PB 37 of 2025
National Health (April 2025 Price Reductions) (Exercise of Ministerial discretion) Determination (No.1) 2025
National Health Act 1953
I, Rebecca Richardson, as delegate of the Minister for Health and Aged Care, make the following determination.
Dated 26 March 2025
REBECCA RICHARDSON
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) 2025.
(2) This instrument may also be cited as PB 37 of 2025.
(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 April 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Note: This table relates only to the provisions of this instrument as originally made.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 subsections 99ACF(3) and 99ADHB(6) 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 3A or item 4A of the table in subsection 99ACF(1) of the Act, as appropriate, in relation to the reduction day.
- I determine, under subsection 99ADHB(6) 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 2 is not reduced under a provision mentioned in subsection 99ADHB(2) of the Act, as appropriate, in relation to the reduction day.
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 | Midazolam | Oromucosal solution (as maleate) 5 mg in 0.5 mL single use pre-filled oral syringe | Buccal | Zyamis |
2 | Midazolam | Oromucosal solution (as maleate) 7.5 mg in 0.75 mL single use pre-filled oral syringe | Buccal | Zyamis |
3 | Midazolam | Oromucosal solution (as maleate) 10 mg in 1 mL single use pre-filled oral syringe | Buccal | Zyamis |
4 | Triglycerides, long chain with glucose polymer | Oral liquid 1 L, 6 (ProZero) | Oral | ProZero |
5 | Ustekinumab | Injection 45 mg in 0.5 mL | Injection | Stelara |
6 | Ustekinumab | Solution for I.V. infusion 130 mg in 26 mL | Injection | Stelara |
Schedule 2 — 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 | Tenofovir with emtricitabine | Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg (s19A) | Oral | Emtricitabine and Tenofovir Disoproxil Fumarate 200mg/300mg Tablets (Laurus Labs, USA) |
Overview
The National Health (April 2025 Price Reductions) (Exercise of Ministerial discretion) Determination (No.1) 2025 was enacted to exercise specific ministerial discretions under the National Health Act 1953, ensuring certain pharmaceutical items do not undergo price reductions as planned. This determination, made by Rebecca Richardson as a delegate of the Minister for Health and Aged Care, aims to maintain the approved ex-manufacturer prices for selected pharmaceutical brands, thereby protecting consumers from potential price hikes on these essential medications. The policy objective underpinning this legislation is to stabilise the pricing of vital pharmaceutical items, ensuring continued access and affordability for patients who rely on these treatments.
This legislative instrument was enacted by the Australian Government, specifically under the authority granted by subsections 99ACF(3) and 99ADHB(6) of the National Health Act 1953. By specifying certain pharmaceutical brands whose prices will not be reduced, the determination addresses the gap in maintaining consistent and affordable pricing for these critical health products, directly impacting the accessibility and sustainability of healthcare services within the country.
Scope and Application
The National Health (April 2025 Price Reductions) (Exercise of Ministerial discretion) Determination (No.1) 2025 applies to the pharmaceutical industry, specifically targeting the pricing of certain pharmaceutical items under the National Health Act 1953. This legislation is enacted at the Commonwealth level and is applicable to all entities involved in the manufacture, distribution, and sale of pharmaceutical products within Australia. It directly impacts the prices of certain pharmaceutical brands by determining which ones are exempt from price reductions on the specified reduction day of 1 April 2025. The Act provides for the exclusion of specific brands from price reductions, which is detailed in Schedules 1 and 2. These schedules list pharmaceutical items, their drug forms, methods of administration, and brand names that are not subject to the price reductions stipulated in the Act. The application of this determination is extended through the exercise of ministerial discretion under subsections 99ACF(3) and 99ADHB(6) of the National Health Act 1953, ensuring that the provisions are implemented as intended by the legislation.
Key Provisions
The main operative sections of this instrument, the National Health (April 2025 Price Reductions) (Exercise of Ministerial discretion) Determination (No.1) 2025, establish the framework for price reductions of certain pharmaceutical items. Section 5 specifies that certain brands of pharmaceutical items are not subject to a price reduction on the reduction day, which is 1 April 2025. This determination is made under subsections 99ACF(3) and 99ADHB(6) of the National Health Act 1953. The specifics of the pharmaceutical items that are exempt from price reductions are detailed in Schedules 1 and 2.
This Act imposes several obligations on the parties it governs. Firstly, it mandates that the approved ex-manufacturer prices of certain pharmaceutical items remain unchanged on the reduction day. This applies to the brands of pharmaceutical items listed in Schedules 1 and 2. The determination specifies which brands and their respective drug forms and administration methods are exempt from the price reduction. Additionally, it requires that the claimed prices, if applicable, of these pharmaceutical items also remain unaffected. The Act ensures that these pharmaceutical items continue to be priced at their approved ex-manufacturer levels without any reductions.
In terms of consequences for breach, the Act does not explicitly detail penalties for non-compliance with the price reduction provisions. However, any breach of the National Health Act 1953, which governs this determination, could lead to civil or criminal liability depending on the nature and severity of the breach. Penalties could range from fines to imprisonment, depending on the specific breach and the discretion of the court. The exact penalties would be determined based on the relevant sections of the National Health Act 1953 and other applicable laws.