An Act to regulate certain activities involving the use of human
embryos, and for related purposes
Part 1—Preliminary
1
Short title [see
Note 1]
This Act may be cited as the Research
Involving Human Embryos 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 9
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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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3. Sections 10 to 12
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At the end of the period of 6 months beginning on the day
on which this Act receives the Royal Assent
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19 June 2003
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4. Sections 13 to 48
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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 regulating
activities that involve the use of certain human embryos created by assisted
reproductive technology or by other means.
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
Definitions
(1) In this Act:
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 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.
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 33(1).
NHMRC Licensing Committee means the Committee
established by section 13.
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.
unsuitable for implantation, in relation to a
human embryo, means a human embryo that:
(a) is diagnosed by preimplantation
genetic diagnosis as unsuitable for implantation, in accordance with the Ethical
Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice
and Research (2004), issued by the CEO of the NHMRC; or
(b) is determined to be unsuitable for
implantation in the body of a woman, in accordance with objective criteria
specified in guidelines issued by the CEO of the NHMRC under the National
Health and Medical Research Council Act 1992 and prescribed by the
regulations for the purposes of this paragraph.
use includes develop, or development, as the
case requires.
woman means a female human.
(2) 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.
(3) A reference in this Act to an embryo
(including a human embryo) is a reference to a living embryo.
(4) A reference in this Act to a human egg is
a reference to a human oocyte.
(5) 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—Regulation of the use of excess ART embryos, other embryos
and human eggs
Division 1—Interpretation
8
Definitions [see
Note 2]
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 9.
HREC means a Human Research Ethics Committee.
licence means a licence issued under section 21.
proper consent, in relation to the use of an
excess ART embryo or a human egg, or the creation or use of any other embryo,
means consent obtained in accordance with guidelines issued by the CEO of the
NHMRC under the National Health and Medical Research Council Act 1992
and prescribed by the regulations for the purposes of this definition.
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 means: [see Note 2]
(a) in relation to an excess ART
embryo:
(i) each person who
provided the egg or sperm from which the embryo was created; and
(ii) the woman for whom the
embryo was created, for the purpose of achieving her pregnancy; and
(iii) any person who was the
spouse of a person mentioned in subparagraph (i) at the time the egg or
sperm mentioned in that subparagraph was provided; and
(iv) any person who was the spouse
of the woman mentioned in subparagraph (ii) at the time the embryo was
created; or
(b) in relation to an embryo other
than an excess ART embryo—each person whose reproductive material, genetic
material or cell was used, or is proposed to be used, in the creation or use of
the embryo; or
(c) in relation to a human egg—the
woman who was the biological donor of the egg.
9
Meaning of excess ART embryo
(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.
Division 2—Offences
10
Offence—use of excess ART embryo
(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
where the suitability of the embryo is determined only on the basis of its
biological fitness for implantation; 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 (2):
diagnostic investigation, in relation to an
excess ART embryo, means any procedure undertaken on embryos for the sole
purpose of diagnostic investigations for the direct benefit of the woman for
whom it was created.
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.
10A
Offence—use of other embryos
A person commits an offence if:
(a) the person intentionally uses an
embryo; and
(b) the embryo is:
(i) a human embryo created
by a process other than the fertilisation of a human egg by a human sperm; or
(ii) a human embryo created
by a process other than the fertilisation of a human egg by a human sperm that
contains genetic material provided by more than 2 persons; or
(iii) a human embryo created
using precursor cells taken from a human embryo or a human fetus; or
(iv) a hybrid embryo; and
(c) the use by the person is not
authorised by a licence.
Maximum penalty: Imprisonment for 5 years.
Note: The creation or development of embryos
mentioned in this section is prohibited under Part 2 of the Prohibition
of Human Cloning for Reproduction Act 2002, unless authorised by a licence
under this Act.
10B
Offence—certain activities involving use of human eggs
A person commits an offence if:
(a) the person undertakes research or
training involving the fertilisation of a human egg by a human sperm up to, but
not including, the first mitotic division, outside the body of a woman for the
purposes of research or training in ART; and
(b) the person is not authorised by a
licence to undertake the research or training.
Maximum penalty: Imprisonment for 5 years.
11
Offence—use of embryo that is not an excess ART embryo
A person commits an offence if:
(a) the person intentionally uses,
outside the body of a woman, a human embryo:
(i) that was created by
fertilisation of a human egg by a human sperm; and
(ii) that is not an excess
ART embryo; and
(b) the use is not for a purpose
relating to the assisted reproductive technology treatment of a woman carried
out by an accredited ART centre, and the person knows or is reckless as to that
fact.
Maximum penalty: Imprisonment for 5 years.
12
Offence—breaching a licence condition
(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.
12A
Person not liable for conduct purportedly authorised
(1) To avoid doubt, a person is not
criminally responsible for an offence against this Act in respect of particular
conduct if:
(a) the conduct by the person is
purportedly authorised by a provision of a licence; and
(b) the licence or the provision is
invalid, whether because of a technical defect or irregularity or for any other
reason; and
(c) the person did not know, and could
not reasonably be expected to have known, of the invalidity of the licence or
the provision.
(2) In this section:
licence includes a purported licence.
Division 3—Embryo Research Licensing Committee of the NHMRC
13
Establishment of Committee
(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) sections 5D and 5E;
(b) section 35;
(c) section 41;
(d) section 80;
(e) subsections 82(1C) and (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) Section 42A 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.
14
Functions of Committee
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.
15
Powers of Committee
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.
16
Membership of Committee
(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;
(b) consult, and have regard to
the views expressed by, the States on the proposed appointment; and
(c) be satisfied upon receipt of a
written declaration by the member proposed to be appointed that the member proposed
does not have a direct or indirect pecuniary interest in a body that undertakes
uses of excess ART embryos or human eggs, or creation or uses of other embryos,
being an interest of a kind that could conflict with the proper performance of
the member’s functions.
(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.
(7) It is the intention of the Parliament
that any vacancy on the NHMRC Licensing Committee be filled as soon as
possible.
(8) If there is a vacancy in the membership
of the NHMRC Licensing Committee for a period of 3 months the Minister must,
within 3 sitting days of the expiration of that 3 months, table in each House
of the Parliament a written statement of reasons for the failure to fill the
vacancy.
17
Terms of appointment
(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.
18
Annual report
(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 CEO of the NHMRC for the
purposes of subsection (1).
19
Reports to Parliament
(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.
(3) The NHMRC Licensing Committee must cause
a report to be tabled in either House of Parliament on or before:
(a) 30 June of each year; and
(b) 31 December of each year; and
(c) any other time required by either
House of Parliament;
that must include information about:
(d) the operation of this Act; and
(e) the licences issued under this
Act.
Division 4—Licensing system
20
Person may apply for licence
(1) A person may apply to the NHMRC Licensing
Committee for a licence authorising one or more of the following:
(a) use of excess ART embryos;
(b) creation of human embryos other
than by fertilisation of a human egg by a human sperm, and use of such embryos;
(c) creation of human embryos other
than by fertilisation of a human egg by a human sperm that contain genetic
material provided by more than 2 persons, and use of such embryos;
(d) creation of human embryos using
precursor cells from a human embryo or a human fetus, and use of such embryos;
(e) research and training involving
the fertilisation of a human egg by a human sperm up to, but not including, the
first mitotic division, outside the body of a woman for the purposes of
research or training in ART;
(f) creation of hybrid embryos by the
fertilisation of an animal egg by a human sperm, and use of such embryos up to,
but not including, the first mitotic division, if:
(i) the creation or use is
for the purposes of testing sperm quality; and
(ii) the creation or use
will occur in an accredited ART centre.
(1A) To avoid doubt, paragraphs (1)(a), (b), (c)
and (d) do not permit the NHMRC Licensing Committee to authorise any use of an
excess ART embryo or other embryo that would result in the development of the
embryo for a period of more than 14 days, excluding any period when development
is suspended.
(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.
21
Determination of application by Committee [see Note 1]
(1) This section applies if a person has made
an application under section 20 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 or human egg is used, or
other embryo is created or used under the licence (see paragraph 24(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 24(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) restricting the
number of excess ART embryos, other embryos or human eggs, to that 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 or human eggs, or the creation or use of other
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 CEO of the NHMRC under the National
Health and Medical Research Council Act 1992 and prescribed by the
regulations for the purposes of this paragraph;
(d) the HREC assessment of the
application mentioned in paragraph (3)(c);
(e) such additional matters (if any)
as are prescribed by the regulations.
22
Notification of decision
(1) The NHMRC Licensing Committee must notify
its decision on an application for a licence under section 20 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 21(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).
23
Period of licence
(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.
24
Licence is subject to conditions [see Note 1]
(1) A licence is subject to the condition
that before an excess ART embryo or human egg is used, or any other embryo is
created or used, as authorised by the licence:
(a) each responsible person in
relation to the excess ART embryo, human egg or other embryo must have given
proper consent to that creation or 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.
(2) A licence is subject to the condition
that the use of an excess ART embryo or human egg, or the creation or use of
any other 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 or human eggs, or create or use other embryos;
(b) the number of excess ART embryos
or human eggs authorised to be used under the licence, or the number of other
embryos authorised to be created or used under 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 or
human eggs, or to create or use other 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 or human eggs, or to create or use other 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 or human eggs, or to create or use other
embryos as are specified in the licence.
(8) For the
purposes of applying the condition referred to in paragraph (1)(a):
(a) a licence may provide that the
guidelines referred to in the definition of proper consent apply
in a modified form in relation to the use, under the licence, of excess ART
embryos that are unsuitable for implantation; and
(b) if a licence so provides, the
guidelines as modified by the licence have effect in relation to the giving of
consent for such creation or use.
Note: For example, the guidelines could apply to a
particular licence in a modified form, to alter the cooling‑off period
required in relation to the use of excess ART embryos that are unsuitable for
implantation.
25
Variation of 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 20
for the licence as varied, the Committee would not have been permitted by this
Part to issue the licence.
26
Suspension or revocation of licence
(1) 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.
(2) If a licence holder is convicted of an
offence under this Act or the Prohibition of Human Cloning Act 2002, the
NHMRC Licensing Committee must, by notice in writing given to the licence
holder, revoke each licence held by the licence holder.
27
Surrender of licence
A licence holder may surrender a licence
by written notice given to the NHMRC Licensing Committee.
28
Notification of variation, suspension or revocation of licence
(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 22.
(2) The NHMRC Licensing Committee must also
notify the bodies mentioned in paragraph (1)(b) if a licence is
surrendered.
Division 5—Reporting and confidentiality
29
NHMRC Licensing Committee to make certain information publicly available
(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 or human eggs, and creations or uses of other
embryos, that are authorised by the licence;
(c) any conditions to which the
licence is subject;
(d) the number of ART embryos or human
eggs authorised to be used under the licence, and the number of other embryos
authorised to be created or used under 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.
30
Confidential commercial information may only be disclosed in certain
circumstances
(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 8.
Division 6—Review provisions
31
Meaning of terms
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 21 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 23—the licence holder; or
(c) in relation to a decision to
specify a licence condition under subsection 24(4)—the licence holder; or
(ca) in relation to a decision to
modify guidelines under subsection 24(8) in respect of a licence—the licence
holder; or
(d) in relation to a decision to vary
or refuse to vary a licence under section 25—the licence holder; or
(e) in relation to a decision to
suspend or revoke a licence under section 26—the person who was the
licence holder immediately before the suspension or revocation.
32
Review of decisions
(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 21
not to issue a licence;
(b) a decision in respect of the
period throughout which the licence is to be in force under section 23;
(c) a decision to specify a licence
condition under subsection 24(4);
(ca) a decision to modify guidelines
under subsection 24(8) in respect of a licence;
(d) a decision to vary or refuse to
vary a licence under section 25;
(e) a decision to suspend or revoke a
licence under section 26.
(2) This section has effect subject to the Administrative
Appeals Tribunal Act 1975.
Part 3—Monitoring powers
33
Appointment of inspectors
(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.
34
Identity card
(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.
35
Powers available to inspectors for monitoring compliance
(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 36.
(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 21, and the entry is at a reasonable time; or
(c) the entry is made under a warrant
under section 37A.
36
Monitoring powers
(1) The monitoring powers that an inspector
may exercise under paragraph 35(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, other
embryo, human egg 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;
(g) in addition to the powers
mentioned in paragraphs (a) to (f), if the inspector was authorised to enter
the premises by a warrant under section 37A—to require any person in or on
the premises to:
(i) answer any questions
put by the inspector; and
(ii) produce any book,
record or document requested by the inspector.
(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.
37
Power to secure
If an inspector, during a search of
premises, believes on reasonable grounds that there is at the premises a human
embryo, another embryo, a human egg or a thing that may afford evidence of the
commission of an offence against this Act, the monitoring powers include
securing the embryo, the egg or the thing pending the obtaining of a warrant
(whether by the inspector or by another person) to seize it.
37A
Monitoring warrants
(1) An inspector may apply to a magistrate for
a warrant under this section in relation to premises.
(2) Subject to subsection (3), the
magistrate may issue the warrant if the magistrate is satisfied by information
on oath or affirmation that it is reasonably necessary that one or more
inspectors should have access to the premises for the purposes of finding out
whether this Act or the regulations have been complied with.
(3) The magistrate must not issue the warrant
unless the inspector or some other person has given to the magistrate, either
orally or by affidavit, such further information (if any) as the magistrate
requires concerning the grounds on which the issue of the warrant is being
sought.
(4) The warrant must:
(a) authorise one or more inspectors
(whether or not named in the warrant) with such assistance and by such force as
is necessary and reasonable:
(i) to enter the premises;
and
(ii) to exercise the powers
set out in section 36 in relation to the premises; and
(b) state whether the entry is
authorised to be made at any time of the day or night or during specified hours
of the day or night; and
(c) specify the day (not more than 15
days after the issue of the warrant) on which the warrant ceases to have
effect; and
(d) state the purpose for which the
warrant is issued.
37B
Details of warrant to be given to occupier etc.
(1) If a warrant under section 37A is
being executed and the occupier of the premises or another person who
apparently represents the occupier is present at the premises, the inspector
must make available to that person a copy of the warrant.
(2) The inspector must identify himself or
herself to that person.
(3) The copy of the warrant referred to in
subsection (1) need not include the signature of the magistrate who issued
the warrant.
37C
Announcement before entry
An inspector must, before entering
premises under a warrant:
(a) announce that he or she is
authorised to enter the premises; and
(b) give any person at the premises an
opportunity to allow entry to the premises.
37D
Occupier entitled to be present during search
(1) If a warrant under section 37A is
being executed and the occupier of the premises, or another person who
apparently represents the occupier is present at the premises, the person is
entitled to observe the search being conducted.
(2) The right to observe the search being
conducted ceases if the person impedes the search.
(3) This section does not prevent 2 or more
areas of the premises being searched at the same time.
38
Inspector must produce identity card on request
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.
39
Consent
(1) Before obtaining the consent of a person
for the purposes of paragraph 35(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.
40
Compensation for damage
(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.
41
Extended operation of Part
A reference in this Part to this Act
includes a reference to the Prohibition of Human Cloning Act 2002, and a
reference in this Part to the regulations includes a reference to regulations
made under the Prohibition of Human Cloning Act 2002.
Part 4—Commonwealth/State arrangements
42
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.
43
Conferral of functions on Commonwealth officers and bodies
(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.
44
When duty imposed
(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 43 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 43.
45
Review of certain decisions
(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.
Part 5—Sunset clause, review provision and regulations
Division 1—Repeal
46
Repeal of paragraphs 21(3)(b) and 24(1)(c) and subsection 24(3) [see Note 1]
Paragraphs 21(3)(b) and 24(1)(c) and
subsection 24(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.
Division 2—Review of Act
47
Review of operation of Act
(1) The CEO of 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 must be:
(a) undertaken by the persons who
undertake the Prohibition of Human Cloning Act review; and
(b) undertaken concurrently with the
Prohibition of Human Cloning Act review.
(3) The persons undertaking the review must
give to the Council of Australian Governments and both Houses of the Parliament
a written report of the review. The report must accompany the report of the
Prohibition of Human Cloning Act review.
(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 (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.
(7) In this section:
Prohibition of Human Cloning Act review means
the review mentioned in section 25 of the Prohibition of Human Cloning
Act 2002.
47A
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 must be:
(a) undertaken by the persons who
undertake the Prohibition of Human Cloning for Reproduction Act further review;
and
(b) undertaken concurrently with that
Prohibition of Human Cloning for Reproduction Act further review.
(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.
(7) In this section:
Prohibition of Human Cloning for Reproduction Act
further review means the review mentioned in section 25A of the Prohibition
of Human Cloning for Reproduction Act 2002.
47B
Minister to report to Parliament
(1) The Minister must prepare a report on the
following matters:
(a) the establishment of a National
Stem Cell Centre and a national register of donated excess ART embryos; and
(b) the making of guidelines referred
to in this Act, to the extent that those guidelines were not in force on the
day on which this Act commenced.
(2) The report must be completed not later
than 6 months after the day on which Prohibition of Human Cloning for
Reproduction and the Regulation of Human Embryo Research Amendment Act 2006
commenced.
(3) The Minister must cause a copy of the
report to be tabled in each House of the Parliament within 15 sitting days of
that House after the day on which the report was completed.
47C
Study of non-blood human tissue based therapies
(1) The Minister must cause to be prepared a
report on the feasibility of establishing a national legislative or regulatory
approach for effective governance of non-blood human tissue based therapies.
(2) The review must be undertaken by persons
chosen by the Minister with the agreement of each State.
(3) The report of the review must contain
recommendations for a national legislative or regulatory framework.
(4) The persons undertaking the review must
give to the Council of Australian Governments and both Houses of the Parliament
a written report of the review.
(5) The report must be completed not later
than 18 months after the day on which the Prohibition of Human Cloning for
Reproduction and the Regulation of Human Embryo Research Amendment Act 2006
receives the Royal Assent.
(6) The Minister must cause a copy of the
report to be tabled in each House of the Parliament within 15 sitting days of
that House after the day on which the report was completed.
Division 3—Regulations
48
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.