An Act to prohibit human cloning for reproduction and other
unacceptable practices associated with reproductive technology, and for related
purposes
Part 1—Preliminary
1
Short title [see Note 1]
This Act may be cited as the Prohibition
of Human Cloning for Reproduction Act 2002.
2
Commencement
(1) Each provision of this Act specified in
column 1 of the table commences, or is taken to have commenced, on the day or
at the time specified in column 2 of the table.
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Commencement
information
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Column 1
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Column 2
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Column 3
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Provision(s)
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Commencement
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Date/Details
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1. Sections 1 and 2 and anything in this Act not
elsewhere covered by this table
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The day on which this Act receives the Royal Assent
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19 December 2002
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2. Sections 3 to 26 and Schedule 1
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The 28th day after the day on which this Act receives the
Royal Assent
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16 January 2003
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Note: This table relates only to the provisions of
this Act as originally passed by the Parliament and assented to. It will not be
expanded to deal with provisions inserted in this Act after assent.
(2) Column 3 of the table is for additional
information that is not part of this Act. This information may be included in
any published version of this Act.
3
Object of Act
The object of this Act 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.
4
Operation of Act
(1) This Act applies as follows:
(a) to things done, or omitted to be
done, by constitutional corporations;
(b) to things done, or omitted to be
done, in the course of constitutional trade or commerce;
(c) to matters within the legislative
power of the Commonwealth under paragraph 51(xxix) of the Constitution;
(d) to the Commonwealth and
Commonwealth authorities;
(e) for purposes relating to the
collection, compilation, analysis and dissemination of statistics;
(f) to matters within the legislative
power of the Commonwealth under paragraph 51(xxxix) of the Constitution, so far
as it relates to the matters mentioned in paragraphs (a) to (e) of this
subsection.
(2) In this section:
constitutional corporation means a trading,
foreign or financial corporation within the meaning of paragraph 51(xx) of the
Constitution.
constitutional trade or commerce means trade
or commerce:
(a) between Australia and places
outside Australia; or
(b) among the States; or
(c) by way of the supply of services
to the Commonwealth or to a Commonwealth authority.
5 Act
to bind the Crown
(1) This Act binds the Crown in each of its
capacities.
(2) Nothing in this Act renders the Crown
liable to be prosecuted for an offence.
6 External
Territories
This Act extends to every external
Territory.
7
Schedule
The Gene Technology Act 2000 is
amended as set out in item 1 of Schedule 1.
8
Definitions
(1) In this Act:
animal does not include a human.
chimeric embryo means:
(a) a human embryo into which a cell,
or any component part of a cell, of an animal has been introduced; or
(b) a thing declared by the
regulations to be a chimeric embryo.
Commonwealth authority means the following:
(a) a body corporate established for a
public purpose by or under an Act;
(b) a company in which a controlling
interest is held by any one of the following persons, or by 2 or more of the
following persons together:
(i) the Commonwealth;
(ii) a body covered by paragraph (a);
(iii) a body covered by
either of the above subparagraphs.
excess ART embryo means a human embryo that:
(a) was created, by assisted
reproductive technology, for use in the assisted reproductive technology
treatment of a woman; and
(b) is excess to the needs of:
(i) the woman for whom it
was created; and
(ii) her spouse (if any) at
the time the embryo was created.
human embryo means a discrete entity that has
arisen from either:
(a) the first mitotic division when
fertilisation of a human oocyte by a human sperm is complete; or
(b) any other process that initiates
organised development of a biological entity with a human nuclear genome or
altered human nuclear genome that has the potential to develop up to, or
beyond, the stage at which the primitive streak appears;
and has not yet reached 8 weeks of development since the
first mitotic division.
human embryo clone means 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.
human sperm includes human spermatids.
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.
licence means a licence issued under section 21
of the Research Involving Human Embryos Act 2002.
NHMRC Licensing Committee means the Committee
established under section 13 of the Research Involving Human Embryos
Act 2002.
precursor cell means a cell that has the
potential to develop into a human egg or human sperm.
spouse, in relation to a person, includes a
person who, although not legally married to the person, is living with the
person as the person’s spouse on a bona fide domestic basis.
State includes the Australian Capital
Territory and the Northern Territory.
woman means a female human.
(2) For the purposes of establishing that a
human embryo clone is a genetic copy of a living or dead human:
(a) it is sufficient to establish that
the set of genes in the nuclei of the cells of the living or dead human has
been copied; and
(b) it is not necessary to establish
that the copy is an identical genetic copy.
(3) For the purposes of the definition of
human embryo in subsection (1), in working out the length of the
period of development of a human embryo, any period when the development of the
embryo is suspended is to be disregarded.
(4) For the purposes of the definition of human
embryo clone in subsection (1), a human embryo that results from
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.
(5) For the purposes of paragraph (b) of
the definition of excess ART embryo, a human embryo is excess to
the needs of the persons mentioned in that paragraph at a particular time if:
(a) each such person has given written
authority for use of the embryo for a purpose other than a purpose relating to
the assisted reproductive technology treatment of the woman concerned, and the
authority is in force at that time; or
(b) each such person has determined in
writing that the embryo is excess to their needs, and the determination is in
force at that time.
(6) A reference in this Act to an embryo
(including a human embryo) is a reference to a living embryo.
(7) A reference in this Act to a human egg is
a reference to a human oocyte.
(8) A reference in this Act to a human embryo
does not include a reference to:
(a) a hybrid embryo; or
(b) a human embryonic stem cell line.
Part 2—Prohibited practices
Division 1—Practices that are completely prohibited
9
Offence—placing a human embryo clone in the human body or the body of an animal
A person commits an offence if the
person intentionally places a human embryo clone in the body of a human or the
body of an animal.
Maximum penalty: Imprisonment for 15 years.
Note: The development of a human embryo (including a
human embryo clone) outside the body of a woman for more than 14 days is
prohibited by section 14.
10
Offence—importing or exporting a human embryo clone
(1) A person commits an offence if the person
intentionally imports a human embryo clone into Australia.
Maximum penalty: Imprisonment for 15 years.
(2) A person commits an offence if the person
intentionally exports a human embryo clone from Australia.
Maximum penalty: Imprisonment for 15 years.
11
No defence that human embryo clone could not survive
It is not a defence to an offence under
section 9 or 10 that the human embryo clone did not survive or could not
have survived.
12
Offence—creating a human embryo for a purpose other than achieving pregnancy in
a woman
(1) A person commits an offence if the person
intentionally creates a human embryo by a process of the fertilisation of a
human egg by a human sperm outside the body of a woman, unless the person’s
intention in creating the embryo is to attempt to achieve pregnancy in a
particular woman.
Maximum penalty: Imprisonment for 15 years.
(2) 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.
13
Offence—creating or developing a human embryo by fertilisation that contains
genetic material provided by more than 2 persons
A person commits an offence if:
(a) the person intentionally creates
or develops a human embryo by a process of the fertilisation of a human egg by
a human sperm outside the body of a woman; and
(b) the human embryo contains genetic
material provided by more than 2 persons.
Maximum penalty: Imprisonment for 15 years.
14
Offence—developing a human embryo outside the body of a woman for more than 14
days
A person commits an offence if the
person intentionally develops a human embryo outside the body of a woman for a
period of more than 14 days, excluding any period when development is
suspended.
Maximum penalty: Imprisonment for 15 years.
15
Offence—heritable alterations to genome
(1) A person commits an offence if:
(a) the person alters the genome of a
human cell in such a way that the alteration is heritable by descendants of the
human whose cell was altered; and
(b) in altering the genome, the person
intended the alteration to be heritable by descendants of the human whose cell
was altered.
Maximum penalty: Imprisonment for 15 years.
(2) In this
section:
human cell includes a human embryonal cell, a
human fetal cell, human sperm or a human egg.
16
Offence—collecting a viable human embryo from the body of a woman
A person commits an offence if the
person removes a human embryo from the body of a woman, intending to collect a
viable human embryo.
Maximum penalty: Imprisonment for 15 years.
17 Offence—creating a
chimeric embryo
A person commits an offence if the
person intentionally creates a chimeric embryo.
Maximum penalty: Imprisonment for 15 years.
18 Offence—developing a
hybrid embryo
A person commits an offence if the
person intentionally develops a hybrid embryo for a period of more than 14
days, excluding any period when development is suspended.
Maximum penalty: Imprisonment for 15 years.
19
Offence—placing of an embryo
(1) A person commits an offence if the person
intentionally places a human embryo in an animal.
Maximum penalty: Imprisonment for 15 years.
(2) A person commits an offence if the person
intentionally places a human embryo in the body of a human, other than in a
woman’s reproductive tract.
Maximum penalty: Imprisonment for 15 years.
(3) A person
commits an offence if the person intentionally places an animal embryo in the
body of a human for any period of gestation.
Maximum penalty: Imprisonment for 15 years.
20
Offence—importing, exporting or placing a prohibited embryo
(1) A person commits an offence if the person
intentionally imports an embryo into Australia knowing that, or reckless as to
whether, the embryo is a prohibited embryo.
Maximum penalty: Imprisonment for 15 years.
(2) A person commits an offence if the person
intentionally exports an embryo from Australia knowing that, or reckless as to
whether, the embryo is a prohibited embryo.
Maximum penalty: Imprisonment for 15 years.
(3) A person commits an offence if the person
intentionally places an embryo in the body of a woman knowing that, or reckless
as to whether, the embryo is a prohibited embryo.
Maximum penalty: Imprisonment for 15 years.
(4) In this section:
prohibited embryo means:
(a) a human embryo created by a
process other than the fertilisation of a human egg by human sperm; or
(b) a human embryo created outside the
body of a woman, unless the intention of the person who created the embryo was
to attempt to achieve pregnancy in a particular woman; or
(c) a human embryo that contains
genetic material provided by more than 2 persons; or
(d) a human embryo that has been
developing outside the body of a woman for a period of more than 14 days,
excluding any period when development is suspended; or
(e) a human embryo created using
precursor cells taken from a human embryo or a human fetus; or
(f) a human embryo that contains a
human cell (within the meaning of section 15) whose genome has been
altered in such a way that the alteration is heritable by human descendants of
the human whose cell was altered; or
(g) a human embryo that was removed
from the body of a woman by a person intending to collect a viable human
embryo; or
(h) a chimeric embryo or a hybrid
embryo.
21
Offence—commercial trading in human eggs, human sperm or human embryos
(1) A person commits an offence if the person
intentionally gives or offers valuable consideration to another person for the
supply of a human egg, human sperm or a human embryo.
Maximum penalty: Imprisonment for 15 years.
(2) A person commits an offence if the person
intentionally receives, or offers to receive, valuable consideration from
another person for the supply of a human egg, human sperm or a human embryo.
Maximum penalty: Imprisonment for 15 years.
(3) In this section:
reasonable expenses:
(a) in relation to the supply of a
human egg or human sperm—includes, but is not limited to, expenses relating to
the collection, storage or transport of the egg or sperm; and
(b) in relation to the supply of a
human embryo:
(i) does not include any
expenses incurred by a person before the time when the embryo became an excess
ART embryo; and
(ii) includes, but is not
limited to, expenses relating to the storage or transport of the embryo.
valuable consideration, in relation to the
supply of a human egg, human sperm or a human embryo by a person, includes any
inducement, discount or priority in the provision of a service to the person,
but does not include the payment of reasonable expenses incurred by the person
in connection with the supply.
Division 2—Practices that are prohibited unless authorised by a licence
22
Offence—creating a human embryo other than by fertilisation, or developing such
an embryo
A person commits an offence if:
(a) the person intentionally creates a
human embryo by a process other than the fertilisation of a human egg by a
human sperm, or develops a human embryo so created; and
(b) the creation or development of the
human embryo by the person is not authorised by a licence.
Maximum penalty: Imprisonment for 10 years.
Note 1: The development of a human embryo outside the
body of a woman for more than 14 days is prohibited by section 14.
Note 2: The placement in the body of a woman of a human
embryo clone, or any other human embryo created other than by the fertilisation
of a human egg by a human sperm, is prohibited by sections 9 and 20.
23
Offence—creating or developing a human embryo containing genetic material
provided by more than 2 persons
A person commits an offence if:
(a) the person intentionally creates
or develops a human embryo by a process other than the fertilisation of a human
egg by a human sperm; and
(b) the human embryo contains genetic
material provided by more than 2 persons; and
(c) the creation or development of the
human embryo by the person is not authorised by a licence.
Maximum penalty: Imprisonment for 10 years.
Note 1: The development of a human embryo outside the
body of a woman for more than 14 days is prohibited by section 14.
Note 2: The placement in the body of a woman of a human
embryo created other than by the fertilisation of a human egg by a human sperm
is prohibited by section 20.
23A
Offence—using precursor cells from a human embryo or a human fetus to create a
human embryo, or developing such an embryo
A person commits an offence if:
(a) the person uses precursor cells taken
from a human embryo or a human fetus, intending to create a human embryo, or
intentionally develops an embryo so created; and
(b) the person engages in activities
mentioned in paragraph (a) without being authorised by a licence, and the
person knows or is reckless as to that fact.
Maximum penalty: Imprisonment for 10 years.
23B Offence—creating a
hybrid embryo
(1) A person commits an offence if the person
intentionally creates a hybrid embryo.
(2) A person commits an offence if the person
intentionally develops a hybrid embryo.
(3) A person does not commit an offence
against subsection (1) or (2) if the creation or development of the hybrid
embryo by the person is authorised by a licence.
Maximum penalty: Imprisonment for 10 years.
Note: A licence to create or develop a hybrid embryo
can only be issued under section 21 of the Research Involving Human
Embryos Act 2002:
(a) for the purposes of testing sperm quality in an
accredited ART centre—up to, but not including, the first mitotic division; or
(b) in the case of hybrid embryo created by
introducing the nucleus of a human cell into an animal egg—for not longer than
14 days.
23C
Regulations under Customs Act
The Minister who administers the Customs
Act 1901 must take all reasonable steps to ensure that regulations are
made, within 6 months after the commencement of this section, permitting,
subject to appropriate conditions or restrictions, the import and export of
human embryonic stem cell lines which have been derived from human embryo
clones using practices consistent with Australian legislation.
Part 3—Commonwealth/State arrangements
24
Operation of State laws
This Act is not intended to exclude the
operation of any law of a State, to the extent that the law of the State is
capable of operating concurrently with this Act.
Part 4—Review provision and regulations
Division 1—Review of Act
25
Review of operation of Act
(1) The Minister must cause an independent
review of the operation of this Act to be undertaken as soon as possible after
the second anniversary of the day on which this Act received the Royal Assent.
(2) The review is to be undertaken by persons
chosen by the Minister, with the agreement of each State.
(3) The persons undertaking the review must
give the Council of Australian Governments and both Houses of the Parliament a
written report of the review before the third anniversary of the day on which
this Act received the Royal Assent.
(4) The persons undertaking the review must
consider and report on the scope and operation of this Act taking into account
the following:
(a) developments in technology in
relation to assisted reproductive technology;
(b) developments in medical research
and scientific research and the potential therapeutic applications of such
research;
(c) community standards;
(d) the applicability of establishing
a National Stem Cell Bank.
(5) The report must contain recommendations
about amendments that should be made to this Act, having regard to the matters
mentioned in subsection (4).
(6) The persons undertaking the review must
consult:
(a) the Commonwealth and the States;
and
(b) a broad range of persons with expertise in or experience of
relevant disciplines;
and the views of the Commonwealth, the States and the
persons mentioned in paragraph (b) must be set out in the report to the
extent that it is reasonably practicable to do so.
25A
Further review of operation of Act
(1) The Minister must cause an independent
review of the operation of this Act as amended by the Prohibition of Human
Cloning for Reproduction and the Regulation of Human Embryo Research Amendment
Act 2006 (the amending Act) to be undertaken as soon as
possible after the third anniversary of the day on which the amending Act received
the Royal Assent.
(2) The review is to be undertaken by persons
chosen by the Minister, with the agreement of each State.
(3) The persons undertaking the review must
give the Council of Australian Governments and both Houses of the Parliament a
written report of the review before the fourth anniversary of the day on which the
amending Act received the Royal Assent.
(4) The persons undertaking the review must
consider and report on the scope and operation of this Act as amended by the amending
Act, taking into account the following:
(a) developments in assisted
reproductive technology, including technological, medical and scientific
developments, and the actual or potential clinical and therapeutic applications
of such research;
(b) developments in embryonic stem
cell research, including technological, medical and scientific developments,
and the actual or potential clinical and therapeutic applications of such
research;
(c) community standards;
(d) a brief analysis of international
developments and legislation relating to the use of human embryos and related
research;
(e) an
analysis of research resulting from the licenses granted;
(f) any National Stem Cell Centre and
any national register of donated excess ART embryos;
(g) an evaluation of the effectiveness
of legislative provisions and NHMRC guidelines relating to proper consent;
(h) an evaluation of the range of
matters for which the NHMRC Licensing Committee may issue a licence and any
recommendations to increase, decrease or alter these arising from the
evaluation;
(i) an analysis of any research or
clinical practice which has been prevented as a result of legislative
restrictions;
(j) the extent to which the NHMRC
Licensing Committee has effectively used information and education tools to
assist researchers working in the field, and any ongoing need for legally
binding rulings;
(k) the extent of Commonwealth/State
cooperation in the area of human embryo research and the requirement for
further Commonwealth or State legislation on the matter.
(5) The report must contain recommendations
about amendments that should be made to this Act, having regard to the matters
mentioned in subsection (4).
(6) The persons undertaking the review must
consult:
(a) the Commonwealth and the States;
and
(b) a broad range of persons with
expertise in or experience of relevant disciplines;
and the views of the Commonwealth, the States and the
persons mentioned in paragraph (b) must be set out in the report to the
extent that it is reasonably practicable to do so.
Division 2—Regulations
26
Regulations
(1) The Governor‑General may make
regulations prescribing matters:
(a) required or permitted by this Act
to be prescribed; or
(b) necessary or convenient to be
prescribed for carrying out or giving effect to this Act.
(2) Before the Governor‑General makes
regulations under this Act, the Minister must be satisfied that:
(a) the States have been consulted in
relation to the proposed regulations; and
(b) the proposed regulations have been
prepared having regard to views expressed by the States in those consultations.