National Health (Originator Brand) Amendment Determination 2019 (No. 1) (PB 6 of 2019)

Overview

The National Health (Originator Brand) Amendment Determination 2019 (No. 1) was enacted to address a gap in the National Health Act 1953 by determining the originator brands of pharmaceutical items for one drug new to the Pharmaceutical Benefits Scheme (PBS) F2 formulary. This determination is necessary to implement the removal of originator brand data from price disclosure calculations, as outlined in the National Health (Pharmaceutical Benefits) Regulations 2017. The policy objective is to potentially increase price reductions on the PBS by ensuring that the government price more closely reflects the prices of generic brands of medicines, rather than all brands, thereby improving the affordability and accessibility of medications for Australians. The Act was amended by the Australian Parliament, with this particular amendment commencing on 1 February 2019.

Scope and Application

The National Health (Originator Brand) Amendment Determination 2019 (No. 1) amends the National Health (Originator Brand) Determination 2015, and applies to the originator brands of pharmaceutical items that are listed on the Pharmaceutical Benefits Scheme (PBS) F2 formulary. The amendment specifically addresses the determination of originator brands for one drug, rasagiline, which moved from the F1 formulary to the F2 formulary on 1 February 2019. The amendment is made pursuant to 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 intended to potentially increase price disclosure-related price reductions, as originator brands typically maintain higher prices than other brands. The amendment applies nationally across Australia, as it pertains to the PBS which is a Commonwealth initiative. This legislative instrument is compatible with human rights by assisting in the progressive realisation of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health as recognised in the International Covenant on Economic, Social and Cultural Rights. By removing originator brand data from price disclosure calculations, the amendment aims to deliver better value for money for PBS medicines, ultimately assisting consumers by reducing out-of-pocket costs for some PBS medicines. The amendment does not specify any exclusions or exemptions, and its application is not extended or restricted through subordinate instruments.

Key Provisions

The National Health (Originator Brand) Amendment Determination 2019 (No. 1) amends the National Health (Originator Brand) Determination 2015 (subsection 99ADB(6B) of the National Health Act 1953) to determine the originator brand of a specific pharmaceutical item, rasagiline, which is new to the Pharmaceutical Benefits Scheme (PBS) F2 formulary (Schedule 1). The determination of originator brands is crucial for implementing the originator removal process outlined in the National Health (Pharmaceutical Benefits) Regulations 2017. Originator removal aims to potentially increase price reductions on the PBS by basing the Government price on the prices of generic brands, rather than all brands, which tend to have higher prices. The Act imposes obligations on entities to comply with the determination of originator brands, which is essential for the PBS's operation. Pharmaceutical companies must ensure that their brands are correctly identified and classified under the F2 formulary. This classification affects price disclosure and the calculation of PBS benefits, impacting how drugs are subsidised and provided to consumers. Accurate determination of originator brands is necessary for transparency and cost-effectiveness in the PBS. Failure to comply with the requirements of this determination may lead to legal and financial consequences. The Regulations provide for potential penalties for non-compliance, although specific penalties are not detailed in the instrument. The Pharmaceutical Benefits Scheme (PBS) operates under the National Health Act 1953, and non-compliance with the Act or Regulations may result in civil or criminal penalties. For example, under the National Health Act, contraventions may lead to fines, and more severe breaches may result in criminal charges. The exact penalties are determined based on the nature and severity of the breach. This legislative instrument ensures that the originator brand of rasagiline is correctly identified for the PBS F2 formulary, facilitating the originator removal process and potentially increasing price reductions. By accurately classifying pharmaceutical items, the Act supports the PBS's objective of providing affordable and cost-effective medicines to Australians. The instrument is compatible with human rights, as it aids in the progressive realisation of the right to the highest attainable standard of physical and mental health by ensuring better access to affordable medicines.