PB 16 of 2026
National Health (February 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 28 January 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 (February 2026 First New Brand Statutory Price Reduction) (Exercise of Ministerial discretion) Determination 2026.
(2) This instrument may also be cited as PB 16 of 2026.
2 Commencement
This instrument commences on 1 February 2026.
3 Authority
This instrument is made under sections 99ACD and 99ACR 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 February 2026.
5 Brands of pharmaceutical item not subject to a price reduction
- 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 ex‑manufacturer price, on the day before the determination day, of the listed brands of the existing item.
6 Brand of pharmaceutical item subject to a lower price reduction than would otherwise apply
- I determine under paragraph 99ACR(6)(b) of the Act that the approved ex-manufacturer price of the related brand of the related item specified in column 2 of an item in the table in Schedule 2 is reduced in relation to the reduction day by the percentage specified in column 3 of the table item.
Schedule 1 Brands of pharmaceutical item 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 24 tablets 3 mg drospirenone with 20 micrograms ethinylestradiol and 4 inert tablets | Oral | Brooke |
1 | Drospirenone with ethinylestradiol | Pack containing 21 tablets 3 mg drospirenone with 30 micrograms ethinylestradiol and 7 inert tablets | Oral | Brooklynn |
Schedule 2 Brand of pharmaceutical item subject to a lower price reduction than would otherwise apply
Part 1
Column 1 | Column 2 | Column 3 |
Item | Brand of pharmaceutical item | |
| Drug | Form | Manner of administration | Brand | % Reduction |
1 | Aflibercept | Solution for intravitreal injection 11.43 mg in 100 microlitres (114.3 mg per mL) | Injection | Eylea | 20% |
Overview
The National Health (February 2026 First New Brand Statutory Price Reduction) (Exercise of Ministerial discretion) Determination 2026 (PB 16 of 2026) was enacted to address the need for statutory price reductions for certain pharmaceutical items under the National Health Act 1953. This determination was issued by Rebecca Richardson, the Assistant Secretary of the Pricing and PBS Listing, Pricing and Policy Branch, Technology Assessment and Access Division, Department of Health, Disability and Ageing, as a delegate of the Minister for Health and Ageing. The primary objective of this determination is to exercise ministerial discretion concerning the reduction of prices for specific pharmaceutical brands to ensure more affordable access to essential medications. The determination came into effect on 1 February 2026, providing clarity on the price adjustments for certain pharmaceutical items, and is rooted in the legislative authority conferred by sections 99ACD and 99ACR of the Act.
Scope and Application
The National Health (February 2026 First New Brand Statutory Price Reduction) (Exercise of Ministerial discretion) Determination 2026 applies specifically to pharmaceutical items listed under the National Health Act 1953. This legislation targets brands of pharmaceutical items that are subject to price reductions, particularly those that have agreed prices or approved ex-manufacturer prices. The determination outlines specific brands that will not undergo a price reduction, ensuring their prices remain at the approved ex-manufacturer price as of the day before the reduction day, which is 1 February 2026. Additionally, it specifies other brands that will be subject to a lower percentage price reduction, as detailed in Schedule 2. The jurisdictional reach of this Act is national, applying across Australia, and it is administered by the Department of Health, Disability and Ageing. The Act does not explicitly mention any exclusions, exemptions, or thresholds, but the detailed specifications in Schedules 1 and 2 provide clarity on which items are affected. The application of this determination may be extended or restricted through subordinate instruments under the authority of the Act.
Key Provisions
The main operative sections of the National Health (February 2026 First New Brand Statutory Price Reduction) (Exercise of Ministerial discretion) Determination 2026 (section 1) state that this instrument may also be referred to as PB 16 of 2026. The instrument commences on 1 February 2026 and is made under sections 99ACD and 99ACR of the National Health Act 1953. It sets out specific provisions regarding the pricing of certain pharmaceutical items.
This legislation imposes obligations on the Minister for Health and Ageing and the Department of Health, Disability and Ageing to ensure that the specified pharmaceutical brands are priced correctly according to the determinations. For certain brands listed in Schedule 1, the price is set to be equal to the approved ex-manufacturer price of the listed brands of the existing item on the day before the reduction day (section 5). For other brands listed in Schedule 2, a lower price reduction is applied as specified in the schedule (section 6).
Breaches of the requirements set out in this determination may lead to various consequences. Although the specific offences, penalties, or civil/criminal consequences are not explicitly detailed in the provided text, under the National Health Act 1953, non-compliance with statutory determinations may result in penalties. These could include fines or other sanctions, as stipulated by the relevant sections of the Act. The maximum penalties, if applicable, would be determined in accordance with the provisions of the National Health Act 1953.