EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 71 OF 2011
NATIONAL HEALTH ACT 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (No.10)
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)).
Section 85AB(5)(a) determines that if a drug is in a combination item that section 85AB does not apply. This means while there is only a single brand combination drug on the PBS, the item would remain on the combination drug list. When a second brand of the combination drug lists on the PBS, this would move the combination drug from the combination drug list to F2.
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, clopidogrel with aspirin to F2 following its removal from the combination drug list due to the listing of a second brand. This change is effective from
1 October 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 October 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 Australian Parliament, serves as the foundation for the Pharmaceutical Benefits Scheme (PBS), which ensures that Australians have dependable, timely, and affordable access to a broad range of medicines. The National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (No.10), made under the authority of the Act, amends the principal determination to facilitate the allocation of drugs to the F1 and F2 formularies within the PBS. This amendment specifically adds clopidogrel with aspirin to the F2 formulary following its removal from the combination drug list due to the listing of a second brand. The determination aims to maintain the integrity of the PBS by ensuring that drugs are appropriately classified according to their therapeutic and market characteristics, thereby supporting the overarching policy objective of providing accessible and cost-effective pharmaceutical benefits to all Australians.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (No.10) amends the National Health (Listed drugs on F1 or F2) Determination 2010, and is made under the authority of the National Health Act 1953. This Act provides the legislative basis for the Pharmaceutical Benefits Scheme (PBS) which ensures Australians have access to affordable and reliable medicines. The amendment pertains to the allocation of drugs to the F1 and F2 formularies within the PBS, 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 instrument specifically adds clopidogrel with aspirin to F2, effective from 1 October 2011, following its removal from the combination drug list due to the listing of a second brand. The instrument applies to pharmaceutical companies with medicines listed on the PBS, and consultation involves detailed discussions with the intended responsible person and recommendations from the Pharmaceutical Benefits Advisory Committee, which includes representatives from various relevant interests and professions.
Key Provisions
The main operative sections of this instrument are sections 3 and 4. Section 3 amends the principal determination to allocate clopidogrel with aspirin to F2, effective from 1 October 2011. Section 4 specifies that this instrument is a legislative instrument under the Legislative Instruments Act 2003. The National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (No.10) requires that pharmaceutical companies ensure their listed drugs comply with the criteria for inclusion in either F1 or F2 formularies. This involves meeting the conditions specified in subsection 85AB(4) for F1 and subsection 85AB(3) for F2. Specifically, for F1, there must be no bioequivalent or biosimilar brands of the drug or any other drug in the same therapeutic group. For F2, the drug must not satisfy the criteria for F1. The determination process includes recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and consultations with affected pharmaceutical companies.
The obligations imposed by this Act on the parties it governs primarily involve compliance with the criteria for drug allocation to the F1 and F2 formularies. Pharmaceutical companies must ensure that their listed drugs meet the specific conditions outlined in the Act. This includes thorough consultation and recommendation processes overseen by the PBAC. The Minister's role is to make determinations under section 85AB that allocate drugs to the appropriate formularies, following the recommendations and ensuring the drugs are appropriately listed on the Pharmaceutical Benefits Scheme (PBS). The Act mandates that these determinations be made in accordance with the criteria set forth in the legislation, ensuring that the allocation process is both transparent and evidence-based.
In terms of consequences for breach, the Act does not explicitly detail offences or penalties for non-compliance with the determination of drug formularies. However, the broader legislative framework under the National Health Act 1953 implies that failure to comply with the Act's provisions could result in legal action by the Commonwealth. The severity of the penalties would depend on the specific nature and impact of the non-compliance. The Act's focus on ensuring reliable, timely, and affordable access to medicines suggests that non-compliance could potentially lead to civil or administrative actions, including fines or other penalties as deemed appropriate by the relevant authorities. The precise penalties are not explicitly stated in the text of this instrument, but they would be determined within the broader legislative context.