National Health (PB 95 of 2016) Amendment Determination 2016 (PB 96 of 2016)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2016, enacted to address the need for a precise and error-free allocation of drugs to the appropriate formularies within the Pharmaceutical Benefits Scheme (PBS), amends the National Health (Listed drugs on F1 or F2) Amendment Determination 2016. The National Health Act 1953, administered by the Parliament of Australia, allows drugs to be assigned to either the F1 or F2 formularies based on specific criteria. F1 is designated for single brand drugs, while F2 accommodates drugs with multiple brands or those within a therapeutic group with multiple brands. The policy objective of the Act is to ensure effective and transparent allocation of drugs within the PBS, providing clear guidelines for statutory price reductions, price disclosure, and supply guarantees. This Amendment Determination corrects a typographical error in the previous determination and correctly assigns the drug lipegfilgrastim to the F1 formulary, ensuring alignment with the legislative intent and the proper functioning of the PBS.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2016 applies to pharmaceutical companies with medicines listed on the Pharmaceutical Benefits Scheme (PBS). This legislative instrument amends the allocation of drugs to the F1 and F2 formularies of the PBS, ensuring they are appropriately categorised to facilitate effective pricing, supply, and transparency provisions as outlined in the National Health Act 1953. The Act allows for the assignment of listed drugs to the F1 formulary for single brand drugs and F2 for drugs with multiple brands or those in therapeutic groups with multiple brands. The Amending Determination corrects a typographical error in the previous determination, correctly allocating the drug lipegfilgrastim to the F1 formulary. This Amendment Determination is subject to consultation with relevant stakeholders, including pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee (PBAC), which advises on the listing and allocation of drugs on the PBS. The application of this legislation is nationwide, impacting all entities involved in the supply and pricing of PBS-listed drugs across Australia. The determination provides clarity and corrects errors in drug categorisation, ensuring compliance with the National Health Act 1953.

Key Provisions

The National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 10) and the subsequent Amending Determination provide the framework for assigning listed drugs to the F1 or F2 formularies of the Pharmaceutical Benefits Scheme (PBS) (sections 84AC and 85AB). Section 85AB(1) of the Act empowers the Minister or their delegate to determine by legislative instrument that a listed drug is on F1 or F2. For a drug to be on F1, it must satisfy specific criteria (subsection 85AB(4)), such as having no listed brands that are bioequivalent or biosimilar, and not being on F2 the day before the determination comes into effect. A drug may only be on F2 if it does not meet the criteria for F1 (subsection 85AB(3)). The Amending Determination corrects a typographical error from the original Determination and correctly allocates the drug lipegfilgrastim to F1. The Act imposes specific obligations on pharmaceutical companies and other entities involved in the PBS. Pharmaceutical companies must ensure their drugs meet the criteria for F1 or F2 classification and are subject to the relevant provisions of the Act. The Minister or their delegate must make determinations based on the criteria outlined in the Act and ensure that drugs are correctly allocated to the appropriate formularies. The Pharmaceutical Benefits Advisory Committee (PBAC) must provide recommendations following detailed consultations and submissions from affected pharmaceutical companies. The PBAC, comprising two-thirds members from relevant interests or professions, plays a crucial role in the recommendation process. Breach of the obligations and requirements set out in the Act can result in various consequences. While the specific offences and penalties are not detailed in the explanatory statement, it is implied that non-compliance with the determinations and criteria could lead to civil or criminal penalties, depending on the nature and severity of the breach. The Act and related legislative instruments provide the legal framework for enforcing these obligations and imposing penalties for non-compliance. The Amending Determination aims to correct an error and ensure that the correct formulary allocation is in place for the specified drug, highlighting the importance of accuracy in these classifications.