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This is a Bill, not an Act. For current law, see the Acts databases.
2019-2020-2021
The Parliament of the
Commonwealth of Australia
HOUSE OF REPRESENTATIVES
Presented and read a first time
Mitochondrial Donation Law Reform
(Maeve's Law) Bill 2021
No. , 2021
(Health)
A Bill for an Act to amend the law relating to
human cloning and research involving human
embryos, and for related purposes
No. , 2021
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
i
Contents
1
Short title ........................................................................................... 1
2
Commencement ................................................................................. 1
3
Schedules ........................................................................................... 2
Schedule 1--Mitochondrial donation
3
Part 1--Main amendments
3
Prohibition of Human Cloning for Reproduction Act 2002
3
Research Involving Human Embryos Act 2002
5
Research Involving Human Embryos Regulations 2017
33
Part 2--Other amendments
39
Freedom of Information Act 1982
39
Prohibition of Human Cloning for Reproduction Act 2002
39
Research Involving Human Embryos Act 2002
41
Research Involving Human Embryos Regulations 2017
57
Therapeutic Goods (Excluded Goods) Determination 2018
58
Part 3--Application and transitional provisions
60
No. , 2021
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
1
A Bill for an Act to amend the law relating to
1
human cloning and research involving human
2
embryos, and for related purposes
3
The Parliament of Australia enacts:
4
1 Short title
5
This Act is the
Mitochondrial Donation Law Reform (Maeve's
6
Law) Act 2021
.
7
2 Commencement
8
(1) Each provision of this Act specified in column 1 of the table
9
commences, or is taken to have commenced, in accordance with
10
column 2 of the table. Any other statement in column 2 has effect
11
according to its terms.
12
2
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
No. , 2021
1
Commencement information
Column 1
Column 2
Column 3
Provisions
Commencement
Date/Details
1. Sections 1 to 3
and anything in
this Act not
elsewhere covered
by this table
The day this Act receives the Royal Assent.
2. Schedule 1
A single day to be fixed by Proclamation.
However, if the provisions do not commence
within the period of 6 months beginning on
the day this Act receives the Royal Assent,
they commence on the day after the end of
that period.
Note:
This table relates only to the provisions of this Act as originally
2
enacted. It will not be amended to deal with any later amendments of
3
this Act.
4
(2) Any information in column 3 of the table is not part of this Act.
5
Information may be inserted in this column, or information in it
6
may be edited, in any published version of this Act.
7
3 Schedules
8
Legislation that is specified in a Schedule to this Act is amended or
9
repealed as set out in the applicable items in the Schedule
10
concerned, and any other item in a Schedule to this Act has effect
11
according to its terms.
12
Note:
The provisions of a legislative instrument (the
principal instrument
)
13
amended or inserted by this Act, and any other provisions of the
14
principal instrument, may be amended or repealed by a legislative
15
instrument made under the enabling provision for the principal
16
instrument (see subsection 13(5) of the
Legislation Act 2003
).
17
Mitochondrial donation
Schedule 1
Main amendments
Part 1
No. , 2021
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
3
Schedule 1--Mitochondrial donation
1
Part 1--Main amendments
2
Prohibition of Human Cloning for Reproduction Act 2002
3
1 Subsection 8(1)
4
Insert:
5
general licence
has the same meaning as in Part 2 of the
Research
6
Involving Human Embryos Act 2002
.
7
mitochondrial donation licence
means any of the following
8
licences issued under section 28J of the
Research Involving Human
9
Embryos Act 2002
:
10
(a) a pre-clinical research and training licence;
11
(b) a clinical trial research and training licence;
12
(c) a clinical trial licence;
13
(d) a clinical practice research and training licence;
14
(e) a clinical practice licence.
15
mitochondrial donation technique
has the same meaning as in
16
Part 2 of the
Research Involving Human Embryos Act 2002
.
17
2 Section 12 (at the end of the heading)
18
Add "
or the purposes of a mitochondrial donation licence
".
19
3 Subsection 12(1)
20
Omit all of the words after "body of a woman," (not including the
21
penalty), substitute:
22
unless either or both of the following apply:
23
(a) the person's intention in creating the embryo is to attempt to
24
achieve pregnancy in a particular woman;
25
(b) the creation of the embryo by the person is permitted under
26
section 28B of the
Research Involving Human Embryos Act
27
2002
(carrying out activities authorised by mitochondrial
28
donation licences).
29
Schedule 1
Mitochondrial donation
Part 1
Main amendments
4
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
No. , 2021
4 After paragraph 13(b)
1
Insert:
2
; and (c) the creation or development of the human embryo by the
3
person is not permitted under section 28B of the
Research
4
Involving Human Embryos Act 2002
(carrying out activities
5
authorised by mitochondrial donation licences).
6
5 After paragraph 15(1)(b)
7
Insert:
8
; and (c) the alteration of the genome by the person is not permitted
9
under section 28B of the
Research Involving Human
10
Embryos Act 2002
(carrying out activities authorised by
11
mitochondrial donation licences).
12
6 At the end of subsection 20(3) (before the penalty)
13
Add:
14
, unless:
15
(a) the embryo is a prohibited embryo under paragraph (a), (c) or
16
(f) of the definition of that expression in subsection (4); and
17
(b) the placement of the embryo by the person is permitted under
18
section 28B of the
Research Involving Human Embryos Act
19
2002
(carrying out activities authorised by mitochondrial
20
donation licences).
21
7 At the end of section 20
22
Add:
23
(5) Despite subsection 13.3(3) of the
Criminal Code
, a defendant does
24
not bear an evidential burden in relation to any matter in
25
subsection (3) of this section.
26
8 Paragraphs 22(b) and 23(c)
27
Omit "a licence", substitute "a general licence or permitted under
28
section 28B of the
Research Involving Human Embryos Act 2002
29
(carrying out activities authorised by mitochondrial donation licences)".
30
Mitochondrial donation
Schedule 1
Main amendments
Part 1
No. , 2021
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
5
Research Involving Human Embryos Act 2002
1
9 Subsection 7(1)
2
Insert:
3
constitutional corporation
means a trading, foreign or financial
4
corporation within the meaning of paragraph 51(xx) of the
5
Constitution.
6
Secretary
means the Secretary of the Department.
7
10 Section 8
8
Insert:
9
clinical practice licence
means a licence referred to in section
10
28G.
11
clinical practice research and training licence
means a licence
12
referred to in section 28F.
13
clinical trial licence
means a licence referred to in section 28E.
14
clinical trial research and training licence
means a licence
15
referred to in section 28D.
16
donor
, in relation to a particular use of a mitochondrial donation
17
technique, has the meaning given by subsection 28R(2).
18
general licence
means a licence issued under section 21.
19
mitochondrial donation licence
means:
20
(a) a pre-clinical research and training licence; or
21
(b) a clinical trial research and training licence; or
22
(c) a clinical trial licence; or
23
(d) a clinical practice research and training licence; or
24
(e) a clinical practice licence.
25
mitochondrial donation technique
means a technique, prescribed
26
by the regulations for the purposes of this definition, that:
27
(a) can be used to minimise the risk of a woman's offspring
28
inheriting mitochondria from that woman that would
29
predispose the offspring to mitochondrial disease; and
30
Schedule 1
Mitochondrial donation
Part 1
Main amendments
6
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
No. , 2021
(b) involves using assisted reproductive technology to create a
1
zygote that:
2
(i) has nuclear DNA from the woman and a man; and
3
(ii) contains mitochondria from a different woman; and
4
(c) does not involve:
5
(i) intentionally modifying nuclear DNA or mitochondrial
6
DNA; or
7
(ii) using any cell, or any component part of a cell, of an
8
animal; or
9
(iii) creating a chimeric embryo (within the meaning of the
10
Prohibition of Human Cloning for Reproduction Act
11
2002
) or a hybrid embryo.
12
patient
means a woman whose pregnancy is sought to be achieved
13
using a mitochondrial donation technique under a clinical practice
14
licence.
15
Note:
For a human embryo to be created for, or placed in the body of, a
16
woman under a clinical practice licence, the NHMRC Licensing
17
Committee must be satisfied that there is a particular risk of the
18
woman's offspring inheriting mitochondria from the woman that
19
would predispose the offspring to mitochondrial disease: see
20
paragraph 28P(4)(a).
21
permitted technique
for a mitochondrial donation licence of a
22
particular kind means a mitochondrial donation technique that is
23
declared by the regulations to be a permitted technique for a
24
mitochondrial donation licence of that kind.
25
pre-clinical research and training licence
means a licence referred
26
to in section 28C.
27
trial participant
means a woman whose pregnancy is sought to be
28
achieved using a mitochondrial donation technique under a clinical
29
trial licence.
30
Note:
For a human embryo to be created for, or placed in the body of, a
31
woman under a clinical trial licence, the NHMRC Licensing
32
Committee must be satisfied that there is a particular risk of the
33
woman's offspring inheriting mitochondria from the woman that
34
would predispose the offspring to mitochondrial disease: see
35
paragraph 28P(4)(a).
36
Mitochondrial donation
Schedule 1
Main amendments
Part 1
No. , 2021
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
7
11 Paragraph 10(1)(a)
1
Repeal the paragraph, substitute:
2
(a) the excess ART embryo is created other than by using a
3
mitochondrial donation technique and the use of the embryo
4
by the person is authorised by a general licence; or
5
(aa) the excess ART embryo is created using a mitochondrial
6
donation technique and the use of the embryo by the person
7
is permitted under section 28B (carrying out activities
8
authorised by mitochondrial donation licences); or
9
12 Paragraph 10(2)(e)
10
Repeal the paragraph, substitute:
11
(e) the use is carried out by an accredited ART centre, and:
12
(i) the use is for the purposes of achieving pregnancy in a
13
woman other than the woman for whom the excess ART
14
embryo was created; and
15
(ii) the excess ART embryo was not created using a
16
mitochondrial donation technique as permitted under
17
section 28B (carrying out activities authorised by
18
mitochondrial donation licences); or
19
13 Paragraph 10A(c)
20
Omit "licence", substitute "general licence or, if subparagraph (b)(i) or
21
(ii) applies, permitted under section 28B (carrying out activities
22
authorised by mitochondrial donation licences)".
23
14 Paragraph 10B(b)
24
Repeal the paragraph, substitute:
25
(b) neither of the following apply:
26
(i) the person is authorised to undertake the research or
27
training by a general licence;
28
(ii) the person is permitted under section 28B to undertake
29
the research or training because of a pre-clinical
30
research and training licence, a clinical trial research
31
and training licence or a clinical practice research and
32
training licence.
33
Schedule 1
Mitochondrial donation
Part 1
Main amendments
8
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
No. , 2021
15 After paragraph 11(b)
1
Insert:
2
; and (c) the use by the person is not permitted under section 28B
3
(carrying out activities authorised by mitochondrial donation
4
licences).
5
16 After section 11
6
Insert:
7
11A Offence--use of material created under mitochondrial donation
8
licence
9
A person commits an offence if:
10
(a) the person intentionally uses any material (other than an
11
excess ART embryo) created, developed or produced under a
12
mitochondrial donation licence; and
13
(b) the use of the material by the person is not permitted under
14
section 28B (carrying out activities authorised by
15
mitochondrial donation licences).
16
Penalty: Imprisonment for 5 years.
17
17 After Division 4 of Part 2
18
Insert:
19
Division 4A--Mitochondrial donation licences
20
Subdivision A--Kinds of mitochondrial donation licences and
21
what they authorise
22
28A Kinds of mitochondrial donation licences
23
There are 5 kinds of mitochondrial donation licences, which are as
24
follows:
25
(a) pre-clinical research and training licences referred to in
26
section 28C;
27
(b) clinical trial research and training licences referred to in
28
section 28D;
29
(c) clinical trial licences referred to in section 28E;
30
Mitochondrial donation
Schedule 1
Main amendments
Part 1
No. , 2021
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
9
(d) clinical practice research and training licences referred to in
1
section 28F;
2
(e) clinical practice licences referred to in section 28G.
3
28B Carrying out activities authorised by mitochondrial donation
4
licences
5
(1) A person may carry out an activity as authorised by a pre-clinical
6
research and training licence, a clinical trial research and training
7
licence or a clinical trial licence (see section 28C, 28D or 28E) if:
8
(a) the licence is in force; and
9
(b) the licence holder is a constitutional corporation.
10
(2) Subsection (1) applies despite a law of a State.
11
(3) A person may carry out an activity as authorised by a clinical
12
practice research and training licence or a clinical practice licence
13
(see section 28F or 28G) in a particular State if:
14
(a) the licence is in force; and
15
(b) carrying out the activity is authorised by a law of that State.
16
28C What a pre-clinical research and training licence authorises
17
(1) A
pre-clinical research and training licence
authorises carrying
18
out any of the activities mentioned in subsection (2) that are
19
specified in the licence in undertaking research and training for the
20
purpose of doing all of the following:
21
(a) developing the permitted technique specified in the licence
22
for potential future use in a clinical setting as a way to
23
minimise the risk of women's offspring inheriting
24
mitochondria that would predispose them to mitochondrial
25
disease, but without the immediate aim of:
26
(i) conducting a clinical trial; or
27
(ii) using the technique in a clinical practice setting;
28
(b) better understanding the technique, including its safety and
29
efficacy in minimising the risk of women's offspring
30
inheriting mitochondria that would predispose them to
31
mitochondrial disease;
32
(c) building expertise in the technique and how to use it.
33
Schedule 1
Mitochondrial donation
Part 1
Main amendments
10
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
No. , 2021
(2) The activities are as follows:
1
(a) creation of human embryos other than by fertilisation of a
2
human egg by a human sperm, using the permitted technique
3
specified in the licence, and use of such embryos;
4
(b) creation of human embryos that contain genetic material
5
provided by more than 2 persons, using the permitted
6
technique specified in the licence:
7
(i) by fertilisation of a human egg by a human sperm
8
outside the body of a woman; or
9
(ii) other than by the fertilisation of a human egg by a
10
human sperm;
11
and use of such embryos;
12
(c) creation of human embryos by a process of the fertilisation of
13
a human egg by a human sperm outside the body of a
14
woman, using the permitted technique specified in the
15
licence, and use of such embryos;
16
(d) research and training involving the fertilisation of a human
17
egg by a human sperm up to, including and after the first
18
mitotic division, outside the body of a woman for the
19
purposes of research or training in the use of the permitted
20
technique specified in the licence;
21
(e) use of any material (other than an excess ART embryo)
22
created, developed or produced under a mitochondrial
23
donation licence.
24
(3) A pre-clinical research and training licence does not authorise any
25
use of a human embryo that would:
26
(a) result in the development of a human embryo for a period of
27
more than 14 days, excluding any period when development
28
is suspended; or
29
(b) involve placing a human embryo into the body of a woman
30
for the purposes of achieving pregnancy in that woman.
31
28D What a clinical trial research and training licence authorises
32
(1) A
clinical trial research and training licence
authorises carrying
33
out any of the activities mentioned in subsection (2) that are
34
specified in the licence, at an accredited ART centre, in
35
undertaking research and training for the purpose of doing all of
36
Mitochondrial donation
Schedule 1
Main amendments
Part 1
No. , 2021
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
11
the following in preparation for using the permitted technique
1
specified in the licence in a particular clinical trial:
2
(a) developing protocols for using the technique safely and
3
effectively, in a clinical trial setting, for the purpose of
4
minimising the risk of women's offspring inheriting
5
mitochondria that would predispose them to mitochondrial
6
disease;
7
(b) ensuring that each embryologist nominated under subsection
8
28H(5) has technical competence in the use of the technique
9
in accordance with those protocols;
10
(c) ensuring that the holder's facilities, equipment, processes and
11
protocols for using the technique are suitable for using the
12
technique in a clinical trial setting.
13
(2) The activities are as follows:
14
(a) creation of human embryos other than by fertilisation of a
15
human egg by a human sperm, using the permitted technique
16
specified in the licence, and use of such embryos;
17
(b) creation of human embryos that contain genetic material
18
provided by more than 2 persons, using the permitted
19
technique specified in the licence:
20
(i) by fertilisation of a human egg by a human sperm
21
outside the body of a woman; or
22
(ii) other than by the fertilisation of a human egg by a
23
human sperm;
24
and use of such embryos;
25
(c) creation of human embryos by a process of the fertilisation of
26
a human egg by a human sperm outside the body of a
27
woman, using the permitted technique specified in the
28
licence, and use of such embryos;
29
(d) research and training involving the fertilisation of a human
30
egg by a human sperm up to, including and after the first
31
mitotic division, outside the body of a woman for the
32
purposes of research or training in the use of the permitted
33
technique specified in the licence;
34
(e) use of any material (other than an excess ART embryo)
35
created, developed or produced under a mitochondrial
36
donation licence.
37
Schedule 1
Mitochondrial donation
Part 1
Main amendments
12
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
No. , 2021
(3) A clinical trial research and training licence does not authorise any
1
use of a human embryo that would:
2
(a) result in the development of a human embryo for a period of
3
more than 14 days, excluding any period when development
4
is suspended; or
5
(b) involve placing a human embryo into the body of a woman
6
for the purposes of achieving pregnancy in that woman.
7
28E What a clinical trial licence authorises
8
(1) A
clinical trial licence
authorises carrying out any of the activities
9
mentioned in subsection (2) that are specified in the licence, at an
10
accredited ART centre, for the purpose of doing both of the
11
following in conducting a clinical trial to determine whether the
12
permitted technique specified in the licence is sufficiently safe and
13
effective to use in a clinical practice setting:
14
(a) creating a human embryo for a trial participant, using the
15
permitted technique specified in the licence, with the
16
intention of minimising the risk of the embryo inheriting
17
mitochondria that would predispose any resulting child to
18
mitochondrial disease;
19
(b) placing the embryo in the body of the trial participant for the
20
purposes of achieving her pregnancy.
21
(2) The activities are as follows:
22
(a) creation of human embryos other than by fertilisation of a
23
human egg by a human sperm, using the permitted technique
24
specified in the licence, and use of such embryos;
25
(b) creation of human embryos that contain genetic material
26
provided by more than 2 persons, using the permitted
27
technique specified in the licence:
28
(i) by fertilisation of a human egg by a human sperm
29
outside the body of a woman; or
30
(ii) other than by the fertilisation of a human egg by a
31
human sperm;
32
and use of such embryos;
33
(c) alteration of the genome of a human cell (within the meaning
34
of section 15 of the
Prohibition of Human Cloning for
35
Reproduction Act 2002
) using the permitted technique
36
specified in the licence, in such a way that the alteration is
37
Mitochondrial donation
Schedule 1
Main amendments
Part 1
No. , 2021
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
13
heritable by descendants of the human whose cell was
1
altered;
2
(d) placement in the body of a woman of any of the following
3
kinds of human embryo created using the permitted
4
technique specified in the licence:
5
(i) a human embryo created by a process other than the
6
fertilisation of a human egg by human sperm;
7
(ii) a human embryo that contains genetic material provided
8
by more than 2 persons;
9
(iii) a human embryo that contains a human cell (within the
10
meaning of section 15 of the
Prohibition of Human
11
Cloning for Reproduction Act 2002
) whose genome has
12
been altered in such a way that the alteration is heritable
13
by descendants of the human whose cell was altered;
14
(e) use of any material (other than an excess ART embryo)
15
created, developed or produced under a mitochondrial
16
donation licence.
17
(3) A clinical trial licence does not authorise any use of a human
18
embryo that would result in the development of the embryo outside
19
the body of a woman for a period of more than 14 days, excluding
20
any period when development is suspended.
21
28F What a clinical practice research and training licence authorises
22
(1) A
clinical practice research and training licence
authorises
23
carrying out any of the activities mentioned in subsection (2) that
24
are specified in the licence, at an accredited ART centre, in
25
undertaking research and training for the purpose of doing all of
26
the following in preparation for using the permitted technique
27
specified in the licence in a clinical practice setting:
28
(a) developing protocols for using the technique safely and
29
effectively, in a clinical practice setting, for the purpose of
30
minimising the risk of women's offspring inheriting
31
mitochondria that would predispose them to mitochondrial
32
disease;
33
(b) ensuring that each embryologist nominated under subsection
34
28H(5) has technical competence in the use of the technique
35
in accordance with those protocols;
36
Schedule 1
Mitochondrial donation
Part 1
Main amendments
14
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
No. , 2021
(c) ensuring that the holder's facilities, equipment, processes and
1
protocols for using the technique are suitable for using the
2
technique in a clinical practice setting.
3
(2) The activities are as follows:
4
(a) creation of human embryos other than by fertilisation of a
5
human egg by a human sperm, using the permitted technique
6
specified in the licence, and use of such embryos;
7
(b) creation of human embryos that contain genetic material
8
provided by more than 2 persons, using the permitted
9
technique specified in the licence:
10
(i) by fertilisation of a human egg by a human sperm
11
outside the body of a woman; or
12
(ii) other than by the fertilisation of a human egg by a
13
human sperm;
14
and use of such embryos;
15
(c) creation of human embryos by a process of the fertilisation of
16
a human egg by a human sperm outside the body of a
17
woman, using the permitted technique specified in the
18
licence, and use of such embryos;
19
(d) research and training involving the fertilisation of a human
20
egg by a human sperm up to, including and after the first
21
mitotic division, outside the body of a woman for the
22
purposes of research or training in the use of the permitted
23
technique specified in the licence;
24
(e) use of any material (other than an excess ART embryo)
25
created, developed or produced under a mitochondrial
26
donation licence.
27
(3) A clinical practice research and training licence does not authorise
28
any use of a human embryo that would:
29
(a) result in the development of a human embryo for a period of
30
more than 14 days, excluding any period when development
31
is suspended; or
32
(b) involve placing a human embryo into the body of a woman
33
for the purposes of achieving pregnancy in that woman.
34
Mitochondrial donation
Schedule 1
Main amendments
Part 1
No. , 2021
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
15
28G What a clinical practice licence authorises
1
(1) A
clinical practice licence
authorises carrying out any of the
2
activities mentioned in subsection (2) that are specified in the
3
licence, at an accredited ART centre, for the purpose of doing both
4
of the following in a clinical practice setting:
5
(a) creating a human embryo for a patient, using the permitted
6
technique specified in the licence, with the intention of
7
minimising the risk of the embryo inheriting mitochondria
8
that would predispose any resulting child to mitochondrial
9
disease;
10
(b) placing the embryo in the body of the patient for the purposes
11
of achieving her pregnancy.
12
(2) The activities are as follows:
13
(a) creation of human embryos other than by fertilisation of a
14
human egg by a human sperm, using the permitted technique
15
specified in the licence, and use of such embryos;
16
(b) creation of human embryos that contain genetic material
17
provided by more than 2 persons, using the permitted
18
technique specified in the licence:
19
(i) by fertilisation of a human egg by a human sperm
20
outside the body of a woman; or
21
(ii) other than by the fertilisation of a human egg by a
22
human sperm;
23
and use of such embryos;
24
(c) alteration of the genome of a human cell (within the meaning
25
of section 15 of the
Prohibition of Human Cloning for
26
Reproduction Act 2002
) using the permitted technique
27
specified in the licence, in such a way that the alteration is
28
heritable by descendants of the human whose cell was
29
altered;
30
(d) placement in the body of a woman of any of the following
31
kinds of human embryo created using the permitted
32
technique specified in the licence:
33
(i) a human embryo created by a process other than the
34
fertilisation of a human egg by human sperm;
35
(ii) a human embryo that contains genetic material provided
36
by more than 2 persons;
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(iii) a human embryo that contains a human cell (within the
1
meaning of section 15 of the
Prohibition of Human
2
Cloning for Reproduction Act 2002
) whose genome has
3
been altered in such a way that the alteration is heritable
4
by descendants of the human whose cell was altered;
5
(e) use of any material (other than an excess ART embryo)
6
created, developed or produced under a mitochondrial
7
donation licence.
8
(2) A clinical practice licence does not authorise any use of a human
9
embryo that would result in the development of the embryo outside
10
the body of a woman for a period of more than 14 days, excluding
11
any period when development is suspended.
12
Subdivision B--Applying for a mitochondrial donation licence
13
28H Applying for a mitochondrial donation licence
14
(1) A person may, subject to subsections (2) to (7), apply to the
15
NHMRC Licensing Committee for:
16
(a) a pre-clinical research and training licence, relating to a
17
permitted technique for such a licence, that authorises one or
18
more of the activities referred to in subsection 28C(2); or
19
(b) a clinical trial research and training licence, relating to a
20
permitted technique for such a licence, that authorises one or
21
more of the activities referred to in subsection 28D(2); or
22
(c) a clinical trial licence, relating to a permitted technique for
23
such a licence, that authorises one or more of the activities
24
referred to in subsection 28E(2); or
25
(d) a clinical practice research and training licence, relating to a
26
permitted technique for such a licence, that authorises one or
27
more of the activities referred to in subsection 28F(2); or
28
(e) a clinical practice licence, relating to a permitted technique
29
for such a licence, that authorises one or more of the
30
activities referred to in subsection 28G(2).
31
(2) A person cannot apply for any of the following licences unless the
32
person is a constitutional corporation:
33
(a) a pre-clinical research and training licence;
34
(b) a clinical trial research and training licence;
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(c) a clinical trial licence.
1
(3) A person cannot apply for a clinical trial licence relating to a
2
particular mitochondrial donation technique unless the person has
3
held a clinical trial research and training licence relating to that
4
technique.
5
(4) A person cannot apply for a clinical practice licence relating to a
6
particular mitochondrial donation technique unless the person has
7
held a clinical practice research and training licence relating to that
8
technique.
9
(5) An application for a mitochondrial donation licence relating to a
10
particular mitochondrial donation technique must nominate one or
11
more embryologists who will be authorised to use the technique
12
under the licence.
13
(6) A single application cannot relate to:
14
(a) more than one kind of mitochondrial donation licence; or
15
(b) more than one permitted technique for a mitochondrial
16
donation licence.
17
(7) An application for a mitochondrial donation licence must:
18
(a) be in the form approved by the NHMRC Licensing
19
Committee; and
20
(b) specify the following:
21
(i) the kind of mitochondrial donation licence;
22
(ii) the permitted technique to which the licence will relate;
23
and
24
(c) be made in accordance with:
25
(i) the requirements specified in the regulations for the
26
purposes of this subparagraph (if any); and
27
(ii) such other requirements (if any) as are specified in
28
writing by the NHMRC Licensing Committee and are
29
not inconsistent with requirements specified under
30
subparagraph (i); and
31
(d) be accompanied by the fee (if any) prescribed by the
32
regulations.
33
(8) A form approved for the purposes of paragraph (7)(a) may require:
34
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(a) an application to contain, or be accompanied by, such
1
information as is required by the form; and
2
(b) any such information to be verified by statutory declaration.
3
Subdivision C--Determining applications for mitochondrial
4
donation licences
5
28J Determination of application by Committee
6
(1) If a person applies under subsection 28H(1) for a mitochondrial
7
donation licence relating to a mitochondrial donation technique
8
that is a permitted technique for the licence, the NHMRC
9
Licensing Committee must decide, in accordance with this section,
10
whether or not to issue the licence.
11
(2) The NHMRC Licensing Committee must not issue the licence
12
unless it is satisfied of the following:
13
(a) that appropriate protocols are in place:
14
(i) to enable proper consent to be obtained before a human
15
egg or a human sperm is used in carrying out the
16
technique (see paragraph 28N(1)(a)); and
17
(ii) to enable compliance with any restrictions on such
18
consent;
19
(b) that the activity or project proposed in the application has
20
been assessed and approved by a HREC that is constituted in
21
accordance with, and acting in compliance with, the National
22
Statement.
23
(3) In deciding whether to issue the licence, the NHMRC Licensing
24
Committee must have regard to the following:
25
(a) restricting the number of
excess ART embryos, other
26
embryos, or human eggs or zygotes, to that likely to be
27
necessary to achieve the goals of the activity or project
28
proposed in the application;
29
(b) any relevant guidelines, or relevant parts of guidelines, issued
30
by the CEO of the NHMRC under the
National Health and
31
Medical Research Council Act 1992
and prescribed by the
32
regulations for the purposes of this paragraph;
33
(c) the HREC assessment of the application mentioned in
34
paragraph (2)(b);
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(d) whether the applicant has complied with the conditions of
1
any other mitochondrial donation licence.
2
(4) Without limiting section 15, the NHMRC Licensing Committee
3
may also request, and have regard to, advice from any person
4
having appropriate expertise.
5
(5) The NHMRC Licensing Committee must not issue a clinical trial
6
licence, or a clinical practice licence, relating to a particular
7
mitochondrial donation technique unless it is satisfied that:
8
(a) the applicant has in place protocols for using the technique
9
safely and effectively in a clinical trial or in clinical practice
10
(as the case requires) for the purpose of minimising the risk
11
of women's offspring inheriting mitochondria that would
12
predispose them to mitochondrial disease; and
13
(b) each embryologist nominated under subsection 28H(5) has:
14
(i) consented in writing to being so nominated; and
15
(ii) demonstrated technical competence in the use of the
16
technique in accordance with the protocols referred to in
17
paragraph (a) of this subsection; and
18
(iii) understands the embryologist's obligations under this
19
Act; and
20
(c) the applicant's facilities, equipment and processes for using
21
the technique under the licence are suitable for that purpose;
22
and
23
(d) the staff, other than embryologists, who will carry out
24
activities directly connected with the clinical trial or clinical
25
practice (as the case requires) are appropriately qualified,
26
trained and competent to do so; and
27
(e) the applicant is likely to be able to comply with its
28
obligations under section 28R (information about donors and
29
children); and
30
(f) the applicant has protocols in place to ensure that each donor
31
in relation to a use of the technique is aware that any children
32
born as a result of a pregnancy achieved by using the
33
technique will be able to obtain information about the donor
34
in accordance with subsections 29A(4) and (6) (disclosure of
35
information on the Mitochondrial Donation Donor Register);
36
and
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(g) the applicant has protocols in place to ensure that trial
1
participants or patients (as the case requires) have been fully
2
informed about:
3
(i) the risks involved in using mitochondrial donation
4
techniques; and
5
(ii) alternatives to using mitochondrial donation techniques.
6
(6) The regulations may specify:
7
(a) matters that the NHMRC Licensing Committee may, must or
8
must not have regard to when deciding whether to issue a
9
mitochondrial donation licence; and
10
(b) matters that the NHMRC Licensing Committee must be
11
satisfied of before issuing a mitochondrial donation licence;
12
and
13
(c) procedural and other requirements that the NHMRC
14
Licensing Committee must follow in deciding whether to
15
issue a mitochondrial donation licence; and
16
(d) requirements for demonstrating the technical competence of
17
an embryologist in the use of a particular mitochondrial
18
donation technique for the purposes of
19
subparagraph (5)(b)(ii).
20
28K Notification of decision
21
(1) The NHMRC Licensing Committee must notify its decision on an
22
application for a licence under section 28H to the following:
23
(a) the applicant;
24
(b) the HREC that assessed and approved the activity or project
25
proposed in the application as mentioned in
26
paragraph 28J(2)(b);
27
(c) the relevant State body in relation to the State in which the
28
use is to occur.
29
(2) If the NHMRC Licensing Committee decides to issue the licence,
30
it must, in addition to issuing the licence to the applicant, give a
31
copy of the licence to the bodies mentioned in paragraphs (1)(b)
32
and (c).
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28L Matters to be specified in a mitochondrial donation licence
1
If the NHMRC Licensing Committee decides to issue a
2
mitochondrial donation licence, the licence must specify the
3
following matters:
4
(a) the mitochondrial donation technique to which the licence
5
relates;
6
(b) the activity or activities referred to in subsection 28C(2),
7
28D(2), 28E(2), 28F(2) or 28G(2) (as the case requires) that
8
are authorised by the licence;
9
(c) the name of each embryologist nominated under subsection
10
28H(5).
11
28M Period of a mitochondrial donation licence
12
(1) A mitochondrial donation licence:
13
(a) comes into force on the day specified in the licence, or if no
14
day is specified, on the day on which it is issued; and
15
(b) remains in force until the day specified in the licence, unless
16
it is suspended, revoked or surrendered before that day.
17
(2) A mitochondrial donation licence is not in force throughout any
18
period of suspension.
19
Subdivision D--Conditions of mitochondrial donation licences
20
28N Conditions of mitochondrial donation licences generally
21
(1) A mitochondrial donation licence is subject to the condition that
22
before a human egg or a human sperm is used as authorised by the
23
licence:
24
(a) the responsible person in relation to the human egg or human
25
sperm must have given proper consent to that use; and
26
(b) the licence holder must have reported in writing to the
27
NHMRC Licensing Committee that such consent has been
28
obtained, and any restrictions to which the consent is subject.
29
(2) A mitochondrial donation licence is subject to the condition that a
30
report to the NHMRC Licensing Committee for the purposes of
31
paragraph (1)(b) must not include the name, or any other
32
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information that could be used to discover the identity, of a
1
responsible person.
2
(3) A mitochondrial donation licence is subject to the condition that
3
the use of a human egg or a human sperm must be in accordance
4
with any restrictions to which the proper consent under
5
subsection (1) is subject.
6
(4) A mitochondrial donation licence is subject to such other
7
conditions as are specified in the licence.
8
(5) The conditions specified in the licence may include, but are not
9
limited to, conditions relating to the following:
10
(a) embryologists and other persons authorised by the licence to
11
carry out activities that are authorised by the licence;
12
(b) the number of human eggs authorised to be used under the
13
licence, or the number of embryos or zygotes authorised to
14
be created or used under the licence;
15
(c) reporting;
16
(d) monitoring;
17
(e) information to be given by the licence holder to the
18
following:
19
(i) embryologists and other persons authorised by the
20
licence to carry out activities that are authorised by the
21
licence;
22
(ii) other persons;
23
(f) disposing of material produced by using the relevant
24
mitochondrial donation technique as authorised by the
25
licence.
26
(6) The licence conditions set out in subsections (1), (2) and (3) apply
27
to:
28
(a) each embryologist specified in the licence who is authorised
29
to use the mitochondrial donation technique to which the
30
licence relates; and
31
(b) each other person who carries out activities that are
32
authorised by the licence.
33
(7) Licence conditions specified in the licence apply to:
34
(a) the licence holder; and
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(b) each embryologist specified in the licence who is authorised
1
to use the mitochondrial donation technique to which the
2
licence relates; and
3
(c) each other person who carries out activities that are
4
authorised by the licence.
5
(8) In this Division:
6
proper consent
in relation to the use of a human egg or a human
7
sperm means consent:
8
(a) that is obtained in accordance with guidelines issued by the
9
CEO of the NHMRC under the
National Health and Medical
10
Research Council Act 1992
and prescribed by the regulations
11
for the purposes of this paragraph; and
12
(b) in relation to which such other requirements (if any) as are
13
prescribed by the regulations for the purposes of this
14
paragraph are satisfied.
15
responsible person
in relation to a human egg or a human sperm
16
means the person who is the biological donor of the human egg or
17
human sperm.
18
(9) Without limiting paragraph (b) of the definition of
proper consent
19
in subsection (8), regulations made for the purposes of that
20
paragraph may:
21
(a) provide in relation to the withdrawal of consent; and
22
(b) without limiting paragraph (a) of this subsection, provide that
23
consent cannot be withdrawn in specified circumstances.
24
28P Additional condition of clinical trial licences and clinical
25
practice licences--Committee approval before creation or
26
placement of embryo
27
(1) A clinical trial licence or clinical practice licence is subject to the
28
condition that an approval granted under subsection (3) is in force
29
at the time either of the following activities are carried out in
30
relation to a woman who is a trial participant or patient (as the case
31
requires) for the licence:
32
(a) creating a human embryo for the woman using the
33
mitochondrial donation technique to which the licence
34
relates;
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(b) placing a human embryo created for the woman using the
1
mitochondrial donation technique to which the licence relates
2
in the body of the woman for the purposes of achieving her
3
pregnancy.
4
(2) The licence holder for a clinical trial licence or a clinical practice
5
licence may apply to the NHMRC Licensing Committee, in the
6
form approved by the Committee and in accordance with such
7
other requirements (if any) as are specified in writing by the
8
Committee, for approval to carry out an activity referred to in
9
paragraph (1)(a) or (b) in relation to a woman who is a trial
10
participant or patient (as the case requires) for the licence.
11
(3) If the NHMRC Licensing Committee receives an application under
12
subsection (2), the Committee must decide whether or not to grant
13
the approval.
14
(4) The NHMRC Licensing Committee must not grant the approval
15
unless it is satisfied:
16
(a) that there is a particular risk of the woman's offspring
17
inheriting mitochondria from the woman that would
18
predispose the offspring to mitochondrial disease; and
19
(b) that there is a significant risk that the mitochondrial disease
20
that would develop in those offspring would result in a
21
serious illness or other serious medical condition; and
22
(c) that other available techniques that could potentially be used
23
to minimise the risks referred to in paragraphs (a) and (b)
24
would be inappropriate or unlikely to succeed; and
25
(d) that the woman and her spouse (if any) have attended
26
counselling and been fully informed of:
27
(i) the risks involved in using mitochondrial donation
28
techniques; and
29
(ii) alternatives to using mitochondrial donation techniques;
30
and
31
(e) that the woman has given written consent to the making of
32
the application; and
33
(f) of such other matters as are specified in the regulations for
34
the purposes of this paragraph.
35
(5) In deciding whether to grant the approval, the NHMRC Licensing
36
Committee must have regard to the following:
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(a) the clinical basis of the risk of the woman's offspring
1
inheriting mitochondria from the woman that would
2
predispose the offspring to mitochondrial disease;
3
(b) the inheritance pattern in the woman's family;
4
(c) the likely clinical manifestations of disease for the woman's
5
offspring.
6
(6) The NHMRC Licensing Committee must notify its decision on an
7
application under subsection (2) to the licence holder.
8
(7) A form approved by the NHMRC Licensing Committee for the
9
purposes of subsection (2):
10
(a) may require an application to contain, or be accompanied by,
11
such information as is required by the form and require the
12
information to be verified by statutory declaration; but
13
(b) must not require an application to contain, or be accompanied
14
by, any of the following information:
15
(i) the name of a trial participant or patient;
16
(ii) any other information that could be used to discover the
17
identity of a trial participant or patient, other than
18
information that is directly necessary for the purpose of
19
determining an application.
20
(8) An approval granted by the NHMRC Licensing Committee in
21
relation to a woman for the purposes of subsection (1) comes into
22
force when it is granted and ceases to be in force at the earlier of
23
the following times:
24
(a) 5 years after the approval is granted;
25
(b) the time a child is born alive as a result of a pregnancy
26
achieved in the woman by the placement of a human embryo
27
under the approval as described in paragraph (1)(b).
28
(9) The licence condition set out in subsection (1) applies to:
29
(a) the licence holder; and
30
(b) each embryologist specified in the licence who is authorised
31
to use the mitochondrial donation technique to which the
32
licence relates.
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28Q Other conditions of clinical trial licences and clinical practice
1
licences
2
(1) A clinical trial licence or a clinical practice licence is subject to the
3
following conditions:
4
(a) that the technique specified in the licence only be used under
5
the licence by an embryologist specified in the licence;
6
(b) that the embryologist's use of the technique is in accordance
7
with the protocols mentioned in paragraph 28J(5)(a);
8
(c) that the embryologist remains technically competent to use
9
the technique;
10
(d) that, if:
11
(i) after attending the counselling mentioned in
12
paragraph 28P(4)(d), the woman and her spouse (if any)
13
so request; and
14
(ii) it is practicable and safe to do so;
15
only male embryos are selected for implantation in the
16
woman.
17
(2) The licence conditions set out in this section apply to:
18
(a) the licence holder; and
19
(b) for a condition set out paragraph (1)(b) or (d)--each
20
embryologist specified in the licence who is authorised to use
21
the mitochondrial donation technique to which the licence
22
relates.
23
Subdivision E--Ongoing requirements for holders of
24
mitochondrial donation licences
25
28R Clinical trial licences and clinical practice licences--
26
information about donors and children
27
(1) The holder of a clinical trial licence or a clinical practice licence
28
must collect the following information for the donor in relation to
29
each use of a mitochondrial donation technique under the licence:
30
(a) the donor's full name;
31
(b) the donor's residential address at the time the donor gave the
32
proper consent required by paragraph 28N(1)(a) to the use of
33
the donor's egg;
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(c) the donor's date and place of birth;
1
(d) any other information the donor gives the licence holder, for
2
the purposes of inclusion on the Mitochondrial Donation
3
Donor Register under section 29A, at the time referred to in
4
paragraph (b) of this subsection;
5
(e) any other information about the donor prescribed by the
6
regulations for the purposes of this paragraph.
7
(2) If a particular use of a mitochondrial donation technique results in
8
the creation of a zygote that:
9
(a) has nuclear DNA from a woman and a man; and
10
(b) contains mitochondria from a different woman;
11
the woman mentioned in paragraph (b) is the
donor
in relation to
12
that use of the technique.
13
(3) A person who is or was the holder of a clinical trial licence or a
14
clinical practice licence must use the person's best endeavours to
15
collect the following information for each child born alive as a
16
result of a pregnancy achieved using a mitochondrial donation
17
technique under the licence:
18
(a) the child's full name;
19
(b) the child's sex;
20
(c) the child's date of birth;
21
(d) any other information about the child prescribed by the
22
regulations for the purposes of this paragraph.
23
(4) A person who is or was the holder of a clinical trial licence or a
24
clinical practice licence must keep records of information the
25
person collects as required by subsection (1) or (3) for the period
26
prescribed by the regulations for the purposes of this subsection.
27
(5) If a person who is or was the holder of a clinical trial licence or a
28
clinical practice licence becomes aware that a child has been born
29
alive as a result of a pregnancy achieved using a mitochondrial
30
donation technique under the licence, the person must:
31
(a) as soon as practicable after the birth of the child, notify the
32
Secretary and the NHMRC Licensing Committee of that fact,
33
in the form (if any) approved by the Secretary; and
34
(b) give the Secretary, in the form (if any) approved by the
35
Secretary:
36
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(i) the information collected as required by subsection (1)
1
for the donor in relation to the particular use of the
2
technique that achieved the pregnancy, as soon as
3
practicable after the birth of the child; and
4
(ii) the information collected as required by subsection (3)
5
for the child, as soon as practicable after the person
6
collects the information.
7
(6) A person who is or was the holder of a clinical trial licence or a
8
clinical practice licence must not include in a notification for the
9
purposes of paragraph (5)(a) the name, or any other information
10
that could be used to discover the identity, of:
11
(a) a trial participant or patient; or
12
(b) a child of a trial participant or patient.
13
(7) Despite subsections (1), (3), (4), (5) and (6), in the case of a
14
clinical trial licence a person is not subject to a requirement under
15
any of those subsections unless the person is a constitutional
16
corporation.
17
(8) A person commits an offence if the person intentionally engages in
18
conduct knowing that, or reckless as to whether, the conduct
19
breaches a requirement under subsection (1), (3), (4), (5) or (6) to
20
which the person is subject.
21
Penalty for a contravention of this subsection:
Imprisonment
22
for 2 years.
23
28S Clinical trial licences and clinical practice licences--
24
requirement for ongoing monitoring protocols and to
25
notify adverse events
26
(1) A person who is or was the holder of a clinical trial licence must
27
have in place, and comply with, protocols for:
28
(a) monitoring the pregnancy of trial participants who achieve
29
pregnancy using a mitochondrial donation technique under
30
the licence and any childbirths resulting from such
31
pregnancies; and
32
(b) monitoring the ongoing health and development of children
33
born as a result of such pregnancies; and
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(c) seeking the ongoing engagement of trial participants referred
1
to in paragraph (a), and children referred to in paragraph (b),
2
in relation to such monitoring; and
3
(d) notifying in accordance with subsection (3) adverse events,
4
for those participants or children, that the person becomes
5
aware of as a result of monitoring referred to in paragraph (a)
6
or (b) of this subsection.
7
(2) A person who is or was the holder of a clinical practice licence
8
must have in place, and comply with, protocols for:
9
(a) monitoring the pregnancy of patients who achieve pregnancy
10
using a mitochondrial donation technique under the licence
11
and any childbirths resulting from such pregnancies; and
12
(b) notifying in accordance with subsection (3) adverse events,
13
for those patients, that the person becomes aware of as a
14
result of monitoring referred to in paragraph (a) of this
15
subsection.
16
(3) If a person who is or was the holder of a clinical trial licence or a
17
clinical practice licence becomes aware of an adverse event for a
18
trial participant referred to in paragraph (1)(a), a child referred to in
19
paragraph (1)(b) or a patient referred to in paragraph (2)(a), the
20
person must notify the adverse event to:
21
(a) the NHMRC Licensing Committee; and
22
(b) the Secretary; and
23
(c) such other persons as are prescribed by the regulations for the
24
purposes of this paragraph;
25
within the period, in a form and manner, and in accordance with
26
any other requirements, specified in the regulations.
27
(4) Without limiting subsection (3), the regulations may require a
28
notification to be in the form approved by the CEO of the NHMRC
29
and to contain any information required by the form.
30
(5) A person who is or was the holder of a clinical trial licence or a
31
clinical practice licence must not include in a notification for the
32
purposes of subsection (3) the name, or any other information that
33
could be used to discover the identity, of:
34
(a) a trial participant or patient; or
35
(b) a child of a trial participant or patient.
36
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Part 1
Main amendments
30
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
No. , 2021
(6) Despite subsections (1), (3) and (5), in the case of a clinical trial
1
licence a person is not subject to a requirement under any of those
2
subsections unless the person is a constitutional corporation.
3
(7) A person commits an offence if the person intentionally engages in
4
conduct knowing that, or reckless as to whether, the conduct
5
breaches a requirement under subsection (1), (2), (3) or (5) to
6
which the person is subject.
7
Penalty: Imprisonment for 2 years.
8
(8) In this section:
9
adverse event
, for a trial participant or patient, or a child of a trial
10
participant, has the meaning given by the regulations.
11
28T Record-keeping obligations for all holders of mitochondrial
12
donation licences
13
(1) The regulations may prescribe record-keeping obligations that
14
apply in relation to the use of mitochondrial donation techniques
15
under mitochondrial donation licences.
16
(2) Regulations for the purposes of subsection (1) may impose such
17
obligations only on a person who:
18
(a) is or was the holder of a mitochondrial donation licence; and
19
(b) for a mitochondrial donation licence other than a clinical
20
practice research and training licence or a clinical practice
21
licence--is a constitutional corporation.
22
(3) Regulations for the purposes of subsection (1) may prescribe
23
penalties, not exceeding 50 penalty units, for offences against such
24
regulations.
25
Subdivision F--Variation, suspension, revocation and
26
surrender
27
28U Variation of a mitochondrial donation licence
28
(1) The NHMRC Licensing Committee may, by notice in writing
29
given to the licence holder, vary a mitochondrial donation licence
30
Mitochondrial donation
Schedule 1
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Part 1
No. , 2021
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
31
if the Committee believes on reasonable grounds that it is
1
necessary or desirable to do so.
2
(2) The NHMRC Licensing Committee may vary a mitochondrial
3
donation licence under subsection (1) on its own initiative or on
4
application by the licence holder.
5
(3) Without limiting subsection (1), the NHMRC Licensing
6
Committee may vary the licence by specifying additional
7
conditions or varying existing conditions.
8
(4) The NHMRC Licensing Committee must not vary a mitochondrial
9
donation licence in such a way that, had a person applied under
10
section 28H for the licence as varied, the Committee would not
11
have been permitted by this Division to issue the licence.
12
28V Suspension or revocation of a mitochondrial donation licence
13
(1) The NHMRC Licensing Committee may, by notice in writing
14
given to the licence holder, suspend or revoke a mitochondrial
15
donation licence if the Committee believes on reasonable grounds
16
that a condition of the licence has been breached.
17
(2) If the holder of a mitochondrial donation licence is convicted of an
18
offence under this Act or the regulations, or the
Prohibition of
19
Human Cloning for Reproduction Act 2002
, the NHMRC
20
Licensing Committee must, by notice in writing given to the
21
licence holder, revoke each mitochondrial donation licence held by
22
the licence holder.
23
(3) If the holder of a pre-clinical research and training licence, a
24
clinical trial research and training licence or a clinical trial licence
25
stops being a constitutional corporation at a particular time, the
26
NHMRC Licensing Committee is taken to have revoked the
27
licence at that time.
28
28W Surrender of a mitochondrial donation licence
29
The holder of a mitochondrial donation licence may surrender the
30
licence by written notice given to the NHMRC Licensing
31
Committee.
32
Schedule 1
Mitochondrial donation
Part 1
Main amendments
32
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
No. , 2021
28X Notification of variation, suspension or revocation of a
1
mitochondrial donation licence
2
(1) If the NHMRC Licensing Committee varies, suspends or revokes a
3
mitochondrial donation licence, the Committee must notify:
4
(a) the licence holder; and
5
(b) the HREC and the relevant State body to which the NHMRC
6
Licensing Committee notified its decision on the application
7
for the licence under section 28K.
8
(2) The NHMRC Licensing Committee must also notify the bodies
9
mentioned in paragraph (1)(b) if a mitochondrial donation licence
10
is surrendered.
11
18 After section 29
12
Insert:
13
29A Mitochondrial Donation Donor Register
14
(1) The Secretary must keep a register, to be known as the
15
Mitochondrial Donation Donor Register, in which the Secretary
16
includes information given to the Secretary in accordance with
17
paragraph 28R(5)(b).
18
(2) The Secretary may keep the register by electronic means.
19
(3) The register must not be made publicly available.
20
(4) A person who:
21
(a) was born as a result of the use of a mitochondrial donation
22
technique under a mitochondrial donation licence; and
23
(b) is 18 or over;
24
may apply, in the form approved by the Secretary, for the Secretary
25
to disclose to the person information in the register about the donor
26
in relation to the use of the technique.
27
(5) The donor in relation to the use of a mitochondrial donation
28
technique may apply, in the form approved by the Secretary, for
29
the Secretary to disclose to the donor information in the register
30
about the donor that is of a kind described in subsection 28R(1).
31
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Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
33
(6) The Secretary must, on application under subsection (4) or (5),
1
disclose the information to the applicant.
2
(7) A person commits an offence if:
3
(a) the person discloses information; and
4
(b) the person knows the information is on the register; and
5
(c) the person has the information only because of performing
6
duties or functions under this section or paragraph 28R(5)(b);
7
and
8
(d) the disclosure is not:
9
(i) in accordance with subsection (6) of this section; or
10
(ii) by order of a court.
11
Penalty: Imprisonment for 2 years.
12
(8) The Secretary may, in writing, delegate any or all of the
13
Secretary's powers or functions under this section or paragraph
14
28R(5)(b) to an SES employee or acting SES employee in the
15
Department.
16
Note:
The expressions
SES employee
and
acting SES employee
are defined
17
in section 2B of the
Acts Interpretation Act 1901
.
18
(9) In exercising powers or functions delegated under subsection (8),
19
the delegate must comply with any directions of the Secretary.
20
(10) The regulations may provide for and in relation to the following:
21
(a) information that must be included in the register in addition
22
to the information mentioned in subsection (1);
23
(b) correcting or updating information on the register;
24
(c) the keeping and maintenance of the register;
25
(d) the verification of information included in an application to
26
the Secretary under subsection (4) or (5) for the disclosure of
27
information on the register, including by statutory
28
declaration.
29
Research Involving Human Embryos Regulations 2017
30
19 Section 5
31
Insert:
32
Schedule 1
Mitochondrial donation
Part 1
Main amendments
34
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
No. , 2021
first polar body transfer
has the meaning given by section 7F.
1
germinal vesicle transfer
has the meaning given by section 7E.
2
maternal spindle transfer
has the meaning given by section 7C.
3
pronuclear transfer
has the meaning given by section 7D.
4
second polar body transfer
has the meaning given by section 7G.
5
20 After section 7
6
Insert:
7
Division 2--Provisions relating to mitochondrial donation
8
licences
9
7A Definition of mitochondrial donation technique
10
For the purposes of the definition of
mitochondrial donation
11
technique
in section 8 of the Act, the following are mitochondrial
12
donation techniques:
13
(a) maternal spindle transfer;
14
(b) pronuclear transfer;
15
(c) germinal vesicle transfer;
16
(d) first polar body transfer;
17
(e) second polar body transfer.
18
7B Definition of permitted technique
19
For the purposes of the definition of
permitted technique
in
20
section 8 of the Act, a mitochondrial donation technique mentioned
21
in an item in the following table is declared to be a permitted
22
technique for a mitochondrial donation licence mentioned in that
23
item.
24
25
Definition of permitted technique
Item
For this kind of mitochondrial
donation licence ...
the permitted techniques are ...
1
a pre-clinical research and training
licence
the following:
Mitochondrial donation
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Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
35
Definition of permitted technique
Item
For this kind of mitochondrial
donation licence ...
the permitted techniques are ...
(a) maternal spindle transfer;
(b) pronuclear transfer;
(c) germinal vesicle transfer;
(d) first polar body transfer;
(e) second polar body transfer
2
a clinical trial research and training
licence or a clinical trial licence
the following:
(a) maternal spindle transfer;
(b) pronuclear transfer
1
7C Definition of maternal spindle transfer
2
Maternal spindle transfer
is a technique that involves taking the
3
following steps, without intentionally modifying any nuclear DNA
4
or mitochondrial DNA:
5
(a) removing the maternal spindle from a human egg (
egg A
) of
6
a woman;
7
(b) removing the maternal spindle from a human egg (
egg B
) of
8
a different woman;
9
(c) implanting into egg B the maternal spindle removed from
10
egg A, while seeking to minimise carryover of mitochondria
11
from egg A to egg B;
12
(d) fertilising egg B with a human sperm to create a zygote.
13
7D Definition of pronuclear transfer
14
Pronuclear transfer
is a technique that involves taking the
15
following steps, without intentionally modifying any nuclear DNA
16
or mitochondrial DNA:
17
(a) fertilising, with a human sperm, a human egg of a woman to
18
create a zygote (
zygote A
);
19
(b) removing the pronuclei from zygote A;
20
(c) fertilising, with a human sperm, a human egg of a different
21
woman to create another zygote (
zygote B
);
22
Schedule 1
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Part 1
Main amendments
36
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
No. , 2021
(d) removing the pronuclei from zygote B;
1
(e) implanting the pronuclei from zygote A into zygote B, while
2
seeking to minimise carryover of mitochondria from zygote
3
A to zygote B.
4
7E Definition of germinal vesicle transfer
5
Germinal vesical transfer
is a technique that involves taking the
6
following steps, without intentionally modifying any nuclear DNA
7
or mitochondrial DNA:
8
(a) removing the germinal vesicle from a maturing human egg
9
(
egg A
) of a woman;
10
(b) removing the germinal vesicle from a maturing human egg
11
(
egg B
) of a different woman;
12
(c) implanting the germinal vesicle removed from egg A into
13
egg B, while seeking to minimise carryover of mitochondria
14
from egg A to egg B;
15
(d) maturing egg B in vitro to the stage ready for fertilisation;
16
(e) fertilising egg B with a human sperm to create a zygote.
17
7F Definition of first polar body transfer
18
First polar body transfer
is a technique that involves taking the
19
following steps, without intentionally modifying any nuclear DNA
20
or mitochondrial DNA:
21
(a) removing the first polar body from a human egg (
egg A
) of a
22
woman;
23
(b) removing the maternal spindle from a human egg (
egg B
) of
24
a different woman;
25
(c) fusing the first polar body to, or implanting the first polar
26
body into, egg B;
27
(d) fertilising egg B with a human sperm to create a zygote.
28
7G Definition of second polar body transfer
29
Second polar body transfer
is a technique that involves taking the
30
following steps, without intentionally modifying any nuclear DNA
31
or mitochondrial DNA:
32
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Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
37
(a) fertilising, with a human sperm, a human egg of a woman to
1
create a zygote (
zygote A
);
2
(b) fertilising, with a human sperm, a human egg of a different
3
woman to produce another zygote (
zygote B
);
4
(c) removing the second polar body from zygote A;
5
(d) removing the female pronucleus from zygote B;
6
(e) transferring the second polar body from zygote A to zygote
7
B.
8
7H Determination by NHMRC Licensing Committee of
9
mitochondrial donation licence applications--prescribed
10
guidelines
11
For the purposes of paragraph 28J(3)(b) of the Act, the following
12
guidelines are prescribed:
13
(a) the ART Guidelines;
14
(b) the National Statement.
15
7J Definition of proper consent--prescribed guidelines
16
For the purposes of the definition of
proper consent
in subsection
17
28N(8) of the Act, the ART Guidelines are prescribed.
18
7K Keeping records--prescribed period
19
For the purposes of subsection 28R(4) of the Act, the period for
20
which a record must be kept is 25 years after the creation of the
21
record.
22
7L Notifying adverse events--form of notification
23
For the purposes of subsection 28S(4) of the Act, a notification for
24
the purposes of subsection 28S(3) of the Act must:
25
(a) be in the form approved by the CEO of the NHMRC; and
26
(b) contain any information required by the form.
27
7M Definition of adverse event
28
For the purposes of the definition of
adverse event
in subsection
29
28S(8) of the Act, an adverse event is:
30
Schedule 1
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Part 1
Main amendments
38
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
No. , 2021
(a) for a trial participant or a patient--any of the following in
1
connection with a pregnancy achieved in the trial participant
2
or patient as a result of using a mitochondrial donation
3
technique:
4
(i) a failed embryo development;
5
(ii) a miscarriage;
6
(iii) a premature birth of a child;
7
(iv) the birth of a child with a birth defect, a genetic
8
abnormality or a diagnosis at birth of mitochondrial
9
disease; and
10
(b) for a child of a trial participant--a diagnosis at any time of
11
mitochondrial disease.
12
Mitochondrial donation
Schedule 1
Other amendments
Part 2
No. , 2021
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
39
Part 2--Other amendments
1
Freedom of Information Act 1982
2
21 Subsection 38(2)
3
Omit "subsection (3)", substitute "subsections (3) and (3A)".
4
22 After subsection 38(3)
5
Insert:
6
(3A) This section applies in relation to a document so far as it contains
7
personal information about a person if:
8
(a) the person requests access to the document; and
9
(b) disclosure of the document, or information contained in the
10
document, is prohibited under subsection 29A(7) of the
11
Research Involving Human Embryos Act 2002
.
12
23 Schedule 3
13
After:
14
Private Health Insurance Act 2007
, sections 323-1 and 323-40
insert:
15
Research Involving Human Embryos Act 2002
, subsection 29A(7).
Prohibition of Human Cloning for Reproduction Act 2002
16
24 At the end of subsection 4(1)
17
Add:
18
Note:
See also section 28B of the
Research Involving Human Embryos Act
19
2002
in relation to mitochondrial donation licences.
20
25 Subsection 8(1) (definition of
licence
)
21
Repeal the definition.
22
26 Division 1 of Part 2 (heading)
23
Repeal the heading.
24
Schedule 1
Mitochondrial donation
Part 2
Other amendments
40
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
No. , 2021
27 Division 2 of Part 2 (heading)
1
Repeal the heading.
2
28 Paragraph 23A(b)
3
Omit "licence", substitute "general licence".
4
29 Subsection 23B(3)
5
Omit "licence", substitute "general licence".
6
30 Subsection 23B(3) (note)
7
Omit "licence", substitute "general licence".
8
31 After section 23B
9
Insert:
10
23BA Person not liable for conduct purportedly authorised
11
(1) To avoid doubt, a person is not criminally responsible for a licence
12
offence in respect of particular conduct if:
13
(a) the conduct by the person is purportedly authorised by a
14
provision of a general licence or a mitochondrial donation
15
licence; and
16
(b) the licence or the provision is invalid, whether because of a
17
technical defect or irregularity or for any other reason; and
18
(c) the person did not know, and could not reasonably be
19
expected to have known, of the invalidity of the licence or
20
the provision.
21
(2) In this section:
22
general licence
includes a purported general licence.
23
licence offence
means:
24
(a) for a general licence--an offence against section 22, 23, 23A
25
or 23B; or
26
(b) for a mitochondrial donation licence--an offence against
27
section 12, 13 or 15, subsection 20(3), or section 22 or 23.
28
mitochondrial donation licence
includes a purported
29
mitochondrial donation licence.
30
Mitochondrial donation
Schedule 1
Other amendments
Part 2
No. , 2021
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
41
32 Sections 25 and 25A
1
Repeal the sections, substitute:
2
25 Review of operation of Act every 7 years
3
(1) The Minister must cause an independent review of the operation of
4
this Act, in so far as it relates to the use of mitochondrial donation
5
techniques, to be undertaken as soon as possible after the end of:
6
(a) the period of 7 years starting on the commencement of
7
Schedule 1 to the
Mitochondrial Donation Law Reform
8
(Maeve's Law) Act 2021
; and
9
(b) each subsequent 7-year period.
10
(2) A review under this section is to be undertaken by persons chosen
11
by the Minister, with the agreement of each State.
12
(3) The persons undertaking a review under this section must prepare
13
and give to the Minister, for presentation to the Parliament, a report
14
of the review.
15
(4) The report must be given to the Minister within 12 months after the
16
end of the relevant 7-year period.
17
Note:
See also section 34C of the
Acts Interpretation Act 1901
, which
18
contains extra rules about periodic reports.
19
(5) The persons undertaking a review under this section must consult:
20
(a) the Commonwealth and the States; and
21
(b) a broad range of persons with expertise in or experience of
22
relevant disciplines;
23
and the views of the Commonwealth, the States and the persons
24
mentioned in paragraph (b) must be set out in the report to the
25
extent that it is reasonably practicable to do so.
26
Research Involving Human Embryos Act 2002
27
33 At the end of subsection 4(1)
28
Add:
29
Note:
See also section 28B in relation to mitochondrial donation licences.
30
Schedule 1
Mitochondrial donation
Part 2
Other amendments
42
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
No. , 2021
34 Subsection 4(2) (definition of
constitutional corporation
)
1
Repeal the definition.
2
35 At the end of subsection 4(2)
3
Add:
4
Note:
For
constitutional corporation
, see subsection 7(1).
5
36 Subsection 7(1) (paragraph (a) of the definition of
6
unsuitable for implantation
)
7
Omit "the
Ethical Guidelines on the Use of Assisted Reproductive
8
Technology in Clinical Practice and Research (2004)
, issued by the
9
CEO of the NHMRC", substitute "the
Ethical guidelines on the use of
10
assisted reproductive technology in clinical practice and research
,
11
issued by the CEO of the NHMRC under the
National Health and
12
Medical Research Council Act 1992
, as existing from time to time".
13
37 Part 2 (heading)
14
Repeal the heading, substitute:
15
Part 2--Regulation of the use of excess ART
16
embryos and other material
17
38 Section 8
18
Insert:
19
engage in conduct
means:
20
(a) do an act; or
21
(b) omit to perform an act.
22
39 Section 8 (definition of
licence
)
23
Repeal the definition.
24
40 Section 8
25
Insert:
26
National Statement
means the
National Statement on Ethical
27
Conduct in Human Research
, issued by the CEO of the NHMRC
28
Mitochondrial donation
Schedule 1
Other amendments
Part 2
No. , 2021
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
43
under the
National Health and Medical Research Council Act
1
1992
, as existing from time to time.
2
Note:
The National Statement could in 2021 be viewed on the website of the
3
NHMRC (https://www.nhmrc.gov.au).
4
41 Section 8 (definition of
proper consent
)
5
Repeal the definition, substitute:
6
proper consent
:
7
(a) for the purposes of Division 4 (general licences) of Part 2--
8
has the meaning given by subsection 24(9); and
9
(b) for the purposes of Division 4A (mitochondrial donation
10
licences) of Part 2--has the meaning given by subsection
11
28N(8).
12
42 Section 8 (definition of
responsible person
)
13
Repeal the definition, substitute:
14
responsible person
:
15
(a) for the purposes of Division 4 (general licences) of Part 2--
16
has the meaning given by subsection 24(9); and
17
(b) for the purposes of Division 4A (mitochondrial donation
18
licences) of Part 2--has the meaning given by subsection
19
28N(8).
20
43 Section 10A (note)
21
Omit "licence under this Act", substitute "general licence under this
22
Act, or if subparagraph (b)(i) or (ii) applies, permitted under section
23
28B of this Act".
24
44 Paragraph 10B(a)
25
Omit "ART", substitute "assisted reproductive technology".
26
45 Section 12 (heading)
27
Omit "
licence
", substitute "
general licence or mitochondrial donation
28
licence
".
29
46 Subsection 12(1)
30
Omit "(1)".
31
Schedule 1
Mitochondrial donation
Part 2
Other amendments
44
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
No. , 2021
47 Subsection 12(1)
1
Omit "licence" (first occurring), substitute "general licence or
2
mitochondrial donation licence".
3
48 Subsection 12(2)
4
Repeal the subsection.
5
49 Subsection 12A(1)
6
Omit "an offence against this Act", substitute "a licence offence".
7
50 Paragraph 12A(1)(a)
8
Omit "licence", substitute "general licence or mitochondrial donation
9
licence".
10
51 Subsection 12A(2)
11
Repeal the subsection, substitute:
12
(2) In this section:
13
general licence
includes a purported general licence.
14
licence offence
means:
15
(a) for a general licence--an offence against section 10, 10A,
16
10B or 12; or
17
(b) for a mitochondrial donation licence--an offence against:
18
(i) section 10; or
19
(ii) section 10A, in so far as it applies because of
20
subparagraph (b)(i) or (ii) of that section; or
21
(iii) section 10B in so far as it applies to a pre-clinical
22
research and training licence, a clinical trial research
23
and training licence or a clinical practice research and
24
training licence; or
25
(iv) section 11, 11A or 12.
26
mitochondrial donation licence
includes a purported
27
mitochondrial donation licence.
28
52 Paragraph 14(a)
29
Omit "licences", substitute "general licences".
30
Mitochondrial donation
Schedule 1
Other amendments
Part 2
No. , 2021
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
45
53 After paragraph 14(a)
1
Insert:
2
(aa) to perform functions in relation to mitochondrial donation
3
licences under Division 4A; and
4
54 Paragraph 14(b)
5
Omit "Division 5", substitute "section 29".
6
55 Paragraph 19(3)(e)
7
Omit "licences", substitute "general licences and mitochondrial
8
donation licences".
9
56 Division 4 of Part 2 (heading)
10
Repeal the heading, substitute:
11
Division 4--General licences
12
57 Section 20 (heading)
13
Repeal the heading, substitute:
14
20 Applying for a general licence
15
58 Subsection 20(1)
16
After "licence", insert "(a
general licence
)".
17
59 Paragraph 20(1)(e)
18
Omit "ART", substitute "assisted reproductive technology".
19
60 After subsection 20(1A)
20
Insert:
21
(1B) Subsection (1) does not permit the NHMRC Licensing Committee
22
to authorise:
23
(a) any activity that involves the use of a mitochondrial donation
24
technique; or
25
(b) the use of any material created, developed or produced under
26
a mitochondrial donation licence.
27
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61 Subsection 21(1)
1
Omit "a licence", substitute "a general licence".
2
62 Paragraph 21(3)(c)
3
Omit "NHMRC
National Statement on Ethical Conduct in Research
4
Involving Humans
(1999), as in force from time to time", substitute
5
"National Statement".
6
63 Subsection 22(1)
7
Omit "a licence", substitute "a general licence".
8
64 Section 23 (heading)
9
Repeal the heading, substitute:
10
23 Period of a general licence
11
65 Subsections 23(1) and (2)
12
Omit "A licence", substitute "A general licence".
13
66 Section 24 (heading)
14
Repeal the heading, substitute:
15
24 Conditions of general licences
16
67 Subsections 24(1), (2) and (4)
17
Omit "A licence", substitute "A general licence".
18
68 Subsection 24(6)
19
Omit "(1), (2) and (3)", substitute "(1) and (2)".
20
69 Paragraph 24(8)(a)
21
Omit "a licence may provide that the guidelines referred to in the
22
definition of
proper consent
apply", substitute "a general licence may
23
provide that the guidelines referred to in the definition of
proper
24
consent
in subsection (9) apply".
25
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70 Paragraph 24(8)(b)
1
Omit "a licence", substitute "a general licence".
2
71 At the end of section 24
3
Add:
4
(9) In this Division:
5
proper consent
, in relation to the use of an excess ART embryo or
6
a human egg, or the creation or use of any other embryo, means
7
consent obtained in accordance with guidelines issued by the CEO
8
of the NHMRC under the
National Health and Medical Research
9
Council Act 1992
and prescribed by the regulations for the
10
purposes of this definition.
11
responsible person
means:
12
(a) in relation to an excess ART embryo:
13
(i) each person who provided the egg or sperm from which
14
the embryo was created; and
15
(ii) the woman for whom the embryo was created, for the
16
purpose of achieving her pregnancy; and
17
(iii) any person who was the spouse of a person mentioned
18
in subparagraph (i) at the time the egg or sperm
19
mentioned in that subparagraph was provided; and
20
(iv) any person who was the spouse of the woman
21
mentioned in subparagraph (ii) at the time the embryo
22
was created; or
23
(b) in relation to an embryo other than an excess ART embryo--
24
each person whose reproductive material, genetic material or
25
cell was used, or is proposed to be used, in the creation or use
26
of the embryo; or
27
(c) in relation to a human egg--the woman who was the
28
biological donor of the egg.
29
72 Section 25 (heading)
30
Repeal the heading, substitute:
31
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Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
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25 Variation of a general licence
1
73 Subsections 25(1), (2) and (4)
2
Omit "a licence", substitute "a general licence".
3
74 Subsection 25(4)
4
Omit "Part", substitute "Division".
5
75 Section 26 (heading)
6
Repeal the heading, substitute:
7
26 Suspension or revocation of a general licence
8
76 Subsection 26(1)
9
Omit "a licence", substitute "a general licence".
10
77 Subsection 26(2)
11
Omit "each licence", substitute "each general licence".
12
78 Section 27 (heading)
13
Repeal the heading, substitute:
14
27 Surrender of a general licence
15
79 Section 27
16
Omit "a licence", substitute "a general licence".
17
80 Section 28 (heading)
18
Repeal the heading, substitute:
19
28 Notification of variation, suspension or revocation of a general
20
licence
21
81 Subsections 28(1) and (2)
22
Omit "a licence", substitute "a general licence".
23
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82 Division 5 of Part 2 (heading)
1
Repeal the heading, substitute:
2
Division 5--Protection and disclosure of information
3
83 Subsection 29(1)
4
Omit "each licence", substitute "each general licence and each
5
mitochondrial donation licence".
6
84 Paragraph 29(1)(b)
7
Before "a short statement", insert "for a general licence--".
8
85 After paragraph 29(1)(b)
9
Insert:
10
(ba) for a mitochondrial donation licence--a short statement
11
about the nature of the uses of excess ART embryos or
12
human eggs, and creations or uses of other embryos or
13
zygotes, that are authorised by the licence;
14
86 Paragraph 29(1)(c)
15
Repeal the paragraph.
16
87 Paragraph 29(1)(d)
17
Omit "the number of ART", substitute "for a general licence--the
18
number of excess ART".
19
88 Paragraphs 29(1)(e) and (f)
20
Repeal the paragraphs, substitute:
21
(e) for a mitochondrial donation licence--the number of excess
22
ART embryos or human eggs authorised to be used under the
23
licence, and the number of other embryos or zygotes
24
authorised to be created or used under the licence;
25
(f) in any case:
26
(i) any conditions to which the licence is subject; and
27
(ii) the date on which the licence was issued; and
28
(iii) the period throughout which the licence is to remain in
29
force.
30
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89 Section 31 (paragraph (a) of the definition of
eligible
1
person
)
2
After "21", insert "or 28J".
3
90 Section 31 (paragraph (b) of the definition of
eligible
4
person
)
5
After "23", insert "or 28M".
6
91 Section 31 (paragraph (c) of the definition of
eligible
7
person
)
8
After "24(4)", insert "or 28N(4)".
9
92 Section 31 (paragraph (d) of the definition of
eligible
10
person
)
11
After "25", insert "or 28U".
12
93 Section 31 (paragraph (e) of the definition of
eligible
13
person
)
14
After "26", insert "or subsection 28V(1) or (2)".
15
94 Section 31 (at the end of the definition of
eligible person
)
16
Add:
17
; or (f) in relation to a decision under subsection 28P(3) not to grant
18
an approval to carry out an activity referred to in paragraph
19
28P(1)(a) or (b) in relation to a trial participant or a patient:
20
(i) the licence holder who applied for the approval; and
21
(ii) the trial participant or patient.
22
95 Paragraph 32(1)(a)
23
After "21", insert "or 28J".
24
96 Paragraph 32(1)(b)
25
After "23", insert "or 28M".
26
97 Paragraph 32(1)(c)
27
After "24(4)", insert "or 28N(4)".
28
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98 Paragraph 32(1)(d)
1
After "25", insert "or 28U".
2
99 Paragraph 32(1)(e)
3
After "26", insert "or subsection 28V(1) or (2)".
4
100 At the end of subsection 32(1)
5
Add:
6
; (f) a decision under subsection 28P(3) not to grant an approval
7
to carry out an activity referred to in paragraph 28P(1)(a) or
8
(b) in relation to a trial participant or patient.
9
101 Paragraph 35(2)(b)
10
After "21", insert "or 28J".
11
102 Part 5 (heading)
12
Repeal the heading, substitute:
13
Part 5--Miscellaneous
14
103 Divisions 1 and 2 of Part 5
15
Repeal the Divisions, substitute:
16
Division 1--Arrangements relating to clinical trials of
17
mitochondrial donation techniques
18
46 Arrangements relating to clinical trials of mitochondrial donation
19
techniques
20
(1) The Commonwealth may make, vary or administer an
21
arrangement:
22
(a) in relation to the carrying out of activities by a constitutional
23
corporation in connection with conducting a clinical trial
24
under a clinical trial licence referred to in section 28E, and
25
associated activities; and
26
(b) for money to be payable by the Commonwealth to the
27
constitutional corporation for that purpose.
28
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(2) The power conferred on the Commonwealth by subsection (1) may
1
be exercised on behalf of the Commonwealth by the Minister or
2
the Secretary.
3
Note:
For the power to delegate, see section 46B.
4
(3) In this section:
5
administer
an arrangement includes give effect to.
6
arrangement
includes contract, agreement or deed.
7
make
an arrangement includes enter into.
8
vary
an arrangement means:
9
(a) vary in accordance with the terms or conditions of the
10
arrangement; or
11
(b) vary with the consent of the non-Commonwealth party or
12
parties to the arrangement.
13
46A Terms and conditions relating to clinical trial arrangements
14
(1) The terms and conditions on which money may be payable by the
15
Commonwealth under an arrangement under section 46 must be set
16
out in a written agreement between the Commonwealth and the
17
corporation.
18
(2) The corporation must comply with the terms and conditions.
19
(3) Without limiting subsection (1), the terms and conditions must
20
provide for the circumstances in which the corporation must repay
21
amounts to the Commonwealth.
22
(4) An agreement under subsection (1) may be entered into on behalf
23
of the Commonwealth by the Minister or the Secretary.
24
Note:
For the power to delegate, see section 46B.
25
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46B Minister or Secretary may delegate powers in relation to
1
arrangements
2
Delegation by the Minister
3
(1) The Minister may, by writing, delegate any or all of the Minister's
4
powers under section 46 or 46A to an SES employee, or acting
5
SES employee, in the Department who is also an official of the
6
Department for the purposes of the
Public Governance,
7
Performance and Accountability Act 2013
.
8
Note:
The expressions
SES employee
and
acting SES employee
are defined
9
in section 2B of the
Acts Interpretation Act 1901
.
10
(2) In exercising powers under a delegation, the delegate must comply
11
with any directions of the Minister.
12
Delegation by the Secretary
13
(3) The Secretary may, by writing, delegate any or all of the
14
Secretary's powers under section 46 or 46A to an SES employee,
15
or acting SES employee, in the Department who is also an official
16
of the Department for the purposes of the
Public Governance,
17
Performance and Accountability Act 2013
.
18
Note:
The expressions
SES employee
and
acting SES employee
are defined
19
in section 2B of the
Acts Interpretation Act 1901
.
20
(4) In exercising powers under a delegation, the delegate must comply
21
with any directions of the Secretary.
22
46C Relationship of this Division with certain other Acts
23
(1) Section 23 of the
Public Governance, Performance and
24
Accountability Act 2013
(which deals with the power of
25
accountable authorities in relation to arrangements and
26
commitments) does not authorise the Secretary to exercise, on
27
behalf of the Commonwealth, a power conferred on the
28
Commonwealth by section 46 of this Act.
29
(2) This Division does not, by implication, limit the operation of the
30
Financial Framework (Supplementary Powers) Act 1997
.
31
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46D Executive power of the Commonwealth
1
This Division does not, by implication, limit the executive power
2
of the Commonwealth.
3
Division 2--Other miscellaneous matters
4
47 Interaction with the
Gene Technology Act 2000
5
(1) A mitochondrial donation technique is taken not to be gene
6
technology for the purposes of the
Gene Technology Act 2000
7
when used as authorised or purportedly authorised by a
8
mitochondrial donation licence.
9
(2) In this section:
10
mitochondrial donation licence
includes a purported
11
mitochondrial donation licence.
12
47A Immunity from civil actions relating to mitochondrial donation
13
licences
14
(1) No civil action, suit or proceeding lies against:
15
(a) the Commonwealth; or
16
(b) a person (a
protected person
) covered by an item of the
17
following table;
18
in respect of loss, damage or injury of any kind suffered by another
19
person as a result of anything done, or omitted to be done, by a
20
protected person in relation to a matter mentioned in the relevant
21
item:
22
23
Immunity from civil actions relating to mitochondrial donation licences
Item
Protected persons
Protected matters
1
any of the following persons:
(a) the Minister;
(b) the Secretary;
(c) a person to whom powers or
functions are delegated under
subsection 29A(8);
the performance or purported
performance, or the exercise or
purported exercise, of the person's
functions, duties or powers under the
following in so far as they relate to
mitochondrial donation licences:
(a) this Act or a legislative
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Immunity from civil actions relating to mitochondrial donation licences
Item
Protected persons
Protected matters
(d) an inspector;
(e) an officer or employee of the
Department;
(f) a member of the NHMRC
Licensing Committee;
(g) the CEO or an employee of the
NHMRC;
(h) a member of a HREC
instrument made under it;
(b) the
Prohibition of Human
Cloning for Reproduction Act
2002
or a legislative instrument
made under that Act
2
a person who the NHMRC
Licensing Committee requests, or
purportedly requests, to provide
advice as mentioned in subsection
28J(4)
the provision, or purported
provision, by the person of advice in
response to such a request
3
a person who gives, or purportedly
gives, information to the Secretary
in accordance with paragraph
28R(5)(b)
the giving, or purported giving, of
the information by the person
1
(2) Subsection (1) does not apply to an act or omission in bad faith.
2
(3) A reference in subsection (1) to anything omitted to be done
3
includes a reference to a failure to make a decision.
4
(4) Subsection (1) is subject to section 40 (compensation for damage).
5
47B Review of operation of Act every 7 years
6
(1) The Minister must cause an independent review of the operation of
7
this Act, in so far as it relates to the use of mitochondrial donation
8
techniques, to be undertaken as soon as possible after the end of:
9
(a) the period of 7 years starting on the commencement of
10
Schedule 1 to the
Mitochondrial Donation Law Reform
11
(Maeve's Law) Act 2021
; and
12
(b) each subsequent 7-year period.
13
(2) A review under this section must be:
14
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(a) undertaken by the persons who undertake the review for the
1
relevant 7-year period required by section 25 of the
2
Prohibition of Human Cloning for Reproduction Act 2002
;
3
and
4
(b) undertaken concurrently with the review mentioned in
5
paragraph (a).
6
(3) The persons undertaking a review under this section must prepare
7
and give to the Minister, for presentation to the Parliament, a report
8
of the review.
9
(4) The report must be given to the Minister within 12 months after the
10
end of the relevant 7-year period.
11
Note:
See also section 34C of the
Acts Interpretation Act 1901
, which
12
contains extra rules about periodic reports.
13
(5) The persons undertaking a review under this section must consult:
14
(a) the Commonwealth and the States; and
15
(b) a broad range of persons with expertise in or experience of
16
relevant disciplines;
17
and the views of the Commonwealth, the States and the persons
18
mentioned in paragraph (b) must be set out in the report to the
19
extent that it is reasonably practicable to do so.
20
(6) Reports under this section and section 25 of the
Prohibition of
21
Human Cloning for Reproduction Act 2002
may be set out in the
22
same document.
23
104 Division 3 of Part 5 (heading)
24
Repeal the heading.
25
105 At the end of section 48
26
Add:
27
(3) Despite subsection 14(2) of the
Legislation Act 2003
, regulations
28
made for the purposes of the following provisions of this Act may
29
make provision in relation to a matter by applying, adopting or
30
incorporating, with or without modification, any matter contained
31
in guidelines issued by the CEO of the NHMRC under the
32
National Health and Medical Research Council Act 1992
as in
33
force or existing from time to time:
34
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(a) Division 4 (general licences) of Part 2;
1
(b) Division 4A (mitochondrial donation licences) of Part 2;
2
(c) a definition in section 7 or 8 of an expression that is used in
3
either or both of those Divisions.
4
Research Involving Human Embryos Regulations 2017
5
106 Section 5 (after the heading)
6
Insert:
7
Note:
A number of expressions used in this instrument are defined in the
8
Act, including the following:
9
(a) National Statement;
10
(b) the NHMRC.
11
107 Section 5 (definition of
ART Guidelines
)
12
Repeal the definition, substitute:
13
ART Guidelines
means the
Ethical guidelines on the use of
14
assisted reproductive technology in clinical practice and research
,
15
issued by the CEO of the NHMRC under the
National Health and
16
Medical Research Council Act 1992
, as existing from time to time.
17
Note:
The ART Guidelines could in 2021 be viewed on the website of the
18
NHMRC (https://www.nhmrc.gov.au).
19
108 Section 5 (definition of
National Statement
)
20
Repeal the definition.
21
109 Section 5 (definition of
Objective Criteria for Unsuitable
22
Embryos
)
23
Repeal the definition, substitute:
24
Objective Criteria for Unsuitable Embryos
means the
Objective
25
Criteria for determining embryos that are unsuitable for
26
implantation
, issued by the CEO of the NHMRC under the
27
National Health and Medical Research Council Act 1992
, as
28
existing from time to time.
29
Note:
The Objective Criteria for Unsuitable Embryos could in 2021 be
30
viewed on the website of the NHMRC (https://www.nhmrc.gov.au).
31
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110 Part 2 (heading)
1
Repeal the heading, substitute:
2
Part 2--Regulation of the use of excess ART
3
embryos and other material
4
Division 1--Provisions relating to general licences
5
111 After section 6
6
Insert:
7
6A Determination by NHMRC Licensing Committee of general
8
licence applications--prescribed guidelines
9
For the purposes of paragraph 21(4)(c) of the Act, the following
10
guidelines are prescribed:
11
(a) the ART Guidelines;
12
(b) the National Statement.
13
112 Section 7
14
Omit "section 8", substitute "subsection 24(9)".
15
113 Before section 8
16
Insert:
17
Division 3--Other provisions
18
114 Section 9
19
Repeal the section.
20
115 Part 4
21
Repeal the Part.
22
Therapeutic Goods (Excluded Goods) Determination 2018
23
116 Schedule 2 (after table item 4D)
24
Insert:
25
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4E
goods that are:
(a) human eggs; or
(b) human sperm
when used in carrying out an activity
as authorised or purportedly
authorised by a mitochondrial
donation licence under the
Research
Involving Human Embryos Act 2002
Schedule 1
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Part 3
Application and transitional provisions
60
Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021
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Part 3--Application and transitional provisions
1
117 Reports to Parliament
2
(1)
For the purposes of a report that is required to be tabled in a House of
3
the Parliament under subsection 19(3) of the
Research Involving Human
4
Embryos Act 2002
during the period of 6 months starting on the
5
commencement of this Schedule, the following are to be disregarded:
6
(a) the amendments of that Act made by this Schedule;
7
(b) any mitochondrial donation licences issued under that Act as
8
amended by this Schedule.
9
(2)
However, any information that would have been required to be included
10
in a report under that subsection apart from subitem (1) must be
11
included in the first report required to be tabled under that subsection
12
after the end of that 6-month period.
13
118 Determination of pre-commencement general licence
14
applications
15
(1)
This item applies in relation to an application for a licence made under
16
subsection 20(1) of the
Research Involving Human Embryos Act 2002
,
17
but not finally determined, before the commencement of this Schedule.
18
(2)
Despite the amendments made by this Schedule, the following
19
provisions, as in force immediately before that commencement,
20
continue to apply on and after that commencement in relation to the
21
application:
22
(a) paragraph 21(3)(c) of the
Research Involving Human
23
Embryos Act 2002
;
24
(b) the following provisions of the
Research Involving Human
25
Embryos Regulations 2017
:
26
(i) the definitions of
ART Guidelines
and
National
27
Statement
in section 5 of those regulations;
28
(ii) sections 7 and 9 of those regulations.
29