Greg Hunt (Flinders, Liberal Party, Minister for Health and Aged Care) Share this | Hansard source

I present a supplementary explanatory memorandum. I seek leave to move government amendments (1) to (16) on sheet QJ138 and government amendment (17) on sheet QJ149 as circulated together.

Leave granted.

I move:

(1) Schedule 1, item 10, page 6 (line 4), after "from", insert "a human egg of".

(2) Schedule 1, item 17, page 18 (lines 14 to 19), omit paragraph 28J(2)(a), substitute:

(a) that appropriate protocols are in place to enable proper consent to be obtained before any of the following activities are carried out under the licence (see paragraph 28N(1A)(a)):

(i) an excess ART embryo, a human egg or a human sperm is used;

(ii) a human zygote or a human embryo (other than an excess ART embryo) is created or used;

(iii) any material not covered by subparagraph (i) or (ii) of this paragraph is created, developed, produced or used;

(aa) that appropriate protocols are in place to enable compliance with any restrictions on such consent;

(3) Schedule 1, item 17, page 21 (lines 22 to 29), omit subsection 28N(1), substitute:

(1) A mitochondrial donation licence is subject to the condition that the requirements of subsection (1A) are met before any of the following activities are carried out as authorised by the licence:

(a) an excess ART embryo, a human egg or a human sperm is used;

(b) a zygote or a human embryo (other than an excess ART embryo) is created or used;

(c) any material not covered by paragraph (a) or (b) of this subsection is created, developed, produced or used.

(1A) The requirements are as follows:

(a) each responsible person in relation to the material referred to in paragraph (1)(a), (b) or (c) must have given proper consent to the carrying out of the activity;

(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.

(4) Schedule 1, item 17, page 21 (line 32), omit "(1)(b)", substitute "(1A)(b)".

(5) Schedule 1, item 17, page 22 (lines 3 to 6), omit subsection 28N(3), substitute:

(3) A mitochondrial donation licence is subject to the condition that the carrying out of an activity referred to in paragraph (1)(a), (b) or (c) must be in accordance with any restrictions to which the proper consent under paragraph (1A)(a) is subject.

(6) Schedule 1, item 17, page 23 (lines 7 and 8), omit "the use of a human egg or a human sperm", substitute "the carrying out of an activity referred to in paragraph (1)(a), (b) or (c)".

(7) Schedule 1, item 17, page 23 (lines 16 to 18), omit the definition of responsible person in subsection 28N(8), substitute:

responsible person, in relation to material mentioned in an item of the following table, means a person mentioned in column 2 of the item.

(8) Schedule 1, item 17, page 25 (after line 6), after subclause 28P(5), insert:

(5A) Without limiting section 15, the NHMRC Licensing Committee may also request, and have regard to, advice from any person having appropriate expertise.

(9) Schedule 1, item 17, page 26 (line 33), omit "28N(1)(a)", substitute "28N(1A)(a)".

(10) Schedule 1, item 17, page 27 (line 11), after "from", insert "a human egg of".

(11) Schedule 1, item 17, page 28 (after line 13), after subclause 28R(6), insert:

(6A) A person who is or was the holder of a clinical trial licence or a clinical practice licence must take reasonable steps to ensure that information the person collects as required by subsection (1) or (3) is not disclosed to another person except for the purpose of complying with this Act.

(6B) A person who is or was any of the following must not disclose information collected as required by subsection (1) or (3) to another person except for the purpose of complying with this Act:

(a) the holder of a clinical trial licence or a clinical practice licence;

(b) an embryologist specified in such a licence;

(c) a person authorised by such a licence to carry out an activity authorised by the licence.

(6C) Subsections (6A) and (6B) apply despite a law of a State. However, those subsections do not prevent a person from disclosing information to a Registrar of births, deaths and marriages (however described) of a State in accordance with a law of that State relating to the notification or registration of births.

Note: A defendant bears an evidential burden in relation to the matter in this subsection (see subsection 13.3(3) of the Criminal Code).

(12) Schedule 1, item 17, page 28 (line 14), omit "and (6)", substitute ", (6), (6A) and (6B)".

(13) Schedule 1, item 17, page 28 (line 16), omit "the person", substitute "the person who is or was the holder of the licence".

(14) Schedule 1, item 17, page 28 (line 20), omit "or (6)", substitute ", (6), (6A) or (6B)".

(15) Schedule 1, page 45 (after line 9), after item 55, insert:

55A At the end of section 19

Add:

(4) A report under this section must not include information about any of the following matters unless the NHMRC Licensing Committee considers that the information does not identify, and is not reasonably capable of being used to identify, any person:

(a) approvals under subsection 28P(3) (including applications for such approvals and the outcomes of those applications);

(b) births of children as a result of pregnancies achieved using a mitochondrial donation technique under a clinical trial licence or a clinical practice licence;

(c) adverse events notified to the NHMRC Licensing Committee under paragraph 28S(3)(a).

(16) Schedule 1, item 103, page 55 (table item 2, column headed "Protected persons"), after "28J(4)", insert "or 28P(5A)".

(17) Schedule 1, item 17, page 26 (lines 11 to 17), omit paragraph 28Q(1)(d), substitute:

(d) that a human embryo created for a woman using the technique is not selected for implantation in that woman on the basis of the sex of the embryo.

The proposed government amendments will (1) clarify that donated mitochondria must be sourced from human eggs; (2) expand and clarify the circumstances for proper consent before mitochondrial donation treatment; (3) clarify the circumstances in which the Embryo Research Licensing Committee of the NHMRC is able to seek expert advice when performing its statutory functions; (4) enhance mitochondrial donor privacy by clarifying the operation of provisions that deal with the mitochondrial donation donor register; (5) further enhance privacy by ensuring that the Embryo Research Licensing Committee's statutory report to parliament cannot disclose identifiable personal information; and (6) address an issue raised by the recent review of the bill by the Senate Community Affairs Legislation Committee that relates to sex selection of embryos by providing that embryos created using mitochondrial donation techniques cannot be selected for implantation on the basis of their sex.

I thank all members of the House from the government, the opposition and the crossbench, those opposed to the bill and those supportive of the bill. I believe we have been able to strike an agreement on these measures which I understand are not controversial. I particularly thank the member for Menzies for his support and the member for Hindmarsh, the member for McMahon and the member for Mayo for their support. These clarify the bill and, I believe, address the concerns of those who may not ultimately vote for it, but I hope these amendments will find the support of all members of the House.

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