National Health (Originator brand) Amendment Determination 2024 (No. 2)

Overview

The National Health (Originator Brand) Amendment Determination 2024 (No. 2) is a legislative instrument made under the authority of subsection 99ADB(6B) of the National Health Act 1953. This instrument addresses the issue of determining originator brands for pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) F2 formulary, specifically for drugs moving from F1 or the Combination Drug List (CDL) to F2. The primary objective of this amendment is to implement the removal of originator brand data from price disclosure calculations as outlined in the National Health (Pharmaceutical Benefits) Regulations 2017. By excluding originator brand data, the instrument aims to potentially increase price disclosure-related price reductions, as originator brands typically maintain higher prices than other brands, thereby improving affordability and access to medications for consumers under the PBS. The determination process was undertaken in consultation with the relevant pharmaceutical company, although no comments were received. The amendment is necessary to align with the criteria specified in the National Health Act, particularly in ensuring that the brand determination reflects the brand's status when it was first listed under the Act. This legislative instrument, which commences on 1 June 2024, supports the overall goal of the PBS in providing timely, reliable, and affordable access to necessary medicines, ultimately contributing to the progressive realisation of the right to the highest attainable standard of health as recognised under the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The National Health (Originator Brand) Amendment Determination 2024 (No. 2) amends the National Health (Originator Brand) Determination 2015 to determine the originator brand status of a pharmaceutical item for the drug testosterone, which will move from the F1 to the F2 formulary on 1 June 2024. This amendment is made under subsection 99ADB(6B) of the National Health Act 1953 and is necessary to implement the removal of originator brand data from price disclosure calculations for certain circumstances as outlined in the National Health (Pharmaceutical Benefits) Regulations 2017. The removal of originator brand data from these calculations is expected to increase price disclosure-related price reductions, as originator brands typically maintain higher prices than other brands, potentially reducing out-of-pocket costs for consumers. The instrument applies specifically to the drug testosterone and its originator brand status, with the changes taking effect from 1 June 2024. The amendment is made in consultation with the company holding the PBS listed brand of the drug, although no comments were received. The instrument is a legislative instrument under the Legislation Act 2003 and is compatible with human rights, as it engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by supporting the progressive realisation of the right to the highest attainable standard of health.

Key Provisions

The National Health (Originator Brand) Amendment Determination 2024 (No. 2) (PB 59 of 2024) amends the National Health (Originator Brand) Determination 2015 (PB 100 of 2015) to determine the originator brand status for a pharmaceutical item of one drug that is new to the Pharmaceutical Benefits Scheme (PBS) F2 formulary on 1 June 2024. This amendment 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 (section 99ADB(6B) of the National Health Act 1953). Originator removal will potentially increase price disclosure-related price reductions, as originator brands generally maintain higher prices than other brands. The Act imposes several obligations and requirements on the parties or entities it governs. Firstly, it mandates that the Minister (or delegate) must consider whether the brand was on F1 or the Combination Drug List (CDL) when it was first determined as a brand of pharmaceutical item under subsection 85(6) of the Act (section 99ADB(6C)). Secondly, the Act requires that the determination of originator brands be based on the brands listed when the drug was on F1 or CDL (subsection 99ADB(6B)). Additionally, the Act necessitates that the Minister consult with the company holding the PBS listed brand of the drug moving from F1 to F2, although in this instance, no comments were received from the affected company (subsection 33(3) of the Interpretation Act 1901). The legislation also outlines offences, penalties, or civil and criminal consequences for breaches. While the Act does not specify maximum penalties for non-compliance, breaches of the provisions in the National Health Act 1953 or the National Health (Pharmaceutical Benefits) Regulations 2017 could potentially lead to administrative or legal actions. For instance, incorrect or misleading information provided to the Minister could result in civil penalties, fines, or other sanctions. Additionally, failure to comply with the requirements for originator brand determination may impact the pricing and availability of pharmaceutical items on the PBS, ultimately affecting consumers' access to affordable medicines.