National Health (Originator Brand) Amendment Determination 2024 (No. 1)

Overview

The National Health (Originator Brand) Amendment Determination 2024 (No. 1) amends the National Health (Originator Brand) Determination 2015 to address the issue of originator brand status for a pharmaceutical item of a drug newly added to the Pharmaceutical Benefits Scheme (PBS) F2 formulary on 1 February 2024. This amendment is made pursuant to subsection 99ADB(6B) of the National Health Act 1953 and 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. The policy objective is to potentially increase price disclosure-related price reductions for PBS medicines, as originator brands typically maintain higher prices than generic brands, thus improving value for money and reducing out-of-pocket costs for consumers. This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by contributing to the progressive realisation of the right to the highest attainable standard of physical and mental health. By improving the operation of the PBS through price disclosure reductions, the amendment assists in providing affordable access to necessary and cost-effective medicines for Australians, thereby supporting the attainment of better health outcomes for the population. The determination of originator brands ensures that the Government price more closely reflects the prices at which generic brands of the medicine are sold, enhancing the overall efficiency and effectiveness of the PBS.

Scope and Application

The National Health (Originator Brand) Amendment Determination 2024 (No. 1) amends the National Health (Originator Brand) Determination 2015, implementing specific changes to the originator brand status of pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) F2 formulary. This amendment applies to the drug amantadine, effective from 1 February 2024, when it transitions from the F1 formulary to F2. The determination of originator brands is crucial as it influences price disclosure calculations, potentially leading to increased price reductions for certain PBS medicines. Originator brands, typically maintaining higher prices than generic brands, when excluded from price disclosure calculations, can result in prices that more closely reflect those of generic brands, thereby reducing costs for consumers. This legislative instrument operates under the authority of the National Health Act 1953 and the National Health (Pharmaceutical Benefits) Regulations 2017, with a focus on improving the affordability and accessibility of essential medications within the PBS framework.

Key Provisions

The National Health (Originator Brand) Amendment Determination 2024 (No. 1) (F2024L00126) amends the National Health (Originator Brand) Determination 2015 (F2015L0100) to determine the originator brand status of a pharmaceutical item for the drug amantadine, which transitions from the F1 to the F2 formulary on 1 February 2024 (section 1(1)). 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(2)). The criteria for determining the originator brand of amantadine are based on whether the brand was listed when the drug was first determined as a pharmaceutical item on the F1 formulary or the Combination Drug List (section 1(3)). The instrument relies on subsection 33(3) of the Act's Interpretation Act 1901 to vary or revoke the determination for the affected medicines (section 1(4)). The Act imposes certain obligations and requirements on the parties governed by it. Firstly, 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 (subsection 99ADB(6C) of the Act). Secondly, the pharmaceutical companies must ensure that their brands meet the criteria set out in the determination to be considered as originator brands (section 1(3)). Thirdly, the Act requires the government to progressively realise the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, which is engaged by Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (section 1(5)). The Regulations prescribe matters and set out details in relation to the operation of the PBS (section 1(6)). Breaches of the provisions of the Act may result in civil or criminal consequences. The maximum penalties for contraventions of the Act are not explicitly stated in the legislation, but penalties for breaches of similar legislation can range from fines to imprisonment, depending on the severity of the offence. For instance, under the Crimes Act 1914, the maximum penalty for a serious drug offence can be up to 25 years imprisonment. Similarly, under the Health Insurance Act 1973, the maximum penalty for contravening the Act can be up to 12 months imprisonment or a fine of up to $10,000, or both. It is important to note that the specific penalties for breaches of the National Health Act 1953 may vary depending on the circumstances of the offence and the relevant provisions of the Act.