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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 "; page 25 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); "; page 29 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 ". page 30 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 page 41 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 page 49 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. page 50 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; page 51 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 page 52 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. page 60 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. page 61 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 ". page 63 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 ".
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