National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 4) (PB 39 of 2020)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 4) amends the National Health (Listed drugs on F1 or F2) Determination 2010. This legislation is enacted by the Australian Government and aims to address the allocation of listed drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). F1 is designated for single brand drugs, whereas F2 accommodates drugs with multiple brands or those within therapeutic groups with multiple brands. The policy objective is to ensure that drugs are appropriately categorised, thereby facilitating effective management and distribution within the PBS framework. This determination specifically adds two new drugs, brigatinib and upadacitinib, to the F1 formulary based on their eligibility under the criteria set out in section 85AB(4) of the National Health Act 1953. The process involved detailed consultations with relevant pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC).

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 4) applies to pharmaceutical companies that have new medicines listed on the Pharmaceutical Benefits Scheme (PBS) in Australia. This legislation is enacted under the National Health Act 1953 and it amends the National Health (Listed drugs on F1 or F2) Determination 2010. Specifically, the 2020 Amendment Determination adds two new drugs, brigatinib and upadacitinib, to the F1 formulary. The F1 formulary is designated for single brand drugs that meet certain criteria, such as having no bioequivalent or biosimilar listed brands and not having been on the F2 formulary previously. The amendment applies across the Commonwealth of Australia, affecting the entire national jurisdiction. The 2020 Amendment Determination does not introduce any exclusions or exemptions from the application of the Act. The criteria for determining whether a drug is placed on F1 or F2 remain consistent with those outlined in the National Health Act 1953. The determination process involves consultation with relevant stakeholders, including pharmaceutical companies and a recommendation from the Pharmaceutical Benefits Advisory Committee. This ensures that the placement of drugs into the appropriate formulary is based on comprehensive assessment and stakeholder input. The 2020 Amendment Determination came into effect on 1 May 2020, and it constitutes a legislative instrument under the Legislation Act 2003.

Key Provisions

The National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 4) (F2020L00526) amends the National Health (Listed drugs on F1 or F2) Determination 2010 (PB 93 of 2010), which allocates drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) (section 85AB(1) of the Act). The National Health Act 1953 (the Act) provides that listed drugs may be assigned to formularies identified as F1 and F2 (section 84AC). F1 is intended for single brand drugs and F2 for drugs that have multiple brands, or are in a therapeutic group with other drugs with multiple brands (subsection 85AB(3) and (4)). For a drug to be on F1, it must satisfy the criteria in subsection 85AB(4) of the Act, which requires that there are no listed brands of pharmaceutical items that have the drug that are bioequivalent or biosimilar, and no listed brands of pharmaceutical items that have another drug in the same therapeutic group as the first drug that are bioequivalent or biosimilar. A drug may only be determined to be on F2 if it does not satisfy one or more of the criteria for F1 (subsection 85AB(3)). The Amending Determination adds two new drugs, brigatinib and upadacitinib, to F1. This amendment follows detailed consultations with the responsible persons and a recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC). The Amending Determination commences on 1 May 2020. The Act imposes obligations on pharmaceutical companies to ensure that their new medicines are properly listed and allocated to the appropriate formulary of the PBS. Pharmaceutical companies must meet the criteria set out in section 85AB(4) of the Act for a drug to be on F1. The Act also requires the Minister (or delegate) to determine by legislative instrument that a listed drug is on F1 or F2 (subsection 85AB(1)). The Amending Determination provides for the allocation of drugs to the F1 and F2 formularies of the PBS. The Act also provides that drugs on F2 are subject to the provisions of the Act relating to first new brand statutory price reductions, price disclosure, and guarantee of supply (subsection 85AB(5)). Pharmaceutical companies must comply with these provisions for drugs allocated to F2. The Act provides for offences, penalties, and civil/criminal consequences for breach. The maximum penalty for an offence under the Act is 2,000 penalty units or imprisonment for five years, or both (subsection 28D(1) of the Crimes Act 1914). The Act also provides for civil penalties for breaches of the Act, including fines of up to 10,000 penalty units (subsection 13AD(1) of the Acts Interpretation Act 1901). Pharmaceutical companies that breach the Act may be subject to these penalties and consequences. The Act also provides for the revocation or variation of the Principal Determination (subsection 33(3) of the Acts Interpretation Act 1901). Pharmaceutical companies must comply with the Amending Determination and the Principal Determination, or face the consequences of non-compliance.