National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 9) (PB 106 of 2015)

Overview

The National Health Act 1953 was enacted to provide a framework for the regulation of pharmaceuticals in Australia, ensuring that they are safe, effective, and accessible. The Act establishes the Pharmaceutical Benefits Scheme (PBS) and allows for the listing of drugs, which are then allocated to different formularies based on their therapeutic and economic profiles. The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 9) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which allocates drugs to the F1 and F2 formularies of the PBS. F1 is for single brand drugs, while F2 is for drugs with multiple brands or those in a therapeutic group with other multi-brand drugs. The amendment aims to address gaps in the current formulary system by adding specific drugs to F1, thereby enhancing access and ensuring appropriate pricing and supply mechanisms are in place. The determination was made by the Minister for Health under the authority of the National Health Act and is intended to align with the policy objective of providing affordable and effective pharmaceutical treatments to the Australian public.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 applies to the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953, affecting pharmaceutical companies with drugs listed on the PBS. The Act facilitates the allocation of drugs to formularies F1 and F2, where F1 is designated for single brand drugs and F2 for drugs with multiple brands or those in a therapeutic group with multiple brands. This Amendment Determination specifically adds three new drugs to F1: amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements, and medium chain triglycerides; lurasidone; and ponatinib. The purpose of this Act is to ensure that listed drugs are appropriately assigned to formularies and to subject drugs on F2 to provisions concerning statutory price reductions, price disclosure, and guarantee of supply. The Act also outlines criteria for drugs to be placed on F1 or F2, including conditions related to bioequivalence and biosimilarity, and specifies that drugs on F2 are subject to certain statutory requirements. The Act extends its reach across the Commonwealth of Australia and applies to any listed drugs that meet the criteria for allocation to F1 or F2 formularies under the PBS. The amendment process involves consultations with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which comprises experts from various health-related fields. The Amending Determination revokes or varies the National Health (Listed drugs on F1 or F2) Determination 2010 unless explicitly stated otherwise, and it constitutes a legislative instrument under the Legislative Instruments Act 2003. The determination came into effect on 1 November 2015, thus altering the allocation of specified drugs within the PBS framework.

Key Provisions

The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 9) amends the National Health (Listed drugs on F1 or F2) Determination 2010 by allocating three new drugs to formularies under the Pharmaceutical Benefits Scheme (PBS). Section 85AB(1) of the National Health Act 1953 (the Act) empowers the Minister to make such determinations by legislative instrument. This particular Instrument adds amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides; lurasidone; and ponatinib to the F1 formulary, which is intended for single brand drugs (subsection 85AB(4)). Under the Act, drugs are assigned to F1 or F2 formularies based on their therapeutic group and the availability of bioequivalent or biosimilar drugs. For a drug to be placed on F1, it must have no listed brands that are bioequivalent or biosimilar, and must not have been on F2 the day before the determination comes into effect (subsection 85AB(4)). If a drug does not meet these criteria, it may be placed on F2, which is intended for drugs that have multiple brands or are in a therapeutic group with other drugs with multiple brands. Drugs on F2 are subject to statutory price reductions, price disclosure and guarantee of supply provisions of the Act. Entities governed by the Act, including pharmaceutical companies, must comply with the criteria for placing drugs on F1 or F2 formularies. This includes ensuring that drugs are bioequivalent or biosimilar where applicable, and that they meet the requirements for inclusion on the PBS. Failure to comply with the requirements of the Act may result in civil or criminal penalties. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a key role in the process by providing recommendations on drug allocations based on submissions from affected parties, including pharmaceutical companies. There are potential civil and criminal consequences for breaches of the Act or the Determination. The specific penalties are not outlined in the Explanatory Statement, but generally, breaches of the Act may result in fines or imprisonment, depending on the severity of the offence. The Act provides for the imposition of pecuniary penalties for breaches, with the maximum penalty varying depending on the nature and circumstances of the offence. The Determination itself does not specify any particular penalties for non-compliance, but non-compliance with the Act may result in enforcement action by the relevant authorities.