National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 5) (PB 41 of 2019)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 5) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which concerns the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). Enacted by the Australian Parliament, this legislation addresses the need to efficiently manage and regulate the provision of pharmaceutical benefits to the public. The primary policy objective is to ensure that listed drugs are appropriately assigned to formularies based on criteria that consider therapeutic equivalence and market dynamics, thereby enhancing the effectiveness and sustainability of the PBS. The 2019 amendment specifically moves fenofibrate and teriflunomide from F1 to F2, reflecting changes in market conditions or therapeutic considerations. This determination is grounded in detailed consultations with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee, ensuring that the amendments are both informed and balanced. The amendment aims to maintain the integrity of the PBS while adapting to evolving pharmaceutical landscapes.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2019 (No. 5) amends the National Health (Listed drugs on F1 or F2) Determination 2010 by reallocating specific drugs from Formulary F1 to Formulary F2 within the Pharmaceutical Benefits Scheme (PBS). This determination applies to listed drugs, which are managed by the Pharmaceutical Benefits Advisory Committee (PBAC) following consultations with relevant pharmaceutical companies. The amendment affects entities involved in the manufacturing, supply, and prescription of these drugs, particularly within the healthcare and pharmaceutical industries. The determination is applicable nationally, given the PBS operates throughout Australia. The Act does not specify any exclusions or exemptions, but it does rely on the criteria set out in the Act for determining whether a drug is allocated to F1 or F2. The legislative instrument also notes that it revokes or varies the Principal Determination to the extent necessary, unless otherwise specified. The amendment commenced on 1 June 2019 and constitutes a legislative instrument under the Legislation Act 2003.

Key Provisions

The main operative sections of this legislation are subsections 85AB(1), 85AB(3), 85AB(4), and 85AB(5) of the National Health Act 1953 (the Act) (subsections 85AB(1) and 85AB(3)–85AB(5) referenced in parentheses), which together provide the framework for determining which listed drugs are allocated to the F1 or F2 formularies of the Pharmaceutical Benefits Scheme (PBS). Under subsection 85AB(1), the Minister (or delegate) can make a determination that a listed drug is on F1 or F2. This determination must comply with the criteria set out in subsections 85AB(3) and 85AB(4). For instance, a drug will be allocated to F1 if it has no listed brands that are bioequivalent or biosimilar, and was not on F2 the day before the determination comes into effect. Conversely, a drug may only be determined to be on F2 if it does not meet the criteria for F1 (subsection 85AB(3)). The Act also provides that a drug will not be placed on F1 or F2 if it has a single brand combination item on the PBS (subsection 85AB(5)), in which case it will be placed on the administrative combination drug list. The obligations and requirements imposed by the Act on the parties or entities it governs include ensuring that listed drugs are allocated to the appropriate formularies, which in this case means moving fenofibrate and teriflunomide from F1 to F2. The Act also requires that any determination made under section 85AB must be in accordance with the criteria set out in subsections 85AB(3) and 85AB(4), and that any revocation or variation of the Principal Determination must be in accordance with subsection 33(3) of the Acts Interpretation Act 1901. Additionally, the Act requires that any determination made under section 85AB must be made in consultation with affected pharmaceutical companies and in accordance with any recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC). Any breach of the provisions of the Act or the Amending Determination may result in criminal or civil penalties. The maximum penalties for breaches of the Act are set out in section 28 of the Crimes Act 1914 (Cth) and can include fines of up to $21,000 for individuals and $105,000 for bodies corporate. Additionally, the Act provides that any person who contravenes a provision of the Act that is also a provision of a regulation may be guilty of an offence and liable to a penalty of up to $21,000 for individuals and $105,000 for bodies corporate. The Act also provides for the imposition of civil penalties, including fines of up to $21,000 for individuals and $105,000 for bodies corporate, for breaches of certain provisions. Finally, the Act provides that any person who is found guilty of an offence under the Act may also be liable to imprisonment for a term of up to two years.