68Waiver of fees for provision of ATAGI advice, submission services or pricing services

68 Waiver of fees for provision of ATAGI advice, submission services or pricing services

(1) The Secretary may, in writing and on request by a person made in accordance with subsection (2), decide whether or not to waive one or more fees payable by the person for the provision of services in response to the person’s ATAGI application, submission or pricing application.

Note: A decision not to waive a fee that is payable is reviewable (see section 71).

(2) The request must be made: (a) in the person’s ATAGI application, submission, or pricing application (as applicable); or (b) if, under section 9, 30 or 48 (as applicable), a notice of intent is required in relation to the proposed ATAGI application, submission or pricing application—in the notice of intent. (3) The Secretary must decide under subsection (1) to waive one or more of the fees if: (a) the ATAGI application, submission or pricing application involves the public interest; and (b) payment of all of the fees would make the ATAGI application, submission or pricing application financially unviable. (4) Without limiting subsection (3), an ATAGI application, submission or pricing application involves the public interest if: (a) it concerns a drug, medicinal preparation or vaccine that would represent suitable therapy for a patient population; and (b) the patient population is not large enough to make the ATAGI application, submission or pricing application financially viable; and (c) the drug, medicinal preparation or vaccine is to be used: (i) for palliative care; or (ii) as a paediatric medicine; or (iii) for medical treatment of Aboriginal or Torres Strait Islander peoples. (5) The Secretary may, by written notice given to the person who made the request, seek further information from the person to assist the Secretary to decide under subsection (1) whether to waive one or more fees.