EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 40 OF 2011
NATIONAL HEALTH ACT 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (No.6)
Purpose
This instrument, made under subsection 85AB(1) of the National Health Act 1953 (the Act), amends the principal determination, the National Health (Listed drugs on F1 or F2) Determination 2010 (PB 93 of 2010) to provide for allocation of drugs to the F1 and F2 formularies for the Pharmaceutical Benefits Scheme (PBS).
Background
Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits. Drugs and medicinal preparations to which Part VII applies are declared by the Minister by legislative instrument under subsection 85(2). These are listed drugs as defined in subsection 84(1).
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 relevantly 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) 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)).
Details of this Instrument
PB 93 of 2010 maintains a list of all F1 and F2 drugs that are currently listed on the PBS. This instrument adds one drug, saxagliptin to F1. It also removes another drug, sulfacetamide, from F1 as it will no longer be listed on the PBS from 1 June 2011.
Consultation
The instrument 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.
General
This instrument commences on 1 June 2011.
This instrument constitutes a legislative instrument for the purpose of the
Legislative Instruments Act 2003.
Overview
The National Health Act 1953, enacted by the Parliament of Australia, serves as the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), which ensures accessible and affordable medicines for Australians. To address the need for a systematic approach to drug allocation within the PBS, the National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (No.6) was introduced. This instrument amends the principal determination to facilitate the allocation of drugs to the F1 and F2 formularies of the PBS. The policy objective is to manage the listing and categorisation of pharmaceutical items to ensure efficient and equitable access to medications. This amendment specifically adjusts the listing of certain drugs, adding saxagliptin to F1 and removing sulfacetamide from F1 as of 1 June 2011, reflecting the dynamic nature of drug availability and therapeutic considerations within the PBS.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (No. 6) pertains to the regulation of pharmaceutical benefits under the National Health Act 1953, specifically amending the National Health (Listed drugs on F1 or F2) Determination 2010. This instrument applies to pharmaceutical companies and entities that manufacture or supply drugs listed under the Pharmaceutical Benefits Scheme (PBS), as well as to the drugs themselves that are subject to the provisions of the Act. The Amendment Determination allocates drugs to the F1 and F2 formularies, where F1 is designated for single brand drugs and F2 for drugs with multiple brands or those within therapeutic groups with other multiple-brand drugs. The instrument operates nationally across Australia, impacting the allocation of drugs listed under the PBS, which is a fundamental component of the Commonwealth's provision of affordable and accessible medicines. There are no specific exclusions or thresholds outlined in this particular instrument, but the allocation criteria for F1 and F2 are stringent and based on bioequivalence and therapeutic grouping. The application and scope of this Act can be further extended or modified through additional subordinate instruments made under the authority of the National Health Act 1953.
Key Provisions
The main operative sections of this instrument, the National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (No.6), are found in sections 2 and 3. Section 2 amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adding saxagliptin to the F1 formulary and removing sulfacetamide from the F1 formulary, effective from 1 June 2011. Section 3 provides the commencement date for the amendment, which is 1 June 2011. These sections outline the changes to the formularies for the Pharmaceutical Benefits Scheme (PBS) and the drugs affected by these changes.
The obligations and requirements imposed by this Act on the parties or entities it governs primarily concern the Pharmaceutical Benefits Advisory Committee (PBAC) and pharmaceutical companies. PBAC must conduct detailed consultations with pharmaceutical companies before making recommendations on the listing and allocation of drugs to the F1 or F2 formularies. Pharmaceutical companies must respond to submissions and provide necessary information to PBAC. The Minister for Health, under subsection 85AB(1) of the National Health Act 1953, has the authority to determine by legislative instrument that a listed drug is on F1 or F2, based on the criteria outlined in subsections 85AB(3) and 85AB(4). The Act also requires that drugs on F2 be subject to statutory price reductions, price disclosure, and a guarantee of supply.
There are no specific offences, penalties, or civil/criminal consequences mentioned in this instrument. However, the National Health Act 1953 includes provisions for penalties and enforcement actions related to breaches of the Act. For example, subsection 103A(1) provides for a penalty of up to $22,200 for contraventions of the Act, and subsection 103A(2) provides for a penalty of up to $111,000 for corporations. These penalties are subject to change based on inflation adjustments and other factors. Additionally, the Act includes provisions for civil and criminal penalties for breaches of the Act, such as providing false or misleading information or engaging in misleading or deceptive conduct.