21Determination of application by Committee

21 Determination of application by Committee

(1) This section applies if a person has made an application under section 20 for a general licence. (2) The NHMRC Licensing Committee must decide, in accordance with this section, whether or not to issue the licence. (3) The NHMRC Licensing Committee must not issue the licence unless it is satisfied of the following: (a) that appropriate protocols are in place: (i) to enable proper consent to be obtained before an excess ART embryo or human egg is used, or other embryo is created or used under the licence (see paragraph 24(1)(a)); and (ii) to enable compliance with any restrictions on such consent; (c) 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. (4) 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, to that likely to be necessary to achieve the goals of the activity or project proposed in the application; (b) the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs, or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means; (c) 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; (d) the HREC assessment of the application mentioned in paragraph (3)(c); (e) such additional matters (if any) as are prescribed by the regulations.