National Health (Originator brand) Amendment Determination 2024 (No. 4)

Overview

The National Health (Originator Brand) Amendment Determination 2024 (No. 4) was enacted to amend the National Health (Originator Brand) Determination 2015, which determines the originator brands of pharmaceutical items that have drugs listed on the Pharmaceutical Benefits Scheme (PBS) F2 formulary. This amendment is necessary to implement the removal of originator brand data from price disclosure calculations for certain drugs, a policy introduced under the National Health (Pharmaceutical Benefits) Regulations 2017. The purpose of this policy is to potentially increase price disclosure related price reductions, as originator brands tend to maintain higher prices than other brands, thereby improving the affordability and accessibility of essential medicines under the PBS. This legislative instrument is made under the authority of subsection 99ADB(6B) of the National Health Act 1953 and has been crafted to ensure that the PBS operates efficiently and cost-effectively, ultimately benefiting consumers by reducing out-of-pocket costs for some PBS medicines. The Australian Government, through the Department of Health and Aged Care, engaged in consultations with companies holding a listed brand of the drugs transitioning from the F1 to F2 formulary. While no comments were received from the affected companies, the determination process leveraged the expertise of relevant stakeholders. This legislative instrument, which commences on 1 December 2024, is compatible with human rights as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health, in line with Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights. By determining originator brands and improving the operation of the PBS, this amendment assists in providing subsidised access to medicines, thereby advancing the protection of human rights.

Scope and Application

The National Health (Originator Brand) Amendment Determination 2024 (No. 4) amends the National Health (Originator Brand) Determination 2015 to address the originator brand status for pharmaceutical items of two drugs, abiraterone and atovaquone, that will be included on the Pharmaceutical Benefits Scheme (PBS) F2 formulary on 1 December 2024. This amendment 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 change aims to increase price disclosure-related price reductions for PBS medicines by ensuring that the Government price more closely reflects the prices of generic brands, which tend to be lower than those of originator brands. This legislative instrument applies to pharmaceutical companies that have brands of abiraterone and atovaquone listed on the PBS and to the Pharmaceutical Benefits Advisory Committee, which provides advice to the Minister for Health regarding the PBS. It operates nationally across Australia and is made under the authority of the National Health Act 1953. The amendment takes effect from 1 December 2024 and is compatible with human rights as it assists in the progressive realisation of the right to the highest attainable standard of physical and mental health by improving the affordability and accessibility of PBS medicines.

Key Provisions

The primary operative sections of the National Health (Originator Brand) Amendment Determination 2024 (No. 4) (PB 130 of 2024) amend the National Health (Originator Brand) Determination 2015 (PB 100 of 2015) to determine the originator brand status for two specific pharmaceutical items, abiraterone and atovaquone, as they transition from the F1 formulary to the F2 formulary on 1 December 2024 (subsection 99ADB(6B)). This amendment is made pursuant to subsection 99ADB(6B) of the National Health Act 1953 (the Act). The amendment is necessary to implement the removal of originator brand data from price disclosure calculations under the National Health (Pharmaceutical Benefits) Regulations 2017 (the Regulations), as detailed in subsection 99ADB(6C). The Act's Interpretation Act 1901 (subsection 33(3)) supports the variation or revocation of the originator brand determination for these drugs. The Act imposes obligations on the parties or entities it governs by ensuring that when determining originator brands, the Minister (or delegate) must consider whether the brand was on the F1 formulary or the Combination Drug List (CDL) when it was first determined as a brand of pharmaceutical item under subsection 85(6) of the Act. The criteria used to determine these brands as originators are based on whether they were the listed brands of the drug when it was on F1 or CDL. Furthermore, the amendment process involved consulting the companies with a Pharmaceutical Benefits Scheme (PBS) listed brand of the drugs moving from F1 to F2, although no comments were received from the affected companies. The determination was made based on the expertise of the consulted parties, and no additional consultation with experts was deemed necessary. Any breaches of the provisions within the Act or the Regulations may lead to civil or criminal consequences. The specific penalties are not detailed in the Explanatory Statement, but penalties for breaches of the National Health Act 1953 or the Regulations can include fines and imprisonment, depending on the severity of the breach. The determination of originator brands and the subsequent price disclosure calculations are crucial for ensuring that the PBS operates efficiently, providing timely, reliable, and affordable access to necessary and cost-effective medicines for Australians. This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011, as it assists with the progressive realisation of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.