Document ID: chunk:federal_register_of_legislation:C2022A00026:clause:1_28p:p1
Version: federal_register_of_legislation:C2022A00026
Segment Type: clause
Provision Reference: sch 1 cl 28P (pt 1/2)
Character Range: 42254–45059

28P  Additional condition of clinical trial licences and clinical practice licences—Committee approval before creation or placement of embryo
 (1) A clinical trial licence or clinical practice licence is subject to the condition that an approval granted under subsection (3) is in force at the time either of the following activities are carried out in relation to a woman who is a trial participant or patient (as the case requires) for the licence:
 (a) creating a human embryo for the woman using the mitochondrial donation technique to which the licence relates;
 (b) placing a human embryo created for the woman using the mitochondrial donation technique to which the licence relates in the body of the woman for the purposes of achieving her pregnancy.
 (2) The licence holder for a clinical trial licence or a clinical practice licence may apply to the NHMRC Licensing Committee, in the form approved by the Committee and in accordance with such other requirements (if any) as are specified in writing by the Committee, for approval to carry out an activity referred to in paragraph (1)(a) or (b) in relation to a woman who is a trial participant or patient (as the case requires) for the licence.
 (3) If the NHMRC Licensing Committee receives an application under subsection (2), the Committee must decide whether or not to grant the approval.
 (4) The NHMRC Licensing Committee must not grant the approval unless it is satisfied:
 (a) that there is a particular risk of the woman's offspring inheriting mitochondria from the woman that would predispose the offspring to mitochondrial disease; and
 (b) that there is a significant risk that the mitochondrial disease that would develop in those offspring would result in a serious illness or other serious medical condition; and
 (c) that other available techniques that could potentially be used to minimise the risks referred to in paragraphs (a) and (b) would be inappropriate or unlikely to succeed; and
 (d) that the woman and her spouse (if any) have attended counselling and been fully informed of:
 (i) the risks involved in using mitochondrial donation techniques; and
 (ii) alternatives to using mitochondrial donation techniques; and
 (e) that the woman has given written consent to the making of the application; and
 (f) of such other matters as are specified in the regulations for the purposes of this paragraph.
 (5) In deciding whether to grant the approval, the NHMRC Licensing Committee must have regard to the following:
 (a) the clinical basis of the risk of the woman's offspring inheriting mitochondria from the woman that would predispose the offspring to mitochondrial disease;
 (b) the inheritance pattern in the woman's family;
 (c) the likely clinical manifestations of disease for the woman's offspring.
 (5A) Without