National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 1) (PB 7 of 2016)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 1) was enacted to amend the National Health (Listed drugs on F1 or F2) Determination 2010. This amendment, introduced by the Minister for Health under the authority of the National Health Act 1953, aims to address the allocation of specific drugs to the F1 or F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The primary objective of this determination is to ensure that drugs are appropriately assigned to either the F1 formulary, which is designated for drugs with a single brand, or the F2 formulary, which accommodates drugs with multiple brands or those in therapeutic groups with other multiple brand drugs. This amendment specifically affects pharmaceutical companies by adding ruxolitinib to F1 and moving apomorphine and voriconazole from F1 to F2, impacting their pricing and supply under the PBS. The determination is made following consultations with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 1) is a legislative instrument made under the National Health Act 1953, which pertains to the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This instrument specifically amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adding ruxolitinib to F1, and moving apomorphine and voriconazole from F1 to F2. The Act applies to pharmaceutical companies with medicines listed on the PBS, impacting the way these drugs are priced, disclosed, and supplied to consumers. The F1 formulary is designated for single brand drugs, while F2 is for drugs with multiple brands or those within therapeutic groups with multiple brands. The Amendment Determination is applicable nationally, as it is an instrument of the Commonwealth of Australia, and affects the entire jurisdiction of the PBS. The Act's jurisdictional reach is national, as it is an instrument of the Commonwealth, and it extends its application through subordinate instruments to affect the entire PBS. There are no specific exclusions mentioned in the text, but it is implied that the criteria for placement on F1 and F2, as well as the conditions for drugs to be exempt from these formularies, are outlined in the Act and its subsidiary legislation. The determination process involves consultations with the intended responsible parties, including pharmaceutical companies, and recommendations from the Pharmaceutical Benefits Advisory Committee, which comprises experts from various relevant fields. The Amendment Determination came into effect on 1 February 2016 and constitutes a legislative instrument under the Legislative Instruments Act 2003.

Key Provisions

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2016 (No. 1) amends the National Health (Listed Drugs on F1 or F2) Determination 2010 by introducing new provisions and altering existing ones. Section 3 of the Amending Determination adds the drug ruxolitinib to the F1 formulary, while sections 4 and 5 move apomorphine and voriconazole from F1 to F2. The F1 formulary is intended for single brand drugs, and F2 for drugs with multiple brands or in a therapeutic group with other multi-brand drugs (subsection 85AB(4) and (3) of the Act). The criteria for F1 require the absence of bioequivalent or biosimilar listed brands for the drug or any drug in the same therapeutic group, and that the drug was not on F2 the day before the determination takes effect (subsection 85AB(4) of the Act). Drugs on F2 are subject to provisions relating to statutory price reductions, price disclosure, and a guarantee of supply (subsection 85AB(5) of the Act). The Amending Determination also provides for the revocation or variation of the Principal Determination, unless expressly stated otherwise (subsection 33(3) of the Acts Interpretation Act 1901). The Amending Determination imposes obligations on pharmaceutical companies with medicines listed on the Pharmaceutical Benefits Scheme (PBS), as well as on the Minister for Health, who has the power to make the determination under subsection 85AB(1) of the Act. Pharmaceutical companies must engage in detailed consultations about the drug with the intended responsible person and provide submissions to the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, which has a majority membership from various relevant interests or professions, makes recommendations following these consultations. These recommendations are considered in the determination process. The Minister, in exercising their power under the Act, must ensure that the criteria for F1 and F2 are met when allocating drugs to the relevant formularies. The Amending Determination does not explicitly state any offences, penalties, or consequences for breach. However, failure to comply with the criteria for F1 or F2 could result in the drug not being allocated to the appropriate formulary, potentially affecting its availability and pricing on the PBS. The Act does not specify maximum penalties for breaches of the Determination. However, breaches of other provisions of the National Health Act 1953 may incur civil or criminal penalties, depending on the nature and severity of the breach.