EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 19 OF 2011
NATIONAL HEALTH ACT 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2011(No.2)
Purpose
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) Amendment Determination 2010 (PB 9 of 2011) to correct a typographical error in the title of that instrument.
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.
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).
Subsection 85AB(1) of the Act empowers the Minister to determine by legislative instrument that a listed drug is on either the F1 or F2 formulary. 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.
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.
From 11 October 2010 all formulary allocations were consolidated in legislative instruments made under subsections 85AB(1) and 85AC(1), and the provisions in the Regulations prescribing formulary allocations have been repealed as they were redundant.
Details of this Instrument
PB 9 of 2011 amended the National Health (Listed drugs on F1 or F2) Determination 2010 (PB 93 of 2010) (“the principal instrument”) to place drugs into the F1 or F2 formularies as of 1 February 2011. However, PB 9 of 2011 contained a typographical error in the title of the instrument – the title of PB 9 of 2011 should have been National Health (Listed drugs on F1 or F2) Amendment Determination 2011 instead of National Health (Listed drugs on F1 or F2) Amendment Determination 2010. This instrument amends subsection 1(1) of PB 9 of 2011 to correct this error in the title.
As PB 9 of 2011 is not being remade, and no items in the Schedule to PB 9 of 2011 (which was what actually amended the principal instrument) are being amended, section 46 of the Legislative Instrument Act 2003 does not prevent this instrument from having effect.
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. Each drug may be allocated into F1 or F2 based on the recommendation of the Pharmaceutical Benefits Advisory Committee (PBAC). The 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 February 2011, immediately after the commencement of PB 9 of 2011.
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 2011 (No. 2) was enacted to correct a typographical error in the title of the National Health (Listed drugs on F1 or F2) Amendment Determination 2010. This amendment was made under subsection 85AB(1) of the National Health Act 1953, which provides the legislative basis for the Pharmaceutical Benefits Scheme (PBS) that ensures Australians have access to a wide range of affordable medicines. The PBS, established under Part VII of the Act, allows the Minister to declare drugs and medicinal preparations by legislative instrument and list them on either the F1 or F2 formulary. The F1 formulary is designated for single brand drugs, while the F2 formulary is for drugs with multiple brands or those in a therapeutic group with other multi-brand drugs. This determination is essential to ensure the correct administration of the PBS and the proper classification of listed drugs within the scheme.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (No. 2) amends the National Health (Listed drugs on F1 or F2) Amendment Determination 2010, specifically addressing a typographical error in the title of the latter instrument. The primary focus of these instruments is to manage the allocation of listed drugs to the F1 or F2 formularies under the National Health Act 1953, thereby facilitating the Pharmaceutical Benefits Scheme (PBS). The Act applies to pharmaceutical companies and other entities involved in the supply of medicines listed on the PBS. The jurisdiction of this legislation is national, encompassing all states and territories of Australia. The instruments do not explicitly state exclusions or exemptions but focus on the correct categorisation of drugs within the PBS framework. This legislative instrument is designed to correct an administrative error in the previous instrument without altering the substance of the formulary allocations. The correction of the title ensures that the instruments comply with legislative requirements and accurately reflect the intended scope and application of the National Health Act 1953 in relation to the PBS.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2011(No.2) is a legislative instrument made under subsection 85AB(1) of the National Health Act 1953 (the Act). Its primary purpose is to correct a typographical error in the title of the National Health (Listed drugs on F1 or F2) Amendment Determination 2010 (PB 9 of 2011). The original title should have been National Health (Listed drugs on F1 or F2) Amendment Determination 2011, but it incorrectly referred to the year 2010. This amendment ensures the title accurately reflects the intended year.
The Act governs the Pharmaceutical Benefits Scheme (PBS), which provides Australians with access to medicines. Drugs and medicinal preparations under the Act are declared by the Minister through legislative instruments. These are referred to as listed drugs as defined in subsection 84(1). Under subsection 85AB(1), the Minister can determine by legislative instrument whether a listed drug should be on either the F1 or F2 formulary. F1 is designated for single brand drugs, whereas F2 is for drugs that have multiple brands or are in a therapeutic group with other drugs that have multiple brands. The criteria for a drug to be placed on F1 or F2 are outlined in subsection 85AB(4).
The Act imposes specific obligations on pharmaceutical companies and the Minister. Pharmaceutical companies must consult with the Minister regarding the listing and allocation of their drugs on the PBS. The Minister, in turn, must make determinations based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC comprises two-thirds members from various interests or professions, including consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and medical specialists. These recommendations are made after considering submissions from the pharmaceutical companies.
In terms of consequences for non-compliance, the National Health Act 1953 does not explicitly outline specific offences, penalties, or civil/criminal consequences for breaches related to the listing and allocation of drugs on the F1 or F2 formularies. However, general provisions in the Act may apply, which could lead to enforcement actions or penalties as prescribed by other sections of the Act or related legislation. The specific penalties would depend on the nature and severity of the breach, and they would be determined in accordance with the relevant provisions of Australian law.