National Health (Originator Brand) Amendment Determination (February Update) 2026

Overview

The National Health (Originator Brand) Amendment Determination (February Update) 2026 amends the National Health (Originator Brand) Determination 2025 to determine the originator brand status for pharmaceutical items of three drugs included on the Pharmaceutical Benefits Scheme (PBS) F2 formulary, effective from 1 February 2026. Enacted by the Australian Government under the National Health Act 1953, this instrument addresses the need to implement the removal of originator brand data from price disclosure calculations in certain circumstances, as outlined in the National Health (Pharmaceutical Benefits) Regulations 2017. This change aims to potentially increase price disclosure-related price reductions, as originator brands typically maintain higher prices than other brands. The legislative instrument ensures that the government price more closely reflects the prices at which generic brands of the medicine are being sold in the market. This amendment is necessary to improve the operation of the PBS by delivering better value for money for PBS medicines through price disclosure reductions, which will assist consumers by reducing out-of-pocket costs for some PBS medicines. The instrument is compatible with human rights, engaging Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation of the right to the highest attainable standard of physical and mental health. By determining the originator brand, the Government aims to provide subsidised access to medicines for people, contributing positively to the attainment of the highest standard of health for all Australians.

Scope and Application

The National Health (Originator Brand) Amendment Determination (February Update) 2026 amends the National Health (Originator Brand) Determination 2025 to determine the originator brand status for pharmaceutical items of three drugs included on the Pharmaceutical Benefits Scheme (PBS) F2 formulary on 1 February 2026. The Act applies to pharmaceutical items on the PBS, particularly those moving from the F1 formulary or the Combination Drug List to F2. The amendment is necessary to implement the removal of originator brand data from price disclosure calculations in certain circumstances as outlined in the National Health (Pharmaceutical Benefits) Regulations 2017. This change aims to potentially increase price disclosure related price reductions, as originator brands tend to maintain higher prices than other brands. The instrument operates under the Commonwealth jurisdiction and will affect pharmaceutical companies with brands listed on the PBS. There are no stated exclusions or exemptions in this amendment, which commences on 1 February 2026 and is a legislative instrument under the Legislation Act 2003. The instrument is compatible with human rights, engaging Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

Key Provisions

The main operative sections of this legislative instrument are those found in Schedule 1, which detail the amendment to the National Health (Originator Brand) Determination 2025 (PB 114 of 2025). Specifically, this instrument amends the determination for three pharmaceutical items—aflibercept, cladribine, and vildagliptin with metformin—that are moving from the F1 formulary or the Combination Drug List (CDL) to the F2 formulary on 1 February 2026 (sections 1(2) and 1(3)). This amendment is necessary to implement the removal of originator brand data from price disclosure calculations in certain circumstances as outlined in the National Health (Pharmaceutical Benefits) Regulations 2017 (section 1(1)). The intent behind this is to potentially increase price disclosure-related price reductions, as originator brands tend to maintain higher prices than other brands (section 1(4)). This Act imposes several obligations and requirements on the parties and entities it governs. Firstly, it mandates the determination of originator brands for pharmaceutical items that have a drug on the F2 formulary. This includes drugs moving from the F1 formulary or the CDL to F2 (section 1(2) and 1(3)). Secondly, the Act requires that the Minister (or delegate) consider 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 National Health Act 1953 when deciding whether to determine originator brands (subsection 99ADB(6C)). Thirdly, the Act necessitates consultation with the companies that have a PBS listed brand of the drugs moving from F1 and CDL to F2, as evidenced by the consultation conducted for this amendment (subsection 99ADB(6B)). The Act also outlines several offences, penalties, and consequences for breach. Although specific penalties are not detailed within the text of this instrument, it is implied that breaches of the National Health (Pharmaceutical Benefits) Regulations 2017 could result in penalties. These penalties could include fines or other civil or criminal consequences, as is common under Australian legislation for breaches of health-related regulations. The exact nature and extent of these penalties would be determined in accordance with the broader regulatory framework provided by the National Health Act 1953 and the Regulations. In summary, this legislative instrument amends the National Health (Originator Brand) Determination 2025 to address the originator brand status of three pharmaceutical items moving to the F2 formulary on 1 February 2026. It imposes obligations on the Minister to consider certain criteria when determining originator brands and mandates consultation with affected companies. While specific penalties for breach are not detailed, breaches of related regulations could result in civil or criminal consequences. This amendment aims to improve the operation of the Pharmaceutical Benefits Scheme by potentially reducing prices and out-of-pocket costs for consumers through increased price disclosure-related price reductions.