National Health (Weighted average disclosed price – April 2023 reduction day) Determination 2022

Administered by Department of Health, Disability and Ageing

Legislation au F2022L01747 Not in force Legislative Instrument

Legislation content

National Health (Weighted average disclosed price – April 2023 reduction day) Determination 2022

PB 132 of 2022

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

National Health Act 1953

Compilation No. 1

Compilation date: 1 March 2023

Includes amendments up to: F2023L00155

Registered: 30 March 2023

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 – April 2023 reduction day) Determination 2022 that shows the text of the law as amended and in force on 1 March 2023 (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. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

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.

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. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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 – April 2023 reduction day) Determination 2022.

 (2) This instrument may also be cited as PB 132 of 2022.

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.

24 December 2022

 (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 – October 2022 reduction day) Determination 2022 (PB 61 of 2022) 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 30 September 2022.

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 April 2023.

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 30 September 2022.

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 – April 2023 reduction day) Determination 2022 was enacted to address the need for a systematic approach to the calculation and application of the weighted average disclosed price for certain brands of pharmaceutical items as stipulated under the National Health Act 1953. This legislative instrument was made under the authority conferred by subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the National Health Act 1953, and it commenced on 24 December 2022, the day after its registration. The primary objective of this determination is to establish the weighted average disclosed prices for specified brands of pharmaceutical items for data collection periods ending on 30 September 2022 and to set the reduction day for these items as 1 April 2023. By providing these specific determinations, the legislation aims to ensure clarity and consistency in the pricing of pharmaceutical items within the national health framework. This determination also repealed the earlier National Health (Weighted average disclosed price – October 2022 reduction day) Determination 2022, aligning with the updated pricing strategy for the forthcoming period. The new determination sets forth the weighted average disclosed prices for brands listed in Schedules 1 and 2, which are to be applied for the specified data collection period. This legislative action underscores the government's commitment to maintaining a transparent and regulated pharmaceutical pricing environment, thereby ensuring that the healthcare system remains both efficient and equitable for all stakeholders involved.

Scope and Application

The National Health (Weighted average disclosed price – April 2023 reduction day) Determination 2022 applies to specific brands of pharmaceutical items as listed in Schedule 1 and Schedule 2 of the instrument. It is made under subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the National Health Act 1953. This legislative instrument specifies the weighted average disclosed price for particular brands of pharmaceutical items for a data collection period ending on 30 September 2022, and it also sets the adjusted approved ex-manufacturer price for these brands. The reduction day for these brands is established as 1 April 2023, as per the Act. The instrument is applicable on a national level across Australia, aligning with the provisions of the National Health Act 1953. Any exclusions, exemptions, or thresholds are not explicitly detailed within the text of the Determination, but they would be derived from the broader legislative context of the National Health Act 1953. The instrument may be further extended or restricted by subordinate instruments made under the authority of the Act.

Key Provisions

The National Health (Weighted average disclosed price – April 2023 reduction day) Determination 2022, also known as PB 132 of 2022, provides specific values for the weighted average disclosed price of certain pharmaceutical brands for the data collection period ending on 30 September 2022. This is outlined in sections 6 and 9. For the brands listed in Schedule 1, section 6(a) specifies the exact weighted average disclosed price for each brand. Similarly, section 9(a) provides the weighted average disclosed price for brands listed in Schedule 2. Section 7 further clarifies that the adjusted approved ex-manufacturer price for the brands in Schedule 1 is equivalent to the weighted average disclosed price as determined by section 6. Additionally, section 8 specifies that the reduction day for the brands in Schedule 1 is 1 April 2023. Under this Determination, pharmaceutical companies and relevant stakeholders are obligated to adhere to the specified weighted average disclosed prices for the brands listed in Schedules 1 and 2. This includes ensuring that these prices are used for the data collection period ending on 30 September 2022, and that any adjustments or reductions are implemented by the specified reduction day of 1 April 2023. Compliance with these prices and timelines is critical to ensuring consistency and transparency in the pricing of these pharmaceutical items. Failure to comply with the provisions of this Determination may result in legal consequences. Although the Determination itself does not explicitly outline penalties for non-compliance, breaches of the National Health Act 1953, under which this Determination is made, can lead to significant civil and criminal penalties. For instance, knowingly making a false statement in a document required by the Act can attract penalties of up to 120 penalty units (approximately AUD 13,560 as of March 2023) for individuals and 600 penalty units (approximately AUD 67,800) for corporations. Additionally, more severe penalties may apply for fraudulent or malicious conduct, including imprisonment terms.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.