National Health (Originator Brand) Amendment Determination 2023 (No. 6)

Overview

The National Health (Originator Brand) Amendment Determination 2023 (No. 6) (PB 120 of 2023) amends the National Health (Originator Brand) Determination 2015 to determine the originator brands of pharmaceutical items for two new drugs entering the Pharmaceutical Benefits Scheme (PBS) F2 formulary on 1 December 2023. Enacted by the Australian Government, this determination addresses the need to implement originator brand removal from price disclosure calculations as outlined in the National Health (Pharmaceutical Benefits) Regulations 2017. The policy objective is to enhance the value for money in PBS medicines by potentially increasing price disclosure-related price reductions, as originator brands typically maintain higher prices than other brands. This amendment ensures that government prices reflect the prices of generic brands more closely, thereby reducing out-of-pocket costs for consumers. The legislation aligns with human rights, particularly Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights, by supporting the progressive realization of the right to the highest attainable standard of health through more affordable access to medicines.

Scope and Application

The National Health (Originator Brand) Amendment Determination 2023 (No. 6) amends the National Health (Originator Brand) Determination 2015 to determine the originator brand status of pharmaceutical items for two drugs new to the Pharmaceutical Benefits Scheme (PBS) F2 formulary on 1 December 2023. The Act applies to the entities and pharmaceutical items affected by this determination, specifically the originator brands of the drugs cyclophosphamide and dabigatran etexilate, which are moving from F1 to F2 on the specified date. This amendment ensures that these drugs are subject to the price disclosure requirements outlined in the National Health (Pharmaceutical Benefits) Regulations 2017, potentially leading to increased price reductions in the PBS due to the removal of originator brand data from price disclosure calculations. This determination is made pursuant to subsection 99ADB(6B) of the National Health Act 1953 and is necessary to implement the originator removal, which is expected to better align the Government price with the market prices of generic brands. The instrument is compatible with human rights as it aims to progressively realise the right to the highest attainable standard of physical and mental health by ensuring more affordable access to necessary and cost-effective medicines through the PBS.

Key Provisions

The National Health (Originator Brand) Amendment Determination 2023 (No. 6) (PB 120 of 2023) amends the National Health (Originator Brand) Determination 2015 (PB 100 of 2015) to determine the originator brand status for two new pharmaceutical items on the Pharmaceutical Benefits Scheme (PBS) F2 formulary, effective from 1 December 2023. The two drugs in question are cyclophosphamide and dabigatran etexilate, both of which are moving from the F1 formulary to F2 on the same date. The determination of originator brands is necessary to implement the removal of originator brand data from price disclosure calculations under certain circumstances, as outlined in the National Health (Pharmaceutical Benefits) Regulations 2017 (the Regulations). This amendment is intended to potentially increase price disclosure-related price reductions for these drugs, as originator brands typically maintain higher prices than other brands. The determination of originator brands for these two drugs is based on the criteria that they were the listed brands when the drugs were first on the F1 formulary or the Combination Drug List (CDL). This decision aligns with subsection 99ADB(6C) of the National Health Act 1953 (the Act), which states that when deciding whether to determine originator brands, the Minister (or delegate) must 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 Act. The amendment to the originator brand determination is set out in Schedule 1 of this amending instrument. The Pharmaceutical Benefits Scheme (PBS) is a crucial part of Australia's healthcare system, providing Australians with affordable access to necessary and cost-effective medicines. The PBS is regulated under Part VII of the National Health Act 1953, which governs the listing, prescribing, pricing, charging, and payment of subsidies for the supply of drugs and medicinal preparations as pharmaceutical benefits. The Regulations outline the operational details of the PBS. The PBS aims to ensure that all Australians have access to essential medicines at a price they can afford, and the determination of originator brands for these two drugs supports this objective by potentially reducing out-of-pocket costs for consumers. The amendment to the originator brand determination imposes certain obligations on the parties or entities it governs. The companies with a PBS listed brand of the drugs moving from F1 to F2 were consulted on the potential originator brand determination, and no comments were received from the affected companies. The instrument's basis for amendments relies on subsection 33(3) of the Act's Interpretation Act 1901 to vary or revoke the determination made under subsection 99ADB(6B) for the medicines affected by this amending instrument. The instrument commences on 1 December 2023 and is a legislative instrument for the purposes of the Legislation Act 2003. Failure to comply with the requirements of the National Health (Originator Brand) Amendment Determination 2023 (No. 6) may result in civil or criminal consequences, depending on the nature and severity of the breach. However, the Explanatory Statement does not provide specific information on the penalties or consequences for non-compliance. It is essential for the parties or entities governed by this instrument to ensure they adhere to the requirements set out in the Act and the Regulations to avoid any potential legal ramifications.