National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No 11) (PB 104 of 2016) [F2016L01833]-Response required [2017] AUSStaCSDLM 19 (8 February 2017)

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Instrument	National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 11) (PB 104 of 2016) [F2016L01833]
Purpose	Amends the National Health (Listed drugs on F1 or F2) Determination 2010 (No. PB 93 of 2010)
Last day to disallow	30 March 2017
Authorising legislation	National Health Act 1953
Department	Health
Scrutiny principle	Standing Order 23(3)(a)

Description of consultation

Section 17 of the Legislation Act 2003 directs a rule-maker to be satisfied that appropriate consultation, as is reasonably practicable, has been undertaken in relation to a proposed instrument. The ES which must accompany an instrument is required to describe the nature of any consultation that has been carried out or, if there has been no consultation, to explain why none was undertaken (paragraphs 15J(2)(d) and (e)).

With reference to these requirements, the committee notes that the ES for this determination states:

The Amending Determination affects pharmaceutical companies with medicines listed on the PBS. Before drugs are listed and allocated to formularies, there are detailed consultations about the drug with the intended responsible person, and a recommendation is received from the Pharmaceutical Benefits Advisory Committee (PBAC). Any PBAC recommendation is made following receipt of submissions by affected pharmaceutical companies. Two-thirds of the PBAC membership is from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists.

While the committee does not usually interpret paragraphs 15J(2)(d) and (e) as requiring a highly detailed description of consultation undertaken, it considers that an overly bare or general description is insufficient to satisfy the requirements of the Legislation Act 2003. In this case, the committee considers that the ES, while providing a description of a general process or approach, does not provide an informative description of consultation that was undertaken specifically in relation to this instrument.

The committee's expectations in this regard are set out in the guideline on consultation contained in Appendix 1.

The committee requests the advice of the minister in relation to the above; and requests that the ES be updated in accordance with the requirements of the Legislation Act 2003.