National Health (Originator Brand) Amendment Determination (December Update) 2025

Overview

The National Health (Originator Brand) Amendment Determination (December Update) 2025 amends the National Health (Originator Brand) Determination 2025, made under the National Health Act 1953. This amendment is necessary to implement the removal of originator brand data from price disclosure calculations in certain circumstances, as set out in the National Health (Pharmaceutical Benefits) Regulations 2017. The Pharmaceutical Benefits Scheme (PBS) is designed to provide Australians with timely, reliable and affordable access to necessary and cost-effective medicines. By determining originator brands for pharmaceutical items that transition from the F1 to F2 formulary, the amendment aims to potentially increase price disclosure-related price reductions, as originator brands typically maintain higher prices than other brands. This measure is expected to provide better value for money for PBS medicines and assist consumers by reducing out-of-pocket costs for some PBS medicines. This legislative instrument was enacted by the Australian Government, in accordance with subsection 99ADB(6B) of the National Health Act 1953. The primary purpose of the amendment is to address the gap in the pricing disclosure calculations by removing originator brand data. This change is anticipated to increase price reductions for certain PBS medicines, ultimately benefiting consumers by reducing their out-of-pocket expenses. The instrument is compatible with human rights, as it advances the protection of human rights by engaging with Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights, assisting with the progressive realisation of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

Scope and Application

The National Health (Originator Brand) Amendment Determination (December Update) 2025, made under the National Health Act 1953, concerns the determination of originator brand status for pharmaceutical items of five drugs that will be included on the Pharmaceutical Benefits Scheme (PBS) F2 formulary on 1 December 2025. The amendment applies to pharmaceutical entities that manufacture or supply these drugs, specifically drospirenone, eribulin, haloperidol, pazopanib, and tranylcypromine, within Australia. The purpose of this amendment is to implement the removal of originator brand data from price disclosure calculations as per the National Health (Pharmaceutical Benefits) Regulations 2017. This change is anticipated to lead to greater price reductions for PBS medicines, as originator brands typically maintain higher prices than generic brands. Consequently, this amendment aims to enhance the affordability and accessibility of essential medications under the PBS. The instrument is limited to the Pharmaceutical Benefits Scheme, which operates under the National Health Act 1953, and it does not apply to other health services or products outside the scope of the PBS. The amendment is effective from 1 December 2025 and is subject to the provisions set forth in the National Health (Pharmaceutical Benefits) Regulations 2017.

Key Provisions

The main operative sections of the National Health (Originator Brand) Amendment Determination (December Update) 2025 (PB 142 of 2025) are found in Schedule 1, where the amendment to the originator brand determination for specific drugs is outlined. The determination sets the originator brand status for drospirenone, eribulin, haloperidol, pazopanib, and tranylcypromine, which are moving from the F1 formulary to the F2 formulary on 1 December 2025. This amendment is crucial for implementing the removal of originator brand data from price disclosure calculations under the National Health (Pharmaceutical Benefits) Regulations 2017. Such removal is expected to increase price disclosure-related price reductions as originator brands typically maintain higher prices compared to generic brands. The decision to determine originator brands is made in accordance with subsection 99ADB(6C) of the National Health Act 1953, which requires consideration of whether the brand was on the F1 formulary or the Combination Drug List when it was first determined. The Act imposes several obligations on the parties involved. Firstly, it mandates that when determining the originator brand status for pharmaceutical items, the Minister or delegate must consider whether the brand was on the F1 formulary or the Combination Drug List when it was first determined as a brand of pharmaceutical item. This is explicitly stated in subsection 99ADB(6C) of the Act. Additionally, the Act requires that any amendments to the originator brand determination be made in accordance with the provisions of the Interpretation Act 1901, as indicated in subsection 33(3). The affected companies with PBS listed brands of the drugs moving from F1 to F2 were consulted regarding the potential originator brand determination. However, no comments were received from the affected companies, and no additional consultation with experts was undertaken. In terms of consequences for breach, the Act does not explicitly state any offences or penalties for failing to comply with the originator brand determination. However, the Regulations, which are referred to in the explanatory statement, may include provisions for civil or criminal penalties in the event of non-compliance with the price disclosure requirements. It is important to note that the instrument is a legislative instrument for the purposes of the Legislation Act 2003, which may provide additional frameworks for enforcement and compliance. The determination of originator brands for specific drugs moving from the F1 to the F2 formulary on the Pharmaceutical Benefits Scheme (PBS) F2 formulary on 1 December 2025 is a key provision of this legislative instrument. This amendment is designed to implement the removal of originator brand data from price disclosure calculations in certain circumstances as set out in the National Health (Pharmaceutical Benefits) Regulations 2017. By removing originator brand data, the instrument aims to potentially increase price disclosure-related price reductions, as originator brands tend to maintain higher prices than other brands. This change is expected to improve the operation of the PBS by delivering better value for money for PBS medicines through price disclosure reductions, ultimately assisting consumers by reducing out-of-pocket costs for some PBS medicines.