Therapeutic Goods Amendment (Advisory Committees and Other Measures) Regulation 2016 [F2016L01614] -Response required [2016] AUSStaCSDLM 347 (23 November 2016)

Instrument	Therapeutic Goods Amendment (Advisory Committees and Other Measures) Regulation 2016 [F2016L01614]
Purpose	Amends the Therapeutic Goods Regulations 1990 to rationalise the current nine advisory committees in Divisions 1A-1EB of Part 6 of those regulations to five advisory committees
Last day to disallow	13 February 2017
Authorising legislation	Therapeutic Goods Act 1989
Department	Health
Scrutiny principle	Standing Order 23(3)(a)

Unclear basis for determining fees

Item 9 of Schedule 2 to the regulation sets fees for providing advice in relation to a registered over-the-counter medicine at the request of the sponsor of the medicine for the purpose of listing the medicine as a pharmaceutical benefit. If the request does not contain clinical data the fee is $1530, and if the request contains clinical data or a justification as to why such data is not needed, the fee is $7860. However, the ES does not explicitly state the basis on which the fees have been calculated.

The committee's usual expectation in cases where an instrument of delegated legislation carries financial implications via the imposition of or change to a charge, fee, levy, scale or rate of costs or payment is that the relevant ES makes clear the specific basis on which an individual imposition or change has been calculated.

The committee requests the advice of the minister in relation to this matter.