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This is a Bill, not an Act. For current law, see the Acts databases.
PARLIAMENT OF VICTORIA
Research Involving Human Embryos Bill 2008
TABLE OF PROVISIONS
Clause Page
PART 1-- PRELIMINARY 1
1 Purpose 1
2 Commencement 2
3 Definitions 2
4 Meaning of excess ART embryo 8
5 Act to bind the Crown 8
PART 2--OFFENCES 9
6 Offence--use of excess ART embryo 9
7 Offence--use of other embryos 10
8 Offence--certain activities involving use of human eggs 11
9 Offence--use of embryo that was created by fertilisation
and that is not an excess ART embryo 12
10 Offence--breaching a licence condition 12
11 Person not liable for conduct purportedly authorised 13
PART 3--LICENSING OF EMBRYO RESEARCH 14
Division 1--Embryo Research Licensing Committee of the
NHMRC 14
12 Functions of Committee 14
13 Powers of Committee 14
Division 2--Licensing system 14
14 Person may apply for licence 14
15 Determination of application by Committee 16
16 Notification of decision 17
17 Period of licence 17
18 Licence is subject to conditions 18
19 Variation of licence 20
20 Suspension or revocation of licence 20
21 Surrender of licence 21
22 Notification of variation, suspension or revocation of licence 21
561273B.I-9/9/2008 i BILL LA INTRODUCTION 9/9/2008
Clause Page
Division 3--Reporting and confidentiality 21
23 NHMRC Licensing Committee to make certain information
publicly available 21
24 Confidential commercial information may only be disclosed
in certain circumstances 22
Division 4--Review provisions 24
25 Meaning of terms 24
26 Review of decisions 25
PART 4--MONITORING POWERS 26
27 Powers available to inspectors for monitoring compliance 27
28 Monitoring powers 27
29 Power to secure 29
30 Monitoring warrants 29
31 Details of warrant to be given to occupier etc. 31
32 Announcement before entry 31
33 Occupier entitled to be present during search 31
34 Inspector must produce identity card on request 32
35 Consent 32
36 Compensation for damage 32
37 Extended operation of this Part 33
PART 5--GENERAL 34
38 Regulations 34
PART 6--TRANSITIONAL PROVISIONS AND
CONSEQUENTIAL AMENDMENT TO OTHER ACTS 35
Division 1--Transitional provisions 35
39 Definitions 35
40 Superseded references 35
41 Existing applications for licences 35
42 Existing licences 35
43 Offences 36
44 Consent 36
45 Donations 36
Division 2--Consequential amendment 37
46 Consequential amendment to the Magistrates' Court Act 1989 37
ENDNOTES 38
561273B.I-9/9/2008 ii BILL LA INTRODUCTION 9/9/2008
PARLIAMENT OF VICTORIA
Introduced in the Assembly
Research Involving Human Embryos
Bill 2008
A Bill for an Act to regulate certain activities involving the use of
human embryos, and for related purposes.
The Parliament of Victoria enacts:
PART 1-- PRELIMINARY
1 Purpose
The purpose of this Act is to address concerns,
including ethical concerns, about scientific
5 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.
561273B.I-9/9/2008 1 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 1-- Preliminary
s. 2
2 Commencement
(1) This Act comes into operation on a day to be
proclaimed.
(2) If this Act does not come into operation before
5 1 January 2010, it comes into operation on that
day.
3 Definitions
(1) In this Act--
accredited ART centre means a person or body
10 accredited to carry out assisted reproductive
technology by--
(a) the Reproductive Technology
Accreditation Committee of the
Fertility Society of Australia; or
15 (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
20 requires;
AHEC means the Australian Health Ethics
Committee established by the National
Health and Medical Research Council Act
1992 of the Commonwealth;
25 animal does not include a human;
assisted reproductive treatment has the meaning
it has in the Assisted Reproductive
Treatment Act 2008;
Authority means the Victorian Assisted
30 Reproductive Treatment Authority
established under Part 9 of the Assisted
Reproductive Treatment Act 2008;
561273B.I-9/9/2008 2 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 1-- Preliminary
s. 3
Commonwealth Act means the Research
Involving Human Embryos Act 2002 of the
Commonwealth;
Commonwealth Authority means the following--
5 (a) a body corporate established for a
public purpose by or under a
Commonwealth Act;
(b) a company in which a controlling
interest is held by any one of the
10 following persons together, or by two
or more of the following persons
together--
(i) the Commonwealth;
(ii) a body covered by paragraph (a);
15 (iii) a body covered by either
subparagraph (i) or (ii);
confidential commercial information means
information that has a commercial or other
value that would be, or could reasonably be
20 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
25 section 4;
HREC means a Human Research Ethics
Committee;
human embryo means a discrete entity that has
arisen from either--
30 (a) the first mitotic division when
fertilisation of a human oocyte by a
human sperm is complete; or
561273B.I-9/9/2008 3 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 1-- Preliminary
s. 3
(b) any other process that initiates
organised development of a biological
entity with a human nuclear genome
that has the potential to develop up to,
5 or beyond, the stage at which the
primitive streak appears--
and has not yet reached 8 weeks of
development since the first mitotic division;
human sperm includes human spermatids;
10 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
15 (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
20 a hybrid embryo;
inspector means a person appointed under
section 33(1) of the Commonwealth Act;
licence means a licence issued under section 15;
NHMRC Licensing Committee means the
25 Committee established by section 13 of the
Commonwealth Act;
oocyte means an ovum from a woman;
partner, in relation to a person, means--
(a) the person's spouse; or
30 (b) another person who lives with the first
person as a couple on a genuine
domestic basis, irrespective of gender;
561273B.I-9/9/2008 4 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 1-- Preliminary
s. 3
precursor cell means a cell that has the potential
to develop into a human egg or human
sperm;
proper consent, in relation to the use of an excess
5 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 Chief Executive Officer of the
NHMRC under the National Health and
10 Medical Research Council Act 1992 of the
Commonwealth and prescribed by the
regulations under the Commonwealth Act for
the purposes of the definition of proper
consent in section 8 of that Act;
15 research includes an experimental procedure or
clinical trial;
responsible person means--
(a) in relation to an excess ART embryo--
(i) each person who provided the egg
20 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
25 (iii) any person who was the partner of
a person mentioned in
subparagraph (i) at the time the
egg or sperm mentioned in that
paragraph was provided; and
30 (iv) any person who was the partner of
the woman mentioned in
subparagraph (ii) at the time the
embryo was created; or
561273B.I-9/9/2008 5 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 1-- Preliminary
s. 3
(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
5 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;
10 sperm means sperm from a man;
spouse, in relation to a person, means the person's
husband or wife;
store means--
(a) to freeze an oocyte, embryo or sperm;
15 or
(b) to otherwise preserve an oocyte,
embryo or sperm by a prescribed
method;
the NHMRC means the National Health and
20 Medical Research Council established by the
National Health and Medical Research
Council Act 1992 of the Commonwealth;
unsuitable for implantation, in relation to a
human embryo, means a human embryo
25 that--
(a) is diagnosed by pre-implantation
genetic diagnosis as unsuitable for
implantation, in accordance with the
Ethical Guidelines on the Use of
30 Assisted Reproductive Technology in
Clinical Practice and Research (2007),
issued by the Chief Executive Officer
of the NHMRC; or
561273B.I-9/9/2008 6 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 1-- Preliminary
s. 3
(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
5 Chief Executive Officer of the
NHMRC under the National Health and
Medical Research Council Act 1992 of
the Commonwealth and prescribed by
the regulations under the
10 Commonwealth Act for the purposes of
paragraph (b) of the definition of
unsuitable for implantation in
section 7(1) of that Act;
use includes develop, or development, as the case
15 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
20 embryo, any period when the development of the
embryo is suspended is to be disregarded.
(3) In this Act, a reference to an embryo is a reference
to a human embryo, unless the contrary intention
appears.
25 (4) A reference in this Act to an embryo (including a
human embryo) is a reference to a living embryo.
(5) A reference in this Act to a human egg is a
reference to a human oocyte.
(6) A reference in this Act to a human embryo does
30 not include a reference to--
(a) a hybrid embryo; or
(b) a human embryonic stem cell line.
561273B.I-9/9/2008 7 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 1-- Preliminary
s. 4
4 Meaning of excess ART embryo
(1) In this Act--
excess ART embryo means a human embryo
that--
5 (a) was created, by assisted reproductive
technology, for use in the assisted
reproductive treatment of a woman; and
(b) is excess to the needs of--
(i) the woman for whom it was
10 created; and
(ii) her partner (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
15 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
20 reproductive 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
25 the determination is in force at that time.
5 Act to bind the Crown
(1) This Act binds the Crown, not only in right of the
State of Victoria, but also, so far as the legislative
power of the Parliament permits, the Crown in all
30 its other capacities.
(2) Nothing in this Act renders the Crown liable to be
prosecuted for an offence.
__________________
561273B.I-9/9/2008 8 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 2--Offences
s. 6
PART 2--OFFENCES
6 Offence--use of excess ART embryo
(1) A person commits an offence if the person
intentionally uses an excess ART embryo,
5 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 (3).
10 (2) An offence against subsection (1) is an indictable
offence punishable by imprisonment for a term
not exceeding 5 years.
(3) A use of an excess ART embryo by a person is an
exempt use for the purposes of subsection (1) if--
15 (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
20 (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
25 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
30 only on the basis of its biological
fitness for implantation; and
561273B.I-9/9/2008 9 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 2--Offences
s. 7
(ii) the use forms part of diagnostic
investigations conducted in connection
with the assisted reproductive treatment
of the woman for whom the excess
5 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
10 created; or
(f) the use is of a kind prescribed by the
regulations for the purposes of this
paragraph.
(4) Despite section 130(1) of the Magistrates' Court
15 Act 1989, a defendant does not bear a burden of
presenting or pointing to evidence in accordance
with that section in relation to any matter in
subsection (1) or (3) of this section.
(5) In subsection (3)--
20 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
25 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.
30 7 Offence--use of other embryos
(1) A person commits an offence if--
(a) the person intentionally uses an embryo; and
561273B.I-9/9/2008 10 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 2--Offences
s. 8
(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
5 (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
10 (iii) a human embryo created using
precursor cells taken from a human
embryo or a human foetus; or
(iv) a hybrid embryo; and
(c) the use by the person is not authorised by a
15 licence.
(2) An offence against subsection (1) is an indictable
offence punishable by imprisonment for a term
not exceeding 5 years.
Note
20 The creation or development of embryos mentioned in this section
is prohibited under the Prohibition of Human Cloning for
Reproduction Act 2008, unless authorised by a licence under this
Act.
8 Offence--certain activities involving use of human
25 eggs
(1) 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
30 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.
561273B.I-9/9/2008 11 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 2--Offences
s. 9
(2) An offence against subsection (1) is an indictable
offence punishable by imprisonment for a term
not exceeding 5 years.
9 Offence--use of embryo that was created by
5 fertilisation and that is not an excess ART embryo
(1) 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
10 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 treatment of a woman
carried out by an accredited ART centre, and
15 the person knows or is reckless as to that
fact.
(2) An offence against subsection (1) is an indictable
offence punishable by imprisonment for a term
not exceeding 5 years.
20 10 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
25 conduct contravenes a condition of such a licence.
(2) An offence against subsection (1) is an indictable
offence punishable by imprisonment for a term
not exceeding 5 years.
(3) In this section--
30 engage in conduct means--
(a) do an act; or
(b) omit to perform an act.
561273B.I-9/9/2008 12 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 2--Offences
s. 11
11 Person not liable for conduct purportedly
authorised
(1) To avoid doubt, a person is not criminally
responsible for an offence against this Act in
5 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
10 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--
15 licence includes a purported licence.
__________________
561273B.I-9/9/2008 13 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 3--Licensing of Embryo Research
s. 12
PART 3--LICENSING OF EMBRYO RESEARCH
Division 1--Embryo Research Licensing Committee of the
NHMRC
12 Functions of Committee
5 The functions of the NHMRC Licensing
Committee under this Act are--
(a) to perform functions in relation to licences
under Division 2; and
(b) to perform functions in relation to databases
10 under Division 3; and
(c) to perform such other functions as are
conferred on it by this Act or any other law.
13 Powers of Committee
The NHMRC Licensing Committee has power to
15 do all things necessary or convenient to be done
for or in connection with the performance of its
functions under this Act.
Division 2--Licensing system
14 Person may apply for licence
20 (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
25 fertilisation of a human egg by a human
sperm, and use of such embryos;
561273B.I-9/9/2008 14 BILL LA INTRODUCTION 9/9/2008
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Part 3--Licensing of Embryo Research
s. 14
(c) creation of human embryos other than by
fertilisation of a human egg by a human
sperm that contains genetic material
provided by more than 2 persons, and use of
5 such embryos;
(d) creation of human embryos using precursor
cells from a human embryo or a human
foetus, and use of such embryos;
(e) research and training involving the
10 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;
15 (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
20 testing sperm quality; and
(ii) the creation or use will occur in an
accredited ART centre.
(2) To avoid doubt, subsection (1)(a), (b), (c) and (d)
do not permit the NHMRC Licensing Committee
25 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.
30 (3) 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)
35 prescribed by the regulations.
561273B.I-9/9/2008 15 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 3--Licensing of Embryo Research
s. 15
15 Determination of application by Committee
(1) This section applies if a person has made an
application under section 14 for a licence.
(2) The NHMRC Licensing Committee must decide,
5 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--
10 (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; and
15 (ii) to enable compliance with any
restrictions on such consent;
(b) that the activity or project proposed in the
application has been assessed and approved
by a HREC that is constituted in accordance
20 with, and acting in compliance with, the
NHMRC National Statement on Ethical
Conduct in Human Research (2007), as in
force from time to time.
(4) In deciding whether to issue the licence, the
25 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
30 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
35 ART embryos or human eggs, or the creation
561273B.I-9/9/2008 16 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 3--Licensing of Embryo Research
s. 16
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
5 guidelines, issued by the NHMRC under the
National Health and Medical Research
Council Act 1992 of the Commonwealth and
prescribed by the regulations under the
Commonwealth Act for the purposes of
10 section 21(4)(c) of that Act;
(d) the HREC assessment of the application
mentioned in subsection (3)(b);
(e) such additional matters (if any) as are
prescribed by the regulations.
15 16 Notification of decision
(1) The NHMRC Licensing Committee must notify
its decision on an application for a licence under
section 15 to the following--
(a) the applicant;
20 (b) the HREC that assessed and approved the
activity or project proposed in the
application as mentioned in section 15(3)(b);
(c) the Authority.
(2) If the NHMRC Licensing Committee decides to
25 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 subsection (1)(b)
and (c).
17 Period of licence
30 (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
561273B.I-9/9/2008 17 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 3--Licensing of Embryo Research
s. 18
(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
5 suspension.
18 Licence is subject to conditions
(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
10 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
15 (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.
20 (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.
25 (3) A licence is subject to such other conditions as are
specified in the licence.
(4) The conditions specified in the licence may
include, but are not limited to, conditions relating
to the following--
30 (a) the persons authorised by the licence to use
excess ART embryos or human eggs, or
create or use other embryos;
561273B.I-9/9/2008 18 BILL LA INTRODUCTION 9/9/2008
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Part 3--Licensing of Embryo Research
s. 18
(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
5 licence;
(c) reporting;
(d) monitoring;
(e) information to be given by the licence holder
to persons authorised by the licence to use
10 excess ART embryos or human eggs, or to
create or use other embryos.
(5) 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
15 human eggs, or to create or use other embryos.
(6) Licence conditions specified in the licence apply
to--
(a) the licence holder; and
(b) such other persons authorised by the licence
20 to use excess ART embryos or human eggs,
or to create or use other embryos, as are
specified in the licence.
(7) For the purposes of applying the condition
referred to in subsection (1)(a)--
25 (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;
30 and
561273B.I-9/9/2008 19 BILL LA INTRODUCTION 9/9/2008
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Part 3--Licensing of Embryo Research
s. 19
(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.
5 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.
10 19 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.
15 (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
20 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 14 for the licence as varied, the
25 Committee would not have been permitted by this
Act to issue the licence.
20 Suspension or revocation of licence
(1) The NHMRC Licensing Committee may, by
notice in writing given to the licence holder,
30 suspend or revoke a licence if the Committee
believes on reasonable grounds that a condition of
the licence has been breached.
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Part 3--Licensing of Embryo Research
s. 21
(2) If a licence holder is convicted of an offence
under this Act or the Prohibition of Human
Cloning for Reproduction Act 2008 or under the
Commonwealth Act or the Prohibition of Human
5 Cloning Act 2002 of the Commonwealth, the
NHMRC Licensing Committee must, by notice in
writing given to the licence holder, revoke each
licence held by the licence holder.
21 Surrender of licence
10 A licence holder may surrender a licence by
written notice given to the NHMRC Licensing
Committee.
22 Notification of variation, suspension or revocation of
licence
15 (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
20 (c) the Authority.
(2) The NHMRC Licensing Committee must also
notify the HREC and the Authority if a licence is
surrendered.
Division 3--Reporting and confidentiality
25 23 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
30 varied)--
(a) the name of the person to whom the licence
was issued;
561273B.I-9/9/2008 21 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 3--Licensing of Embryo Research
s. 24
(b) a short statement about the nature of the uses
of excess ART embryos or human eggs, and
creations or uses of any other embryos, that
are authorised by the licence;
5 (c) any conditions to which the licence is
subject;
(d) the number of excess ART embryos or
human eggs authorised to be used under the
licence, or the number of other embryos
10 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.
15 (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
20 information.
24 Confidential commercial information may only be
disclosed in certain circumstances
(1) A person commits an offence if--
(a) the person discloses confidential commercial
25 information that the person has only because
of performing duties or functions under this
Act or the Commonwealth Act; and
(b) the person knows that the information is
confidential commercial information; and
30 (c) the disclosure is not--
(i) to a State agency, the Commonwealth
or a Commonwealth authority in the
course of carrying out duties or
561273B.I-9/9/2008 22 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 3--Licensing of Embryo Research
s. 24
functions under this Act or the
Commonwealth Act; or
(ii) by order of a court; or
(iii) with the consent of each person to
5 whom the information has a
commercial or other value.
(2) A person commits an offence if--
(a) the person discloses confidential commercial
information that the person has only because
10 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--
15 (i) to a State agency, the Commonwealth
or a Commonwealth authority in the
course of carrying out duties or
functions under this Act or the
Commonwealth Act; or
20 (ii) by order of a court; or
(iii) with the consent of each person to
whom the information has a
commercial or other value.
(3) An offence against subsection (1) or (2) is
25 punishable by imprisonment for a term not
exceeding 2 years.
(4) In this section--
court includes a tribunal, authority or person
having power to require the production of
30 documents or the answering of questions;
561273B.I-9/9/2008 23 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 3--Licensing of Embryo Research
s. 25
State agency means the following--
(a) the Crown in right of the State;
(b) a Minister of the State;
(c) a State Government department;
5 (d) the Authority or any other
instrumentality of the State, including a
body corporate established for a public
purpose by or under a law of the State;
(e) a company in which a controlling
10 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 the State;
(ii) a person or body covered by
15 paragraph (b) or (d);
(iii) a person or body covered by either
subparagraph (i) or (ii).
Note
For the definition of confidential commercial information, see
20 section 3.
Division 4--Review provisions
25 Meaning of terms
In this Division--
Administrative Appeals Tribunal means the
25 Administrative Appeals Tribunal established
by the Administrative Appeals Tribunal Act
1975 of the Commonwealth;
decision has the same meaning as in the
Administrative Appeals Tribunal Act 1975
30 of the Commonwealth;
561273B.I-9/9/2008 24 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 3--Licensing of Embryo Research
s. 26
eligible person, in relation to a decision of the
NHMRC Licensing Committee, means--
(a) in relation to a decision under
section 15 not to issue a licence--the
5 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 17--the
licence holder; or
10 (c) in relation to a decision to specify a
licence condition under section 18(4)--
the licence holder; or
(d) in relation to a decision to modify
guidelines under section 18(7) in
15 respect of a licence--the licence
holder; or
(e) in relation to a decision to vary or
refuse to vary a licence under
section 19--the licence holder; or
20 (f) in relation to a decision to suspend or
revoke a licence under section 20--the
person who was the licence holder
immediately before the suspension or
revocation.
25 26 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--
30 (a) a decision under section 15 not to issue a
licence;
(b) a decision in respect of the period throughout
which the licence is to be in force under
section 17;
561273B.I-9/9/2008 25 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 3--Licensing of Embryo Research
s. 26
(c) a decision to specify a licence condition
under section 18(4);
(d) a decision to modify guidelines under
section 18(7) in respect of a licence;
5 (e) a decision to vary or refuse to vary a licence
under section 19;
(f) a decision to suspend or revoke a licence
under section 20.
(2) This section has effect subject to the
10 Administrative Appeals Tribunal Act 1975 of the
Commonwealth.
__________________
561273B.I-9/9/2008 26 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 4--Monitoring Powers
s. 27
PART 4--MONITORING POWERS
27 Powers available to inspectors for monitoring
compliance
(1) For the purpose of finding out whether this Act or
5 the regulations made for the purposes of this Act
have been complied with, an inspector may--
(a) enter any premises; and
(b) exercise the monitoring powers set out in
section 28.
10 (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
15 occupier of the premises is carrying out
activities authorised by a licence issued
under section 15, and the entry is at a
reasonable time; or
(c) the entry is made under a warrant under
20 section 30.
28 Monitoring powers
(1) The monitoring powers that an inspector may
exercise under section 27(1)(b) are as follows--
(a) to search the premises and any thing on the
25 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;
30 (c) to take photographs, make video or audio
recordings or make sketches of the premises
or any thing on the premises;
561273B.I-9/9/2008 27 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 4--Monitoring Powers
s. 28
(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;
5 (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
10 paragraphs (a) to (f), if the inspector was
authorised to enter the premises by a warrant
under section 30--to require any person in or
on the premises to--
(i) answer any questions put by the
15 inspector; and
(ii) produce any book, record or document
requested by the inspector.
(2) For the purposes of this Act, monitoring powers
include the power to operate equipment at
20 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
25 associated with it--
contains information that is relevant to
determining whether there has been compliance
with this Act or the regulations made for the
purposes of this Act.
561273B.I-9/9/2008 28 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 4--Monitoring Powers
s. 29
(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),
5 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
10 (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
15 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.
20 29 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
25 the commission of an offence against this Part, the
monitoring powers include securing the embryo,
the egg or thing pending the obtaining of a
warrant (whether by the inspector or by another
person) to seize it.
30 30 Monitoring warrants
(1) An inspector may apply to a magistrate for the
issue of a warrant under this section in relation to
premises.
561273B.I-9/9/2008 29 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 4--Monitoring Powers
s. 30
(2) Subject to subsection (3), the magistrate may issue
the warrant if the magistrate is satisfied by
evidence on oath, whether oral or by affidavit, that
it is reasonably necessary that one or more
5 inspectors should have access to the premises for
the purposes of finding out whether this Act or the
regulations made for the purposes of this Act have
been complied with.
(3) The magistrate must not issue the warrant unless
10 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.
15 (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--
20 (i) to enter the premises; and
(ii) to exercise the powers set out in
section 28 in relation to the premises;
and
(b) state whether the entry is authorised to be
25 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
30 warrant ceases to have effect; and
(d) state the purpose for which the warrant is
issued.
561273B.I-9/9/2008 30 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 4--Monitoring Powers
s. 31
(5) Except as provided by this Act, the rules to be
observed with respect to search warrants under the
Magistrates' Court Act 1989 extend and apply to
warrants under this section.
5 31 Details of warrant to be given to occupier etc.
(1) If a warrant under section 30 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
10 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
15 the magistrate who issued the warrant.
32 Announcement before entry
An inspector must, before entering premises under
a warrant--
(a) announce that he or she is authorised to enter
20 the premises; and
(b) give any person at the premises an
opportunity to allow entry to the premises.
33 Occupier entitled to be present during search
(1) If a warrant under section 30 is being executed
25 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
30 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.
561273B.I-9/9/2008 31 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 4--Monitoring Powers
s. 34
34 Inspector must produce identity card on request
(1) An inspector is not entitled to exercise any powers
under this Act in relation to premises if--
(a) the occupier of the premises has required the
5 inspector to produce his or her identity card
for inspection by the occupier; and
(b) the inspector fails to comply with the
requirement.
(2) In this section identity card means identity card
10 issued under section 34(1) of the Commonwealth
Act.
35 Consent
(1) Before obtaining the consent of a person for the
purposes of section 27(2)(a), the inspector must
15 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.
20 36 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
25 other facilities as a result of it being operated
by an inspector as mentioned in this Act; and
(b) the damage was caused as a result of
insufficient care being exercised by the
inspector operating the equipment or other
30 facilities.
(2) Compensation is payable by the NHMRC
Licensing Committee.
561273B.I-9/9/2008 32 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 4--Monitoring Powers
s. 37
(3) In determining the amount of compensation
payable, regard is to be had to whether the
occupier of the premises and the occupier's
employees and agents, if they were available at
5 the time, had provided any warning or guidance as
to the operation of the equipment or other
facilities that was appropriate in the
circumstances.
37 Extended operation of this Part
10 A reference in this Part to this Act includes a
reference to the Prohibition of Human Cloning
for Reproduction Act 2008, and a reference in
this Part to the regulations includes a reference to
the regulations made under the Prohibition of
15 Human Cloning for Reproduction Act 2008.
__________________
561273B.I-9/9/2008 33 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 5--General
s. 38
PART 5--GENERAL
38 Regulations
The Governor in Council may make regulations
prescribing matters--
5 (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.
__________________
561273B.I-9/9/2008 34 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 6--Transitional Provisions and Consequential Amendment to Other Acts
s. 39
PART 6--TRANSITIONAL PROVISIONS AND
CONSEQUENTIAL AMENDMENT TO OTHER ACTS
Division 1--Transitional provisions
39 Definitions
5 In this Division--
commencement means the commencement of this
Act;
repealed Act means the Infertility Treatment
Act 1995.
10 40 Superseded references
On and from the commencement, a reference in an
Act (other than this Act) or a document to Part 2A
of the repealed Act is taken, if the context permits,
to be a reference to this Act.
15 41 Existing applications for licences
(1) This section applies if--
(a) before the commencement a person had
applied for a licence under section 21H of
the repealed Act; and
20 (b) immediately before the commencement, the
NHMRC Licensing Committee had not
decided the application.
(2) On and from the commencement, the application
is to be decided under this Act as if it had been
25 made after the commencement.
42 Existing licences
(1) This section applies to a licence issued under
section 21I of the repealed Act that was in force
immediately before the commencement.
561273B.I-9/9/2008 35 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 6--Transitional Provisions and Consequential Amendment to Other Acts
s. 43
(2) On and from the commencement, the licence
continues in force, on the terms and conditions
that applied to the licence immediately before the
commencement, as if it were a licence issued
5 under this Act.
43 Offences
If, immediately before the commencement,
proceedings for an offence against Part 2A of the
repealed Act had started but had not yet been
10 determined, the proceedings may continue under
the repealed Act as if that Act had not been
repealed.
44 Consent
(1) This section applies if--
15 (a) under the repealed Act a person had
consented to the use of human sperm, an
oocyte or a human embryo for research
purposes; and
(b) immediately before the commencement, the
20 consent had not been withdrawn or lapsed.
(2) On and from the commencement, the consent is
taken to be a consent given for the purposes of
this Act.
45 Donations
25 (1) This section applies, if immediately before the
commencement, human sperm, an oocyte or a
human embryo donated for the purposes of
research under the repealed Act has not been used
for that purpose.
30 (2) On and from the commencement, the sperm,
oocyte or embryo is taken to have been donated
for the purposes of research under this Act.
561273B.I-9/9/2008 36 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Part 6--Transitional Provisions and Consequential Amendment to Other Acts
s. 46
Division 2--Consequential amendment
46 Consequential amendment to the Magistrates'
Court Act 1989
In Schedule 4 to the Magistrates' Court Act See:
Act No.
5 1989, after item 62 insert-- 51/1989.
Reprint No. 13
"62A Research Involving Human Embryos Act as at
15 August
2008 2007
and
Indictable offences under the Research amending
Involving Human Embryos Act 2008.". Act Nos
77/2004,
62/2005,
51/2006,
50/2007,
52/2007,
53/2007,
8/2008,
12/2008,
18/2008,
23/2008 and
34/2008.
LawToday:
www.
legislation.
vic.gov.au
561273B.I-9/9/2008 37 BILL LA INTRODUCTION 9/9/2008
Research Involving Human Embryos Bill 2008
Endnotes
ENDNOTES
By Authority. Government Printer for the State of Victoria.
561273B.I-9/9/2008 38 BILL LA INTRODUCTION 9/9/2008
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