “ART program”  as an assisted reproductive technology program carried out in accordance with the Code of Practice for Centres Using Assisted Reproductive Technology issued by the Reproductive Technology Accreditation Committee of the Fertility Society of Australia (which is used as the basis for accrediting ART clinics) or any similar code as prescribed in regulations.

 

The effect of this clause is to ensure that there is no loophole for the inappropriate use of ART embryos that are not excess to the needs of the woman (and any spouse) for whom they were created.  For example, it would be illegal to use an ART embryo that has not been declared “excess” in the training of ART technicians or to derive embryonic stem cells.

 

The maximum penalty for an offence under this clause is 5 years imprisonment which may, at the discretion of the Courts be supplemented by, or converted to a monetary penalty of up to $165,000 for a corporation and $33,000 for an individual.

 

Clause 27 - Offence - breaching a licence condition

 

This clause provides that a person is guilty of an offence if they intentionally do something, or fail to do something, that they know will result in a breach of a condition of licence or that they do so being reckless as to whether or not the action or omission will contravene a condition of licence.

 

The maximum penalty for breaching a condition of licence is 5 years imprisonment which may, at the discretion of the Courts be supplemented by, or converted to a monetary penalty of up to $165,000 for a corporation and $33,000 for an individual.

DIVISION 3 - Embryo Research Licensing Committee of the NHMRC
Clause 28 - Establishment of Committee

 

This clause establishes the NHMRC Licensing Committee as a Principal Committee of the NHMRC.  As detailed in relation to clause 29, the NHMRC Licensing Committee will be tasked with considering licence applications in relation to the use of excess ART embryos.

 

The National Health and Medical Research Council Act 1992 (the NHMRC Act) establishes the NHMRC and two Principal Committees - the Research Committee and the Australian Health Ethics Committee (AHEC).  The purpose of clause 28 of this Bill is to establish the new NHMRC Licensing Committee as a Principal Committee of the NHMRC.  By establishing the Committee in this Bill, the Committee automatically becomes a Principal Committee of the NHMRC for the purposes of the NHMRC Act.

 

By establishing the NHMRC Licensing Committee as a Principal Committee for the purposes of the NHMRC Act this means that many of the provisions in the NHMRC Act that apply to Principal Committees generally will also apply to this Committee.  This avoids the need to re-state all of these provisions in this Bill. The following sections of the NHMRC Act will apply in respect of the operations of the NHMRC Licensing Committee:

 

·         section 37A  - responsibilities of the Chairperson and Deputy Chairperson;

·         section 38 - operating procedures;

·         section 39 - working committees;

·         section 40 - arrangements to assist committees;

·         section 41 - remuneration and allowances;

·         section 42 - leave of absence;

·         section 43 -  resignation;

·         section 44 - termination of appointment;

·         section 81 - protection from civil actions; and

·         section 82(3), (4) and (5) - delegations.

 

Sub-clause 28(2) provides that the following clauses of the NHMRC Act will not apply to the NHMRC Licensing Committee:

 

·         section 10  - allowing the Minister to issue certain directions to the NHMRC and other Principal Committees;

·         section 35 - relating to appointment of committee members (see clause 31, below);

·         section 80 - treatment of confidential commercial information; and

·         subsection 82(2) of the NHMRC Act - delegations from the NHMRC to the NHMRC Licensing Committee.

 

Sub-clauses 28(4) and (5) provide that regulations may include disclosure of interest provisions.  If such regulations are in force, these override the current NHMRC disclosure of interest provisions which are detailed as part of NHMRC committee procedures made under paragraph 38(b)(vi) of the NHMRC Act.  

 

Clause 29 - Functions of Committee

 

This clause sets out the functions of the NHMRC Licensing Committee. In essence, the NHMRC Licensing Committee will be tasked with:

 

·         considering licence applications;

·         refusing licences or granting licences including subject to conditions;

·         notifying relevant people of the Committee’s decision regarding the application for licence including the applicant, the relevant Human Research Ethics Committee (HREC) and the relevant State authority;

·         varying, suspending or cancelling licences, should this be necessary;

·         establishing and maintaining a publicly available database containing information about work involving excess ART embryos that has been licensed by the Committee;

·         monitoring compliance with the legislation (the NHMRC Licensing Committee may also delegate this function to a Commonwealth or State officer) and taking any necessary enforcement action;

·         providing information about the Committee’s functions for inclusion in the NHMRC annual report; and

·         providing advice to applicants on the licensing requirements and the preparation of applications.

 

Clause 30 - Powers of Committee

 

This clause provides that the NHMRC Licensing Committee has power to do all things needed to be done in connection with the performance of the NHMRC Licensing Committee’s functions.

 

Clause 31 - Membership of Committee

 

This clause describes the members to be appointed to the NHMRC Licensing Committee and the means for appointing such members.

 

Sub-clause 31(1) provides that the NHMRC Licensing Committee will be comprised of 9 members as follows:

 

(a)                 a member of AHEC;

(b)                a person with expertise in research ethics;

(c)                 a person with expertise in a relevant area of research;

(d)                a person with expertise in assisted reproductive technology;

(e)                 a person with expertise in a relevant area of law;

(f)                  a person with expertise in consumer health issues as they relate to disability and disease;

(g)                 a person with expertise in consumer issues relating to assisted reproductive technology;

(h)                 a person with expertise in the regulation of assisted reproductive technology; and

(i)                   a person with expertise in embryology.

 

The members of the NHMRC Licensing Committee must be appointed by the Minister with portfolio responsibility for this Act.  Before appointing any members to the NHMRC Licensing Committee the Minister must seek nominations from the organisations described in regulations accompanying this legislation.  Placing the list of organisations in the regulations enables the list to be updated relatively simply as organisations change their name or as new organisations are formed that should be consulted.  The Minister must also seek nominations from all States and Territories, consult the States and Territories on proposed appointments and have regard to the views expressed by the States and Territories.

 

Sub-clause 31(4) expressly provides that the AHEC member must not be appointed as the Chair of the NHMRC Licensing Committee.  This is important because otherwise it would theoretically be possible for a member of AHEC to be both the Chair of AHEC and the Chair of the NHMRC Licensing Committee. On a practical level the workload would be considerable if an AHEC member were also the Chair of the NHMRC Licensing Committee.  Further, such an arrangement could pose potential conflicts of interest.

 

Sub-clause 31(5) provides that before appointing the Chair of the Committee, or the person with expertise in the regulation of assisted reproductive technology, the Minister must have the majority agreement of the States and Territories.

 

Sub-clause 31(6) provides that in appointing members to the NHMRC Licensing Committee the Minister must also have regard to the desirability of ensuring that the Committee as a whole comprises members from different States and Territories.

 

Clause 32 - Terms of appointment

 

This clause clarifies that members of the NHMRC Licensing Committee hold office on a part-time basis and for the period specified in their instrument of appointment which must not exceed 3 years.  Members may be reappointed for further terms.  This is consistent with the appointment terms for the NHMRC and its other Principal Committees.

 

Clause 33 - Annual Report

 

Under section 83 of the National Health and Medical Research Council Act 1992 , the NHMRC must prepare an Annual Report. The NHMRC is required to provide its Annual Report to the Minister as soon as practicable after the end of each calendar year and the Minister is required to table the report in Federal Parliament within 15 sitting days after receiving the Report.

 

This clause provides that the NHMRC Licensing Committee must provide details of its operations to the NHMRC for inclusion in the NHMRC Annual Report.

 

Clause 34 - Reports to Parliament

 

This clause enables the NHMRC Licensing Committee to make a Report to Parliament at any time should the NHMRC Licensing Committee consider this necessary.  The clause provides that the NHMRC Licensing Committee must provide a copy of the report to the responsible Minister and to each State and Territory.

 

DIVISION 4 - Licensing System

 

Clause 35 - Person may apply for licence

 

This clause provides that a person may apply to the NHMRC Licensing Committee for a licence.  Such an application must be in accordance with the application requirements of the NHMRC Licensing Committee.  It is proposed that the NHMRC Licensing Committee will issue application forms and detailed explanatory material about the Committee’s expectations with respect to the information that should be included in any application.

 

It is expected that the “person” who applies for a licence will be the organisation in which the work with excess ART embryos is proposed to be undertaken, rather than the individual proposing to undertake the work.

 

The application must also be accompanied by an application fee if such an application fee is prescribed in the regulations.

 

 

Clause 36 - Determination of application by Committee

 

This clause describes the matters that must be considered by the NHMRC Licensing Committee when deciding whether or not to issue a licence.  The clause sets out certain things that the NHMRC Licensing Committee must be satisfied of before they issue a licence and other issues that the NHMRC Licensing Committee must have regard to when deciding whether or not to grant a licence.

 

Sub-clause 36(3) provides that the NHMRC Licensing Committee must not issue the 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 and to ensure that where the couple for whom the embryo was created have specified any restrictions on the use of an embryo, these restrictions will be observed;

·         if the proposed use of the excess ART embryo may damage or destroy the embryo (as determined by the NHMRC Licensing Committee), that appropriate protocols are in place to ensure that the excess ART embryos used in the project (should the licence be approved) have been created before 5 April 2002; and

·         the proposed project has been considered and assessed by a Human Research Ethics Committee (HREC) that is constituted in accordance with, and acting in compliance with, the National Statement on Ethical Conduct in Research Involving Humans (1999) issued by the NHMRC (or such other document that may replace the National Statement).

 

Sub-clause 36(4) provides that in deciding whether to issue a licence, the NHMRC Licensing Committee must have regard to the following:

 

·         the number of excess ART embryos likely to be necessary to achieve the goals of the activity or project proposed in the application;

·         the likelihood of significant advance in knowledge, or improvement in technologies for treatment, as a result of the use of excess ART embryos proposed in the application which could not reasonably be achieved by other means;

·         any relevant guidelines, or parts of guidelines issued by the NHMRC.  For example, the NHMRC (through the Australian Health Ethics Committee) is currently undertaking a review of the NHMRC Ethical Guidelines on Assisted Reproductive Technology (1996).  It is anticipated that following the review, the NHMRC will issue revised guidelines that will include information about the criteria to be taken into account for the purposes of determining whether a use of an excess ART embryo will be likely to result in a significant advance in knowledge or improvement in technologies for treatment that could not reasonably be achieved by other means;

·         the HREC assessment of the application; and

·         such additional matters (if any) as are prescribed by the regulations.

 

Clause 37 - Notification of decision

 

This clause requires the NHMRC Licensing Committee to notify its decision on an application to the applicant, the HREC that considered the application and the relevant State body (as notified by the State government).  In addition, if the NHMRC Licensing Committee issues a licence to the applicant, a copy of the licence must also be provided to the HREC and to the relevant State body.

 

Clause 38 - Period of licence

 

This clause provides that a licence comes into force on the day specified in the licence or if no such date is specified, the day that the licence is issued.  The licence ceases operation on the day specified in the licence unless it is suspended, revoked or surrendered before that day.

 

Sub-clause 38(2) clarifies that a licence is not in force throughout any period of suspension.

 

Clause 39 - Licence is subject to conditions

 

This clause describes the conditions to which all licences issued by the NHMRC Licensing Committee are subject and enables the NHMRC Licensing Committee to impose any other conditions that it considers necessary.

 

Sub-clauses 39(1), (2) and (3) describe the conditions that all licence holders must comply with.  These sub-clauses provide that before a person can commence using an excess ART embryo (under a licence issued by the NHMRC Licensing Committee), the licence holder must confirm with the NHMRC Licensing Committee (by notice in writing):

 

·         that consent has been obtained for the use of all the embryos, in accordance with the protocol considered by the NHMRC Licensing Committee;

·         any restrictions on the use of the embryos (as determined by the couples for whom the embryos were created); and

·         in the case of uses of the embryos that may damage or destroy the embryos, that the embryos were created before 5 April 2002.

 

Once a licence holder has provided this information to the NHMRC Licensing Committee they may commence work with the excess ART embryos provided they do so in accordance with any restrictions imposed by the couples for whom the embryos were created. Further, if the work with the excess ART embryos may harm or destroy the embryos, then it must be carried out on embryos created before 5 April 2002. 

 

Sub-clauses 39(4) and (5) provide that the NHMRC Licensing Committee may impose any other conditions that are necessary and provides some examples of the types of conditions the NHMRC Licensing Committee may impose.  For example, the NHMRC Licensing Committee may impose conditions relating to:

 

(a)            the persons or classes of person, authorised by the licence to use the excess  ART embryos;

(b)           the number of excess ART embryos in respect of which use in authorised by the licence;

(c)            reporting;

(d)           monitoring; and

(e)            information to be given by the licence holder to persons authorised by the licence to use excess ART embryos.

 

Sub-clause 39(6) provides that the conditions included in sub-clauses 39(1), (2) and (3) are applicable to all people who are authorised by the licence to use excess ART embryos as specified in the licence.

 

Sub-clause 39(7) provides that any other licence conditions are applicable to the licence holder and any other people who are authorised by the licence to use excess ART embryos as specified in the licence.

 

Clause 40 - Variation of licence

 

This clause enables the NHMRC Licensing Committee to vary a licence.  There are two possible circumstances in which the NHMRC Licensing Committee may need to vary a licence:

 

·         on request of the licence holder.  For example, if the licence holder wishes to change administrative details on the licence such as contact details or more significant details such as the duration of the licence; and

·         when the NHMRC Licensing Committee considers it necessary or desirable to vary a condition of licence.  For example, should the NHMRC Licensing Committee wish to add additional conditions of licence, change the wording of existing conditions of licence or delete existing conditions of licence.

 

Sub-clause 40(4) clarifies that the NHMRC Licensing Committee can not vary a licence so that the varied licence would be contrary to the requirements set out in clause 35.  For example, the NHMRC Licensing Committee could not vary the licence after it has been issued so as to allow a use of embryos that have been created after 5 April 2002 that may damage or destroy the embryos (unless, that requirement ceases to have effect in three years or at an earlier time, as agreed by COAG as detailed in clause 60 of the Bill).

 

Clause 41 - Suspension or revocation of licence

 

This clause enables the NHMRC Licensing Committee to suspend or revoke a licence that has been issued if they believe, on reasonable grounds, that a condition of the licence has been breached.  This is a very important provision because it enables the NHMRC Licensing Committee to take immediate action in the event of apparent non-compliance.  By suspending or revoking the licence the work can no longer continue.

 

The NHMRC Licensing Committee has the power to re-instate the licence should the suspected breach of condition fail to be established or should the licence holder rectify the situation and the Committee is convinced that the work can continue without risk of further breaches.  Whether or not the licence is suspended, cancelled or subsequently reinstated would depend on the individual circumstances of the case and the extent, severity and importance of the alleged breach.

 

It is important that the NHMRC Licensing Committee has a degree of discretion in this respect given that breaches of licence can range from fairly minor infringements (for example, late submission of annual reports to the NHMRC Licensing Committee) through to very serious breaches such as using more embryos than has been authorised by the licence.

  

Clause 42 - Surrender of licence

 

This clause provides that a licence holder may surrender a licence by written notice given to the NHMRC Licensing Committee.  An organisation may wish to surrender a licence if, for example, they have completed the work involving the use of the excess ART embryos.

 

Clause 43 - Notification of variation, suspension or revocation of licence

 

This clause provides that if the NHMRC Licensing Committee varies, suspends or cancels a licence the Committee must notify the changes to the relevant State or Territory body to which it notified its original decision.  This ensures that State and Territory governments are kept fully informed about any variations to licences.  In addition, if the change to the licence impacts on the information that is included on the publicly available database, the database must also be amended to reflect the change.

 

DIVISION 5 - Reporting, record-keeping and confidentiality

 

Clause 44 - NHMRC Licensing Committee to make certain information publicly available

 

This clause provides that the NHMRC Licensing Committee must establish and maintain a comprehensive, publicly available database containing information about licences that have been issued by the NHMRC Licensing Committee. 

 

Sub-clause 44(1) provides that the database must include the following information in relation to each licence:

 

(a)            the name of the person to whom the licence was issued.  Under Commonwealth legislation this would be a body corporate or other legal entity.  The names of individual people will not be included on the database without the express consent of the person in accordance with the Privacy Act 1988 ;

(b)           the nature of the uses of the embryos authorised by the licence.  For example, the record would state whether the embryos are proposed to be used for the derivation of stem cells, for use for testing culture medium, for training of technicians etc;

(c)            the conditions of licence;

(d)           the number of embryos proposed to be used.  At the time that a licence is granted, one of the conditions would describe the maximum number of embryos permitted to be used as part of the project.  Another condition of licence would describe reporting requirements including in relation to how many embryos were actually used and when they were used.  It is proposed that the NHMRC Licensing Committee will update the database to reflect the number of embryos actually used in a project;

(e)            the date on which the licence was issued; and

(f)             the period of the licence.

 

It is proposed that the database would be included on the NHMRC website and that hard-copy extracts of the database would be available from the NHMRC Licensing Committee on request.  The database would not include information that is confidential commercial information (refer clause 45) or any personal information that would be prohibited from disclosure under the Privacy Act 1988 , including for example, names of individuals.

 

Clause 45 - Confidential commercial information may only be disclosed in certain circumstances

 

This clause is intended to protect, from public disclosure, certain information that is legitimately confidential commercial information.

 

“Confidential commercial information” is defined in clause 23 of the Bill to mean information that has a commercial or other value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed. 

 

The effect of clause 45 is that the NHMRC Licensing Committee can decide not to release certain information into the public domain (for example, by inclusion on the database established by clause 44) if the NHMRC Licensing Committee is satisfied that the information is commercial information or "other" information (such as research findings) that has a value that would be, or could reasonably be expected to be, destroyed or diminished as the result of disclosure.

 

The NHMRC Licensing Committee would have access to the confidential commercial information in assessing applications and could disclose such information to States and Territories (and to relevant Commonwealth agencies) but these bodies could not disclose the information to anyone else.

 

The information may also be disclosed by order of a court or with the consent of the person to whom the information has a commercial or other value.

 

DIVISION 6 - Review provisions

 

Clause 46 - Meaning of terms

 

This clause describes those persons who are able to seek review in relation to various types of decisions made by the NHMRC Licensing Committee. In summary, the clause provides that an “eligible person” in relation to a decision of the NHMRC Licensing Committee means:

 

·         a licence applicant  - in relation to a decision by the NHMRC Licensing Committee not to issue a licence; and

·         the licence holder in relation to:

Ø        a decision by the NHMRC Licensing Committee relating to the period of a licence;

Ø        a condition of licence imposed by the NHMRC Licensing Committee; and

Ø        a decision by the NHMRC Licensing Committee to vary, refuse to vary, suspend or revoke a licence.

 

Clause 47 - Review of decisions

 

Sub-clause 47(1) provides that an eligible person (as defined in clause 46) may apply to the Administrative Appeals Tribunal for review of the following decisions of the NHMRC Licensing Committee:

 

(a)                 a decision under clause 36 not to issue a licence;

(b)                a decision in respect of the period throughout which the licence is to be in force under clause 38;

(c)                 a decision to specify a licence condition under sub-clause 39(4);

(d)                a decision to vary or refuse to vary a licence under clause 40; or

(e)                 a decision to suspend or revoke a licence under clause 41.

 

Sub-clause 47(2) provides that clause 47 has effect subject to the Administrative Appeals Tribunal Act 1975 .

 

PART 4 - MONITORING POWERS

 

Clause 48 - Appointment of inspectors

 

Sub-clause 48(1) enables the Chairperson of the NHMRC Licensing Committee to appoint inspectors for the purposes of exercising all the powers under this Part. The persons the Chairperson of the NHMRC Licensing Committee may appoint as inspectors are Commonwealth employees and State or Territory employees.  The Chairperson of the Licensing Committee must also ensure that each person appointed as an inspector has appropriate skills and experience ( sub-clause 48(3) ).

 

Sub-clause 48(2) requires a person appointed as an inspector to comply with any directions of the Chairperson of the NHMRC Licensing Committee when exercising powers or performing functions in that capacity.

 

Clause 49 - Identity card

 

Sub-clauses 49(1) and 49(2) require the Chairperson of the NHMRC Licensing Committee to issue an identity card, in a form prescribed by the regulations, to every person appointed as an inspector.  The identity card must have a recent photograph of the inspector.

 

Sub-clause 49(3) provides that it is an offence for a person who ceases to be appointed as an inspector to fail to return his or her identity card, as soon as practicable, to the Chairperson of the NHMRC Licensing Committee.  The offence attracts a maximum penalty of 1 penalty unit which is equivalent to $110.

 

Sub-clause 49(4) requires the inspector to carry his or her identity card at all times when exercising powers or performing functions as an inspector.

 

Clause 50 - Powers available to inspectors for monitoring compliance

 

Sub-clause 50(1) confers powers upon an inspector to enter any premises and to exercise any or all of the powers set out in clause 51 for the purposes of establishing whether or not the Act or regulations are being complied with.

 

Sub-clause 50(2) provides that an inspector may only enter premises under this clause if he or she has the consent of the occupier of the premises or if the occupier of the premises is a licence holder, or a person covered by a licence, and the entry is at a reasonable time. 

 

Clause 51 - Monitoring powers

 

This clause describes the monitoring powers that an inspector may exercise for the purposes of finding out whether the Act or regulations have been complied with.

 

Clause 52 - Power to secure

 

This clause provides that if an inspector, during the course of inspecting premises, finds something that may be evidence in relation to an offence committed under the Act, the inspector may secure the thing pending the obtaining of a warrant to seize it.

 

 

Clause 53 - 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 54 - Consent

 

This clause provides that, before obtaining consent from a person to enter premises (under paragraph 50(2)(a)), the inspector must inform the person that he or she may refuse consent. 

 

Sub-clause 54(2) clarifies that any consent given by a person to enable entry to premises by the inspector must be voluntary.

 

Clause 55 - 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.

 

Compensation is payable out of money appropriated by the Parliament.  In determining the amount payable, regard is to be had to whether the occupier (or his or her employees and agents) had provided any warning or guidance as to the operation of the equipment or facility.  This is to minimise compensation in cases where, for example, there has been a deliberate programming of software to destroy or cause damage if not accessed in a particular manner, or where the occupier failed to mitigate damage by providing warning or guidance.

 

PART 5 - COMMONWEALTH/STATE ARRANGEMENTS

 

Clause 56 - Operation of State laws

 

This clause provides that the Act is not intended to exclude the operation of State and Territory laws except where the State or Territory laws are inconsistent with the Act and cannot operate concurrently. 

 

One of the intended effects of this clause is that if a State has existing legislation that, for example, bans the use of excess ART embryos, such a law would not be capable of operating concurrently with the Act and as such it is intended that the Act override the State law to the extent that it is inconsistent. 

 

By virtue of clause 2 of this Bill, clause 25 of this Bill (which provides that a person must not use an excess ART embryo unless the use is authorised by a licence from the NHMRC Licensing Committee or is an exempt use) will not commence operation for 6 months from the date that this Bill receives Royal Assent.  During this time, any inconsistent State laws that ban the use of excess ART embryos will continue to operate subject to amendment by the relevant State Parliaments.

 

Clause 57 - Conferral of functions on Commonwealth officers and bodies

 

The purpose of this clause is to enable corresponding State laws to confer functions, powers and duties on the NHMRC Licensing Committee, a Commonwealth Authority and an officer of the Commonwealth or a Commonwealth authority and to empower a person or body on whom a function, power, or duty is conferred, to perform the function or duty, or exercise the power.

 

This clause, along with clause 58, provides for the effective operation of the national scheme relating to the regulation of uses of excess ART embryos. This Commonwealth Bill is one part of the national scheme.  It is anticipated that all States and Territories will implement corresponding legislation. Clauses 56 and 57 effectively enable the corresponding State laws to provide that the licensing functions exercised under a State law actually be undertaken by the NHMRC Licensing Committee.  It is not intended that there be dual licensing systems in any jurisdictions.  Rather, anyone wishing to undertake work using excess ART embryos (other than exempt uses) would need to apply for a licence from the NHMRC Licensing Committee whether or not they are technically organisations that come within the scope of the Commonwealth’s constitutional powers or State powers.

 

Clause 57 also clarifies that the conferral of such functions or powers, or the imposition of duties, on the NHMRC Licensing Committee or on other Commonwealth bodies is limited by any relevant constitutional doctrines and the legislative power of the Commonwealth.

 

Clause 58 - When duty imposed

 

This clause recognises that there are constitutional doctrines that have developed on the basis of case law that restrict the duties that may be imposed on a Commonwealth officer or Commonwealth authority under State laws.  Recognising these doctrines, this clause clarifies that the extent to which duties may be imposed on the NHMRC Licensing Committee, Commonwealth authorities or Commonwealth officers, by corresponding State laws, is limited by such doctrines. 

 

The clause clarifies that any duty purported to be imposed under a State law is taken to be imposed by force of a State law where State legislative power is sufficient to support that duty.  Where such power does not exist, to ensure the validity of the duty’s imposition, reliance is then to be placed on Commonwealth legislative power if it is sufficient to support the duty.

 

The clause also clarifies that, if the imposition of a duty on a Commonwealth officer or authority under applied State law contravenes a relevant constitutional doctrine or exceeds the legislative power of both the State and the Commonwealth, the State law is not taken to confer a duty on the Commonwealth officer or authority. 

 

Clause 59 - Review of certain decisions

 

This clause provides the capacity for the Administrative Appeals Tribunal to review decisions made under a corresponding State law where the decision by the NHMRC Licensing Committee is actually made under State law.

 

Sub-clause 59(2) provides that a decision of the NHMRC Licensing Committee is a “reviewable State decision” where the State law provides for review by the Administrative Appeals Tribunal and where the decision is declared in the regulations to be a “reviewable State decision”.

 

Sub-clause 59(3) provides that for the purposes of this clause the Administrative Appeals Tribunal Act 1975 has effect as if a corresponding State law were an enactment of the Commonwealth.

 

PART 6 - SUNSET CLAUSE, REVIEW PROVISION AND REGULATIONS

 

DIVISION 1 - Repeal

 

Clause 60 - Repeal of paragraphs 36(3)(b) and 39(1)(c) and subsection 39(3)

 

This clause gives effect to the Council of Australian Governments’ decision that the regulation restricting the use of excess ART embryos created after 5 April 2002 will cease to have effect on 5 April 2005, unless an earlier time is agreed by the Council of Australian Governments.

 

DIVISION 2 - Review of Act

 

Clause 61 - Review of operation of Act

 

Sub-clause 61(1) provides that the NHMRC must cause an independent review of this Act to be undertaken commencing 2 years after the Act receives Royal Assent. 

 

Sub-clauses 61(2), (3), (4), (5) and (6 ) describe the nature of the review and the report to be prepared as a result of the review.  In summary, the review must:

 

·         be undertaken by independent persons chosen by the NHMRC with the agreement of all States and Territories;

·         include a consideration of the scope and operation of Parts 2 and 3 of the Act particularly taking into account developments in assisted reproductive technology, scientific and research developments, the potential therapeutic applications of any research and community standards;

·         contain recommendations about any amendments that should be made to the Act;

·         be informed by consultation with the Commonwealth, States, Territories and a broad range of stakeholders;

·         include information about the views of the Commonwealth, States and Territories (to the extent that it is reasonably practicable to do so); and

·         be completed within three years of the Act receiving Royal Assent with the report of the review being provided to the Council of Australian Governments. 

 

DIVISION 3 - Regulations

 

Clause 62 - Regulations

 

This clause empowers the Governor-General to make regulations prescribing matters required or permitted to be prescribed by the Act, or necessary or convenient to be prescribed, for carrying out or giving effect to the Act.

 

Sub-clause 62(2) clarifies that, before the Governor-General makes regulations under this Act, the Minister must be satisfied that the States and Territories have been consulted in relation to the proposed regulations and that there was regard to the views of States and Territories in the preparation of the proposed regulations.

 

SCHEDULE 1 - Consequential Amendment

 

The purpose of this schedule is to repeal the existing provisions in the Gene Technology Act 2000 that ban human cloning, certain experiments involving animal eggs and certain experiments involving putting human and animal cells into a human uterus.

 

As a result of Senate debate on the Gene Technology Bill 2000, three clauses were inserted in the Gene Technology Bill - clauses 192B, 192C, 192D.  At the time that the clauses were inserted it was recognised that this was a “stop-gap” measure and that the Commonwealth, States, Territories and the NHMRC would work together to identify the most effective and comprehensive wording for a ban on human cloning and the creation of hybrid embryos. 

 

Recognising that the purpose of this Bill is, among other things, to comprehensively prohibit human cloning and the creation of hybrid embryos it will no longer be necessary to continue to include prohibitions on these activities in the Gene Technology Act 2000 once the Research Involving Embryos and Prohibition of Human Cloning Bill 2002 has been agreed and enacted.

 

This Schedule therefore repeals sections 192B, 192C and 192D of the Gene Technology Act 2000 .



 

ATTACHMENT 1

 

REGULATION IMPACT STATEMENT

 

1.         Background

 

On 5 April 2002 the Council of Australian Governments (COAG) agreed that the Commonwealth, States and Territories would introduce nationally consistent legislation banning human cloning and other unacceptable practices and establishing a national regulatory framework for the use of excess assisted reproductive technology (ART) embryos.  It was agreed that the National Health and Medical Research Council (NHMRC) would be the licensing and regulatory body. 

 

This Regulation Impact Statement (RIS) focuses on the costs and benefits of the two key components of the regulatory scheme - the prohibited practices and the regulatory scheme for the use of excess ART embryos. 

 

2.         Issues to be addressed

 

The problems that currently exist in relation to the prohibition of certain unacceptable practices associated with reproductive technology and the regulation of research on (and other uses of) human embryos include:

 

·         lack of consistency in regulatory coverage of human cloning and other unacceptable practices through the existence of legislation in three States (Victoria, South Australia and Western Australia), the Commonwealth Gene Technology Act 2000 and the absence of regulation in other jurisdictions;

·         the fundamental ethical issues posed by destruction of embryos for research and other uses and the absence of a comprehensive, nationally consistent system for the regulation of research involving human embryos;

·         inconsistent regulation of research involving embryos which creates an uneven playing field for researchers, which may limit the capacity of some researchers to carry out particular work and access funding for such work.  This may reduce their competitiveness relative to researchers in other jurisdictions.  For example, if a national funding body identifies a particular type of research as a priority (such as embryonic stem cell research) only researchers in jurisdictions where such work is permitted would be able to carry out this research and have potential access to funding for such research; and

·         the impact that the current lack of certainty or national consistency in the regulatory environment may have on Australia’s international competitiveness.

 

3.         Objectives

 

On 5 April 2002 COAG agreed that the Commonwealth, States and Territories would introduce nationally consistent legislation banning human cloning and other unacceptable practices and that the legislation would establish a national regulatory framework for the use of excess ART embryos, to be administered by the NHMRC as the national regulatory and licensing body. 

 

4.         Options and impact analysis

 

Groups likely to experience the benefits and costs

 

The groups likely to be affected by legislated prohibited practices and the regulation of uses of excess ART embryos are ART service providers, consumers of ART services, researchers, Government and the community.

 

ART service providers

 

The Australian Institute of Health and Welfare’s National Perinatal Statistics Unit reported that there were 34 IVF units in Australia in 2000.  

 

Consumers of ART services

 

Data available from the National Perinatal Statistics Unit for the year 2000 showed that women underwent 27,067 treatment cycles with oocyte retrieval or embryo transfer for all techniques of assisted conception in Australia’s 34 IVF units.  

 

Researchers

 

Currently in Australia, research on excess ART embryos is only carried out by a limited number of organisations, predominantly ART clinics examining the effectiveness of ART techniques, particularly new methods for culturing gametes and embryos to improve infertility treatments.  As destructive research on excess ART embryos has been banned in Victoria, South Australia and Western Australia for a number of years, only very limited research that is not destructive to embryos has been undertaken in these jurisdictions.  It is, however, likely that when the bans are lifted there will be a number of researchers from these jurisdictions who may wish to undertake more extensive research that could be destructive to excess ART embryos particularly scientific investigations including for the derivation of new embryonic stem cell lines.  Commercial companies may also have an interest in undertaking such work. 

 

Government

 

This includes the Commonwealth Government, State and Territory Governments and existing regulatory authorities in Victoria, South Australia and Western Australia.

 

Community

 

Given the subject matter of the regulation, the oversight applied to the use of excess ART embryos has the potential to impact upon everyone in the community.  This is not only because the use of excess ART embryos poses ethical issues that affect many but also because of the potential benefits that may flow to the community as a result of scientific advancements and medical applications developed from the study of embryos and embryonic stem cell lines. 

 

 

A.        Options and impact analysis in relation to prohibited practices

 

On 5 April 2002 COAG agreed that certain unacceptable practices should be prohibited in nationally consistent legislation.

 

In making their decision, COAG considered the recommendations of a report entitled the “Report on Human Cloning, Assisted Reproductive Technology and Related Matters”.  This Report included a list of all of the unacceptable practices and was accompanied by a detailed RIS exploring the impacts of bans on the unacceptable practices. 

 

The two options outlined in the report were:

 

Option 1 :         Voluntary compliance with unacceptable practices as detailed in revised NHMRC/AHEC Guidelines [1] In order to achieve national consistency, this option would mean that the three States with legislation would need to repeal such legislation (at present there are some differences between the practices banned in legislation in three States and the unacceptable practices detailed in the NHMRC/AHEC Ethical Guidelines on ART - refer Attachment A of this RIS).  All people would be expected to voluntarily comply with the nationally consistent unacceptable practices detailed in revised NHMRC/AHEC Ethical Guidelines on ART .  This would essentially reflect a national adoption of the position that currently occurs in the five jurisdictions without legislation; or

 

Option 2 :         Nationally consistent legislated bans on the unacceptable practices.  This option would involve each jurisdiction enacting legislation, or amending existing legislation, to ban the unacceptable practices as detailed in Table 1.  The unacceptable practices banned in the legislation would be reviewed within three years.  The purpose of the review would be to determine whether each of the practices are still considered unacceptable and whether they should continue to be banned in legislation.  This review would be undertaken with broad consultation to assess the acceptability of each of these practices at that time.

 

Following is a table that is based on the table included in the RIS accompanying the Report to COAG, detailing the potential impacts of banning the various unacceptable practices in nationally consistent legislation. 

 

Table 1: Summary of the impacts of banning certain unacceptable practices in nationally consistent legislation

 

Proposed Prohibition

Impacts of banning certain unacceptable practices

Creating a human clone.

No attempts at cloning a human being (commonly referred to as “reproductive cloning”) are currently evident in Australia.  Prohibition therefore unlikely to have an impact on researchers or ART clinics.

Creation of an embryo for purposes other than assisted reproduction or by a process other than the fertilisation of a human ovum by human sperm.

Will prevent the creation of embryonic stem (ES) cells via the process of somatic cell nuclear transfer (SCNT), for potential therapeutic uses.  On the basis of early research in this area, it appears that there may be potential to create ES cells that are compatible with individual patients or patient groups and could therefore be used in therapeutic applications, reducing the chance of rejection problems after transplantation.  ES cells have been reported to have potential to treat cancer, Alzheimer’s disease, Parkinson’s disease, paraplegia, and other diseases.

 

Prohibiting the creation of embryos by SCNT will also limit potential use of ES cells in drug screening.  SCNT could be used to create libraries of stem cells representative of specific disease states to test how a drug acts in the human body.

 

Researchers in Israel and the UK, and private-sector researchers in the USA are currently permitted to create embryos by SCNT.  Relative to these more permissive countries, Australia may lose international competitiveness, overseas and local investment, and access to intellectual property.  Such negative effects may result even if the ban is only maintained in Australia for three years.

 

Whilst there is unconfirmed evidence that researchers overseas have created embryos via SCNT for the purposes of research, there are no confirmed reports that such embryos have been able to be developed to the point that stem cells can be obtained and used in human treatments.  The potential benefits detailed above are based on preliminary research. To date, there is no evidence of any attempts being made in Australia to create a human embryo via SCNT as this practice has been considered unacceptable under NHMRC/AHEC Guidelines and banned in Victoria, SA and WA.

Work is continuing in relation to embryonic stem cell based nuclear programming which involves replacing the nucleus of an embryonic stem cell with the nucleus of an adult cell.  This technique does not involve the creation of an embryo (and is therefore not prohibited) but also has the potential to lead to genetically compatible cells for transplantation and tissue engineering.

 

This prohibition would also ban the creation of embryos, by fertilisation of an egg by sperm, purely for research purposes.  This may limit some researchers access to embryos for research.  This may impact on the capacity of researchers to undertake certain work exploring the process of embryonic development, where embryos are created specifically for this research purpose.  However it would not impact on research involving excess ART embryos.

Creation or development of an embryo for assisted reproduction that contains genetic material from more than 2 people.

Prevents the use of a relatively new technique that involves the transfer of the cytoplasm from a healthy egg (generally donated by a younger woman) to the egg of another woman who has had fertility problems (often older women).  This has the potential to increase the chances of successful conception via IVF for some older women.  Currently this technique is not in use in Australia as it is thought to be unsafe, due to possible impacts of the existence of a third party’s genetic material, but has been used overseas.  There are also ethical concerns associated with the creation of embryos with genetic material from three people.

Creation or development of an embryo for assisted reproduction that uses any precursor cells of eggs or sperm from an embryo or fetus.

Currently no evidence of this technique being used in Australia nor any intention to utilise this practice for clinical or research purposes in the near future. 

Maintaining an embryo outside the body of a woman after the 14 th day of its development excluding any time in which its development is suspended.

Currently no evidence of this practice occurring in Australia nor any intention to utilise this practice for clinical or research purposes in the near future.

Altering the genome of a cell of a human being or in vitro embryo such that the alteration is heritable.

Removes the possibility of using germ line gene therapy to permanently cure inherited diseases such as sickle cell anaemia, haemophilia and cystic fibrosis in subsequent generations.  Currently, there are concerns regarding unintended consequences and the safety of using germ line gene therapy - as such it is not clear if Australian scientists appear to be contemplating using germ line gene therapy. 

Embryo flushing.

Currently no evidence of this practice occurring in Australia nor any intention to utilise this practice for clinical or research purposes in the near future.

Creating or developing a hybrid or chimeric embryo or placing such an embryo in the body of a human or animal for any period of gestation.

Currently no evidence of this practice occurring in Australia.  Anecdotal evidence suggests that, should this practice not be prohibited, some researchers may wish to use some types of hybrid or chimeric embryos particularly for drug screening applications.   

Placing a human embryo in an animal or in any human body cavity other than the female human reproductive tract or placing an animal embryo in a human for any period of gestation.

Currently no evidence of this practice occurring in Australia nor any intention to utilise this practice for clinical or research purposes in the near future.

 

Giving or offering valuable consideration to any person for donation of gametes or embryos of that person or of any other person.  Note that it is not intended to exclude the disbursement of reasonable expenses incurred by a person in connection with a donation of their genetic material.

Currently no evidence of this practice occurring in Australia.

 

Consultation

 

Consultations on an exposure draft of the Bill and RIS, including the proposed prohibited practices, were conducted with a range of people in the fields of ART, medical research, consumer issues, ethics and law, in each capital city between 24 May and 6 June 2002. 

 

During consultations, there was general support for the inclusion of unacceptable practices in legislation.  However two prohibitions in particular gave rise to considerable comment and debate regarding the costs and benefits of banning such practices:

 

·         the ban on the creation of embryos by a process other than the fertilisation of a human egg by human sperm by somatic cell nuclear transfer (or so called “therapeutic cloning”) to create embryonic stem cells. 

 

Those who did not support prohibiting “therapeutic cloning” expressed concern that:

 

Ø        the ban would put Australian research behind other countries where such a ban does not exist which may in turn impact on the Australian research community’s international competitiveness and the broader community’s access to potential cell therapies; and

Ø        the intended review of the legislation within three years that may result in a lifting of this ban may be too late to alleviate these possible impacts.

 

Others considered that:

 

Ø        the need for “therapeutic cloning” is questionable as there may be alternative avenues to achieve the outcomes desired; and

Ø        discussion within the broader community of the benefits of “therapeutic cloning” may be premature as there are currently no confirmed reports that a human embryo created by SCNT has developed to the stage that stem cells could be derived.

 

·         creation or development of an embryo for assisted reproduction that contains genetic material from more than 2 people, particularly as it effectively bans the use of cytoplasmic transfer in ART clinical practice. 

 

Those that did not support a provision that effectively banned cytoplasmic transfer expressed concern that women who might otherwise be able to achieve a pregnancy following the use of cytoplasmic transfer on their eggs will be disadvantaged compared to women in other countries where this technique is permitted. 

 

Others considered that:

 

Ø        cytoplasmic transfer is a very new technique and its safety with respect to babies created using the technique is yet to be established; and

Ø        any live born child may have DNA from three separate people (posing ethical questions) and the impact of the third party mitochondrial DNA on normal development is not totally clear at this stage.

 

It was however noted that if the technique can be refined to the point that there is no additional genetic material contained in the transferred cytoplasm then the ban on the technique would no longer be applicable, subject to approval of the use of the techniques under the RTAC accreditation guidelines and approval by the relevant ART licensing bodies in Victoria, South Australia and Western Australia. 

 

Conclusion

 

It is desirable that governments have the ability to apply appropriate sanctions for non-compliance, with regard to certain unacceptable practices, to both publicly and privately funded organisations (at present there is non-equivalent regulatory environments for private and public institutions in Australia). Consumer and community confidence would also be likely to be improved with the introduction of legislative sanctions. 

 

A legislative approach provides a clear basis of operation for ART service providers and researchers (including organisations seeking to commercialise the products of embryo research and embryonic stem cell research).  As the practices proposed to be banned in legislation are broadly consistent with those that are deemed unacceptable under the NHMRC/AHEC Guidelines and existing legislation in three States, the fact that the bans will be included in legislation in all jurisdictions is likely to have minimal practical impact in terms of compliance. 

 

A prohibition on the creation of embryos via somatic cell nuclear transfer (so-called “therapeutic cloning”) for any period of time may, however, impact on Australia’s competitiveness with other more liberal countries particularly with respect to intellectual property ownership, level of research expertise and industry investment.

 

In relation to this point governments have decided, that at this time there is insufficient evidence to prove the efficacy of “therapeutic cloning” and that it also continues to pose significant ethical and safety issues.  Therefore COAG decided to include it as a prohibited practice to be banned in nationally consistent legislation.  The same consideration by COAG was given in relation to the technique of cytoplasmic transfer. 

 

The review of the legislative prohibitions within three years will enable reconsideration of scientific developments and associated benefits as well as any changes in community views on all the practices (including “therapeutic cloning” and cytoplasmic transfer) that may result.

 

COAG recommended that nationally consistent legislative bans on unacceptable practices be implemented with a review of the bans within 3 years.

 

 

B.        Options and impact analysis for the scope of the regulation of uses of excess ART embryos

 

Options

 

Currently in Australia there is a lack of national consistency regarding the regulation of research using excess ART embryos.  In Victoria, South Australia, and Western Australia, research that involves the destruction of an embryo (or may not otherwise leave it in an implantable condition) is not permitted under any circumstances.  By contrast, in all other jurisdictions the NHMRC/AHEC Ethical Guidelines on ART apply and researchers may receive approval from a Human Research Ethics Committee (HREC) to undertake research that involves the destruction of an embryo under exceptional circumstances.

 

COAG agreed that the status quo is not acceptable and that the NHMRC would issue a licence for a person to use an excess embryo from an ART program for research or therapy that damages or destroys the embryo. 

 

There are essentially two options for implementing the COAG decision.  The difference between these two options is that one requires a person to have a licence for any use of an excess ART embryo (other than exempt uses) leaving the decision making about whether the work may damage or destroy the embryo with the NHMRC Licensing Committee.  The other option requires a licence for uses of an excess ART embryo that may damage or destroy the embryo  (other than exempt uses), with the decision making about whether the work may damage or destroy the embryo resting with the ART service provider or researcher.

 

Option 1:         That all uses of excess ART embryos require a licence from the NHMRC (with uses that may damage or destroy the embryo subject to additional restrictions) unless the uses are exempt uses including:

 

·         for donation of an excess ART embryo to another couple;

·         for storage of the embryo, for removal of the embryo from storage, for transportation of the embryo, for allowing the embryo to succumb at the request of the people for whom it was created

·         for observation of the embryo; or

·         for use that forms part of diagnostic investigations conducted in connection with the assisted reproductive technology treatment of the woman for whom the excess ART embryo was created.

 

Option 2:         That only those uses of excess ART embryos that involve research or therapy that may damage or destroy the embryos be subject to the licensing system with exemptions for:

 

·         donation of an excess ART embryo to another couple;

·         storage of the embryo, for removal of the embryo from storage, for transportation of the embryo, for allowing the embryo to succumb at the request of the people for whom it was created

·         observation of the embryo; or

·         use that forms part of diagnostic investigations conducted in connection with the assisted reproductive technology treatment of the woman for whom the excess ART embryo was created.

 

Impact analysis

 

Impacts of Option 1:             That all uses of excess ART embryos require a licence from the NHMRC (with uses that may harm or destroy the embryo subject to additional restrictions) unless the uses are exempt uses. 

 

On ART service providers:   ART service providers who wish to undertake work on excess ART embryos would require a licence for such work unless the work is exempt.  A licence would be required for uses that may damage or destroy the embryo (such as research, derivation of stem cells and training of clinicians in certain techniques carried out on embryos) and work that may not damage the embryo such as quality assurance testing, for example, of culture media. 

 

The licensing system will impose costs on ART service providers, particularly those in New South Wales, Queensland, Tasmania, Northern Territory and the Australian Capital Territory where there have, to date, been no requirements for a licence for such work.  In Victoria, South Australia and Western Australia research involving the destruction of excess ART embryos has not previously been permitted.  Should ART service providers in these States wish to undertake such research in the future it is expected that they will incur additional costs

 

The major cost drivers for ART service providers are expected to be associated with  applying for a licence, implementing any necessary systems to enable compliance with the legislation and reporting to the NHMRC Licensing Committee.  In most cases ART service providers are currently providing such information to institutional Human Research Ethics Committees and the Reproductive Technology Accreditation Committee.  Any increased costs can also be minimised through streamlined administration of the legislation, particularly in relation to uses of excess ART embryos that do not damage or destroy the embryo.  For example, ART service providers could apply for one licence to undertake quality assurance work using a certain number of excess ART embryos rather than having to apply each time they chose to test a different culture medium. 

 

As the licensing requirements would apply to all uses of excess ART embryos (not just uses that damage or destroy the excess ART embryos), it is possible that this will impose additional costs on ART service providers (compared to Option 2) because licences would be required for non-destructive work, where it is proposed that the embryo be discarded following the work.  However these costs may be offset (compared to Option 2) because there will be regulatory certainty and less need to seek case by case clarification from the NHMRC Licensing Committee about whether the proposed work may damage or destroy the embryo.  Further, it is expected that costs are not fully additional given that some service providers may, under Option 2, apply for licences unnecessarily, erring on the side of caution.

 

In relation to both Option 1 and Option 2, the inclusion of clear exemptions in the legislation means that there is greater clarity for ART service providers about the work that is part of routine ART clinical practice and does not require licensing by the NHMRC Licensing Committee.  

 

On consumers of ART services: Couples would be assured that there is regulatory oversight for all uses of excess ART embryos and that work would not be undertaken on their ART embryo unless they have provided fully informed consent.  They may also specify any conditions relating to such consent and the nature of the work that may be undertaken.  Should there be increased costs to ART service providers as a result of the licensing requirements, there may be flow on costs to all consumers of ART services.

 

On researchers:   On the basis of information available to date, it appears that most of the work proposed to be undertaken by researchers will be work that may lead to the destruction of the excess ART embryo.  For example, use of excess ART embryos for the derivation of stem cells.  It is therefore unlikely that this Option will have any additional impact compared with Option 2.  Compared to the current situation, costs are likely to increase for all researchers proposing to undertake uses of excess ART embryos, as the result of the need to obtain, and ensure compliance with, a licence from the NHMRC to undertake research that involves destruction of the excess ART embryos.  This is also the case for Option 2.  The cost drivers are the same as those detailed in relation to ART service providers.

 

On Government:   In addition to the NHMRC’s cost of supporting the regulatory framework, as set out in the Financial Impact Statement, there will also be costs in relation to implementing a nationally-consistent scheme as agreed to by COAG.  It is not anticipated that the cost as described in the Financial Impact Statement would be substantially different under Option 2, as detailed below. 

 

It is difficult to compare these costs to existing regulatory models because in all three States that have a licensing system, uses of embryos that may damage or destroy the embryo are banned.  As such, very few research licences are issued each year and the vast majority of work undertaken by licensing authorities in those States relates to the regulation of routine ART clinical practice.   However, as the authorities in Victoria, South Australia and Western Australia will no longer be required to issue licences in relation to research (as this will be done by the NHMRC Licensing Committee), it is expected that there may be a minor decrease in costs to these State agencies overtime.  However in the short term there are likely to be increased costs to all States and Territories as the result of implementing corresponding State and Territory laws.  These costs are likely to be the same under Option 2.

 

In terms of government policy, this approach avoids “loopholes” in regulatory coverage as the NHMRC Licensing Committee will oversee all non-exempt uses of excess ART embryos and such oversight is not dependent on the researcher or ART clinic self-assessing that the work they are proposing to undertake will not damage or destroy the embryo.  Further, the publicly available database of licensed uses of excess ART embryos will be much more comprehensive than under Option 2, providing greater transparency in terms of the actual work being conducted on excess ART embryos.

 

On the community:   By regulating all uses of ART embryos, the NHMRC will be able to publicly report in a more meaningful way.  By only regulating some of the uses of excess ART embryos (Option 2), the information available to the community about the number of excess ART embryos and the uses of such embryos may be incomplete.  The community would also be reassured that there are no gaps in regulatory coverage and that uses of excess ART embryos are being appropriately overseen.

 

Impacts of Option 2:             Only those uses of excess ART embryos that involve research or therapy that may damage or destroy the embryos be subject to the regulatory system and therefore require a licence from the NHMRC (unless the uses are exempt uses).

 

On ART service providers:   This Option means that a more limited class of activity would be regulated and require a licence.  Therefore it is expected that the costs to ART service providers would likely be less than under Option 1.  However, if it is not clear to service providers whether the work on excess ART embryos is likely to cause harm or lead to their destruction, it is likely that clinics would need to seek clarification from the NHMRC on a case by case basis and may unnecessarily apply for licences, erring on the side of caution.  This may lead to increased costs comparable to those described in Option 1.

 

On consumers of ART services:   There may be less reassurance for consumers that there is government oversight of all uses (for research, quality assurance and training) of their excess ART embryos.  That is, consumers would know that, should researchers self-assess their work as not being research or therapy that is harmful to an excess ART embryo, then there would be no national oversight of such work (other than internal oversight by an institutional ethics committee).  While there may be increased costs to ART service providers as the result of requiring a licence for certain work, if such costs are passed on to consumers these may be less under this Option than Option 1 (as fewer licences are likely to be required).  However, this may be negated by clinics passing on the costs of the possible additional burden of having to clarify, on a case by case basis with the NHMRC, the need for a licence for any work using excess ART embryos, where they are uncertain of the potential harmful impact of the work on those embryos.

 

On researchers:   As for Option 1.

 

On Government:   As the class of work required to be licensed is narrower under this Option than under Option 1, the costs to the  Commonwealth Government as the result of administering the scheme should be lower than for Option 1.  However as detailed in relation to impacts on ART service providers, the lower level of certainty on the face of the legislation may mean that in reality ART service providers and researchers seek advice from the NHMRC on a case by case basis regarding whether they need a licence, meaning that the costs to government are likely to be similar to those for Option 1. 

 

On the community:   The community may perceive a logical inconsistency in regulating only certain uses of excess ART embryos when all work involving excess ART embryos will involve the destruction and disposal of those embryos at some point.  That is, at the completion of non-destructive quality assurance work involving excess ART embryos  the excess ART embryos cannot be made available for any other work and are therefore discarded.  Many people feel that the key issues of donor consent and justification for use are the same irrespective of the nature of the work and require the same level of oversight.  Further, the community may have concerns about service providers and researchers deciding whether their research is likely to damage or destroy an embryo and therefore whether to seek a licence.  By contrast, in Option 1, a wider range of uses must be licensed, removing the possibility for inappropriate threshold decision making by ART service providers and researchers. 

 

Consultation

 

A draft Bill and accompanying RIS was provided to experts in a range of fields, for comment.  In that draft of the RIS, Option 1 was different to Option 1 in this RIS.  In the previous draft, Option 1 proposed regulating all uses of ART embryos unless such embryos were for use in achieving pregnancy in a woman.  This approach attracted considerable criticism from ART service providers because of the uncertainty surrounding what would be required to be licensed and what could be considered to be related to “achieving pregnancy in a woman”.  For example, it was not entirely clear whether licences would be required for routine ART clinical activities such as diagnostic tests on embryos intended for implantation, diagnostic investigations on chromosomally abnormal embryos and observational work.  The revised Option 1 addresses these concerns by clarifying that the regulatory system only relates to excess ART embryos and does not apply to “exempt” uses such as observation of an embryo and diagnostic investigations on embryos that are unsuitable for implantation. 

 

Notwithstanding the concerns relating to the lack of clarity with respect to the previous version of Option 1 (and therefore the potential unintended impacts on routine ART clinical practice), there was greater support for Option 1 than Option 2.  In general, most people felt that Option 2 could leave loopholes if ART service providers and researchers were self-assessing regarding whether certain work was likely to damage or destroy an embryo and therefore whether they require a licence.  It was generally felt that this decision should rest with the NHMRC Licensing Committee. 

 

One of the issues that led to considerable debate during consultations was the impact of  COAG’s decision that embryos not be used for research that damages or destroys an embryo unless the embryo was created before 5 April 2002.  Of principal concern was that by regulating all uses of excess ART embryos, and applying the 5 April criteria to all uses of excess ART embryos, this could significantly affect the capacity of ART clinics to undertake routine training and quality assurance testing that does not damage or destroy the embryo.   As a result of the consultations, Option 1 has been adjusted to better accord with the COAG decision and clarify that while all uses of excess ART embryos will be required to be licensed (except exempt uses), the NHMRC Licensing Committee will determine whether such uses are likely to damage or destroy the embryo and if so, only embryos created before 5 April 2002 may be used.    

 

 

Conclusion

 

On balance it is considered that Option 1 provides a greater level of regulatory certainty and does not rely on researchers self assessing in each instance regarding whether the work may harm the excess ART embryo or not.  The need for case by case consideration (outside the parameters of the legislation) may, in fact, be a greater burden for both researchers and Government than a clear requirement for a licence in all cases.

 

While Option 1 is likely to lead to more licence applications by ART service providers, the additional burden associated with the regulatory uncertainty of Option 2, may balance the costs to ART service providers and therefore also any flow on costs to consumers.  Therefore the additional certainty and reassurance to consumers (and to the general community) under Option 1 makes Option 1 a more attractive option compared with Option 2.

 

5.         Implementation and Review

 

As stated in the COAG communique the regulatory system will be reviewed within three years.  The review will be carried out on all aspects of the legislation, including the prohibited practices, which will take into account changes in technology, the potential therapeutic uses for such technology, and any changes in community standards.

 

Specifically, the Research Involving Embryos and Prohibition of Human Cloning Bill 2002 provides for the NHMRC to ensure that an independent review of the legislation be undertaken 2 years after the legislation in enacted.  In summary, the review must:

 

·         be undertaken by independent people chosen by the NHMRC with the agreement of all States and Territories;

·         include a consideration of the scope and operation of parts of the legislation that deal with prohibited practices (including human cloning), particularly taking into account developments in assisted reproductive technology (such as refinement of cytoplasmic transfer), scientific and research developments, the potential therapeutic applications of any research (including for “therapeutic cloning”) and community standards;

·         contain recommendations about any amendments that should be made to the legislation;

·         be informed by consultation with the Commonwealth, States, Territories and a broad range of stakeholders;

·         include information about the views of the Commonwealth, States and Territories (to the extent that it is reasonably practicable to do so); and

·         be completed and provided to the Council of Australian Governments within 12 months (by the third anniversary of the legislation).

 

It is also proposed that the issue of cost recovery be examined as part of the general review of the legislation in three years.

 

COAG also agreed that the NHMRC would report to COAG within 12 months on the adequacy of supply and distribution for research of excess ART embryos that would otherwise have been destroyed.  This will allow consideration of the need to maintain the restriction on the use of embryos to those embryos created before 5 April 2002. 



Attachment A

 

The following table is based on one that was included in the Regulation Impact Statement that accompanied the “Report on Human Cloning, Assisted Reproductive Technology and Related Matters”, the recommendations of which were considered by COAG at their meeting on 5 April 2002. 

 

A comparison of the practices to be banned in proposed nationally consistent legislation and those practices that are currently considered unacceptable. 

 

Proposed Prohibition

Related unacceptable practice in NHMRC/AHEC Guidelines and inclusion in current legislation (Vic, SA and WA)

Reasons for inclusion of prohibition as proposed

Cloning of a human being.

Guideline 11.3 and prohibited in all three Acts.  There is also a prohibition in the Gene Technology Act 2000 .

Scientific developments have occurred that have caused reconsideration of the wording used in the current bans on human cloning.  Revised wording is proposed that ensures that regardless of the means used for the development of a human clone, human cloning is banned.

Creation of an embryo for purposes other than assisted reproduction or by a process other than the fertilisation of a human ovum by human sperm.

Guideline 11.1 and effectively prohibited in all three Acts.

Reflects the current prohibition but clarifies that an embryo can only be created for assisted reproduction through fertilisation.

Creation or development of an embryo for assisted reproduction that contains genetic material from more than 2 people.

Not included in Guidelines.  Prohibited in Vic.  Not explicitly prohibited in WA and SA but any procedure leading to this outcome would require approval by licensing body.

Prohibited under RTAC guidelines for the accreditation of ART clinics.

Not currently practiced in Australia due to concerns that procedures leading to this outcome may not be completely safe.  Inclusion of this prohibition brings it into line with the more recent RTAC Guidelines.  

Creation or development of an embryo for assisted reproduction that uses any precursor cells of eggs or sperm from an embryo or fetus.

Guideline 11.4 and effectively prohibited in Vic and WA.

Prohibition re-worded to clarify potentially inaccurate terminology.

Maintaining an embryo outside the body of a woman after the 14 th day of its development excluding any time in which its development is suspended.

Guideline 11.2 and specifically prohibited in SA and WA.

Prohibition re-worded to clarify that development excludes periods of storage.

Altering the genome of a cell of a human being or in vitro embryo such that the alteration is inheritable.

Effectively prohibited in all three Acts and considered ethically unacceptable by NHMRC (“Guidelines for Ethical Review of Research Proposals for Human Somatic Cell Gene Therapy and Related Therapies”).

Concerns that, despite potential benefits, the effects of inheritable changes to the genome are too poorly understood to allow practice to be carried out.

Embryo flushing.

Guideline 11.8, specifically prohibited in SA and WA and effectively prohibited in Vic.

While it is intended that this prohibition continue, it is recommended that the wording be changed so as to reflect the outcome rather than the technique which is  the intentional removal of a viable embryo from a woman.

Creating or developing a hybrid embryo or placing a hybrid embryo in the body of a human or animal for any period of gestation.

Guideline 11.5 and effectively prohibited in all 3 Acts.  There is also a prohibition in the Gene Technology Act 2000 .

Reflects the current prohibition but clarifies that a hybrid embryo must not be implanted in the body of a human or animal.

Placing a human embryo in an animal or in any human body cavity other than the female human reproductive tract or placing an animal embryo in a human for any period of gestation.

Guideline 11.7 and effectively prohibited in all 3 Acts.

NHMRC/AHEC prohibition expanded to be brought more in line with State prohibitions and to expressly ban putting an animal embryo in a human.

Giving or offering valuable consideration to any person for donation of gametes or embryos of that person or of any other person.  Note that it is not intended to exclude the disbursement of reasonable expenses incurred by a person in connection with a donation of their genetic material.

Guidelines 11.9 and 11.10 effectively prohibited in all 3 Acts.

Combination of NHMRC/AHEC prohibitions relying on the wording of prohibitions included in SA and WA Acts.

 

 

 

 

 

 




[1] It should be noted that the NHMRC/AHEC Ethical Guidelines on ART are currently subject to review and will be reissued in early 2003.  Information on the nature of the revisions is not yet available.