National Health (Originator Brand) Amendment Determination 2016 (No 6) [F2016L01329] -Advice only [2016] AUSStaCSDLM 237 (12 October 2016)

• Advice only

Advice only

The committee draws the following matters to the attention of relevant ministers or instrument-makers on an advice only basis. These comments do not require a response.

Instrument	National Health (Originator Brand) Amendment Determination 2016 (No. 6) [F2016L01329]
Purpose	Amends the National Health (Originator Brand) Determination 2015 (PB 100 of 2015) by determining an orginator brand of a pharmaceutical item for an existing F2 formulary drug
Last day to disallow	21 November 2016
Authorising legislation	National Health Act 1953
Department	Health
Scrutiny principle	Standing Order 23(3)(a)

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 to the determination states:

The responsible person for the brand recommended to be the originator in the Amending Determination was not asked for comments in relation to the potential originator brand determination. The responsible person made the application for a variant to their brand name, and made no comment seeking that this variant to an already determined originator brand be treated any differently.

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, it appears that consultation (within the general meaning of public consultation or consultation with relevant stakeholders) was considered unnecessary due to the machinery nature of the request from the sponsor company of the relevant listed drug. In terms of complying with paragraphs 15J(2)(d) and (e) of the Legislation Act 2003, the committee's preferred approach would be for the ES to have explicitly stated that consultation was considered unnecessary (or inappropriate) for this reason. The committee's expectations in this regard are set out in the guideline on consultation contained in Appendix 2.

The committee draws this matter to the minister's attention.