Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) If a person applies under subsection 28H(1) for a mitochondrial donation licence relating to a mitochondrial donation technique that is a permitted technique for the licence, the NHMRC Licensing Committee must decide, in accordance with this section, whether or not to issue the licence.
(2) The NHMRC Licensing Committee must not issue the licence unless it is satisfied of the following:
(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;
(b) that the activity or project proposed in the application has been assessed and approved by a HREC that is constituted in accordance with, and acting in compliance with, the National Statement.
(3) In deciding whether to issue the licence, the NHMRC Licensing Committee must have regard to the following:
(a) restricting the number of excess ART embryos, other embryos, or human eggs or zygotes, to that likely to be necessary to achieve the goals of the activity or project proposed in the application;
(b) any relevant guidelines, or relevant parts of 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;
(c) the HREC assessment of the application mentioned in paragraph (2)(b);
(d) whether the applicant has complied with the conditions of any other mitochondrial donation licence.
(4) Without limiting section 15, the NHMRC Licensing Committee may also request, and have regard to, advice from any person having appropriate expertise.
(5) The NHMRC Licensing Committee must not issue a clinical trial licence, or a clinical practice licence, relating to a particular mitochondrial donation technique unless it is satisfied that:
(a) the applicant has in place protocols for using the technique safely and effectively in a clinical trial or in clinical practice (as the case requires) for the purpose of minimising the risk of women's offspring inheriting mitochondria that would predispose them to mitochondrial disease; and
(b) each embryologist nominated under subsection 28H(5) has:
(i) consented in writing to being so nominated; and
(ii) demonstrated technical competence in the use of the technique in accordance with the protocols referred to in paragraph (a) of this subsection; and
(iii) understands the embryologist's obligations under this Act; and
(c) the applicant's facilities, equipment and processes for using the technique under the licence are suitable for that purpose; and
(d) the staff, other than embryologists, who will carry out activities directly connected with the clinical trial or clinical practice (as the case requires) are appropriately qualified, trained and competent to do so; and
(e) the applicant is likely to be able to comply with its obligations under section 28R (information about donors and children); and
(f) the applicant has protocols in place to ensure that each donor in relation to a use of the technique is aware that any children born as a result of a pregnancy achieved by using the technique will be able to obtain information about the donor in accordance with subsections 29A(4) and (6) (disclosure of information on the Mitochondrial Donation Donor Register); and
(g) the applicant has protocols in place to ensure that trial participants or patients (as the case requires) have been fully informed about:
(i) the risks involved in using mitochondrial donation techniques; and
(ii) alternatives to using mitochondrial donation techniques.
(6) The regulations may specify:
(a) matters that the NHMRC Licensing Committee may, must or must not have regard to when deciding whether to issue a mitochondrial donation licence; and
(b) matters that the NHMRC Licensing Committee must be satisfied of before issuing a mitochondrial donation licence; and
(c) procedural and other requirements that the NHMRC Licensing Committee must follow in deciding whether to issue a mitochondrial donation licence; and
(d) requirements for demonstrating the technical competence of
an embryologist in the use of a particular mitochondrial donation technique
for the purposes of subparagraph (5)(b)(ii).