National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 5) (PB 61 of 2015)

Overview

The National Health Act 1953, as amended by the National Health (Listed drugs on F1 or F2) Amendment Determination 2015, aims to address the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). Enacted by the Parliament of Australia, the Act seeks to ensure a systematic approach to the categorisation of listed drugs, where F1 is designated for single brand drugs and F2 for drugs with multiple brands or those within therapeutic groups containing multiple brands. The legislative instrument, created under the authority of subsection 85AB(1) of the Act, amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adding three new drugs—crizotinib, pertuzumab, and trastuzumab emtansine—to F1. The policy objective underpinning this amendment is to provide clarity and consistency in the PBS formulary system, ensuring that drugs are appropriately categorised to facilitate statutory price reductions, price disclosure, and supply guarantees.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 5) amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adding three new drugs—crizotinib, pertuzumab, and trastuzumab emtansine—to the F1 formulary of the Pharmaceutical Benefits Scheme (PBS). This Act applies to pharmaceutical companies with medicines listed on the PBS and the therapeutic drugs themselves, specifically those added to F1. The geographic reach of the Act is national, impacting entities and individuals across Australia. The Act excludes drugs that do not meet the specific criteria for F1 or F2 placement, such as those that are bioequivalent or biosimilar or have already been placed on F2. The Act allows for the extension or restriction of its application through subordinate instruments, empowering the Minister to determine by legislative instrument the placement of drugs on F1 or F2. The Amending Determination operates under the authority of the National Health Act 1953 and the Acts Interpretation Act 1901, which provides the framework for its revocation or variation.

Key Provisions

The main operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 5) (the Amending Determination) amend the National Health (Listed drugs on F1 or F2) Determination 2010 by adding three new drugs to the F1 formulary. Section 85AB(1) of the National Health Act 1953 (the Act) empowers the Minister to determine by legislative instrument that a listed drug is on F1 or F2, and this instrument adds crizotinib, pertuzumab, and trastuzumab emtansine to the F1 formulary (section 3(1)). The criteria for a drug to be placed on F1 are outlined in subsection 85AB(4) of the Act, which requires that there are no bioequivalent or biosimilar listed brands of pharmaceutical items that have the drug or any drug in the same therapeutic group as the first drug, and that the drug was not on F2 the day before the determination comes into effect. Drugs that do not meet these criteria for F1 may be placed on F2, subject to the provisions of the Act relating to statutory price reductions, price disclosure and guarantee of supply. The Amending Determination imposes specific obligations and requirements on pharmaceutical companies with medicines listed on the Pharmaceutical Benefits Scheme (PBS). Before drugs are listed and allocated to formularies, there are detailed consultations with the intended responsible person, and a recommendation is received from the Pharmaceutical Benefits Advisory Committee (PBAC). Any PBAC recommendation is made following receipt of submissions by affected pharmaceutical companies, with two-thirds of the PBAC membership comprising representatives from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists. This ensures that the interests of all stakeholders are considered in the allocation of drugs to the F1 and F2 formularies. The Act includes provisions for offences, penalties, and civil or criminal consequences for breaches of its provisions. However, the specific offences, penalties, or consequences for breach of the Amending Determination are not detailed in the Explanatory Statement. In general, however, breaches of the Act or its regulations may result in criminal or civil penalties, including fines and imprisonment, depending on the nature and severity of the breach. The maximum penalties for offences under the Act are set out in the Act itself and may vary depending on the specific offence. The Amending Determination constitutes a legislative instrument for the purpose of the Legislative Instruments Act 2003. It revokes or varies the National Health (Listed drugs on F1 or F2) Determination 2010 unless there is an express power to revoke or vary it cited in the instrument and explanatory statement, in which case subsection 33(3) of the Acts Interpretation Act 1901 is relied upon. The Amending Determination commences on 1 July 2015, and its provisions apply to the three new drugs added to the F1 formulary from that date. Pharmaceutical companies with medicines listed on the PBS must comply with the requirements of the Amending Determination and any other relevant provisions of the Act and its regulations.