EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 9)
PB 76 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 one new listed drug eribulin to F1. It also removes one drug polyethylene glycol 400 from F1.
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 October 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. 9) was enacted to amend the National Health (Listed drugs on F1 or F2) Determination 2010, which provides for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The National Health Act 1953 introduced this framework to address the need for a structured system to categorise listed drugs based on their brand and therapeutic group status. The determination is made by the Minister for Health under subsection 85AB(1) of the National Health Act 1953. The policy objective of this legislation is to ensure that drugs are appropriately assigned to either F1 or F2 based on specific criteria, thereby facilitating effective management and access to medications within the PBS.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 amends the National Health (Listed drugs on F1 or F2) Determination 2010, providing for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The Act applies to listed drugs that are allocated to the formularies, and the Amending Determination specifically adds the drug eribulin to F1 and removes polyethylene glycol 400 from F1. The F1 formulary is designated for single brand drugs, while F2 is for drugs with multiple brands or those in a therapeutic group with multiple brands. The geographic reach of this Act is national, applying throughout Australia under the Commonwealth jurisdiction. The Act does not specify any exclusions, exemptions, or thresholds for the application of these formularies. The Minister for Health has the authority to determine the allocation of drugs through legislative instruments, and this process involves detailed consultation with the Pharmaceutical Benefits Advisory Committee and affected pharmaceutical companies. The Amending Determination commences on 1 October 2014, and constitutes a legislative instrument under the Legislative Instruments Act 2003.
Key Provisions
The main operative sections of the National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 9) (the Amending Determination) are subsections 85AB(1) and 85AB(5) of the National Health Act 1953 (the Act), which empower the Minister to determine by legislative instrument that a listed drug is on F1 or F2. 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. The Amending Determination amends the National Health (Listed drugs on F1 or F2) Determination 2010 (the Principal Determination) by adding one new listed drug eribulin to F1 and removing one drug polyethylene glycol 400 from F1. When subsection 85AB(5) of the Act applies, which relates to listed drugs with a single brand combination item on the Pharmaceutical Benefits Scheme (PBS), the listed drug is not placed on F1 or F2, but on the administrative combination drug list.
The Act imposes several obligations and requirements on the parties and entities it governs. Pharmaceutical companies must consult with the intended responsible person before drugs are listed and allocated to formularies, and a recommendation must be received from the Pharmaceutical Benefits Advisory Committee (PBAC). 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 Act also requires that listed drugs on F1 must satisfy certain criteria, including 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.
The Amending Determination includes provisions for offences, penalties, and civil/criminal consequences for breach. However, the Explanatory Statement does not provide specific details on the penalties or consequences for breach of the Act or the Amending Determination. It is important to note that the Amending Determination constitutes a legislative instrument for the purpose of the Legislative Instruments Act 2003, and any breach of the Act or the Amending Determination may result in legal action or other consequences as provided by law. The Amending Determination commences on 1 October 2014.