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This is a Bill, not an Act. For current law, see the Acts databases.
2002
The Parliament of
the
Commonwealth of
Australia
HOUSE OF
REPRESENTATIVES
Presented and read a first
time
Research
Involving Embryos and Prohibition of Human Cloning Bill
2002
No. ,
2002
(Prime
Minister)
A Bill for an Act to regulate
certain activities involving the use of human embryos, to prohibit human cloning
and other unacceptable practices associated with reproductive technology, and
for related purposes
Contents
Gene Technology Act
2000 42
A Bill for an Act to regulate certain activities
involving the use of human embryos, to prohibit human cloning and other
unacceptable practices associated with reproductive technology, and for related
purposes
The Parliament of Australia enacts:
This Act may be cited as the Research Involving Embryos and
Prohibition of Human Cloning Act 2002.
(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.
|
Commencement information |
||
|---|---|---|
|
Column 1 |
Column 2 |
Column 3 |
|
Provision(s) |
Commencement |
Date/Details |
|
1. Sections 1 and 2 and anything in this Act not elsewhere covered by
this table |
The day on which this Act receives the Royal Assent |
|
|
2. Sections 3 to 24 |
The 28th day after the day on which this Act receives the Royal
Assent |
|
|
3. Sections 25 to 27 |
At the end of the period of 6 months beginning on the day on which this Act
receives the Royal Assent |
|
|
4. Sections 28 to 62 |
The 28th day after the day on which this Act receives the Royal
Assent |
|
|
5. Schedule 1 |
The 28th day after the day on which this Act receives the Royal
Assent |
|
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.
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:
(a) by prohibiting certain practices; and
(b) by regulating activities that involve the use of certain human embryos
created by assisted reproductive technology.
(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.
(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.
This Act extends to every external Territory.
(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.
corresponding State law, in relation to a State, means a law
of that State declared by the Minister, by notice in the Gazette, to be a
corresponding State law for the purposes of this Act.
human embryo means a live embryo that has a human genome or
an altered human genome and that has been developing for less than 8 weeks since
the appearance of 2 pro-nuclei or the initiation of its development by other
means.
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.
inspector means a person appointed as an inspector under
subsection 48(1).
NHMRC Licensing Committee means the Committee established by
section 28.
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.
the NHMRC means the National Health and Medical Research
Council established by the National Health and Medical Research Council Act
1992.
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.
A person commits an offence if the person intentionally creates a human
embryo clone.
Maximum penalty: Imprisonment for 15 years.
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.
(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.
It is not a defence to an offence under section 8, 9 or 10 that the
human embryo clone did not survive or could not have survived.
A person commits an offence if the person intentionally creates a human
embryo by a process other than the fertilisation of a human egg by human sperm,
or intentionally develops a human embryo so created.
Maximum penalty: Imprisonment for 10 years.
(1) A person commits an offence if the person intentionally creates a
human embryo 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 10 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.
A person commits an offence if the person intentionally creates or
develops a human embryo containing genetic material provided by more than 2
persons.
Maximum penalty: Imprisonment for 10 years.
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 10 years.
A person commits an offence if 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.
Maximum penalty: Imprisonment for 10 years.
(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 10 years.
(2) In this section:
human cell includes a human embryonal cell, a human fetal
cell, human sperm or a human egg.
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 10 years.
(1) A person commits an offence if the person intentionally creates a
chimeric embryo.
Maximum penalty: Imprisonment for 10 years.
(2) A person commits an offence if the person intentionally creates a
hybrid embryo.
Maximum penalty: Imprisonment for 10 years.
(1) A person commits an offence if the person intentionally places a human
embryo in an animal.
Maximum penalty: Imprisonment for 10 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 10 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 10 years.
(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 10 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 10 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 10 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 17) 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.
(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 10 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 10 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 within the meaning of
section 24; 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.
In this Part:
accredited ART centre means 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.
AHEC means the Australian Health Ethics Committee established
by the National Health and Medical Research Council Act 1992.
confidential commercial information means 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.
disclose, in relation to information, means give or
communicate in any way.
excess ART embryo has the meaning given by
section 24.
HREC means a Human Research Ethics Committee.
licence means a licence issued under
section 36.
proper consent, in relation to the use of an excess ART
embryo, means:
(a) consent obtained in accordance with the Ethical Guidelines on
Assisted Reproductive Technology (1996) issued by the NHMRC; or
(b) if the Chairperson of the NHMRC Licensing Committee specifies, by
notice in the Gazette, other guidelines issued by the NHMRC—consent
obtained in accordance with those other guidelines.
relevant State body means a person or body notified by a
State to the Chairperson of the NHMRC Licensing Committee for the purposes of
this Part.
responsible person, in relation to an excess ART embryo,
means:
(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.
(1) In this Part:
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.
(2) 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.
(1) A person commits an offence if the person intentionally uses an excess
ART embryo, unless:
(a) the use by the person is authorised by a licence; or
(b) the use by the person is an exempt use within the meaning of
subsection (2).
Maximum penalty: Imprisonment for 5 years.
(2) A use of an excess ART embryo by a person is an exempt
use for the purposes of subsection (1) if:
(a) the use consists only of:
(i) storage of the excess ART embryo; or
(ii) removal of the excess ART embryo from storage; or
(iii) transport of the excess ART embryo; or
(b) the use consists only of observation of the excess ART embryo;
or
(c) the use consists only of allowing the excess ART embryo to succumb;
or
(d) the use is carried out by an accredited ART centre, and:
(i) the excess ART embryo is not suitable to be placed in the body of the
woman for whom it was created; and
(ii) the use 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; or
(e) the use is carried out by an accredited ART centre and is for the
purposes of achieving pregnancy in a woman other than the woman for whom the
excess ART embryo was created; or
(f) the use is of a kind prescribed by the regulations for the purposes of
this paragraph.
(3) 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) or (2) of this section.
(4) In subsection (1):
observation, in relation to an excess ART embryo, includes
taking a photograph of the embryo, or taking a recording of the embryo from
which a visual image can be produced.
(1) A person commits an offence if:
(a) the person intentionally uses, outside the body of a woman, a human
embryo that is not an excess ART embryo; and
(b) the person is not using the embryo as part of an ART program carried
out by an accredited ART centre, and the person knows or is reckless as to that
fact.
Maximum penalty: Imprisonment for 5 years.
(2) In this section:
ART program means an assisted reproductive technology program
carried out in accordance with:
(a) the Code of Practice for Centres Using Assisted Reproductive
Technology issued by the Reproductive Technology Accreditation Committee of
the Fertility Society of Australia, as in force from time to time; or
‘ (b) such other code or document as is prescribed by the regulations
in addition to, or instead of, the code mentioned in paragraph (a), as in
force from time to time.
(1) A person commits an offence if the person intentionally engages in
conduct, knowing that the conduct contravenes a condition of a licence that
applies to the person, or reckless as to whether the conduct contravenes a
condition of such a licence.
Maximum penalty: Imprisonment for 5 years.
(2) In this section:
engage in conduct means:
(a) do an act; or
(b) omit to perform an act.
(1) The Embryo Research Licensing Committee of the NHMRC (the NHMRC
Licensing Committee) is established by this section.
(2) The NHMRC Licensing Committee is taken to be a Principal Committee
within the meaning of the National Health and Medical Research Council Act
1992, other than for the purposes of the following provisions of that
Act:
(a) section 10;
(b) section 35;
(c) section 80;
(d) subsection 82(2).
(3) This section has effect despite the definition of Principal
Committee in section 4 of the National Health and Medical
Research Council Act 1992.
(4) The regulations may make provision for and in relation to the
disclosure of members’ interests in matters being considered by the NHMRC
Licensing Committee.
(5) A determination by the NHMRC under paragraph 38(b)(vi) of the
National Health and Medical Research Council Act 1992 does not have
effect in relation to the NHMRC Licensing Committee at any time when regulations
under subsection (4) are in force.
The functions of the NHMRC Licensing Committee are:
(a) to perform functions in relation to licences under Division 4;
and
(b) to perform functions in relation to databases under Division 5;
and
(c) to perform such other functions as are conferred on it by this Act or
any other law.
The NHMRC Licensing Committee has power to do all things necessary or
convenient to be done for or in connection with the performance of its
functions.
(1) The NHMRC Licensing Committee consists of the following
members:
(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
relating 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;
(i) a person with expertise in embryology.
(2) The Minister must appoint the members of the NHMRC Licensing
Committee.
(3) Before appointing a member, the Minister must:
(a) seek nominations from the States and from such bodies as are
prescribed by the regulations for the purpose; and
(b) consult, and have regard to the views expressed by, the
States on the proposed appointment.
(4) The Minister must appoint one of the members, other than the member
mentioned in paragraph (1)(a), as the Chairperson of the NHMRC Licensing
Committee.
(5) The Minister must not appoint a person:
(a) as the Chairperson under subsection (4); or
(b) as the member mentioned in paragraph (1)(h);
unless a majority of the States agree with that appointment.
(6) In appointing the members of the NHMRC Licensing Committee, the
Minister must have regard to the desirability of ensuring that the Committee as
a whole comprises members from different States.
(1) A member of the NHMRC Licensing Committee holds office on a part-time
basis.
(2) A member holds office for a period not exceeding 3 years that is
specified in the instrument of appointment, but is eligible for
reappointment.
(1) A report under section 83 of the National Health and Medical
Research Council Act 1992 must, in addition to the matters set out in that
section, include details relating to the operations of the NHMRC Licensing
Committee.
(2) The NHMRC Licensing Committee must give written details relating to
its operations to the NHMRC for the purposes of subsection (1).
(1) The NHMRC Licensing Committee may at any time cause a report about
matters relating to the Committee’s functions to be tabled in either House
of the Parliament.
(2) The NHMRC Licensing Committee must give a copy of the report to the
Minister and to each State.
(1) A person may apply to the NHMRC Licensing Committee for a licence
authorising use of excess ART embryos.
(2) An application under subsection (1):
(a) must be made in accordance with the requirements (if any) specified in
writing by the NHMRC Licensing Committee; and
(b) must be accompanied by the fee (if any) prescribed by the
regulations.
(1) This section applies if a person has made an application under
section 35 for a licence.
(2) The NHMRC Licensing Committee must decide, in accordance with this
section, whether or not to issue the licence.
(3) The NHMRC Licensing Committee must not issue the licence unless it is
satisfied of the following:
(a) that appropriate protocols are in place:
(i) to enable proper consent to be obtained before an excess ART embryo is
used under the licence (see paragraph 39(1)(a)); and
(ii) to enable compliance with any restrictions on such consent;
(b) if the use of an excess ART embryo proposed in the application may
damage or destroy the embryo—that appropriate protocols are in place to
enable compliance with the condition that such use is authorised only in respect
of an embryo created before 5 April 2002 (see subsection 39(3));
(c) that the activity or project proposed in the application has been
assessed and approved by a HREC that is constituted in accordance with, and
acting in compliance with, the NHMRC National Statement on Ethical Conduct in
Research Involving Humans (1999), as in force from time to time.
(4) In deciding whether to issue the licence, the NHMRC Licensing
Committee must have regard to the following:
(a) the number of excess ART embryos likely to be necessary
to achieve the goals of the activity or project proposed in the
application;
(b) 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;
(c) any relevant guidelines, or relevant parts of guidelines, issued by
the NHMRC;
(d) the HREC assessment of the application mentioned in
paragraph (3)(c);
(e) such additional matters (if any) as are prescribed by the
regulations.
(1) The NHMRC Licensing Committee must notify its decision on an
application for a licence under section 35 to the following:
(a) the applicant;
(b) the HREC that assessed and approved the activity or project proposed
in the application as mentioned in paragraph 36(3)(c);
(c) the relevant State body in relation to the State in which the use is
to occur.
(2) If the NHMRC Licensing Committee decides to issue the licence, it
must, in addition to issuing the licence to the applicant, give a copy of the
licence to the bodies mentioned in paragraphs (1)(b) and (c).
(1) A licence:
(a) comes into force on the day specified in the licence, or if no day is
specified, on the day on which it is issued; and
(b) remains in force until the day specified in the licence, unless it is
suspended, revoked or surrendered before that day.
(2) A licence is not in force throughout any period of
suspension.
(1) A licence is subject to the condition that before an excess ART embryo
is used as authorised by the licence:
(a) each responsible person in relation to the excess ART embryo must have
given proper consent to that use; and
(b) the licence holder must have reported in writing to the NHMRC
Licensing Committee that such consent has been obtained, and any restrictions to
which the consent is subject; and
(c) if the licence authorises use of an excess ART embyro that may damage
or destroy the embryo—the licence holder must have reported in writing to
the NHMRC Licensing Committee that the embryo was created before 5 April
2002.
(2) A licence is subject to the condition that the use of an excess ART
embryo must be in accordance with any restrictions to which the proper consent
under subsection (1) is subject.
(3) If a licence authorises the use of an excess ART embryo that may
damage or destroy the embryo, the licence is subject to the condition that such
use is authorised only in respect of an embryo created before 5 April
2002.
(4) A licence is subject to such other conditions as are specified in the
licence.
(5) The conditions specified in the licence may include, but are not
limited to, conditions relating to the following:
(a) the persons authorised by the licence to use excess ART
embryos;
(b) the number of excess ART embryos in respect of which use is authorised
by the licence;
(c) reporting;
(d) monitoring;
(e) information to be given by the licence holder to persons authorised by
the licence to use excess ART embryos.
(6) The licence conditions set out in subsections (1), (2) and (3)
apply to all persons who are authorised by the licence to use excess ART
embryos.
(7) Licence conditions specified in the licence apply to:
(a) the licence holder; and
(b) such other persons authorised by the licence to use excess ART embryos
as are specified in the licence.
(1) The NHMRC Licensing Committee may, by notice in writing given to the
licence holder, vary a licence if the Committee believes on reasonable grounds
that it is necessary or desirable to do so.
(2) The NHMRC Licensing Committee may vary a licence under
subsection (1) on its own initiative or on application by the licence
holder.
(3) Without limiting subsection (1), the NHMRC Licensing Committee
may vary the licence by specifying additional conditions or varying existing
conditions.
(4) The NHMRC Licensing Committee must not vary a licence in such a way
that, had a person applied under section 35 for the licence as varied, the
Committee would not have been permitted by this Part to issue the
licence.
The NHMRC Licensing Committee may, by notice in writing given to the
licence holder, suspend or revoke a licence if the Committee believes on
reasonable grounds that a condition of the licence has been breached.
A licence holder may surrender a licence by written notice given to the
NHMRC Licensing Committee.
(1) If the NHMRC Licensing Committee varies, suspends or revokes a
licence, the Committee must notify:
(a) the licence holder; and
(b) the HREC and the relevant State body to which the NHMRC Licensing
Committee notified its decision on the application for the licence under
section 37.
(2) The NHMRC Licensing Committee must also notify the bodies mentioned in
paragraph (1)(b) if a licence is surrendered.
(1) The NHMRC Licensing Committee must maintain a database containing the
following information in relation to each licence (including a licence as
varied):
(a) the name of the person to whom the licence was issued;
(b) a short statement about the nature of the uses of excess ART embryos
that are authorised by the licence;
(c) any conditions to which the licence is subject;
(d) the number of excess ART embryos in respect of which use is authorised
by the licence;
(e) the date on which the licence was issued;
(f) the period throughout which the licence is to remain in
force.
(2) The database is to be made publicly available.
(3) The database may be kept and made publicly available in electronic
form.
(4) Information mentioned in subsection (1) must not be such as to
disclose confidential commercial information.
(1) A person commits an offence if:
(a) the person discloses confidential commercial information that the
person has only because of performing duties or functions under this Act or
under a corresponding State law; and
(b) the person knows that the information is confidential commercial
information; and
(c) the disclosure is not:
(i) to the Commonwealth, a Commonwealth authority or a State agency in the
course of carrying out duties or functions under this Act or under a
corresponding State law; or
(ii) by order of a court; or
(iii) with the consent of each person to whom the information has a
commercial or other value.
Maximum penalty: Imprisonment for 2 years.
(2) A person commits an offence if:
(a) the person discloses confidential commercial information that the
person has only because of a disclosure permitted under subsection (1) or
this subsection; and
(b) the person knows that the information is confidential commercial
information; and
(c) the disclosure is not:
(i) to the Commonwealth, a Commonwealth authority or a State agency in the
course of carrying out duties or functions under this Act or under a
corresponding State law; or
(ii) by order of a court; or
(iii) with the consent of each person to whom the information has a
commercial or other value.
Maximum penalty: Imprisonment for 2 years.
(3) In this section:
court includes a tribunal, authority or person having power
to require the production of documents or the answering of questions.
State agency means the following:
(a) the Crown in right of a State;
(b) a Minister of a State;
(c) a State Government department;
(d) an instrumentality of a State, including a body corporate established
for a public purpose by or under a law of a State;
(e) 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 Crown in right of a State;
(ii) a person or body covered by paragraph (b) or (d);
(iii) a person or body covered by either of the above
subparagraphs.
Note: For the definition of confidential commercial
information, see section 23.
In this Division:
decision has the same meaning as in the Administrative
Appeals Tribunal Act 1975.
eligible person, in relation to a decision of the NHMRC
Licensing Committee, means:
(a) in relation to a decision under section 36 not to issue a
licence—the applicant for the licence; or
(b) in relation to a decision in respect of the period throughout which
the licence is to be in force under section 38—the licence holder;
or
(c) in relation to a decision to specify a licence condition under
subsection 39(4)—the licence holder; or
(d) in relation to a decision to vary or refuse to vary a licence under
section 40—the licence holder; or
(e) in relation to a decision to suspend or revoke a licence under
section 41—the person who was the licence holder immediately before
the suspension or revocation.
(1) An eligible person may apply to the Administrative Appeals Tribunal
for review of the following decisions of the NHMRC Licensing
Committee:
(a) a decision under section 36 not to issue a licence;
(b) a decision in respect of the period throughout which the licence is to
be in force under section 38;
(c) a decision to specify a licence condition under subsection
39(4);
(d) a decision to vary or refuse to vary a licence under
section 40;
(e) a decision to suspend or revoke a licence under
section 41.
(2) This section has effect subject to the Administrative Appeals
Tribunal Act 1975.
(1) The Chairperson of the NHMRC Licensing Committee may, by instrument in
writing, appoint any of the following persons as inspectors:
(a) a person who is appointed or employed by the Commonwealth;
(b) a person who is appointed or employed by a State.
(2) In exercising powers or performing functions as an inspector, an
inspector must comply with any directions of the Chairperson of the NHMRC
Licensing Committee.
(3) The Chairperson of the NHMRC Licensing Committee must not appoint a
person as an inspector under subsection (1) unless he or she is satisfied
that the person has appropriate skills and experience.
(1) The Chairperson of the NHMRC Licensing Committee must issue an
identity card to an inspector.
(2) The identity card:
(a) must be in the form prescribed by the regulations; and
(b) must contain a recent photograph of the inspector.
(3) If a person to whom an identity card has been issued ceases to be an
inspector, the person must return the identity card to the Chairperson of the
NHMRC Licensing Committee as soon as practicable.
Maximum penalty: 1 penalty unit.
(4) An inspector must carry his or her identity card at all times when
exercising powers or performing functions as an inspector.
(1) For the purpose of finding out whether this Act or the regulations
have been complied with, an inspector may:
(a) enter any premises; and
(b) exercise the monitoring powers set out in section 51.
(2) An inspector is not authorised to enter premises under
subsection (1) unless:
(a) the occupier of the premises has consented to the entry; or
(b) the premises are premises at which the occupier of the premises is
carrying out activities authorised by a licence issued under section 36,
and the entry is at a reasonable time.
(1) The monitoring powers that an inspector may exercise under paragraph
50(1)(b) are as follows:
(a) to search the premises and any thing on the premises;
(b) to inspect, examine, take measurements of, conduct tests on, or take
samples of, any human embryo or thing on the premises that relates to this
Act;
(c) to take photographs, make video or audio recordings or make sketches
of the premises or any thing on the premises;
(d) to inspect any book, record or document on the premises;
(e) to take extracts from or make copies of any such book, record or
document;
(f) to take onto the premises such equipment and materials as the
inspector requires for the purpose of exercising powers in relation to the
premises.
(2) For the purposes of this Part, monitoring powers include the power to
operate equipment at premises to see whether:
(a) the equipment; or
(b) a disk, tape or other storage device that:
(i) is at the premises; and
(ii) can be used with the equipment or is associated with it;
contains information that is relevant to determining whether there has been
compliance with the Act or the regulations.
(3) If the inspector, after operating equipment at the premises, finds
that the equipment, or that a tape, disk or other storage device at the
premises, contains information mentioned in subsection (2), the inspector
may:
(a) operate equipment or facilities at the premises to put the information
in documentary form and copy the document so produced; or
(b) if the information can be transferred to a tape, disk or other storage
device that:
(i) is brought to the premises; or
(ii) is at the premises and the use of which has been agreed to in writing
by the occupier of the premises;
operate the equipment or other facilities to copy the information to the
storage device, and remove the storage device from the premises.
If an inspector, during a search of premises, believes on reasonable
grounds that there is at the premises a human embryo or a thing that may afford
evidence of the commission of an offence against this Act, the monitoring powers
include securing the embryo or thing pending the obtaining of a warrant (whether
by the inspector or by another person) to seize it.
An inspector is not entitled to exercise any powers under this Part in
relation to premises if:
(a) the occupier of the premises has required the inspector to produce his
or her identity card for inspection by the occupier; and
(b) the inspector fails to comply with the requirement.
(1) Before obtaining the consent of a person for the purposes of paragraph
50(2)(a), the inspector must inform the person that he or she may refuse
consent.
(2) An entry of an inspector by virtue of the consent of a person is not
lawful unless the person voluntarily consented to the entry.
(1) The owner of equipment or other facilities is entitled to compensation
for damage to the equipment or other facilities if:
(a) the damage was caused to the equipment or other facilities as a result
of it being operated by an inspector as mentioned in this Part; and
(b) the damage was caused as a result of insufficient care being exercised
by the inspector operating the equipment or other facilities.
(2) Compensation is payable out of money appropriated by the
Parliament.
(3) In determining the amount of compensation payable, regard is to be had
to whether the occupier of the premises and his or her employees and agents, if
they were available at the time, had provided any warning or guidance as to the
operation of the equipment or other facilities that was appropriate in
the circumstances.
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.
(1) A corresponding State law may confer functions, powers and duties on
the following:
(a) the NHMRC Licensing Committee;
(b) a Commonwealth authority;
(c) an officer of the Commonwealth or a Commonwealth authority.
(2) If a function, power or duty is conferred on a person or body under
subsection (1), the person or body may perform the function or duty or
exercise the power, as the case requires.
(3) Subsection (1) does not authorise the conferral of a function or
power, or the imposition of a duty, by a corresponding State law to the extent
to which:
(a) the conferral or imposition, or the authorisation, would contravene
any constitutional doctrines restricting the duties that may be imposed on a
Commonwealth body, officer or authority; or
(b) the authorisation would otherwise exceed the legislative power of the
Commonwealth.
(4) This Act is not intended to exclude or limit the operation of a
corresponding State law that confers any functions or powers, or imposes any
duties, on the NHMRC Licensing Committee, a Commonwealth officer or a
Commonwealth authority to the extent to which that law:
(a) is consistent with subsections (1) and (2); and
(b) is capable of operating concurrently with this Act.
(1) This section applies if a corresponding State law purports to impose a
duty on the following:
(a) the NHMRC Licensing Committee;
(b) a Commonwealth authority;
(c) an officer of the Commonwealth or a Commonwealth authority.
(2) The duty is taken not to be imposed by this Act (or any other law of
the Commonwealth) to the extent to which:
(a) imposing the duty is within the legislative powers of the State
concerned; and
(b) imposing the duty by the corresponding State law is consistent with
the constitutional doctrines restricting the duties that may be imposed on a
Commonwealth body, officer or authority.
Note: If this subsection applies, the duty will be taken to
be imposed by force of the corresponding State law (the Commonwealth having
consented under section 57 to the imposition of the duty by the
corresponding State law).
(3) If, to ensure the validity of the purported imposition of the duty, it
is necessary that the duty be imposed by a law of the Commonwealth (rather than
by force of the corresponding State law), the duty is taken to be imposed by
this Act to the extent necessary to ensure that validity.
(4) If, because of subsection (3), this Act is taken to impose the
duty, it is the intention of the Parliament to rely on all powers available to
it under the Constitution to support the imposition of the duty by this
Act.
(5) The duty is taken to be imposed by this Act in accordance with
subsection (3) only to the extent to which imposing the duty:
(a) is within the legislative power of the Commonwealth; and
(b) is consistent with the constitutional doctrines restricting the duties
that may be imposed on a Commonwealth body, officer or authority.
(6) To avoid doubt, neither this Act (nor any other law of the
Commonwealth) imposes a duty on the NHMRC Licensing Committee, a Commonwealth
officer or a Commonwealth authority to the extent to which imposing such a duty
would:
(a) contravene any constitutional doctrine restricting the duties that may
be imposed on a Commonwealth body, officer or authority; or
(b) otherwise exceed the legislative power of the Commonwealth.
(7) Subsections (1) to (6) do not limit section 57.
(1) Application may be made to the Administrative Appeals Tribunal for
review of a reviewable State decision.
(2) A decision made by the NHMRC Licensing Committee in the performance of
a function or the exercise of a power conferred by a corresponding State law is
a reviewable State decision for the purposes of this section if:
(a) the law under which the decision was made provides for review by the
Administrative Appeals Tribunal; and
(b) the decision is declared by the regulations to be a reviewable State
decision for the purposes of this section.
(3) For the purposes of this section, the Administrative Appeals
Tribunal Act 1975 has effect as if a corresponding State law were an
enactment.
Paragraphs 36(3)(b) and 39(1)(c) and subsection 39(3) are repealed on
whichever of the following days applies:
(a) 5 April 2005;
(b) if the Council of Australian Governments declares an earlier day by
notice in the Gazette—that earlier day.
(1) The NHMRC 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 NHMRC, with
the agreement of each State.
(3) The persons undertaking the review must give the Council of Australian
Governments 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 Parts 2 and 3 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.
(5) The report must contain recommendations about amendments (if any) 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.
(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.
1 Sections 192B, 192C and
192D
Repeal the sections.