EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No. 5)
PB 53 of 2012
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 five new listed drugs cabazitaxel, icatibant, mannitol, rasagiline and ticagrelor to F1. It also moves five drugs from F1 to F2 hydroxychloroquine, lamivudine, latanoprost, pramipexole and topotecan. It also moves one drug latanoprost with timolol, from the combination drug list to F2.
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 August 2012.
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 2012 (No. 5) is an amendment to the National Health (Listed drugs on F1 or F2) Determination 2010, made under the authority of the National Health Act 1953. This amendment was introduced to address the need for updating the formularies of the Pharmaceutical Benefits Scheme (PBS) by reallocating certain drugs between the F1 and F2 formularies and adding new drugs. The National Health Act 1953 provides the framework for the PBS, which aims to ensure that essential medicines are affordable and accessible to Australians. The policy objective of this amendment is to align the formulary allocation of specific drugs with their therapeutic characteristics and market conditions, ensuring the most efficient use of resources within the PBS.
The determination was enacted by the Minister for Health under subsection 85AB(1) of the National Health Act 1953 and was subject to consultation with relevant stakeholders, including pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee, which comprises experts from various health-related professions. The instrument aims to maintain the integrity and effectiveness of the PBS by ensuring that drugs are appropriately classified and managed within the scheme. The changes made by this determination commenced on 1 August 2012 and constitute a legislative instrument under the Legislative Instruments Act 2003.
Scope and Application
The National Health (Listed Drugs on F1 or F2) Amendment Determination 2012 (No. 5) amends the National Health (Listed Drugs on F1 or F2) Determination 2010, applying to the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. This Act applies to listed drugs, pharmaceutical companies, and entities involved in the supply and distribution of pharmaceutical items in Australia. The geographic and jurisdictional reach of the Act is national, as it pertains to the Commonwealth level under Australian law. The Amending Determination adds specific drugs to F1 or F2 and involves detailed consultation with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee, ensuring a balanced consideration of various interests. The instrument excludes drugs not listed or recommended for changes, and its effects are delineated through subordinate instruments.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No. 5) amends the National Health (Listed drugs on F1 or F2) Determination 2010 (subsection 85AB(1) of the National Health Act 1953). This determination provides for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) (section 84AC). The purpose of the amendment is to add five new drugs to F1 and to move five drugs from F1 to F2, and one drug from the combination drug list to F2 (subsection 85AB(5)). The amendment applies to cabazitaxel, icatibant, mannitol, rasagiline, ticagrelor, hydroxychloroquine, lamivudine, latanoprost, pramipexole, topotecan, and latanoprost with timolol.
The determination imposes obligations on the Minister for Health to determine by legislative instrument whether a listed drug is on F1 or F2 (subsection 85AB(1) of the National Health Act 1953). A drug can only be on F1 if it satisfies the criteria in subsection 85AB(4) of the Act, which 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. 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)). If a drug has a single brand combination item on the PBS, it is not placed on F1 or F2, but on the administrative combination drug list (subsection 85AB(5) of the Act).
There are no offences, penalties, or civil/criminal consequences for breach of the National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No. 5). However, 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 (section 84AC of the Act). If a drug is not allocated to F1 or F2, it will not be on the PBS, and patients will not be able to access it under the scheme. The determination is made by the Minister for Health, following detailed consultations with the intended responsible person and a recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC is made up of two-thirds members from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists.