National Health (Originator Brand) Amendment Determination 2023 (No. 3)

Overview

The National Health (Originator Brand) Amendment Determination 2023 (No. 3) amends the National Health (Originator Brand) Determination 2015, addressing the issue of originator brand determination for pharmaceutical items that transition from the F1 formulary to the F2 formulary of the Pharmaceutical Benefits Scheme (PBS). This legislative instrument was introduced to address the need for the removal of originator brand data from price disclosure calculations in certain circumstances, as specified in the National Health (Pharmaceutical Benefits) Regulations 2017. This change is anticipated to increase price disclosure-related price reductions, given that originator brands typically maintain higher prices than other brands, thereby potentially lowering out-of-pocket costs for consumers. The amendment was made pursuant to subsection 99ADB(6B) of the National Health Act 1953 and was enacted by the Australian Parliament. The policy objective behind this amendment is to improve the affordability and accessibility of medicines for Australians by ensuring better value for money through PBS price reductions. 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 determining originator brands and facilitating price reductions, the amendment supports the PBS's mission to provide subsidised access to necessary and cost-effective medicines, thereby enhancing the overall health outcomes for Australians. The determination of an originator brand for the drug fosaprepitant, which is moving from the F1 to the F2 formulary on 1 June 2023, is a specific instance of this broader policy objective. The legislative instrument is compatible with human rights, as it advances the protection of human rights by ensuring that the PBS operates in a manner that benefits all Australians by reducing the cost of essential medicines.

Scope and Application

The National Health (Originator Brand) Amendment Determination 2023 (No. 3) is an amendment to the National Health (Originator Brand) Determination 2015 under the National Health Act 1953. It specifically applies to the pharmaceutical item fosaprepitant, which is moving from the F1 formulary to the F2 formulary of the Pharmaceutical Benefits Scheme (PBS) on 1 June 2023. The determination of the originator brand for fosaprepitant is necessary to implement the removal of originator brand data from price disclosure calculations, as outlined in the National Health (Pharmaceutical Benefits) Regulations 2017. This amendment is expected to increase price disclosure-related price reductions because originator brands typically maintain higher prices than other brands. The amendment is made under the authority of subsection 99ADB(6B) of the Act and is effective from 1 June 2023. The affected company was consulted, but no comments were received. This legislative instrument is compatible with human rights, particularly the right to the enjoyment of the highest attainable standard of physical and mental health, as it supports the progressive realisation of this right through better value for money for PBS medicines and reduced out-of-pocket costs for consumers.

Key Provisions

The primary operative sections of the National Health (Originator Brand) Amendment Determination 2023 (No. 3) (PB 49 of 2023) amend the National Health (Originator Brand) Determination 2015 (PB 100 of 2015) by determining originator brand status for the drug fosaprepitant, which is moving from the F1 formulary to the F2 formulary of the Pharmaceutical Benefits Scheme (PBS) on 1 June 2023 (subsection 99ADB(6B) of 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 (subsection 99ADB(6C) of the Act). The drug fosaprepitant was determined to be an originator brand based on it being the listed brand of the drug when it was on the F1 formulary or the Combination Drug List (subsection 99ADB(6C) of the Act). This amendment reflects the criteria used to determine originator brands, which are the brands of the drug when it was on the F1 formulary or the CDL. The obligations and requirements imposed by the Act on the parties or entities it governs include ensuring that drugs listed on the F2 formulary are subject to price disclosure (section 99AD(1) of the Act). The Act also mandates that 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 when deciding whether to determine originator brands (subsection 99ADB(6C) of the Act). For the purposes of this amendment, the company with a PBS listed brand of fosaprepitant was consulted, and no comments were received from the affected company (subsection 33(3) of the Interpretation Act 1901). The determination of originator brand status for fosaprepitant under this instrument does not create any specific offences, penalties, or civil/criminal consequences for breach. However, non-compliance with the provisions of the National Health Act 1953, including the provisions related to price disclosure and originator brand determination, could potentially result in legal consequences. The Regulations and other related provisions of the Act may impose penalties or other consequences for non-compliance with the requirements of the PBS. For instance, under the National Health Act 1953, there are provisions for penalties in relation to false or misleading statements and other related offences, although these are not specifically addressed in this instrument. The primary focus of this amendment is to ensure that the PBS operates efficiently and effectively by accurately determining originator brands and implementing the removal of originator brand data from price disclosure calculations where appropriate.