EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (No. 7)
PB 76 of 2013
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 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 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 eight new listed drugs alogliptin, canagliflozin, dabrafenib, dapagliflozin,
dimethyl fumarate, ivabradine, rifaximin and teriflunomide to F1. It also moves one drug ziprasidone from F1 to F2.
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 December 2013.
This instrument constitutes a legislative instrument for the purpose of the
Legislative Instruments Act 2003.
Overview
The National Health (Listed drugs on F1 or F2) Amendment Determination 2013, made under the authority of the National Health Act 1953, was enacted to address the need for updating the allocation of listed drugs within the Pharmaceutical Benefits Scheme (PBS). The Act empowers the Minister to determine by legislative instrument that a listed drug is on either F1 or F2, depending on specific criteria such as the presence of bioequivalent or biosimilar drugs. This amendment specifically introduces eight new drugs to the F1 formulary, which is designated for single brand drugs, and moves one drug from F1 to F2. The policy objective is to ensure that drugs are appropriately categorised to facilitate effective management and accessibility within the PBS, while also considering the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC), which comprises representatives from various health-related interests and professions. This determination underscores the importance of consultation with stakeholders, including pharmaceutical companies, to ensure the decisions are evidence-based and aligned with public health needs.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2013 applies to pharmaceutical companies involved in the provision of medicines listed on the Pharmaceutical Benefits Scheme (PBS). This legislation amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adding eight new drugs—alogliptin, canagliflozin, dabrafenib, dapagliflozin, dimethyl fumarate, ivabradine, rifaximin, and teriflunomide—to the F1 formulary, which is designated for single brand drugs, and moving ziprasidone from F1 to F2. This instrument is made under the authority of the National Health Act 1953 and is designed to adjust the allocation of drugs within the PBS formularies. The Amendment Determination is applicable nationally, as it pertains to the Commonwealth's administration of the PBS. The determination does not include specific exclusions, but its application is governed by the criteria set out in the principal Act, particularly focusing on the bioequivalence or biosimilarity of drugs and their therapeutic grouping. The application and interpretation of this Act can be further defined through subordinate instruments, which may provide additional detail or clarification on specific aspects of the drug allocation process.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2013 (No. 7) amends the National Health (Listed drugs on F1 or F2) Determination 2010. This amendment involves the allocation of specific drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The determination adds eight new drugs—alogliptin, canagliflozin, dabrafenib, dapagliflozin, dimethyl fumarate, ivabradine, rifaximin, and teriflunomide—to the F1 formulary. Additionally, it moves ziprasidone from the F1 to the F2 formulary (sections 1 and 2). F1 is designated for single-brand drugs, while F2 is for drugs that have multiple brands or belong to a therapeutic group with other drugs that have multiple brands. The F2 formulary is subject to statutory price reductions, price disclosure, and the guarantee of supply as stipulated by the Act.
The Act imposes obligations on the Minister to determine the allocation of drugs to the F1 or F2 formularies, based on the criteria set out in the Act. To qualify for the F1 formulary, a drug must not have bioequivalent or biosimilar listed brands, and it must not have been on the F2 formulary the day before the determination comes into effect. Conversely, a drug can only be placed on the F2 formulary if it does not meet the criteria for the F1 formulary (section 85AB(3) and (4)). For drugs with a single brand combination item on the PBS, they are placed on the administrative combination drug list rather than F1 or F2 (section 85AB(5)).
The Amending Determination does not explicitly state the penalties for non-compliance. However, the broader National Health Act 1953 includes provisions for penalties and enforcement mechanisms. Violations of the Act can lead to civil or criminal penalties, depending on the nature and severity of the breach. The maximum penalties for breaches can include fines and imprisonment, as stipulated in the relevant sections of the National Health Act 1953. Pharmaceutical companies and other entities affected by the Act must adhere to the requirements to avoid these legal consequences.