National Health (Weighted average disclosed price – October 2025 reduction day) Determination 2025

Administered by Department of Health, Disability and Ageing

Legislation au F2025L00782 Not in force Legislative Instrument

Legislation content

National Health (Weighted average disclosed price – October 2025 reduction day) Determination 2025

PB 71 of 2025

made under subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the

National Health Act 1953

Compilation No. 1

Compilation date: 30 August 2025

Includes amendments: F2025L01008

This compilation is in 3 volumes

Volume 1: sections 1-9

Volume 2: Schedule 1

Volume 3: Schedule 2

 Endnotes

About this compilation

This compilation

This is a compilation of the National Health (Weighted average disclosed price – October 2025 reduction day) Determination 2025 that shows the text of the law as amended and in force on 30 August 2025 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au).

Application, saving and transitional provisions

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Presentational changes

The Legislation Act 2003 provides for First Parliamentary Counsel to make presentational changes to a compilation. Presentational changes are applied to give a more consistent look and feel to legislation published on the Register, and enable the user to more easily navigate those documents.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. Any modifications affecting the law are accessible on the Register.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

 

 

 

Contents

1 Name

2 Commencement

3 Repeal

4 Authority

5 Definitions

Part 1 – Brands of pharmaceutical items with a weighted average disclosed price; adjusted approved ex-manufacturer price and reduction day

6 Weighted average disclosed price for brands of pharmaceutical items in Schedule 1

7 Adjusted approved ex-manufacturer price for brands of pharmaceutical items

8 Reduction Day

Part 2 – Brands of pharmaceutical items with a weighted average disclosed price

9 Weighted average disclosed price for brands of pharmaceutical items in Schedule 2

 

1 Name

(1) This instrument is the National Health (Weighted average disclosed price – October 2025 reduction day) Determination 2025.

(2) This instrument may also be cited as PB 71 of 2025.

 

2 Commencement

(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

The day after this instrument is registered.

28 June 2025

(2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

 

3 Repeal

The National Health (Weighted average disclosed price – April 2025 reduction day) Determination 2024 (PB 146 of 2024) is repealed.

 

4 Authority

This instrument is made under subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the National Health Act 1953.

 

5 Definitions

Note: A number of expressions used in this instrument are defined in section 99ADB of the Act, including the following:

(a) adjusted approved ex-manufacturer price;

(b) data collection period

(c) unadjusted price reduction;

(d) weighted average disclosed price.

 

In this instrument:

 

Act means the National Health Act 1953.

 

Part 1 – Brands of pharmaceutical items with a weighted average disclosed price; adjusted approved ex-manufacturer price and reduction day

 

6 Weighted average disclosed price for brands of pharmaceutical items in Schedule 1

 

(a) For subsection 99ADB(4) of the Act, the weighted average disclosed price of a brand of pharmaceutical item specified in column 2 of an item in the table to Schedule 1 is the amount specified in column 3 of that table item. 

 

(b) Subsection (a) applies in respect of a data collection period for a brand of pharmaceutical item ending on 31 March 2025.

 

Note: Paragraph 99ADH(1)(a) of the Act applies if, under section 99ADB, the Minister determines the weighted average disclosed price of a brand of a pharmaceutical item in respect of a data collection period for the brand.

 

7 Adjusted approved ex-manufacturer price for brands of pharmaceutical items

 

The adjusted approved ex-manufacturer price of a brand of pharmaceutical item specified in column 2 of the table to Schedule 1 is the amount equal to the amount of the weighted average disclosed price of that brand of pharmaceutical item determined under section 6 of this instrument.

 

Note: Subsection 99ADB(7) of the Act provides that a determination made under subsection 99ADB(4) in relation to a brand of pharmaceutical item may include the adjusted approved ex-manufacturer price of the brand of pharmaceutical item.

 

8 Reduction Day

 

For paragraph 99ADH(1)(aa) of the Act, a brand of pharmaceutical item specified in column 2 of an item in the table to Schedule 1 has a reduction day of 1 October 2025.

 

Part 2 – Brands of pharmaceutical items with a weighted average disclosed price

 

9 Weighted average disclosed price for brands of pharmaceutical items in Schedule 2

 

(a) For subsection 99ADB(4) of the Act, the weighted average disclosed price of a brand of pharmaceutical item specified in column 2 of an item in the table to Schedule 2 is the amount specified in column 3 of that table item.

 

(b) Subsection (a) applies in respect of a data collection period for a brand of pharmaceutical item ending on 31 March 2025.

 

Note:  This instrument does not determine a reduction day for paragraph 99ADH(1)(aa) of the Act for a brand.

 

 

Overview

The National Health (Weighted average disclosed price – October 2025 reduction day) Determination 2025 is a legislative instrument enacted to address the need for a specific determination regarding the weighted average disclosed price of certain pharmaceutical brands for the data collection period ending on 31 March 2025, as well as to establish the reduction day for these brands. This instrument was made under subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the National Health Act 1953 by the relevant authority, which appears to be the Minister for Health under the legislative framework provided by the Act. The policy objective appears to be to provide clarity and consistency in the determination of pharmaceutical prices for the purposes of the Act, ensuring that the weighted average disclosed prices for specified pharmaceutical items are accurately determined and communicated. This determination sets out the weighted average disclosed price for brands of pharmaceutical items listed in Schedules 1 and 2, as well as establishing the reduction day for brands listed in Schedule 1. The instrument provides for the adjusted approved ex-manufacturer price to be equal to the weighted average disclosed price for the specified brands. The whole of this instrument commences on the day after it is registered, which is 28 June 2025, and it repeals the previous determination made for the April 2025 reduction day. This legislative instrument is an important tool in ensuring that the National Health Act can effectively regulate pharmaceutical pricing and maintain transparency in the healthcare market.

Scope and Application

The National Health (Weighted average disclosed price – October 2025 reduction day) Determination 2025 applies to brands of pharmaceutical items listed in Schedule 1 and Schedule 2, which determine the weighted average disclosed price and adjusted approved ex-manufacturer price for those items, respectively. The legislation operates under the National Health Act 1953 and applies specifically to pharmaceutical items with a specified data collection period ending on 31 March 2025. The instrument sets the weighted average disclosed price and adjusted approved ex-manufacturer price for the brands listed in the schedules, and specifies a reduction day of 1 October 2025 for brands in Schedule 1, although it does not determine a reduction day for brands in Schedule 2. This legislation impacts the pharmaceutical industry by setting specific pricing and reduction parameters for listed pharmaceutical brands, ensuring compliance with national health policies and regulations.

Key Provisions

The National Health (Weighted average disclosed price – October 2025 reduction day) Determination 2025 sets out the weighted average disclosed prices (WADP) for certain pharmaceutical brands and specifies the adjusted approved ex-manufacturer price for these brands. This determination is made under the National Health Act 1953. Specifically, section 6 of the determination specifies the WADP for brands listed in Schedule 1 for a data collection period ending on 31 March 2025, while section 9 does the same for brands listed in Schedule 2. Section 7 then equates the adjusted approved ex-manufacturer price to the WADP for the brands specified in Schedule 1. Section 8 sets the reduction day for brands listed in Schedule 1 as 1 October 2025. The Act imposes certain obligations on the entities and individuals it governs. For instance, pharmaceutical companies must ensure that the prices they disclose are in line with the WADPs specified in the determination. This involves accurately calculating the WADPs for the relevant data collection period and ensuring that these prices are consistent with the figures provided in Schedules 1 and 2 of the determination. Companies must also ensure that their pricing practices comply with the adjusted approved ex-manufacturer prices specified in section 7 of the determination. Failure to comply with the provisions of the determination may result in various consequences. While the determination itself does not specify particular offences, non-compliance with the National Health Act 1953 could lead to legal action. This could include civil penalties for misleading or deceptive conduct under the Australian Consumer Law, which is incorporated into the National Health Act. Additionally, companies found to be in breach of the Act could face criminal charges, which may result in substantial fines. The exact penalties for breaching the Act are not detailed within the determination but are set out in the Act and may vary depending on the severity and intent of the breach.

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