Commonwealth Consolidated Acts Commonwealth Consolidated Acts(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.
(2) A mitochondrial donation licence is subject to the condition that a report to the NHMRC Licensing Committee for the purposes of paragraph (1A)(b) must not include the name, or any other information that could be used to discover the identity, of a responsible person.
(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.
(4) A mitochondrial donation 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) embryologists and other persons authorised by the licence to carry out activities that are authorised by the licence;
(b) the number of human eggs authorised to be used under the licence, or the number of embryos or zygotes authorised to be created or used under the licence;
(c) reporting;
(d) monitoring;
(e) information to be given by the licence holder to the following:
(i) embryologists and other persons authorised by the licence to carry out activities that are authorised by the licence;
(ii) other persons;
(f) disposing of material produced by using the relevant mitochondrial donation technique as authorised by the licence.
(6) The licence conditions set out in subsections (1), (2) and (3) apply to:
(a) each embryologist specified in the licence who is authorised to use the mitochondrial donation technique to which the licence relates; and
(b) each other person who carries out activities that are authorised by the licence.
(7) Licence conditions specified in the licence apply to:
(a) the licence holder; and
(b) each embryologist specified in the licence who is authorised to use the mitochondrial donation technique to which the licence relates; and
(c) each other person who carries out activities that are authorised by the licence.
(8) In this Division:
"proper consent" in relation to the carrying out of an activity referred to in paragraph (1)(a), (b) or (c) means consent:
(a) that is obtained in accordance with guidelines issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992 and prescribed by the regulations for the purposes of this paragraph; and
(b) in relation to which such other requirements (if any) as are prescribed by the regulations for the purposes of this paragraph are satisfied.
"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 |
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 | 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 |
(9) Without limiting paragraph (b) of the definition of proper consent in subsection (8), regulations made for the purposes of that paragraph may:
(a) provide in relation to the withdrawal of consent; and
(b) without limiting paragraph (a) of this subsection, provide that consent cannot be withdrawn in specified circumstances.