[s 5]
Health Legislation Amendment Bill (No. 3) 2025
Part 2 Amendment of Assisted Reproductive Technology Act 2024
Page 10
Authorised by the Parliamentary Counsel
5 Insertion of new s 16A
After section 16—
insert—
16A Consent required for obtaining, or attempting
to obtain, gamete
(1) The consent of a gamete provider is required for
obtaining, or attempting to obtain, a gamete from
the gamete provider for use in an ART procedure
or for storage for use in an ART procedure.
(2) The consent of a gamete provider is not required
for anything authorised under division 5.
(3) The consent of a child includes the consent of a
parent of the child or a person with parental
responsibility for the child.
(4) A reference in this section to a gamete provider
includes, in relation to an attempt to obtain a
gamete, a reference to the individual who would
have been the gamete provider had the attempt
been successful.
6 Amendment of s 18 (Consent of gamete provider in case
of donated gametes or donated embryos)
(1) Section 18(2)(b), from ‘for which’—
omit, insert—
during which the donated gametes or donated
embryos may be used in an ART procedure; and
(2) Section 18—
insert—
(3A) Subsection (1) does not apply to the extent a
donated gamete or donated embryo is used in an
ART procedure under an approval of the chief
executive given, for the purpose of section 25(2)
or 27(1), under section 39B.
Clause 1
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Clause 20
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[s 7]
Health Legislation Amendment Bill (No. 3) 2025
Part 2 Amendment of Assisted Reproductive Technology Act 2024
Page 11
Authorised by the Parliamentary Counsel
(3) Section 18(3A) and (4)—
renumber as section 18(4) and (5).
7 Amendment of s 25 (Limit on number of donor-related
Australian families)
(1) Section 25—
insert—
(1A) Subsection (1) does not apply if the ART provider
has the approval of the chief executive given, for
the purpose of this subsection, under section 39B
to use the donated gamete or donated embryo in
the ART procedure.
(2) Section 25(1A) to (6)—
renumber as section 25(2) to (7).
8 Amendment of s 27 (Time limit on use of donated
gametes or embryos and their disposal)
(1) Section 27(1), ‘written approval of the chief executive’—
omit, insert—
approval of the chief executive given, for the
purpose of this subsection, under section 39B
(2) Section 27(2) and (3)—
omit, insert—
(2) The ART provider must dispose of the donated
gamete or donated embryo, within the period
mentioned in subsection (3), if—
(a) the chief executive has decided under
section 39B(2) to refuse to approve the use
of the donated gamete or donated embryo in
the ART procedure (the refusal decision);
and
(b) either—
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Clause 3
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Clause 14
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[s 9]
Health Legislation Amendment Bill (No. 3) 2025
Part 2 Amendment of Assisted Reproductive Technology Act 2024
Page 12
Authorised by the Parliamentary Counsel
(i) the period for applying for internal
review of the refusal decision under
section 122 has ended and no
application for internal review has been
made; or
(ii) an application for internal review of the
refusal decision has been made under
section 122 and the chief executive has
decided under section 123 to confirm
the refusal decision.
Maximum penalty—100 penalty units.
(3) For subsection (2), the period within which the
ART provider must dispose of the donated gamete
or donated embryo is as soon as practicable after
the end of the period of 90 days starting on—
(a) if subsection (2)(b)(i) applies—the day the
ART provider is given an information notice
for the refusal decision under section
39B(3); or
(b) if subsection (2)(b)(ii) applies—the day the
ART provider is given a notice under section
123(1)(c)(i) of the chief executive’s decision
on the internal review of the refusal
decision.
9 Amendment of s 33 (Information to be collected about
gamete providers)
(1) Section 33(1)(a)(ii), from ‘residential’ to ‘email address’—
omit, insert—
contact information
(2) Section 33(3)—
omit.
(3) Section 33(5), from ‘unless’ to ‘under’—
omit, insert—
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Clause 25
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[s 10]
Health Legislation Amendment Bill (No. 3) 2025
Part 2 Amendment of Assisted Reproductive Technology Act 2024
Page 13
Authorised by the Parliamentary Counsel
for an ART procedure unless the provider has
collected the information mentioned in
(4) Section 33—
insert—
(6) Subsection (4) does not apply if the ART provider
has the approval of the chief executive given
under section 39C to use the gamete or embryo for
the ART procedure.
(7) This section is not limited by, and does not limit,
section 34.
Note—
See section 149 for the application of this section in
relation to gametes obtained before 19 September 2024.
(5) Section 33(4) to (7)—
renumber as section 33(3) to (6).
10 Amendment of s 34 (Transfer between ART providers of
information about gametes or embryos)
(1) Section 34(2)(a) and (b), ‘consents and other information’—
omit, insert—
information mentioned in subsection (3)
(2) Section 34—
insert—
(3) For subsection (2)(a) and (b), the information is—
(a) the information mentioned in section 33(1)
in relation to the gametes or gametes used to
create the embryos; and
(b) any other consents or information in relation
to the gametes or embryos.
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Clause 16
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[s 11]
Health Legislation Amendment Bill (No. 3) 2025
Part 2 Amendment of Assisted Reproductive Technology Act 2024
Page 14
Authorised by the Parliamentary Counsel
11 Amendment of s 35 (Information to be collected about
persons who undergo ART procedures)
(1) Section 35(1)(b), from ‘residential address’ to ‘email
address’—
omit, insert—
contact information
(2) Section 35(1)(d), from ‘any’—
omit, insert—
a spouse of the person at the time of the
procedure, other than a spouse from whom, at that
time, the person is separated and is living
separately and apart.
12 Amendment of s 36 (Keeping of records)
(1) Section 36—
insert—
(2A) An ART provider must keep a record of—
(a) each consent of a person under section 16A
for attempting to obtain a gamete from the
person; and
(b) a notice given to the ART provider by a
gamete provider under section 20(2)
modifying or withdrawing a consent of the
gamete provider under division 3.
(2) Section 36(3)—
insert—
(c) each consent of a person under division 3
undergoing the ART procedures mentioned
in that division.
(3) Section 36(4)(b), from ‘name’ to ‘email address’—
omit, insert—
Clause 1
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Clause 13
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[s 13]
Health Legislation Amendment Bill (No. 3) 2025
Part 2 Amendment of Assisted Reproductive Technology Act 2024
Page 15
Authorised by the Parliamentary Counsel
name and contact information
(4) Section 36—
insert—
(7) A reference in this section to an ART provider
includes a reference to a person who was an ART
provider.
(5) Section 36(2A) to (7)—
renumber as section 36(3) to (8).
13 Amendment of s 37 (Destruction of records prohibited)
(1) Section 37(2), from ‘that’ to ‘authorises’—
omit, insert—
for which the chief executive gives approval
(2) Section 37(3), ‘authorise’—
omit, insert—
give approval for
(3) Section 37—
insert—
(4) If the chief executive decides to refuse to approve
an application for approval to destroy a record
under subsection (3), the chief executive must, as
soon as practicable after the decision is made,
give the applicant an information notice for the
decision.
(5) A reference in this section to an ART provider
includes a reference to a person who was an ART
provider.
14 Insertion of new pt 2, div 8
Part 2—
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2
3
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5
6
7
8
Clause 9
10
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Clause 27
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[s 14]
Health Legislation Amendment Bill (No. 3) 2025
Part 2 Amendment of Assisted Reproductive Technology Act 2024
Page 16
Authorised by the Parliamentary Counsel
insert—
Division 8 Chief executive’s approval
to use particular gametes
or embryos
39A Purpose of division
The purpose of this division is to enable the chief
executive to give an ART provider approval to
use a gamete or embryo in an ART procedure
even though—
(a) for a donated gamete or donated embryo—
(i) the use of the donated gamete or
donated embryo would result in more
than 10 donor-related Australian
families; or
(ii) the donated gamete, or a gamete used
to create the donated embryo, was
obtained from the gamete provider
more than 15 years before the ART
procedure; or
(b) for any gamete or embryo—the ART
provider has not collected the information
mentioned in section 33(1) in relation to the
gamete or a gamete used to create the
embryo.
39B Chief executive may approve use of particular
donated gamete or donated embryo—ss 25
and 27
(1) This section applies for the purposes of section
25(2) or 27(1).
(2) The chief executive may, on application by an
ART provider, approve the use of a donated
gamete or donated embryo in an ART procedure
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[s 14]
Health Legislation Amendment Bill (No. 3) 2025
Part 2 Amendment of Assisted Reproductive Technology Act 2024
Page 17
Authorised by the Parliamentary Counsel
if the chief executive is satisfied—
(a) either—
(i) the gamete provider, or the gamete
provider from whom a gamete used to
create the embryo was obtained, has
consented to the making of the
application by the ART provider; or
(ii) the ART provider has been unable to
contact the gamete provider mentioned
in subparagraph (i) despite taking
reasonable steps to do so; and
(b) there are reasonable grounds for using the
donated gamete or donated embryo in the
ART procedure, having regard to—
(i) the terms of the consent given by the
gamete provider for the use of the
gamete, to the extent the consent
relates to the provision mentioned in
subsection (1) that is the subject of the
application; and
(ii) whether, in the circumstances, the
consequences of giving, or refusing to
give, the approval would be unfairly
harsh for any person.
(3) If the chief executive decides to refuse to approve
an application under subsection (2), the chief
executive must, as soon as practicable after the
decision is made, give the applicant an
information notice for the decision.
39C Chief executive may approve use of other
particular gamete or embryo—s 33
(1) This section applies for the purposes of section
33(5).
(2) The chief executive may, on application by an
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[s 15]
Health Legislation Amendment Bill (No. 3) 2025
Part 2 Amendment of Assisted Reproductive Technology Act 2024
Page 18
Authorised by the Parliamentary Counsel
ART provider, approve the use of a gamete or
embryo in an ART procedure if the chief
executive is satisfied—
(a) the ART provider has taken reasonable steps
to collect the information mentioned in
section 33(1) in relation to the gamete or a
gamete used to create the embryo; and
(b) there are reasonable grounds for using the
gamete or embryo, having regard to—
(i) the information the ART provider has
collected; and
(ii) whether, in the circumstances, the
consequences of giving, or refusing to
give, the approval would be unfairly
harsh for any person.
(3) If the chief executive decides to approve an
application under subsection (2), the applicant
and any other ART provider to whom the gamete
or embryo is supplied—
(a) may use the gamete or embryo despite
section 33(4); and
(b) is taken to have complied with section 33(1)
in relation to the gamete, or a gamete used
to create the embryo.
(4) If the chief executive decides to refuse to approve
an application under subsection (2), the chief
executive must, as soon as practicable after the
decision is made, give the applicant an
information notice for the decision.
15 Amendment of s 40 (Definitions for part)
(1) Section 40, definition contact information—
omit.
(2) Section 40, definition relevant information, from ‘, relating’—
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Clause 30
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[s 16]
Health Legislation Amendment Bill (No. 3) 2025
Part 2 Amendment of Assisted Reproductive Technology Act 2024
Page 19
Authorised by the Parliamentary Counsel
omit, insert—
see section 44(1).
16 Amendment of s 41 (Information relating to
donor-conceived persons to which part applies)
(1) Section 41, heading, ‘relating to donor-conceived persons’—
omit.
(2) Section 41, from ‘relating’—
omit, insert—
in relation to a donor-conceived person.
17 Amendment of s 44 (Relevant information to be included
in register)
(1) Section 44(1)—
omit, insert—
(1) The information mentioned in subsection (2) (the
relevant information), in relation to a
donor-conceived person, that is provided to the
registrar is the information that is to be included
in the register.
(2) Section 44(2)(i)—
omit, insert—
(i) the full name and date of birth of—
(i) the person who gave birth to the
donor-conceived person as a result of
the procedure; and
(ii) a spouse of the person at the time of the
procedure, other than a spouse from
whom, at that time, the person was
separated and was living separately and
apart;
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Clause 3
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Clause 10
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[s 18]
Health Legislation Amendment Bill (No. 3) 2025
Part 2 Amendment of Assisted Reproductive Technology Act 2024
Page 20
Authorised by the Parliamentary Counsel
18 Amendment of s 45 (Mandatory provision of information
by ART providers)
Section 45(1), ‘relating to the birth of a donor-conceived
person’—
omit, insert—
in relation to a donor-conceived person born
19 Amendment of s 46 (Mandatory provision of historical
information)
Section 46(1)(a), ‘relates to the birth of a donor-conceived
person’—
omit, insert—
is information in relation to a donor-conceived
person born
20 Amendment of s 47 (Voluntary provision of information
by parties to private donor conception procedures)
Section 47(1), ‘relating to the birth of a donor-conceived
person’—
omit, insert—
in relation to a donor-conceived person born
21 Insertion of new s 56A
Before section 57—
insert—
56A Meaning of accreditation standard
(1) The accreditation standard is a document that—
(a) provides for matters in relation to prescribed
accreditation; and
(b) is approved by regulation for this paragraph,
with or without modifications.
Clause 1
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Clause 7
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Clause 14
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Clause 20
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[s 22]
Health Legislation Amendment Bill (No. 3) 2025
Part 2 Amendment of Assisted Reproductive Technology Act 2024
Page 21
Authorised by the Parliamentary Counsel
(2) The Minister may recommend to the Governor in
Council the making of a regulation under
subsection (1) only if the Minister is satisfied the
document, including any modifications, provides
for the following matters—
(a) persons who are personnel for sections
57(2)(b)(iv), 61(1) and 65(2)(d);
(b) events that are serious adverse events for
section 61.
22 Amendment of s 57 (Application for licence)
(1) Section 57(1)(a), ‘RTAC accreditation’—
omit, insert—
prescribed accreditation
(2) Section 57(2)(b)(iv), from ‘any’ to ‘regulation’—
omit, insert—
the name of each of the personnel, within the
meaning of the accreditation standard,
23 Amendment of s 61 (Chief executive to be notified of
certain events)
(1) Section 61(1), table, items 2 and 3, column 1, ‘RTAC
accreditation’—
omit, insert—
prescribed accreditation
(2) Section 61(1), table, item 8, column 1, from ‘any’ to
‘regulation’—
omit, insert—
any of the personnel, within the meaning of the
accreditation standard,
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Clause 10
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Clause 18
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[s 24]
Health Legislation Amendment Bill (No. 3) 2025
Part 2 Amendment of Assisted Reproductive Technology Act 2024
Page 22
Authorised by the Parliamentary Counsel
(3) Section 61(3), definition serious adverse event, ‘prescribed by
regulation’—
omit, insert—
identified in the accreditation standard
24 Amendment of s 64 (Cancellation or suspension of
licence)
Section 64(1)(a), ‘RTAC accreditation’—
omit, insert—
prescribed accreditation
25 Amendment of s 65 (Public register of licensed providers)
(1) Section 65(2)(d), from ‘names’ to ‘regulation’—
omit, insert—
name of each of the personnel, within the meaning
of the accreditation standard,
(2) Section 65(2)(e)—
omit, insert—
(e) the date of expiry of the prescribed
accreditation of the licensed provider;
26 Amendment of s 111 (Power to require information)
(1) Section 111—
insert—
(1A) This section also applies if an inspector
reasonably believes—
(a) a person may be able to give information
(compliance information) about a licensed
provider's compliance with this Act; and
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Clause 5
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Clause 10
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Clause 19
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