EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 77 OF 2011
NATIONAL HEALTH ACT 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (No.11)
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, eltrombopag to F1. This change is effective from
1 November 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 November 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. 11) was enacted in 2011 to amend the National Health (Listed Drugs on F1 or F2) Determination 2010, providing for the allocation of drugs to the F1 and F2 formularies for the Pharmaceutical Benefits Scheme (PBS). This instrument was made under subsection 85AB(1) of the National Health Act 1953 by the Minister for Health and is intended to provide a more efficient and effective mechanism for listing drugs on the PBS, thereby enhancing access to affordable medicines for all Australians. This amendment adds eltrombopag to the F1 formulary, effective from 1 November 2011. The determination process involves detailed consultation with relevant pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee, ensuring a balanced and informed approach to drug listing and allocation.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (No.11) applies to pharmaceutical companies with medicines listed on the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. This instrument amends the National Health (Listed drugs on F1 or F2) Determination 2010 to include the drug eltrombopag in the F1 formulary, effective from 1 November 2011. Formulary F1 is designated for single brand drugs that meet specific criteria, including the absence of bioequivalent or biosimilar listed brands within the same therapeutic group. This amendment ensures that eltrombopag, once listed, adheres to the regulations governing F1 drugs, including statutory price reductions, price disclosure, and the guarantee of supply as stipulated by the Act. The instrument also allows for the extension or restriction of its application through subordinate instruments, ensuring that the PBS remains a reliable and affordable source of medicines for all Australians.
Key Provisions
The National Health (Listed Drugs on F1 or F2) Amendment Determination 2011 (No. 11) amends the National Health (Listed Drugs on F1 or F2) Determination 2010 to allocate drugs to the F1 and F2 formularies for the Pharmaceutical Benefits Scheme (PBS). The primary purpose of this instrument, made under subsection 85AB(1) of the National Health Act 1953, is to update the list of drugs on F1 and F2. This change is effective from 1 November 2011 and adds eltrombopag to F1, a formulary intended for single brand drugs. F2, on the other hand, is designated for drugs that have multiple brands or are in a therapeutic group with other drugs having multiple brands, and these drugs are subject to statutory price reductions, price disclosure, and a guarantee of supply.
Under the National Health Act 1953, drugs and medicinal preparations are declared by the Minister to be listed drugs as defined in subsection 84(1). These drugs are then assigned to formularies F1 or F2 based on specific criteria. A drug can be placed on F1 if there are no listed brands of pharmaceutical items that are bioequivalent or biosimilar to the drug, and if the drug was not on F2 the day before the determination comes into effect (subsection 85AB(4)). Conversely, 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)). It is important to note that section 85AB(5)(a) excludes combination items from these criteria, meaning that combination drugs will remain on the combination drug list until a second brand is listed on the PBS, at which point the drug will move to F2.
The obligations imposed by this Act on pharmaceutical companies and other entities include adherence to the criteria for drug allocation to F1 or F2 formularies. Pharmaceutical companies must consult with the intended responsible person and submit recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) before drugs are listed and allocated to formularies. The PBAC, which comprises two-thirds members from relevant interests or professions such as consumers, health economists, and medical specialists, evaluates the drugs based on detailed submissions. Failure to comply with these obligations may result in legal consequences and the potential exclusion of the drug from the PBS.
For breaches of the provisions under the National Health Act 1953, there may be significant civil and criminal consequences. The Act does not specify particular offences or penalties in this context but indicates that non-compliance with the Act's provisions could lead to legal action. Such actions may include fines, penalties, and other civil remedies. The severity of these consequences depends on the nature and extent of the breach, but they underscore the importance of adhering to the legislative requirements for drug allocation to the F1 and F2 formularies.