EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 10)
PB 113 of 2015
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 one new drug, axitinib, to F1. It also moves four already PBS listed drugs, infliximab, rizatriptan, somatropin and zoledronic acid, 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 2015.
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 2015 (No. 10) amends the National Health (Listed drugs on F1 or F2) Determination 2010, under the authority of the National Health Act 1953. This legislative instrument was introduced to address the need for updating the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The purpose of this amendment is to ensure that the formulary allocation reflects the most current therapeutic groupings and market conditions for listed drugs, thereby facilitating appropriate pricing, availability, and accessibility of medications. The determination process involves extensive consultation with pharmaceutical companies, recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), and alignment with the policy objectives of the National Health Act. The changes implemented by this determination are effective from 1 December 2015.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 applies to pharmaceutical companies and the entities they represent that have drugs listed on the Pharmaceutical Benefits Scheme (PBS). Specifically, it affects the allocation of drugs to formularies identified as F1 and F2, which are designated for single brand drugs and drugs that have multiple brands or are in a therapeutic group with other multiple brand drugs, respectively. The determination affects the drugs axitinib, infliximab, rizatriptan, somatropin, and zoledronic acid by either adding or moving them between the formularies. The geographic reach of this Act is national, as it pertains to the PBS, which operates across Australia. The Act does not specify exclusions or exemptions, but drugs may not be placed on F1 or F2 if they do not meet the criteria set out in the National Health Act 1953. The application of the Act may be extended or restricted through subordinate instruments as necessary.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 10) (Amending Determination) amends the National Health (Listed drugs on F1 or F2) Determination 2010 (Principal Determination) by adding axitinib to F1 and moving four drugs—infliximab, rizatriptan, somatropin, and zoledronic acid—from F1 to F2. This determination is made under the authority of subsection 85AB(1) of the National Health Act 1953 (the Act), which empowers the Minister to allocate listed drugs to the F1 or F2 formularies of the Pharmaceutical Benefits Scheme (PBS).
The F1 formulary is intended for drugs that have only one brand, while F2 includes drugs that have multiple brands or are part of a therapeutic group with other drugs that have multiple brands. The Amending Determination imposes certain criteria for drugs to be allocated to F1 or F2. For instance, to be placed on F1, a drug must not have any listed brands that are bioequivalent or biosimilar, and it must not have been on F2 the day before the determination takes effect. Conversely, a drug may only be placed on F2 if it does not meet the criteria for F1. In cases where a listed drug has a single brand combination item on the PBS, it is placed on the administrative combination drug list instead of F1 or F2.
The Act imposes several obligations on the parties and entities it governs. Pharmaceutical companies with drugs listed on the PBS must engage in detailed consultations about their drugs. These consultations occur before the drugs are listed and allocated to formularies. Additionally, recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) are considered in this process. The PBAC, composed of members with expertise in various relevant fields, makes recommendations following submissions from affected pharmaceutical companies. The determination of drug allocation must comply with these consultative and advisory processes as mandated by the Act.
Offences and penalties for breaches of the Act are outlined in various sections. For instance, unauthorised modifications to the PBS list or non-compliance with the statutory requirements for drug allocation could result in civil or criminal consequences. Although the specific penalties are not detailed in the explanatory statement, breaches of the Act could lead to fines, imprisonment, or both, depending on the severity of the offence. The maximum penalties for such breaches are prescribed in the relevant sections of the Act, though these are not explicitly stated in the explanatory statement provided.