National Health (Originator Brand) Amendment Determination 2021 (No. 4)

Overview

The National Health (Originator Brand) Amendment Determination 2021 (No. 4) amends the National Health (Originator Brand) Determination 2015 to address the issue of originator brand data in price disclosure calculations for the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. This legislative instrument was introduced to ensure that the originator brand of a new pharmaceutical item on the PBS F2 formulary is determined, specifically for the drug deferasirox, which is moving from the F1 to F2 formulary on 1 August 2021. The determination of originator brands is crucial for implementing the originator removal provision in the National Health (Pharmaceutical Benefits) Regulations 2017, which aims to increase price disclosure-related price reductions by excluding higher-priced originator brands from calculations, thereby reflecting the prices of generic brands more accurately. The policy objective of this determination is to enhance the cost-effectiveness and affordability of medicines under the PBS, ultimately benefiting consumers by potentially reducing their out-of-pocket costs for certain PBS medicines.

Scope and Application

The National Health (Originator Brand) Amendment Determination 2021 (No. 4) amends the National Health (Originator Brand) Determination 2015 to determine the originator brand of a pharmaceutical item for deferasirox, a drug new to the Pharmaceutical Benefits Scheme (PBS) F2 formulary on 1 August 2021. This determination is made under the National Health Act 1953, which regulates the listing, prescribing, pricing, and payment of subsidies for drugs supplied under the PBS. The instrument 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. This change aims to increase price disclosure-related price reductions, as originator brands tend to maintain higher prices than other brands. The removal of originator brand data from price disclosure calculations will result in government prices more closely reflecting the prices at which generic brands of the medicine are sold in the market, not the prices of all brands. This instrument applies to the specific drug deferasirox and the relevant stakeholders within the PBS, including pharmaceutical companies, suppliers, and consumers. The geographic reach of this amendment is national, as it applies to the Pharmaceutical Benefits Scheme across Australia. No specific exclusions or thresholds are mentioned in the text, but it is subject to the criteria outlined in the National Health Act 1953 and the National Health (Pharmaceutical Benefits) Regulations 2017.

Key Provisions

The National Health (Originator Brand) Amendment Determination 2021 (No. 4) (F2021L01063) amends the National Health (Originator Brand) Determination 2015 to determine the originator brand of a pharmaceutical item for the drug deferasirox, which is moving from the F1 to the F2 formulary on 1 August 2021 (subsection 99ADB(6B) of the National Health Act 1953). The criteria for determining the originator brand include the brand being listed when the drug was on the F1 formulary (subsection 99ADB(6C) of the Act). This amendment implements the removal of originator brand data from price disclosure calculations under certain circumstances as set out in the National Health (Pharmaceutical Benefits) Regulations 2017. This change is expected to increase price disclosure-related price reductions, as originator brands typically maintain higher prices than other brands. The Act imposes specific obligations and requirements on the parties involved. 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 under subsection 85(6) of the Act when deciding whether to determine originator brands. The criteria for determining originator brands include the brand being listed when the drug was on the F1 formulary (subsection 99ADB(6C) of the Act). The Act also requires that consultation be undertaken with the company holding a PBS listed brand of the drug moving from F1 to F2. In this instance, consultation was conducted with the affected company, and no comments were received. The National Health Act 1953 and the Regulations do not specify any particular offences, penalties, or civil or criminal consequences for breach of the provisions in this amending instrument. However, the Regulations do set out details in relation to the operation of the Pharmaceutical Benefits Scheme (PBS) and the listing, prescribing, pricing, charging, and payment of subsidies for supply of drugs and medicinal preparations as pharmaceutical benefits. The Regulations also provide for the enforcement of the PBS, including the imposition of penalties for non-compliance with the Scheme. The Pharmaceutical Society of Australia Act 1994 and the Health Insurance Act 1973 may also contain provisions that are relevant to the operation of the PBS and the enforcement of the Scheme. In summary, the National Health (Originator Brand) Amendment Determination 2021 (No. 4) amends the National Health (Originator Brand) Determination 2015 to determine the originator brand of the drug deferasirox, which is moving from the F1 to the F2 formulary on 1 August 2021. The Act imposes specific obligations and requirements on the parties involved, including consultation with the affected company. The Regulations provide for the enforcement of the PBS and the imposition of penalties for non-compliance with the Scheme. The instrument is compatible with human rights as it advances the protection of human rights by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.