EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 37 of 2013
NATIONAL HEALTH ACT 1953
National Health (Weighted average disclosed price – main disclosure cycle) Amendment Determination 2013 (No. 2)
Authority
This legislative instrument is made pursuant to subsection 99ADB(4) of the National Health Act 1953 (the Act), which provides that the Minister may, by legislative instrument, determine the weighted average disclosed price (WADP) of a brand of a pharmaceutical item (listed brand) in accordance with the National Health (Pharmaceutical Benefits) Regulations 1960 (the Regulations).
Subsection 99ADB(7) of the Act further provides that a subsection 99ADB(4) determination for a listed brand may include the adjusted approved ex-manufacturer price (AAEMP) for the listed brand.
Purpose
This legislative instrument amends the National Health (Weighted average disclosed price – main disclosure cycle) Determination 2013(No. 1) (PB 26 of 2013) (the Principal Instrument), which is made pursuant to subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the Act and makes certain determinations relating to price disclosure for listed brands in the main disclosure cycle with a data collection period ending 30 September 2012.
The purpose of this amending instrument is to amend the WADP and the AAEMP for two brands of pharmaceutical items that were incorrect in the Principal Instrument because an out of date quantity was used for one brand of pharmaceutical item with the drug etoposide administered by injection when working out the WADP for all brands with that drug and manner of administration. The new WADP for the Etoposide Ebewe brand is made for the corrected quantity. The very small adjustment to the WADP for the Etopophos brand was caused by the correction to the quantity used for the other brand.
A responsible person for a listed brand appearing in Schedule 1 of the Principal Instrument will receive a price disclosure reduction on and from 1 August 2013, provided that, on that date, the ‘approved ex-manufacturer price’ for the listed brand is more than the determined ‘AAEMP’ for that brand.
Schedule 1 of the Principal Instrument includes a WADP and AAEMP for the two affected brands of pharmaceutical items. This amending instrument inserts the revised WADPs in the appropriate column, and the same amount is also determined as the AAEMP for the brands. These listed brands are included in Schedule 1 of the Principal Instrument because they have an unadjusted price reduction that has been calculated to be at least 10%.
Consultation
This instrument affects two pharmaceutical companies that are responsible persons for brands of two pharmaceutical items containing the drug etoposide administered by injection, which are due for price disclosure reduction on 1 August 2013.
The Department wrote to the two affected companies on 28 May 2013, and telephoned the companies to discuss the issue. Neither company indicated concern about the change to the WADP and AAEMP which flowed from correction to the quantity used in calculations for one of the medicines.
This instrument commences on the day after it is registered on the Federal Register of Legislative Instruments.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.