National Health (Originator Brand) Amendment Determination (No. 1) 2025

Administered by Department of Health, Disability and Ageing

Legislation au F2025L00060 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

National Health Act 1953

National Health (Originator Brand) Amendment Determination (No. 1) 2025

PB 9 of 2025

Authority

This legislative instrument is made pursuant to subsection 99ADB(6B) of the National Health Act 1953 (the Act).

Purpose

This legislative instrument amends the National Health (Originator Brand) Determination 2015 (PB 100 of 2015) (the Principal Instrument) to determine originator brand status for pharmaceutical items of four drugs included on the Pharmaceutical Benefits Scheme (PBS) F2 formulary on 1 February 2025.

The Principal Instrument determines originator brands of pharmaceutical items that have a drug on the F2 formulary. On meeting certain criteria, drugs move from the F1 formulary (s85AB of the Act), or the single brand Combination Drug List (CDL), to F2. All drugs on F2 are subject to price disclosure. This instrument is necessary to implement removal of originator brand data from price disclosure calculations (originator removal) in certain circumstances as set out in the National Health (Pharmaceutical Benefits) Regulations 2017 (the Regulations). Originator removal will potentially increase price disclosure related price reductions because originator brands tend to maintain higher prices than other brands.

Amendment

An amendment to the originator brand determination is set out in Schedule 1 of this amending instrument for the drugs that are moving from F1 to F2 (dapsone, maraviroc, paclitaxel, nanoparticle albumin-bound and ticagrelor on 1 February 2025). Subsection 99ADB(6C) of the Act provides that when deciding whether to determine originator brands, the Minister (or delegate) must have regard to whether the brand was on F1 or CDL when it was first determined as a brand of pharmaceutical item under subsection 85(6) of the Act.

The main criteria used to determine these brands as originators were that they were the listed brands of the drug when it was on F1 or CDL.

Basis for amendments

Subsection 33(3) of the Act’s Interpretation Act 1901 is relied upon to vary or revoke the determination made under subsection 99ADB(6B) for the medicines affected by this amending instrument.

Consultation

The companies with a PBS listed brand of the drugs moving from F1 to F2 were consulted on the potential originator brand determination. No comments were received from the affected companies. No additional consultation with experts was undertaken regarding this determination because consultation with the affected companies drew on the knowledge of persons with relevant expertise.

This instrument commences on 1 February 2025.

This instrument is a legislative instrument for the purposes of the Legislation Act 2003.


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Health (Originator Brand) Amendment Determination (No. 1) 2025 (PB 9 of 2025)

This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

This legislative instrument amends the National Health (Originator Brand) Determination 2015 (PB 100 of 2015) (the Principal Instrument) to determine originator brands of pharmaceutical items for four drugs new to the PBS F2 formulary on
1 February 2025.

The instrument is necessary to implement removal of originator brand data for price disclosure calculations in certain circumstances as set out in the National Health (Pharmaceutical Benefits) Regulations 2017 (the Regulations). Originator brand removal from price disclosure calculations will potentially increase PBS price reductions, as originator brands tend to maintain higher prices than other brands. Originator brand removal means that the Government price would more closely reflect the prices at which generic brands of the medicine are being sold in the market, not the prices of all brands.

The PBS provides Australians with timely, reliable and affordable access to necessary and
cost-effective medicines. The PBS operates under Part VII of the National Health Act 1953, which regulates the listing, prescribing, pricing, charging and payment of subsidies for supply of drugs and medicinal preparations as pharmaceutical benefits. The Regulations prescribe matters and set out details in relation to the operation of the PBS.

Human rights implications

This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The PBS is a benefits scheme that assists with providing subsidised access to medicines for people. This is a positive and supportive step towards attaining the highest standard of health for all Australians.

Determining an originator brand will improve the operation of the PBS by delivering better value for money for PBS medicines through price disclosure reductions. This will assist consumers by reducing out-of-pocket costs for some PBS medicines.

Conclusion

This legislative instrument is compatible with human rights as it advances the protection of human rights.

 

Rebecca Richardson

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health and Aged Care

Overview

The National Health (Originator Brand) Amendment Determination (No. 1) 2025 is an amendment to the National Health (Originator Brand) Determination 2015, enacted to address the issue of price disclosure for pharmaceutical items on the Pharmaceutical Benefits Scheme (PBS) F2 formulary. This amendment was made pursuant to subsection 99ADB(6B) of the National Health Act 1953 and aims to determine the originator brand status for certain drugs that are moving from the F1 formulary to F2 on 1 February 2025. The purpose of this amendment is to implement the removal of originator brand data from price disclosure calculations, potentially increasing price reductions for certain PBS medicines. This amendment ensures that the Government price reflects the prices of generic brands more accurately, thereby reducing out-of-pocket costs for consumers. The amendment process involved consultation with the companies holding PBS listed brands of the affected drugs, although no comments were received. The determination is compatible with human rights as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health under the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The National Health (Originator Brand) Amendment Determination (No. 1) 2025 amends the National Health (Originator Brand) Determination 2015 to address the originator brand status of four specific drugs that transition to the Pharmaceutical Benefits Scheme (PBS) F2 formulary on 1 February 2025. This amendment applies to drugs that were originally listed on the F1 formulary or the single brand Combination Drug List (CDL), which will now be subject to price disclosure requirements. The Act applies to these specific drugs and their pharmaceutical items, focusing on the pharmaceutical industry and the conduct related to the pricing and disclosure of originator brands. The jurisdictional reach of this amendment is national, operating under the Commonwealth's authority as prescribed by the National Health Act 1953. The amendment does not exclude any particular entities or industries but specifically targets the criteria for determining originator brands, which is essential for price disclosure calculations outlined in the National Health (Pharmaceutical Benefits) Regulations 2017. The changes will potentially lead to increased price reductions within the PBS, as the removal of originator brand data from price disclosure calculations aims to better reflect the prices of generic brands.

Key Provisions

The National Health (Originator Brand) Amendment Determination (No. 1) 2025 amends the National Health (Originator Brand) Determination 2015, specifically targeting four drugs moving from the F1 formulary to the F2 formulary on 1 February 2025 (Section 99ADB(6B)). These drugs are dapsone, maraviroc, paclitaxel, nanoparticle albumin-bound, and ticagrelor. The amendment aims to establish the originator brand status for these drugs under the Pharmaceutical Benefits Scheme (PBS) (Schedule 1). This determination is crucial for implementing the removal of originator brand data from price disclosure calculations, which is outlined in the National Health (Pharmaceutical Benefits) Regulations 2017. The legislation imposes specific obligations on the parties involved, primarily focusing on the Pharmaceutical Benefits Advisory Committee (PBAC) and the Department of Health. The PBAC must review and determine the originator brand status of the drugs moving from F1 to F2, ensuring that the criteria are met, which primarily involves identifying the brands of the drugs when they were initially listed under the F1 formulary or the Combination Drug List (CDL). The Department of Health, in turn, is responsible for implementing these determinations and ensuring compliance with the PBS regulations. These obligations are rooted in the criteria specified under subsection 85(6) of the Act and the provisions of the Regulations. In terms of consequences, the legislation does not explicitly outline criminal or civil penalties for non-compliance with the originator brand determinations. However, the overarching National Health Act 1953 provides a framework under which non-compliance could lead to enforcement actions. Such actions might include administrative penalties, fines, or other corrective measures as deemed appropriate by the relevant authorities. While the specific penalties are not detailed in this amending instrument, they fall within the purview of the broader regulatory framework established by the Act and the Regulations. The amendment also aligns with the National Health (Pharmaceutical Benefits) Regulations 2017, which detail the operational aspects of the PBS. By removing originator brand data from price disclosure calculations, the legislation seeks to ensure that the government prices for PBS medicines more accurately reflect the prices of generic brands, potentially leading to reduced out-of-pocket costs for consumers. This change is intended to enhance the efficiency and effectiveness of the PBS, ensuring that Australians have access to cost-effective and necessary medications. Ultimately, this legislative change supports the broader objectives of the PBS, which is to provide affordable access to essential medicines and promote public health.

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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.