Human Reproductive Technology Amendment Act 2004 (WA)

Western Australia

Human Reproductive Technology Amendment

Act 2004

Western Australia

Human Reproductive Technology Amendment

Act 2004

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

3A.

Meaning of “human embryo”

7.	Section 4 amended	9
8.	Section 5A inserted	9

5A.

Application

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	24
20.	Section 26 amended	24
21.	Section 27 amended	26
22.	Section 28 amended	27
23.	Section 28A inserted	27

28A.

Exemptions relating to storage of certain

embryos

Human Reproductive Technology Amendment Act 2004

Contents

24.	Section 29 amended	28
25.	Section 30 amended	29
26.	Section 32 amended	29
27.	Section 33 amended	29
28.	Section 40 amended	31
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
Part 4B — Regulation of certain uses involving

excess ART embryos

Division 1 — General

53S.	Object of this Part	37
53T.	Definitions	38

Division 2 — Performance of functions

53U.	Functions not affected by State laws	42
53V.	Extent to which functions are conferred	42

Division 3 — Offences

53W.	Offence — use of excess ART embryo	42
53X.	Offence — breaching a licence condition	44

Division 4 — Embryo Research Licensing Committee

of the NHMRC

53Y.	Functions of Committee	45
53Z.	Powers of Committee	45

Division 5 — Licensing system

53ZA.	Person may apply for licence	45
53ZB.	Determination of application by Committee	46
53ZC.	Notification of decision	47
53ZD.	Period of licence	48
53ZE.	Licence is subject to conditions	48
53ZF.	Variation of licence	50
53ZG.	Suspension or revocation of licence	50
53ZH.	Surrender of licence	51
53ZI.	Notification of variation, suspension,
revocation or surrender of licence	51

Division 6 — Reporting and confidentiality

53ZJ.

NHMRC Licensing Committee to make

certain information publicly available

53ZK.

Confidential commercial information may

only be disclosed in certain circumstances

Human Reproductive Technology Amendment Act 2004

Contents

53ZKA.

Annual Reports

Division 7 — Review provisions

53ZL.	Meaning of terms	55
53ZM.	Review of decisions	55

Division 8 — Monitoring powers

53ZN.	Appointment of inspectors	56
53ZO.	Identity card	57
53ZP.	Powers available to inspectors for
monitoring compliance	57
53ZQ.	Monitoring powers	58
53ZR.	Power to secure	59
53ZS.	Inspector must produce identity card on
request	60
53ZT.	Consent	60
53ZU.	Compensation for damage	60

Division 9 — Expiry

53ZV.

Expiry of certain provisions

Division 10 — Conscientious objection to use of

excess ART embryos

53ZVA.

Conscientious objection to use of excess

ART embryos

Division 11 — Review of Part

53ZW.

Review of Part

37.	Section 54 amended	62
38.	Section 56 amended	63
39.	Section 57 amended	64
40.	Section 59 amended	64

Western Australia

Human Reproductive Technology Amendment

Act 2004

No. 17 of 2004

An Act to amend the Human Reproductive Technology Act 1991.

[Assented to 16 July 2004]

The Parliament of Western Australia enacts as follows:

1. Short title

This Act may be cited as the Human Reproductive Technology

Amendment Act 2004.

Human Reproductive Technology Amendment Act 2004

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

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

(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 ”;

(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 procedures upon an egg in the process of fertilisation or an embryo” and inserting instead —

“

research procedures and other uses upon a human

embryo

”;

(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.

Human Reproductive Technology Amendment Act 2004

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”;
(b)	after paragraph (c) by inserting — “

and

(d)

in relation to the powers referred to in conferred by the Commissioner of Health under section 53ZQ(4);

”.

(2)	Section 3(1) is amended in the definition of “biological parent” as follows:

(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 —

“ 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; ”.

(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 ”;

Human Reproductive Technology Amendment Act 2004

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 a human embryo

”;

(c)	in paragraph (a)(iii) by deleting “egg in the process of fertilisation or embryo” and inserting instead —

“

human egg undergoing fertilisation or

human embryo

”;

(d)	by deleting paragraph (b)(i) and inserting instead the following subparagraph —

“

(i) a human egg;

”;

(e)

in paragraph (b)(ii) by deleting “an egg in the process of woman or by another woman and” and inserting instead —

“

a human egg undergoing fertilisation

or a human embryo,

”.

(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 ethical oversight of research involving humans;

”.

Human Reproductive Technology Amendment Act 2004

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 ”;

(b)

by inserting before paragraph (a) the following “

(aa)	a person who holds an exemption under section 28A;

”;

(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 “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

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 —

“ human gametes ”;

(b)	by deleting “eggs in the process of fertilisation or embryos;” and inserting instead —

“

human eggs undergoing fertilisation or

human embryos;

”.

Human Reproductive Technology Amendment Act 2004

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

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

Research Involving Human Embryos Act 2002 of the Commonwealth;

“excess ART embryo” has the meaning given to that

term in section 53T;

“exemption” means —

(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;

“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

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;

“NHMRC” means the National Health and Medical

Research Council established by the National

Human Reproductive Technology Amendment Act 2004

s. 5

Health and Medical Research Council Act 1992 of the Commonwealth;

“NHMRC licence” means a licence granted under —

(a)	section 53ZB; or
(b)	section 21 of the Commonwealth Human Embryo Act;

“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.

”.

(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 —

“

a human egg undergoing fertilisation or a human

embryo

”;

(c)	by deleting paragraph (b) and inserting instead —

“

(b)	only if the egg or the embryo has been or is developed in consequence of an in vitro fertilisation procedure.

”.

(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

Human Reproductive Technology Amendment Act 2004

s. 6

(ii) by deleting “an egg in the process of fertilisation;” and inserting instead —

“ a human egg undergoing fertilisation; ”;

(c)	in paragraph (d) by deleting “sperm” and inserting instead —

“ human sperm ”.

(14)	Section 3(4) is amended as follows:

(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

”;

(b)

egg in the process of fertilisation or embryo” and

in paragraph (b) by deleting “gametes which are, or egg, “

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 —

“ licence supervisor ”.

6. Section 3A inserted

After section 3 the following section is inserted —

“

3A.

Meaning of “human embryo”

(1) In this Act —

“human embryo” means a live embryo that has a

human genome or an altered human genome and

Human Reproductive Technology Amendment Act 2004

s. 7

that has been developing for less than 8 weeks

since the appearance of 2 pro-nuclei or the

initiation of its development by other means.

(2)	For the purposes of the definition of “human embryo” in subsection (1), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.

”.

7. Section 4 amended

(1)	Section 4 is amended as follows:

(a)	by inserting before “The” the subsection designation “(1)”;
(b)	by deleting “The” and inserting instead —

“ Generally, the ”.

(2)	At the end of section 4 the following subsection is inserted —

“

(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

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

embryo that is an exempt use as defined in

section 53W(2).

”.

Human Reproductive Technology Amendment Act 2004

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 —

“ 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 inserting instead —

“ a human embryo; ”;

(d)	in paragraph (b) by deleting “sperm,” and inserting instead —

“ human sperm, ”;

(e)	by deleting “or” after paragraph (b);
(f)	by deleting the comma at the end of paragraph (c) and inserting instead —

“

; or

(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,

”.

(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.

Summary conviction penalty: Imprisonment for

one year.

Human Reproductive Technology Amendment Act 2004

”.

10. Section 7 amended

(1)	Section 7(1) is amended as follows:

(a)	by deleting “who causes or permits —” and inserting instead —

“ 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

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 — “

a human egg undergoing fertilisation, or any

embryo,

”;

(e)	by deleting the semicolon at the end of paragraph (b) 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 —

“

(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.

”.

Human Reproductive Technology Amendment Act 2004

s. 11

(3)	Section 7(5) is amended as follows:

(a)

the process of fertilisation or embryo” and inserting

in paragraph (a) by deleting “any gametes, or any egg in “

human gametes, a human egg undergoing

fertilisation or a human embryo

”;

(b)	by deleting “$10 000 or”.

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 ”;

(b)	in paragraph (e)(i) by deleting “egg” and inserting instead —

“ human egg ”;

(c)	in paragraph (e)(ii) by deleting “gametes” and inserting instead —

“ 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 instead —

“ human embryo ”.

(2)	Section 14(2) is repealed and the following subsections are inserted instead —

Human Reproductive Technology Amendment Act 2004

s. 11

“

(2)

Subsection (1)(e)(iv) 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).

(2a)

The Council must not grant approval to any research

being conducted upon or with a human embryo

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 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).

(2b)	The Council must not grant approval to any diagnostic procedure to be carried out upon or with a human embryo unless —

(a)

reproductive technology treatment of a woman

the embryo is intended for use in the existing scientific and medical knowledge, that —

(i) the diagnostic procedure is unlikely to leave the embryo unfit to be implanted 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 the embryo;

Human Reproductive Technology Amendment Act 2004

s. 12

(b)	the diagnostic procedure consists of a use referred to in section 53W(2)(d) or (f).

”.

(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, ”;

(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 inserting instead —

“ principle ”.

12. Section 17 amended

Section 17 is amended as follows:

(a)	by inserting after “prohibit” —

“

the mixing in the same artificial fertilisation procedure

of multiple sources of

”;

(b)	by deleting paragraphs (a) and (b) and “or” between those paragraphs and inserting instead —

“

(a) human gametes;

(b)	human eggs undergoing fertilisation; or

in such a manner as may create confusion as to the

biological parentage of any child born as a result of the

procedure.

Human Reproductive Technology Amendment Act 2004

”.

13. Section 18 amended

(1)	Section 18(1) is amended as follows:

(a)	in paragraph (c) by inserting before “gametes” —

“ human ”;

(b)	in paragraph (c) by deleting “, including their genetic modification”;
(c)	in paragraph (d) by deleting “an embryo” and inserting instead —

“ a human embryo ”;

(d)	process of fertilisation or embryo” and inserting

in paragraph (d) by deleting “any gametes, egg in the “

human gametes, a human egg undergoing

fertilisation or a human embryo

”;

(e)	in paragraph (f) by deleting “gametes, eggs in the process of fertilisation or embryos” and inserting instead —

“

human gametes, human eggs undergoing

fertilisation or human embryos

”.

(2)	Section 18(2)(a)(ii) is amended by deleting “any gametes, egg in the process of fertilisation or embryo;” and inserting instead —

“

human gametes, a human egg

undergoing fertilisation or a human

embryo;

Human Reproductive Technology Amendment Act 2004

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 —

“ 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

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 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

Section 21 is amended as follows:

(a)

in paragraph (c) by deleting “gametes, eggs in the process “

human gametes, human eggs undergoing

fertilisation or human embryos

”;

(b)	in paragraph (d) by deleting “gametes, eggs in the process of fertilisation or embryos,” and inserting instead —

Human Reproductive Technology Amendment Act 2004

s. 15

“

human gametes, human eggs undergoing

fertilisation or human embryos,

”;

(c)	in paragraph (f) by deleting “gametes, eggs in the process of fertilisation or embryos;” and inserting instead —

“

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 instead —

“

human gametes, human eggs undergoing

fertilisation or human embryos;

”;

(e)	in paragraph (h) by deleting “gametes, eggs in the process of fertilisation or embryos” and inserting instead —

“

human gametes, human eggs undergoing

fertilisation or human embryos

”;

(f)

in paragraph (i) by deleting “gametes, egg in the process “

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 —

Human Reproductive Technology Amendment Act 2004

s. 16

“

human egg undergoing fertilisation or human

embryo

”;

(h)	in paragraph (k) by deleting “egg in the process of fertilisation or an embryo” and inserting instead — “

human egg undergoing fertilisation or human

embryo

”.

16. Section 22 amended

(1)	Section 22(1) is amended as follows:

(a)	by deleting “Where by or under this Act consent is 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

section 33(2)(e) —

”;

(b)	human egg undergoing fertilisation or human embryo

in paragraph (c) by deleting “egg in the process of “

”;

(c)	in paragraph (d) by deleting “in the process of fertilisation or an embryo” and inserting instead —

“ 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 —

Human Reproductive Technology Amendment Act 2004

s. 16

“

a human egg undergoing fertilisation or a

human embryo

”;

(e)	after paragraph (e)(i) by inserting the following subparagraphs —

“

(ia)

in the case of a use outside the body of a

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 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:

(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 ”;

(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 —

“

human egg undergoing fertilisation or human embryo

”;

Human Reproductive Technology Amendment Act 2004

s. 16

(e)	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

human embryo,

”;

(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, or an embryo,” and inserting instead —

“

where a human egg in the process of fertilisation, or a

human embryo,

”;

(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 — “

human gametes, human eggs undergoing fertilisation or

human embryos

”.

(4)	Section 22(4) is amended by deleting “gametes, egg in the process of fertilisation or embryo” and inserting instead — “

human gametes, a human egg undergoing fertilisation

or a human embryo

”.

(5)	Section 22(5) is repealed and the following subsection is inserted instead —

Human Reproductive Technology Amendment Act 2004

s. 17

“

(5)

A consent to the use of a human egg undergoing fertilisation or a human embryo must specify the 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.

”.

(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

or a human embryo

”.

(7)	Section 22(8) is amended by deleting “gametes, egg in the process of fertilisation or embryo” and inserting instead — “

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” —

“ 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 —

“

any human gametes, human egg undergoing

fertilisation or human embryo —

”;

Human Reproductive Technology Amendment Act 2004

s. 18

(b)	in paragraph (a) by deleting “an egg in the process of fertilisation or any embryo” and inserting instead —

“ a human embryo ”;

(c)	embryo or its probable future use under an NHMRC licence

in paragraph (a) by deleting “egg or embryo” and “

”;

(d)	in paragraph (b) by deleting subparagraphs (i), (ii) and (iii) and the “or” between subparagraphs (ii) and (iii) and inserting instead —

“

(i) human gametes;

(ii) a human egg undergoing fertilisation; or (iii) a human embryo,

”;

(e)	no human egg undergoing fertilisation or human embryo

by deleting “no egg in the process of fertilisation or “

”;

(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” —

“ , on an application by an eligible person, ”;

(b)	by deleting “an egg in the process of fertilisation or an embryo” and inserting instead —

Human Reproductive Technology Amendment Act 2004

s. 18

“

a human egg undergoing fertilisation or a human

embryo

”.

(3)

Section 24(1c) is amended by deleting “the permitted storage

period” and inserting instead —

“ 10 years ”.

(4)

Section 24(2), (3) and (4) are repealed and the following

subsections are inserted instead —

“

(2) In subsection (1a) —

“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;
(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 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

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

licensee has complied with subsection (3), allow the

Human Reproductive Technology Amendment Act 2004

s. 19

human egg undergoing fertilisation or the human embryo to succumb and will not be liable to anyone for so doing.

”.

19. Section 25 amended

Section 25 is amended as follows:

(a)	by deleting “gametes —” and inserting instead —

“ human gametes — ”;

(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 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 —

“

a human egg undergoing fertilisation or

a human embryo

”;

(e)	in paragraph (c) by deleting “gametes” and inserting instead —

“ human gametes ”.

20. Section 26 amended

(1)	Before section 26(1) the following subsection is inserted into section 26 —

“

(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).

”.

Human Reproductive Technology Amendment Act 2004

s. 20

(2)	Section 26(1) is amended as follows:

(a)	by deleting “In” and inserting instead —

“ Subject to section 24(4), in ”;

(b)	by deleting “egg in the process of fertilisation or embryo” and inserting instead —

“

human egg undergoing fertilisation or human embryo

”;

(c)

in paragraph (a) by deleting “for implantation”;

(d)

a human egg undergoing fertilisation or a

human embryo

in paragraph (a) by deleting “an egg in the process of “

”;

(e)

process of fertilisation or embryo” and inserting

in paragraph (c) by deleting “gametes an egg in the “

human gametes, a human egg undergoing

fertilisation or a human embryo

”;

(f)	in paragraph (c) by deleting “gamete” and inserting instead —

“ human gamete ”;

(g)	in paragraph (c) by deleting “gametes” and inserting instead —

“ human gametes ”;

(h)	in paragraph (d) by deleting “an egg in the process of ” and inserting instead —

“ a human egg undergoing ”;

Human Reproductive Technology Amendment Act 2004

s. 21

(i) in paragraph (d) by deleting “an embryo” and inserting instead —

“ a human embryo ”;

(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”;
(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

”.

(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

embryo

”.

21. Section 27 amended

(1)	Section 27(1)(d) is amended by inserting after “section 28” —
“ or 28A ”.
(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 the “or” between those paragraphs and inserting instead —

“

(ii) any human embryo; or

Human Reproductive Technology Amendment Act 2004

s. 22

(iii) any human egg undergoing fertilisation;

”;

(c)	in paragraph (b) by deleting “sperm” and inserting instead —

“ human sperm ”.

(3)

Section 27(4)(a)(v) is amended by deleting “person responsible”

and inserting instead —

“ licence supervisor ”.

22. Section 28 amended

(1)

Section 28(1) is amended by deleting “Act” and inserting

instead —

“ Part ”.

(2)

Section 28(2) is amended as follows:

(a)	in paragraph (a) by deleting “Act” and inserting instead —

“ Part ”;

(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 —

“ Part ”.

23. Section 28A inserted

After section 28 the following section is inserted —

“

28A.

Exemptions relating to storage of certain embryos

(1)	The Commissioner of Health may, on an application by a person who holds an NHMRC licence grant an

Human Reproductive Technology Amendment Act 2004

s. 24

exemption from the requirement to hold a licence

under this Part to store excess ART embryos to which

the NHMRC licence applies.

(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)

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.

”.

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 —

(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 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”

and inserting instead —

“ licence supervisor ”.

Human Reproductive Technology Amendment Act 2004

s. 25

25. Section 30 amended

Section 30(4) is amended as follows:

(a)	by deleting “person responsible” and inserting instead —

“ licence supervisor ”;

(b)

in paragraph (a) by deleting “gametes, egg in the process “

human gametes, a human egg undergoing

fertilisation or a human embryo

”.

26. Section 32 amended

Section 32(3) is amended by deleting “person responsible” and

inserting instead —

“ 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 —

“ 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 process of fertilisation or embryos,” and inserting instead —

“

human gametes, a human egg undergoing

fertilisation or a human embryo,

”;

Human Reproductive Technology Amendment Act 2004

s. 27

(d)	by deleting paragraph (e) and inserting instead —

“

(e)

that section 22(1) is complied with;

(ea)

that the licensee maintains the accreditation

required by section 29(5)(a);

”;

(e)	in paragraph (g) by deleting “gametes, egg in the process of fertilisation or embryo” and inserting instead —

“

human gametes, a human egg undergoing

fertilisation or a human embryo

”.

(2)	Section 33(3) is amended as follows:

(a)

egg in the process of fertilisation or an embryo” and

in paragraph (a) by deleting “gametes of a person or an “

human gametes, a human egg undergoing

fertilisation or a human embryo

”;

(b)	a human egg undergoing fertilisation or a human embryo

in paragraph (b) by deleting “an egg in the process of “

”;

(c)

in paragraph (c) by deleting “gametes, eggs in the process “

human gametes, human eggs undergoing

fertilisation or human embryos

Human Reproductive Technology Amendment Act 2004

”;

(d)	human gametes, human egg undergoing fertilisation or human embryo

in paragraph (d) by deleting “gametes, egg in the process “

”.

28. Section 40 amended

Section 40(1)(f) is amended by deleting “person responsible”

and inserting instead —

“ licence supervisor ”.

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:

(a)	by deleting “egg in the process of fertilisation or any embryo” and inserting instead —

“

human egg undergoing fertilisation or human embryo

”;

(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:

(a)	in paragraph (a) by deleting “gametes, eggs in the process of fertilisation and embryos” and inserting instead —

Human Reproductive Technology Amendment Act 2004

s. 30

“

human gametes, human eggs undergoing

fertilisation or human embryos

”;

(b)	in paragraph (a)(i) by deleting “gametes,” and inserting instead —

“ human gametes, ”;

(c)	by deleting paragraph (a)(ii) and inserting instead the following subparagraph —

“

(ii)	or human embryos, their biological

if human eggs undergoing fertilisation commenced;

”;

(d)	in paragraph (a)(iv) by deleting “gametes, an egg in the process of fertilisation or an embryo was” and inserting instead —

“

human gametes, human eggs

undergoing fertilisation or human

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 —

“

, eggs undergoing fertilisation or

embryos were

”;

(f)	in paragraph (b)(v)(B) by deleting “person responsible” and inserting instead —

“ licence supervisor ”.

Human Reproductive Technology Amendment Act 2004

s. 31

(2)

Section 44(2) is amended by inserting after “section 28” —

“ or 28A ”.

(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

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 process of fertilisation or embryo used;” and inserting instead —

“

human gametes, human egg undergoing

fertilisation or human embryo used;

”;

(b)	after paragraph (d) by deleting the “and” and inserting instead —

“

(da)	any information obtained from the NHMRC 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

”.

32. Section 48 amended

Section 48 is amended by deleting “gametes or an embryo” and

inserting instead —

“ human gametes or a human embryo ”.

Human Reproductive Technology Amendment Act 2004

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 —

“

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), ”.
(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
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 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 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 subsection (1)(a) applies may be divulged or communicated to a child resulting from the donation

Human Reproductive Technology Amendment Act 2004

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 —

(a)	the donation was made on or after the day on which the Human Reproductive Technology Amendment Act 2004 came into operation (the “commencement day”); or
(b)	the donation was made before the 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 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

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 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 —

“

human gametes, a human egg undergoing

fertilisation or a human embryo;

”.

Human Reproductive Technology Amendment Act 2004

s. 34

34. Section 51 amended

(1)	Section 51(1)(a) is amended by deleting “person responsible” and inserting instead —
“ licence supervisor ”.
(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 “

human gametes, human eggs undergoing

fertilisation and human embryos

”;

(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 —
“ 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 both places where it occurs and inserting instead —
“ licence supervisor ”.
(7)	Section 51(7) is amended by deleting “person responsible” and inserting instead —

Human Reproductive Technology Amendment Act 2004

s. 35

“ licence supervisor ”.

(8)

Section 51(8) is amended by deleting “person responsible” and

inserting instead —

“ licence supervisor ”.

35. Section 53 amended

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 —

“

Part 4B — Regulation of certain uses involving

excess ART embryos

Division 1 — General

53S.

Object of this Part

(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 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 involve the use of certain human embryos created by assisted reproductive technology.

Human Reproductive Technology Amendment Act 2004

s. 36

(2)

For that purpose, this Part contains a number of

provisions that are similar to provisions in the

Commonwealth Human Embryo Act.

(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) —

“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 injury in persons;

(ii) influencing, inhibiting or modifying a physiological process in persons;

(iii) testing the susceptibility of persons to a disease or ailment;

(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;

(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) or (b).

53T.

Definitions

(1)	In this Part, unless the contrary intention appears —

Human Reproductive Technology Amendment Act 2004

s. 36

“AHEC” means the Australian Health Ethics

Committee established by the National Health and

Medical Research Council Act 1992 of the

Commonwealth;

“Commonwealth Human Embryo regulations”

means the regulations in force under the

Commonwealth Human Embryo Act;

“confer” includes to impose;

“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;

“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;

“disclose”, in relation to information, means give or

communicate in any way;

“excess ART embryo” means a human embryo that —

(a)	technology, for use in the assisted

was created, by assisted reproductive woman; and

(b)	is excess to the needs of —

(i) the woman for whom it was created; and

(ii) her spouse or de facto partner (if any) at the time the embryo was created;

“HREC” means a Human Research Ethics Committee;

Human Reproductive Technology Amendment Act 2004

s. 36

“inspector” means a person appointed as an inspector

under section 53ZN(1);

“licence” means a licence issued under section 53ZB;

“licensed ART centre” means a person licensed under

Part 4;

“NHMRC Licensing Committee” means the Committee of that name established under section 13 of the Commonwealth Human Embryo

Act;

“proper consent”, in relation to the use of an excess

ART embryo, means —

(a)

consent obtained in accordance with the Technology (1996) issued by the NHMRC;

(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 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 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;

“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;

Human Reproductive Technology Amendment Act 2004

s. 36

(b)	the woman for whom the embryo was created, 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
(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;

“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
a particular time if —

(a)	each such person has given written authority for use of the embryo for a purpose other than a purpose relating to the assisted reproductive technology treatment of the woman concerned, and the authority is in force at that time; or
(b)	each such person has determined in writing that the embryo is excess to their needs, and the determination is in force at that time.

(3)

A reference in this Part to a number of penalty units is

a reference to the amount calculated in accordance with

the following formula —

A B

where —

is that number of penalty units; and

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.

Human Reproductive Technology Amendment Act 2004

s. 36

(4)	In this Part, a reference to a Commonwealth Act includes a reference to —

(a)	that Commonwealth Act, as amended and in force for the time being; and
(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

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

(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.

(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 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).

Human Reproductive Technology Amendment Act 2004

s. 36

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.

(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;

(ii) removal of the excess ART embryo from storage; or

(iii) transport of the excess ART embryo;

(b)	the use consists only of observation of the 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 —

(i) the excess ART embryo is not suitable to be placed in the body of the woman for whom it was created where the

suitability of the embryo is determined

only on the basis of its biological fitness

for implantation; and

(ii)

investigations conducted in connection

with the assisted reproductive

the use forms part of diagnostic 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

Human Reproductive Technology Amendment Act 2004

s. 36

in a woman other than the woman for whom the

excess ART embryo was created; or

(f)	the use is of a kind prescribed by the Commonwealth Human Embryo regulations for the purposes of section 10(2)(f) of the Commonwealth Human Embryo Act.

(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

ART embryo, means any procedure undertaken on embryos for the sole purpose of diagnostic investigations for the direct benefit of the woman for whom it was created;

“observation”, in relation to an excess ART embryo,

includes taking a photograph of the embryo, or taking a recording of the embryo from which a visual image can be produced.

53X.

Offence — breaching a licence condition

(1)

A person commits a crime if the person engages in

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

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.

Human Reproductive Technology Amendment Act 2004

s. 36

Division 4 — Embryo Research Licensing Committee of

the NHMRC

53Y.

Functions of Committee

The functions of the NHMRC Licensing Committee

are —

(a)	to perform functions in relation to licences under Division 5;
(b)	to perform functions in relation to databases under Division 6; and
(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

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

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
(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.

Human Reproductive Technology Amendment Act 2004

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 accordance with this section, whether or not to issue the licence.

(3)

The NHMRC Licensing Committee must not issue the

licence unless it is satisfied of the following —

(a)	that appropriate protocols are in place —

(i)	before an excess ART embryo is used

to enable proper consent to be obtained section 53ZE(1)(a)); and

(ii) to enable compliance with any restrictions on such consent;

(b)

if the use of an excess ART embryo proposed in the application may damage or destroy the embryo — that appropriate protocols are in

place to enable compliance with the condition

that such use is authorised only in respect of an

embryo created before 5 April 2002 (see

section 53ZE(3));

(c)

that the activity or project proposed in the application has been assessed and approved by a HREC that is constituted in accordance with, and acting in compliance with, the NHMRC National Statement on Ethical Conduct in Research Involving Humans (1999), as in force from time to time.

Human Reproductive Technology Amendment Act 2004

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 to that likely to be necessary to achieve the goals of the activity or project proposed in the application;
(b)	the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos 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 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;

(d)

the HREC assessment of the application mentioned in subsection (3)(c);

(e)

prescribed by the Commonwealth Human

Embryo regulations for the purposes of

such additional matters (if any) as are Embryo Act.

53ZC.

Notification of decision

(1)	The NHMRC Licensing Committee must notify its decision on an application for a licence under section 53ZA to the following —

(a) the applicant;

Human Reproductive Technology Amendment Act 2004

s. 36

(b)	the HREC that assessed and approved the activity or project proposed in the application as mentioned in section 53ZB(3)(c);
(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 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 licence, or if no day is specified, on the day on which it is issued; and
(b)	remains in force until the day specified in the licence, unless it is suspended, revoked or surrendered before that day.

(2)	A licence is not in force throughout any period of suspension.

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 licence —

(a)

each responsible person in relation to the excess to that use;

(b)	the licence holder must have reported in writing to the NHMRC Licensing Committee that such consent has been obtained, and any restrictions to which the consent is subject; and

Human Reproductive Technology Amendment Act 2004

s. 36

(c)	if the licence authorises use of an excess ART embryo that may damage or destroy the embryo — the licence holder must have reported in writing to the NHMRC Licensing 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 restrictions to which the proper consent under
subsection (1) is subject.
(3)	If a licence authorises the use of an excess ART embryo that may damage or destroy the embryo, the licence is subject to the condition that such use is authorised only in respect of an embryo created before 5 April 2002.
(4)	A licence is subject to such other conditions as are specified in the licence.
(5)	The conditions specified in the licence may include, but are not limited to, conditions relating to the following —

(a)	the persons authorised by the licence to use excess ART embryos;
(b)	the number of excess ART embryos in respect of which use is authorised by the licence;

(d) monitoring;

(e)	information to be given by the licence holder to persons authorised by the licence to use excess 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.

Human Reproductive Technology Amendment Act 2004

s. 36

(7)	Licence conditions specified in the licence apply to — (a) the licence holder; and

(b)	such other persons authorised by the licence to use excess ART embryos as are specified in the licence.

53ZF.

Variation of licence

(1)	The NHMRC Licensing Committee may, by notice in writing given to the licence holder, vary a licence if the Committee believes on reasonable grounds that it is necessary or desirable to do so.
(2)	The NHMRC Licensing Committee may vary a licence under subsection (1) on its own initiative or on application by the licence holder.
(3)	Without limiting subsection (1), the NHMRC Licensing Committee may vary the licence by specifying additional conditions or varying existing
conditions.
(4)	The NHMRC Licensing Committee must not vary a licence in such a way that, had a person applied under section 53ZA for the licence as varied, the Committee would not have been permitted by this Part to issue the 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

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

Human Reproductive Technology Amendment Act 2004

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NHMRC Licensing Committee must, by notice in writing given to the licence holder, revoke each licence held by the licence holder.

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

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;

(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 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 database containing the following information in relation to each licence (including a licence as varied) —

(a)	the name of the person to whom the licence was issued;
(b)	a short statement about the nature of the uses of excess ART embryos that are authorised by the licence;

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(c)	any conditions to which the licence is subject;
(d)	the number of excess ART embryos in respect of which use is authorised by the licence;
(e)	the date on which the licence was issued;
(f)	the period throughout which the licence is to remain in force.

(2)

The database is to be made publicly available.

(3)

The database may be kept and made publicly available

in electronic form.

(4)

Information mentioned in subsection (1) must not be such

as to disclose confidential commercial information.

53ZK.

Confidential commercial information may only be

disclosed in certain circumstances

(1)	A person commits an offence if —

(a)	the person discloses confidential commercial information that the person has only because of performing duties or functions under this Part or under a corresponding law;
(b)	the person knows that the information is confidential commercial information; and
(c)	the disclosure is not —

(i)

to the Commonwealth, a 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 or other value.

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Penalty: A fine of 120 penalty units or imprisonment

for 2 years or both.

(2)	A person commits an offence if —

(a)	the person discloses confidential commercial information that the person has only because of a disclosure permitted under subsection (1) or this subsection;
(b)	the person knows that the information is confidential commercial information; and
(c)	the disclosure is not —

(i)

to the Commonwealth, a 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 or other value.

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 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

together —

(i) the Commonwealth;

(ii) a body covered by paragraph (a);

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(iii) a body covered by subparagraph (i) or (ii).

“court” includes a tribunal, authority or person having

power to require the production of documents or

the answering of questions;

“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;
(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 by 2 or more of the following persons

together —

(i) the Crown in right of a State;

(ii) a person or body covered by paragraph (b) or (d);

(iii) a person or body covered by subparagraph (i) or (ii).

53ZKA. Annual Reports

(1)

The NHMRC Licensing Committee must furnish to the

Minister a copy of any report prepared under

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

report to be laid before each House of Parliament.

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Division 7 — Review provisions

53ZL.	Meaning of terms
In this Division —
“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

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 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 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 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 Appeals Tribunal for review of the following decisions of the NHMRC Licensing Committee —

(a)	a decision under section 53ZB not to issue a licence;

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(b)	a decision in respect of the period throughout which the licence is to be in force under section 53ZD;
(c)	a decision to specify a licence condition under section 53ZE(4);
(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.

(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

(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 State.

(2)

In exercising powers or performing functions as an

inspector, an inspector must comply with any

directions of the Chairperson of the NHMRC Licensing

Committee.

(3)

The Chairperson of the NHMRC Licensing Committee

must not appoint a person as an inspector under

subsection (1) unless he or she is satisfied that the

person has appropriate skills and experience.

Human Reproductive Technology Amendment Act 2004

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53ZO.

Identity card

(1)	The Chairperson of the NHMRC Licensing Committee must issue an identity card to an inspector.

(2) The identity card —

(a)	must be in the form prescribed by the Commonwealth Human Embryo regulations for the purposes of section 34(2)(a) of the Commonwealth Human Embryo Act; and
(b)	must contain a recent photograph of the inspector.

(3)	If a person to whom an identity card has been issued ceases to be an inspector, the person must return the identity card to the Chairperson of the NHMRC
Licensing Committee as soon as practicable.
Penalty: One penalty unit.
(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

(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.

(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

Human Reproductive Technology Amendment Act 2004

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(b)	of the premises is carrying out activities authorised by a licence issued under

the premises are premises at which the occupier time.

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 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;
(c)	to take photographs, make video or audio recordings or make sketches of the premises or any thing on the premises;
(d)	to inspect any book, record or document on the premises;
(e)	to take extracts from or make copies of any such book, record or document;
(f)	to take onto the premises such equipment and materials as the inspector requires for the purpose of exercising powers in relation to the premises.

(2)	For the purposes of this Division, monitoring powers include the power to operate equipment at premises to see whether —

(a) the equipment; or

(b)	a disk, tape or other storage device that —

(i) is at the premises; and

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(ii) can be used with the equipment or is associated with it,

contains information that is relevant to determining

whether there has been compliance with this Part.

(3)	If the inspector, after operating equipment at the premises, finds that the equipment, or that a tape, disk or other storage device at the premises, contains information mentioned in subsection (2), the inspector may —

(a)	operate equipment or facilities at the premises to put the information in documentary form and copy the document so produced; or
(b)	if the information can be transferred to a tape, disk or other storage device that —

(i) is brought to the premises; or

(ii) is at the premises and the use of which has been agreed to in writing by the occupier of the premises,

operate the equipment or other facilities to copy

the information to the storage device, and

remove the storage device from the premises.

(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

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

the inspector or by another person) to seize it.

Human Reproductive Technology Amendment Act 2004

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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 inspector to produce his or her identity card for inspection by the occupier; and
(b)	the inspector fails to comply with the requirement.

53ZT. Consent

(1)

Before obtaining the consent of a person for the

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.

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 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 inspector operating the equipment or other facilities.

(2)	An application for compensation is to be made to the NHMRC Licensing Committee.

Human Reproductive Technology Amendment Act 2004

s. 36

(3)

In determining the amount of compensation payable,

regard is to be had to whether the occupier of the

premises and his or her employees and agents, if they

were available at the time, had provided any warning

or guidance as to the operation of the equipment or

other facilities that was appropriate in the

circumstances.

Division 9 — Expiry

53ZV.

Expiry of certain provisions

(1)

Sections 53ZB(3)(b) and 53ZE(1)(c) and (3) expire on

5 April 2005.

(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

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.

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.

(2)

The review must take into account —

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(a)	developments in technology in relation to assisted reproductive technology;

(b) (c) community standards; and	developments in medical research and scientific applications of such research;
(d)	the applicability of establishing a National Stem Cell Bank.

(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

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

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.

”.

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 —

“

human egg undergoing fertilisation or

human embryo

”;

Human Reproductive Technology Amendment Act 2004

s. 38

(b)	in paragraph (a)(ii) by deleting “gametes” and inserting instead —

“ 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 —

“

human gametes or participants or any human egg undergoing fertilisation or human embryo;

”;

(d)

in paragraph (a) by deleting “gametes, egg in the process “

human gametes, human egg undergoing

fertilisation or human embryo,

”;

(e)	in paragraph (c) by deleting “gametes, an egg in the process of fertilisation or an embryo,” and inserting instead —

“

human gametes, a human egg undergoing

fertilisation or a human embryo,

”.

38. Section 56 amended

Section 56(1) is amended by deleting “an offence” and inserting

instead —

“ a simple offence ”.

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s. 39

39. Section 57 amended

Section 57(1) is amended as follows:

(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

fertilisation or a human embryo

”;

(b)	in paragraph (b)(iii) by deleting “person responsible” and inserting instead —

“ licence supervisor ”.

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 inserting instead —

“

; or

(d)	a person on whom a power is conferred under section 53ZQ(4),

”.