EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 8)
PB 78 of 2016
Authority
This Instrument, made under subsection 85AB(1) of the National Health Act 1953 (the Act), amends the National Health (Listed drugs on F1 or F2) Determination 2010 (PB 93 of 2010) (the Principal Determination).
The Principal Determination provides for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS).
Purpose
The Act provides that listed drugs may be assigned to formularies identified as F1 and F2.
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. 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.
Section 84AC of the Act provides that a drug is on F1 or F2 if there is a determination in force under section 85AB that the drug is on F1 or F2.
Subsection 85AB(1) of the Act empowers the Minister (or delegate) to determine by legislative instrument that a listed drug is on F1 or F2. For a drug to be on F1, it must satisfy the criteria in subsection 85AB(4). This 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. It also requires that the drug was not on F2 the day before the determination comes into effect. 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)).
When subsection 85AB(5) of the Act applies, which relates to listed drugs with a single brand combination item on the PBS, the listed drug is not placed on F1 or F2, but on the administrative combination drug list.
This Instrument (the Amending Determination) amends the Principal Determination by adding one new drug – pasireotide to F1.
Variation and revocation
Unless there is an express power to revoke or vary PB 93 of 2010 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 93 of 2010.
Consultation
The Amending Determination affects pharmaceutical companies with medicines listed on the PBS. Before drugs are listed and allocated to formularies, there are detailed consultations about the drug 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. Two-thirds of the PBAC membership is from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists.
The Amending Determination Instrument commences on 1 September 2016.
This Instrument constitutes a legislative instrument for the purpose of the
Legislation Act 2003.
Overview
The National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 8) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which allocates drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). Enacted under the National Health Act 1953, this legislation was introduced to address the need for a structured and transparent allocation of drugs to specific formularies within the PBS, ensuring that drugs are categorised appropriately based on their therapeutic characteristics and brand availability. The determination is made by the Minister for Health (or a delegate) under the authority of section 85AB(1) of the Act, aiming to streamline the process and ensure that drugs are placed in the correct formulary to facilitate appropriate pricing and supply mechanisms. The 2016 amendment adds pasireotide to the F1 formulary, reflecting the ongoing evaluation and adjustment of drug allocations to meet the evolving needs of the healthcare system.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 8) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which allocates drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). This legislation applies to pharmaceutical companies with drugs listed on the PBS, and its purpose is to ensure that listed drugs are assigned to appropriate formularies, with F1 intended for single brand drugs and F2 for drugs with multiple brands or in therapeutic groups with multiple brands. The determination is made under the authority of the National Health Act 1953, with the Minister (or delegate) empowered to determine by legislative instrument whether a listed drug is on F1 or F2. The criteria for F1 and F2 are outlined in the Act, with specific requirements for bioequivalence, biosimilarity, and previous formulary placement. Drugs that do not meet the criteria for F1 or F2 may be placed on the administrative combination drug list. The Amending Determination specifically adds pasireotide to F1 and is effective from 1 September 2016, with the ability to revoke or vary the Principal Determination relying on the Acts Interpretation Act 1901 unless otherwise specified.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 8) amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adding the drug pasireotide to F1. This decision is made under subsection 85AB(1) of the National Health Act 1953, which empowers the Minister to determine by legislative instrument that a listed drug is on F1 or F2. F1 is designated for single brand drugs, while F2 is for drugs that have multiple brands or are in a therapeutic group with other drugs with multiple brands. The criteria for F1 require 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 (subsection 85AB(4)). Additionally, the drug must not have been on F2 the day before the determination comes into effect. If the drug does not satisfy the criteria for F1, it may be placed on F2 (subsection 85AB(3)). However, if subsection 85AB(5) applies, the drug is placed on the administrative combination drug list instead of F1 or F2.
The Amending Determination imposes specific obligations on pharmaceutical companies that have 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). The PBAC is composed of two-thirds members from various interests and professions, including consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and medical specialists. The Amending Determination affects these companies by adding pasireotide to F1, which may have implications for pricing, supply, and market competition.
Failure to comply with the provisions of the National Health Act 1953 and the Amending Determination may result in civil or criminal consequences. The Act provides for penalties for breaches of its provisions, including fines and imprisonment. The maximum penalties for breaches of the Act and the Amending Determination are not specified in the Explanatory Statement, but they may be found in the relevant sections of the Act and the Determination. It is essential for pharmaceutical companies and other affected parties to understand their obligations under the Act and the Amending Determination to avoid potential penalties and consequences.