EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 6)
PB 54 of 2014
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 two new listed drugs aclidinium and betaine to F1. It also moves five drugs capecitabine, metoprolol succinate, omalizumab, sildenafil and tirofiban from F1 to F2.
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 2014.
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 2014 (No. 6) is a legislative instrument made under the authority of the National Health Act 1953. This Act enables the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The primary purpose of this determination is to amend the National Health (Listed drugs on F1 or F2) Determination 2010 by adding two new drugs, aclidinium and betaine, to the F1 formulary and reassigning five existing drugs, capecitabine, metoprolol succinate, omalizumab, sildenafil, and tirofiban, from F1 to F2. The F1 formulary is intended for single brand drugs, while the F2 formulary accommodates drugs with multiple brands or those within a therapeutic group with multiple brands. The determination is subject to statutory requirements for price reductions, price disclosure, and guaranteed supply, as outlined in the Act. This legislative instrument was enacted to address the need for dynamic adjustments in the allocation of drugs within the PBS, ensuring that the scheme remains responsive to therapeutic needs and market changes. The determination was developed following extensive consultation with relevant pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee, which comprises experts from various health-related fields.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 6) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which governs the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. This determination applies to pharmaceutical companies and other entities that supply listed drugs within the scope of the PBS. It has a national jurisdictional reach as it pertains to the Commonwealth's legislative framework for the PBS. The Act specifies that drugs may be assigned to F1, intended for single brand drugs, or F2, which is designated for drugs with multiple brands or those within therapeutic groups with other multi-branded drugs, subject to statutory price reductions, price disclosure, and guaranteed supply provisions. The Amendment Determination specifically adds aclidinium and betaine to F1 and reclassifies capecitabine, metoprolol succinate, omalizumab, sildenafil, and tirofiban from F1 to F2. The Act provides for variations and revocations of the Principal Determination under the Acts Interpretation Act 1901, and the Amendment Determination is subject to consultation processes involving the Pharmaceutical Benefits Advisory Committee and affected pharmaceutical companies before implementation.
Key Provisions
The main operative sections of this legislation are sections 85AB(1), (3), (4) and (5) of the National Health Act 1953. Section 85AB(1) allows the Minister to determine by legislative instrument that a listed drug is on F1 or F2. Section 85AB(3) states that a drug may only be on F2 if it does not satisfy the criteria for F1. Section 85AB(4) sets out the criteria for a drug to be on F1, and section 85AB(5) relates to listed drugs with a single brand combination item on the PBS, which are placed on the administrative combination drug list. The main effect of this legislation is to amend the National Health (Listed drugs on F1 or F2) Determination 2010 by adding two new drugs aclidinium and betaine to F1 and moving five drugs capecitabine, metoprolol succinate, omalizumab, sildenafil and tirofiban from F1 to F2.
The obligations imposed by this legislation on the parties it governs include compliance with the criteria set out in section 85AB(4) for a drug to be on F1, and the requirement for drugs on F2 to be subject to statutory price reductions, price disclosure and guarantee of supply provisions. Pharmaceutical companies with medicines listed on the PBS are also required to consult with the intended responsible person and provide submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) before drugs are listed and allocated to formularies.
There are no explicit offences, penalties, or civil/criminal consequences for breach stated in this legislation. However, failure to comply with the requirements of the National Health Act 1953 and the National Health (Listed drugs on F1 or F2) Determination 2010 may result in enforcement action by the Minister or other relevant authorities. The maximum penalties for contraventions of the Act or the Determination are not specified in this legislation, but may be found in other relevant legislation.