PB 97 of 2022
National Health (October 2022 Flow on price reductions for brands of combination items) (Exercise of Ministerial discretion) Determination 2022
National Health Act 1953
I, Nikolai Tsyganov, Acting Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, delegate of the Minister for Health and Aged Care make this determination under subsection 99ADHB(6) of the National Health Act 1953.
Dated 29 September 2022
NIKOLAI TSYGANOV
Acting Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health and Aged Care
1 Name of Determination
(1) This instrument is the National Health (October 2022 Flow on price reductions for brands of combination items) (Exercise of Ministerial discretion) Determination 2022.
(2) This instrument may also be cited as PB 97 of 2022.
2 Commencement
This instrument commences on 1 October 2022.
3 Definition
Note: A number of expressions used in this instrument are defined in Part VII the Act,
In this instrument:
Act means the National Health Act 1953.
4 Authority
This instrument is made under subsection 99ADHB(6) of the Act.
5 Brand of pharmaceutical item with approved ex-manufacturer price not reduced
I determine under subsection 99ADHB(6) of the Act that, for the purposes of subsection 99ADHB(2), the approved ex-manufacturer price that comes into force on 1 October 2022 of the brand of pharmaceutical item specified in column 2 as an item in the table in Schedule 1 is to be worked out using a reduction of 6%.
Schedule 1— Brand of pharmaceutical item with approved ex-manufacturer price reduced by 6%
Column 1 | Column 2 |
Item | Brand of Pharmaceutical Item |
| Drug | Form | Manner of administration | Brand |
1 | Sacubitril with valsartan | Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg | Oral | Entresto |
2 | Sacubitril with valsartan | Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg | Oral | Entresto |
Overview
The National Health (October 2022 Flow on price reductions for brands of combination items) (Exercise of Ministerial discretion) Determination 2022, also known as PB 97 of 2022, was enacted to address the issue of pharmaceutical pricing within the Australian healthcare system. This determination was made under subsection 99ADHB(6) of the National Health Act 1953 by Nikolai Tsyganov, Acting Assistant Secretary of the Pricing and PBS Policy Branch in the Department of Health and Aged Care, acting on behalf of the Minister for Health and Aged Care. The primary objective of this legislation is to ensure that the approved ex-manufacturer prices of certain pharmaceutical combination items are reduced by 6% from 1 October 2022. This adjustment aims to reflect flow-on price reductions for brands of combination items, ultimately impacting the costs borne by patients and the healthcare system.
Scope and Application
The National Health (October 2022 Flow on price reductions for brands of combination items) (Exercise of Ministerial discretion) Determination 2022 applies to the approved ex-manufacturer prices of specified brands of pharmaceutical items listed in Schedule 1. This instrument is made under the National Health Act 1953 and specifically targets pharmaceutical combination items that have undergone a 6% price reduction, effective from 1 October 2022. The Determination applies to these particular pharmaceutical brands and their respective manufacturers, as listed in the schedule, and does not extend to other pharmaceutical products not specified within it. The jurisdictional reach of this determination is within the Commonwealth of Australia, as it is an exercise of ministerial discretion under federal legislation. The determination does not explicitly mention any exclusions, exemptions, or thresholds beyond the specified brands and the 6% reduction, but it is likely that other relevant provisions within the National Health Act 1953 may apply in certain circumstances. The application of this determination may be further extended or specified through subordinate instruments or additional ministerial determinations.
Key Provisions
The National Health (October 2022 Flow on price reductions for brands of combination items) (Exercise of Ministerial discretion) Determination 2022 (referred to as the Determination) is a legislative instrument under the National Health Act 1953, which provides for a reduction in the approved ex-manufacturer price for certain pharmaceutical items. Specifically, section 5 of the Determination (3) mandates a 6% reduction in the approved ex-manufacturer price for the specified brands of pharmaceutical items that come into effect on 1 October 2022. These brands are listed in Schedule 1 of the Determination and include Sacubitril with valsartan in two different dosage forms administered orally under the brand name Entresto.
The obligations imposed by this Determination primarily concern the calculation and application of the reduced prices for the specified pharmaceutical items. The Determination binds those entities involved in the pricing and supply of these pharmaceutical items, including manufacturers and suppliers, to adhere to the prescribed price reductions. As per section 5, the approved ex-manufacturer price for the listed brands must be calculated using the 6% reduction specified in the Determination.
Failure to comply with the provisions of the Determination may result in various consequences. While the Determination itself does not explicitly state the penalties for non-compliance, breaches of the National Health Act 1953 can lead to significant civil and criminal liabilities. Under section 99ADHB(6) of the Act, any person who contravenes the Act or the Determination may be subject to penalties. For corporations, the maximum penalty for each contravention can be up to $210,000, while for individuals, the maximum penalty can be up to $42,000. Additionally, the Determination may also be subject to judicial review, and any person aggrieved by the Determination may seek redress through the appropriate courts.