National Health (Originator Brand) Amendment Determination 2018 (No. 5) (PB 71 of 2018)

Overview

The National Health (Originator Brand) Amendment Determination 2018 (No. 5) is an amendment to the National Health (Originator Brand) Determination 2015, made pursuant to subsection 99ADB(6B) of the National Health Act 1953. The determination was enacted by the Australian Government and aims to address the issue of originator brand drugs maintaining higher prices than generic brands, which affects the affordability and accessibility of necessary medications under the Pharmaceutical Benefits Scheme (PBS). The determination also makes several administrative amendments to the Principal Instrument. The policy objective of the amendment is to enhance the affordability of PBS medicines by potentially increasing price reductions through 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 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.

Scope and Application

The National Health (Originator Brand) Amendment Determination 2018 (No. 5) amends the National Health (Originator Brand) Determination 2015 to determine the originator brand of a specific pharmaceutical item for one drug new to the Pharmaceutical Benefits Scheme (PBS) F2 formulary, in addition to making various administrative amendments. The Act applies to drugs on the PBS, specifically targeting those moving from the F1 formulary or the single brand Combination Drug List to F2, and mandates that all drugs on F2 are subject to price disclosure. This amendment is made under the authority of 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. This change is expected to potentially increase price-related reductions on the PBS, as originator brands typically maintain higher prices than generic brands, thereby delivering better value for money to consumers by reducing out-of-pocket costs. The instrument is compatible with human rights as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health by providing subsidised access to medicines for Australians.

Key Provisions

The main operative sections of the National Health (Originator Brand) Amendment Determination 2018 (No. 5) (the Amendment Determination) primarily involve determining the originator brand of a pharmaceutical item for a specific drug, nebivolol, which has transitioned from the F1 formulary to the F2 formulary under the Pharmaceutical Benefits Scheme (PBS). The Amendment Determination amends the National Health (Originator Brand) Determination 2015 (PB 100 of 2015) (the Principal Instrument) to set out this determination, and includes several administrative amendments (Schedule 1, Clause 3). These changes are made pursuant to subsection 99ADB(6B) of the National Health Act 1953 (the Act), and they are necessary to implement the removal of originator brand data from price disclosure calculations, as outlined in the National Health (Pharmaceutical Benefits) Regulations 2017 (the Regulations). The Amendment Determination imposes obligations on the entities it governs, primarily concerning the identification and listing of originator brands for drugs on the F2 formulary. These obligations include ensuring that the originator brand of pharmaceutical items is accurately identified and listed in the PBS, which is crucial for the calculation of price reductions under the PBS. By determining the originator brand, the Amendment Determination ensures that the PBS can effectively implement the originator removal policy, which aims to reflect the prices of generic brands in the Government price, thereby potentially reducing out-of-pocket costs for consumers. The Amendment Determination also delineates consequences for breaches of its provisions. While the specific penalties for non-compliance are not detailed in the explanatory statement, breaches of the provisions of the Act or the Regulations could result in civil or criminal penalties, including fines and imprisonment. The exact penalties would depend on the nature and severity of the breach, as well as the specific provisions of the Act and Regulations that are contravened. The determination of originator brands is crucial for the accurate implementation of the originator removal policy, and failure to comply with these obligations could lead to significant financial and legal repercussions for the entities involved. The Amendment Determination is designed to enhance the efficiency and effectiveness of the PBS by ensuring that the originator brand of pharmaceutical items is accurately identified, particularly for drugs transitioning to the F2 formulary. By doing so, it supports the broader objectives of the PBS, which include providing Australians with timely, reliable, and affordable access to necessary and cost-effective medicines. The human rights implications of the Amendment Determination are also considered, with the instrument being deemed compatible with the human rights and freedoms recognised in international instruments, particularly in advancing the right to the highest attainable standard of physical and mental health.