EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 98 OF 2011
NATIONAL HEALTH ACT 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (No.13)
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, apixaban to F1. Two drugs; drotrecogin alfa (activated) and peginterferon alfa-2b are delisting from the PBS so will be removed from F1. These changes are effective from 1 January 2012.
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 January 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 2011 (No. 13) was enacted to amend the National Health (Listed drugs on F1 or F2) Determination 2010 under subsection 85AB(1) of the National Health Act 1953. This legislative instrument addresses the need to update the list of drugs assigned to the F1 and F2 formularies within the Pharmaceutical Benefits Scheme (PBS) to ensure that the scheme continues to provide reliable, timely, and affordable access to a wide range of medicines for all Australians. The determination is made by the Minister for Health under the authority granted by the Act and is effective from 1 January 2012. The changes made by this instrument include the addition of apixaban to the F1 formulary and the removal of drotrecogin alfa (activated) and peginterferon alfa-2b from the F1 formulary as they are being delisted from the PBS. This amendment aims to reflect the current therapeutic landscape and ensure the continued efficient operation of the PBS.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (No.13) amends the National Health (Listed drugs on F1 or F2) Determination 2010 to adjust the allocation of certain drugs within the Pharmaceutical Benefits Scheme (PBS). The National Health Act 1953 provides the legislative framework for the PBS, which ensures Australians have reliable, timely, and affordable access to a wide range of medicines. The Act applies to listed drugs, which are declared by the Minister and subject to the provisions of the Act, including assignment to formularies F1 and F2. This instrument specifically adds apixaban to F1 and delists drotrecogin alfa (activated) and peginterferon alfa-2b from the PBS, effective from 1 January 2012. The instrument is applicable nationally and targets pharmaceutical companies with medicines listed on the PBS. The changes are made following consultation with the Pharmaceutical Benefits Advisory Committee, which includes representatives from various relevant interests and professions. The instrument is a legislative instrument under the Legislative Instruments Act 2003.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (No.13) amends the National Health (Listed drugs on F1 or F2) Determination 2010 to adjust the allocation of drugs to the F1 and F2 formularies for the Pharmaceutical Benefits Scheme (PBS) (section 1). Under the National Health Act 1953 (the Act), the Minister is empowered to determine by legislative instrument whether a listed drug is to be allocated to F1 or F2. A drug is placed on F1 if it meets the criteria in subsection 85AB(4) and on F2 if it does not meet the criteria for F1 (subsection 85AB(3)). For a drug to be placed on F1, it must satisfy specific conditions including there being 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. Additionally, the drug must not have been on F2 the day before the determination comes into effect (subsection 85AB(4)).
The obligations imposed by this Act on the parties and entities it governs primarily involve the allocation of drugs to the appropriate formulary based on the criteria set out in the Act. Pharmaceutical companies must ensure their drugs meet the necessary criteria for either F1 or F2 allocation, which involves providing comprehensive information and data for evaluation by the Pharmaceutical Benefits Advisory Committee (PBAC). The Minister, guided by recommendations from the PBAC, determines the formulary allocation of drugs and updates the list of F1 and F2 drugs accordingly. The Act mandates that any changes to the list must be communicated effectively to relevant stakeholders, including pharmaceutical companies and healthcare providers, to ensure compliance and proper implementation.
Failure to comply with the provisions of the Act and the amendments made by this instrument can result in various legal consequences. Although the explanatory statement does not explicitly detail specific offences or penalties, breaches of the Act generally can lead to administrative actions, fines, or other enforcement measures as prescribed by relevant legislation. For instance, incorrect allocation of drugs could result in non-compliance with the PBS guidelines, potentially affecting the availability and pricing of medications for consumers. In severe cases, criminal charges could be brought against individuals or companies that deliberately or negligently fail to adhere to the legislative requirements, leading to potential criminal penalties as stipulated by the broader legislative framework governing health and pharmaceutical regulations in Australia.
In summary, the National Health (Listed drugs on F1 or F2) Amendment Determination 2011 (No.13) provides a framework for updating the allocation of drugs within the PBS, ensuring that medications are appropriately categorized to maintain the integrity and efficiency of the scheme. The obligations placed on pharmaceutical companies and the Minister involve careful assessment and adherence to the criteria for F1 and F2 formularies. While the specific penalties for non-compliance are not detailed in the explanatory statement, breaches of the Act can lead to significant administrative and potentially criminal consequences.