EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 6)
PB 75 of 2015
Authority
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) Determination 2010 (PB 93 of 2010) (the Principal Determination).
The Principal Determination provides for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS).
Purpose
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 of the Act 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) of the Act 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)).
When subsection 85AB(5) of the Act applies, which relates to listed drugs with a single brand combination item on the PBS, the listed drug is not placed on F1 or F2, but on the administrative combination drug list.
This Instrument (the Amending Determination) amends the Principal Determination by adding four new drugs obinutuzumab, pomalidomide, trametinib and vedolizumab to F1. It also moves one already PBS listed drug propranolol from F1 to F2 and removes two listed drugs canagliflozin and cinacalcet from F1. In addition, an administrative amendment is being applied to the PBS listed drug polythylene glycol 400 with propylene glycol changing the description to polyethylene glycol 400 with propylene glycol to match for consistency, the description in the National Health (Listing of Pharmaceutical Benfits) Instrument 2012
(PB 71 of 2012).
Variation and revocation
Unless there is an express power to revoke or vary PB 93 of 2010 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 93 of 2010.
Consultation
The Amending Determination 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.
The Amending Determination Instrument commences on 1 August 2015.
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 2015, enacted by the Minister for Health under the National Health Act 1953, addresses the need for adjustments in the allocation of certain drugs within the Pharmaceutical Benefits Scheme (PBS). This amendment specifically updates the National Health (Listed Drugs on F1 or F2) Determination 2010 by adding and removing drugs from the F1 and F2 formularies. The F1 formulary is designated for single brand drugs, while F2 is for drugs with multiple brands or those within a therapeutic group containing multiple brands. The purpose of this determination is to ensure that the PBS effectively manages the pharmaceutical market by categorising drugs according to their brand and therapeutic group characteristics. The determination process involves extensive consultation with the Pharmaceutical Benefits Advisory Committee and affected pharmaceutical companies to ensure that the changes align with public health needs and economic considerations. This legislative instrument aims to maintain the integrity and efficiency of the PBS by facilitating the appropriate allocation of drugs based on their market characteristics.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 applies to the Pharmaceutical Benefits Scheme (PBS) and pertains to the classification and allocation of listed drugs to the F1 and F2 formularies. F1 is designated for drugs with a single brand, while F2 accommodates drugs with multiple brands or those in therapeutic groups with multiple brand drugs. This legislation, made under the National Health Act 1953, amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adjusting the classification of specific drugs, adding new drugs to F1, moving one drug from F1 to F2, and removing two drugs from F1. Additionally, it includes an administrative amendment to ensure consistency in the description of a drug listed on the PBS. The Amending Determination impacts pharmaceutical companies with drugs listed on the PBS and is subject to consultation with affected parties, including pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee (PBAC), before implementation. This legislative instrument operates at the Commonwealth level and does not specify exclusions or thresholds beyond the criteria for F1 and F2 allocations. The Amending Determination is effective as of 1 August 2015.
Key Provisions
The main operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 6) are found in section 85AB of the National Health Act 1953. This section provides the framework for determining whether a listed drug should be allocated to the F1 or F2 formularies of the Pharmaceutical Benefits Scheme (PBS). F1 is designated for drugs with a single brand, while F2 is for drugs with multiple brands or those in a therapeutic group with other drugs having multiple brands. The amendment specifically adds four new drugs (obinutuzumab, pomalidomide, trametinib, and vedolizumab) to F1, moves propranolol from F1 to F2, and removes canagliflozin and cinacalcet from F1. Additionally, there is an administrative amendment to the description of polyethylene glycol 400 with propylene glycol to ensure consistency with other instruments.
The obligations and requirements imposed by this Act on the parties and entities it governs include ensuring that the criteria for F1 and F2 are met when assigning drugs to these formularies. For a drug to be placed on F1, it must not have any listed brands that are bioequivalent or biosimilar, and it must not have been on F2 the day before the determination comes into effect. Conversely, a drug can only be placed on F2 if it does not meet the criteria for F1. The Minister is empowered to make these determinations through legislative instruments. Pharmaceutical companies and other stakeholders must comply with these allocations and the associated pricing and supply provisions, particularly for drugs on F2.
Breaches of the provisions set out in this Act can lead to various consequences. Under the National Health Act 1953, there are both civil and criminal penalties for non-compliance. Civil penalties may include fines, and in more severe cases, criminal penalties can be imposed, which might involve imprisonment. The exact penalties depend on the nature and severity of the breach, but they are designed to enforce compliance with the statutory requirements and protect the integrity of the PBS. The Act and its accompanying instruments provide the legal basis for these enforcement actions.