EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 67 OF 2014
NATIONAL HEALTH ACT 1953
National Health (Weighted average disclosed price – October 2014 reduction day)
Amendment Determination 2014 (No.1)
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 – October 2014 reduction day) Determination 2014 (PB 42 of 2014) (the Principal Instrument) by amending the WADP and the AAEMP for all brands of pharmaceutical items containing the drug filgrastim for administration by injection (filgrastim injection). The Principal Instrument was made pursuant to subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the Act for brands of pharmaceutical items with a data collection period ending 31 March 2014 (2014 October cycle).
Amendment
The amendment is made following consideration of matters raised by a responsible person for a brand of pharmaceutical item containing filgrastim for injection concerning the WADPs and AAEMPs determined in the Principal Instrument for brands containing filgrastim injection. A review of the determination, in response to the matters raised by the responsible person, resulted in the submission of corrected data by some responsible persons for filgrastim injection brands for the 2014 October cycle.
Schedule 1 of the Principal Instrument includes a WADP and AAEMP for brands of the filgrastim injection 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 due to the operation of section 6 of the Principal instrument. These revised figures were worked out under the Act and Regulations based on the corrected disclosed data.
The filgrastim injection 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%.
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 October 2014, provided that, on that date, the ‘approved ex-manufacturer price’ for the listed brand is more than the determined ‘AAEMP’ for that brand.
Subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to vary the determination made under subsection 99ADB(4) for filgrastim injection brands in PB 42 of 2014.
Consultation
This instrument affects companies that are a responsible person for brands of pharmaceutical items containing filgrastim injection. This amending instrument is made as a result of consultation with those affected companies concerning the WADP and AAEMP determinations in the Principal Instrument for brands of filgrastim injection for the 2014 October cycle.
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.
Overview
The National Health (Weighted average disclosed price – October 2014 reduction day) Amendment Determination 2014 (No.1) was enacted to amend the weighted average disclosed price (WADP) and the adjusted approved ex-manufacturer price (AAEMP) for pharmaceutical items containing filgrastim for injection. The determination was made in response to concerns raised by responsible persons regarding the initial determinations in the National Health (Weighted average disclosed price – October 2014 reduction day) Determination 2014. This amendment was authorised by the Minister for Health under the National Health Act 1953 and is intended to reflect the corrected data submitted by the responsible persons, thereby ensuring the accuracy and fairness of the pricing determinations. The policy objective of this amendment is to provide an appropriate price reduction for listed brands, taking into account the unadjusted price reductions calculated to be at least 10%. This legislative instrument was created by the Australian Parliament and is subject to the Legislative Instruments Act 2003.
Scope and Application
The National Health (Weighted average disclosed price – October 2014 reduction day) Amendment Determination 2014 (No.1) amends the National Health (Weighted average disclosed price – October 2014 reduction day) Determination 2014, addressing the weighted average disclosed price (WADP) and adjusted approved ex-manufacturer price (AAEMP) for pharmaceutical items containing filgrastim for injection. This determination applies to companies responsible for these pharmaceutical brands, specifically those with a data collection period ending on 31 March 2014. It aims to correct the WADPs and AAEMPs identified in the original determination following a review and the submission of corrected data by responsible persons. The amendment applies to pharmaceutical brands listed in Schedule 1 of the principal instrument, which includes brands with an unadjusted price reduction of at least 10%. The amendment will provide a price disclosure reduction to responsible persons for these brands on 1 October 2014, provided the 'approved ex-manufacturer price' exceeds the determined 'AAEMP'. This legislative instrument is made under the authority of the National Health Act 1953 and the National Health (Pharmaceutical Benefits) Regulations 1960, and it follows consultation with the affected companies.
Key Provisions
The main operative sections of the National Health (Weighted average disclosed price – October 2014 reduction day) Amendment Determination 2014 (No.1) are sections 1 and 2, which amend the weighted average disclosed price (WADP) and the adjusted approved ex-manufacturer price (AAEMP) for brands of pharmaceutical items containing filgrastim for injection. Section 1 of the instrument amends the WADP for these brands, while section 2 amends the AAEMP. This is done in response to concerns raised by a responsible person for a brand of pharmaceutical item containing filgrastim for injection regarding the WADPs and AAEMPs determined in the Principal Instrument. The amendments are based on corrected data submitted by some responsible persons for filgrastim injection brands for the 2014 October cycle.
The obligations and requirements imposed by the Act on the parties or entities it governs are to ensure that the WADP and AAEMP for brands of pharmaceutical items containing filgrastim for injection are determined accurately and in accordance with the National Health (Pharmaceutical Benefits) Regulations 1960. This includes the submission of corrected data by responsible persons when necessary and the calculation of the WADP and AAEMP based on the disclosed data. The Act also requires responsible persons to receive a price disclosure reduction on and from 1 October 2014, provided that the approved ex-manufacturer price for the listed brand is more than the determined AAEMP for that brand.
There are no specific offences, penalties, or civil/criminal consequences for breach mentioned in the text. However, it is implied that any failure to comply with the requirements of the Act and Regulations could result in legal action or other consequences. The maximum penalties for breaches of the National Health Act 1953 and the National Health (Pharmaceutical Benefits) Regulations 1960 are not specified in the text, but they may vary depending on the nature and severity of the breach. It is important for responsible persons to ensure that they comply with the requirements of the Act and Regulations to avoid any potential consequences.