2019‑2020‑2021

 

The Parliament of the

Commonwealth of Australia

 

HOUSE OF REPRESENTATIVES

 

 

 

Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021

 

 

(Government)

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

[source of mitochondria]

(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;

[proper 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.

[proper consent]

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

[proper consent]

(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.

[proper consent]

(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)”.

[proper consent]

(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.

 

Responsible persons for material
Item	Column 1 Material	Column 2 Responsible persons
1	a human egg	the person who was the biological donor of the egg
2	a human sperm	the person who was the biological donor of the sperm
3	a zygote	each person whose reproductive material, genetic material or cell was used, or is proposed to be used, in the creation or use of the zygote
4	an excess ART embryo	each of the following: (a) each person whose reproductive material, genetic material or cell was used in the creation of the embryo; (b) the spouse of each person mentioned in paragraph (a), at the time the reproductive material, genetic material or cell was provided; (c) the woman for whom the embryo was created, for the purpose of achieving her pregnancy; (d) the spouse of the woman referred to in paragraph (c) at the time the embryo was created
5	a human embryo other than an excess ART embryo	each person whose reproductive material, genetic material or cell was used, or is proposed to be used, in the creation or use of the embryo
6	any material not covered by any of table items 1 to 5 that is created, developed or produced as authorised by a mitochondrial donation licence	each person whose reproductive material, genetic material or cell was used, or is proposed to be used, in the creation, development, production or use of the material

 

[proper consent]

(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.

[expert advice]

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

[proper consent]

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

[source of mitochondria]

(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).

[disclosure of information]

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

[disclosure of information]

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

[disclosure of information]

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

[disclosure of information]

(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).

[reports to Parliament]

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

[expert advice]