National Health (Pharmaceutical Benefits) Amendment Regulation 2013 (No 1) [Select Legislative Instrument No 53, 2013] [F2013L00650]-New and continuing matters [2013] AUSStaCSDLM 228 (20 June 2013)

• National Health (Pharmaceutical Benefits) Amendment Regulation 2013 (No. 1) [Select Legislative Instrument No. 53, 2013] [F2013L00650]
• Insufficient description regarding consultation undertaken

National Health (Pharmaceutical Benefits) Amendment Regulation 2013 (No. 1) [Select Legislative Instrument No. 53, 2013] [F2013L00650]

Purpose	Amends the National Health (Pharmaceutical Benefits) Regulations 1960 to reflect changes to the provisions in Part 6A reflecting the reasons in the December 2012 Sanofi-Aventis Australia Pty Limited v Minister for Health Federal Court judgment
Last day to disallow	27 August 2013
Authorising legislation	National Health Act 1953
Department	Health and Ageing

ISSUE:

Insufficient description regarding consultation undertaken

Section 17 of the Legislative Instruments 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, particularly where that instrument is likely to have an effect on business. Section 18, however, provides that in some circumstances such consultation may be unnecessary or inappropriate. 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 (section 26). With reference to these requirements, the committee notes that the ES for the instrument states, in part, that 'representatives of the medicines industry, consumer, pharmacy and wholesaler organisations were briefed' in relation to the making of the instrument. While the committee does not usually interpret section 26 as requiring a highly detailed description of consultation undertaken, it considers that an overly bare or general description of consultation undertaken, such as in this case, is not sufficient to satisfy the requirements of the Legislative Instruments Act 2003 [the committee sought further information from the minister and requested that the ES be updated in accordance with the requirements of the Legislative Instruments Act 2003].

MINISTER'S RESPONSE:

The minister advised that the regulation was made following a December 2012 Federal Court decision concerning calculations for the Pharmaceutical Benefits Scheme price disclosure arrangements. However, while the minister undertook to update the ES in accordance with the committee's request, the minister's letter did not provide any information regarding consultation as per the committee's request.

COMMITTEE RESPONSE:

The committee thanks the minister for her response. However, as no further information was provided regarding the consultation undertaken in this case, the committee again requests this information from the minister.