National Health (June 2026 First New Brand Statutory Price Reduction) (Exercise of Ministerial discretion) Determination 2026

Administered by Department of Health, Disability and Ageing

Legislation au F2026N00292 In force Notifiable Instrument

Legislation content

 

 


 

 

PB 45 of 2026

 

National Health (June 2026 First New Brand Statutory Price Reduction) (Exercise of Ministerial discretion) Determination 2026

I, Rebecca Richardson, Assistant Secretary, Pricing and PBS Listing, Pricing and Policy Branch, Technology Assessment and Access Division, Department of Health, Disability and Ageing, delegate of the Minister for Health and Ageing, make the following determination.

Dated    29   April 2026

 

 

 

 

REBECCA RICHARDSON

Assistant Secretary

PBS Listing, Pricing and Policy Branch

Technology Assessment and Access Division

Department of Health, Disability and Ageing

 

 

1  Name

 (1) This instrument is the National Health (June 2026 First New Brand Statutory Price Reduction) (Exercise of Ministerial discretion) Determination 2026.

   (2) This instrument may also be cited as PB 45 of 2026.

 

2  Commencement

  This instrument commences on 1 June 2026.

3  Authority

  This instrument is made under sections 99ACB and 99ACD of the National Health Act 1953.

4  Definitions

 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 refers to 1 June 2026.

 

5  Brands of pharmaceutical item (combination items) not subject to a price reduction

  1.     I determine under paragraph 99ACD(7A)(a) of the Act that the agreed price of the brand of pharmaceutical item specified in item 1 in the table in Part 1 of Schedule 1 that comes into force on the reduction day is to be equal to the approved exmanufacturer price, on the day before the determination day, of the listed brands of the existing item. 

6  Brands of pharmaceutical item (not combination items) not subject to a price reduction

  1.     I determine under paragraph 99ACB(6A)(a) of the Act that the agreed price of the brand of pharmaceutical item specified in item 1 in the table in Part 1 of Schedule 2 that comes into force on the reduction day is to be equal to the approved exmanufacturer price, on the day before the determination day, of the listed brands of the existing item. 

 

 

 

Schedule 1 Brands of pharmaceutical item (combination items) not subject to a price reduction

Part 1

Column 1

Column 2

Item

Brand of pharmaceutical item

 

Drug

Form

Manner of administration

Brand

1

Drospirenone with ethinylestradiol

Pack containing 21 tablets 3 mg drospirenone with 30 micrograms ethinylestradiol and 7 inert tablets

Oral

Mila

 


Schedule 2 Brands of pharmaceutical item (not combination items) not subject to a price reduction

Part 1

Column 1

Column 2

Item

Brand of pharmaceutical item

 

Drug

Form

Manner of administration

Brand

1

Febuxostat

Tablet 80 mg

Oral

Febexic

 

Overview

The National Health (June 2026 First New Brand Statutory Price Reduction) (Exercise of Ministerial discretion) Determination 2026, also referred to as PB 45 of 2026, was enacted to address the need for statutory price reductions for certain pharmaceutical items listed under the National Health Act 1953. This determination was made to exercise ministerial discretion regarding the agreed prices of specified brands of pharmaceutical items, aiming to align their pricing with the approved ex-manufacturer prices effective from 1 June 2026. The enactment of this determination was authorised under sections 99ACB and 99ACD of the National Health Act 1953, and it was made by Rebecca Richardson, the Assistant Secretary of PBS Listing, Pricing and Policy Branch, Technology Assessment and Access Division, Department of Health, Disability and Ageing, as the delegate of the Minister for Health and Ageing. The primary objective of this determination is to ensure that the pricing of certain pharmaceutical brands reflects the approved ex-manufacturer prices, thus maintaining fairness and consistency within the national health framework.

Scope and Application

The National Health (June 2026 First New Brand Statutory Price Reduction) (Exercise of Ministerial discretion) Determination 2026 applies to the pricing of specific brands of pharmaceutical items as outlined in the schedules of the determination. This legislation is relevant to pharmaceutical manufacturers and suppliers of the specified brands of pharmaceutical items, particularly those involved in the production and supply of combination and non-combination items listed in Schedules 1 and 2. The determination is made under sections 99ACB and 99ACD of the National Health Act 1953 and affects the agreed prices of these pharmaceutical brands, setting them equal to the approved ex-manufacturer price on the day before the commencement of the reduction day, which is 1 June 2026. This legislative instrument has a national jurisdictional reach as it is enacted under Commonwealth law. The application of this Act is not restricted by any stated exclusions or exemptions within the text provided, though it is possible that further regulations or subordinate instruments could introduce such conditions.

Key Provisions

The National Health (June 2026 First New Brand Statutory Price Reduction) (Exercise of Ministerial discretion) Determination 2026 (sections 1-6) specifies that certain pharmaceutical brands will not undergo a price reduction on 1 June 2026, referred to as the "Reduction day." Section 1 names the instrument and provides an alternative citation as PB 45 of 2026, with section 2 indicating the commencement date of 1 June 2026. Section 3 clarifies the authority under which this determination is made, citing sections 99ACB and 99ACD of the National Health Act 1953. Definitions provided in this instrument refer to specific terms such as "Reduction day," which is 1 June 2026. Sections 5 and 6 detail the brands of pharmaceutical items, both combination and non-combination, that are exempt from the price reduction. The obligations imposed by this Determination (sections 5-6) require that the agreed prices of specified brands of pharmaceutical items remain unchanged on the Reduction day. Specifically, Section 5 states that the price of the brand of pharmaceutical item listed in Schedule 1, which includes combination items, must equal the approved ex-manufacturer price on the day before the Reduction day. Similarly, Section 6 stipulates that the price of the brand listed in Schedule 2, which includes non-combination items, must also equal the approved ex-manufacturer price on the day before the Reduction day. This ensures that the prices of these particular pharmaceutical brands remain unaffected by the statutory price reduction. There are no explicit offences, penalties, or consequences for breach outlined in this Determination. However, the legislative framework under which this determination is made, sections 99ACB and 99ACD of the National Health Act 1953, may include provisions for enforcement and penalties for non-compliance with related statutory requirements. It is important to consult the primary legislation for any applicable sanctions. The focus of this Determination is on specifying the brands exempt from the price reduction, rather than on punitive measures for non-compliance with the specified pricing.

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Health Law
Pharmaceutical Law
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Determination
Concepts
Definitions & Interpretation
Commencement Provisions
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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.