National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 1) 2026

Administered by Department of Health, Disability and Ageing

Legislation au F2026N00130 In force Notifiable Instrument

Legislation content

 

PB 8 of 2026

 

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 1) 2026

I, Rebecca Richardson, as delegate of the Minister for Health, Disability and Ageing, make the following Determination.

Dated      17 February 2026

    

 

Rebecca Richardson

Assistant Secretary
PBS Listing, Pricing and Policy Branch
Technology Assessment and Access Division
Department of Health, Disability and Ageing

Contents

1  Name

2  Commencement

3  Authority

4  Schedules

Schedule 1—Amendments—Additional designated brands effective from 1 August 2026

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023

 

 

1  Name

 (1) This instrument is the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 1) 2026.

 (2) This instrument may also be cited as PB 8 of 2026.

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.  Sections 1 to 4 and anything in this instrument not elsewhere covered by this table

The day after this instrument is registered.

 

2.  Schedule 1

1 August 2026

1 August 2026

Note: This table relates only to the provisions of this instrument as originally made.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.

3  Authority

  This instrument is made under subsection 99ADHC(2) of the National Health Act 1953.

4  Schedules

  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

 

Schedule 1—Amendments—Additional designated brands effective from 1 August 2026

National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023

1  Section 5 (after table item dealing with the brand Lax-Tab of the drug Bisacodyl in the form Tablet 5 mg)

Insert:

DBL Bleomycin Sulfate

Bleomycin

Powder for injection containing bleomycin sulfate 15,000 I.U.

Injection

 

2  Section 5 (after table item dealing with the brand Triumeq of the drug Dolutegravir with abacavir and lamivudine in the form Tablet containing dolutegravir 50 mg with abacavir 600 mg and lamivudine 300 mg)

Insert:

Adriamycin

Doxorubicin

Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial

Injection/Intravesical

Doxorubicin ACC

Doxorubicin

Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial

Injection

3  Section 5 (after table item dealing with the brand Flucil of the drug Flucloxacillin in the form Powder for oral liquid 250 mg (as sodium monohydrate) per 5 mL, 100 mL)

Insert:

Fludarabine Juno

Fludarabine

Powder for I.V. injection containing fludarabine phosphate 50 mg

Injection

Fludarabine Ebewe

Fludarabine

Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL

Injection

 

 

 

 

4  Section 5 (after table item dealing with the brand Lasix of the drug Furosemide in the form Oral solution 10 mg per ml, 30 ml)

Insert:

Lasix

Furosemide

Injection 20 mg in 2 mL

Injection

 

 

 

 

5  Section 5 (after table item dealing with the brand Moduretic of the drug Hydrochlorothiazide with amiloride in the form Tablet containing hydrochlorothiazide 50 mg with amiloride hydrochloride 5 mg)

Insert:

Solu-Cortef

Hydrocortisone

Injection 100 mg (as sodium succinate) with 2 mL solvent

Injection

Solu-Cortef

Hydrocortisone

Injection 250 mg (as sodium succinate) with 2 mL solvent

Injection

6  Section 5 (after table item dealing with the brand Vancomycin Viatris of the drug Vancomycin with amiloride in the form Powder for injection 500 mg (500,000 I.U.) (as hydrochloride))

Insert:

DBL Vinblastine

Vinblastine

Solution for I.V. injection containing vinblastine sulfate 10 mg in 10 mL

Injection

 

Overview

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 1) 2026, also known as PB 8 of 2026, was enacted to address the need for additional regulation of pharmaceutical pricing within the National Health Scheme, specifically targeting certain brands of pharmaceutical items to ensure affordability and access. This amendment to the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023 was introduced to further refine the pricing structure for selected pharmaceutical brands, thereby maintaining equitable access to essential medications for patients while controlling costs within the healthcare system. The determination was made under the authority granted by subsection 99ADHC(2) of the National Health Act 1953, and it was issued by Rebecca Richardson, as delegate of the Minister for Health, Disability and Ageing, within the Department of Health, Disability and Ageing. The overarching policy objective is to ensure the sustainability of the Pharmaceutical Benefits Scheme (PBS) by setting a floor price for certain pharmaceutical brands, thus preventing excessive pricing practices that could otherwise limit patient access to necessary medications.

Scope and Application

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 1) 2026 applies to designated pharmaceutical brands within the Australian healthcare system. It amends the National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023 by introducing additional pharmaceutical brands that will be subject to a floor price effective from 1 August 2026. The Act applies to pharmaceutical manufacturers, suppliers, and distributors of the specified brands, as well as to the pharmaceutical items themselves. The geographic reach of this Determination is national, covering all states and territories within Australia. The Act does not specify any exclusions or exemptions, and it extends its application through the subordinate instrument mentioned in Schedule 1, which details the additional designated brands and their effective date.

Key Provisions

The National Health (Floor Price for Certain Brands of Pharmaceutical Items) Amendment Determination (No. 1) 2026 introduces several amendments to the existing National Health (Floor Price for Certain Brands of Pharmaceutical Items) Determination 2023. Section 1 of the determination provides the name and citation of the instrument, while Section 2 outlines the commencement of its provisions. Notably, the amendments in Schedule 1, which detail the additional designated brands, will take effect from 1 August 2026. Section 3 identifies the authority under which the instrument is made, specifically subsection 99ADHC(2) of the National Health Act 1953. The Schedules section confirms that each instrument specified in the Schedule is amended as per the items outlined, with any other items having effect according to their terms. The obligations imposed by this Determination primarily concern the pharmaceutical companies that manufacture or supply the designated brands of pharmaceutical items. These companies must adhere to the newly established floor prices for the specified brands, ensuring that the pricing does not fall below the mandated minimum levels. This is intended to provide consistency and affordability in the pricing of essential pharmaceutical items, particularly for those listed in Schedule 1. By specifying the brands and their corresponding dosages and forms, the Determination aims to ensure that patients have access to necessary medications at a fair price. Failure to comply with the provisions of this Determination can result in significant consequences for the parties involved. The determination itself does not explicitly detail the offences, penalties, or consequences for breach. However, under the National Health Act 1953, breaches of the Act's provisions can lead to substantial penalties. For example, corporations may face fines of up to $210,000, while individuals could be fined up to $42,000. In addition to financial penalties, non-compliance could also result in civil or criminal proceedings, depending on the nature and severity of the breach. The overarching goal of these potential sanctions is to enforce adherence to the established floor prices and to protect public health by ensuring the affordability and accessibility of essential medications.

Legal classification tags

Area of Law
Health Law
Pharmaceutical Law
Instrument
Notifiable instrument
Concepts
Commencement Provisions
Amendments
Licensing & Registration
Regulatory Standards

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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.