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This is a Bill, not an Act. For current law, see the Acts databases.
Western Australia
Human Reproductive Technology Amendment
Bill 2003
CONTENTS
1. Short title 1
2. Commencement 2
3. The Act amended 2
4. Preamble amended 2
5. Section 3 amended 3
6. Section 3A inserted 8
7. Section 4 amended 9
8. Section 5A inserted 9
9. Section 6 amended 10
10. Section 7 amended 11
11. Section 14 amended 12
12. Section 17 amended 14
13. Section 18 amended 15
14. Section 20 amended 16
15. Section 21 amended 16
16. Section 22 amended 18
17. Section 23 amended 21
18. Section 24 amended 21
19. Section 25 amended 23
20. Section 26 amended 24
21. Section 27 amended 26
22. Section 28 amended 27
23. Section 28A inserted 27
24. Section 29 amended 28
25. Section 30 amended 28
26. Section 32 amended 29
27. Section 33 amended 29
28. Section 40 amended 31
page i
212--3
Human Reproductive Technology Amendment Bill 2003
Contents
29. Section 41 amended 31
30. Section 44 amended 31
31. Section 45 amended 33
32. Section 48 amended 33
33. Section 49 amended 34
34. Section 51 amended 36
35. Section 53 amended 37
36. Part 4B inserted 37
37. Section 54 amended 62
38. Section 56 amended 63
39. Section 57 amended 63
40. Section 59 amended 64
page ii
Western Australia
LEGISLATIVE ASSEMBLY
(As amended in Committee)
Human Reproductive Technology Amendment
Bill 2003
A Bill for
An Act to amend the Human Reproductive Technology Act 1991.
The Parliament of Western Australia enacts as follows:
1. Short title
This Act may be cited as the Human Reproductive Technology
Amendment Act 2003.
page 1
Human Reproductive Technology Amendment Bill 2003
s. 2
2. Commencement
This Act comes into operation on a day fixed by proclamation.
3. The Act amended
The amendments in this Act are to the Human Reproductive
5 Technology Act 1991*.
[*Act No. 22 of 1991.
For subsequent amendments see Western Australian
Legislation Information Tables for 2002, Table 1, p. 177.]
4. Preamble amended
10 (1) Paragraph B of the Preamble is amended as follows:
(a) by deleting "egg in the process of fertilisation or" in the
first place where it occurs;
(b) by inserting before "disease" --
" a ";
15 (c) by deleting "by giving an egg in the process of
fertilisation or an embryo all reasonable opportunities
for implanting".
(2) Paragraph C of the Preamble is amended as follows:
(a) by deleting "non harmful research and diagnostic
20 procedures upon an egg in the process of fertilisation or
an embryo" and inserting instead --
"
research procedures and other uses upon a human
embryo
25 ";
(b) by deleting "egg in the process of fertilisation or an" in
the second place where it occurs.
(3) Paragraph D of the Preamble is deleted.
page 2
Human Reproductive Technology Amendment Bill 2003
s. 5
5. Section 3 amended
(1) Section 3(1) is amended in the definition of "authorised officer"
as follows:
(a) after paragraph (b) by deleting "and";
5 (b) after paragraph (c) by inserting --
"
and
(d) in relation to the powers referred to in
section 54, a person on whom the powers are
10 conferred by the Commissioner of Health
under section 53ZQ(4);
".
(2) Section 3(1) is amended in the definition of "biological parent"
as follows:
15 (a) in paragraph (a) by deleting "an egg or sperm" and
inserting instead --
" a human egg or human sperm ";
(b) in paragraph (b) by deleting "an embryo" and inserting
instead --
20 " a human embryo ".
(3) Section 3(1) is amended in the definition of "fertilisation" by
deleting "with the appearance of a two-cell zygote;" and
inserting instead --
" when an embryo is formed; ".
25 (4) Section 3(1) is amended in the definition of "in vitro
fertilisation procedure" as follows:
(a) in paragraph (a) by deleting "an egg" in the first place
where it occurs and inserting instead --
" a human egg ";
page 3
Human Reproductive Technology Amendment Bill 2003
s. 5
(b) in paragraph (a)(ii) by deleting "an egg in the process of
fertilisation or an embryo" and inserting instead --
"
a human egg undergoing fertilisation or
5 a human embryo
";
(c) in paragraph (a)(iii) by deleting "egg in the process of
fertilisation or embryo" and inserting instead --
"
10 human egg undergoing fertilisation or
human embryo
";
(d) by deleting paragraph (b)(i) and inserting instead the
following subparagraph --
15 "
(i) a human egg;
";
(e) in paragraph (b)(ii) by deleting "an egg in the process of
fertilisation or an embryo, whether produced by that
20 woman or by another woman and" and inserting
instead --
"
a human egg undergoing fertilisation or
a human embryo,
25 ".
(5) Section 3(1) is amended in the definition of "Institutional Ethics
Committee" by deleting paragraph (b) and inserting instead --
"
(b) functions, and a composition, complying
30 with requirements of the NHMRC relating to
ethical oversight of research involving
humans;
".
page 4
Human Reproductive Technology Amendment Bill 2003
s. 5
(6) Section 3(1) is amended in the definition of "licensee" as
follows:
(a) by deleting "this Act" and inserting instead --
" Part 4 ";
5 (b) by inserting before paragraph (a) the following
paragraph --
"
(aa) a person who holds an exemption under
section 28A;
10 ";
(c) in paragraph (b) by deleting "person responsible," and
inserting instead --
" licence supervisor, ".
(7) Section 3(1) is amended in paragraph (a)(ii) of the definition of
15 "participant" by deleting "gametes, of an egg in the process of
fertilisation, or of an embryo" and inserting instead --
"
human gametes, of a human egg
undergoing fertilisation or of a human
20 embryo
".
(8) Section 3(1) is amended in paragraph (b) of the definition of
"reproductive technology" as follows:
(a) by deleting "gametes" and inserting instead --
25 " human gametes ";
(b) by deleting "eggs in the process of fertilisation or
embryos;" and inserting instead --
"
human eggs undergoing fertilisation or
30 human embryos;
".
page 5
Human Reproductive Technology Amendment Bill 2003
s. 5
(9) Section 3(1) is amended by deleting the definitions of
"chimaera", "cloning", "embryo", "embryo flushing",
"exemption", "parthenogenesis" and "person responsible".
(10) Section 3(1) is amended by deleting the full stop at the end of
5 the definition of "treatment" and inserting instead a semicolon.
(11) Section 3(1) is amended by inserting in the appropriate
alphabetical positions the following definitions --
"
"Commonwealth Human Embryo Act" means the
10 Research Involving Human Embryos Act 2002 of
the Commonwealth;
"excess ART embryo" has the meaning given to that
term in section 53T;
"exemption" means --
15 (a) an exemption that is applied for and is not
refused, or is specifically issued, under
section 28; or
(b) an exemption under section 28A;
"human egg" means a live human egg;
20 "human embryo" has the meaning given to that term
in section 3A;
"human gamete" means a human egg or a human
sperm;
"human sperm" means live human sperm or
25 spermatids;
"licence supervisor", in relation to a licence or
exemption, means the individual under whose
supervision the storage or practice authorised is, or
is to be, carried on;
30 "NHMRC" means the National Health and Medical
Research Council established by the National
Health and Medical Research Council Act 1992 of
the Commonwealth;
page 6
Human Reproductive Technology Amendment Bill 2003
s. 5
"NHMRC licence" means a licence granted under --
(a) section 53ZB; or
(b) section 21 of the Commonwealth Human
Embryo Act;
5 "summary conviction penalty", in relation to a crime,
has the same meaning as that term has in section 5
of The Criminal Code;
"woman" means any female human.
".
10 (12) Section 3(2) is amended as follows:
(a) by inserting after "This Act" --
" , other than Part 4B ";
(b) by deleting "an egg in the process of fertilisation or an
embryo" and inserting instead --
15 "
a human egg undergoing fertilisation or a human
embryo
";
(c) by deleting paragraph (b) and inserting instead --
20 "
(b) only if the egg or the embryo has been or is
developed in consequence of an in vitro
fertilisation procedure.
".
25 (13) Section 3(3) is amended as follows:
(a) by deleting paragraph (a);
(b) in paragraph (b) --
(i) by deleting "an egg," and inserting instead --
" a human egg, "; and
30 (ii) by deleting "an egg in the process of
fertilisation;" and inserting instead --
" a human egg undergoing fertilisation; ";
page 7
Human Reproductive Technology Amendment Bill 2003
s. 6
(c) in paragraph (d) by deleting "sperm" and inserting
instead --
" human sperm ".
(14) Section 3(4) is amended as follows:
5 (a) by deleting "gametes, an egg in the process of
fertilisation or any embryo," and inserting instead --
"
human gametes, a human egg undergoing fertilisation
or a human embryo
10 ";
(b) in paragraph (b) by deleting "gametes which are, or egg,
egg in the process of fertilisation or embryo" and
inserting instead --
"
15 human gametes which are or a human egg or
embryo
".
(15) Section 3(5) is amended by deleting "person responsible" in
each place where it occurs and inserting instead --
20 " licence supervisor ".
6. Section 3A inserted
After section 3 the following section is inserted --
"
3A. Meaning of "human embryo"
25 (1) In this Act --
"human embryo" means a live embryo that has a
human genome or an altered human genome and
that has been developing for less than 8 weeks
since the appearance of 2 pro-nuclei or the
30 initiation of its development by other means.
page 8
Human Reproductive Technology Amendment Bill 2003
s. 7
(2) For the purposes of the definition of "human embryo"
in subsection (1), in working out the length of the
period of development of a human embryo, any period
when the development of the embryo is suspended is to
5 be disregarded.
".
7. Section 4 amended
(1) Section 4 is amended as follows:
(a) by inserting before "The" the subsection designation
10 "(1)";
(b) by deleting "The" and inserting instead --
" Generally, the ".
(2) At the end of section 4 the following subsection is inserted --
"
15 (2) The particular objects of Part 4B are set out in
section 53S.
".
8. Section 5A inserted
After section 5 the following section is inserted into Part 1
20 Division 2 --
"
5A. Application
This Division does not apply in relation to an excess
ART embryo except in relation to a use of such an
25 embryo that is an exempt use as defined in
section 53W(2).
".
page 9
Human Reproductive Technology Amendment Bill 2003
s. 9
9. Section 6 amended
(1) Section 6(1) is amended as follows:
(a) in paragraph (a)(i) by deleting "an egg" and inserting
instead --
5 " a human egg ";
(b) in paragraph (a)(ii) by deleting "an egg in the process
of " and inserting instead --
" a human egg undergoing ";
(c) in paragraph (a)(iii) by deleting "an embryo;" and
10 inserting instead --
" a human embryo; ";
(d) in paragraph (b) by deleting "sperm," and inserting
instead --
" human sperm, ";
15 (e) by deleting "or" after paragraph (b);
(f) by deleting the comma at the end of paragraph (c) and
inserting instead --
"
; or
20 (d) any other use, outside the body of a woman, of
a human embryo, if the use is not for a purpose
relating to the reproductive technology
treatment of the woman,
".
25 (2) Section 6(2) and (3) are repealed and the following subsection is
inserted instead --
"
(2) A person who contravenes subsection (1) commits a
crime and is liable to imprisonment for 5 years.
30 Summary conviction penalty: Imprisonment for
one year.
".
page 10
Human Reproductive Technology Amendment Bill 2003
s. 10
10. Section 7 amended
(1) Section 7(1) is amended as follows:
(a) by deleting "who causes or permits --" and inserting
instead --
5 " must not cause or permit -- ";
(b) in paragraph (a) by deleting "an egg in the process of
fertilisation, or any embryo," and inserting instead --
"
a human egg undergoing fertilisation, or any
10 embryo,
";
(c) after paragraph (a) by inserting "or";
(d) in paragraph (b) by deleting "an egg in the process of
fertilisation, or any embryo," and inserting instead --
15 "
a human egg undergoing fertilisation, or any
embryo,
";
(e) by deleting the semicolon at the end of paragraph (b)
20 and inserting instead a full stop;
(f) by deleting paragraphs (c) to (j);
(g) by deleting "commits an offence.".
(2) Section 7(2), (3) and (4) are repealed and the following
subsection is inserted instead --
25 "
(2) A person who contravenes subsection (1) commits a
crime and is liable to imprisonment for 5 years.
Summary conviction penalty: Imprisonment for
one year.
30 ".
page 11
Human Reproductive Technology Amendment Bill 2003
s. 11
(3) Section 7(5) is amended as follows:
(a) in paragraph (a) by deleting "any gametes, or any egg in
the process of fertilisation or embryo" and inserting
instead --
5 "
human gametes, a human egg undergoing
fertilisation or a human embryo
";
(b) by deleting "$10 000 or".
10 11. Section 14 amended
(1) Section 14(1) is amended as follows:
(a) in paragraph (c) by deleting "person responsible" and
inserting instead --
" licence supervisor ";
15 (b) in paragraph (e)(i) by deleting "egg" and inserting
instead --
" human egg ";
(c) in paragraph (e)(ii) by deleting "gametes" and inserting
instead --
20 " human gametes ";
(d) in paragraph (e)(iii) by deleting "egg in the process of "
and inserting instead --
" human egg undergoing ";
(e) in paragraph (e)(iv) by deleting "embryo" and inserting
25 instead --
" human embryo ".
(2) Section 14(2) is repealed and the following subsections are
inserted instead --
"
30 (2) Subsection (1)(e)(iv) does not apply in relation to an
excess ART embryo except in relation to the use of
page 12
Human Reproductive Technology Amendment Bill 2003
s. 11
such an embryo that is an exempt use as defined in
section 53W(2).
(2a) The Council must not grant approval to any research
being conducted upon or with a human embryo
5 unless --
(a) the embryo is intended for use in the
reproductive technology treatment of a woman
and the Council is satisfied, on the basis of
existing scientific and medical knowledge, that
10 the research is unlikely to leave the embryo
unfit to be implanted in the body of a woman;
or
(b) the research consists of a use referred to in
section 53W(2)(b) or (f).
15 (2b) The Council must not grant approval to any diagnostic
procedure to be carried out upon or with a human
embryo unless --
(a) the embryo is intended for use in the
reproductive technology treatment of a woman
20 and the Council is satisfied, on the basis of
existing scientific and medical knowledge,
that --
(i) the diagnostic procedure is unlikely to
leave the embryo unfit to be implanted
25 in the body of a woman; and
(ii) where the diagnostic procedure is for
the genetic testing of the embryo, there
is a significant risk of a serious genetic
abnormality or disease being present in
30 the embryo;
or
(b) the diagnostic procedure consists of a use
referred to in section 53W(2)(d) or (f).
".
page 13
Human Reproductive Technology Amendment Bill 2003
s. 12
(3) Section 14(3)(b) is amended as follows:
(a) in subparagraph (i) by deleting "National Health and
Medical Research Council," and inserting instead --
" NHMRC, ";
5 (b) in subparagraph (ii) by deleting "the Reproductive
Technology Accreditation Committee for the Fertility
Society of Australia" and inserting instead --
" a body referred to in section 29(5)(a)(i) or (ii) ";
(c) in subparagraph (iii) by deleting "principal" and
10 inserting instead --
" principle ".
12. Section 17 amended
Section 17 is amended as follows:
(a) by inserting after "prohibit" --
15 "
the mixing in the same artificial fertilisation procedure
of multiple sources of
";
(b) by deleting paragraphs (a) and (b) and "or" between
20 those paragraphs and inserting instead --
"
(a) human gametes;
(b) human eggs undergoing fertilisation; or
(c) human embryos,
25 in such a manner as may create confusion as to the
biological parentage of any child born as a result of the
procedure.
".
page 14
Human Reproductive Technology Amendment Bill 2003
s. 13
13. Section 18 amended
(1) Section 18(1) is amended as follows:
(a) in paragraph (c) by inserting before "gametes" --
" human ";
5 (b) in paragraph (c) by deleting ", including their genetic
modification";
(c) in paragraph (d) by deleting "an embryo" and inserting
instead --
" a human embryo ";
10 (d) in paragraph (d) by deleting "any gametes, egg in the
process of fertilisation or embryo" and inserting
instead --
"
human gametes, a human egg undergoing
15 fertilisation or a human embryo
";
(e) in paragraph (f) by deleting "gametes, eggs in the
process of fertilisation or embryos" and inserting
instead --
20 "
human gametes, human eggs undergoing
fertilisation or human embryos
".
(2) Section 18(2)(a)(ii) is amended by deleting "any gametes, egg
25 in the process of fertilisation or embryo;" and inserting
instead --
"
human gametes, a human egg
undergoing fertilisation or a human
30 embryo;
".
page 15
Human Reproductive Technology Amendment Bill 2003
s. 14
14. Section 20 amended
(1) Section 20(2)(a) is amended as follows:
(a) in subparagraph (i) by deleting "gametes" and inserting
instead --
5 " human gametes ";
(b) in subparagraph (ii) by deleting "an egg in the process of
fertilisation, or any embryo" and inserting instead --
"
a human egg undergoing fertilisation or
10 a human embryo
".
(2) After section 20(2) the following subsection is inserted --
"
(2a) Subsection (2)(a)(ii) does not apply in relation to an
15 excess ART embryo except in relation to a use of such
an embryo that is an exempt use as defined in
section 53W(2).
".
15. Section 21 amended
20 Section 21 is amended as follows:
(a) in paragraph (c) by deleting "gametes, eggs in the process
of fertilisation or embryos" and inserting instead --
"
human gametes, human eggs undergoing
25 fertilisation or human embryos
";
(b) in paragraph (d) by deleting "gametes, eggs in the process
of fertilisation or embryos," and inserting instead --
"
30 human gametes, human eggs undergoing
fertilisation or human embryos,
";
page 16
Human Reproductive Technology Amendment Bill 2003
s. 15
(c) in paragraph (f) by deleting "gametes, eggs in the
process of fertilisation or embryos;" and inserting
instead --
"
5 human gametes, human eggs undergoing
fertilisation or human embryos;
";
(d) in paragraph (g) by deleting "gametes, eggs in the
process of fertilisation or embryos;" and inserting
10 instead --
"
human gametes, human eggs undergoing
fertilisation or human embryos;
";
15 (e) in paragraph (h) by deleting "gametes, eggs in the
process of fertilisation or embryos" and inserting
instead --
"
human gametes, human eggs undergoing
20 fertilisation or human embryos
";
(f) in paragraph (i) by deleting "gametes, egg in the process
of fertilisation or embryo" and inserting instead --
"
25 human gametes, human eggs undergoing
fertilisation or human embryos
";
(g) in paragraph (j) by deleting "egg in the process of
fertilisation or embryo" and inserting instead --
30 "
human egg undergoing fertilisation or human
embryo
";
page 17
Human Reproductive Technology Amendment Bill 2003
s. 16
(h) in paragraph (k) by deleting "egg in the process of
fertilisation or an embryo" and inserting instead --
"
human egg undergoing fertilisation or human
5 embryo
".
16. Section 22 amended
(1) Section 22(1) is amended as follows:
(a) by deleting "Where by or under this Act consent is
10 required to be given in relation to the use or keeping of
any gametes, egg in the process of fertilisation or
embryo --" and inserting instead --
"
For the purposes of the licence condition referred to in
15 section 33(2)(e) --
";
(b) in paragraph (c) by deleting "egg in the process of
fertilisation or embryo" and inserting instead --
"
20 human egg undergoing fertilisation or human
embryo
";
(c) in paragraph (d) by deleting "in the process of
fertilisation or an embryo" and inserting instead --
25 " undergoing fertilisation or a human embryo ";
(d) in paragraph (e) by deleting "an egg in the process of
fertilisation or an embryo" and inserting instead --
"
a human egg undergoing fertilisation or a
30 human embryo
";
page 18
Human Reproductive Technology Amendment Bill 2003
s. 16
(e) after paragraph (e)(i) by inserting the following
subparagraphs --
"
(ia) in the case of a use outside the body of a
5 woman, there is an effective consent to
the use for that purpose by the woman on
whose behalf it is being developed and
her spouse or defacto partner, if any;
(ib) in the case of implantation in the body of
10 a woman, there is an effective consent to
the implantation by the woman and her
spouse or defacto partner, if any;
".
(2) Section 22(2) is amended as follows:
15 (a) by deleting "gametes" in each place where it occurs and
inserting instead --
" human gametes ";
(b) by deleting "whether eggs" and inserting instead --
" whether human eggs ";
20 (c) by deleting "sperm" in the first and third places where it
occurs and inserting instead --
" human sperm ";
(d) by deleting "egg in the process of fertilisation or
embryo" and inserting instead --
25 "
human egg undergoing fertilisation or human embryo
";
(e) in paragraph (b) by deleting "an egg in the process of
fertilisation, or an embryo," and inserting instead --
30 "
a human egg undergoing fertilisation or a
human embryo,
";
page 19
Human Reproductive Technology Amendment Bill 2003
s. 16
(f) in paragraph (b) by deleting "any egg" and inserting
instead --
" any human egg ";
(g) by deleting "where an egg in the process of fertilisation,
5 or an embryo," and inserting instead --
"
where a human egg in the process of fertilisation, or a
human embryo,
";
10 (h) by deleting "particular egg in the process of " and
inserting instead --
" particular egg undergoing ".
(3) Section 22(3) is amended by deleting "gametes, egg in the
process of fertilisation or embryo" and inserting instead --
15 "
human gametes, human eggs undergoing fertilisation or
human embryos
".
(4) Section 22(4) is amended by deleting "gametes, egg in the
20 process of fertilisation or embryo" and inserting instead --
"
human gametes, a human egg undergoing fertilisation
or a human embryo
".
25 (5) Section 22(5) is repealed and the following subsection is
inserted instead --
"
(5) A consent to the use of a human egg undergoing
fertilisation or a human embryo must specify the
30 purposes for which the egg or embryo may be used and
may specify conditions subject to which the egg or
embryo shall or shall not be used.
".
page 20
Human Reproductive Technology Amendment Bill 2003
s. 17
(6) Section 22(6) is amended by deleting "gametes, egg in the
process of fertilisation or embryo" and inserting instead --
"
human gametes, a human egg undergoing fertilisation
5 or a human embryo
".
(7) Section 22(8) is amended by deleting "gametes, egg in the
process of fertilisation or embryo" and inserting instead --
"
10 human gametes, a human egg undergoing fertilisation
or a human embryo
".
17. Section 23 amended
Section 23(a)(ii) is amended by inserting before "disease" --
15 " a ".
18. Section 24 amended
(1) Section 24(1) is amended as follows:
(a) by deleting "any eggs, sperm, egg in the process of
fertilisation or embryo --" and inserting instead --
20 "
any human gametes, human egg undergoing
fertilisation or human embryo --
";
(b) in paragraph (a) by deleting "an egg in the process of
25 fertilisation or any embryo" and inserting instead --
" a human embryo ";
(c) in paragraph (a) by deleting "egg or embryo" and
inserting instead --
"
30 embryo or its probable future use under an
NHMRC licence
";
page 21
Human Reproductive Technology Amendment Bill 2003
s. 18
(d) in paragraph (b) by deleting subparagraphs (i), (ii) and
(iii) and the "or" between subparagraphs (ii) and (iii)
and inserting instead --
"
5 (i) human gametes;
(ii) a human egg undergoing fertilisation; or
(iii) a human embryo,
";
(e) by deleting "no egg in the process of fertilisation or
10 embryo" and inserting instead --
"
no human egg undergoing fertilisation or
human embryo
";
15 (f) by deleting "the permitted storage period" and inserting
instead --
" 10 years ".
(2) Section 24(1a) is amended as follows:
(a) by inserting after "may" --
20 " , on an application by an eligible person, ";
(b) by deleting "an egg in the process of fertilisation or an
embryo" and inserting instead --
"
a human egg undergoing fertilisation or a human
25 embryo
".
(3) Section 24(1c) is amended by deleting "the permitted storage
period" and inserting instead --
" 10 years ".
page 22
Human Reproductive Technology Amendment Bill 2003
s. 19
(4) Section 24(2), (3) and (4) are repealed and the following
subsections are inserted instead --
"
(2) In subsection (1a) --
5 "eligible person", in relation to a human egg undergoing
fertilisation or a human embryo, means --
(a) a person who is or is to be a participant in an
artificial fertilisation procedure in which the
egg or embryo is to be used;
10 (b) a person for whom the egg or embryo was
developed; or
(c) in the case of an excess ART embryo, except
in relation to the use of such an embryo
referred to in section 10(2)(e) of the
15 Commonwealth Human Embryo Act, the
licensee.
(3) Three months before the end of a period of storage
permitted under this section the licensee must take
reasonable steps to notify each person for whom the
20 human egg undergoing fertilisation or human embryo
is being stored.
(4) If a period of storage permitted under this section comes
to an end and no application has been made for the
extension of the storage period, the licensee may, if the
25 licensee has complied with subsection (3), allow the
human egg undergoing fertilisation or the human embryo
to succumb and will not be liable to anyone for so doing.
".
19. Section 25 amended
30 Section 25 is amended as follows:
(a) by deleting "gametes --" and inserting instead --
" human gametes -- ";
page 23
Human Reproductive Technology Amendment Bill 2003
s. 20
(b) in paragraph (a) by deleting "eggs and sperm," and
inserting instead --
" human eggs and human sperm, ";
(c) in paragraph (b) by deleting "where gametes" and
5 inserting instead --
" where human gametes ";
(d) in paragraph (b)(i) by deleting "an egg in the process of
fertilisation or an embryo" and inserting instead --
"
10 a human egg undergoing fertilisation or
a human embryo
";
(e) in paragraph (c) by deleting "gametes" and inserting
instead --
15 " human gametes ".
20. Section 26 amended
(1) Before section 26(1) the following subsection is inserted into
section 26 --
"
20 (1a) This section does not apply in relation to an excess
ART embryo except in relation to the use of such an
embryo that is an exempt use as defined in
section 53W(2).
".
25 (2) Section 26(1) is amended as follows:
(a) by deleting "In" and inserting instead --
" Subject to section 24(4), in ";
page 24
Human Reproductive Technology Amendment Bill 2003
s. 20
(b) by deleting "egg in the process of fertilisation or
embryo" and inserting instead --
"
human egg undergoing fertilisation or human embryo
5 ";
(c) in paragraph (a) by deleting "for implantation";
(d) in paragraph (a) by deleting "an egg in the process of
fertilisation or embryo" and inserting instead --
"
10 a human egg undergoing fertilisation or a
human embryo
";
(e) in paragraph (c) by deleting "gametes an egg in the
process of fertilisation or embryo" and inserting
15 instead --
"
human gametes, a human egg undergoing
fertilisation or a human embryo
";
20 (f) in paragraph (c) by deleting "gamete" and inserting
instead --
" human gamete ";
(g) in paragraph (c) by deleting "gametes" and inserting
instead --
25 " human gametes ";
(h) in paragraph (d) by deleting "an egg in the process of "
and inserting instead --
" a human egg undergoing ";
(i) in paragraph (d) by deleting "an embryo" and inserting
30 instead --
" a human embryo ";
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Human Reproductive Technology Amendment Bill 2003
s. 21
(j) in paragraph (d) by inserting after "that purpose," --
" the egg may be used ";
(k) in paragraph (d) by deleting "it may be donated for the
purpose of providing treatment for a specific recipient";
5 (l) in paragraph (e) by deleting "an egg in the process of
fertilisation or in an embryo" and inserting instead --
"
a human egg undergoing fertilisation or a
human embryo
10 ".
(3) Section 26(2) is amended by deleting "an egg in the process of
fertilisation or an embryo" and inserting instead --
"
a human egg undergoing fertilisation or a human
15 embryo
".
21. Section 27 amended
(1) Section 27(1)(d) is amended by inserting after "section 28" --
" or 28A ".
20 (2) Section 27(2) is amended as follows:
(a) in paragraph (a)(i) by deleting "egg" and inserting
instead --
" human egg ";
(b) in paragraph (a) by deleting subparagraphs (ii) and (iii) and
25 the "or" between those paragraphs and inserting instead --
"
(ii) any human embryo; or
(iii) any human egg undergoing fertilisation;
";
page 26
Human Reproductive Technology Amendment Bill 2003
s. 22
(c) in paragraph (b) by deleting "sperm" and inserting
instead --
" human sperm ".
(3) Section 27(4)(a)(v) is amended by deleting "person responsible"
5 and inserting instead --
" licence supervisor ".
22. Section 28 amended
(1) Section 28(1) is amended by deleting "Act" and inserting
instead --
10 " Part ".
(2) Section 28(2) is amended as follows:
(a) in paragraph (a) by deleting "Act" and inserting
instead --
" Part ";
15 (b) in paragraph (b) by deleting "person responsible" and
inserting instead --
" licence supervisor ".
(3) Section 28(3) is amended by deleting "Act" and inserting
instead --
20 " Part ".
23. Section 28A inserted
After section 28 the following section is inserted --
"
28A. Exemptions relating to storage of certain embryos
25 (1) The Commissioner of Health may, on an application by
a person who holds an NHMRC licence grant an
exemption from the requirement to hold a licence
under this Part to store excess ART embryos to which
the NHMRC licence applies.
page 27
Human Reproductive Technology Amendment Bill 2003
s. 24
(2) A person who holds an exemption under subsection (1)
is not required to hold a licence under this Part to store
the excess ART embryos.
(3) A person who holds an exemption under subsection (1)
5 is subject to the disciplinary procedures in relation to
that exemption as if the exemption were a licence
under this Part and the person were the licence
supervisor in relation to that licence.
".
10 24. Section 29 amended
(1) After section 29(5)(a) the following paragraph is inserted --
"
(aa) that the applicant is accredited to carry out
reproductive technology by --
15 (i) the Reproductive Technology
Accreditation Committee of the Fertility
Society of Australia; or
(ii) if the regulations prescribe another body
or other bodies in addition to, or instead
20 of, the body mentioned in paragraph (a),
that other body or any of those other
bodies, as the case requires;
".
(2) Section 29(6)(b)(i) is amended by deleting "person responsible"
25 and inserting instead --
" licence supervisor ".
25. Section 30 amended
Section 30(4) is amended as follows:
(a) by deleting "person responsible" and inserting
30 instead --
" licence supervisor ";
page 28
Human Reproductive Technology Amendment Bill 2003
s. 26
(b) in paragraph (a) by deleting "gametes, egg in the process
of fertilisation, embryo" and inserting instead --
"
human gametes, a human egg undergoing
5 fertilisation or a human embryo
".
26. Section 32 amended
Section 32(3) is amended by deleting "person responsible" and
inserting instead --
10 " licence supervisor ".
27. Section 33 amended
(1) Section 33(2) is amended as follows:
(a) by deleting "Act" in the first place where it occurs and
inserting instead --
15 " Part ";
(b) in paragraph (a)(i) by deleting "person responsible" and
inserting instead --
" licence supervisor ";
(c) in paragraph (b) by deleting "gametes, eggs in the
20 process of fertilisation or embryos," and inserting
instead --
"
human gametes, a human egg undergoing
fertilisation or a human embryo,
25 ";
(d) by deleting paragraph (e) and inserting instead --
"
(e) that section 22(1) is complied with;
(ea) that the licensee maintains the accreditation
30 required by section 29(5)(a);
";
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Human Reproductive Technology Amendment Bill 2003
s. 27
(e) in paragraph (g) by deleting "gametes, egg in the
process of fertilisation or embryo" and inserting
instead --
"
5 human gametes, a human egg undergoing
fertilisation or a human embryo
".
(2) Section 33(3) is amended as follows:
(a) in paragraph (a) by deleting "gametes of a person or an
10 egg in the process of fertilisation or an embryo" and
inserting instead --
"
human gametes, a human egg undergoing
fertilisation or a human embryo
15 ";
(b) in paragraph (b) by deleting "an egg in the process of
fertilisation or an embryo" and inserting instead --
"
a human egg undergoing fertilisation or a
20 human embryo
";
(c) in paragraph (c) by deleting "gametes, eggs in the process
of fertilisation or embryos" and inserting instead --
"
25 human gametes, human eggs undergoing
fertilisation or human embryos
";
(d) in paragraph (d) by deleting "gametes, egg in the process
of fertilisation or embryo" and inserting instead --
30 "
human gametes, human egg undergoing
fertilisation or human embryo
".
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Human Reproductive Technology Amendment Bill 2003
s. 28
28. Section 40 amended
Section 40(1)(f) is amended by deleting "person responsible"
and inserting instead --
" licence supervisor ".
5 29. Section 41 amended
(1) Section 41(2) is amended by deleting "person responsible" and
inserting instead --
" licence supervisor ".
(2) Section 41(3) is amended as follows:
10 (a) by deleting "egg in the process of fertilisation or any
embryo" and inserting instead --
"
human egg undergoing fertilisation or human embryo
";
15 (b) by deleting "gametes" in the first place where it occurs
and inserting instead --
" human gametes ".
30. Section 44 amended
(1) Section 44(1) is amended as follows:
20 (a) in paragraph (a) by deleting "gametes, eggs in the process
of fertilisation and embryos" and inserting instead --
"
human gametes, human eggs undergoing
fertilisation or human embryos
25 ";
(b) in paragraph (a)(i) by deleting "gametes," and inserting
instead --
" human gametes, ";
page 31
Human Reproductive Technology Amendment Bill 2003
s. 30
(c) by deleting paragraph (a)(ii) and inserting instead the
following subparagraph --
"
(ii) if human eggs undergoing fertilisation
5 or human embryos, their biological
parentage and the date fertilisation
commenced;
";
(d) in paragraph (a)(iv) by deleting "gametes, an egg in the
10 process of fertilisation or an embryo was" and inserting
instead --
"
human gametes, human eggs
undergoing fertilisation or human
15 embryos were
";
(e) in paragraph (a)(iv) by deleting "were, or an egg in the
process of fertilisation or an embryo was," and inserting
instead --
20 "
, eggs undergoing fertilisation or
embryos were
";
(f) in paragraph (b)(v)(B) by deleting "person responsible"
25 and inserting instead --
" licence supervisor ".
(2) Section 44(2) is amended by inserting after "section 28" --
" or 28A ".
page 32
Human Reproductive Technology Amendment Bill 2003
s. 31
(3) Section 44(4)(b) is amended by deleting "gametes, egg in the
process of fertilisation or an embryo;" and inserting instead --
"
human gametes, a human egg undergoing
5 fertilisation or a human embryo;
".
31. Section 45 amended
Section 45(1) is amended as follows:
(a) in paragraph (a)(ii) by deleting "gametes, egg in the
10 process of fertilisation or embryo used;" and inserting
instead --
"
human gametes, human egg undergoing
fertilisation or human embryo used;
15 ";
(b) after paragraph (d) by deleting the "and" and inserting
instead --
"
(da) any information obtained from the NHMRC
20 Licensing Committee established under
section 13 of the Commonwealth Human
Embryo Act in relation to any NHMRC
licences held or applied for in this State; and
".
25 32. Section 48 amended
Section 48 is amended by deleting "gametes or an embryo" and
inserting instead --
" human gametes or a human embryo ".
page 33
Human Reproductive Technology Amendment Bill 2003
s. 33
33. Section 49 amended
(1) Section 49(1)(a) is amended by deleting "gametes, an egg in the
process of fertilisation or an embryo;" and inserting instead --
"
5 human gametes, a human egg undergoing
fertilisation or a human embryo;
".
(2) Section 49(2)(d) is amended by inserting before "with" --
" subject to subsections (2a) to (2c), ".
10 (3) After section 49(2) the following subsections are inserted --
"
(2a) Information that would identify a child born as a result
of the relevant procedure who has not reached 16 years
of age cannot be divulged or communicated under
15 paragraph (d) of subsection (2) unless each person who
has given consent for the purposes of that paragraph
has completed approved counselling before giving that
consent.
(2b) Except as provided in subsection (2c), a child who has
20 not reached 16 years of age cannot consent for the
purposes of paragraph (d) of subsection (2).
(2c) A person who has parental responsibility (as defined in
section 68 of the Family Court Act 1997) for the child
may, after completing approved counselling, consent
25 for the purposes of paragraph (d) of subsection (2) on
behalf of that child and in that case the child is to be
taken to have consented for the purposes of that
paragraph.
(2d) Subject to subsection (2e), information to which
30 subsection (1)(a) applies may be divulged or
communicated to a child resulting from the donation
page 34
Human Reproductive Technology Amendment Bill 2003
s. 33
who has reached 16 years of age and who has
completed approved counselling.
(2e) Information cannot be divulged or communicated
under subsection (2d) unless --
5 (a) the donation was made on or after the day on
which the Human Reproductive Technology
Amendment Act 2003 came into operation (the
"commencement day"); or
(b) the donation was made before the
10 commencement day and --
(i) was used with the effective consent of
the donor given on or after the
commencement day; or
(ii) the Commissioner of Health is satisfied
15 that the donor was, before the donation,
adequately informed that future changes
in legislation might enable the
information to be divulged or
communicated to the child without the
20 donor's consent.
(2f) In subsections (2a), (2c) and (2d) --
"approved counselling" means counselling approved by
the Commissioner of Health in relation to the
divulging or communication of information to
25 which subsection (1) applies.
".
(4) Section 49(3)(a) is amended by deleting "gametes, an egg in the
process of fertilisation or an embryo;" and inserting instead --
"
30 human gametes, a human egg undergoing
fertilisation or a human embryo;
".
page 35
Human Reproductive Technology Amendment Bill 2003
s. 34
34. Section 51 amended
(1) Section 51(1)(a) is amended by deleting "person responsible"
and inserting instead --
" licence supervisor ".
5 (2) Section 51(2) is amended by deleting "person responsible" and
inserting instead --
" licence supervisor ".
(3) Section 51(2)(c) is amended as follows:
(a) by deleting "gametes, eggs in the process of fertilisation
10 and embryos" and inserting instead --
"
human gametes, human eggs undergoing
fertilisation and human embryos
";
15 (b) by deleting "gametes or any such eggs" and inserting
instead --
" any such gametes, eggs ".
(4) Section 51(3) is amended by deleting "person responsible" and
inserting instead --
20 " licence supervisor ".
(5) Section 51(5) is amended by deleting "person responsible" in
both places where it occurs and inserting instead --
" licence supervisor ".
(6) Section 51(6) is amended by deleting "person responsible" in
25 both places where it occurs and inserting instead --
" licence supervisor ".
(7) Section 51(7) is amended by deleting "person responsible" and
inserting instead --
" licence supervisor ".
page 36
Human Reproductive Technology Amendment Bill 2003
s. 35
(8) Section 51(8) is amended by deleting "person responsible" and
inserting instead --
" licence supervisor ".
35. Section 53 amended
5 Section 53(1)(b) is amended by deleting "person responsible"
and inserting instead --
" licence supervisor ".
36. Part 4B inserted
Before Part 5 the following Part is inserted --
10 "
Part 4B -- Regulation of certain uses involving
excess ART embryos
Division 1 -- General
53S. Object of this Part
15 (1) The object of this Part is --
(a) to address concerns, including ethical concerns,
about scientific developments in relation to
human reproduction and the utilisation of
human embryos by regulating activities that
20 involve the use of certain human embryos
created by assisted reproductive technology;
and
(b) to adopt in this State a uniform Australian
approach to the regulation of activities that
25 involve the use of certain human embryos
created by assisted reproductive technology.
(2) For that purpose, this Part contains a number of
provisions that are similar to provisions in the
Commonwealth Human Embryo Act.
page 37
Human Reproductive Technology Amendment Bill 2003
s. 36
(3) Nothing in this Part or in a licence under this Part
authorises or permits the use of an excess ART embryo
if that use is not a therapeutic use.
(4) In subsection (3) --
5 "therapeutic use", in relation to an excess ART embryo,
means --
(a) its use in, or in connection with --
(i) preventing, diagnosing, curing or
alleviating a disease, ailment, defect or
10 injury in persons;
(ii) influencing, inhibiting or modifying a
physiological process in persons;
(iii) testing the susceptibility of persons to a
disease or ailment;
15 (iv) influencing, controlling or preventing
conception in persons;
(v) testing for pregnancy in persons; or
(vi) the replacement or modification of parts
of the anatomy of persons;
20 (b) a use of it that is prescribed in the
regulations and is not inconsistent with a use
referred to in paragraph (a); or
(c) its use in training or research for the
purposes of a use referred to in paragraph (a)
25 or (b).
53T. Definitions
(1) In this Part, unless the contrary intention appears --
"AHEC" means the Australian Health Ethics
Committee established by the National Health and
30 Medical Research Council Act 1992 of the
Commonwealth;
page 38
Human Reproductive Technology Amendment Bill 2003
s. 36
"Commonwealth Human Embryo regulations"
means the regulations in force under the
Commonwealth Human Embryo Act;
"confer" includes to impose;
5 "confidential commercial information" means
information that has a commercial or other value
that would be, or could reasonably be expected to
be, destroyed or diminished if the information
were disclosed;
10 "corresponding law" means --
(a) the Commonwealth Human Embryo Act; or
(b) an Act of another State that is a
corresponding State law as defined in the
Commonwealth Human Embryo Act;
15 "disclose", in relation to information, means give or
communicate in any way;
"excess ART embryo" means a human embryo that --
(a) was created, by assisted reproductive
technology, for use in the assisted
20 reproductive technology treatment of a
woman; and
(b) is excess to the needs of --
(i) the woman for whom it was created;
and
25 (ii) her spouse or de facto partner (if any) at
the time the embryo was created;
"HREC" means a Human Research Ethics Committee;
"inspector" means a person appointed as an inspector
under section 53ZN(1);
30 "licence" means a licence issued under section 53ZB;
"licensed ART centre" means a person licensed under
Part 4;
page 39
Human Reproductive Technology Amendment Bill 2003
s. 36
"NHMRC Licensing Committee" means the
Committee of that name established under
section 13 of the Commonwealth Human Embryo
Act;
5 "proper consent", in relation to the use of an excess
ART embryo, means --
(a) consent obtained in accordance with the
Ethical Guidelines on Assisted Reproductive
Technology (1996) issued by the NHMRC;
10 (b) if other guidelines are issued by the NHMRC
under the National Health and Medical
Research Council Act 1992 of the
Commonwealth and prescribed by the
Commonwealth Human Embryo regulations
15 for the purposes of paragraph (b) of the
definition of "proper consent" in section 8 of
the Commonwealth Human Embryo Act --
consent obtained in accordance with those
other guidelines, rather than the guidelines
20 mentioned in paragraph (a); or
(c) where an intended use is to provide a human
embryonic stem cell line, the uses to which
the human embryonic stem cell line may be
put must have been disclosed and explained;
25 "responsible person", in relation to an excess ART
embryo, means --
(a) each person who provided the egg or sperm
from which the embryo was created;
(b) the woman for whom the embryo was created,
30 for the purpose of achieving her pregnancy;
(c) any person who was the spouse or de facto
partner of a person mentioned in paragraph (a)
at the time the egg or sperm mentioned in that
paragraph was provided; and
page 40
Human Reproductive Technology Amendment Bill 2003
s. 36
(d) any person who was the spouse or de facto
partner of the woman mentioned in
paragraph (b) at the time the embryo was
created;
5 "State" includes the Australian Capital Territory and
the Northern Territory.
(2) For the purposes of paragraph (b) of the definition of
"excess ART embryo", a human embryo is excess to
the needs of the persons mentioned in that paragraph at
10 a particular time if --
(a) each such person has given written authority for
use of the embryo for a purpose other than a
purpose relating to the assisted reproductive
technology treatment of the woman concerned,
15 and the authority is in force at that time; or
(b) each such person has determined in writing that
the embryo is excess to their needs, and the
determination is in force at that time.
(3) A reference in this Part to a number of penalty units is
20 a reference to the amount calculated in accordance with
the following formula --
A×B
where --
A is that number of penalty units; and
25 B is the amount (in dollars) that is for the time
being a penalty unit under section 4AA of the
Crimes Act 1914 of the Commonwealth.
(4) In this Part, a reference to a Commonwealth Act
includes a reference to --
30 (a) that Commonwealth Act, as amended and in
force for the time being; and
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Human Reproductive Technology Amendment Bill 2003
s. 36
(b) an Act enacted in substitution for that Act and,
if it is amended, as amended and in force for
the time being.
Division 2 -- Performance of functions
5 53U. Functions not affected by State laws
The NHMRC Licensing Committee or an officer of the
Commonwealth is not precluded by any law of the State
from performing a function conferred by this Part.
53V. Extent to which functions are conferred
10 (1) This Part does not purport to impose any duty on the
NHMRC Licensing Committee or an officer of the
Commonwealth to perform a function if the imposition
of the duty would be beyond the legislative power of
the Parliament of the State.
15 (2) This section does not limit the operation of section 7 of
the Interpretation Act 1984.
Division 3 -- Offences
53W. Offence -- use of excess ART embryo
(1) A person commits a crime if the person uses an excess
20 ART embryo, unless --
(a) the use by the person is authorised by a licence;
or
(b) the use by the person is an exempt use as
defined in subsection (2).
25 Penalty: A fine of 300 penalty units or imprisonment
for 5 years or both.
Summary conviction penalty: A fine of 60 penalty
units or imprisonment for 12 months or both.
page 42
Human Reproductive Technology Amendment Bill 2003
s. 36
(2) A use of an excess ART embryo by a person is an
"exempt use" for the purposes of subsection (1) if --
(a) the use consists only of --
(i) storage of the excess ART embryo;
5 (ii) removal of the excess ART embryo
from storage; or
(iii) transport of the excess ART embryo;
or
(b) the use consists only of observation of the
10 excess ART embryo;
(c) the use consists only of allowing the excess
ART embryo to succumb;
(d) the use is carried out by a licensed ART centre,
and --
15 (i) the excess ART embryo is not suitable
to be placed in the body of the woman
for whom it was created where the
suitability of the embryo is determined
only on the basis of its biological fitness
20 for implantation; and
(ii) the use forms part of diagnostic
investigations conducted in connection
with the assisted reproductive
technology treatment of the woman for
25 whom the excess ART embryo was
created;
(e) the use is carried out by a licensed ART centre
and is for the purposes of achieving pregnancy
in a woman other than the woman for whom the
30 excess ART embryo was created; or
(f) the use is of a kind prescribed by the
Commonwealth Human Embryo regulations for
the purposes of section 10(2)(f) of the
Commonwealth Human Embryo Act.
page 43
Human Reproductive Technology Amendment Bill 2003
s. 36
(3) A defendant does not bear an evidential burden in
relation to any matter in subsection (1).
(4) In subsection (2) --
"diagnostic investigation", in relation to an excess
5 ART embryo, means any procedure undertaken on
embryos for the sole purpose of diagnostic
investigations for the direct benefit of the woman
for whom it was created;
"observation", in relation to an excess ART embryo,
10 includes taking a photograph of the embryo, or
taking a recording of the embryo from which a
visual image can be produced.
53X. Offence -- breaching a licence condition
(1) A person commits a crime if the person engages in
15 conduct that contravenes a condition of a licence that
applies to the person.
Penalty: A fine of 300 penalty units or imprisonment
for 5 years or both.
Summary conviction penalty: A fine of 60 penalty
20 units or imprisonment for 12 months or both.
(2) In this section --
"engage in conduct" means --
(a) do an act; or
(b) omit to perform an act.
page 44
Human Reproductive Technology Amendment Bill 2003
s. 36
Division 4 -- Embryo Research Licensing Committee of
the NHMRC
53Y. Functions of Committee
The functions of the NHMRC Licensing Committee
5 are --
(a) to perform functions in relation to licences
under Division 5;
(b) to perform functions in relation to databases
under Division 6; and
10 (c) to perform such other functions as are conferred
on it by this Part or any other law.
53Z. Powers of Committee
The NHMRC Licensing Committee has power to do all
things necessary or convenient to be done for or in
15 connection with the performance of its functions.
Division 5 -- Licensing system
53ZA. Person may apply for licence
(1) A person may apply to the NHMRC Licensing
Committee for a licence authorising use of excess ART
20 embryos.
(2) An application under subsection (1) --
(a) must be made in accordance with the
requirements (if any) specified in writing by the
NHMRC Licensing Committee; and
25 (b) must be accompanied by a fee that is equal to
the fee (if any) prescribed by the
Commonwealth Human Embryo regulations for
the purposes of section 20(2)(b) of the
Commonwealth Human Embryo Act.
page 45
Human Reproductive Technology Amendment Bill 2003
s. 36
53ZB. Determination of application by Committee
(1) This section applies if a person has made an application
under section 53ZA for a licence.
(2) The NHMRC Licensing Committee must decide, in
5 accordance with this section, whether or not to issue
the licence.
(3) The NHMRC Licensing Committee must not issue the
licence unless it is satisfied of the following --
(a) that appropriate protocols are in place --
10 (i) to enable proper consent to be obtained
before an excess ART embryo is used
under the licence (see
section 53ZE(1)(a)); and
(ii) to enable compliance with any
15 restrictions on such consent;
(b) if the use of an excess ART embryo proposed
in the application may damage or destroy the
embryo -- that appropriate protocols are in
place to enable compliance with the condition
20 that such use is authorised only in respect of an
embryo created before 5 April 2002 (see
section 53ZE(3));
(c) that the activity or project proposed in the
application has been assessed and approved by
25 a HREC that is constituted in accordance with,
and acting in compliance with, the NHMRC
National Statement on Ethical Conduct in
Research Involving Humans (1999), as in force
from time to time.
page 46
Human Reproductive Technology Amendment Bill 2003
s. 36
(4) In deciding whether to issue the licence, the NHMRC
Licensing Committee must have regard to the
following --
(a) restricting the number of excess ART embryos
5 to that likely to be necessary to achieve the
goals of the activity or project proposed in the
application;
(b) the likelihood of significant advance in
knowledge or improvement in technologies for
10 treatment as a result of the use of excess ART
embryos proposed in the application, which could
not reasonably be achieved by other means;
(c) any relevant guidelines, or relevant parts of
guidelines, issued by the NHMRC under the
15 National Health and Medical Research Council
Act 1992 of the Commonwealth and prescribed
by the Commonwealth Human Embryo
regulations for the purposes of section 21(4)(c)
of the Commonwealth Human Embryo Act;
20 (d) the HREC assessment of the application
mentioned in subsection (3)(c);
(e) such additional matters (if any) as are
prescribed by the Commonwealth Human
Embryo regulations for the purposes of
25 section 21(4)(e) of the Commonwealth Human
Embryo Act.
53ZC. Notification of decision
(1) The NHMRC Licensing Committee must notify its
decision on an application for a licence under
30 section 53ZA to the following --
(a) the applicant;
(b) the HREC that assessed and approved the
activity or project proposed in the application
as mentioned in section 53ZB(3)(c);
page 47
Human Reproductive Technology Amendment Bill 2003
s. 36
(c) the Commissioner as defined in section 3(1) of
the Health Act 1911.
(2) If the NHMRC Licensing Committee decides to issue
the licence, it must, in addition to issuing the licence to
5 the applicant, give a copy of the licence to the bodies
mentioned in subsection (1)(b) and (c).
53ZD. Period of licence
(1) A licence --
(a) comes into force on the day specified in the
10 licence, or if no day is specified, on the day on
which it is issued; and
(b) remains in force until the day specified in the
licence, unless it is suspended, revoked or
surrendered before that day.
15 (2) A licence is not in force throughout any period of
suspension.
53ZE. Licence is subject to conditions
(1) A licence is subject to the condition that before an
excess ART embryo is used as authorised by the
20 licence --
(a) each responsible person in relation to the excess
ART embryo must have given proper consent
to that use;
(b) the licence holder must have reported in writing
25 to the NHMRC Licensing Committee that such
consent has been obtained, and any restrictions
to which the consent is subject; and
(c) if the licence authorises use of an excess ART
embryo that may damage or destroy the
30 embryo -- the licence holder must have
reported in writing to the NHMRC Licensing
page 48
Human Reproductive Technology Amendment Bill 2003
s. 36
Committee that the embryo was created before
5 April 2002.
(2) A licence is subject to the condition that the use of an
excess ART embryo must be in accordance with any
5 restrictions to which the proper consent under
subsection (1) is subject.
(3) If a licence authorises the use of an excess ART
embryo that may damage or destroy the embryo, the
licence is subject to the condition that such use is
10 authorised only in respect of an embryo created before
5 April 2002.
(4) A licence is subject to such other conditions as are
specified in the licence.
(5) The conditions specified in the licence may include,
15 but are not limited to, conditions relating to the
following --
(a) the persons authorised by the licence to use
excess ART embryos;
(b) the number of excess ART embryos in respect
20 of which use is authorised by the licence;
(c) reporting;
(d) monitoring;
(e) information to be given by the licence holder to
persons authorised by the licence to use excess
25 ART embryos.
(6) The licence conditions set out in subsections (1), (2)
and (3) apply to all persons who are authorised by the
licence to use excess ART embryos.
(7) Licence conditions specified in the licence apply to --
30 (a) the licence holder; and
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Human Reproductive Technology Amendment Bill 2003
s. 36
(b) such other persons authorised by the licence to
use excess ART embryos as are specified in the
licence.
53ZF. Variation of licence
5 (1) The NHMRC Licensing Committee may, by notice in
writing given to the licence holder, vary a licence if the
Committee believes on reasonable grounds that it is
necessary or desirable to do so.
(2) The NHMRC Licensing Committee may vary a licence
10 under subsection (1) on its own initiative or on
application by the licence holder.
(3) Without limiting subsection (1), the NHMRC
Licensing Committee may vary the licence by
specifying additional conditions or varying existing
15 conditions.
(4) The NHMRC Licensing Committee must not vary a
licence in such a way that, had a person applied under
section 53ZA for the licence as varied, the Committee
would not have been permitted by this Part to issue the
20 licence.
53ZG. Suspension or revocation of licence
(1) The NHMRC Licensing Committee may, by notice in
writing given to the licence holder, suspend or revoke a
licence if the Committee believes on reasonable
25 grounds that a condition of the licence has been
breached.
(2) If a licence holder is convicted of an offence under this
Division, a corresponding law or the Prohibition of
Human Cloning Act 2002 of the Commonwealth, the
30 NHMRC Licensing Committee must, by notice in
writing given to the licence holder, revoke each licence
held by the licence holder.
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Human Reproductive Technology Amendment Bill 2003
s. 36
53ZH. Surrender of licence
A licence holder may surrender a licence by written
notice given to the NHMRC Licensing Committee.
53ZI. Notification of variation, suspension, revocation or
5 surrender of licence
If the NHMRC Licensing Committee varies, suspends
or revokes a licence, or a licence is surrendered, the
Committee must notify --
(a) the licence holder;
10 (b) the HREC to which the NHMRC Licensing
Committee notified its decision on the
application for the licence under section 53ZC;
and
(c) the Commissioner as defined in section 3(1) of
15 the Health Act 1911.
Division 6 -- Reporting and confidentiality
53ZJ. NHMRC Licensing Committee to make certain
information publicly available
(1) The NHMRC Licensing Committee must maintain a
20 database containing the following information in
relation to each licence (including a licence as
varied) --
(a) the name of the person to whom the licence was
issued;
25 (b) a short statement about the nature of the uses of
excess ART embryos that are authorised by the
licence;
(c) any conditions to which the licence is subject;
(d) the number of excess ART embryos in respect
30 of which use is authorised by the licence;
(e) the date on which the licence was issued;
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Human Reproductive Technology Amendment Bill 2003
s. 36
(f) the period throughout which the licence is to
remain in force.
(2) The database is to be made publicly available.
(3) The database may be kept and made publicly available
5 in electronic form.
(4) Information mentioned in subsection (1) must not be such
as to disclose confidential commercial information.
53ZK. Confidential commercial information may only be
disclosed in certain circumstances
10 (1) A person commits an offence if --
(a) the person discloses confidential commercial
information that the person has only because of
performing duties or functions under this Part
or under a corresponding law;
15 (b) the person knows that the information is
confidential commercial information; and
(c) the disclosure is not --
(i) to the Commonwealth, a
Commonwealth authority or a State
20 agency in the course of carrying out
duties or functions under this Part or
under a corresponding law;
(ii) by order of a court; or
(iii) with the consent of each person to
25 whom the information has a commercial
or other value.
Penalty: A fine of 120 penalty units or imprisonment
for 2 years or both.
(2) A person commits an offence if --
30 (a) the person discloses confidential commercial
information that the person has only because of
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Human Reproductive Technology Amendment Bill 2003
s. 36
a disclosure permitted under subsection (1) or
this subsection;
(b) the person knows that the information is
confidential commercial information; and
5 (c) the disclosure is not --
(i) to the Commonwealth, a
Commonwealth authority or a State
agency in the course of carrying out
duties or functions under this Part or
10 under a corresponding law;
(ii) by order of a court; or
(iii) with the consent of each person to
whom the information has a commercial
or other value.
15 Penalty: A fine of 120 penalty units or imprisonment
for 2 years or both.
(3) In this section --
"Commonwealth authority" means --
(a) a body corporate established for a public
20 purpose by or under an Act of the
Commonwealth; or
(b) a company in which a controlling interest is
held by any one of the following persons, or
by 2 or more of the following persons
25 together --
(i) the Commonwealth;
(ii) a body covered by paragraph (a);
(iii) a body covered by subparagraph (i) or
(ii).
30 "court" includes a tribunal, authority or person having
power to require the production of documents or
the answering of questions;
page 53
Human Reproductive Technology Amendment Bill 2003
s. 36
"State agency" means --
(a) the Crown in right of a State;
(b) a Minister of a State;
(c) a department of the Government of a State;
5 (d) an instrumentality of a State, including a
body corporate established for a public
purpose by or under a law of a State; or
(e) a company in which a controlling interest is
held by any one of the following persons, or
10 by 2 or more of the following persons
together --
(i) the Crown in right of a State;
(ii) a person or body covered by
paragraph (b) or (d);
15 (iii) a person or body covered by
subparagraph (i) or (ii).
53ZKA. Annual Reports
(1) The NHMRC Licensing Committee must furnish to the
Minister a copy of any report prepared under
20 section 19(3) of the Research Involving Human
Embryos Act 2002 of the Commonwealth (insofar as
the report is relevant to the operation of this Act).
(2) The Minister must, within 12 sitting days after receipt
of a report under subsection (1), cause copies of the
25 report to be laid before each House of Parliament.
Division 7 -- Review provisions
53ZL. Meaning of terms
In this Division --
page 54
Human Reproductive Technology Amendment Bill 2003
s. 36
"decision" has the same meaning as in the
Administrative Appeals Tribunal Act 1975 of the
Commonwealth;
"eligible person", in relation to a decision of the
5 NHMRC Licensing Committee, means --
(a) in relation to a decision under section 53ZB
not to issue a licence -- the applicant for the
licence;
(b) in relation to a decision in respect of the
10 period throughout which the licence is to be
in force under section 53ZD -- the licence
holder;
(c) in relation to a decision to specify a licence
condition under section 53ZE(4) -- the
15 licence holder;
(d) in relation to a decision to vary or refuse to
vary a licence under section 53ZF -- the
licence holder; or
(e) in relation to a decision to suspend or revoke
20 a licence under section 53ZG -- the person
who was the licence holder immediately
before the suspension or revocation.
53ZM. Review of decisions
(1) An eligible person may apply to the Administrative
25 Appeals Tribunal for review of the following decisions
of the NHMRC Licensing Committee --
(a) a decision under section 53ZB not to issue a
licence;
(b) a decision in respect of the period throughout
30 which the licence is to be in force under
section 53ZD;
(c) a decision to specify a licence condition under
section 53ZE(4);
page 55
Human Reproductive Technology Amendment Bill 2003
s. 36
(d) a decision to vary or refuse to vary a licence
under section 53ZF;
(e) a decision to suspend or revoke a licence under
section 53ZG.
5 (2) This section has effect subject to the Administrative
Appeals Tribunal Act 1975 of the Commonwealth and
section 43 of the Commonwealth Human Embryo Act.
Division 8 -- Monitoring powers
53ZN. Appointment of inspectors
10 (1) The Chairperson of the NHMRC Licensing Committee
may, by instrument in writing, appoint any of the
following persons as inspectors --
(a) an officer of the Commonwealth;
(b) a person who is appointed or employed by the
15 State.
(2) In exercising powers or performing functions as an
inspector, an inspector must comply with any
directions of the Chairperson of the NHMRC Licensing
Committee.
20 (3) The Chairperson of the NHMRC Licensing Committee
must not appoint a person as an inspector under
subsection (1) unless he or she is satisfied that the
person has appropriate skills and experience.
53ZO. Identity card
25 (1) The Chairperson of the NHMRC Licensing Committee
must issue an identity card to an inspector.
(2) The identity card --
(a) must be in the form prescribed by the
Commonwealth Human Embryo regulations for
page 56
Human Reproductive Technology Amendment Bill 2003
s. 36
the purposes of section 34(2)(a) of the
Commonwealth Human Embryo Act; and
(b) must contain a recent photograph of the
inspector.
5 (3) If a person to whom an identity card has been issued
ceases to be an inspector, the person must return the
identity card to the Chairperson of the NHMRC
Licensing Committee as soon as practicable.
Penalty: One penalty unit.
10 (4) An inspector must carry his or her identity card at all
times when exercising powers or performing functions
as an inspector.
53ZP. Powers available to inspectors for monitoring
compliance
15 (1) For the purpose of finding out whether this Part has
been complied with, an inspector may --
(a) enter any premises; and
(b) exercise the monitoring powers set out in
section 53ZQ.
20 (2) An inspector is not authorised to enter premises under
subsection (1) unless --
(a) the occupier of the premises has consented to
the entry; or
(b) the premises are premises at which the occupier
25 of the premises is carrying out activities
authorised by a licence issued under
section 53ZB, and the entry is at a reasonable
time.
page 57
Human Reproductive Technology Amendment Bill 2003
s. 36
53ZQ. Monitoring powers
(1) The monitoring powers that an inspector may exercise
under section 53ZP(1)(b) are as follows --
(a) to search the premises and any thing on the
5 premises;
(b) to inspect, examine, take measurements of,
conduct tests on, or take samples of, any human
embryo or thing on the premises that relates to
this Part;
10 (c) to take photographs, make video or audio
recordings or make sketches of the premises or
any thing on the premises;
(d) to inspect any book, record or document on the
premises;
15 (e) to take extracts from or make copies of any
such book, record or document;
(f) to take onto the premises such equipment and
materials as the inspector requires for the
purpose of exercising powers in relation to the
20 premises.
(2) For the purposes of this Division, monitoring powers
include the power to operate equipment at premises to
see whether --
(a) the equipment; or
25 (b) a disk, tape or other storage device that --
(i) is at the premises; and
(ii) can be used with the equipment or is
associated with it,
contains information that is relevant to determining
30 whether there has been compliance with this Part.
(3) If the inspector, after operating equipment at the
premises, finds that the equipment, or that a tape, disk
page 58
Human Reproductive Technology Amendment Bill 2003
s. 36
or other storage device at the premises, contains
information mentioned in subsection (2), the inspector
may --
(a) operate equipment or facilities at the premises
5 to put the information in documentary form and
copy the document so produced; or
(b) if the information can be transferred to a tape,
disk or other storage device that --
(i) is brought to the premises; or
10 (ii) is at the premises and the use of which
has been agreed to in writing by the
occupier of the premises,
operate the equipment or other facilities to copy
the information to the storage device, and
15 remove the storage device from the premises.
(4) In addition, the Commissioner of Health may confer on
an inspector the powers set out in section 54.
53ZR. Power to secure
If an inspector, during a search of premises, believes on
20 reasonable grounds that there is at the premises a
human embryo or a thing that may afford evidence of
the commission of an offence against this Part, the
monitoring powers include securing the embryo or
thing pending the obtaining of a warrant (whether by
25 the inspector or by another person) to seize it.
53ZS. Inspector must produce identity card on request
An inspector is not entitled to exercise any powers
under this Division in relation to premises if --
(a) the occupier of the premises has required the
30 inspector to produce his or her identity card for
inspection by the occupier; and
page 59
Human Reproductive Technology Amendment Bill 2003
s. 36
(b) the inspector fails to comply with the
requirement.
53ZT. Consent
(1) Before obtaining the consent of a person for the
5 purposes of section 53ZP(2)(a), the inspector must
inform the person that he or she may refuse consent.
(2) An entry of an inspector by virtue of the consent of a
person is not lawful unless the person voluntarily
consented to the entry.
10 53ZU. Compensation for damage
(1) The owner of equipment or other facilities is entitled to
compensation for damage to the equipment or other
facilities if --
(a) the damage was caused to the equipment or
15 other facilities as a result of it being operated
by an inspector as mentioned in this Division;
and
(b) the damage was caused as a result of
insufficient care being exercised by the
20 inspector operating the equipment or other
facilities.
(2) An application for compensation is to be made to the
NHMRC Licensing Committee.
(3) In determining the amount of compensation payable,
25 regard is to be had to whether the occupier of the
premises and his or her employees and agents, if they
were available at the time, had provided any warning
or guidance as to the operation of the equipment or
other facilities that was appropriate in the
30 circumstances.
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Human Reproductive Technology Amendment Bill 2003
s. 36
Division 9 -- Expiry
53ZV. Expiry of certain provisions
(1) Sections 53ZB(3)(b) and 53ZE(1)(c) and (3) expire on
5 April 2005.
5 (2) Subsection (1) may be repealed by resolution passed by
both Houses of Parliament.
Division 10 -- Conscientious objection to use of excess
ART embryos
53ZVA. Conscientious objection to use of excess ART
10 embryos
Despite any requirement under a contract or a written
law, a person is not required to use, or assist another
person in using, an excess ART embryo under this Part
if the person has a conscientious objection to doing so.
15 Division 11 -- Review of Part
53ZW. Review of Part
(1) The Minister must cause a review of the operation of
this Part to be undertaken as soon as possible after
19 December 2004.
20 (2) The review must take into account --
(a) developments in technology in relation to
assisted reproductive technology;
(b) developments in medical research and scientific
research and the potential therapeutic
25 applications of such research;
(c) community standards; and
(d) the applicability of establishing a National
Stem Cell Bank.
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Human Reproductive Technology Amendment Bill 2003
s. 37
(3) The review of this Part may be undertaken as part of
the review of the Commonwealth Human Embryo Act
mentioned in section 47 of that Act.
(4) The Minister is to prepare a report based on the review
5 made under subsection (1) and cause the report to be
laid before each House of Parliament not later than 12
months from the date on which the review is first
commenced.
(5) The Minister must cause a copy of the report based on
10 the review conducted under section 47 of the
Commonwealth Human Embryo Act to be laid before
each House of Parliament not later than six sitting days
from the date of receipt of the report.
".
15 37. Section 54 amended
Section 54(1) is amended as follows:
(a) in paragraph (a)(i) by deleting "egg in the process of
fertilisation or any embryo" and inserting instead --
"
20 human egg undergoing fertilisation or
human embryo
";
(b) in paragraph (a)(ii) by deleting "gametes" and inserting
instead --
25 " human gametes ";
(c) in paragraph (a)(iv) by deleting "gametes or participants
or any egg in the process of fertilisation or embryo;" and
inserting instead --
"
30 human gametes or participants or any
human egg undergoing fertilisation or
human embryo;
";
page 62
Human Reproductive Technology Amendment Bill 2003
s. 38
(d) in paragraph (a) by deleting "gametes, egg in the process
of fertilisation or embryo," and inserting instead --
"
human gametes, human egg undergoing
5 fertilisation or human embryo,
";
(e) in paragraph (c) by deleting "gametes, an egg in the
process of fertilisation or an embryo," and inserting
instead --
10 "
human gametes, a human egg undergoing
fertilisation or a human embryo,
".
38. Section 56 amended
15 Section 56(1) is amended by deleting "an offence" and inserting
instead --
" a simple offence ".
39. Section 57 amended
Section 57(1) is amended as follows:
20 (a) in paragraph (a) by deleting "gametes, an egg in the
process of fertilisation or an embryo" and inserting
instead --
"
human gametes, a human egg undergoing
25 fertilisation or a human embryo
";
(b) in paragraph (b)(iii) by deleting "person responsible"
and inserting instead --
" licence supervisor ".
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Human Reproductive Technology Amendment Bill 2003
s. 40
40. Section 59 amended
Section 59(2) is amended as follows:
(a) after paragraph (b) by deleting "or";
(b) at the end of paragraph (c) by deleting the comma and
5 inserting instead --
"
; or
(d) a person on whom a power is conferred under
section 53ZQ(4),
10 ".
page 64
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