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Tuesday, 3 December 2002
Page: 7040

Senator PATTERSON (Minister for Health and Ageing) (6:22 PM) — With regard to Senator Harradine's amendment (4) on sheet 2696, clause 20(2)(a) of the bill provides that an application made to the NHMRC Licensing Committee:

(a) must be made in accordance with the requirements (if any) specified in writing by the NHMRC Licensing Committee ...

The intent of the clause is to enable the NHMRC Licensing Committee to issue application forms or other information about the way that it expects applications to be presented to the committee and examples of the types of information that the applications are expected to include. The words `if any' were included as a drafting safeguard so that if the NHMRC Licensing Committee did not issue guidance initially then applications could still be made to the NHMRC Licensing Committee.

It is important to note that this would not affect the detail of the information that is provided to the NHMRC Licensing Committee or the matters that must be taken into account by the NHMRC Licensing Committee in making a decision. The NHMRC Licensing Committee must still be satisfied of all the matters detailed in the legislation, and it is still up to the applicant to satisfy the committee of such matters. If at any stage the licensing committee consider that they do not have enough information before them in order to make a proper decision, they can go back to the applicant and request additional information.

This is in no way affected by the drafting of clause 22. For that reason, I do not consider that Senator Harradine's amendment is necessary and I will not support it. With regard to his amendment (5) on sheet 2696, this amendment adds an additional factor that the NHMRC Licensing Committee must consider and be satisfied of before issuing a licence. The additional factor is:

(d) that the applicant has the expertise and capacity to carry out the functions authorised under the licence.

I will be opposing the amendment since this is already covered by the legislation through the matters that the NHMRC Licensing Committee is required to take into account when considering an application. For this reason, I do not consider the amendment to be necessary. Firstly, or first—whichever is more correct as far as Fowler is concerned, and just as a sideline, if anybody wants a bit of light entertainment, they should read the entry entitled `Formal enumerations' in Fowler—

Senator Hogg —You're doing very well. Just keep going, Minister.

Senator PATTERSON —Before an application can be made to the NHMRC Licensing Committee, it must first be evaluated and approved by an institutional human research ethics committee that is constituted and operating in accordance with the NHMRC National Statement on Ethical Conduct in Research Involving Humans. The ability, expertise and experience of the applicant to carry out the intended project are the key considerations of the human research ethics committee, as required by the national statement. The national statement says:

Research must be conducted or supervised only by persons or teams with experience, qualifications and competence appropriate to the research. Research must only be conducted using facilities appropriate for the research and where there are appropriate skills and resources for dealing with any contingencies that may affect participants.

Secondly, if an application is approved by an appropriately constituted human research ethics committee, the applicant is required to submit the human research ethics committee's evaluation proposal and the NHMRC Licensing Committee is required to include this evaluation in its own considerations. Thirdly, clause 21(4)(b) states:

... the NHMRC Licensing Committee must have regard to

... ... ...

(b) the likelihood of significant advance in knowledge, or improvement in technologies for treatment, as a result of the use of excess ART embryos proposed in the application, which could not reasonably be achieved by other means ...

I think that is very important. The skills and expertise of the applicant are critical in determining whether there is likely to be a significant advance in knowledge or an improvement in technology as a result of the proposed use of the excess ART embryo.

Fourthly, the NHMRC Licensing Committee must be satisfied that the protocols are in place to enable proper consent to be obtained before an excess ART embryo is used, and any restrictions on consent are to be complied with. I have just paused—I always look for and see grammatical errors in my notes. I would not actually end a sentence with the word `with', but that is beside the point. A key part of this provision is ensuring that the applicant and the organisation have the capacity and competence to ensure that the requirements are met. It is for these reasons I will not be supporting Senator Harradine's amendments (4) or (5). Senator Harradine, I hope that that has given you sufficient information so that you may be of a mind to withdraw the amendments.