28PAdditional condition of clinical trial licences and clinical practice licences—Committee approval before creation or placement of embryo

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 limiting section 15, the NHMRC Licensing Committee may also request, and have regard to, advice from any person having appropriate expertise. (6) The NHMRC Licensing Committee must notify its decision on an application under subsection (2) to the licence holder. (7) A form approved by the NHMRC Licensing Committee for the purposes of subsection (2): (a) may require an application to contain, or be accompanied by, such information as is required by the form and require the information to be verified by statutory declaration; but (b) must not require an application to contain, or be accompanied by, any of the following information: (i) the name of a trial participant or patient; (ii) any other information that could be used to discover the identity of a trial participant or patient, other than information that is directly necessary for the purpose of determining an application. (8) An approval granted by the NHMRC Licensing Committee in relation to a woman for the purposes of subsection (1) comes into force when it is granted and ceases to be in force at the earlier of the following times: (a) 5 years after the approval is granted; (b) the time a child is born alive as a result of a pregnancy achieved in the woman by the placement of a human embryo under the approval as described in paragraph (1)(b). (9) The licence condition set out in subsection (1) applies 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.