EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No. 8)
PB 99 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 two new listed drugs aflibercept and hyaluronic acid to F1. It also moves three drugs imiquimod, nevirapine and riluzole from F1 to F2. In addition two drugs, amlodipine with valsartan and amlodipine with valsartan and hydrochlorothiazide move 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 December 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. 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 subsection 85AB(1) of the National Health Act 1953, the Act empowers the Minister to determine by legislative instrument that a listed drug is on F1 or F2, with F1 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. This determination addresses the need for efficient and effective drug allocation within the PBS, ensuring that listed drugs are appropriately assigned to the relevant formularies based on their characteristics and therapeutic group. The policy objective is to manage drug pricing and supply under the provisions of the Act relating to statutory price reductions, price disclosure, and guarantee of supply.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No. 8) amends the National Health (Listed drugs on F1 or F2) Determination 2010 by altering the allocation of listed drugs to the Pharmaceutical Benefits Scheme (PBS) formularies F1 and F2. This Act applies to entities involved in the pharmaceutical industry, specifically pharmaceutical companies with medicines listed on the PBS, and to the Minister for Health who has the authority to make such determinations under section 85AB of the National Health Act 1953. The geographic and jurisdictional reach of this Act is national, as it pertains to the PBS, which is a Commonwealth scheme. The Act provides for the assignment of drugs to formularies F1 and F2, with F1 intended for single brand drugs and F2 for drugs with multiple brands or in therapeutic groups with multiple brands. The Amending Determination adds two new drugs to F1, moves three drugs from F1 to F2, and also moves two combination drugs from the combination drug list to F2. The application of the Act may be further extended or restricted by subordinate instruments.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2012 (No. 8) amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adjusting the allocation of certain drugs within the Pharmaceutical Benefits Scheme (PBS). Specifically, the amendment adds two new drugs, aflibercept and hyaluronic acid, to F1, which is intended for drugs with a single brand (subsection 85AB(4) of the National Health Act 1953). Additionally, it moves three drugs—imiquimod, nevirapine, and riluzole—from F1 to F2, which accommodates drugs with multiple brands or those in a therapeutic group with other drugs having multiple brands (subsection 85AB(3)). The amendment also transitions two combination drugs—amlodipine with valsartan and amlodipine with valsartan and hydrochlorothiazide—from the administrative combination drug list to F2.
The determination imposes specific obligations on pharmaceutical companies and entities involved in the PBS. These include ensuring that drugs listed and allocated to formularies adhere to the criteria outlined in the Act. For instance, pharmaceutical companies must confirm that drugs assigned to F1 meet the strict criteria that no bioequivalent or biosimilar drugs are present, both within the same drug and in the same therapeutic group, and that the drug has not previously been on F2. Additionally, the entities must ensure that drugs assigned to F2 comply with the provisions of the Act regarding statutory price reductions, price disclosure, and guarantee of supply.
The Act also stipulates various penalties and consequences for non-compliance. Offences under the National Health Act 1953 can lead to both civil and criminal penalties. For example, failure to comply with the provisions relating to drug listing and formulary allocation may result in financial penalties for pharmaceutical companies. The exact penalties can vary depending on the severity of the breach but can include fines and other sanctions as prescribed by the Act. Additionally, criminal penalties may apply in more severe cases, potentially involving imprisonment for individuals found guilty of significant breaches.