PB 148 of 2024
National Health (April 2025 Price Reductions) (Exercise of Ministerial discretion) Determination (No.1) 2024
National Health Act 1953
I, Eden Simon, as delegate of the Minister for Health and Aged Care, make the following determination.
Dated 19 December 2024
EDEN SIMON
Acting Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Health Resourcing Group
Department of Health and Aged Care
(1) This instrument is the National Health (April 2025 Price Reductions) (Exercise of Ministerial discretion) Determination (No.1) 2024.
(2) This instrument may also be cited as PB 148 of 2024.
(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 | 1 January 2025 | |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(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.
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.
reduction day in this instrument refers to 1 April 2025.
This instrument is made under subsection 99ACF(3) of the Act.
5 Brand of pharmaceutical item not subject to a price reduction
I determine, under paragraph 99ACF(3)(a) of the Act, that the approved ex-manufacturer price, and each of the claimed prices (if applicable) of each brand of pharmaceutical item specified in column 2 as an item in the table in Schedule 1 is not reduced under a provision mentioned in item 2A or item 3A or item 4A of the table in subsection 99ACF(1) of the Act, as appropriate, in relation to the reduction day.
6 Brand of pharmaceutical item subject to a lower price reduction than would otherwise apply
I determine, under paragraph 99ACF(3)(b) of the Act, that the approved ex-manufacturer price, and each of the claimed prices (if applicable) of a brand of pharmaceutical item specified in column 2 of an item in the table in Schedule 2 is reduced under a provision mentioned in items 2A or 4A of the table in subsection 99ACF(1) of the Act, as appropriate, in relation to the reduction day by the percentage specified in column 3 of the table item.
Schedule 1 — Brands of pharmaceutical items with approved ex-manufacturer price not reduced
Column 1 | Column 2 |
Item | Brand of Pharmaceutical Item |
| Drug | Form | Manner of administration | Brand(s) |
1 | Arginine with carbohydrate | Sachets of oral powder 4 g containing 500 mg arginine, 30 (Arginine 500) | Oral | Arginine 500 |
2 | Arginine with carbohydrate | Sachets of oral powder 4 g containing 2 g arginine, 30 (Arginine 2000) | Oral | Arginine 2000 |
3 | Arginine with carbohydrate | Sachets of oral powder 7.6 g containing 5 g arginine, 30 (Arginine 5000) | Oral | Arginine 5000 |
4 | Encorafenib | Capsule 50 mg | Oral | Braftovi |
5 | Essential amino acids formula | Oral powder 200 g (Essential Amino Acid Mix) | Oral | Essential Amino Acid Mix |
6 | High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate | Oral liquid 200 mL, 32 (KetoCal 4:1 LQ) | Oral | KetoCal 4:1 LQ |
7 | High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate | Oral semi-solid 100 g, 36 (K.Yo) | Oral | K.Yo |
8 | Mupirocin | Nasal ointment 20 mg (as calcium) per g, 5 g | Nasal | Mupirocin Nasal (Medsurge) |
9 | Vitamins, minerals and trace elements with carbohydrate | Oral powder 200 g (Paediatric Seravit) | Oral | Paediatric Seravit |
10 | Vitamins, minerals and trace elements with carbohydrate | Sachets containing oral powder 6 g, 30 (FruitiVits) | Oral | FruitiVits |
Schedule 2 — Brands of pharmaceutical items with approved ex-manufacturer price reduced by a lower percentage than would otherwise apply
Column 1 | Column 2 | Column 3 |
Item | Brand of pharmaceutical item | % reduction |
| Drug | Form | Manner of administration | Brand | |
1 | Binimetinib | Tablet 15 mg | Oral | Mektovi | 2.50% |
2 | Encorafenib | Capsule 75 mg | Oral | Braftovi | 2.50% |
3 | High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate | Oral powder 300 g (KetoCal 3:1) | Oral | KetoCal 3:1 | 15.75% |
4 | High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate | Oral powder 300 g (KetoCal 4:1) | Oral | KetoCal 4:1 | 11.64% |
Overview
The National Health (April 2025 Price Reductions) (Exercise of Ministerial Discretion) Determination (No. 1) 2024, made under the authority of subsection 99ACF(3) of the National Health Act 1953, was enacted to address the need for discretionary adjustments to pharmaceutical pricing ahead of the scheduled April 2025 reductions. This determination allows the Minister for Health and Aged Care to exercise discretion in modifying the approved ex-manufacturer prices and claimed prices of specific pharmaceutical brands to ensure more equitable pricing within the healthcare system. The determination sets out particular brands that will either not be subject to any price reduction or will experience a lower reduction than stipulated in the Act, as listed in Schedules 1 and 2.
This legislative instrument was developed by Eden Simon, acting as the delegate of the Minister for Health and Aged Care, with the primary policy objective of achieving a balanced approach to pharmaceutical pricing that takes into account various market factors and the needs of patients. The determination aims to ensure that the forthcoming price adjustments are implemented in a manner that is both fair and sustainable for all stakeholders involved in the healthcare sector.
Scope and Application
The National Health (April 2025 Price Reductions) (Exercise of Ministerial discretion) Determination (No.1) 2024 applies to specific pharmaceutical brands, their approved ex-manufacturer prices, and claimed prices, with the aim of setting price reductions for these items on 1 April 2025. This determination is made under the authority of the National Health Act 1953 and involves the Minister for Health and Aged Care exercising discretion in relation to certain pharmaceutical items. It identifies particular brands of pharmaceutical items that will not be subject to the price reductions that would otherwise apply under the Act, and other brands that will be subject to a reduced percentage of price reduction. The geographic reach of this determination is national, as it applies across Australia. The determination does not explicitly mention any exclusions or exemptions, and its application is contingent on the specified brands and the reduction percentages outlined in the schedules. The implementation of this determination is further detailed through subordinate instruments, which may include additional specifications or clarifications on the application of the price reductions.
Key Provisions
The main sections of the National Health (April 2025 Price Reductions) (Exercise of Ministerial discretion) Determination (No.1) 2024 (section 1) outline the determination's name and citation, which is PB 148 of 2024. The determination is made under subsection 99ACF(3) of the National Health Act 1953 (section 4) and commences on 1 January 2025 (section 2). The determination specifies that certain brands of pharmaceutical items will not undergo price reductions on 1 April 2025 (section 5), while other brands will be subject to a lower percentage reduction than would otherwise apply (section 6). These pharmaceutical items and their respective reductions are detailed in Schedules 1 and 2.
The Act imposes specific obligations on parties involved in the pharmaceutical industry. Manufacturers and suppliers of the pharmaceutical items listed in Schedule 1 must ensure that the approved ex-manufacturer prices and claimed prices of the specified brands remain unchanged on the reduction day. Conversely, for brands listed in Schedule 2, the Act requires that the approved ex-manufacturer prices and claimed prices be reduced by the specified percentages as detailed in the table. These obligations are critical for maintaining compliance with the Act and ensuring that the price reductions are accurately implemented.
Failure to comply with the provisions of this determination could result in civil or criminal consequences. Specifically, the Act may provide for penalties or other enforcement actions against parties that do not adhere to the specified price reductions or fail to adjust prices as required. While the determination does not explicitly state the maximum penalties, the Act under which this determination is made may impose fines or other sanctions for non-compliance. These penalties are intended to ensure that the price reduction measures are effectively implemented and that the intended benefits are realised for consumers and the healthcare system.
In summary, the National Health (April 2025 Price Reductions) (Exercise of Ministerial discretion) Determination (No.1) 2024 establishes specific price reduction measures for certain pharmaceutical items, effective from 1 April 2025. This determination outlines the brands that will not undergo any price reductions and those that will experience a lower percentage reduction. The Act imposes clear obligations on manufacturers and suppliers to adhere to these price adjustments, with potential civil or criminal consequences for non-compliance. The determination aims to ensure that the intended price reductions are implemented accurately and effectively.