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2002
THE PARLIAMENT OF THE
COMMONWEALTH OF AUSTRALIA
SENATE
PROHIBITION
OF HUMAN CLONING BILL 2002
REVISED EXPLANATORY
MEMORANDUM
THIS EXPLANATORY MEMORANDUM TAKES ACCOUNT OF AMENDMENTS
MADE BY THE HOUSE OF REPRESENTATIVES TO THE BILL AS
INTRODUCED
(Circulated by authority of the Prime Minister, the
Hon John Howard MP)
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. The Bill prohibits certain
practices associated with reproductive technologies, including the cloning of a
human being.
The Bill originally formed part of another bill, the
Research Involving Embryos and Prohibition of Human Cloning Bill 2002,
introduced into Parliament on 27 June 2002. The Research Involving Embryos and
Prohibition of Human Cloning Bill 2002, was amended in the House of
Representatives by division into two bills, the Prohibition of Human Cloning
Bill 2002 and the Research Involving Embryos Bill 2002. (The latter bill
contains the provisions dealing with the use of excess ART embryos).
Consistent with its object, the Prohibition of Human Cloning Bill
2002:
(a) prohibits the creation, importation, exportation or
implantation of a human embryo clone; and
(b) prohibits the creation,
importation, exportation or implantation of certain other embryos for ethical
and safety reasons.
In developing and implementing the Prohibition of Human Cloning Bill
2002, the Government will not incur significant establishment or ongoing costs.
If the Research Involving Embryos Bill 2002 is passed, the monitoring of
the provisions of that Bill will apply to Prohibition of Human Cloning Bill
2002, enabling inspectors appointed by the NHMRC Licensing Committee to monitor
compliance with both pieces of legislation. This will incur additional costs to
government and these are described in more detail in the Financial Impact
Statement to the Research Involving Embryos Bill 2002.
Please refer to Attachment 1 to this Explanatory Memorandum.
This is a formal provision that specifies the short title of the Bill as
the Prohibition of Human Cloning Act 2002.
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 26
and Schedule 1 will commence 28 days after the day on which the Bill receives
Royal Assent.
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 by prohibiting certain
practices.
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.
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.
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.
This provides that the Gene Technology Act 2000 is amended as set
out in item 1 of Schedule 1. It is intended that matters relating to cloning be
dealt with comprehensively in the Prohibition of Human Cloning Bill
2002.
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:
Ø 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
Ø 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 8(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 8(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 8(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.
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 8 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.
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.
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.
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 9, 10 or
11. 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.
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 22) it could not be
developed by the person who imported it or any other person without an offence
being committed.
The definition of human sperm (in clause 8) 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 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 to
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 the Research Involving Embryos
Bill 2002.
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 14(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.
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.
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 13 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.
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.
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.
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.
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 8, 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).
This clause prevents the placement of:
• a human embryo in
an animal;
• a human embryo into the body of a human, including a man
or any part of a woman’s body, other than the female reproductive tract;
• an animal embryo in a human, for any period of
gestation.
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 16 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.
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 13, 14, 15, 16, 17, 18, 19 and 20. 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.
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.
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 or introduces legislation that, for example, permits the creation of
a human embryo clone in certain circumstances, such a law would not be capable
of operating concurrently with the Commonwealth Act. It is intended that the
Commonwealth Act would override the State law to the extent that it is
inconsistent.
PART 4 - REVIEW PROVISION AND REGULATIONS
Sub-clause 25(1) provides that the Minister must cause an
independent review of the Act to be undertaken commencing 2 years after it
receives Royal Assent. Provisions in the Research Involving Embryos Bill 2002
will ensure the reviews of both the Prohibition of Human Cloning Act 2002 and
the Research Involving Embryos Act 2002 are undertaken concurrently and by the
same people.
Sub-clauses 25(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 persons chosen by the Minister
with the agreement of all States and Territories;
• include a
consideration of the scope and operation of the Act particularly taking into
account developments in assisted reproductive technology, scientific and medical
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.
Sub-clause 26(1) 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 26(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.
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
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.